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.