Cimetidine QID and BID in rapid heartburn relief and healing of lesions in gastroesophageal reflux disease.

This multicenter, double-blind, randomized, placebo-controlled trial investigated QID and BID regimens of cimetidine (total daily dosage of 1600 mg) in adult patients with moderate or severe gastroesophageal reflux disease. Healing of endoscopically documented lesions and heartburn pain relief were compared among three treatment groups: placebo (n = 82), cimetidine 800 mg BID (n = 85), and cimetidine 400 mg QID (n = 83). To maintain the double-blind conditions, all groups received two tablets QID (a combination of placebo and drug). Healing and improvement were evaluated with repeat endoscopy at 6 and 12 weeks, and pain severity for daytime and nighttime heartburn was recorded separately on diary cards and was rated on a four-point scale (severe = 3, moderate = 2, mild = 1, or none = 0). Efficacy results for the three treatment groups are presented in the following order: placebo, cimetidine 800 mg BID, and cimetidine 400 mg QID. Cumulative healing at week 12, using life-table methods, was 42%, 60% (P < 0.05 vs placebo), and 66% (P < 0.01 vs placebo), respectively. Cumulative improvement was 49%, 66% (P < 0.05 vs placebo), and 75% (P < 0.01 vs placebo), respectively. Median time in days to achieve 24 hours of complete freedom from heartburn was 18, 9, and 4 (P < 0.01 vs placebo), respectively.(ABSTRACT TRUNCATED AT 250 WORDS)