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preserveAspectRatio="none"><path fill="none" stroke="#000" stroke-width="36" stroke-linecap="round" style="fill:#FFF" d="m320,350a153,153 0 1,0-2,2l170,170m-91-117 110,110-26,26-110-110"></path></svg></a><a id="jr-fip-done" class="wsprkl btn" title="Dismiss find">✘</a></nav><nav id="jr-fip-info-p"><a id="jr-fip-prev" class="wsprkl btn" title="Jump to previuos match">◀</a><button id="jr-fip-matches">no matches yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style"><div class="fm-sec bkr_bottom_sep"><div class="bkr_thumb"><a href="https://www.nice.org.uk" title="National Institute for Health and Care Excellence (NICE)" class="img_link icnblk_img" ref="pagearea=logo&targetsite=external&targetcat=link&targettype=publisher"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-niceng215er2-lrg.png" alt="Cover of Evidence review: Optimum prescribing strategies or interventions delivered alongside prescribing" /></a></div><div class="bkr_bib"><h1 id="_NBK580675_"><span itemprop="name">Evidence review: Optimum prescribing strategies or interventions delivered alongside prescribing</span></h1><div class="subtitle">Medicines associated with dependence or withdrawal symptoms: safe prescribing and withdrawal management for adults</div><p><b>Evidence review B</b></p><p><i>NICE Guideline, No. 215</i></p><p class="contrib-group"><h4>Authors</h4><span itemprop="author">National Guideline Centre (UK)</span>.</p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2022 Apr</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-4508-5</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2022.</div></div><div class="bkr_clear"></div></div><div id="niceng215er2.s1"><h2 id="_niceng215er2_s1_">1. Optimum prescribing strategies</h2><div id="niceng215er2.s1.1"><h3>1.1. Review question: What are the optimum prescribing strategies or interventions delivered alongside prescribing, to limit the risk of dependence or withdrawal symptoms?</h3><div id="niceng215er2.s1.1.1"><h4>1.1.1. Introduction</h4><p>It is not possible to predict which individuals will develop dependence on prescribed medicines or who will experience withdrawal symptoms if the medicine is reduced and stopped. Prescribers also vary in their confidence to manage these issues in clinical practice, often depending on previous experience to guide their actions. There may, however, be general strategies which could be applied when prescribing medicines associated with increased risk of dependence and withdrawal. Approaches to ensure safe use of medicines, especially when extended periods of use are necessary or the medicine needs to be stopped, will be considered for this review.</p></div><div id="niceng215er2.s1.1.2"><h4>1.1.2. Summary of the protocol</h4><p>For full details see the review protocol in <a href="#niceng215er2.appa">Appendix A</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab1"><a href="/books/NBK580675/table/niceng215er2.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab1" rid-ob="figobniceng215er2tab1"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab1/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab1/?report=previmg" alt="Table 1. PICO characteristics of review question." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab1"><a href="/books/NBK580675/table/niceng215er2.tab1/?report=objectonly" target="object" rid-ob="figobniceng215er2tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">PICO characteristics of review question. </p></div></div></div><div id="niceng215er2.s1.1.3"><h4>1.1.3. Methods and process</h4><p>This evidence review was developed using the methods and processes described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. Methods specific to this review question are described in the review protocol in <a href="#niceng215er2.appa">appendix A</a> and the methods document.</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng215er2.s1.1.4"><h4>1.1.4. Effectiveness evidence</h4><p>This guideline and this review question relate to the stage in the treatment pathway after a decision has been made to prescribe one of the relevant medicines. This review question looks at the evidence for what the best prescribing strategy is in terms of reducing the risk of or preventing dependence or withdrawal symptoms. This is highlighted in the aims and interventions of the review protocol. Determining which is the most effective treatment for the underlying condition was outside the scope of this guideline. Therefore, this review did not include efficacy and safety studies, unless the aim of the study was also to assess whether one of the prescribing strategies reduced the risk of dependence. Some studies were identified in the literature assessing 2 different prescribing strategies and then a subsequent withdrawal (with the withdrawal schedule being the same in both arms of the study), and reports withdrawal symptoms within the outcomes. These studies did not necessarily have an aim of reducing dependence. However, such studies were included, as they are involving a withdrawal stage, and therefore are more than just efficacy studies. Antidepressants are not considered to be dependence forming, but can cause withdrawal symptoms on withdrawal. The committee agreed if any studies were identified that did report dependence for antidepressants, they would be included.</p><div id="niceng215er2.s1.1.4.1"><h5>1.1.4.1. Included studies</h5><p>Ten studies were included in the review;<a class="bibr" href="#niceng215er2.ref36" rid="niceng215er2.ref36"><sup>36</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref47" rid="niceng215er2.ref47"><sup>47</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref52" rid="niceng215er2.ref52"><sup>52</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref74" rid="niceng215er2.ref74"><sup>74</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref76" rid="niceng215er2.ref76"><sup>76</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref90" rid="niceng215er2.ref90"><sup>90</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref92" rid="niceng215er2.ref92"><sup>92</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref98" rid="niceng215er2.ref98"><sup>98</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref105" rid="niceng215er2.ref105"><sup>105</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref108" rid="niceng215er2.ref108"><sup>108</sup></a> these are summarised by drug class in <a class="figpopup" href="/books/NBK580675/table/niceng215er2.tab2/?report=objectonly" target="object" rid-figpopup="figniceng215er2tab2" rid-ob="figobniceng215er2tab2">Table 2</a> to <a class="figpopup" href="/books/NBK580675/table/niceng215er2.tab5/?report=objectonly" target="object" rid-figpopup="figniceng215er2tab5" rid-ob="figobniceng215er2tab5">Table 5</a> below. Evidence from these studies is summarised in the clinical evidence summaries below (<a class="figpopup" href="/books/NBK580675/table/niceng215er2.tab8/?report=objectonly" target="object" rid-figpopup="figniceng215er2tab8" rid-ob="figobniceng215er2tab8">Table 8</a> to <a class="figpopup" href="/books/NBK580675/table/niceng215er2.tab18/?report=objectonly" target="object" rid-figpopup="figniceng215er2tab18" rid-ob="figobniceng215er2tab18">Table 18</a>).</p><p>Evidence was identified in people prescribed opioids (n=4<a class="bibr" href="#niceng215er2.ref36" rid="niceng215er2.ref36"><sup>36</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref52" rid="niceng215er2.ref52"><sup>52</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref90" rid="niceng215er2.ref90"><sup>90</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref98" rid="niceng215er2.ref98"><sup>98</sup></a>), gabapentinoids (n=2<a class="bibr" href="#niceng215er2.ref47" rid="niceng215er2.ref47"><sup>47</sup></a><sup>, </sup><a class="bibr" href="#niceng215er2.ref74" rid="niceng215er2.ref74"><sup>74</sup></a>), Z-drugs (n=1<a class="bibr" href="#niceng215er2.ref105" rid="niceng215er2.ref105"><sup>105</sup></a>) and antidepressants (n=3<a class="bibr" href="#niceng215er2.ref76" rid="niceng215er2.ref76"><sup>76</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref92" rid="niceng215er2.ref92"><sup>92</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref108" rid="niceng215er2.ref108"><sup>108</sup></a>). No evidence was identified in people prescribed benzodiazepines.</p><p>Prescribing strategies or interventions used to reduce the risk of dependence or withdrawal symptoms included: different dosage regimens (gabapentinoids, n=2; antidepressants, n=2; Z-drugs, n=1),<a class="bibr" href="#niceng215er2.ref47" rid="niceng215er2.ref47"><sup>47</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref74" rid="niceng215er2.ref74"><sup>74</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref76" rid="niceng215er2.ref76"><sup>76</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref92" rid="niceng215er2.ref92"><sup>92</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref105" rid="niceng215er2.ref105"><sup>105</sup></a> providing patient or physician information and education (opioids, n=1),<a class="bibr" href="#niceng215er2.ref98" rid="niceng215er2.ref98"><sup>98</sup></a> adding an extra drug to the prescription (opioids, n=1),<a class="bibr" href="#niceng215er2.ref36" rid="niceng215er2.ref36"><sup>36</sup></a> varying the rate of upward titration (escalating versus stable dose, opioids, n=1),<a class="bibr" href="#niceng215er2.ref90" rid="niceng215er2.ref90"><sup>90</sup></a> the use of mindfulness alongside the prescription (opioids, n=1),<a class="bibr" href="#niceng215er2.ref52" rid="niceng215er2.ref52"><sup>52</sup></a> and class comparison (antidepressants, n=1).<a class="bibr" href="#niceng215er2.ref108" rid="niceng215er2.ref108"><sup>108</sup></a></p><p>Three studies assessed the effectiveness of a prescribing strategy or intervention on the risk of dependence.<a class="bibr" href="#niceng215er2.ref52" rid="niceng215er2.ref52"><sup>52</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref90" rid="niceng215er2.ref90"><sup>90</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref98" rid="niceng215er2.ref98"><sup>98</sup></a> All of these studies were in people taking opioids. For the studies assessing dependence as the outcome, and the effect of a prescribing strategy or intervention on the risk of dependence, it was noted as important that the population did not have dependence at baseline. Therefore, the protocol stated that ideally the population should be initiating the prescribed medicines, or if currently taking it, the majority (at least 80%) shown not to have behaviours related to dependence at baseline. As all of these studies included participants who were already receiving the medication at baseline, the exclusion criteria was checked to ensure that people with behaviours related to dependence were excluded (this is noted in the summary of included studies listed below, see <a class="figpopup" href="/books/NBK580675/table/niceng215er2.tab2/?report=objectonly" target="object" rid-figpopup="figniceng215er2tab2" rid-ob="figobniceng215er2tab2">Table 2</a>).</p><p>When agreeing the protocol, the committee acknowledged that dependence might not be commonly reported as an outcome, as it is difficult to measure. Therefore, any definition of dependence as described by the study authors was accepted, this could include measures indicating problems with dependence, such as early refill requests, shopping behaviour, or measures of medicine misuse</p><p>The seven other studies included in the review were studies assessing the effectiveness of a prescribing strategy or intervention on the risk of withdrawal symptoms: opioids;<a class="bibr" href="#niceng215er2.ref36" rid="niceng215er2.ref36"><sup>36</sup></a> gabapentinoids;<a class="bibr" href="#niceng215er2.ref47" rid="niceng215er2.ref47"><sup>47</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref74" rid="niceng215er2.ref74"><sup>74</sup></a> antidepressants<a class="bibr" href="#niceng215er2.ref76" rid="niceng215er2.ref76"><sup>76</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref92" rid="niceng215er2.ref92"><sup>92</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng215er2.ref108" rid="niceng215er2.ref108"><sup>108</sup></a> and Z-drugs.<a class="bibr" href="#niceng215er2.ref105" rid="niceng215er2.ref105"><sup>105</sup></a></p><p>See also the study selection flow chart in <a href="#niceng215er2.appc">Appendix C</a>, study evidence tables in <a href="#niceng215er2.appd">Appendix D</a>, forest plots in <a href="#niceng215er2.appe">Appendix E</a> and GRADE tables in <a href="#niceng215er2.appf">Appendix F</a>.</p></div><div id="niceng215er2.s1.1.4.2"><h5>1.1.4.2. Excluded studies</h5><p>One Cochrane review was identified as potentially relevant to this review.<a class="bibr" href="#niceng215er2.ref5" rid="niceng215er2.ref5"><sup>5</sup></a> The aim of the Cochrane review was to determine the effect of interventions to optimise overall prescribing for older people living in care homes, rather than reducing dependence or withdrawal symptoms. The population of the Cochrane review was also not limited to people being prescribed one of the five medicines associated with dependence or withdrawal symptoms in the current review protocol. Therefore, this review was not relevant to include.</p><p>See the excluded studies list in <a href="#niceng215er2.appj">Appendix J</a>.</p></div></div><div id="niceng215er2.s1.1.5"><h4>1.1.5. Summary of studies included in the effectiveness evidence</h4><div id="niceng215er2.s1.1.5.1"><h5>1.1.5.1. Opioids</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab2"><a href="/books/NBK580675/table/niceng215er2.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab2" rid-ob="figobniceng215er2tab2"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab2/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab2/?report=previmg" alt="Table 2. Summary of studies included in the evidence review: opioids." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab2"><a href="/books/NBK580675/table/niceng215er2.tab2/?report=objectonly" target="object" rid-ob="figobniceng215er2tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the evidence review: opioids. </p></div></div></div><div id="niceng215er2.s1.1.5.2"><h5>1.1.5.2. Gabapentinoids</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab3"><a href="/books/NBK580675/table/niceng215er2.tab3/?report=objectonly" target="object" title="Table 3" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab3" rid-ob="figobniceng215er2tab3"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab3/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab3/?report=previmg" alt="Table 3. Summary of studies included in the evidence review: gabapentinoids." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab3"><a href="/books/NBK580675/table/niceng215er2.tab3/?report=objectonly" target="object" rid-ob="figobniceng215er2tab3">Table 3</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the evidence review: gabapentinoids. </p></div></div></div><div id="niceng215er2.s1.1.5.3"><h5>1.1.5.3. Z-drugs</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab4"><a href="/books/NBK580675/table/niceng215er2.tab4/?report=objectonly" target="object" title="Table 4" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab4" rid-ob="figobniceng215er2tab4"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab4/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab4/?report=previmg" alt="Table 4. Summary of studies included in the evidence review: Z-drugs." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab4"><a href="/books/NBK580675/table/niceng215er2.tab4/?report=objectonly" target="object" rid-ob="figobniceng215er2tab4">Table 4</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the evidence review: Z-drugs. </p></div></div></div><div id="niceng215er2.s1.1.5.4"><h5>1.1.5.4. Antidepressants</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab5"><a href="/books/NBK580675/table/niceng215er2.tab5/?report=objectonly" target="object" title="Table 5" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab5" rid-ob="figobniceng215er2tab5"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab5/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab5/?report=previmg" alt="Table 5. Summary of studies included in the evidence review: antidepressants." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab5"><a href="/books/NBK580675/table/niceng215er2.tab5/?report=objectonly" target="object" rid-ob="figobniceng215er2tab5">Table 5</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the evidence review: antidepressants. </p></div></div><p>See <a href="#niceng215er2.appd">Appendix D</a> for full evidence tables.</p></div></div><div id="niceng215er2.s1.1.6"><h4>1.1.6. Summary of the effectiveness evidence</h4><div id="niceng215er2.s1.1.6.1"><h5>1.1.6.1. Opioids</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab6"><a href="/books/NBK580675/table/niceng215er2.tab6/?report=objectonly" target="object" title="Table 6" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab6" rid-ob="figobniceng215er2tab6"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab6/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab6/?report=previmg" alt="Table 6. Clinical evidence summary: Risk of Withdrawal Symptoms: Morphine plus Ondansetron vs Morphine plus placebo." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab6"><a href="/books/NBK580675/table/niceng215er2.tab6/?report=objectonly" target="object" rid-ob="figobniceng215er2tab6">Table 6</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Risk of Withdrawal Symptoms: Morphine plus Ondansetron vs Morphine plus placebo. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab7"><a href="/books/NBK580675/table/niceng215er2.tab7/?report=objectonly" target="object" title="Table 7" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab7" rid-ob="figobniceng215er2tab7"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab7/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab7/?report=previmg" alt="Table 7. Clinical evidence summary: Risk of Dependence: MORE vs support group." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab7"><a href="/books/NBK580675/table/niceng215er2.tab7/?report=objectonly" target="object" rid-ob="figobniceng215er2tab7">Table 7</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Risk of Dependence: MORE vs support group. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab8"><a href="/books/NBK580675/table/niceng215er2.tab8/?report=objectonly" target="object" title="Table 8" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab8" rid-ob="figobniceng215er2tab8"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab8/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab8/?report=previmg" alt="Table 8. Clinical evidence summary: Risk of Dependence: Escalating vs stable dose." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab8"><a href="/books/NBK580675/table/niceng215er2.tab8/?report=objectonly" target="object" rid-ob="figobniceng215er2tab8">Table 8</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Risk of Dependence: Escalating vs stable dose. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab9"><a href="/books/NBK580675/table/niceng215er2.tab9/?report=objectonly" target="object" title="Table 9" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab9" rid-ob="figobniceng215er2tab9"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab9/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab9/?report=previmg" alt="Table 9. Clinical evidence summary: Risk of Dependence: Physician education vs physician patient information (opioids)." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab9"><a href="/books/NBK580675/table/niceng215er2.tab9/?report=objectonly" target="object" rid-ob="figobniceng215er2tab9">Table 9</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Risk of Dependence: Physician education vs physician patient information (opioids). </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab10"><a href="/books/NBK580675/table/niceng215er2.tab10/?report=objectonly" target="object" title="Table 10" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab10" rid-ob="figobniceng215er2tab10"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab10/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab10/?report=previmg" alt="Table 10. Clinical evidence summary: Risk of Dependence: Physician education vs usual care." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab10"><a href="/books/NBK580675/table/niceng215er2.tab10/?report=objectonly" target="object" rid-ob="figobniceng215er2tab10">Table 10</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Risk of Dependence: Physician education vs usual care. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab11"><a href="/books/NBK580675/table/niceng215er2.tab11/?report=objectonly" target="object" title="Table 11" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab11" rid-ob="figobniceng215er2tab11"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab11/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab11/?report=previmg" alt="Table 11. Clinical evidence summary: Risk of Dependence: Physician patient information and education vs physician patient information." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab11"><a href="/books/NBK580675/table/niceng215er2.tab11/?report=objectonly" target="object" rid-ob="figobniceng215er2tab11">Table 11</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Risk of Dependence: Physician patient information and education vs physician patient information. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab12"><a href="/books/NBK580675/table/niceng215er2.tab12/?report=objectonly" target="object" title="Table 12" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab12" rid-ob="figobniceng215er2tab12"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab12/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab12/?report=previmg" alt="Table 12. Clinical evidence summary: Risk of Dependence: Physician patient information and education vs physician education." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab12"><a href="/books/NBK580675/table/niceng215er2.tab12/?report=objectonly" target="object" rid-ob="figobniceng215er2tab12">Table 12</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Risk of Dependence: Physician patient information and education vs physician education. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab13"><a href="/books/NBK580675/table/niceng215er2.tab13/?report=objectonly" target="object" title="Table 13" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab13" rid-ob="figobniceng215er2tab13"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab13/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab13/?report=previmg" alt="Table 13. Clinical evidence summary: Risk of Dependence: Physician patient information vs usual care." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab13"><a href="/books/NBK580675/table/niceng215er2.tab13/?report=objectonly" target="object" rid-ob="figobniceng215er2tab13">Table 13</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Risk of Dependence: Physician patient information vs usual care. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab14"><a href="/books/NBK580675/table/niceng215er2.tab14/?report=objectonly" target="object" title="Table 14" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab14" rid-ob="figobniceng215er2tab14"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab14/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab14/?report=previmg" alt="Table 14. Clinical evidence summary: Risk of Dependence: Physician patient information and education vs usual care." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab14"><a href="/books/NBK580675/table/niceng215er2.tab14/?report=objectonly" target="object" rid-ob="figobniceng215er2tab14">Table 14</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Risk of Dependence: Physician patient information and education vs usual care. </p></div></div></div><div id="niceng215er2.s1.1.6.2"><h5>1.1.6.2. Gabapentinoids</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab15"><a href="/books/NBK580675/table/niceng215er2.tab15/?report=objectonly" target="object" title="Table 15" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab15" rid-ob="figobniceng215er2tab15"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab15/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab15/?report=previmg" alt="Table 15. Clinical evidence summary: high vs low dose short-term treatment (gabapentinoids)." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab15"><a href="/books/NBK580675/table/niceng215er2.tab15/?report=objectonly" target="object" rid-ob="figobniceng215er2tab15">Table 15</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: high vs low dose short-term treatment (gabapentinoids). </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab16"><a href="/books/NBK580675/table/niceng215er2.tab16/?report=objectonly" target="object" title="Table 16" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab16" rid-ob="figobniceng215er2tab16"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab16/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab16/?report=previmg" alt="Table 16. Clinical evidence summary: High vs low dose (long-term) gabapentinoids." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab16"><a href="/books/NBK580675/table/niceng215er2.tab16/?report=objectonly" target="object" rid-ob="figobniceng215er2tab16">Table 16</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: High vs low dose (long-term) gabapentinoids. </p></div></div></div><div id="niceng215er2.s1.1.6.3"><h5>1.1.6.3. Z-drugs</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab17"><a href="/books/NBK580675/table/niceng215er2.tab17/?report=objectonly" target="object" title="Table 17" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab17" rid-ob="figobniceng215er2tab17"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab17/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab17/?report=previmg" alt="Table 17. Clinical evidence summary: 20mg zolpidem vs 10mg zolpidem." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab17"><a href="/books/NBK580675/table/niceng215er2.tab17/?report=objectonly" target="object" rid-ob="figobniceng215er2tab17">Table 17</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: 20mg zolpidem vs 10mg zolpidem. </p></div></div></div><div id="niceng215er2.s1.1.6.4"><h5>1.1.6.4. Antidepressants</h5><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab18"><a href="/books/NBK580675/table/niceng215er2.tab18/?report=objectonly" target="object" title="Table 18" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab18" rid-ob="figobniceng215er2tab18"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab18/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab18/?report=previmg" alt="Table 18. Clinical evidence summary: 6mg doxepin vs 3mg doxepin (tricyclic antidepressants)." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab18"><a href="/books/NBK580675/table/niceng215er2.tab18/?report=objectonly" target="object" rid-ob="figobniceng215er2tab18">Table 18</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: 6mg doxepin vs 3mg doxepin (tricyclic antidepressants). </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab19"><a href="/books/NBK580675/table/niceng215er2.tab19/?report=objectonly" target="object" title="Table 19" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab19" rid-ob="figobniceng215er2tab19"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab19/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab19/?report=previmg" alt="Table 19. Clinical evidence summary: 20mg vortioxetine vs 10mg vortioxetine (other antidepressants)." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab19"><a href="/books/NBK580675/table/niceng215er2.tab19/?report=objectonly" target="object" rid-ob="figobniceng215er2tab19">Table 19</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: 20mg vortioxetine vs 10mg vortioxetine (other antidepressants). </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab20"><a href="/books/NBK580675/table/niceng215er2.tab20/?report=objectonly" target="object" title="Table 20" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab20" rid-ob="figobniceng215er2tab20"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab20/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab20/?report=previmg" alt="Table 20. Clinical evidence summary: 10mg vortioxetine vs 5mg vortioxetine (other antidepressants)." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab20"><a href="/books/NBK580675/table/niceng215er2.tab20/?report=objectonly" target="object" rid-ob="figobniceng215er2tab20">Table 20</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: 10mg vortioxetine vs 5mg vortioxetine (other antidepressants). </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab21"><a href="/books/NBK580675/table/niceng215er2.tab21/?report=objectonly" target="object" title="Table 21" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab21" rid-ob="figobniceng215er2tab21"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab21/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab21/?report=previmg" alt="Table 21. Clinical evidence summary: 20mg vortioxetine vs 5mg vortioxetine (other antidepressants)." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab21"><a href="/books/NBK580675/table/niceng215er2.tab21/?report=objectonly" target="object" rid-ob="figobniceng215er2tab21">Table 21</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: 20mg vortioxetine vs 5mg vortioxetine (other antidepressants). </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng215er2tab22"><a href="/books/NBK580675/table/niceng215er2.tab22/?report=objectonly" target="object" title="Table 22" class="img_link icnblk_img figpopup" rid-figpopup="figniceng215er2tab22" rid-ob="figobniceng215er2tab22"><img class="small-thumb" src="/books/NBK580675/table/niceng215er2.tab22/?report=thumb" src-large="/books/NBK580675/table/niceng215er2.tab22/?report=previmg" alt="Table 22. Clinical evidence summary: Sertraline vs Venlafaxine (SSRI / other antidepressants)." /></a><div class="icnblk_cntnt"><h4 id="niceng215er2.tab22"><a href="/books/NBK580675/table/niceng215er2.tab22/?report=objectonly" target="object" rid-ob="figobniceng215er2tab22">Table 22</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Sertraline vs Venlafaxine (SSRI / other antidepressants). </p></div></div><p>See <a href="#niceng215er2.appf">Appendix F</a> for full GRADE tables.</p></div></div><div id="niceng215er2.s1.1.7"><h4>1.1.7. Economic evidence</h4><div id="niceng215er2.s1.1.7.1"><h5>1.1.7.1. Included studies</h5><p>No health economic studies were included.</p></div><div id="niceng215er2.s1.1.7.2"><h5>1.1.7.2. Excluded studies</h5><p>No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.</p><p>See also the health economic study selection flow chart in <a href="#niceng215er2.appg">Appendix G</a>.</p></div></div><div id="niceng215er2.s1.1.8"><h4>1.1.8. Summary of included economic evidence</h4><p>None.</p></div><div id="niceng215er2.s1.1.9"><h4>1.1.9. Economic model</h4><p>This area was not prioritised for new cost-effectiveness analysis.</p></div><div id="niceng215er2.s1.1.10"><h4>1.1.10. Evidence statements</h4><div id="niceng215er2.s1.1.10.1"><h5>1.1.10.1. Economic</h5><ul><li class="half_rhythm"><div>No relevant economic evaluations were identified.</div></li></ul></div></div><div id="niceng215er2.s1.1.11"><h4>1.1.11. The committee's discussion and interpretation of the evidence</h4><div id="niceng215er2.s1.1.11.1"><h5>1.1.11.1. The outcomes that matter most</h5><div id="niceng215er2.s1.1.11.1.1"><h5>Dependence</h5><p>This review aimed to assess the effectiveness of different prescribing strategies (such as the initial prescribing dose or duration), or interventions delivered alongside prescribing, to reduce the risk of the person developing dependence on the prescribed medicine. Therefore, dependence was agreed as a critical outcome. When agreeing the protocol, the committee acknowledged that dependence might not be commonly reported as an outcome, as it is difficult to measure. Therefore, any definition as defined by the study authors was accepted, which could also include measures indicating problems with dependence or addiction, such as early refill requests, shopping behaviour, or measures of medicine misuse.</p><p>The medicines of interest also included antidepressants, which are not considered to be dependence forming, unlike the other included medicines. However, any studies reporting dependence on antidepressants were reported, if identified.</p></div><div id="niceng215er2.s1.1.11.1.2"><h5>Withdrawal</h5><p>Antidepressants are known to cause withdrawal symptoms, therefore the committee were also interested in the effectiveness of the prescribing strategies or interventions on withdrawal symptoms, as a critical outcome. The committee acknowledged that this would also be influenced by other factors such as the withdrawal strategy, as well as the risk from the initial prescribing strategy.</p><p>The other critical outcomes for this review were mortality and health related quality of life. Important outcomes for this review were: use of illicit drugs or alcohol as a replacement to prescribed drugs, non-fatal overdose, patient satisfaction, self-harm or harm to others and symptoms for which the medication was originally prescribed.</p><p>Evidence was identified in people prescribed opioids, gabapentinoids, Z-drugs and antidepressants. No evidence was identified in people prescribed benzodiazepines.</p></div><div id="niceng215er2.s1.1.11.1.3"><h5>Opioids</h5><p>Dependence was reported as opioid medication discontinuation for non-compliance, opioid misuse (on the current opioid misuse measure score, COMM), uncoordinated opioid use and a diagnosis of opioid abuse. Evidence was also available on withdrawal symptoms in people prescribed and withdrawing from opioids plus ondansetron versus opioids plus placebo. None of the other protocol outcomes were reported.</p></div><div id="niceng215er2.s1.1.11.1.4"><h5>Gabapentinoids</h5><p>The only outcome reported was withdrawal symptoms in people prescribed and withdrawing from a higher versus a lower dose.</p></div><div id="niceng215er2.s1.1.11.1.5"><h5>Z-drugs</h5><p>Withdrawal symptoms and mortality were reported in people prescribed and withdrawing from a higher versus a lower dose. None of the other protocol outcomes were reported.</p></div><div id="niceng215er2.s1.1.11.1.6"><h5>Antidepressants</h5><p>The only outcome reported was withdrawal symptoms in people prescribed and withdrawing from either a higher versus a lower dose, or from sertraline versus venlafaxine.</p></div></div><div id="niceng215er2.s1.1.11.2"><h5>1.1.11.2. The quality of the evidence</h5><p>Overall, there was a lack of evidence across all drug classes, with a limited number of prescribing strategies or interventions identified in the literature, and only 1 or 2 outcomes reported for each comparison.</p><div id="niceng215er2.s1.1.11.2.1"><h5>Opioids</h5><p>The quality of evidence for all of the comparisons and outcomes for opioids were of very low or low quality due to risk of bias and imprecision. The main reason for high or very high risk of bias was due to incomplete outcome reporting (a high number of people who dropped out), along with some comparisons and outcomes also being rated as high risk of bias for selection bias or blinding.</p></div><div id="niceng215er2.s1.1.11.2.2"><h5>Gabapentinoids</h5><p>The quality of evidence for a higher versus lower dose, when given for short-term treatment before withdrawal, was of moderate quality for withdrawal symptoms assessed using the physician withdrawal checklist (PWC). The evidence was very low quality for a number of withdrawal symptoms when assessed with the Discontinuation- Emergent Signs and Symptoms checklist (DESS). This was due to evidence being downgraded for risk of bias for all outcomes, and additionally downgraded for imprecision for the DESS withdrawal symptom outcomes.</p><p>For a higher versus lower dose, long term before withdrawal, all of the withdrawal symptoms outcomes were downgraded for both risk of bias and imprecision, and were of low or very low quality. The main reason for high or very high risk of bias was due to selection bias, along with some comparisons and outcomes also being rated as high risk of bias for incomplete outcome reporting.</p></div><div id="niceng215er2.s1.1.11.2.3"><h5>Z-drugs</h5><p>The quality of evidence for the comparison of 20mg or 10mg zolpidem, with subsequent withdrawal, was of moderate quality for the occurrence of withdrawal symptoms, due to risk of bias. For mortality, the evidence was of very low quality due to risk of bias and imprecision. The main reason for high or very high risk of bias was due to selection bias, along with some outcomes also being rated as high risk of bias for blinding and outcome reporting.</p></div><div id="niceng215er2.s1.1.11.2.4"><h5>Antidepressants</h5><p>The quality of evidence for the comparison of 20mg, 10mg, or 5mg vortioxetine was of low quality, due to risk of bias and imprecision for the occurrence of withdrawal symptoms. For the comparison of sertraline versus venlafaxine, a number of withdrawal symptom measures were reported, with the quality of the evidence being low or very low quality, due to risk of bias and imprecision. The quality of evidence for the comparison of 6mg or 3mg doxepin was of very low quality, due to risk of bias and imprecision for withdrawal symptoms. The main reason for high or very high risk of bias was due to selection bias, along with some comparisons and outcomes also being rated as high risk of bias for incomplete outcome reporting or blinding.</p></div></div><div id="niceng215er2.s1.1.11.3"><h5>1.1.11.3. Benefits and harms</h5><div id="niceng215er2.s1.1.11.3.1"><h5>Opioids</h5><p>The committee acknowledged that all the studies reported problems associated with dependence, but that these were signs of misuse or abuse rather than dependence per se. They noted that people can be dependent on medicines without showing any problems of dependence such as misuse. Therefore, the committee interpreted this evidence with caution.</p><p>One study compared morphine plus ondansetron versus morphine plus placebo. The outcomes reported were withdrawal symptoms after a naloxone-induced withdrawal. Therefore, this study differed from the others in that it was an experimentally induced withdrawal. The committee agreed that it was not usual practice in the UK for ondansetron to be prescribed alongside opioids, and that this study was probably testing the hypothesis that 5HT-3 receptor antagonists (such as ondansetron) may help decrease withdrawal symptoms. There was no clinical difference demonstrated between the groups in terms of withdrawal symptoms when assessed with the objective opioid withdrawal scale. There was, however, a clinical benefit of placebo for withdrawal symptoms when assessed with the subjective opioid withdrawal scale. From the available evidence, the committee found no reason to recommend the use of ondansetron alongside prescribing, to reduce the risk of subsequent withdrawal symptoms.</p><p>One study compared MORE (a mindfulness-based intervention) versus the support group. There was no clinical difference in terms of dependence when assessed by the study as opioid misuse (COMM score). This intervention consisted of group mindfulness sessions over 8 weeks. The committee noted the active control condition of the support group in this study which also received 8 weekly group sessions, covering similar themes to the MORE intervention group. The committee agreed that it was likely the control group were receiving benefit from this support group and this may contribute to the lack of difference in effect seen, when compared to the mindfulness intervention in preventing opioid misuse. This was the only study providing evidence for a psychological intervention alongside prescribing. The committee agreed that this was insufficient evidence to inform a recommendation for psychological interventions to be offered alongside prescribing to limit the risk of dependence. However, the committee discussed the importance of providing the person with support and information at the time of prescribing. From committee experience, this is important in setting expectations with the person about what the medicine can and cannot do, but also can help prevent problems with dependence later down the line.</p><p>One study compared escalating versus stable dose. Escalating dose was associated with a clinical benefit in terms of dependence, when assessed by ‘opioid medication discontinuation for non-compliance’. The committee discussed that this was counter-intuitive if the assumption is that the escalating dose group end up on higher doses, as from the committee’s experience, higher doses tend to lead to more problems with dependence. The data from the study suggested that the final morphine equivalent doses only differed by around 10mg between groups at the end of the study, which the committee agreed was not a clinically meaningful difference in dose, and therefore cast doubt on the reliability of comparisons between these two groups. The committee also noted that it would depend on when dose escalations occurred, during the treatment period, and by how much. Starting at a lower dose and slowly increasing the dose may be better than starting on a dose that is too high for the person. One explanation for the benefit of the escalating dose group is about the control the person has over the medicine. If a person has more control over their dose, then they may feel more comfortable staying at a lower dose, as they know the option to increase is available. The committee also noted that increasing opioid doses too fast can have a cumulative effect and cause respiratory depression. Therefore, in addition to the considerations around the best prescribing strategy to reduce the risk of dependence, there may be considerations within condition-specific guidance around the most efficacious doses that reduce the chance of side effects or adverse effects.</p><p>One study compared interventions aimed at the physician responsible for prescribing. The interventions were, providing the physician with patient-specific information, providing the physician with links to education materials, providing the physician with both of these, or usual care. For the majority of these when compared to each other, there was no clinical difference between the groups in terms of development of dependence as assessed by ‘uncoordinated opioid use’ or ‘diagnosis of opioid abuse’. The exception was when providing the physician with both educational materials and patient-specific information, versus usual care. For this comparison there was potentially a clinical benefit from the physician intervention on the subsequent diagnosis of opioid abuse. The committee questioned what the aim of the interventions was, and whether the study was aiming to reduce overall prescribing or influence prescribing behaviour, but that this was not necessarily an intervention to give alongside prescribing intended to limit the individual’s risk of dependence. The committee noted they did not have enough evidence to make a recommendation on education for prescribers. However, the committee agreed that it is important that healthcare professionals prescribe within the limits of their competence and expertise, and that the GMC has guidance on good practice in prescribing which highlights this point.</p><p>No specific recommendations were made on the basis of the evidence for opioids.</p></div><div id="niceng215er2.s1.1.11.3.2"><h5>Gabapentinoids</h5><p>Two studies compared lower (150–300mg/day) versus higher dose (450–600mg/day) pregabalin, for both short-term (6 weeks flexible dose followed by 12 weeks fixed dose) or longer-term treatment (6 weeks flexible dose followed by 24 weeks fixed dose), both followed by a 1-week taper period.</p><p>For the short-term treatment study, there was a clinical benefit of the lower dose for withdrawal symptoms when assessed by the number of people with anxiety on the DESS checklist and the number of people with dizziness on the DESS checklist. There was no clinical difference for the other withdrawal symptoms outcomes including the PWC score, the number of people with symptoms on the DESS checklist, the number of people with rebound anxiety, or the number of people with headache, insomnia or nausea on the DESS checklist.</p><p>For the evidence of longer-term treatment, there was a clinical benefit of the lower dose for withdrawal symptoms when assessed by the number of people with symptoms on the DESS checklist and the number of people with rebound anxiety. However, there was no clinical difference for the other withdrawal symptoms outcomes including the PWC score, or the number of people with headache, insomnia or anxiety on the DESS checklist. The committee agreed this suggests that lower doses could result in a lower risk of withdrawal symptoms and agreed this reflected their experience of risk of both dependence and withdrawal with gabapentinoids. The committee noted that, as with other medicines considered in this review, withdrawal symptoms will be influenced by factors other than the initial prescribing strategy alone, and this evidence should be interpreted with caution. See discussion below for the recommendation on prescribing low doses.</p></div><div id="niceng215er2.s1.1.11.3.3"><h5>Z-drugs</h5><p>One study compared different doses of zolpidem (20mg and 10mg) given for 3 weeks followed by a subsequent withdrawal. There was no clinical difference between groups for withdrawal symptoms. However, it was noted that the study only reported narratively the number of people with ‘no withdrawal symptoms’, which was no one in either group. Indicating that all the participants in both groups experienced at least one withdrawal symptom, but conclusions could not be drawn on whether one group experienced more or less than the other. There was a clinical benefit of the group receiving 10mg of zolpidem for mortality, due to one death from pneumonia (post-treatment) in the 20mg group. The committee agreed they could not draw any firm conclusions on the use of different Z-drug doses from this study and no recommendations were made from this evidence.</p></div><div id="niceng215er2.s1.1.11.3.4"><h5>Antidepressants</h5><p>Three antidepressant studies reported withdrawal symptoms from antidepressants, each was a different comparison and reported a different measure of withdrawal symptom occurrence or severity (for example, total DESS score, BWSQ, rebound insomnia, and the antidepressant discontinuation scale) and therefore these could not be pooled. The committee noted that the antidepressant discontinuation scale was not validated, but that other withdrawal symptom outcomes were available for the relevant comparison. One compared different doses of vortioxetine (20mg, 10mg and 5mg) given for 8 weeks followed by a subsequent 2-week withdrawal period. One compared doxepin 6mg versus 3mg, given for 5 weeks followed by an abrupt withdrawal. Finally, one study compared sertraline with venlafaxine, given for 8 weeks followed by a 2-week taper period. There was no clinical difference in withdrawal symptoms in any of these included studies or comparisons, with one exception; a clinical benefit of sertraline for the number of people experiencing no or minimal discontinuation symptoms as assessed using investigator global assessment when compared to withdrawal from venlafaxine.</p><p>The committee noted that in each of these studies antidepressants were prescribed for a relatively short time period which did not reflect clinical practice where antidepressants would be given for much longer before being withdrawn. Therefore, it was thought likely that the withdrawal symptoms measured in these studies could underestimate occurrence in practice. The committee also acknowledged that other factors would influence withdrawal symptoms, not only the initial prescribing strategy. In particular, the withdrawal or dose reduction strategy would influence the risk of withdrawal symptoms. The committee agreed the withdrawal strategies used in the studies were not reflective of clinical practice, as antidepressants were either withdrawn abruptly or over a short 2-week period. Therefore, the committee did not base any recommendations on the evidence from withdrawal symptoms outcomes alone.</p></div><div id="niceng215er2.s1.1.11.3.5"><h5>Considerations across all medicine classes</h5><p>The committee agreed that it was difficult to base recommendations on the available evidence due to the limited evidence base and the concerns in interpretation. Furthermore, all dependence outcomes were reported by the studies as misuse or abuse outcomes. Therefore, it was difficult to determine which prescribing strategies or interventions may be effective in limiting the risk of dependence. They also noted that the majority of the studies reporting these outcomes of misuse are from the US where there are different prescribing practices and so the evidence was not necessarily generalisable to the UK setting.</p><p>For withdrawal symptoms, the committee also discussed that, at the stage of initial prescribing, the focus is more likely to be on the efficacy of the particular medicine and prescribing strategy, for the given indication. At this stage, the committee agreed it is important to also consider the risk of dependence of that prescribing strategy, but that withdrawal symptoms may be less impacted by the initial prescribing strategy, because if the medicine is reduced and withdrawn safely, this will decrease the risk of withdrawal symptoms. However, it was also noted from committee experience, that prescribing strategies that have a lower risk of dependence (such as prescribing at a lower dose for shorter periods) may also result in less problems with withdrawal. There was also an indication from some of the evidence that prescribing with lower doses was associated with a benefit on withdrawal symptoms outcomes upon subsequent withdrawal.</p><p>There was no evidence identified in the literature on interventions such as educational or support interventions that could be given to the person alongside prescribing, to limit the risks of dependence. The committee agreed that one of the most important aspects in terms of safe prescribing and avoiding future problems with dependence, is to give the person information and support before prescribing, in order to structure expectations. Therefore, the committee made recommendations on the information that should be given before starting treatment, including a management plan that should be given to the person prior to starting treatment. This was based both on the experience and consensus opinion of the committee and supported by evidence review A, the Patient Information and Support chapter of this guideline. For more detail, see the section on Patient Information and Support.</p><p>The committee agreed that although the evidence was limited, there was some indication from the evidence on gabapentinoids that prescribing at a lower dose may reduce the risk of withdrawal symptoms, albeit with the caveats of the limitations in this evidence as described above. Evidence was not available for the effect of prescribed dose on subsequent dependence to the medicine. However, there was some evidence from review E, the Risk Factors evidence review for this guideline demonstrating that higher opioid doses may increase the risk of problems associated with dependence. The committee agreed that this was consistent with their clinical experience that a person should be prescribed the lowest effective dose in order to reduce the risk of developing dependence. This would involve starting at the lowest dose likely to be safe and effective, and having a period of titration and observation to find the person’s lowest effective dose. The committee agreed (by consensus) that there was no reason that this recommendation should not apply to all the medicine classes.</p><p>No evidence was identified in the literature on comparisons of different prescribing durations. From their clinical experience, the committee agreed that longer duration of use of these medicines is more likely to result in dependence. The committee discussed that some people may be on these medicines longer than they need to be. There was also evidence from review E, the Risk Factors chapter of this guideline, that long-term opioid therapy is a risk factor for dependence and abuse related behaviours to opioids (see section on Risk Factors), and that being on a higher daily dose long-term increased the risk further. Based on this evidence and the committee’s consensus, it was agreed that a recommendation should be made for regular reviews, to ensure that the benefits of the medicine continue to outweigh the potential harms, to avoid medicines being used for longer than they are needed and in order to avoid risks of dependence from long-term use. The committee agreed based on consensus that it was important to take particular care during dose adjustments and not to automatically increase dose due to lack of response. They noted that although pharmacological tolerance is a property of the medicines considered, if a person has an initially favourable response which then diminishes, it is rarely helpful to increase the dose to try to restore the clinical benefit. They considered such an approach increases the risk of harms, and the loss of benefit is rarely due to pharmacological tolerance, but due to other factors.</p><p>It was highlighted that for some people long-term use at safe doses can be appropriate if they are beneficial. The committee agreed the trade-off between the risks associated with problematic use or dependence and the clinical benefit the person derives from the medication should determine prescribing decisions and it may be clinically appropriate for medicines to continue being prescribed for as long as they continue to be helpful. It was also noted that within the content of the management plan, regular reviews should pick up when it might be an appropriate time to stop a medicine. Discussions about the continued effectiveness of the medicine should be initiated at the point of initial prescribing and again at each encounter. This should be captured within the management plan. The point was raised that people may assume their prescriber will tell them when a medicine is no longer needed and may not necessarily know themselves. The information given along with the management plan may give people more awareness of this.</p><p>In addition, it was noted that someone should not be given multiple repeat prescriptions or be given a long duration of prescription without review, as this could lead to people remaining on medicines longer than necessary. There was also some qualitative evidence within the Patient Information and Support chapter (Evidence review A) showing that health care professionals emphasised the importance of setting short-term timeframes for the prescription of benzodiazepines. The committee discussed that when there are concerns around a person’s risk of dependence, it would be best practice to give shorter prescriptions. In addition, a shorter duration of prescription may also allow for an early assessment of whether the medicine is effective. However, the committee agreed it wasn’t possible to recommend a minimum length as it would vary according to medicine and condition being treated, therefore, the committee recommended that the duration of each prescription should be given for a duration reflecting the plan for review. Some of the medicines of interest are controlled drugs and the committee discussed that it is also important to highlight that the length of each prescription should be in line with relevant legislation.</p></div></div><div id="niceng215er2.s1.1.11.4"><h5>1.1.11.4. Cost effectiveness and resource use</h5><p>No economic evidence was found for this question.</p><p>The committee decided to make recommendations reflecting best practice when prescribing medicines and emphasised the need for determining the lowest effective dose to minimise the risk of dependence and harms. Higher doses at initial prescription was found in the clinical review to be related to increased withdrawal symptoms for gabapentinoids. This was supported by evidence in the risk factors review, demonstrating dose to be a risk factor for problems associated with dependence.</p><p>The committee noted that there is currently heterogeneity in prescribing strategies across different Trusts and these recommendations should encourage prescribers to adopt best practice. Longer consultations or additional follow-up may be needed to allow for a full discussion of treatments and treatment options when starting or reviewing a medicine. However, encouraging effective discussions, at the time of prescriptions, about risk and benefits could reduce unnecessary prescribing for people who could potentially experience harms, dependence or withdrawal symptoms in the future. This, in turn, should reduce costs to the NHS and ultimately improve its efficiency.</p></div><div id="niceng215er2.s1.1.11.5"><h5>1.1.11.5. Other factors the committee took into account</h5><p>The committee strongly agreed that every effort should be made to reach a shared decision with the person, however there are instances when agreement cannot be reached, and the healthcare professional believes the prescribing is particularly unsafe and is not in the person’s best interest. The committee noted that the prescriber has a professional obligation to not continue something which is unsafe. It was agreed that guidance should be in line with advice on ‘handling patient requests for medicines you don’t think will benefit them’ in the <a href="https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-practice-in-prescribing-and-managing-medicines-and-devices/about-this-guidance" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">General Medical Council guidance: good practice in prescribing and managing medicines and devices</a>. The reasons for the decision should be explained to the person and documented, and the person should be offered a second opinion.</p><p>The committee discussed situations that can occur in clinical practice, such as prescribing at the suggestion of another health care professional, taking over care for or becoming the prescriber of a person already taking a medicine. The committee agreed that the new prescriber should decide if the current medicine and dose are in the best interest of the person. For this decision to be made, it is essential that the health care professional has sufficient knowledge of the person’s health and personal circumstances. This is in line with good practice in prescribing guidance set out by the GMC. Even in cases where continued prescribing is deemed not to be in the person’s best interest, it would not be appropriate to abruptly withdraw the medicine, but rather that careful withdrawal would be advised in line with the recommendations in section 1.5 of this guideline: Withdrawing Medicines associated with dependence and withdrawal symptoms. There were concerns around the anxiety a person could feel if a healthcare professional takes over their prescribing and decides that the medicine should be stopped. To avoid this anxiety, it is important when prescribing is inherited that the person is seen promptly, and the information provided when starting treatment is reiterated to help establish the new therapeutic relationship and employ the principles of shared decision making. It was highlighted that there would be additional considerations if a person was going into prison, and therefore their care was being transferred to a new prescriber.</p><p>The committee emphasised the importance of continuity of care when prescribing recommendations are made in different settings, for example in secondary care with the recommendation to be prescribed in primary care. To facilitate this, they agreed that it is important for prescribers to provide clear information on the management plan and how to follow up. They also agreed that the person should be informed that this is only a recommendation to their primary care prescriber, as their primary care provider may wish to make a decision about whether the prescribed medicine is the best option for the person, potentially based on more in-depth information about the patient from a primary care perspective. In some situations, a medicine may be prescribed in secondary care to be reviewed in primary care. In these cases, it should be explained to the person that the medicine will be reviewed in primary care and may not be prescribed long term. Where primary care prescribers do not agree that a prescription recommended by a specialist is appropriate for prescription in primary care, then this should be discussed with the specialist to agree how the prescribing will be managed. They should involve the person in these discussions and ensure they are made aware if prescribing needs to be delayed while discussions continue.</p><p>The committee discussed that ensuring one person has overall responsibility for the prescribing could be difficult in a fast-flowing environment when people don’t always see the same GP or healthcare professional each time. In cases when the prescriber is unable to review the person, continuity of care is extremely important and there should be a consistent line of communication. The management plan should also be clearly documented in the person’s medical record, setting out aims and directions that everyone can follow as part of a multidisciplinary team. They noted that pharmacists are likely to play a key role in leading prescribing and can help ensure continuity of care in medicines reviews. It was noted that this is discussed in recommendations for structured medicines reviews in the <a href="https://www.nice.org.uk/guidance/ng5/chapter/1-Recommendations#medication-review" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE Medicines Optimisation guideline</a> and so the committee agreed to cross refer to this section of that guideline.</p><p>The committee discussed that take home naloxone was commonly used in people with known current or history or substance misuse and discussed whether this might be a strategy that could be used when prescribing opioids to help prevent problems associated with dependence and withdrawal. However, it was noted that there is no evidence that this is an effective strategy for dependence on prescribed medicines, and although it is a strategy that is beginning to be used in the US, there is much more cross over in the US setting of people with prescription drug dependence and substance misuse problems. Therefore, this is likely to be a context-dependent strategy that is less likely to be relevant in the UK setting. The committee therefore agreed not to include a research recommendation on this topic.</p></div></div><div id="niceng215er2.s1.1.12"><h4>1.1.12. Recommendations supported by this evidence review</h4><p>This evidence review supports recommendations 1.2.7, 1.3.4, 1.3.5, 1.3.7, 1.3.8, 1.3.9, 1.3.10, 1.3.11, 1.3.12, 1.3.13 and 1.3.14. No research recommendations were made from this evidence review. 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AS, Bonar
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EE, Cunningham
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B, Li
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PR, Ives
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R, Deyo
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R, Turner
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JM, Scharf
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H, Fong
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VS, Plante
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Efficacy of gemfibrozil as an adjunct to sertraline in major depressive disorder, a double-blind, randomized, and placebo-controlled clinical trial. Iranian journal of psychiatry. 2021; 16(1):52–59 [<a href="/pmc/articles/PMC8140300/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC8140300</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34054983" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34054983</span></a>]</div></dd></dl></dl></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng215er2.appa"><h3>Appendix A. Review protocols</h3><div id="niceng215er2.appa.s1"><h4>A.1. Review protocol for optimum prescribing strategies or interventions delivered alongside prescribing</h4><p id="niceng215er2.appa.et1"><a href="/books/NBK580675/bin/niceng215er2-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (248K)</span></p></div><div id="niceng215er2.appa.s2"><h4>A.2. Review protocol for health economics</h4><p id="niceng215er2.appa.et2"><a href="/books/NBK580675/bin/niceng215er2-appa-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (156K)</span></p></div></div><div id="niceng215er2.appb"><h3>Appendix B. Literature search strategies</h3><p>This literature search strategy was used for the following review:
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<ul><li class="half_rhythm"><div>Optimum prescribing strategies or interventions delivered alongside prescribing, to limit the risk of dependence on opioids, benzodiazepines, gabapentinoids and Z-drugs or withdrawal symptoms associated with antidepressants</div></li></ul></p><p>The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.<a class="bibr" href="#niceng215er2.ref91" rid="niceng215er2.ref91"><sup>91</sup></a> For more information, please see the Methodology review published as part of the accompanying documents for this guideline.</p><p>Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the search where appropriate and where possible English language limits</p><p id="niceng215er2.appb.et1"><a href="/books/NBK580675/bin/niceng215er2-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 23. Database date parameters and filters used</a><span class="small"> (PDF, 191K)</span></p><div id="niceng215er2.appb.s1"><h4>Medline (Ovid) search terms</h4><p id="niceng215er2.appb.et2"><a href="/books/NBK580675/bin/niceng215er2-appb-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (189K)</span></p></div><div id="niceng215er2.appb.s2"><h4>Embase (Ovid) search terms</h4><p id="niceng215er2.appb.et3"><a href="/books/NBK580675/bin/niceng215er2-appb-et3.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (181K)</span></p></div><div id="niceng215er2.appb.s3"><h4>Cochrane Library (Wiley) search terms</h4><p id="niceng215er2.appb.et4"><a href="/books/NBK580675/bin/niceng215er2-appb-et4.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (126K)</span></p></div><div id="niceng215er2.appb.s4"><h4>Epistemonikos search terms</h4><p id="niceng215er2.appb.et5"><a href="/books/NBK580675/bin/niceng215er2-appb-et5.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (118K)</span></p></div><div id="niceng215er2.appb.s5"><h4>Health and evidence</h4><p id="niceng215er2.appb.et6"><a href="/books/NBK580675/bin/niceng215er2-appb-et6.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (164K)</span></p></div><div id="niceng215er2.appb.s6"><h4>Health Economics literature search strategy</h4><p>Health economic evidence was identified by conducting searches with the terms used in the clinical search for prescription withdrawal and drug types. The NHS Economic Evaluation Database (NHS EED - this ceased to be updated after 31<sup>st</sup> March 2015) and the Health Technology Assessment database (HTA - this ceased to be updated from 31<sup>st</sup> March 2018) were searched via the Centre for Research and Dissemination (CRD). Searches for recent evidence were run on Medline and Embase from 2014 onwards for health economics, and all years for economic modelling and quality of life studies.</p><p id="niceng215er2.appb.et7"><a href="/books/NBK580675/bin/niceng215er2-appb-et7.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 24. Database date parameters and filters used</a><span class="small"> (PDF, 156K)</span></p></div><div id="niceng215er2.appb.s7"><h4>Medline (Ovid) search terms</h4><p id="niceng215er2.appb.et8"><a href="/books/NBK580675/bin/niceng215er2-appb-et8.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (189K)</span></p></div><div id="niceng215er2.appb.s8"><h4>Embase (Ovid) search terms</h4><p id="niceng215er2.appb.et9"><a href="/books/NBK580675/bin/niceng215er2-appb-et9.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (194K)</span></p></div><div id="niceng215er2.appb.s9"><h4>NHS EED and HTA (CRD) search terms</h4><p id="niceng215er2.appb.et10"><a href="/books/NBK580675/bin/niceng215er2-appb-et10.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (166K)</span></p></div></div><div id="niceng215er2.appc"><h3>Appendix C. Effectiveness evidence study selection</h3><p id="niceng215er2.appc.et1"><a href="/books/NBK580675/bin/niceng215er2-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 1: Flow chart of clinical study selection for the review of optimum prescribing strategies or interventions delivered alongside prescribing</a><span class="small"> (PDF, 108K)</span></p></div><div id="niceng215er2.appd"><h3>Appendix D. Effectiveness evidence</h3><p id="niceng215er2.appd.et1"><a href="/books/NBK580675/bin/niceng215er2-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (567K)</span></p></div><div id="niceng215er2.appe"><h3>Appendix E. Forest plots</h3><div id="niceng215er2.appe.s1"><h4>E.1. Opioids</h4><div id="niceng215er2.appe.s1.1"><h5>E.1.1. Morphine plus Ondansetron vs Morphine plus Placebo</h5><p id="niceng215er2.appe.et1"><a href="/books/NBK580675/bin/niceng215er2-appe-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 2: Withdrawal symptoms (OOWS) at 12 months</a><span class="small"> (PDF, 133K)</span></p><p id="niceng215er2.appe.et2"><a href="/books/NBK580675/bin/niceng215er2-appe-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 3: Withdrawal symptoms (SOWS) at 12 months</a><span class="small"> (PDF, 135K)</span></p></div><div id="niceng215er2.appe.s1.2"><h5>E.1.2. MORE vs Support Group</h5><p id="niceng215er2.appe.et3"><a href="/books/NBK580675/bin/niceng215er2-appe-et3.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 22: Dependence on the prescribed medicine (Opioid misuse- assessed with Current Opioid Misuse Measure) at 3-month follow-up</a><span class="small"> (PDF, 153K)</span></p></div><div id="niceng215er2.appe.s1.3"><h5>E.1.3. Escalating vs Stable dose</h5><p id="niceng215er2.appe.et4"><a href="/books/NBK580675/bin/niceng215er2-appe-et4.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 4: Dependence on the prescribed medicine (Medication discontinuation for non-compliance at 12 months)</a><span class="small"> (PDF, 143K)</span></p></div><div id="niceng215er2.appe.s1.4"><h5>E.1.4. Physician education vs Physician patient information</h5><p id="niceng215er2.appe.et5"><a href="/books/NBK580675/bin/niceng215er2-appe-et5.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 5: Dependence on the prescribed medicine (Uncoordinated opioid use* at 91–270 days post intervention)</a><span class="small"> (PDF, 150K)</span></p><p id="niceng215er2.appe.et6"><a href="/books/NBK580675/bin/niceng215er2-appe-et6.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 6: Dependence on the prescribed medicine (Diagnosis of opioid abuse at 91–270 days post intervention)</a><span class="small"> (PDF, 150K)</span></p></div><div id="niceng215er2.appe.s1.5"><h5>E.1.5. Physician education vs usual care (opioids)</h5><p id="niceng215er2.appe.et7"><a href="/books/NBK580675/bin/niceng215er2-appe-et7.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 7: Dependence on the prescribed medicine (Uncoordinated opioid use* at 91–270 days post intervention)</a><span class="small"> (PDF, 145K)</span></p><p id="niceng215er2.appe.et8"><a href="/books/NBK580675/bin/niceng215er2-appe-et8.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 8: Dependence on the prescribed medicine (Diagnosis of opioid abuse at 91–270 days post intervention)</a><span class="small"> (PDF, 145K)</span></p></div><div id="niceng215er2.appe.s1.6"><h5>E.1.6. Physician patient information and education vs Physician patient information (opioids)</h5><p id="niceng215er2.appe.et9"><a href="/books/NBK580675/bin/niceng215er2-appe-et9.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 9: Dependence on the prescribed medicine (Uncoordinated opioid use* at 91–270 days post intervention)</a><span class="small"> (PDF, 145K)</span></p><p id="niceng215er2.appe.et10"><a href="/books/NBK580675/bin/niceng215er2-appe-et10.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 10: Dependence on the prescribed medicine (Diagnosis of opioid abuse at 91–270 days post intervention)</a><span class="small"> (PDF, 125K)</span></p></div><div id="niceng215er2.appe.s1.7"><h5>E.1.7. Physician patient information and education vs Physician education (opioids)</h5><p id="niceng215er2.appe.et11"><a href="/books/NBK580675/bin/niceng215er2-appe-et11.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 11: Dependence on the prescribed medicine (Uncoordinated opioid use* at 91–270 days post intervention)</a><span class="small"> (PDF, 143K)</span></p><p id="niceng215er2.appe.et12"><a href="/books/NBK580675/bin/niceng215er2-appe-et12.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 12: Dependence on the prescribed medicine (Diagnosis of opioid abuse at 91–270 days post intervention)</a><span class="small"> (PDF, 151K)</span></p></div><div id="niceng215er2.appe.s1.8"><h5>E.1.8. Physician patient information vs Usual care (opioids)</h5><p id="niceng215er2.appe.et13"><a href="/books/NBK580675/bin/niceng215er2-appe-et13.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 13: Dependence on the prescribed medicine (Uncoordinated opioid use* at 91–270 days post intervention)</a><span class="small"> (PDF, 143K)</span></p><p id="niceng215er2.appe.et14"><a href="/books/NBK580675/bin/niceng215er2-appe-et14.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 14: Dependence on the prescribed medicine (Diagnosis of opioid abuse at 91–270 days post intervention)</a><span class="small"> (PDF, 143K)</span></p></div><div id="niceng215er2.appe.s1.9"><h5>E.1.9. Physician patient information and education vs Usual care (opioids)</h5><p id="niceng215er2.appe.et15"><a href="/books/NBK580675/bin/niceng215er2-appe-et15.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 15: Dependence on the prescribed medicine (Uncoordinated opioid use* at 91–270 days post intervention)</a><span class="small"> (PDF, 143K)</span></p><p id="niceng215er2.appe.et16"><a href="/books/NBK580675/bin/niceng215er2-appe-et16.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 16: Dependence on the prescribed medicine (Diagnosis of opioid abuse at 91–270 days post intervention)</a><span class="small"> (PDF, 143K)</span></p></div></div><div id="niceng215er2.appe.s2"><h4>E.2. Gabapentinoids</h4><div id="niceng215er2.appe.s2.1"><h5>E.2.1. High vs low dose treatment, short-term (gabapentinoids)</h5><p id="niceng215er2.appe.et17"><a href="/books/NBK580675/bin/niceng215er2-appe-et17.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 2: Withdrawal symptoms (Physician Withdrawal Checklist) at week 5, 1 week after initiating taper</a><span class="small"> (PDF, 132K)</span></p><p id="niceng215er2.appe.et18"><a href="/books/NBK580675/bin/niceng215er2-appe-et18.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 3: Withdrawal symptoms (Physician Withdrawal Checklist) at week 14, week 2 after initiating taper</a><span class="small"> (PDF, 132K)</span></p><p id="niceng215er2.appe.et19"><a href="/books/NBK580675/bin/niceng215er2-appe-et19.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 17: Withdrawal symptoms –People with DESS during the 2 week post taper period (weeks 13 and 14)</a><span class="small"> (PDF, 132K)</span></p><p id="niceng215er2.appe.et20"><a href="/books/NBK580675/bin/niceng215er2-appe-et20.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 18: Withdrawal symptoms – anxiety (DESS) during the 2 week post taper period (weeks 13 and 14)</a><span class="small"> (PDF, 154K)</span></p><p id="niceng215er2.appe.et21"><a href="/books/NBK580675/bin/niceng215er2-appe-et21.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 19: Withdrawal symptoms- dizziness (DESS) during the 2 week post taper period (weeks 13 and 14)</a><span class="small"> (PDF, 143K)</span></p><p id="niceng215er2.appe.et22"><a href="/books/NBK580675/bin/niceng215er2-appe-et22.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 20: Withdrawal symptoms- headache (DESS) during the 2-week post taper period (weeks 13 and 14)</a><span class="small"> (PDF, 143K)</span></p><p id="niceng215er2.appe.et23"><a href="/books/NBK580675/bin/niceng215er2-appe-et23.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 21: Withdrawal symptoms- insomnia (DESS) during the 2-week post taper period (weeks 13 and 14)</a><span class="small"> (PDF, 143K)</span></p><p id="niceng215er2.appe.et24"><a href="/books/NBK580675/bin/niceng215er2-appe-et24.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 22: Withdrawal symptoms- nausea (DESS) during the 2 week post taper period (weeks 13 and 14)</a><span class="small"> (PDF, 143K)</span></p><p id="niceng215er2.appe.et25"><a href="/books/NBK580675/bin/niceng215er2-appe-et25.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 23: Withdrawal symptoms (Rebound anxiety) during the 2 week post taper period (weeks 13 and 14)</a><span class="small"> (PDF, 143K)</span></p></div><div id="niceng215er2.appe.s2.2"><h5>E.2.2. High vs low dose treatment, long-term (gabapentinoids)</h5><p id="niceng215er2.appe.et26"><a href="/books/NBK580675/bin/niceng215er2-appe-et26.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 24: Withdrawal symptoms (Physician Withdrawal Checklist) at week 26 (week 2 after initiating taper)</a><span class="small"> (PDF, 143K)</span></p><p id="niceng215er2.appe.et27"><a href="/books/NBK580675/bin/niceng215er2-appe-et27.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 25: Withdrawal symptoms- People with DESS during the 2-week taper period (weeks 25 and 26)</a><span class="small"> (PDF, 145K)</span></p><p id="niceng215er2.appe.et28"><a href="/books/NBK580675/bin/niceng215er2-appe-et28.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 26: Withdrawal symptoms- anxiety (DESS) during the 2 -week taper period (weeks 25 and 26)</a><span class="small"> (PDF, 145K)</span></p><p id="niceng215er2.appe.et29"><a href="/books/NBK580675/bin/niceng215er2-appe-et29.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 27: Withdrawal symptoms- headache (DESS) during the 2- week taper period (weeks 25 and 26)</a><span class="small"> (PDF, 145K)</span></p><p id="niceng215er2.appe.et30"><a href="/books/NBK580675/bin/niceng215er2-appe-et30.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 28: Withdrawal symptoms- insomnia (DESS) during the 2- week taper period (weeks 25 and 26)</a><span class="small"> (PDF, 154K)</span></p><p id="niceng215er2.appe.et31"><a href="/books/NBK580675/bin/niceng215er2-appe-et31.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 29: Withdrawal symptoms (Rebound anxiety) during 2-week taper period (weeks 25 and 26)</a><span class="small"> (PDF, 143K)</span></p></div></div><div id="niceng215er2.appe.s3"><h4>E.3. Z-drugs</h4><div id="niceng215er2.appe.s3.1"><h5>E.3.1. 20mg Zolpidem vs 10mg Zolpidem (Z-drugs)</h5><p id="niceng215er2.appe.et32"><a href="/books/NBK580675/bin/niceng215er2-appe-et32.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 30: Mortality during the 7-day withdrawal period (22–28 days)</a><span class="small"> (PDF, 144K)</span></p><p id="niceng215er2.appe.et33"><a href="/books/NBK580675/bin/niceng215er2-appe-et33.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 31: Withdrawal symptoms during the 7-day withdrawal period (22–28 days)</a><span class="small"> (PDF, 121K)</span></p></div></div><div id="niceng215er2.appe.s4"><h4>E.4. Antidepressants</h4><div id="niceng215er2.appe.s4.1"><h5>E.4.1. 6mg doxepin vs 3mg doxepin (TCA antidepressants)</h5><p id="niceng215er2.appe.et34"><a href="/books/NBK580675/bin/niceng215er2-appe-et34.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 32: Withdrawal symptoms (rebound insomnia) at 5 weeks</a><span class="small"> (PDF, 132K)</span></p><p id="niceng215er2.appe.et35"><a href="/books/NBK580675/bin/niceng215er2-appe-et35.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 33: Withdrawal symptoms (BWSQ 3 or more new symptoms at 5 weeks)</a><span class="small"> (PDF, 132K)</span></p></div><div id="niceng215er2.appe.s4.2"><h5>E.4.2. 20 mg Vortioxetine qd vs 10 mg Vortioxetine qd (Other antidepressants)</h5><p id="niceng215er2.appe.et36"><a href="/books/NBK580675/bin/niceng215er2-appe-et36.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 34: Withdrawal symptoms (DESS) at week 10</a><span class="small"> (PDF, 132K)</span></p></div><div id="niceng215er2.appe.s4.3"><h5>E.4.3. 10 mg Vortioxetine qd vs 5 mg Vortioxetine qd (Other antidepressants)</h5><p id="niceng215er2.appe.et37"><a href="/books/NBK580675/bin/niceng215er2-appe-et37.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 35: Withdrawal symptoms (DESS) at week 10</a><span class="small"> (PDF, 124K)</span></p></div><div id="niceng215er2.appe.s4.4"><h5>E.4.4. 20 mg Vortioxetine qd vs 5 mg Vortioxetine qd (Other antidepressants)</h5><p id="niceng215er2.appe.et38"><a href="/books/NBK580675/bin/niceng215er2-appe-et38.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 36: Withdrawal symptoms (DESS) at week 10</a><span class="small"> (PDF, 132K)</span></p></div><div id="niceng215er2.appe.s4.5"><h5>E.4.5. Sertraline vs Venlafaxine SR (SSRI and other antidepressants)</h5><p id="niceng215er2.appe.et39"><a href="/books/NBK580675/bin/niceng215er2-appe-et39.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 37: Withdrawal symptoms: Deterioration during taper (weeks 8–10)</a><span class="small"> (PDF, 132K)</span></p><p id="niceng215er2.appe.et40"><a href="/books/NBK580675/bin/niceng215er2-appe-et40.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 38: Worst severity of discontinuation symptoms (investigator global assessment); none (weeks 8–10)</a><span class="small"> (PDF, 132K)</span></p><p id="niceng215er2.appe.et41"><a href="/books/NBK580675/bin/niceng215er2-appe-et41.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 39: Worst severity of discontinuation symptoms (investigator global assessment); minimal (weeks 8–10)</a><span class="small"> (PDF, 131K)</span></p><p id="niceng215er2.appe.et42"><a href="/books/NBK580675/bin/niceng215er2-appe-et42.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 40: Worst severity of discontinuation symptoms (investigator global assessment); mild (weeks 8–10)</a><span class="small"> (PDF, 131K)</span></p><p id="niceng215er2.appe.et43"><a href="/books/NBK580675/bin/niceng215er2-appe-et43.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 41: Worst severity of discontinuation symptoms (investigator global assessment); moderate (weeks 8–10)</a><span class="small"> (PDF, 131K)</span></p><p id="niceng215er2.appe.et44"><a href="/books/NBK580675/bin/niceng215er2-appe-et44.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 42: Worst severity of discontinuation symptoms (investigator global assessment); severe (weeks 8–10)</a><span class="small"> (PDF, 94K)</span></p><p id="niceng215er2.appe.et45"><a href="/books/NBK580675/bin/niceng215er2-appe-et45.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Figure 43: Worst severity of discontinuation symptoms (investigator global assessment); very severe (weeks 8–10)</a><span class="small"> (PDF, 126K)</span></p></div></div></div><div id="niceng215er2.appf"><h3>Appendix F. GRADE tables</h3><div id="niceng215er2.appf.s1"><h4>F.1. Opioids</h4><p id="niceng215er2.appf.et1"><a href="/books/NBK580675/bin/niceng215er2-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 25. Clinical evidence profile: Morphine plus Ondansetron vs Morphine plus placebo (opioids)</a><span class="small"> (PDF, 164K)</span></p><p id="niceng215er2.appf.et2"><a href="/books/NBK580675/bin/niceng215er2-appf-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 26. Clinical evidence profile: MORE vs Support group (opioids)</a><span class="small"> (PDF, 212K)</span></p><p id="niceng215er2.appf.et3"><a href="/books/NBK580675/bin/niceng215er2-appf-et3.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 27. Clinical evidence profile: Escalating vs Stable dose (opioids)</a><span class="small"> (PDF, 212K)</span></p><p id="niceng215er2.appf.et4"><a href="/books/NBK580675/bin/niceng215er2-appf-et4.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 28. Clinical evidence profile: Physician education vs physician patient information (opioids)</a><span class="small"> (PDF, 217K)</span></p><p id="niceng215er2.appf.et5"><a href="/books/NBK580675/bin/niceng215er2-appf-et5.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 29. Clinical evidence profile: Physician education vs usual care (opioids)</a><span class="small"> (PDF, 178K)</span></p><p id="niceng215er2.appf.et6"><a href="/books/NBK580675/bin/niceng215er2-appf-et6.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 30. Clinical evidence profile: Physician patient information and education vs Physician patient information (opioids)</a><span class="small"> (PDF, 216K)</span></p><p id="niceng215er2.appf.et7"><a href="/books/NBK580675/bin/niceng215er2-appf-et7.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 31. Clinical evidence profile: Physician patient information and education vs Physician education (opioids)</a><span class="small"> (PDF, 218K)</span></p><p id="niceng215er2.appf.et8"><a href="/books/NBK580675/bin/niceng215er2-appf-et8.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 32. Clinical evidence profile: Physician patient information vs usual care (opioids)</a><span class="small"> (PDF, 178K)</span></p><p id="niceng215er2.appf.et9"><a href="/books/NBK580675/bin/niceng215er2-appf-et9.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 33. Clinical evidence profile: Physician patient information and education vs Usual care (opioids)</a><span class="small"> (PDF, 216K)</span></p></div><div id="niceng215er2.appf.s2"><h4>F.2. Gabapentinoids</h4><p id="niceng215er2.appf.et10"><a href="/books/NBK580675/bin/niceng215er2-appf-et10.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 34. Clinical evidence profile: High dose pregabalin (short-term) vs low dose pregabalin (short-term)</a><span class="small"> (PDF, 190K)</span></p><p id="niceng215er2.appf.et11"><a href="/books/NBK580675/bin/niceng215er2-appf-et11.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 35. Clinical evidence profile: High dose pregabalin (long-term) vs low dose pregabalin (long-term)</a><span class="small"> (PDF, 185K)</span></p></div><div id="niceng215er2.appf.s3"><h4>F.3. Z-drugs</h4><p id="niceng215er2.appf.et12"><a href="/books/NBK580675/bin/niceng215er2-appf-et12.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 36. Clinical evidence profile: 20mg Zolpidem vs 10mg Zolpidem (Z-drugs)</a><span class="small"> (PDF, 178K)</span></p></div><div id="niceng215er2.appf.s4"><h4>F.4. Antidepressants</h4><p id="niceng215er2.appf.et13"><a href="/books/NBK580675/bin/niceng215er2-appf-et13.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 37. Clinical evidence profile: Doxepin 6mg vs Doxepin 3mg SR (TCA antidepressants)</a><span class="small"> (PDF, 174K)</span></p><p id="niceng215er2.appf.et14"><a href="/books/NBK580675/bin/niceng215er2-appf-et14.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 38. Clinical evidence profile: 20 mg Vortioxetine qd vs 10 mg Vortioxetine qd (Other antidepressants)</a><span class="small"> (PDF, 213K)</span></p><p id="niceng215er2.appf.et15"><a href="/books/NBK580675/bin/niceng215er2-appf-et15.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 39. Clinical evidence profile: 20 mg Vortioxetine qd vs 5 mg Vortioxetine qd (Other antidepressants)</a><span class="small"> (PDF, 214K)</span></p><p id="niceng215er2.appf.et16"><a href="/books/NBK580675/bin/niceng215er2-appf-et16.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 40. Clinical evidence profile: 10 mg Vortioxetine qd vs 5 mg Vortioxetine qd (Other antidepressants)</a><span class="small"> (PDF, 164K)</span></p><p id="niceng215er2.appf.et17"><a href="/books/NBK580675/bin/niceng215er2-appf-et17.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 41. Clinical evidence profile: Sertraline vs Venlafaxine SR (SSRI and SNRI antidepressants)</a><span class="small"> (PDF, 191K)</span></p></div></div><div id="niceng215er2.appg"><h3>Appendix G. Economic evidence study selection</h3><p id="niceng215er2.appg.et1"><a href="/books/NBK580675/bin/niceng215er2-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (179K)</span></p></div><div id="niceng215er2.apph"><h3>Appendix H. Economic evidence tables</h3><p>None.</p></div><div id="niceng215er2.appi"><h3>Appendix I. Health economic model</h3><p>This question was not prioritised for health economic modelling.</p></div><div id="niceng215er2.appj"><h3>Appendix J. Excluded studies</h3><div id="niceng215er2.appj.s1"><h4>J.1. Clinical studies</h4><p id="niceng215er2.appj.et1"><a href="/books/NBK580675/bin/niceng215er2-appj-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Table 42. Studies excluded from the clinical review</a><span class="small"> (PDF, 272K)</span></p></div><div id="niceng215er2.appj.s2"><h4>J.2. Health Economic studies</h4><p>Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2005 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below. See the health economic protocol for more details.</p><p>None.</p></div></div><div id="niceng215er2.appk"><h3>Appendix K. List of medicines to be included</h3><p>This list refers to codes from BNF version 68.</p><p id="niceng215er2.appk.et1"><a href="/books/NBK580675/bin/niceng215er2-appk-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (119K)</span></p></div></div></div><div class="fm-sec"><div><p>Final version</p></div><div><p>Evidence reviews underpinning recommendations 1.2.7, 1.3.4, 1.3.5, 1.3.7, 1.3.8, 1.3.9, 1.3.10, 1.3.11, 1.3.12, 1.3.13, 1.3.14 in the NICE guideline</p><p>These evidence reviews were developed by the National Guideline Centre</p></div><div><p><b>Disclaimer</b>: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.</p><p>Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2022.</div><div class="small"><span class="label">Bookshelf ID: NBK580675</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/35609132" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">35609132</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng215er2tab1"><div id="niceng215er2.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">PICO characteristics of review question</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng215er2.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng215er2.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Inclusion: adults (≥18 years) being initiated on or currently being prescribed medicines associated with dependence or withdrawal symptoms (opioids for chronic pain, benzodiazepines, gabapentinoids, Z-drugs, antidepressants). This will include people being prescribed these medicines either at initiation or being re-prescribed. However, if the population are already taking the medicine, the majority (at least 80%) should be shown not to have behaviours related to dependence at the start of the study (if it is unclear, the study will be excluded).</p>
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<p>
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<b>Stratification</b>
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<ul><li class="half_rhythm"><div>Opioids</div></li><li class="half_rhythm"><div>Benzodiazepines,</div></li><li class="half_rhythm"><div>Gabapentinoids</div></li><li class="half_rhythm"><div>Z-drugs</div></li><li class="half_rhythm"><div>Antidepressants (further stratified by SSRIs, MAOIs, tricyclics, others).</div></li></ul>
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</p>
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</td></tr><tr><th id="hd_b_niceng215er2.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Interventions</th><td headers="hd_b_niceng215er2.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Any prescribing strategy or intervention aimed at reducing the risk of dependence or preventing dependence.</p>
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<p>The interventions listed in the full protocol in <a href="#niceng215er2.appa">Appendix A</a> are examples and not an extensive list.</p>
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</td></tr><tr><th id="hd_b_niceng215er2.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparisons</th><td headers="hd_b_niceng215er2.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Any prescribing strategy compared to another, or to usual care</td></tr><tr><th id="hd_b_niceng215er2.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_niceng215er2.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>HRQOL</div></li><li class="half_rhythm"><div>Mortality</div></li><li class="half_rhythm"><div>Dependence on the prescribed medicine</div></li><li class="half_rhythm"><div>Withdrawal symptoms including rebound symptoms / intensity or duration of withdrawal syndrome</div></li><li class="half_rhythm"><div>Non-fatal overdose</div></li><li class="half_rhythm"><div>Use of illicit or over the counter drugs or alcohol as a replacement to prescribed drugs</div></li><li class="half_rhythm"><div>Patient Satisfaction</div></li><li class="half_rhythm"><div>Self-harm or harm to others</div></li><li class="half_rhythm"><div>Increase in symptoms for which the medication was originally prescribed</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng215er2.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_niceng215er2.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Randomised controlled trials</p>
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<p>Comparative non-randomised or cohort studies</p>
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<p>Systematic review of randomised controlled trials or non-randomised comparative studies.</p>
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</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab2"><div id="niceng215er2.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of studies included in the evidence review: opioids</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_niceng215er2.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng215er2.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention and comparison</th><th id="hd_h_niceng215er2.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><th id="hd_h_niceng215er2.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><th id="hd_h_niceng215er2.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Chu 2018<a class="bibr" href="#niceng215er2.ref36" rid="niceng215er2.ref36"><sup>36</sup></a></p>
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<p>Withdrawal study</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<b>Additional drug</b>
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</p>
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<p>
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<b>Morphine plus ondansetron</b>
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</p>
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<p>Vs</p>
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<p>
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<b>Morphine plus placebo</b>
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</p>
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<p>10 days taper on, 20 days maintenance and 10 days taper off</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Low back pain</p>
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<p>Status at start of study: mixture of existing opioid and initiating medicine (7 had current chronic opioid use)</p>
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<p>Dependence at baseline: n/a</p>
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<p>In the past 5 years 21/48 were opioid naïve 7 had current chronic opioid use</p>
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<p>N= 76</p>
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<p>Age: Mean (SD): 39.3 (11.2).</p>
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<p>USA</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Objective Opioid Withdrawal Scale (OOWS)</p>
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<p>Subjective Opioid Withdrawal Scale (SOWS)</p>
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<p>At 40 days</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Taper: IV naloxone was used to induce acute withdrawal</p>
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<p>Baseline data only available for study completers (n=48).</p>
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<p>Baseline opioid dosage (7 patients) shows marked difference between groups- likely to affect findings.</p>
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</td></tr><tr><td headers="hd_h_niceng215er2.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Garland 2019<a class="bibr" href="#niceng215er2.ref52" rid="niceng215er2.ref52"><sup>52</sup></a></p>
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<p>Dependence study</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<b>Mindfulness- Orientated Recovery Enhancement (MORE)</b>
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</p>
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<p>Vs</p>
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<p>
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<b>Support group</b>
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</p>
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<p>14 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Chronic non-cancer pain</p>
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<p>Status at start of study: all were taking opioids for analgesia daily or nearly every day for at least the past 90 days</p>
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<p>Dependence at baseline: COMM score <13 only included</p>
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<p>N= 95</p>
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<p>Age: - Mean (SD): 56.8 (11.7)</p>
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<p>USA</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Dependence on the prescribed medicine: misuse (Current Opioid Misuse Measure- COMM)</p>
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<p>At 3 months</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Attempt made by the study to avoid dependence on the prescribed medicine at baseline by only including people with COMM score <13 (i.e., people without opioid misuse, as this is a validated cut- off point to identify opioid misuse among chronic pain patients).</td></tr><tr><td headers="hd_h_niceng215er2.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Naliboff 2011<a class="bibr" href="#niceng215er2.ref90" rid="niceng215er2.ref90"><sup>90</sup></a></p>
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<p>Dependence study</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<b>Escalating dose</b>
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</p>
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<p>Vs</p>
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<p>
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<b>Stable dose</b>
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</p>
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<p>12–13-month follow-up</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Chronic non-cancer pain.</p>
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<p>Status at start of study: all participants were using opioids</p>
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<p>Dependence at baseline: Addiction Behaviours Checklist (ABC) 1.6 and 1.5 (scale of 0–20) at baseline Excluded current diagnosis of, or history of, substance abuse</p>
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<p>N= 140</p>
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<p>Age 52.6 (7.48) years</p>
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<p>94% male</p>
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<p>USA</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Dependence on the prescribed medicine (Opioid medication discontinuation for non-compliance)</p>
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<p>At 12–13 months</p>
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</td><td headers="hd_h_niceng215er2.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Unclear whether <20% had dependence at baseline, but baseline values for the Addiction Behaviours Checklist (ABC) score are provided, and the mean score is below the threshold of 3 for flagging possible opioid misuse. ABC baseline scores: stable dose: 1.6 (2.1); escalating dose: 1.5 (2.0).</p>
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<p>47% had a history of substance-related (excluding alcohol) disorder</p>
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<p>65% history of alcohol related disorder</p>
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<p>40% history of both substance-related and alcohol related disorder</p>
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</td></tr><tr><td headers="hd_h_niceng215er2.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Pasquale 2017<a class="bibr" href="#niceng215er2.ref98" rid="niceng215er2.ref98"><sup>98</sup></a></p>
|
|
<p>Dependence study</p>
|
|
</td><td headers="hd_h_niceng215er2.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p><b>Physician received patient specific information</b> (opioid utilization, pain diagnoses etc.)</p>
|
|
<p>Vs</p>
|
|
<p><b>Physicians given links to educational materials</b> (diagnosis and management of pain)</p>
|
|
<p>Vs</p>
|
|
<p>
|
|
<b>Physician given patient information and education</b>
|
|
</p>
|
|
<p>Vs</p>
|
|
<p>
|
|
<b>Usual care</b>
|
|
</p>
|
|
<p>Follow up: 91–270 days post intervention</p>
|
|
</td><td headers="hd_h_niceng215er2.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Physician/patient clusters</p>
|
|
<p>Status at start of study: Enrolment in MAPD plan with ≥1 claim for opioid prescription (July 2012-April 2014), ≥180 days continuous enrolment pre index</p>
|
|
<p>Dependence at baseline: Excluded patients diagnosed with opioid abuse dependence (ICD codes) or if diagnosed with opioid abuse or dependence during 180 days prior to intervention</p>
|
|
<p>N=2391 (Patients were grouped into mutually exclusive patient-physician clusters, stratified by size and geographic region.)</p>
|
|
<p>Age, range of means 57.3 (10.6) to 58.7 (11.8) years</p>
|
|
<p>USA</p>
|
|
</td><td headers="hd_h_niceng215er2.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
|
|
<ul><li class="half_rhythm"><div>Uncoordinated opioid use (>3 opioid prescription fills of any ingredient written by ≥3 prescribers within any 90-day period)</div></li><li class="half_rhythm"><div>Diagnosis of opioid abuse</div></li></ul>
|
|
|
|
<p>At 91–270 days follow-up</p>
|
|
</td><td headers="hd_h_niceng215er2.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Attempt made by the study to avoid dependence on opioids at baseline by excluding people with a diagnosis of opioid abuse or dependence. Unclear if this would only include abuse or dependence on illicit opioids, and therefore unclear if there may have been some undiagnosed dependence on the prescribed medicine at baseline.</p>
|
|
<p>Risk that some participants were using opioids for acute pain conditions may have been included</p>
|
|
<p>No adequate adjustment for cluster differences within intervention groups only differences between intervention arms.</p>
|
|
</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab3"><div id="niceng215er2.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Summary of studies included in the evidence review: gabapentinoids</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab3_lrgtbl__"><table><thead><tr><th id="hd_h_niceng215er2.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng215er2.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention and comparison</th><th id="hd_h_niceng215er2.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><th id="hd_h_niceng215er2.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><th id="hd_h_niceng215er2.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Feltner 2003<a class="bibr" href="#niceng215er2.ref47" rid="niceng215er2.ref47"><sup>47</sup></a></p>
|
|
<p>Withdrawal study</p>
|
|
</td><td headers="hd_h_niceng215er2.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>High dose pregabalin (200mg tid (600mg/day))</b>
|
|
</p>
|
|
<p>Vs</p>
|
|
<p>
|
|
<b>Low dose pregabalin (50mg tid (150mg/day))</b>
|
|
</p>
|
|
<p>4 weeks treatment (short term), 1 week taper</p>
|
|
</td><td headers="hd_h_niceng215er2.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Generalised Anxiety Disorder (GAD)</p>
|
|
<p>Status at start of study: no details on existing medication therefore no information about whether any of the participants had previously used pregabalin.</p>
|
|
<p>Dependence at baseline: n/a</p>
|
|
<p>N= 271 total, 136 included in this review (4-arm trial, of which only 2 arms were relevant for the current review)</p>
|
|
<p>Age: Mean (SD): Pregabalin 50mg group: 37.9 (10.9); Pregabalin 200mg group: 36.3 (10.9).</p>
|
|
<p>USA</p>
|
|
</td><td headers="hd_h_niceng215er2.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Withdrawal symptoms: (Physician’s Withdrawal Checklist (PWC)</p>
|
|
<p>At 5 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Taper details: 1 week</p>
|
|
<p>Z-drug allowed if required during study, but not on night before assessments.</p>
|
|
</td></tr><tr><td headers="hd_h_niceng215er2.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Kasper 2014<a class="bibr" href="#niceng215er2.ref74" rid="niceng215er2.ref74"><sup>74</sup></a></p>
|
|
<p>Withdrawal study</p>
|
|
</td><td headers="hd_h_niceng215er2.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p><b>High dose pregabalin 450–600mg/d</b> (short/long term)</p>
|
|
<p>Vs</p>
|
|
<p><b>Low dose pregabalin 150–300mg/d</b> (short/ long term)</p>
|
|
<p>Initiation and withdrawal of medication (flexible dose for 6 weeks, followed by fixed dose)</p>
|
|
<p>12 (short term) and 24 (long term) weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Primary diagnosis of GAD</p>
|
|
<p>Status at start of study: initiating medication (people with prior exposure to pregabalin were excluded.)</p>
|
|
<p>Dependence at baseline: n/a</p>
|
|
<p>N= 139</p>
|
|
<p>Age: mean 59 (11.4) years</p>
|
|
<p>60 centres in 16 countries</p>
|
|
</td><td headers="hd_h_niceng215er2.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>PWC</p>
|
|
<p>Discontinuation- Emergent Signs and Symptoms (DESS)</p>
|
|
<p>Rebound anxiety (increase in symptoms for which the medication was originally prescribed)</p>
|
|
</td><td headers="hd_h_niceng215er2.tab3_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Taper details: 1-week double-blind taper schedule; if a patient experienced severe discontinuation symptoms during the taper periods and up to 7 days afterwards could be provided with a more gradual ‘rescue’ taper, extending the taper to 4 weeks while maintaining the blind. The same taper was used for all patients, regardless of when treatment was discontinued.</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab4"><div id="niceng215er2.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">Summary of studies included in the evidence review: Z-drugs</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab4_lrgtbl__"><table><thead><tr><th id="hd_h_niceng215er2.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng215er2.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention and comparison</th><th id="hd_h_niceng215er2.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><th id="hd_h_niceng215er2.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><th id="hd_h_niceng215er2.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Shaw 1992<a class="bibr" href="#niceng215er2.ref105" rid="niceng215er2.ref105"><sup>105</sup></a></p>
|
|
<p>Withdrawal study</p>
|
|
</td><td headers="hd_h_niceng215er2.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>High dose: 20mg Zolpidem</b>
|
|
</p>
|
|
<p>Vs</p>
|
|
<p>
|
|
<b>Low dose: 10mg Zolpidem</b>
|
|
</p>
|
|
<p>3–14-day washout, 7-day placebo, 21 days treatment, 7 days placebo (withdrawal)</p>
|
|
</td><td headers="hd_h_niceng215er2.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Older people (65–85 years) with insomnia</p>
|
|
<p>Status at start of study: initiating treatment. 84.9% had prior treatment for insomnia, the most frequent was temazepam</p>
|
|
<p>Dependence at baseline: n/a</p>
|
|
<p>N=119 (n=80 in 2 arms, placebo arm excluded)</p>
|
|
<p>Age 74.9 (1.0) & 72.9 (1.0) years</p>
|
|
<p>Unknown country</p>
|
|
</td><td headers="hd_h_niceng215er2.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Mortality</p>
|
|
<p>Withdrawal symptoms</p>
|
|
<p>During the 7-day withdrawal period</p>
|
|
</td><td headers="hd_h_niceng215er2.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Taper: 7 days placebo (abrupt discontinuation of z-drug)</p>
|
|
<p>Majority of participants had been hospitalised for a number of years.</p>
|
|
<p>Majority of patients were taking concomitant drugs likely to have an effect on sleep.</p>
|
|
</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab5"><div id="niceng215er2.tab5" class="table"><h3><span class="label">Table 5</span><span class="title">Summary of studies included in the evidence review: antidepressants</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab5/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab5_lrgtbl__"><table><thead><tr><th id="hd_h_niceng215er2.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng215er2.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention and comparison</th><th id="hd_h_niceng215er2.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><th id="hd_h_niceng215er2.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><th id="hd_h_niceng215er2.tab5_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Krystal 2011<a class="bibr" href="#niceng215er2.ref76" rid="niceng215er2.ref76"><sup>76</sup></a></p>
|
|
<p>Class: antidepressants (TCA)</p>
|
|
<p>Withdrawal study</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p><b>6 mg doxepin</b>.</p>
|
|
<p>Vs</p>
|
|
<p>
|
|
<b>3 mg doxepin</b>
|
|
</p>
|
|
<p>Initiation and withdrawal of medication</p>
|
|
<p>5 weeks treatment and abrupt discontinuation</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Primary insomnia.</p>
|
|
<p>Status at start of study: initiating medication</p>
|
|
<p>Dependence at baseline: n/a</p>
|
|
<p>N=229</p>
|
|
<p>age: Mean (SD): Doxepin 3mg: 45.5 (10.6), Doxepin 6mg: 44.2 (11.1)</p>
|
|
<p>USA</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Increase in symptoms for which the medicine was originally prescribed -rebound insomnia.</p>
|
|
<p>Withdrawal symptoms (≥3 new symptoms on Benzodiazepine Withdrawal Symptom Questionnaire-BWSQ.</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Taper: Abrupt discontinuation with placebo for 2 days.</p>
|
|
<p>Mean BWSQ was reported by the study without variance, unable to analyse.</p>
|
|
</td></tr><tr><td headers="hd_h_niceng215er2.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Nishimura 2018<a class="bibr" href="#niceng215er2.ref92" rid="niceng215er2.ref92"><sup>92</sup></a></p>
|
|
<p>Class: Antidepressants (SSRI)</p>
|
|
<p>Withdrawal study</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>5mg Vortioxetine</b>
|
|
</p>
|
|
<p>Vs</p>
|
|
<p>
|
|
<b>10mg Vortioxetine</b>
|
|
</p>
|
|
<p>Vs</p>
|
|
<p>
|
|
<b>20mg Vortioxetine</b>
|
|
</p>
|
|
<p>8-week intervention, 2-week discontinuation period</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Primary diagnosis of Major Depressive Disorder (MDD),</p>
|
|
<p>Status at start of study: unclear previous medication but this did not include Vortioxetine</p>
|
|
<p>Dependence at baseline: n/a</p>
|
|
<p>N=600 (n=448 in 3 arms, placebo arm excluded)</p>
|
|
<p>Age 44.4 (11.54) years</p>
|
|
<p>Multiple countries</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
|
|
<ul><li class="half_rhythm"><div>Withdrawal symptoms (DESS)</div></li></ul>
|
|
|
|
<p>At week 10</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unclear method of scoring used for the DESS</td></tr><tr><td headers="hd_h_niceng215er2.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Sir 2005<a class="bibr" href="#niceng215er2.ref108" rid="niceng215er2.ref108"><sup>108</sup></a></p>
|
|
<p>Class: Antidepressants (SSRI and SNRI)</p>
|
|
<p>Withdrawal study</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>Sertraline (50–150mg/ day)</b>
|
|
</p>
|
|
<p>Vs</p>
|
|
<p>
|
|
<b>Venlafaxine XR (75–225mg/day)</b>
|
|
</p>
|
|
<p>8-week intervention, 2-week taper</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Major depression (diagnosis made using the Mini International Neuropsychiatric Interview (MINI) 5.0.0)</p>
|
|
<p>Status at start of study: initiation of medication (excluded those with a history of non-response to either study drug)</p>
|
|
<p>Dependence at baseline: n/a</p>
|
|
<p>N=163</p>
|
|
<p>Age - Mean (SD): 37.0 (12.9).</p>
|
|
<p>Turkey and Australia</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Deterioration during taper period (Antidepressant Discontinuation Scale, ADDS).</p>
|
|
<p>Worst severity of discontinuation symptoms (investigator global assessment) rated none, minimal, mild, moderate, severe or very severe).</p>
|
|
<p>At weeks 8–10 (taper period)</p>
|
|
</td><td headers="hd_h_niceng215er2.tab5_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Taper: 2 weeks</p>
|
|
<p>ADDS is an unvalidated scale Unclear if the investigators rating is added to the total intensity score (risk of double counting)</p>
|
|
</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab6"><div id="niceng215er2.tab6" class="table"><h3><span class="label">Table 6</span><span class="title">Clinical evidence summary: Risk of Withdrawal Symptoms: Morphine plus Ondansetron vs Morphine plus placebo</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab6/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab6_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab6_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab6_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab6_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab6_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab6_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab6_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab6_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab6_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab6_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab6_1_1_1_5" id="hd_h_niceng215er2.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Morphine+ placebo</th><th headers="hd_h_niceng215er2.tab6_1_1_1_5" id="hd_h_niceng215er2.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Morphine+ Ondansetron</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Withdrawal Symptoms (OOWS)</p>
|
|
<p>assessed with: Objective Opioid Withdrawal Scale</p>
|
|
<p>Scale from: 0 to 13</p>
|
|
<p>follow up: 40 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">48 (1 RCT)</td><td headers="hd_h_niceng215er2.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab6_1_1_1_5 hd_h_niceng215er2.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean OOWS score was 4.2</td><td headers="hd_h_niceng215er2.tab6_1_1_1_5 hd_h_niceng215er2.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 0.3 higher (1.09 lower to 1.69 higher)</td></tr><tr><td headers="hd_h_niceng215er2.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Withdrawal Symptoms (SOWS)</p>
|
|
<p>assessed with: Subjective Opioid Withdrawal Scale</p>
|
|
<p>Scale from: 0 to 64</p>
|
|
<p>follow up: 40 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">48 (1 RCT)</td><td headers="hd_h_niceng215er2.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab6_1_1_1_5 hd_h_niceng215er2.tab6_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean SOWS score was 12</td><td headers="hd_h_niceng215er2.tab6_1_1_1_5 hd_h_niceng215er2.tab6_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 4.4 higher (2.24 lower to 11.04 higher)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab6_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.
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|
</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab6_2"><p class="no_margin">Downgraded by 2 increments as the confidence interval crossed 2 MIDs. MID for OOWS was 0.325 and MID for SOWS was 0.9 (0.5* median baseline SDs of intervention and control groups).</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab7"><div id="niceng215er2.tab7" class="table"><h3><span class="label">Table 7</span><span class="title">Clinical evidence summary: Risk of Dependence: MORE vs support group</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab7/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab7_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab7_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab7_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab7_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab7_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab7_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab7_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab7_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab7_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab7_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab7_1_1_1_5" id="hd_h_niceng215er2.tab7_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Support group</th><th headers="hd_h_niceng215er2.tab7_1_1_1_5" id="hd_h_niceng215er2.tab7_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with MORE</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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|
<p>Dependence on the prescribed drug</p>
|
|
<p>assessed with: Opioid misuse (Current Opioid Misuse Measure: COMM; 17 items rated on a 5-point Likert scale 0–4; higher values = worse outcome)</p>
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|
<p>follow up: 3 months</p>
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|
</td><td headers="hd_h_niceng215er2.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">95 (1 RCT)</td><td headers="hd_h_niceng215er2.tab7_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab7_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab7_1_1_1_5 hd_h_niceng215er2.tab7_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean dependence on the prescribed drug was 9.08</td><td headers="hd_h_niceng215er2.tab7_1_1_1_5 hd_h_niceng215er2.tab7_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 1.36 lower (3.5 lower to 0.78 higher)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab7_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab7_2"><p class="no_margin">Downgraded by 1 increment as the CI crossed 1 MID. MID calculated by 0.5× median of baseline SD for intervention and control groups. Calculated MID was 1.36</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab8"><div id="niceng215er2.tab8" class="table"><h3><span class="label">Table 8</span><span class="title">Clinical evidence summary: Risk of Dependence: Escalating vs stable dose</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab8/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab8_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab8_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab8_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab8_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab8_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab8_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab8_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab8_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab8_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab8_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab8_1_1_1_5" id="hd_h_niceng215er2.tab8_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with stable dose</th><th headers="hd_h_niceng215er2.tab8_1_1_1_5" id="hd_h_niceng215er2.tab8_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Escalating dose</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab8_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed drug</p>
|
|
<p>assessed with: Opioid medication discontinuation for non-compliance</p>
|
|
<p>follow up: 12 months</p>
|
|
</td><td headers="hd_h_niceng215er2.tab8_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">140 (1 RCT)</td><td headers="hd_h_niceng215er2.tab8_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab8_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.79 (0.46 to 1.38)</td><td headers="hd_h_niceng215er2.tab8_1_1_1_5 hd_h_niceng215er2.tab8_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">301 per 1,000</td><td headers="hd_h_niceng215er2.tab8_1_1_1_5 hd_h_niceng215er2.tab8_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">63 fewer per 1,000 (163 fewer to 115 more)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab8_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab8_2"><p class="no_margin">Downgraded by 2 increments as the confidence interval crossed 2 MIDs. The MID for dichotomous outcomes was 0.8 and 1.25.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab9"><div id="niceng215er2.tab9" class="table"><h3><span class="label">Table 9</span><span class="title">Clinical evidence summary: Risk of Dependence: Physician education vs physician patient information (opioids)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab9/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab9_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab9_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab9_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab9_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab9_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab9_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab9_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab9_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab9_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab9_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab9_1_1_1_5" id="hd_h_niceng215er2.tab9_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with physician patient information</th><th headers="hd_h_niceng215er2.tab9_1_1_1_5" id="hd_h_niceng215er2.tab9_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Physician education</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab9_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: uncoordinated opioid use (>3 opioid prescription fills of any ingredient written by ≥3 prescribers within any 90-day period)</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab9_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">790 (1 RCT)</td><td headers="hd_h_niceng215er2.tab9_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab9_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.08 (0.81 to 1.43)</td><td headers="hd_h_niceng215er2.tab9_1_1_1_5 hd_h_niceng215er2.tab9_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">185 per 1,000</td><td headers="hd_h_niceng215er2.tab9_1_1_1_5 hd_h_niceng215er2.tab9_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">15 more per 1,000 (35 fewer to 80 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab9_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: diagnosis of opioid abuse</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab9_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">726 (1 RCT)</td><td headers="hd_h_niceng215er2.tab9_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab9_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.90 (0.58 to 1.39)</td><td headers="hd_h_niceng215er2.tab9_1_1_1_5 hd_h_niceng215er2.tab9_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">106 per 1,000</td><td headers="hd_h_niceng215er2.tab9_1_1_1_5 hd_h_niceng215er2.tab9_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">11 fewer per 1,000 (45 fewer to 41 more)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab9_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab9_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab10"><div id="niceng215er2.tab10" class="table"><h3><span class="label">Table 10</span><span class="title">Clinical evidence summary: Risk of Dependence: Physician education vs usual care</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab10/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab10_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab10_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab10_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab10_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab10_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab10_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab10_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab10_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab10_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab10_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab10_1_1_1_5" id="hd_h_niceng215er2.tab10_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with usual care</th><th headers="hd_h_niceng215er2.tab10_1_1_1_5" id="hd_h_niceng215er2.tab10_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Physician education</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab10_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: Uncoordinated opioid use</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab10_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1212 (1 RCT)</td><td headers="hd_h_niceng215er2.tab10_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab10_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.04 (0.81 to 1.32)</td><td headers="hd_h_niceng215er2.tab10_1_1_1_5 hd_h_niceng215er2.tab10_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">192 per 1,000</td><td headers="hd_h_niceng215er2.tab10_1_1_1_5 hd_h_niceng215er2.tab10_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">8 more per 1,000 (37 fewer to 62 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab10_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: Diagnosis of opioid abuse</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab10_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1090 (1 RCT)</td><td headers="hd_h_niceng215er2.tab10_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab10_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">OR 0.83 (0.55 to 1.26)</td><td headers="hd_h_niceng215er2.tab10_1_1_1_5 hd_h_niceng215er2.tab10_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unable to calculate<sup>c</sup></td><td headers="hd_h_niceng215er2.tab10_1_1_1_5 hd_h_niceng215er2.tab10_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unable to calculate<sup>c</sup></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab10_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab10_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25.</p></div></dd></dl><dl class="bkr_refwrap"><dt>c.</dt><dd><div id="niceng215er2.tab10_3"><p class="no_margin">Unable to calculate control group risk and absolute effect as adjusted OR reported by study.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab11"><div id="niceng215er2.tab11" class="table"><h3><span class="label">Table 11</span><span class="title">Clinical evidence summary: Risk of Dependence: Physician patient information and education vs physician patient information</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab11/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab11_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab11_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab11_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab11_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab11_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab11_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab11_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab11_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab11_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab11_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab11_1_1_1_5" id="hd_h_niceng215er2.tab11_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with physician patient information</th><th headers="hd_h_niceng215er2.tab11_1_1_1_5" id="hd_h_niceng215er2.tab11_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Physician patient information and education</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab11_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: uncoordinated opioid use</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab11_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">807 (1 RCT)</td><td headers="hd_h_niceng215er2.tab11_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab11_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.07 (0.81 to 1.42)</td><td headers="hd_h_niceng215er2.tab11_1_1_1_5 hd_h_niceng215er2.tab11_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">185 per 1,000</td><td headers="hd_h_niceng215er2.tab11_1_1_1_5 hd_h_niceng215er2.tab11_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13 more per 1,000 (35 fewer to 78 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab11_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: diagnosis of opioid abuse</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab11_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">731 (1 RCT)</td><td headers="hd_h_niceng215er2.tab11_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab11_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.78 (0.50 to 1.23)</td><td headers="hd_h_niceng215er2.tab11_1_1_1_5 hd_h_niceng215er2.tab11_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">106 per 1,000</td><td headers="hd_h_niceng215er2.tab11_1_1_1_5 hd_h_niceng215er2.tab11_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">23 fewer per 1,000 (53 fewer to 24 more)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab11_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab11_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab12"><div id="niceng215er2.tab12" class="table"><h3><span class="label">Table 12</span><span class="title">Clinical evidence summary: Risk of Dependence: Physician patient information and education vs physician education</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab12/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab12_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab12_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab12_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab12_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab12_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab12_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab12_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab12_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab12_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab12_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab12_1_1_1_5" id="hd_h_niceng215er2.tab12_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with Physician education</th><th headers="hd_h_niceng215er2.tab12_1_1_1_5" id="hd_h_niceng215er2.tab12_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Physician patient information and education</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: uncoordinated opioid use</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab12_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">799 (1 RCT)</td><td headers="hd_h_niceng215er2.tab12_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab12_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.00 (0.75 to 1.31)</td><td headers="hd_h_niceng215er2.tab12_1_1_1_5 hd_h_niceng215er2.tab12_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">199 per 1,000</td><td headers="hd_h_niceng215er2.tab12_1_1_1_5 hd_h_niceng215er2.tab12_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 fewer per 1,000 (50 fewer to 62 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab12_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: diagnosis of opioid abuse</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab12_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">721 (1 RCT)</td><td headers="hd_h_niceng215er2.tab12_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab12_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.87 (0.54 to 1.39)</td><td headers="hd_h_niceng215er2.tab12_1_1_1_5 hd_h_niceng215er2.tab12_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">95 per 1,000</td><td headers="hd_h_niceng215er2.tab12_1_1_1_5 hd_h_niceng215er2.tab12_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12 fewer per 1,000 (44 fewer to 37 more)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab12_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab12_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab13"><div id="niceng215er2.tab13" class="table"><h3><span class="label">Table 13</span><span class="title">Clinical evidence summary: Risk of Dependence: Physician patient information vs usual care</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab13/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab13_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab13_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab13_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab13_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab13_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab13_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab13_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab13_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab13_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab13_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab13_1_1_1_5" id="hd_h_niceng215er2.tab13_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with usual care</th><th headers="hd_h_niceng215er2.tab13_1_1_1_5" id="hd_h_niceng215er2.tab13_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Physician patient information</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab13_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: uncoordinated opioid use</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab13_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1220 (1 RCT)</td><td headers="hd_h_niceng215er2.tab13_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab13_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.96 (0.75 to 1.24)</td><td headers="hd_h_niceng215er2.tab13_1_1_1_5 hd_h_niceng215er2.tab13_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">192 per 1,000</td><td headers="hd_h_niceng215er2.tab13_1_1_1_5 hd_h_niceng215er2.tab13_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">8 fewer per 1,000 (48 fewer to 46 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab13_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: diagnosis of opioid abuse</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab13_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1100 (1 RCT)</td><td headers="hd_h_niceng215er2.tab13_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab13_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">OR 0.95 (0.63 to 1.43)</td><td headers="hd_h_niceng215er2.tab13_1_1_1_5 hd_h_niceng215er2.tab13_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unable to calculate<sup>c</sup></td><td headers="hd_h_niceng215er2.tab13_1_1_1_5 hd_h_niceng215er2.tab13_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unable to calculate<sup>c</sup></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab13_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab13_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25.</p></div></dd></dl><dl class="bkr_refwrap"><dt>c.</dt><dd><div id="niceng215er2.tab13_3"><p class="no_margin">Unable to calculate control group risk and absolute effect as adjusted OR reported by study.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab14"><div id="niceng215er2.tab14" class="table"><h3><span class="label">Table 14</span><span class="title">Clinical evidence summary: Risk of Dependence: Physician patient information and education vs usual care</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab14/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab14_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab14_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab14_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab14_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab14_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab14_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab14_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab14_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab14_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab14_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab14_1_1_1_5" id="hd_h_niceng215er2.tab14_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with usual care</th><th headers="hd_h_niceng215er2.tab14_1_1_1_5" id="hd_h_niceng215er2.tab14_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Physician patient information and education</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: Uncoordinated opioid use</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1229 (1 RCT)</td><td headers="hd_h_niceng215er2.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.03 (0.81 to 1.31)</td><td headers="hd_h_niceng215er2.tab14_1_1_1_5 hd_h_niceng215er2.tab14_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">192 per 1,000</td><td headers="hd_h_niceng215er2.tab14_1_1_1_5 hd_h_niceng215er2.tab14_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">6 more per 1,000 (37 fewer to 60 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab14_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Dependence on the prescribed medicine</p>
|
|
<p>assessed with: Diagnosis of opioid abuse</p>
|
|
<p>follow up: 91–270 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab14_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1100 (1 RCT)</td><td headers="hd_h_niceng215er2.tab14_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕◯◯ LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab14_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">OR 0.72 (0.46 to 1.13)</td><td headers="hd_h_niceng215er2.tab14_1_1_1_5 hd_h_niceng215er2.tab14_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unable to calculate<sup>c</sup></td><td headers="hd_h_niceng215er2.tab14_1_1_1_5 hd_h_niceng215er2.tab14_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unable to calculate<sup>c</sup></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab14_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab14_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25.</p></div></dd></dl><dl class="bkr_refwrap"><dt>c.</dt><dd><div id="niceng215er2.tab14_3"><p class="no_margin">Unable to calculate control group risk and absolute effect as adjusted OR reported by study.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab15"><div id="niceng215er2.tab15" class="table"><h3><span class="label">Table 15</span><span class="title">Clinical evidence summary: high vs low dose short-term treatment (gabapentinoids)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab15/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab15_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab15_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab15_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab15_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab15_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab15_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab15_1_1_1_5" id="hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with low dose pregabalin (short-term)</th><th headers="hd_h_niceng215er2.tab15_1_1_1_5" id="hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with High dose pregabalin (short-term)</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms (PWC) week 1 after taper</p>
|
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<p>assessed with: Physician Withdrawal Checklist</p>
|
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<p>Scale from: 0 to 60</p>
|
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<p>follow up: 5 weeks (post-taper)</p>
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|
</td><td headers="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">95 (1 RCT)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕⊕◯ MODERATE <sup>a</sup></td><td headers="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean PWC score was 2.306</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 0.54 higher (1.89 lower to 2.98 higher)</td></tr><tr><td headers="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Withdrawal symptoms- week 2 after initiating taper (PWC)</p>
|
|
<p>assessed with: Physician Withdrawal Checklist</p>
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<p>Scale from: 0 to 60</p>
|
|
<p>follow up: 14 weeks (follow-up)</p>
|
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</td><td headers="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">103 (1 RCT)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕⊕◯ MODERATE <sup>a</sup></td><td headers="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean PWC score was 2.0</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 0.1 higher (2.17 lower to 2.37 higher)</td></tr><tr><td headers="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal Symptoms (DESS)</p>
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<p>assessed with: Number of people with Discontinuation- Emergent Signs and Symptoms</p>
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<p>follow up: 14 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">110 (1 RCT)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.11 (0.66 to 1.86)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">327 per 1,000</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">36 more per 1,000 (111 fewer to 281 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal Symptoms- number of people with anxiety (DESS)</p>
|
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<p>assessed with: Discontinuation- Emergent Signs and Symptoms</p>
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<p>follow up: 14 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">110 (1 RCT)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peto OR 6.90 (0.70 to 68.01)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1,000</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">50 more per 1,000 (from 10 fewer to 120 more)<sup>c</sup></td></tr><tr><td headers="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal Symptoms- number of people with dizziness (DESS)</p>
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<p>assessed with: Discontinuation- Emergent Signs and Symptoms</p>
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<p>follow up: 14 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">110 (1 RCT)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peto OR 6.90 (0.70 to 68.01)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1,000</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">50 more per 1,000 (from 10 fewer to 120 more)<sup>c</sup></td></tr><tr><td headers="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal Symptoms- number of people with headache (DESS)</p>
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<p>assessed with: Discontinuation- Emergent Signs and Symptoms</p>
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<p>follow up: 14 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">110 (1 RCT)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.67 (0.16 to 2.86)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">77 per 1,000</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">25 fewer per 1,000 (65 fewer to 143 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal Symptoms- number of people with insomnia (DESS)</p>
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<p>assessed with: Discontinuation- Emergent Signs and Symptoms</p>
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<p>follow up: 14 weeks</p>
|
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</td><td headers="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">110 (1 RCT)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.34 (0.40 to 4.50)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">77 per 1,000</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">26 more per 1,000 (46 fewer to 269 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal Symptoms- number of people with nausea (DESS)</p>
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<p>assessed with: Discontinuation- Emergent Signs and Symptoms</p>
|
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<p>follow up: 14 weeks</p>
|
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</td><td headers="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">110 (1 RCT)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.20 (0.28 to 5.09)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">58 per 1,000</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">12 more per 1,000 (42 fewer to 236 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab15_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Withdrawal symptoms (Rebound anxiety)</p>
|
|
<p>assessed with: Hamilton Anxiety Rating Scale</p>
|
|
<p>follow up: 14 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab15_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">110 (1 RCT)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab15_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 2.69 (0.29 to 25.06)</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">19 per 1,000</td><td headers="hd_h_niceng215er2.tab15_1_1_1_5 hd_h_niceng215er2.tab15_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">33 more per 1,000 (14 fewer to 463 more)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab15_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab15_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25. The MID for PWC was 0.5 × the control group SD as they were change scores. This was 2.98 for the outcome at 5 weeks, and 2.61 for the outcome at 14 weeks.</p></div></dd></dl><dl class="bkr_refwrap"><dt>c.</dt><dd><div id="niceng215er2.tab15_3"><p class="no_margin">Calculated from risk difference due to zero events in control arm.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab16"><div id="niceng215er2.tab16" class="table"><h3><span class="label">Table 16</span><span class="title">Clinical evidence summary: High vs low dose (long-term) gabapentinoids</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab16/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab16_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab16_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab16_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab16_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab16_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab16_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab16_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab16_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab16_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab16_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab16_1_1_1_5" id="hd_h_niceng215er2.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with low dose pregabalin (long-term)</th><th headers="hd_h_niceng215er2.tab16_1_1_1_5" id="hd_h_niceng215er2.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with High dose pregabalin (long-term)</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Withdrawal Symptoms - week 2 after initiating taper (PWC)</p>
|
|
<p>assessed with: Physician Withdrawal Checklist</p>
|
|
<p>Scale from: 0 to 60</p>
|
|
<p>follow up: 26 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">190 (1 RCT)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕◯◯ LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean PWC score was 1.7</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 1.1 higher (0.46 lower to 2.66 higher)</td></tr><tr><td headers="hd_h_niceng215er2.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Withdrawal Symptoms (DESS)</p>
|
|
<p>assessed with: Discontinuation Signs and Symptoms</p>
|
|
<p>follow up: 26 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">203 (1 RCT)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕◯◯ LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.40 (0.87 to 2.23)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">223 per 1,000</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">89 more per 1,000 (29 fewer to 275 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal Symptoms- anxiety (DESS)</p>
|
|
<p>assessed with: Discontinuation Signs and Symptoms</p>
|
|
<p>follow up: 26 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">203 (1 RCT)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.51 (0.46 to 5.00)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">43 per 1,000</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">22 more per 1,000 (23 fewer to 170 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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|
<p>Withdrawal symptoms- headache (DESS)</p>
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<p>assessed with: Discontinuation Signs and Symptoms</p>
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|
<p>follow up: 26 weeks</p>
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|
</td><td headers="hd_h_niceng215er2.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">203 (1 RCT)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.44 (0.35 to 5.85)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">32 per 1,000</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">14 more per 1,000 (21 fewer to 155 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms- insomnia (DESS)</p>
|
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<p>assessed with: Discontinuation Signs and Symptoms</p>
|
|
<p>follow up: 26 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">203 (1 RCT)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.40 (0.61 to 3.23)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">85 per 1,000</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">34 more per 1,000 (33 fewer to 190 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab16_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Withdrawal symptoms (Rebound anxiety)</p>
|
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<p>assessed with: Hamilton Anxiety Rating Scale</p>
|
|
<p>follow up: 26 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab16_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">203 (1 RCT)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab16_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peto OR 6.62 (0.91 to 47.97)</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1,000</td><td headers="hd_h_niceng215er2.tab16_1_1_1_5 hd_h_niceng215er2.tab16_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">40 more per 1,000 (0 fewer to 80 more)<sup>c</sup></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab16_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab16_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25. The MID for the PWC outcome was 0.5* control group SD as they were change scores. This was 2.46 for the 14-week outcome.</p></div></dd></dl><dl class="bkr_refwrap"><dt>c.</dt><dd><div id="niceng215er2.tab16_3"><p class="no_margin">Calculated from risk difference due to zero events in control arm.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab17"><div id="niceng215er2.tab17" class="table"><h3><span class="label">Table 17</span><span class="title">Clinical evidence summary: 20mg zolpidem vs 10mg zolpidem</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab17/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab17_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab17_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab17_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab17_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab17_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab17_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab17_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab17_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab17_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab17_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab17_1_1_1_5" id="hd_h_niceng215er2.tab17_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with 10mg Zolpidem</th><th headers="hd_h_niceng215er2.tab17_1_1_1_5" id="hd_h_niceng215er2.tab17_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with 20mg Zolpidem</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab17_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Mortality</p>
|
|
<p>follow up: 22–28 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab17_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">80 (1 RCT)</td><td headers="hd_h_niceng215er2.tab17_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab17_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peto OR 7.29 (0.15 to 372.38)</td><td headers="hd_h_niceng215er2.tab17_1_1_1_5 hd_h_niceng215er2.tab17_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1,000</td><td headers="hd_h_niceng215er2.tab17_1_1_1_5 hd_h_niceng215er2.tab17_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">30 more per 1,000 (40 fewer to 90 more)<sup>c</sup></td></tr><tr><td headers="hd_h_niceng215er2.tab17_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Withdrawal symptoms</p>
|
|
<p>assessed with: Narrative report of “no withdrawal symptoms during the second 7-day placebo treatment period”.</p>
|
|
<p>follow up: 22–28 days</p>
|
|
</td><td headers="hd_h_niceng215er2.tab17_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">74 (1 RCT)</td><td headers="hd_h_niceng215er2.tab17_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕⊕◯ MODERATE <sup>a</sup></td><td headers="hd_h_niceng215er2.tab17_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">not estimable</td><td headers="hd_h_niceng215er2.tab17_1_1_1_5 hd_h_niceng215er2.tab17_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1,000</td><td headers="hd_h_niceng215er2.tab17_1_1_1_5 hd_h_niceng215er2.tab17_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 fewer per 1,000 (50 fewer to 50 more)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab17_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab17_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25.</p></div></dd></dl><dl class="bkr_refwrap"><dt>c.</dt><dd><div id="niceng215er2.tab17_3"><p class="no_margin">Calculated from risk difference due to zero events in control arm.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab18"><div id="niceng215er2.tab18" class="table"><h3><span class="label">Table 18</span><span class="title">Clinical evidence summary: 6mg doxepin vs 3mg doxepin (tricyclic antidepressants)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab18/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab18_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab18_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab18_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab18_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab18_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab18_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab18_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab18_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab18_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab18_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab18_1_1_1_5" id="hd_h_niceng215er2.tab18_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with 3mg Doxepin</th><th headers="hd_h_niceng215er2.tab18_1_1_1_5" id="hd_h_niceng215er2.tab18_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with 6mg Doxepin</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab18_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Withdrawal symptoms (Withdrawal signs)</p>
|
|
<p>assessed with: 3 or more new symptoms in the BWSQ</p>
|
|
<p>Follow-up: 5 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab18_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">148 (1 RCT)</td><td headers="hd_h_niceng215er2.tab18_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab18_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peto OR 0.14 (0.00 to 7.01)</td><td headers="hd_h_niceng215er2.tab18_1_1_1_5 hd_h_niceng215er2.tab18_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13 per 1,000</td><td headers="hd_h_niceng215er2.tab18_1_1_1_5 hd_h_niceng215er2.tab18_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">10 fewer per 1,000 (50 fewer to 20 more)<sup>c</sup></td></tr><tr><td headers="hd_h_niceng215er2.tab18_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Withdrawal symptoms assessed with: Rebound insomnia based on wake time after sleep onset (WASO) criteria experienced over the 2 nights after discontinuation</p>
|
|
<p>Follow-up: 5 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab18_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">148 (1 RCT)</td><td headers="hd_h_niceng215er2.tab18_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab18_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 3.08 (0.33 to 28.96)</td><td headers="hd_h_niceng215er2.tab18_1_1_1_5 hd_h_niceng215er2.tab18_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">13 per 1,000</td><td headers="hd_h_niceng215er2.tab18_1_1_1_5 hd_h_niceng215er2.tab18_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">28 more per 1,000 (9 fewer to 373 more)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab18_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab18_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25.</p></div></dd></dl><dl class="bkr_refwrap"><dt>c.</dt><dd><div id="niceng215er2.tab18_3"><p class="no_margin">Calculated from risk difference due to zero events in intervention arm.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab19"><div id="niceng215er2.tab19" class="table"><h3><span class="label">Table 19</span><span class="title">Clinical evidence summary: 20mg vortioxetine vs 10mg vortioxetine (other antidepressants)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab19/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab19_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab19_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab19_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab19_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab19_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab19_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab19_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab19_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab19_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab19_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab19_1_1_1_5" id="hd_h_niceng215er2.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with 10mg Vortioxetine qd</th><th headers="hd_h_niceng215er2.tab19_1_1_1_5" id="hd_h_niceng215er2.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with 20mg Vortioxetine qd</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab19_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Withdrawal symptoms (DESS)</p>
|
|
<p>assessed with: Discontinuation -Emergent Signs and Symptoms</p>
|
|
<p>Range of values unclear</p>
|
|
<p>follow up: 10 weeks</p>
|
|
</td><td headers="hd_h_niceng215er2.tab19_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">254 (1 RCT)</td><td headers="hd_h_niceng215er2.tab19_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕◯◯ LOW <sup>a</sup>
|
|
<sup>b</sup></td><td headers="hd_h_niceng215er2.tab19_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab19_1_1_1_5 hd_h_niceng215er2.tab19_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean DESS score was 1.1</td><td headers="hd_h_niceng215er2.tab19_1_1_1_5 hd_h_niceng215er2.tab19_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 0.4 lower (0.92 lower to 0.12 higher)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab19_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab19_2"><p class="no_margin">Not downgraded for imprecision as the confidence interval did not cross the MID. The MID for DESS was 1.26 (0.5*control group SD for DESS score)</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab20"><div id="niceng215er2.tab20" class="table"><h3><span class="label">Table 20</span><span class="title">Clinical evidence summary: 10mg vortioxetine vs 5mg vortioxetine (other antidepressants)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab20/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab20_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab20_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab20_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab20_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab20_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab20_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab20_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab20_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab20_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab20_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab20_1_1_1_5" id="hd_h_niceng215er2.tab20_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with 5mg Vortioxetine qd</th><th headers="hd_h_niceng215er2.tab20_1_1_1_5" id="hd_h_niceng215er2.tab20_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with 10mg Vortioxetine qd</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab20_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms (DESS)</p>
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<p>assessed with: Discontinuation-Emergent Signs and Symptoms</p>
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<p>Range of values unclear</p>
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<p>follow up: 10 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab20_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">250 (1 RCT)</td><td headers="hd_h_niceng215er2.tab20_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕◯◯ LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab20_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab20_1_1_1_5 hd_h_niceng215er2.tab20_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean DESS score was 0.8</td><td headers="hd_h_niceng215er2.tab20_1_1_1_5 hd_h_niceng215er2.tab20_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 0.3 higher (0.28 lower to 0.88 higher)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab20_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab20_2"><p class="no_margin">Not downgraded for imprecision as the confidence interval did not cross the MID. The MID for DESS was 1.11 (0.5*control group SD for DESS score)</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab21"><div id="niceng215er2.tab21" class="table"><h3><span class="label">Table 21</span><span class="title">Clinical evidence summary: 20mg vortioxetine vs 5mg vortioxetine (other antidepressants)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab21/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab21_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab21_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab21_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab21_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab21_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab21_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab21_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab21_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab21_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab21_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab21_1_1_1_5" id="hd_h_niceng215er2.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with 5mg Vortioxetine qd</th><th headers="hd_h_niceng215er2.tab21_1_1_1_5" id="hd_h_niceng215er2.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with 20mg Vortioxetine qd</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab21_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal Symptoms (DESS)</p>
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<p>assessed with: Discontinuation -Emergent Signs and Symptoms</p>
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<p>Range of values unclear</p>
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<p>follow up: 10 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab21_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">248 (1 RCT)</td><td headers="hd_h_niceng215er2.tab21_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕◯◯ LOW <sup>a</sup>
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<sup>b</sup></td><td headers="hd_h_niceng215er2.tab21_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab21_1_1_1_5 hd_h_niceng215er2.tab21_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean DESS score was 0.8</td><td headers="hd_h_niceng215er2.tab21_1_1_1_5 hd_h_niceng215er2.tab21_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 0.1 lower (0.59 lower to 0.39 higher)</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab21_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab21_2"><p class="no_margin">Not downgraded for imprecision as the confidence interval did not cross the MID. The MID for DESS was 1.11 (0.5*control group SD for DESS score)</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng215er2tab22"><div id="niceng215er2.tab22" class="table"><h3><span class="label">Table 22</span><span class="title">Clinical evidence summary: Sertraline vs Venlafaxine (SSRI / other antidepressants)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK580675/table/niceng215er2.tab22/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng215er2.tab22_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng215er2.tab22_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab22_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng215er2.tab22_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab22_1_1_1_2" style="text-align:left;vertical-align:bottom;">N<u>o</u> of participants (studies) Follow up</th><th id="hd_h_niceng215er2.tab22_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab22_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng215er2.tab22_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng215er2.tab22_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng215er2.tab22_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng215er2.tab22_1_1_1_5" id="hd_h_niceng215er2.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with venlafaxine SR</th><th headers="hd_h_niceng215er2.tab22_1_1_1_5" id="hd_h_niceng215er2.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Sertraline</th></tr></thead><tbody><tr><td headers="hd_h_niceng215er2.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms (Deterioration during taper) (ADDS)</p>
|
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<p>assessed with: Antidepressant discontinuation scale (unvalidated)</p>
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<p>Scale from: 0 to 210</p>
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<p>follow up: 8–10 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">136 (1 RCT)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕⊕◯◯ LOW <sup>a</sup></td><td headers="hd_h_niceng215er2.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean ADDS score was 10.2</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MD 2.4 lower (2.79 lower to 2.01 lower)</td></tr><tr><td headers="hd_h_niceng215er2.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms</p>
|
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<p>assessed with: Worst severity of discontinuation symptoms (Investigator global assessment); none</p>
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<p>follow up: 8–10 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">129 (1 RCT)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.59 (0.67 to 3.77)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">113 per 1,000</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">67 more per 1,000 (37 fewer to 313 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms</p>
|
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<p>assessed with: Worst severity of discontinuation symptoms (Investigator global assessment); minimal</p>
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<p>follow up: 8–10 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">129 (1 RCT)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.35 (0.68 to 2.67)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">177 per 1,000</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">62 more per 1,000 (57 fewer to 296 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms</p>
|
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<p>assessed with: (Worst severity of discontinuation symptoms (Investigator global assessment); mild)</p>
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<p>follow up: 8–10 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">129 (1 RCT)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.87 (0.48 to 1.57)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">274 per 1,000</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">36 fewer per 1,000 (143 fewer to 156 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms</p>
|
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<p>assessed with: Worst severity of discontinuation symptoms (Investigator global assessment); moderate</p>
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<p>follow up: 8–10 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">129 (1 RCT)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.89 (0.56 to 1.40)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">387 per 1,000</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">43 fewer per 1,000 (170 fewer to 155 more)</td></tr><tr><td headers="hd_h_niceng215er2.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms</p>
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<p>assessed with: Worst severity of discontinuation symptoms (Investigator global assessment); severe</p>
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<p>follow up: 8–10 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">129 (1 RCT)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peto OR 0.12 (0.01 to 1.99)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">32 per 1,000</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">30 fewer per 1,000 (80 fewer to 20 more)<sup>c</sup></td></tr><tr><td headers="hd_h_niceng215er2.tab22_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Withdrawal symptoms</p>
|
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<p>assessed with: Worst severity of discontinuation symptoms (Investigator global assessment); very severe</p>
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<p>follow up: 8–10 weeks</p>
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</td><td headers="hd_h_niceng215er2.tab22_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">129 (1 RCT)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">⊕◯◯◯ VERY LOW <sup>a</sup><sup>,</sup><sup>b</sup></td><td headers="hd_h_niceng215er2.tab22_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peto OR 0.12 (0.00 to 6.31)</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">16 per 1,000</td><td headers="hd_h_niceng215er2.tab22_1_1_1_5 hd_h_niceng215er2.tab22_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">20 fewer per 1,000 (60 fewer to 30 more)<sup>c</sup></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>a.</dt><dd><div id="niceng215er2.tab22_1"><p class="no_margin">Downgraded by 1 increment if the evidence was at high risk of bias and by 2 increments if the evidence was at very high risk of bias.</p></div></dd></dl><dl class="bkr_refwrap"><dt>b.</dt><dd><div id="niceng215er2.tab22_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed 1 MID and by 2 increments if the confidence interval crossed 2 MIDs. MID for dichotomous outcomes was 0.8 and 1.25. For continuous outcomes the MID was calculated as 0.6 for deterioration during taper (0.5 × SD for change score in control group).</p></div></dd></dl><dl class="bkr_refwrap"><dt>c.</dt><dd><div id="niceng215er2.tab22_3"><p class="no_margin">Calculated from risk difference due to zero events in intervention arm.</p></div></dd></dl></dl></div></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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