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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-niceng50er3-lrg.png" alt="Cover of Evidence review for the clinical and cost effectiveness of non-selective beta-blockers for the primary prevention of decompensation in people with compensated cirrhosis" /></a></div><div class="bkr_bib"><h1 id="_NBK595737_"><span itemprop="name">Evidence review for the clinical and cost effectiveness of non-selective beta-blockers for the primary prevention of decompensation in people with compensated cirrhosis</span></h1><div class="subtitle">Cirrhosis in over 16s: assessment and management (update)</div><p><b>Evidence review C</b></p><p><i>NICE Guideline, No. 50</i></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">2023 Sep</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-5352-3</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2023.</div></div><div class="bkr_clear"></div></div><div id="niceng50er3.s1"><h2 id="_niceng50er3_s1_">1. Non-selective beta-blockers for preventing decompensation in people with cirrhosis</h2><div id="niceng50er3.s1.1"><h3>1.1. Review question</h3><p>What is the clinical and cost effectiveness of non-selective beta-blockers (NSBBs) for the primary prevention of decompensation in people with compensated cirrhosis?</p><div id="niceng50er3.s1.1.1"><h4>1.1.1. Introduction</h4><p>The original guideline <a href="https://www.nice.org.uk/guidance/ng50" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NG50</a> was intended to focus on areas of uncertainty and variability in practice and as such was limited in scope. It did not cover all approaches to the prevention of decompensation. During surveillance, stakeholders highlighted new published research about the use of non-selective beta-blockers for the primary prevention of decompensation (for example, ascites) in people with compensated cirrhosis. This is therefore a new area in which the evidence will be reviewed and in which the committee will consider making recommendations.</p></div><div id="niceng50er3.s1.1.2"><h4>1.1.2. Summary of the protocol</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng50er3tab1"><a href="/books/NBK595737/table/niceng50er3.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng50er3tab1" rid-ob="figobniceng50er3tab1"><img class="small-thumb" src="/books/NBK595737/table/niceng50er3.tab1/?report=thumb" src-large="/books/NBK595737/table/niceng50er3.tab1/?report=previmg" alt="Table 1. PICOS inclusion criteria." /></a><div class="icnblk_cntnt"><h4 id="niceng50er3.tab1"><a href="/books/NBK595737/table/niceng50er3.tab1/?report=objectonly" target="object" rid-ob="figobniceng50er3tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">PICOS inclusion criteria. </p></div></div><p>For the full protocol see <a href="#niceng50er3.appa">appendix A</a>.</p></div><div id="niceng50er3.s1.1.3"><h4>1.1.3. Methods and process</h4><p>This evidence review was developed using the methods and process 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="#niceng50er3.appa">appendix A</a> and the <a href="https://www.nice.org.uk/guidance/NG50/history" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">methods document</a>.</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 id="niceng50er3.s1.1.3.1"><h5>1.1.3.1. Search methods</h5><p>The searches for the clinical effectiveness evidence were run on 1<sup>st</sup> February 2023. The following databases were searched: Central Register of Controlled Trials (Wiley), Cochrane Database of Systematic Reviews (Wiley), Embase (Ovid), Epistemonikos and MEDLINE (Ovid), MEDLINE-in-Process (Ovid), MEDLINE Epub Ahead-of-Print (Ovid). The searches focused on the effectiveness of non-selective beta blockers to prevent decompensation in people with compensated cirrhosis. Full search strategies for each database are provided in <a href="#niceng50er3.appb">appendix B</a>.</p><p>The searches for the cost effectiveness evidence were run on 2<sup>nd</sup> February 2023. The following databases were searched: EconLit (Ovid), Embase (Ovid), INAHTA and MEDLINE (Ovid), MEDLINE-in-Process (Ovid), MEDLINE Epub Ahead-of-Print (Ovid). Full search strategies for each database are provided in <a href="#niceng50er3.appb">appendix B</a>.</p><p>A NICE information specialist conducted the searches. The MEDLINE strategy was quality assured by a trained NICE information specialist and all translated search strategies were peer reviewed to ensure their accuracy. Both procedures were adapted from the <a href="https://www.sciencedirect.com/science/article/pii/S0895435616000585" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">2015 PRESS Guideline Statement</a>.</p></div><div id="niceng50er3.s1.1.3.2"><h5>1.1.3.2. Protocol deviations</h5><p>During the sifting for this review question, an individual patient data (IPD) meta-analysis was identified that incorporated unpublished data from authors of the included studies. This meta-analysis is summarised narratively within this review to supplement the data from primary studies.</p></div></div><div id="niceng50er3.s1.1.4"><h4>1.1.4. Effectiveness evidence</h4><div id="niceng50er3.s1.1.4.1"><h5>1.1.4.1. Included studies</h5><p>A systematic search carried out to identify potentially relevant studies found 335 references (see <a href="#niceng50er3.appb">appendix B</a> for the literature search strategy).</p><p>These 335 references were screened at title and abstract level against the review protocol, with 331 excluded at this level. 10% of references were screened separately by two reviewers with 100% agreement.</p><p>The full texts of 4 RCTs and systematic reviews were ordered for closer inspection. 1 of these studies met the criteria specified in the review protocol (<a href="#niceng50er3.appa">appendix A</a>) and 1 IPD meta-analysis was also deemed to be directly relevant and was also included (see <a href="#niceng50er3.s1.1.3.2">1.1.3.2 protocol deviations</a>). For a summary of the 2 included studies see <a class="figpopup" href="/books/NBK595737/table/niceng50er3.tab2/?report=objectonly" target="object" rid-figpopup="figniceng50er3tab2" rid-ob="figobniceng50er3tab2">table 2</a>.</p><p>The clinical evidence study selection is presented as a PRISMA diagram in <a href="#niceng50er3.appc">appendix C</a>.</p><p>See section <a href="#niceng50er3.rl.r1">1.1.14 References – included studies</a> for the full references of the included studies.</p></div><div id="niceng50er3.s1.1.4.2"><h5>1.1.4.2. Excluded studies</h5><p>Details of studies excluded at full text, along with reasons for exclusion are given in <a href="#niceng50er3.appj">appendix J</a>.</p></div></div><div id="niceng50er3.s1.1.5"><h4>1.1.5. Summary of studies included in the effectiveness evidence</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng50er3tab2"><a href="/books/NBK595737/table/niceng50er3.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figniceng50er3tab2" rid-ob="figobniceng50er3tab2"><img class="small-thumb" src="/books/NBK595737/table/niceng50er3.tab2/?report=thumb" src-large="/books/NBK595737/table/niceng50er3.tab2/?report=previmg" alt="Table 2. Summary of studies included in the effectiveness evidence." /></a><div class="icnblk_cntnt"><h4 id="niceng50er3.tab2"><a href="/books/NBK595737/table/niceng50er3.tab2/?report=objectonly" target="object" rid-ob="figobniceng50er3tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the effectiveness evidence. </p></div></div><p>See <a href="#niceng50er3.appd">appendix D</a> for full evidence tables.</p></div><div id="niceng50er3.s1.1.6"><h4>1.1.6. Summary of the effectiveness evidence</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng50er3tab3"><a href="/books/NBK595737/table/niceng50er3.tab3/?report=objectonly" target="object" title="Table 3" class="img_link icnblk_img figpopup" rid-figpopup="figniceng50er3tab3" rid-ob="figobniceng50er3tab3"><img class="small-thumb" src="/books/NBK595737/table/niceng50er3.tab3/?report=thumb" src-large="/books/NBK595737/table/niceng50er3.tab3/?report=previmg" alt="Table 3. Summary of the effectiveness evidence for decompensation." /></a><div class="icnblk_cntnt"><h4 id="niceng50er3.tab3"><a href="/books/NBK595737/table/niceng50er3.tab3/?report=objectonly" target="object" rid-ob="figobniceng50er3tab3">Table 3</a></h4><p class="float-caption no_bottom_margin">Summary of the effectiveness evidence for decompensation. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng50er3tab4"><a href="/books/NBK595737/table/niceng50er3.tab4/?report=objectonly" target="object" title="Table 4" class="img_link icnblk_img figpopup" rid-figpopup="figniceng50er3tab4" rid-ob="figobniceng50er3tab4"><img class="small-thumb" src="/books/NBK595737/table/niceng50er3.tab4/?report=thumb" src-large="/books/NBK595737/table/niceng50er3.tab4/?report=previmg" alt="Table 4. Summary of the effectiveness evidence for adverse events." /></a><div class="icnblk_cntnt"><h4 id="niceng50er3.tab4"><a href="/books/NBK595737/table/niceng50er3.tab4/?report=objectonly" target="object" rid-ob="figobniceng50er3tab4">Table 4</a></h4><p class="float-caption no_bottom_margin">Summary of the effectiveness evidence for adverse events. </p></div></div><p>See <a href="#niceng50er3.appf">appendix F</a> for full GRADE tables.</p><div id="niceng50er3.s1.1.6.1"><h5>1.1.6.1. Narrative summary</h5><p>One study (<a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">Villanueva 2022</a>) was not amenable to assessment using GRADE because it was an individual patient data (IPD) meta-analysis, however it was critically appraised using a checklist based on the PRISMA-NMA criteria and was found to be at low risk of bias. The purpose of the meta-analysis was to compare carvedilol to endoscopic variceal band ligation or placebo for the primary prevention of decompensation in adults with compensated cirrhosis. They defined decompensation as the appearance of ascites, gastrointestinal bleeding related to portal hypertension, or overt hepatic encephalopathy.</p><p>The authors undertook a competing risk time-to-event meta-analysis using individual patient data IPD obtained by contacting the primary authors of relevant RCTs.</p><p>Villanueva et al reviewed125 studies at full text and contacted the authors of relevant studies to request individual patient data. The authors of 4 studies responded. The 4 studies were included in the IPD. They comprised 352 patients with compensated cirrhosis, 181 treated with carvedilol and 171 controls (79 received EVL and 92 placebo). Baseline characteristics were similar between groups in all 4 studies.</p><p>The risk of developing decompensation of cirrhosis was lower with carvedilol than in controls (sub-distribution hazard ratio [SHR] 0.506; 95% CI 0.289–0.887; p = 0.017; I2 = 0.0%, Q-statistic-p = 0.880), mainly due to a reduced risk of ascites (SHR 0.491; 95% CI 0.247–0.974; p = 0.042; I2 = 0.0%, Q-statistic-p = 0.384). The risk of death was also lower with carvedilol (SHR 0.417; 95% CI 0.194–0.896; p = 0.025; I2 = 0.0%, Q-statistic-p = 0.989).</p><p>The authors conclude that “Long-term carvedilol therapy reduced decompensation of cirrhosis and significantly improved survival in compensated patients with clinically significant portal hypertension. This suggests that screening patients with compensated cirrhosis for CSPH to enable the prompt initiation of carvedilol could improve outcomes.”</p></div></div><div id="niceng50er3.s1.1.7"><h4>1.1.7. Economic evidence</h4><div id="niceng50er3.s1.1.7.1"><h5>1.1.7.1. Included studies</h5><p>A search was performed to identify published economic evaluations of relevance to this guideline update. This search retrieved 71 studies. Based on title and abstract screening, all studies were excluded for this question as they did not meet the inclusion criteria.</p></div><div id="niceng50er3.s1.1.7.2"><h5>1.1.7.2. Excluded studies</h5><p>No studies were examined at full text.</p></div></div><div id="niceng50er3.s1.1.8"><h4>1.1.8. Summary of included economic evidence</h4><p>No economic studies were included in this review.</p></div><div id="niceng50er3.s1.1.9"><h4>1.1.9. Economic model</h4><p>We conducted an analysis to evaluate the cost savings of NSBBs that could be realised by preventing decompensation of cirrhosis. To be cost saving, NSBBs has to prevent at least one case of decompensation per 79.13 person years. The clinical evidence shows that prophylactic treatment with NSBBs can reduce incidence of decompensation by 116 cases per 1,000 (1 case in every 8.6 people). Based on the clinical evidence, NSBBs appears to be cost saving compared with no active intervention, as the cost savings from averting decompensation and the associated treatment is greater than the cost of providing NSBBs. The full write up of the methods and results is in <a href="#niceng50er3.appi">Appendix I</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng50er3tab5"><a href="/books/NBK595737/table/niceng50er3.tab5/?report=objectonly" target="object" title="Table 5" class="img_link icnblk_img figpopup" rid-figpopup="figniceng50er3tab5" rid-ob="figobniceng50er3tab5"><img class="small-thumb" src="/books/NBK595737/table/niceng50er3.tab5/?report=thumb" src-large="/books/NBK595737/table/niceng50er3.tab5/?report=previmg" alt="Table 5. Health economic evidence profile: non-selective beta blockers (NSBBs) vs placebo for preventing decompensation of cirrhosis." /></a><div class="icnblk_cntnt"><h4 id="niceng50er3.tab5"><a href="/books/NBK595737/table/niceng50er3.tab5/?report=objectonly" target="object" rid-ob="figobniceng50er3tab5">Table 5</a></h4><p class="float-caption no_bottom_margin">Health economic evidence profile: non-selective beta blockers (NSBBs) vs placebo for preventing decompensation of cirrhosis. </p></div></div></div><div id="niceng50er3.s1.1.10"><h4>1.1.10. Unit costs</h4><p>The costs of the drugs and the costs of managing decompensation events included in recommendations for this review question are given below, respectively. For further details about how the cost of decompensation events were calculated, see <a href="#niceng50er3.appi">Appendix I</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng50er3tab6"><a href="/books/NBK595737/table/niceng50er3.tab6/?report=objectonly" target="object" title="Table 6" class="img_link icnblk_img figpopup" rid-figpopup="figniceng50er3tab6" rid-ob="figobniceng50er3tab6"><img class="small-thumb" src="/books/NBK595737/table/niceng50er3.tab6/?report=thumb" src-large="/books/NBK595737/table/niceng50er3.tab6/?report=previmg" alt="Table 6. Unit costs of non-selective beta blockers." /></a><div class="icnblk_cntnt"><h4 id="niceng50er3.tab6"><a href="/books/NBK595737/table/niceng50er3.tab6/?report=objectonly" target="object" rid-ob="figobniceng50er3tab6">Table 6</a></h4><p class="float-caption no_bottom_margin">Unit costs of non-selective beta blockers. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng50er3tab7"><a href="/books/NBK595737/table/niceng50er3.tab7/?report=objectonly" target="object" title="Table 7" class="img_link icnblk_img figpopup" rid-figpopup="figniceng50er3tab7" rid-ob="figobniceng50er3tab7"><img class="small-thumb" src="/books/NBK595737/table/niceng50er3.tab7/?report=thumb" src-large="/books/NBK595737/table/niceng50er3.tab7/?report=previmg" alt="Table 7. Unit costs of managing decompensation events." /></a><div class="icnblk_cntnt"><h4 id="niceng50er3.tab7"><a href="/books/NBK595737/table/niceng50er3.tab7/?report=objectonly" target="object" rid-ob="figobniceng50er3tab7">Table 7</a></h4><p class="float-caption no_bottom_margin">Unit costs of managing decompensation events. </p></div></div></div><div id="niceng50er3.s1.1.11"><h4>1.1.11. Evidence statements</h4><div id="niceng50er3.s1.1.11.1"><h5>Effectiveness evidence</h5><p>• A directly applicable IPD meta-analysis, at low risk of bias containing data from 352 people calculated that carvedilol is associated with a reduced risk of decompensating events (appearance of ascites, gastrointestinal bleeding related to portal hypertension, or overt hepatic encephalopathy) - SHR = 0.506; 95% CI 0.289–0.887 and death SHR = 0.417; 95% CI 0.194–0.896 when compared to placebo or endoscopic variceal band ligation.</p></div><div id="niceng50er3.s1.1.11.2"><h5>Economic evidence</h5><p>• No published economic studies were identified. A costing analysis based on evidence from the effectiveness review suggests that NSBB may be cost saving for preventing decompensation of cirrhosis.</p></div></div><div id="niceng50er3.s1.1.12"><h4>1.1.12. The committee's discussion and interpretation of the evidence</h4><div id="niceng50er3.s1.1.12.1"><h5>1.1.12.1. The outcomes that matter most</h5><p>The committee agreed that the most important outcomes for this question were decompensation, mortality and quality of life. They also noted that it was important to look at the proxy measures for decompensation such as liver transplantation, hospitalisation and infection. Finally adverse events were identified as important to look for and included intervention compliance or discontinuation.</p></div><div id="niceng50er3.s1.1.12.2"><h5>1.1.12.2. The quality of the evidence</h5><p>The committee considered the evidence from one RCT (<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva et al 2019</a>) and in a deviation from the protocol one individual patient data (IPD) meta-analysis (<a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">Villanueva et al 2022</a>). The RCT (<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva et al 2019</a>) was assessed by outcome using GRADE as being of low to moderate quality for outcomes related to decompensation and as being of low to high quality for outcomes related to adverse events (see <a href="#niceng50er3.appf">appendix F</a>). The downgrading for both outcomes was due to imprecision, due to the confidence intervals that bound the effect estimate crossing 1 or 2 minimum important differences (MIDs). The IPD meta-analysis (<a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">Villanueva et al 2022</a>) was identified during the initial evidence sift for this review question. <a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">Villanueva et al 2022</a> was assessed and was found to be at low risk of bias. The deviation from protocol, which was on the basis of study type as a non-RCT and on comparator as the study combines data from study arms that considered placebo and endoscopic variceal ligation (EVL). <a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">Villanueva et al 2022</a> was included as <a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">Villanueva et al 2022</a> contacted study authors of 4 RCTs identified through a systematic review, for unpublished decompensation data in compensated patients which was not included in the published papers. This data was deemed directly relevant to this review question and the NICE team felt it would be useful for the committee to consider it in their deliberations. <a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">Villanueva et al 2022</a> was summarised narratively within this review to supplement the data from the initially identified RCT (<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva et al 2019</a>).</p><p>The committee considered the findings of <a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva et al 2019</a> which were equivocal for comparison of non-selective beta-blockers (NSBBs) and placebo for decompensation or death for carvedilol or propranolol individually or when all NSBBs (carvedilol and propranolol) were considered together. There was also equivalence in effect for the comparison of all NSBBs (carvedilol and propranolol) with placebo for decompensated liver resulting in death, and for adverse events. When considering decompensation alone NSBBs (propranolol or carvedilol) were significantly more effective than placebo. The committee considered the findings of the IPD meta-analysis (<a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">Villanueva et al 2022</a>) which indicated a significant effect for carvedilol over placebo or EVL for the risk of developing decompensation of cirrhosis, risk of ascites and risk of death.</p></div><div id="niceng50er3.s1.1.12.3"><h5>1.1.12.3. Benefits and harms</h5><p>The committee acknowledged that based on the evidence and their experience that non-selective beta-blockers (NSBBs) may be an effective treatment option for the primary prevention of decompensation.</p><p>The committee discussed NSBB treatment options of carvedilol or propranolol and the lack of current (as of September 2023) UK marketing authorisation for the primary prevention of decompensation for either of those drugs. They also noted that carvedilol is contraindicated in those with ‘clinically significant hepatic dysfunction’. The committee discussed each of these issues based on the evidence presented and their experience, and highlighted that since this recommendation was about the primary prevention of decompensation, the people who would be included in it would not be considered to have clinically significant hepatic impairment. However, they noted that some caution was always needed when prescribing carvedilol to people with cirrhosis, and for that reason people should be started on a much lower dose and the dose titrated up depending on their tolerance.</p><p>The committee noted <a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva et al 2019</a> recruited people with clinically significant portal hypertension. They noted that in the UK it is uncommon to directly measure portal venous pressure and that the decision about clinically significant portal hypertension was therefore more likely to be a clinical judgment based on tests like ultrasound, platelet count, presence of oesophageal varices and other factors. They acknowledged that there may be variation in access to equipment for example FibroScan to support this.</p><p>The committee noted that as carvedilol and propranolol did not have UK marketing authorisation, prescribing regimens for NSBBs for this indication were not established. The committee agreed that, because propranolol and carvedilol have a greater impact on heart rate and blood pressure in people with cirrhosis, they needed to be used with caution and started at a lower dose that could be titrated upward depending on the persons tolerance. They agreed that dosage regimen set out in the included studies was sensible and was in line with what they had recommended for preventing bleeding of oesophageal varices earlier in this update. Therefore they recommended carvedilol 6.25 mg per day starting dose (<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva, 2019</a>, <a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">2022</a>) and for propranolol 40 mg twice a day (<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva et al 2019</a>), keeping heart rate above 55 beats per min and systolic blood pressure greater than 90 mm Hg would as an appropriate baseline though they noted this might need to be adjusted based on clinical judgment, for example if the person was very frail.</p></div><div id="niceng50er3.s1.1.12.4"><h5>1.1.12.4. Cost effectiveness and resource use</h5><p>No recent and relevant published economic studies were identified.</p><p>We carried out an analysis to evaluate the cost savings of NSBBs that could be realised by preventing decompensation of cirrhosis in people with clinically significant portal hypertension. The analysis takes into account the annual cost of propranolol and carvedilol, the cost of treating uncomplicated ascites and cost of treating refractory ascites. The analysis focused on the management costs of ascites as opposed to other decompensation events, such as hepatic encephalopathy, because the evidence for the treatment effect of NSBBs was mainly driven by a reduction in ascites. The committee acknowledged that NSBBs may be more cost saving if evidence could support a broader range of decompensated events to be considered in the analysis, as conditions such as hepatic encephalopathy are more expensive to manage.</p><p>We estimated that the average cost of treating uncomplicated ascites is about £200, assuming 90% of people would develop moderate ascites and 10% would develop large ascites. People with moderate ascites are treated with a 6-month course of spironolactone while people with large ascites are treated with an average of 2 sessions of large volume paracentesis (LVP) plus human albumin. 10% of people with uncomplicated ascites are assumed to develop refractory ascites. We estimated the annual treatment cost of refractory ascites to be around £20,115. This is based on the assumption that 90% of people are given LVP every 2 weeks in combination with human albumin as per the EASL guidelines, and 10% are treated with transjugular intrahepatic portosystemic shunt (TIPS) according to NICE recommendations.</p><p>The committee noted that data on the proportion of people with each grade of ascites and their natural history were sparse, and based the assumption on their experience in the clinical practice. The treatment strategy for ascites is varied and complex, as it depends upon multiple patient factors such as their lifestyle or treatment preferences. As a result, it is challenging to accurately judge the resource utilisation for managing ascites but the committee was content that the costs in our analysis were broadly representative.</p><p>The total cost of managing a case of ascites is approximately £2,200, and the average annual cost of NSBBs (namely, propranolol and carvedilol) is approximately £27. Based on these costs, the analysis suggests that NSBBs may be cost saving overall if they prevent at least 1 episode averted per 82 person years. The evidence indicates that NSBBs can reduce incidence of decompensation by an average of 116 cases per 1,000 (1 case in every 8.6 people). While the outcome of this analysis is compelling enough to support NSBBs given the large cost difference between NSBB drugs and treatment of ascites, the committee noted that this evidence was based on a single study based outside of the UK and subsequently was subject to some degree of uncertainty, and thus elected to make a weak, rather than a strong recommendation to consider the use of NSBBs.</p><p>The committee discussed how people with clinically significant portal hypertension would be detected in England. In the PREDESCI trial, people with CSPH were defined by a hepatic venous pressure gradient (HVPG) ≥10 mm Hg. This is considered the gold standard approach, but requires an invasive and often painful procedure in order to measure, and may not be acceptable to a large number of people with cirrhosis. HVPG measurement is done in few liver centres in the UK, and there is not presently the capacity among the interventional radiologists to cope with the increased number of required procedures if this was implemented before giving non-selective beta blockers to these patients and to continue monitoring to estimate dose adjustments. CSPH can alternatively be diagnosed on the basis of clinical features (e.g. ascites, varices) as well as non-invasive methods including liver stiffness (transient elastography, or Fibroscan), serum biomarkers and other imaging. According to current NICE guidelines, these tests should be done as part of diagnosing cirrhosis or are part of ongoing monitoring to detect progression of disease, and so would not constitute any additional resources to implement.</p><p>The committee also highlighted that patients receiving non-selective beta blockers to prevent decompensation may not require ongoing monitoring with endoscopy to detect the development of varices, and this would possibly constitute some cost and capacity savings.</p></div><div id="niceng50er3.s1.1.12.5"><h5>1.1.12.5. Other factors the committee took into account</h5><p>The committee discussed whether the new recommendations might have any impact on health inequalities, and noted that people would have to be compliant with any regime of NSBB to get the full benefit from them. They acknowledged this might be a challenge for some people living with cirrhosis.</p></div></div><div id="niceng50er3.s1.1.13"><h4>1.1.13. Recommendations supported by this evidence review</h4><p>This evidence review supports recommendations 1.3.1 to 1.3.3 and the research recommendation on preventing decompensation.</p></div><div id="niceng50er3.rl.r1"><h4>1.1.14. References – included studies</h4><ul class="simple-list"><div id="niceng50er3.rl.r1.1"><h5>1.1.14.1. Effectiveness</h5><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="niceng50er3.ref1">Villanueva
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Candid, Albillos
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Agustin, Genesca
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Joan
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et al (2019) beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet (London, England)
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393(10181): 1597–1608 [<a href="https://pubmed.ncbi.nlm.nih.gov/30910320" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30910320</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng50er3.ref2">Villanueva
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Candid, Torres
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Ferran, Sarin
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Shiv Kumar
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et al (2022) Carvedilol reduces the risk of decompensation and mortality in patients with compensated cirrhosis in a competing-risk meta-analysis. Journal of hepatology
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77(4): 1014–1025 [<a href="https://pubmed.ncbi.nlm.nih.gov/35661713" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 35661713</span></a>]</div></p></li></ul></div><div id="niceng50er3.rl.r1.2"><h5>1.1.14.2. Economic</h5><ul class="simple-list"><p>None included.</p></ul></div><div id="niceng50er3.rl.r1.3"><h5>11.1.14.3. Other references</h5><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="niceng50er3.ref4">Mattock
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Tripathi, O'Neill
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Craig, Tanner
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Patch
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et al (2021) Economic evaluation of covered stents for transjugular intrahepatic portosystemic stent shunt in patients with variceal bleeding and refractory ascites secondary to cirrhosis. BMJ Open Gastroenterology
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8(1): e000641 [<a href="/pmc/articles/PMC8386212/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC8386212</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/34429322" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 34429322</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng50er3.ref5">Solà
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E., Solé
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C. and Ginès
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P. (2016), Management of uninfected and infected ascites in cirrhosis. Liver Int, 36: 109–115. [<a href="https://pubmed.ncbi.nlm.nih.gov/26725907" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26725907</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng50er3.ref6">British National Formulary (2023). Accessed at: <a href="https://bnf.nice.org.uk/" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://bnf<wbr style="display:inline-block"></wbr>​.nice.org.uk/</a></div></p></li></ul></div></ul></div></div></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng50er3.appa"><h3>Appendix A. Review protocols</h3><p id="niceng50er3.appa.et1"><a href="/books/NBK595737/bin/niceng50er3-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Review protocol for cirrhosis is in over 16s: assessment and management – primary prevention of decompensation in people with compensated cirrhosis</a><span class="small"> (PDF, 221K)</span></p></div><div id="niceng50er3.appb"><h3>Appendix B. Literature search strategies</h3><div id="niceng50er3.appb.s1"><h4>Background and development</h4><div id="niceng50er3.appb.s1.1"><h5>Search design and peer review</h5><p>A NICE information specialist conducted the literature searches for the evidence review. The searches were run on 1<sup>st</sup> February and 2<sup>nd</sup> February 2023. This search report is compliant with the requirements of the PRISMA Statement for Reporting Literature Searches in Systematic Reviews (for further details see: Rethlefsen M et al. <a href="https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-020-01542-z" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">PRISMA-S</a>. <i>Systematic Reviews</i>, 10(1), 39).</p><p>The MEDLINE strategy below was quality assured (QA) by a trained NICE information specialist. All translated search strategies were peer reviewed to ensure their accuracy. Both procedures were adapted from the Peer Review of Electronic Search Strategies Guideline Statement (for further details see: McGowan J et al. <a href="https://www.sciencedirect.com/science/article/pii/S0895435616000585" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">PRESS 2015 Guideline Statement</a>. <i>Journal of Clinical Epidemiology</i>, 75, 40–46). The principal search strategy was developed in MEDLINE (Ovid interface) and adapted, as appropriate, for use in the other sources listed in the protocol, taking into account their size, search functionality and subject coverage.</p></div><div id="niceng50er3.appb.s1.2"><h5>Review management</h5><p>The search results were managed in EPPI-Reviewer v5. Duplicates were removed in EPPI-R5 using a two-step process. First, automated deduplication is performed using a high-value algorithm. Second, manual deduplication is used to assess ‘low-probability’ matches. All decisions made for the review can be accessed via the deduplication history.</p></div><div id="niceng50er3.appb.s1.3"><h5>Prior work</h5><p>The population element of the search strategy is based on the standard population search used in the original guideline: <a href="https://www.nice.org.uk/guidance/ng50/evidence/appendices-ah-pdf-2546538877" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Cirrhosis in over 16s: Assessment and management. Appendix G</a> (2016) NICE guideline 50 Search terms for beta blockers have previously been used in RQ1 of this guideline update.</p></div><div id="niceng50er3.appb.s1.4"><h5>Limits and restrictions</h5><p>English language limits were applied in adherence to standard NICE practice and the review protocol. The limit to remove animal studies in the searches was the standard NICE practice, which has been adapted from: Dickersin K, Scherer R & Lefebvre C. (1994) <a href="https://www.bmj.com/content/309/6964/1286" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Systematic Reviews: Identifying relevant studies for systematic reviews</a>. <i>BMJ</i>, 309(6964), 1286.</p></div><div id="niceng50er3.appb.s1.5"><h5>Search filters and classifiers</h5><div id="niceng50er3.appb.s1.5.1"><h5>Clinical searches</h5><ul><li class="half_rhythm"><div>RCT filters:
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<ul class="circle"><li class="half_rhythm"><div class="half_rhythm"><a href="https://hiru.mcmaster.ca/hiru/HIRU_Hedges_MEDLINE_Strategies.aspx" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">McMaster Therapy – Medline - “best balance of sensitivity and specificity” version</a>.</div><div class="half_rhythm">Haynes
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RB
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et al (2005) Optimal search strategies for retrieving scientifically strong studies of treatment from Medline: analytical survey.
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<em>BMJ</em>, 330, 1179–1183. [<a href="/pmc/articles/PMC558012/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC558012</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/15894554" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15894554</span></a>]</div></li><li class="half_rhythm"><div class="half_rhythm"><a href="https://hiruweb.mcmaster.ca/hkr/hedges/embase/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">McMaster Therapy – Embase</a> “best balance of sensitivity and specificity” version.</div><div class="half_rhythm">Wong
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SSL
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et al (2006) Developing optimal search strategies for detecting clinically sound treatment studies in EMBASE. Journal of the Medical Library Association, 94(1), 41–47. [<a href="/pmc/articles/PMC1324770/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC1324770</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/16404468" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16404468</span></a>]</div></li></ul></div></li><li class="half_rhythm"><div>Systematic reviews filters:
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<ul class="simple-list"><li class="half_rhythm"><div>Lee, E.
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et al (2012) An optimal search filter for retrieving systematic reviews and meta-analyses. <em>BMC Medical Research Methodology,</em>
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12(1), 51 [<a href="/pmc/articles/PMC3515398/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3515398</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/22512835" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22512835</span></a>].</div></li></ul></div></li></ul><p>In MEDLINE, the standard NICE modifications were used: pubmed.tw added; systematic review.pt added from MeSH update 2019.</p><p>In Embase, the standard NICE modifications were used: pubmed.tw added to line medline.tw.</p></div><div id="niceng50er3.appb.s1.5.2"><h5>Cost effectiveness searches</h5><p>The following search filters were applied to the search strategies in MEDLINE and Embase to identify cost-effectiveness studies:
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<ul><li class="half_rhythm"><div>Glanville
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J
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et al (2009) Development and Testing of Search Filters to Identify Economic Evaluations in MEDLINE and EMBASE. Alberta: Canadian Agency for Drugs and Technologies in Health (CADTH)</div></li><li id="niceng50er3.lt8" class="half_rhythm"><div>Hubbard
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W, Walsh
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N, Hudson
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T
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et al (2022) Development and validation of paired MEDLINE and Embase search filters for cost-utility studies. BMC Medical Research Methodology
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22(1), 310 [<a href="/pmc/articles/PMC9719242/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC9719242</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36463100" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36463100</span></a>]</div></li></ul></p></div><div id="niceng50er3.appb.s1.5.3"><h5>Key decisions</h5><p>The population element of the search strategy was based on the previous guideline standard population strategy. The intervention elements of the search were based on the requirements of the review protocol. Relevant free text terms and database subject terms were identified as part of strategy development. The search strategy was simplified for Epistemonikos to adapt to that databases functionality.</p><p>In January 2023 there was a data processing error in Ovid Embase. This error was fixed on 22nd February 2023. Additional results missed during the data processing error in Embase were added to the total search results on 22nd February 2023.</p></div></div></div><div id="niceng50er3.appb.s1.6"><h4>Clinical searches</h4><div id="niceng50er3.appb.s1.6.1"><h5>Main search – Databases</h5><p id="niceng50er3.appb.et1"><a href="/books/NBK595737/bin/niceng50er3-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (177K)</span></p></div><div id="niceng50er3.appb.s1.6.2"><h5>Search strategy history</h5><p id="niceng50er3.appb.et2"><a href="/books/NBK595737/bin/niceng50er3-appb-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (208K)</span></p></div></div><div id="niceng50er3.appb.s1.7"><h4>Cost-effectiveness searches</h4><div id="niceng50er3.appb.s1.7.1"><h5>Main search – Databases</h5><p id="niceng50er3.appb.et3"><a href="/books/NBK595737/bin/niceng50er3-appb-et3.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (189K)</span></p></div><div id="niceng50er3.appb.s1.7.2"><h5>Search strategy history</h5><p id="niceng50er3.appb.et4"><a href="/books/NBK595737/bin/niceng50er3-appb-et4.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (266K)</span></p></div></div></div><div id="niceng50er3.appc"><h3>Appendix C. Effectiveness evidence study selection</h3><p id="niceng50er3.appc.et1"><a href="/books/NBK595737/bin/niceng50er3-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (116K)</span></p></div><div id="niceng50er3.appd"><h3>Appendix D. Effectiveness evidence</h3><p id="niceng50er3.appd.et1"><a href="/books/NBK595737/bin/niceng50er3-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (310K)</span></p></div><div id="niceng50er3.appe"><h3>Appendix E. Forest plots</h3><p>No meta-analysis was undertaken for this review.</p></div><div id="niceng50er3.appf"><h3>Appendix F. GRADE tables</h3><p id="niceng50er3.appf.et1"><a href="/books/NBK595737/bin/niceng50er3-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (182K)</span></p></div><div id="niceng50er3.appg"><h3>Appendix G. Economic evidence study selection</h3><p id="niceng50er3.appg.et1"><a href="/books/NBK595737/bin/niceng50er3-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (90K)</span></p></div><div id="niceng50er3.apph"><h3>Appendix H. Economic evidence tables</h3><p>No economic studies were identified.</p></div><div id="niceng50er3.appi"><h3>Appendix I. Health economic model</h3><p id="niceng50er3.appi.et1"><a href="/books/NBK595737/bin/niceng50er3-appi-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (185K)</span></p></div><div id="niceng50er3.appj"><h3>Appendix J. Excluded studies</h3><div id="niceng50er3.appj.s1.1"><h4>Effectiveness evidence</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng50er3appjtab1"><a href="/books/NBK595737/table/niceng50er3.appj.tab1/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figniceng50er3appjtab1" rid-ob="figobniceng50er3appjtab1"><img class="small-thumb" src="/books/NBK595737/table/niceng50er3.appj.tab1/?report=thumb" src-large="/books/NBK595737/table/niceng50er3.appj.tab1/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="niceng50er3.appj.tab1"><a href="/books/NBK595737/table/niceng50er3.appj.tab1/?report=objectonly" target="object" rid-ob="figobniceng50er3appjtab1">Table</a></h4></div></div></div><div id="niceng50er3.appj.s1.2"><h4>Economic evidence</h4><p>All studies were excluded after title and abstract screening, and none were reviewed at full text.</p></div></div><div id="niceng50er3.appk"><h3>Appendix K. Research recommendations – full details</h3><div id="niceng50er3.appk.s1"><h4>K1.1. Research recommendation</h4><p>What is the clinical and cost effectiveness, and acceptability, of non-selective beta-blockers for the primary prevention of decompensation in people with compensated cirrhosis and signs of clinically significant portal hypertension?</p><div id="niceng50er3.appk.s1.1"><h5>K1.1.1. Why this is important</h5><p>Data from 1 RCT and 1 IPD meta-analysis indicate that propranolol and carvedilol may significantly reduce decompensation in people with cirrhosis. Decompensation is associated with negative outcomes such as bleeding and death.</p></div><div id="niceng50er3.appk.s1.2"><h5>K1.1.2. Rationale for research recommendation</h5><p id="niceng50er3.appk.et1"><a href="/books/NBK595737/bin/niceng50er3-appk-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (103K)</span></p></div><div id="niceng50er3.appk.s1.3"><h5>K1.1.3. Modified PICO table</h5><p id="niceng50er3.appk.et2"><a href="/books/NBK595737/bin/niceng50er3-appk-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (106K)</span></p></div></div></div></div></div><div class="fm-sec"><div><p>Final version</p></div><div><p>Evidence reviews underpinning recommendations 1.3.1 to 1.3.3 and research recommendations in the NICE guideline</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="https://www.gov.scot/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="https://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 2023.</div><div class="small"><span class="label">Bookshelf ID: NBK595737</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/37816097" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">37816097</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng50er3tab1"><div id="niceng50er3.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">PICOS inclusion criteria</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595737/table/niceng50er3.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng50er3.tab1_lrgtbl__"><table><tbody><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Inclusion:</p>
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<p>People aged 16 years and older with compensated cirrhosis.</p>
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<p>Exclusion:</p>
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<p>People who have had previous episodes of decompensated cirrhosis.</p>
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</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Interventions</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Non-selective beta-blockers (NSBBs):<ul><li class="half_rhythm"><div>Nadolol,</div></li><li class="half_rhythm"><div>Timolol maleate,</div></li><li class="half_rhythm"><div>Sotalol,</div></li><li class="half_rhythm"><div>Carvedilol,</div></li><li class="half_rhythm"><div>Labetalol,</div></li><li class="half_rhythm"><div>Propranolol.</div></li></ul></p>
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<p>All non-selective beta-blockers (NSBBs) (as class vs placebo/no intervention)</p>
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</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparator</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Each other</div></li><li class="half_rhythm"><div>Placebo/no intervention</div></li></ul>
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</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p><b>Primary outcomes</b> (at longest timepoint)<ul><li class="half_rhythm"><div>Decompensation (as defined by the study)</div></li><li class="half_rhythm"><div>Mortality</div></li><li class="half_rhythm"><div>Quality of life (using a validated scale)</div></li></ul></p>
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<p><b>Secondary outcomes</b> (at longest timepoint)<ul><li class="half_rhythm"><div>Liver transplant</div></li><li class="half_rhythm"><div>Hospitalisation (including length of hospital stay)</div></li><li class="half_rhythm"><div>Other adverse events<ul class="circle"><li class="half_rhythm"><div>Compliance with intervention/discontinuation</div></li><li class="half_rhythm"><div>Infection</div></li></ul></div></li></ul></p>
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</td></tr><tr><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study type</td><td rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Randomised Controlled Trials</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng50er3tab2"><div id="niceng50er3.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of studies included in the effectiveness evidence</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595737/table/niceng50er3.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng50er3.tab2_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng50er3.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Study details</th><th id="hd_h_niceng50er3.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Setting/Location</th><th id="hd_h_niceng50er3.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Population</th><th id="hd_h_niceng50er3.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Intervention</th><th id="hd_h_niceng50er3.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Comparison</th><th id="hd_h_niceng50er3.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:middle;">Risk of bias</th></tr></thead><tbody><tr><td headers="hd_h_niceng50er3.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<a class="bibr" href="#niceng50er3.ref2" rid="niceng50er3.ref2">Villanueva (2022)</a>
|
|
</p>
|
|
<p>N=352</p>
|
|
<p>Study type: IPD meta-analysis</p>
|
|
<p>Follow up time: The mean follow-up in the included RCTs ranged from 13 to 36 months.</p>
|
|
</td><td headers="hd_h_niceng50er3.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Setting: NA</p>
|
|
<p>Location: NA</p>
|
|
</td><td headers="hd_h_niceng50er3.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Adults with compensated cirrhosis and no history of decompensation.</p>
|
|
<p>Mean age (IQR):<ul><li class="half_rhythm"><div>Intervention: 53 (45 – 60)</div></li><li class="half_rhythm"><div>Placebo/EVL: 51 (44 – 59)</div></li></ul></p>
|
|
</td><td headers="hd_h_niceng50er3.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Carvedilol was administered up to 12.5 mg/day in 2 studies (Tripathi et al 2009; Bhardwaj et al 2017) and up to 25 mg/day in 2 studies (<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva 2019</a>; Shah et al 2014)</td><td headers="hd_h_niceng50er3.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Endoscopic variceal band ligation (Tripathi et al 2009; Bhardwaj et al 2017) and Placebo (<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva 2019</a>; Shah et al 2014).</td><td headers="hd_h_niceng50er3.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low</td></tr><tr><td headers="hd_h_niceng50er3.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>
|
|
<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva (2019)</a>
|
|
</p>
|
|
<p>N=201</p>
|
|
<p>Study type: RCT</p>
|
|
<p>Follow up time:</p>
|
|
<p>Mean (SD) follow up (months) -<ul><li class="half_rhythm"><div>Placebo group 37 (16)</div></li><li class="half_rhythm"><div>Intervention group 36 (16)</div></li></ul></p>
|
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</td><td headers="hd_h_niceng50er3.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>Setting: Eight hospitals</p>
|
|
<p>Location: Spain</p>
|
|
</td><td headers="hd_h_niceng50er3.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>Patients with cirrhosis aged between 18 and 80 years inclusive, without any previous decompensation of cirrhosis and without high-risk oesophageal varices (i.e. no varices or small varices without red signs).</p>
|
|
<p>Mean age (SD):<ul><li class="half_rhythm"><div>Intervention: 60 (10)</div></li><li class="half_rhythm"><div>Control: 59 (11)</div></li></ul></p>
|
|
</td><td headers="hd_h_niceng50er3.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Propranolol or carvedilol titrated against clinical tolerance.<ul><li class="half_rhythm"><div>Mean dose of propranolol per day = 95mg (SD: 81)</div></li><li class="half_rhythm"><div>Mean dose carvedilol per day = 20mg (SD: 6)</div></li></ul></td><td headers="hd_h_niceng50er3.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Oral placebo allocated and administered in line with the approach to beta-blocker regimen.</td><td headers="hd_h_niceng50er3.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Low</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Abbreviations: EVL – endoscopic variceal band ligation</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng50er3tab3"><div id="niceng50er3.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Summary of the effectiveness evidence for decompensation</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595737/table/niceng50er3.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng50er3.tab3_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng50er3.tab3_1_1_1_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">NSBB compared to placebo for decompensation</th></tr><tr><th headers="hd_h_niceng50er3.tab3_1_1_1_1" id="hd_h_niceng50er3.tab3_1_1_2_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
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<span class="hr"></span>
|
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</th></tr><tr><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1" id="hd_h_niceng50er3.tab3_1_1_3_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;"></th></tr><tr><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1" id="hd_h_niceng50er3.tab3_1_1_4_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
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<span class="hr"></span>
|
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</th></tr><tr><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1" id="hd_h_niceng50er3.tab3_1_1_5_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_2" id="hd_h_niceng50er3.tab3_1_1_5_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>No of Participants (studies)</p>
|
|
<p>Follow up</p>
|
|
</th><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_3" id="hd_h_niceng50er3.tab3_1_1_5_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Quality of the evidence (GRADE)</th><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_4" id="hd_h_niceng50er3.tab3_1_1_5_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Relative effect (95% CI)</th><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1" id="hd_h_niceng50er3.tab3_1_1_5_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Anticipated absolute effects</th><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_6" id="hd_h_niceng50er3.tab3_1_1_5_6" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Interpretation of effect</th></tr><tr><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5" id="hd_h_niceng50er3.tab3_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Risk with 1</th><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5" id="hd_h_niceng50er3.tab3_1_1_6_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Risk difference with NSBB (95% CI)</th></tr><tr><th headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_5_6" id="hd_h_niceng50er3.tab3_1_1_7_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</th></tr></thead><tbody><tr><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Decompensation or death - NSBB (all) vs placebo</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>201</p>
|
|
<p>(1 study<sup>1</sup>)</p>
|
|
<p>36.5 months</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊖</p>
|
|
<p>
|
|
<b>MODERATE</b>
|
|
<sup>
|
|
3
|
|
</sup>
|
|
</p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>RR 0.6</b>
|
|
</p>
|
|
<p>(0.34 to 1.04)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>267 per 1000</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>107 fewer per 1000</b>
|
|
</p>
|
|
<p>(from 176 fewer to 11 more)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_6 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Could not differentiate</b>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_7_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_5_6" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Decompensation or death - Carvedilol vs placebo</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>66</p>
|
|
<p>(1 study<sup>1</sup>)</p>
|
|
<p>36.5 months</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊖</p>
|
|
<p>
|
|
<b>MODERATE</b>
|
|
<sup>
|
|
3
|
|
</sup>
|
|
</p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>RR 0.33</b>
|
|
</p>
|
|
<p>(0.1 to 1.12)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>273 per 1000</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>183 fewer per 1000</b>
|
|
</p>
|
|
<p>(from 245 fewer to 33 more)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_6 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Could not differentiate</b>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_7_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_5_6" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Decompensation or death - Propranolol vs placebo</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>135</p>
|
|
<p>(1 study<sup>1</sup>)</p>
|
|
<p>36.5</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊖⊖</p>
|
|
<p>
|
|
<b>LOW</b>
|
|
<sup>
|
|
3
|
|
</sup>
|
|
</p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>RR 0.73</b>
|
|
</p>
|
|
<p>(0.39 to 1.37)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>265 per 1000</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>71 fewer per 1000</b>
|
|
</p>
|
|
<p>(from 161 fewer to 98 more)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_6 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Could not differentiate</b>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_7_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_5_6" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Decompensation - Decompensation (all)</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>201</p>
|
|
<p>(1 study<sup>1</sup>)</p>
|
|
<p>36.5 months</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊖</p>
|
|
<p>
|
|
<b>MODERATE</b>
|
|
<sup>
|
|
3
|
|
</sup>
|
|
</p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>RR 0.51</b>
|
|
</p>
|
|
<p>(0.27 to 0.95)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>238 per 1000</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>116 fewer per 1000</b>
|
|
</p>
|
|
<p>(from 12 fewer to 173 fewer)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_6 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Favours NSBB</b>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_7_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_5_6" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Decompensation - Decompensated liver resulting in death</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>36</p>
|
|
<p>(1 study<sup>1</sup>)</p>
|
|
<p>36.5 months</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_3 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊖⊖</p>
|
|
<p>
|
|
<b>LOW</b>
|
|
<sup>
|
|
3
|
|
</sup>
|
|
</p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_4 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>RR 0.89</b>
|
|
</p>
|
|
<p>(0.34 to 2.3)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_1 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>375 per 1000</b>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_5 hd_h_niceng50er3.tab3_1_1_6_2 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>41 fewer per 1000</b>
|
|
</p>
|
|
<p>(from 248 fewer to 487 more)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab3_1_1_1_1 hd_h_niceng50er3.tab3_1_1_2_1 hd_h_niceng50er3.tab3_1_1_3_1 hd_h_niceng50er3.tab3_1_1_4_1 hd_h_niceng50er3.tab3_1_1_5_6 hd_h_niceng50er3.tab3_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Could not differentiate</b>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>*</dt><dd><div id="niceng50er3.tab3_1"><p class="no_margin">The basis for the <b>assumed risk</b> is the median control group risk across studies. The <b>corresponding risk</b> (and its 95% confidence interval) is based on the assumed risk in the comparison group and the <b>relative effect</b> of the intervention (and its 95% CI).</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>CI:</b> Confidence interval; <b>RR:</b> Risk ratio;</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">GRADE Working Group grades of evidence</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>High quality:</b> Further research is very unlikely to change our confidence in the estimate of effect.</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>Moderate quality:</b> Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>Low quality:</b> Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>Very low quality:</b> We are very uncertain about the estimate.</p></div></dd></dl><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng50er3.tab3_2"><p class="no_margin">
|
|
<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva 2019</a>
|
|
</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng50er3.tab3_3"><p class="no_margin">Downgraded once for crossing 1 MID</p></div></dd></dl><dl class="bkr_refwrap"><dt>3</dt><dd><div id="niceng50er3.tab3_4"><p class="no_margin">Downgraded twice for crossing 2 MIDs.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng50er3tab4"><div id="niceng50er3.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">Summary of the effectiveness evidence for adverse events</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595737/table/niceng50er3.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng50er3.tab4_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng50er3.tab4_1_1_1_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">NSBB compared to placebo for adverse events</th></tr><tr><th headers="hd_h_niceng50er3.tab4_1_1_1_1" id="hd_h_niceng50er3.tab4_1_1_2_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</th></tr><tr><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1" id="hd_h_niceng50er3.tab4_1_1_3_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;"></th></tr><tr><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1" id="hd_h_niceng50er3.tab4_1_1_4_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</th></tr><tr><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_1" id="hd_h_niceng50er3.tab4_1_1_5_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_2" id="hd_h_niceng50er3.tab4_1_1_5_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>No of Participants (studies)</p>
|
|
<p>Follow up</p>
|
|
</th><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_3" id="hd_h_niceng50er3.tab4_1_1_5_3" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Quality of the evidence (GRADE)</th><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_4" id="hd_h_niceng50er3.tab4_1_1_5_4" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Relative effect (95% CI)</th><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1" id="hd_h_niceng50er3.tab4_1_1_5_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:top;">Anticipated absolute effects</th><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_6" id="hd_h_niceng50er3.tab4_1_1_5_6" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Interpretation of effect</th></tr><tr><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_5" id="hd_h_niceng50er3.tab4_1_1_6_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Risk with Control</th><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_5" id="hd_h_niceng50er3.tab4_1_1_6_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Risk difference with (95% CI)</th></tr><tr><th headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_1 hd_h_niceng50er3.tab4_1_1_5_2 hd_h_niceng50er3.tab4_1_1_5_3 hd_h_niceng50er3.tab4_1_1_5_4 hd_h_niceng50er3.tab4_1_1_5_5 hd_h_niceng50er3.tab4_1_1_6_1 hd_h_niceng50er3.tab4_1_1_6_2 hd_h_niceng50er3.tab4_1_1_5_6" id="hd_h_niceng50er3.tab4_1_1_7_1" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</th></tr></thead><tbody><tr><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_1 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Adverse events - Adverse events - all</b>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_2 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>201</p>
|
|
<p>(1 study<sup>1</sup>)</p>
|
|
<p>36.5 months</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_3 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊕</p>
|
|
<p>
|
|
<b>HIGH</b>
|
|
</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_4 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>RR 0.96</b>
|
|
</p>
|
|
<p>(0.86 to 1.08)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_5 hd_h_niceng50er3.tab4_1_1_6_1 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>871 per 1000</b>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_5 hd_h_niceng50er3.tab4_1_1_6_2 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>35 fewer per 1000</b>
|
|
</p>
|
|
<p>(from 122 fewer to 70 more)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_6 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Could not differentiate</b>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_1 hd_h_niceng50er3.tab4_1_1_7_1 hd_h_niceng50er3.tab4_1_1_5_2 hd_h_niceng50er3.tab4_1_1_5_3 hd_h_niceng50er3.tab4_1_1_5_4 hd_h_niceng50er3.tab4_1_1_5_5 hd_h_niceng50er3.tab4_1_1_6_1 hd_h_niceng50er3.tab4_1_1_6_2 hd_h_niceng50er3.tab4_1_1_5_6" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_1 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Adverse events - Adverse events - probably related to treatment</b>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_2 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>201</p>
|
|
<p>(1 study<sup>1</sup>)</p>
|
|
<p>36.5 months</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_3 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊕⊖</p>
|
|
<p>
|
|
<b>MODERATE</b>
|
|
<sup>
|
|
2
|
|
</sup>
|
|
</p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_4 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>RR 1.31</b>
|
|
</p>
|
|
<p>(0.89 to 1.93)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_5 hd_h_niceng50er3.tab4_1_1_6_1 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>297 per 1000</b>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_5 hd_h_niceng50er3.tab4_1_1_6_2 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>92 more per 1000</b>
|
|
</p>
|
|
<p>(from 33 fewer to 276 more)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_6 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Could not differentiate</b>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_1 hd_h_niceng50er3.tab4_1_1_7_1 hd_h_niceng50er3.tab4_1_1_5_2 hd_h_niceng50er3.tab4_1_1_5_3 hd_h_niceng50er3.tab4_1_1_5_4 hd_h_niceng50er3.tab4_1_1_5_5 hd_h_niceng50er3.tab4_1_1_6_1 hd_h_niceng50er3.tab4_1_1_6_2 hd_h_niceng50er3.tab4_1_1_5_6" colspan="7" rowspan="1" style="text-align:left;vertical-align:top;">
|
|
<span class="hr"></span>
|
|
</td></tr><tr><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_1 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Adverse events - Adverse events - very probably related to treatment</b>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_2 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>201</p>
|
|
<p>(1 study<sup>1</sup>)</p>
|
|
<p>36.5 months</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_3 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>⊕⊕⊖⊖</p>
|
|
<p>
|
|
<b>LOW</b>
|
|
<sup>
|
|
3
|
|
</sup>
|
|
</p>
|
|
<p>due to imprecision</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_4 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>
|
|
<b>RR 1.08</b>
|
|
</p>
|
|
<p>(0.56 to 2.06)</p>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_5 hd_h_niceng50er3.tab4_1_1_6_1 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>0 per 1000</b>
|
|
</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_5 hd_h_niceng50er3.tab4_1_1_6_2 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng50er3.tab4_1_1_1_1 hd_h_niceng50er3.tab4_1_1_2_1 hd_h_niceng50er3.tab4_1_1_3_1 hd_h_niceng50er3.tab4_1_1_4_1 hd_h_niceng50er3.tab4_1_1_5_6 hd_h_niceng50er3.tab4_1_1_7_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<b>Could not differentiate</b>
|
|
</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>*</dt><dd><div id="niceng50er3.tab4_1"><p class="no_margin">The basis for the <b>assumed risk</b> is. the median control group risk across studies. The <b>corresponding risk</b> (and its 95% confidence interval) is based on the assumed risk in the comparison group and the <b>relative effect</b> of the intervention (and its 95% CI).</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>CI:</b> Confidence interval; <b>RR:</b> Risk ratio;</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">GRADE Working Group grades of evidence</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>High quality:</b> Further research is very unlikely to change our confidence in the estimate of effect.</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>Moderate quality:</b> Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>Low quality:</b> Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.</p></div></dd></dl><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin"><b>Very low quality:</b> We are very uncertain about the estimate.</p></div></dd></dl><dl class="bkr_refwrap"><dt>1</dt><dd><div id="niceng50er3.tab4_2"><p class="no_margin">
|
|
<a class="bibr" href="#niceng50er3.ref1" rid="niceng50er3.ref1">Villanueva 2019</a>
|
|
</p></div></dd></dl><dl class="bkr_refwrap"><dt>2</dt><dd><div id="niceng50er3.tab4_3"><p class="no_margin">Downgraded once for crossing 1 MID</p></div></dd></dl><dl class="bkr_refwrap"><dt>3</dt><dd><div id="niceng50er3.tab4_4"><p class="no_margin">Downgraded twice for crossing 2 MIDs.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng50er3tab5"><div id="niceng50er3.tab5" class="table"><h3><span class="label">Table 5</span><span class="title">Health economic evidence profile: non-selective beta blockers (NSBBs) vs placebo for preventing decompensation of cirrhosis</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595737/table/niceng50er3.tab5/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng50er3.tab5_lrgtbl__"><table><thead><tr><th id="hd_h_niceng50er3.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study type</th><th id="hd_h_niceng50er3.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Applicability</th><th id="hd_h_niceng50er3.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Threshold (cases averted to be cost saving)</th><th id="hd_h_niceng50er3.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Risk reduction in decompensation</th><th id="hd_h_niceng50er3.tab5_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost saving</th></tr></thead><tbody><tr><td headers="hd_h_niceng50er3.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Threshold analysis</td><td headers="hd_h_niceng50er3.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Directly applicable</td><td headers="hd_h_niceng50er3.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1 episode averted per 82.68 person years</td><td headers="hd_h_niceng50er3.tab5_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">1 case in every 8.6 people</td><td headers="hd_h_niceng50er3.tab5_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Yes</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng50er3tab6"><div id="niceng50er3.tab6" class="table"><h3><span class="label">Table 6</span><span class="title">Unit costs of non-selective beta blockers</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595737/table/niceng50er3.tab6/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng50er3.tab6_lrgtbl__"><table><thead><tr><th id="hd_h_niceng50er3.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Resource</th><th id="hd_h_niceng50er3.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Daily dose</th><th id="hd_h_niceng50er3.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unit costs</th><th id="hd_h_niceng50er3.tab6_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Source</th></tr></thead><tbody><tr><td headers="hd_h_niceng50er3.tab6_1_1_1_1" rowspan="3" colspan="1" style="text-align:left;vertical-align:top;">Propranolol (tablets)</td><td headers="hd_h_niceng50er3.tab6_1_1_1_2" rowspan="3" colspan="1" style="text-align:left;vertical-align:top;">80–320 mg</td><td headers="hd_h_niceng50er3.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.79 for 28 40mg tablets</td><td headers="hd_h_niceng50er3.tab6_1_1_1_4" rowspan="7" colspan="1" style="text-align:left;vertical-align:top;">BNF (accessed Mar 2023)</td></tr><tr><td headers="hd_h_niceng50er3.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£1.57 for 56 80mg tablets</td></tr><tr><td headers="hd_h_niceng50er3.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£5.88 for 56 160mg tablets</td></tr><tr><td headers="hd_h_niceng50er3.tab6_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Propranolol (oral solution)</td><td headers="hd_h_niceng50er3.tab6_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">80–320 mg</td><td headers="hd_h_niceng50er3.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£45.84 for 40mg</td></tr><tr><td headers="hd_h_niceng50er3.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£50.45 for 50mg</td></tr><tr><td headers="hd_h_niceng50er3.tab6_1_1_1_1" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">Carvedilol</td><td headers="hd_h_niceng50er3.tab6_1_1_1_2" rowspan="2" colspan="1" style="text-align:left;vertical-align:top;">6.25–12.5 mg</td><td headers="hd_h_niceng50er3.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.88 for 28 6.25mg tablets</td></tr><tr><td headers="hd_h_niceng50er3.tab6_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£1.25 for 28 12.5mg tablets</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng50er3tab7"><div id="niceng50er3.tab7" class="table"><h3><span class="label">Table 7</span><span class="title">Unit costs of managing decompensation events</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595737/table/niceng50er3.tab7/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng50er3.tab7_lrgtbl__"><table><thead><tr><th id="hd_h_niceng50er3.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Decompensation event</th><th id="hd_h_niceng50er3.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Annual cost per person</th></tr></thead><tbody><tr><td headers="hd_h_niceng50er3.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Treatment costs of managing uncomplicated ascites (moderate and large)</td><td headers="hd_h_niceng50er3.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£201</td></tr><tr><td headers="hd_h_niceng50er3.tab7_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Treatment costs of managing refractory ascites</td><td headers="hd_h_niceng50er3.tab7_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£20,115</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng50er3appjtab1"><div id="niceng50er3.appj.tab1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595737/table/niceng50er3.appj.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng50er3.appj.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_niceng50er3.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng50er3.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Reason for exclusion</th></tr></thead><tbody><tr><td headers="hd_h_niceng50er3.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Gillespie, S.-L., Hanrahan, T.P., Rockeye, D.C.
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et al (2023) Review article: controversies surrounding the use of carvedilol and other beta blockers in the management of portal hypertension and cirrhosis. Alimentary pharmacology & therapeutics [<a href="https://pubmed.ncbi.nlm.nih.gov/36691947" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36691947</span></a>]
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</td><td headers="hd_h_niceng50er3.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Review article but not a systematic review</td></tr><tr><td headers="hd_h_niceng50er3.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Groszmann
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RJ, Garcia-Tsao
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G, Bosch
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J
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et al (2005) Beta-blockers to prevent gastroesophageal varices in patients with cirrhosis. The New England journal of medicine
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353(21): 2254–2261 [<a href="https://pubmed.ncbi.nlm.nih.gov/16306522" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16306522</span></a>]
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</td><td headers="hd_h_niceng50er3.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Does not report outcome of interest</td></tr></tbody></table></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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