PURPOSE: We pooled data from randomized, double-blind, placebo-controlled trials to determine the frequency of adverse reactions among patients treated withcimetidinefor acute acid-peptic disorders. METHODS: Meta-analysis was used to analyze data obtained from a search of English language reports of trials of cimetidine in the ambulatory treatment of acute acid-peptic disorders that were published between January 1982 and April 1987. RESULTS: Of 161 trials of cimetidine that we identified, 84 provided complete reporting of data on adverse reactions and, of these, 24 employed a randomized, double-blind, placebo-controlled design. Across these 24 trials, the overall rate of reported adverse reactions among 622 patients randomly assigned to receivecimetidine was 10.9%; the corresponding rate among 516 patients randomly assigned to receive placebo was 10.1%. This difference was not statistically significant (p greater than 0.10), nor were any significant differences noted in the frequencies of reported central nervous system or gastrointestinal adverse reactions (p greater than 0.10). Rates of adverse reactions also did not differ by dosage or trial duration. The overall rate of adverse reactions reported in the 60 trials that did not utilize a randomized, double-blind, placebo-controlled design was similar to the rate reported in those that did. CONCLUSIONS: Our findings suggest that the frequency of adverse reactions among patients receiving cimetidinefor acute acid-peptic disorders is not significantly different from that of patients receiving placebo.
RCT Entities:
PURPOSE: We pooled data from randomized, double-blind, placebo-controlled trials to determine the frequency of adverse reactions among patients treated with cimetidine for acute acid-peptic disorders. METHODS: Meta-analysis was used to analyze data obtained from a search of English language reports of trials of cimetidine in the ambulatory treatment of acute acid-peptic disorders that were published between January 1982 and April 1987. RESULTS: Of 161 trials of cimetidine that we identified, 84 provided complete reporting of data on adverse reactions and, of these, 24 employed a randomized, double-blind, placebo-controlled design. Across these 24 trials, the overall rate of reported adverse reactions among 622 patients randomly assigned to receive cimetidine was 10.9%; the corresponding rate among 516 patients randomly assigned to receive placebo was 10.1%. This difference was not statistically significant (p greater than 0.10), nor were any significant differences noted in the frequencies of reported central nervous system or gastrointestinal adverse reactions (p greater than 0.10). Rates of adverse reactions also did not differ by dosage or trial duration. The overall rate of adverse reactions reported in the 60 trials that did not utilize a randomized, double-blind, placebo-controlled design was similar to the rate reported in those that did. CONCLUSIONS: Our findings suggest that the frequency of adverse reactions among patients receiving cimetidine for acute acid-peptic disorders is not significantly different from that of patients receiving placebo.
Authors: R A Smallwood; R G Berlin; N Castagnoli; H P Festen; C J Hawkey; S K Lam; M J Langman; P Lundborg; A Parkinson Journal: Dig Dis Sci Date: 1995-02 Impact factor: 3.199