Interferon and lamivudine vs. interferon for hepatitis B e antigen-positive hepatitis B treatment: meta-analysis of randomized controlled trials.

AIMS: To compare interferon monotherapy with its combination with lamivudine for hepatitis B e antigen (HBeAg)-positive hepatitis B treatment. METHODS: Two independent researchers identified pertinent randomized controlled trials. The trials were evaluated for methodological quality and heterogeneity. Rates of sustained virological and biochemical responses, and HBeAg clearance and seroconversion were used as primary efficacy measures. Quantitative meta-analyses were conducted to assess differences between groups for conventional and pegylated interferon, and overall. RESULTS: Greater sustained virological, biochemical and seroconversion rates were observed with addition of lamivudine to conventional [odds ratio (OR)=3.1, 95% confidence intervals (CI) (1.7-5.5), P<0.0001, OR=1.8, 95% CI (1.2-2.7), P=0.007 and OR=1.8, 95% CI (1.1-2.8), P=0.01 respectively], although not pegylated [OR=1.1, 95% CI (0.5-2.3), P=0.8, OR=1.0, 95% CI (0.7-1.3), P=0.94, and OR=0.9, 95% CI (0.6-1.2), P=0.34 respectively] interferon-alpha, with no significant affect on HBeAg clearance rates [OR=1.6, 95% CI (0.9-2.7), P=0.09, and OR=0.8, 95% CI (0.6-1.1), P=0.26 respectively]. Excluding virological response (P<0.001), pegylated interferon monotherapy and conventional interferon and lamivudine combination therapy were similarly efficacious (P>0.05), with the former studied in harder to treat patients, as evidenced by the superior virological response observed with conventional as compared with pegylated interferon monotherapy (P<0.0001). CONCLUSION: In comparable populations, pegylated interferon monotherapy is likely to be equally or more efficacious than conventional interferon and lamivudine combination therapy, thus constituting the treatment of choice, with no added benefit with lamivudine addition. However, when conventional interferon is used, its combination with lamivudine should be considered.

Somatostatin and gabexate for post-endoscopic retrograde cholangiopancreatography pancreatitis prevention: meta-analysis of randomized placebo-controlled trials.

BACKGROUND AND AIM: Prior studies have suggested the efficacy of somatostatin and gabexate in post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis prevention. We examined this notion in our study. METHODS: An extensive literature search led to the inclusion of seven homogeneous high-quality studies (Jadad score >or=4), involving 3,130 patients. The studies were grouped according to the drug's length of administration: given as an infusion for 12 h (groups SOM1 and GAB1 for somatostatin and gabexate, respectively); given as an infusion for less then 12 h (groups SOM2 and GAB2 for somatostatin and gabexate, respectively); and given as a bolus (group SOM3 for somatostatin, none identified for gabexate). Separate meta-analyses investigating post-procedural pancreatitis and hyperamylasemia rates were conducted in a random effects model. RESULTS: Pancreatitis analyses yielded significant risk differences for the SOM1, SOM3 and GAB1 groups. The resulting values were 7.7% (95% confidence intervals [CI][3.4 to 12.0], P < 0.0001), 8.2% (95% CI [4.4 to 12.0], P < 0.0001) and 5.2% (95% CI [1.1 to 9.4], P = 0.01), respectively. No statistically significant risk differences were observed for the SOM2 and GAB2 groups: -2.3% (95% CI [-5.2 to 0.5], P = 0.11) and -1.1% (95% CI [-3.8 to 1.6], P = 0.41), respectively. Hyperamylasemia analyses yielded significant risk differences for the SOM1 and SOM3 groups (P = 0.017 and 0.001, respectively), although not for the SOM2, GAB1 and GAB2 groups (P = 0.44, 0.49 and 0.47, respectively). CONCLUSIONS: Somatostatin administered as a bolus seems to be an efficacious measure of post-ERCP pancreatitis prevention, reducing pancreatitis and hyperamylasemia rates, and being applicable to clinical practice. Further study is required before its introduction into routine care.