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Propranolol and sclerotherapy in the prevention of gastrointestinal Rebleeding in patients with cirrhosis: a meta-analysis |
Bernard B, Lebrec D, Mathurin P, Opolon P, Poynard T |
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Authors' objectives To assess the efficacy of the beta-blocker propranolol and sclerotherapy for the prevention of gastrointestinal rebleeding and survival in patients with cirrhosis.
Searching The studies were identified by searching MEDLINE (search dates are unclear), Current Contents, general reviews, and references of published RCTs, and by contacting pharmaceutical companies. Manual searches were also performed. Only RCTs published in English, French, German and Spanish were included.
Study selection Study designs of evaluations included in the reviewRandomised controlled trials (RCTs). In addition, the studies had to be published as an abstract or article; include patients with cirrhosis and oesophageal varices, patients enrolled after initial rebleeding from oesophageal varices, and patients in whom bleeding was not treated with sclerotherapy; a comparison of propranolol with endoscopic sclerotherapy; have a mean follow-up of more than 11 months; and have at least one of the previously mentioned end points.
Specific interventions included in the reviewPropranolol and endoscopic sclerotherapy (polidocanol; or ethanolamine oleate) given either paravariceally or intravariceally.
Participants included in the reviewPatients with cirrhosis and oesophageal varices were included. Other patient characteristics were summarised individually for the primary studies; these included age, gender, alcoholic cirrhosis and Pugh score.
Outcomes assessed in the reviewThe outcomes assessed were rebleeding, oesophageal rebleeding, death, death from rebleeding and adverse events.
How were decisions on the relevance of primary studies made?Two reviewers independently selected the papers for the review, and any disagreements were resolved with a third reviewer.
Assessment of study quality Methodological quality was assessed using 14 criteria dealing with randomisation, blinding and statistical analysis. The authors do not state how the papers were assessed for quality, or how many of the authors performed the quality assessment.
Data extraction The authors do not state how many of them performed the data extraction, but all data were extracted on an intention-to-treat basis. All patients with missing data were considered failures.
Methods of synthesis How were the studies combined?The studies were combined using the fixed-effect model of Peto (see Other Publications of Related Interest no.1)) and the random-effects model of DerSimonian and Laird (see Other Publications of Related Interest no. 2).
How were differences between studies investigated?Differences between the studies were investigated using the chi-squared test for homogeneity, and the methods of Peto and DerSimonian and Laird (see Other Publications of Related Interest nos.1-2). Four sensitivity analyses were performed where differences were evident: treatment duration, type of publication, severity of cirrhosis and methodological quality.
Results of the review Nine RCTs (359 patients treated with propranolol and 371 treated with sclerotherapy) were included.
In the mean percentage of patients free of rebleeding, no significant difference was found between treatments: Peto method, odds ratio (OR) 0.89 (95% confidence interval, CI: 0.65, 1.23); DerSimonian and Laird method, effect size (ES) 2% (95% CI: -8, +13). Similarly, for mean survival rate, OR 0.88 (95% CI: 0.65, 1.19) and ES 2.9% (95% CI: -4.2, +10.1); for mean percentage of patients free of death from bleeding, OR 0.75 (95% CI: 0.52, 1.08) and ES 4.9 (95% CI: -1.5, +11.4).
Treatment with sclerotherapy was associated with a higher mean percentage of patients free of variceal rebleeding, OR 0.50 (95% CI: 0.36, 0.69) and ES 17% (95% CI: 9, 25), but a greater risk of adverse events: for mean percentage of patients free of adverse events, the OR was 3.1 (95% CI: 2.1, 4.5) and the ES was 22% (95% CI: 6, 38).
Authors' conclusions In patients with cirrhosis and oesophageal varices, endoscopic sclerotherapy is more effective than propranolol in preventing variceal rebleeding, but the incidence of adverse events is significantly higher with sclerotherapy. There was no difference in survival between the treatments. Propranolol should be considered as a first-choice treatment for preventing rebleeding.
CRD commentary This is a well-executed and structured systematic review.
Bibliographic details Bernard B, Lebrec D, Mathurin P, Opolon P, Poynard T. Propranolol and sclerotherapy in the prevention of gastrointestinal Rebleeding in patients with cirrhosis: a meta-analysis. Journal of Hepatology 1997; 26(2): 312-324 Other publications of related interest 1. Yusuf S, Peto R, Lewis J, Collins R, Sleight P. Beta blockade during and after myocardial infarction: an overview of the randomized trials. Prog Cardiovasc Dis 1985;27:335-71. 2. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986;7:177-88. 3. Bernard B, Lebrec D, Mathurin P, Opolon P, Poynard T. Beta-adrenergic antagonists in the prevention of gastrointestinal rebleeding in patients with cirrhosis: a meta-analysis. Hepatology 1997;25:63-70.
Indexing Status Subject indexing assigned by NLM MeSH Adult; Female; Gastrointestinal Hemorrhage /prevention & Humans; Liver Cirrhosis /complications; Male; Middle Aged; Propranolol /adverse effects /therapeutic use; Recurrence; Sclerotherapy /adverse effects; Survival Rate; control AccessionNumber 11997000301 Date bibliographic record published 30/04/1998 Date abstract record published 30/04/1998 Record Status This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. |
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