Systematic reviews included in this broad synthesis

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Systematic review

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Banding ligation versus beta-blockers for primary prevention in oesophageal varices in adults.

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Authors Gluud LL , Krag A
Journal Cochrane Database of Systematic Reviews
Year 2012
Links Pubmed DOI

This article is included in 3 Broad syntheses 19 Broad syntheses (3 references)

This article includes 23 Primary studies 19 Primary studies (23 references)

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Non-selective beta-blockers are used as a first-line treatment for primary prevention in patients with medium- to high-risk oesophageal varices. The effect of non-selective beta-blockers on mortality is debated and many patients experience adverse events. Trials on banding ligation versus non-selective beta-blockers for patients with oesophageal varices and no history of bleeding have reached equivocal results. To compare the benefits and harms of banding ligation versus non-selective beta-blockers as primary prevention in adult patients with endoscopically verified oesophageal varices that have never bled, irrespective of the underlying liver disease (cirrhosis or other cause). In Febuary 2012, electronic searches (the Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded) and manual searches (including scanning of reference lists in relevant articles and conference proceedings) were performed. Randomised trials were included irrespective of publication status, blinding, and language. Review authors independently extracted data. All-cause mortality was the primary outcome. Intention-to-treat random-effects and fixed-effect model meta-analyses were performed. Results were presented as risk ratios (RR) and 95% confidence intervals (CI) with I(2) statistic values as a measure of intertrial heterogeneity. Subgroup, sensitivity, regression, and trial sequential analyses were performed to evaluate the robustness of the overall results, risks of bias, sources of intertrial heterogeneity, and risks of random errors. Nineteen randomised trials on banding ligation versus non-selective beta-blockers for primary prevention in oesophageal varices were included. Most trials specified that only patients with large or high-risk oesophageal varices were included. Bias control was unclear in most trials. In total, 176 of 731 (24%) of the patients randomised to banding ligation and 177 of 773 (23%) of patients randomised to non-selective beta-blockers died. The difference was not statistically significant in a random-effects meta-analysis (RR 1.09; 95% CI 0.92 to 1.30; I(2) = 0%). There was no evidence of bias or small study effects in regression analysis (Egger's test P = 0.997). Trial sequential analysis showed that the heterogeneity-adjusted low-bias trial relative risk estimate required an information size of 3211 patients, that none of the interventions showed superiority, and that the limits of futility have not been reached. When all trials were included, banding ligation reduced upper gastrointestinal bleeding and variceal bleeding compared with non-selective beta-blockers (RR 0.69; 95% CI 0.52 to 0.91; I(2) = 19% and RR 0.67; 95% CI 0.46 to 0.98; I(2) = 31% respectively). The beneficial effect of banding ligation on bleeding was not confirmed in subgroup analyses of trials with adequate randomisation or full paper articles. Bleeding-related mortality was not different in the two intervention arms (29/567 (5.1%) versus 37/585 (6.3%); RR 0.85; 95% CI 0.53 to 1.39; I(2) = 0%). Both interventions were associated with adverse events. This review found a beneficial effect of banding ligation on primary prevention of upper gastrointestinal bleeding in patient with oesophageal varices. The effect on bleeding did not reduce mortality. Additional evidence is needed to determine whether our results reflect that non-selective beta-blockers have other beneficial effects than on bleeding.[CINAHL Note: The Cochrane Collaboration systematic reviews contain interactive software that allows various calculations in the MetaView.]

Systematic review

Unclassified

Meta-analysis: beta-blockers versus banding ligation for primary prophylaxis of esophageal variceal bleeding.

Journal Annals of hepatology
Year 2012
Links Pubmed Google Scholar

This article is included in 1 Structured summary of systematic reviews 19 Structured summaries of systematic reviews (1 reference) 2 Broad syntheses 19 Broad syntheses (2 references)

This article includes 19 Primary studies 19 Primary studies (19 references)

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AIM: To perform an updated meta-analysis comparing β-blockers (BB) with endoscopic variceal banding ligation (EVBL) in the primary prophylaxis of esophageal variceal bleeding. MATERIAL AND METHODS: Randomized controlled trials were identified through electronic databases, article reference lists and conference proceedings. Analysis was performed using both fixed-effect and random-effect models. Heterogeneity and publication bias were systematically taken into account. Main outcomes were variceal bleeding rates and all-cause mortality, calculated overall and at 6, 12, 18 and 24 months. RESULTS: 19 randomized controlled trials were analyzed including a total of 1,483 patients. Overall bleeding rates were significantly lower for the EVBL group: odds ratio (OR) 2.06, 95% confidence interval (CI) [1.55-2.73], p < 0.0001, without evidence of publication bias. Bleeding rates were also significantly lower at 18 months (OR 2.20, 95% CI [1.04-4.60], P = 0.04), but publication bias was detected. When only high quality trials were taken into account, results for bleeding rates were no longer significant. No significant difference was found for either bleeding-related mortality or for all-cause mortality overall or at 6, 12, 18 or 24 months. BB were associated with more frequent severe adverse events (OR 2.61, 95% CI 1.60-4.40, P < 0.0001) whereas fatal adverse events were more frequent with EVBL (OR 0.14, 95% CI 0.02-0.99, P = 0.05). CONCLUSION: EVBL appears to be superior to BB in preventing the first variceal bleed, although this finding may be biased as it was not confirmed by high quality trials. No difference was found for mortality. Current evidence is insufficient to recommend EVBL over BB as first-line therapy.

Systematic review

Unclassified

Endoscopic band ligation versus pharmacological therapy for variceal bleeding in cirrhosis: a meta-analysis.

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Authors Li L , Yu C , Li Y
Journal Canadian journal of gastroenterology = Journal canadien de gastroenterologie
Year 2011
Links Pubmed DOI PubMed Central

This article is included in 1 Structured summary of systematic reviews 18 Structured summaries of systematic reviews (1 reference) 2 Broad syntheses 18 Broad syntheses (2 references)

This article includes 18 Primary studies 18 Primary studies (18 references)

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OBJECTIVE: To conduct a meta-analysis of published, full-length, randomized controlled trials evaluating the efficacy of endoscopic band ligation (EBL) versus pharmacological therapy for the primary and secondary prophylaxis of variceal hemorrhage in patients with cirrhosis. METHODS: Literature searches were conducted using the PubMed, EMBASE and Cochrane Library databases. Eighteen randomized clinical trials that fulfilled the inclusion criteria were further pooled into a meta-analysis. RESULTS: Among 1023 patients in 12 trials comparing EBL with beta-blockers for primary prevention, there was no significant difference in gastrointestinal bleeding (RR 0.79 [95% CI 0.61 to 1.02]), all-cause deaths (RR 1.06 [95% CI 0.86 to 1.30]) or bleeding-related deaths (RR 0.66 [95% CI 0.38 to 1.16]). There was a reduced trend toward significance in variceal bleeding with EBL compared with betablockers (RR 0.72 [95% CI 0.54 to 0.96]). However, variceal bleeding was not significantly different between the two groups in high-quality trials (RR 0.84 [95% CI 0.60 to 1.17]). Among 687 patients from six trials comparing EBL with beta-blockers plus isosorbide mononitrate for secondary prevention, there was no effect on either gastrointestinal bleeding (RR 0.95 [95% CI 0.65 to 1.40]) or variceal bleeding (RR 0.89 [95% CI 0.53 to 1.49]). The risk for all-cause deaths in the EBL group was significantly higher than in the medical group (RR 1.25 [95% CI 1.01 to 1.55]); however, the rate of bleeding related deaths was unaffected (RR 1.16 [95% CI 0.68 to 1.97]). CONCLUSIONS: Both EBL and beta-blockers may be considered first-line treatments to prevent first variceal bleeding, whereas betablockers plus isosorbide mononitrate may be the best choice for the prevention of rebleeding.

Systematic review

Unclassified

Banding ligation versus beta-blockers as primary prophylaxis in esophageal varices: systematic review of randomized trials.

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Journal The American journal of gastroenterology
Year 2007
Links Pubmed DOI

This article is included in 2 Structured summaries of systematic reviews 16 Structured summaries of systematic reviews (2 references) 1 Broad synthesis 16 Broad syntheses (1 reference)

This article includes 16 Primary studies 16 Primary studies (16 references)

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OBJECTIVE: To compare banding ligation versus beta-blockers as primary prophylaxis in patients with esophageal varices and no previous bleeding. METHODS: Randomized trials were identified through electronic databases, reference lists in relevant articles, and correspondence with experts. Three authors extracted data. Random effects meta-analysis and metaregression were performed. The reported allocation sequence generation and concealment were extracted as measures of bias control. RESULTS: The initial searches identified 1,174 references. Sixteen trials were included. In 15 trials, patients had high-risk varices. Three trials reported adequate bias control. All trials reported mortality for banding ligation (116/573 patients) and beta-blockers (115/594 patients). Mortality in the two treatment groups was not significantly different in the trials with adequate bias control (relative risk 1.22, 95% CI 0.84-1.78) or unclear bias control (RR 1.02, 95% CI 0.75-1.39). Trials with adequate bias control found no significant difference in bleeding rates (RR 0.86, 95% CI 0.55-1.35). Trials with unclear bias control found that banding ligation significantly reduced bleeding (RR 0.56, 95% CI 0.41-0.77). Both treatments were associated with adverse events. In metaregression analyses, the estimated effect of ligation was significantly more positive if trials were published as abstracts. Likewise, the shorter the follow-up, the more positive the estimated effect of ligation. CONCLUSIONS: Banding ligation and beta-blockers may be used as primary prophylaxis in high-risk esophageal varices. The estimated effect of banding ligation in some trials may be biased and was associated with the duration of follow-up. Further high-quality trials are still needed.

Systematic review

Unclassified

Variceal band ligation versus beta-blockers for primary prevention of variceal bleeding: a meta-analysis.

Authors Tripathi D , Graham C , Hayes PC
Journal European journal of gastroenterology & hepatology
Year 2007
Links Pubmed DOI

This article is included in 1 Structured summary of systematic reviews 9 Structured summaries of systematic reviews (1 reference) 1 Broad synthesis 9 Broad syntheses (1 reference)

This article includes 9 Primary studies 9 Primary studies (9 references)

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BACKGROUND/AIMS: Variceal band ligation (VBL) can reduce the rate of the first variceal by 45-52% compared with beta-blockers (BBs). We performed an updated meta-analysis of nine randomized controlled trials published as full papers, comparing VBL with BB for primary prevention. METHODS: Relative risk (RR) was computed using a random effects model. Sensitivity analysis was performed using a fixed effects model. Publication bias was also assessed using funnel plots and the rank correlation test. RESULTS: In total, 734 patients were studied (356, VBL; 378, BB). The pooled RR favoured VBL for first variceal bleed [0.63; 95% confidence interval (CI), 0.43-0.92] with number needed to treat being 13 (95% CI, 7-33), and for adverse events resulting in treatment withdrawal (0.24; 95% CI, 0.12-0.47) with the corresponding number needed to treat being 10 (95% CI, 6-25). Banding-related bleeding occurred in six patients (fatal in two). No difference was seen in bleeding-related deaths (RR, 0.71; 95% CI, 0.38-1.32), or overall mortality (RR, 1.09; 95% CI, 0.86-1.38). No significant heterogeneity or publication bias was present, and outcomes remained robust after sensitivity analyses. CONCLUSIONS: VBL was superior to BB in preventing the first variceal bleed, with fewer adverse events resulting in treatment discontinuation. Careful attention to technique and patient selection are important to minimize iatrogenic complications with VBL. VBL has a role in patients with poor drug compliance, or tolerance, and in those who bleed on BB therapy.

Systematic review

Unclassified

Meta-analysis: endoscopic variceal ligation for primary prophylaxis of oesophageal variceal bleeding.

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Journal Alimentary pharmacology & therapeutics
Year 2005
Links Pubmed DOI

This article is included in 1 Structured summary of systematic reviews 8 Structured summaries of systematic reviews (1 reference) 1 Broad synthesis 8 Broad syntheses (1 reference)

This article includes 8 Primary studies 8 Primary studies (8 references)

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BACKGROUND: The treatment effects of primary prophylactic endoscopic variceal ligation are unclear. AIM: To compare the treatment effects of endoscopic variceal ligation and beta-blockers for primary prophylaxis of oesophageal variceal bleeding. In addition, a subgroup analysis was done with the purpose to delineate differences in the effects of intervention that were biologically based. METHODS: We performed a literature search for randomized controlled trials, which compared the treatment effects of endoscopic variceal ligation with beta-blockers for primary prophylaxis of oesophageal variceal bleeding. Of the 955 articles screened, eight randomized-controlled trials including 596 subjects (285 with endoscopic variceal ligation and 311 with beta-blockers) were analysed. Outcomes measures evaluated were first gastrointestinal bleed, first variceal bleed, all-cause deaths, bleed-related deaths and severe adverse events. The measure of association employed was relative risk; with heterogeneity and sensitivity analyses. RESULTS: Variceal obliteration was obtained in 261 (91.6%) patients and target beta-blockers therapy was achieved in 294 (94.5%) patients (P = 0.19). Endoscopic variceal ligation compared with beta-blockers significantly reduced rates of first gastrointestinal bleed by 31% (RR, 0.69; 95% CI: 0.49-0.96; P = 0.03; NNTB = 15) and first variceal bleed by 43% (RR, 0.57; 95% CI: 0.38-0.85; P = 0.0067; NNTB = 11). All-cause deaths and bleed-related deaths were unaffected (RR, 1.03; 95% CI: 0.79-1.36; P = 0.81 and RR, 0.84; 95% CI: 0.44-1.61; P = 0.60 respectively). Severe adverse events were significantly less in endoscopic variceal ligation compared with beta-blockers (RR, 0.34; 95% CI: 0.17-0.69; P = 0.0024; NNTB = 28). Sensitivity analysis of five trials published in peer review journals and four trials with high quality showed results similar to those seen in the primary analysis of all the eight trials, confirming stability of conclusions. Following variceal obliteration with endoscopic variceal ligation, oesophageal varices recurred in 83 (29.1%) patients. Seven (28.1%) patients bled with one fatal outcome. In subgroup analyses, endoscopic variceal ligation had significant advantage compared wtih beta-blockers in trials including < or =30% patients with alcoholic cirrhosis, >30% patients with Child Class C cirrhosis and >50% patients with large varices. CONCLUSIONS: In patients with cirrhosis with moderate to large varices and who have not bled, endoscopic varices ligation compared with beta-blockers significantly reduced bleeding episodes and severe adverse events, but had no effect on mortality.

Systematic review

Unclassified

A meta-analysis of endoscopic variceal ligation for primary prophylaxis of esophageal variceal bleeding.

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Authors Imperiale TF , Chalasani N
Journal Hepatology (Baltimore, Md.)
Year 2001
Links Pubmed DOI

This article is included in 1 Structured summary of systematic reviews 9 Structured summaries of systematic reviews (1 reference) 1 Broad synthesis 9 Broad syntheses (1 reference)

This article includes 9 Primary studies 9 Primary studies (9 references)

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Despite publication of several randomized trials of prophylactic variceal ligation, the effect on bleeding-related outcomes is unclear. We performed a meta-analysis of the trials, as identified by electronic database searching and cross-referencing. Both investigators independently applied inclusion and exclusion criteria, and abstracted data from each trial. Standard meta-analytic techniques were used to compute relative risks and the number needed to treat (NNT) for first variceal bleed, bleed-related mortality, and all-cause mortality. Among 601 patients in 5 homogeneous trials comparing prophylactic ligation with untreated controls, relative risks of first variceal bleed, bleed-related mortality, and all-cause mortality were 0.36 (0.26-0.50), 0.20 (0.11-0.39), and 0.55 (0.43-0.71), with respective NNTs of 4.1, 6.7, and 5.3. Among 283 subjects from 4 trials comparing ligation with beta-blocker therapy, the relative risk of first variceal bleed was 0.48 (0.24-0.96), with NNT of 13; however, there was no effect on either bleed-related mortality (relative risk [RR], 0.61; confidence interval [CI], 0.20-1.88) or all-cause mortality (RR, 0.95; CI, 0.56-1.62). In conclusion, compared with untreated controls, prophylactic ligation reduces the risks of variceal bleeding and mortality. Compared with beta-blockers, ligation reduces the risk for first variceal bleed but has no effect on mortality. Prophylactic ligation should be considered for patients with large esophageal varices who cannot tolerate beta-blockers. Subsequent research should further compare ligation and beta-blockers to determine the effect on mortality, and measure ligation's cost-effectiveness.