Treatment of endoscopy-negative NSAID-induced upper gastrointestinal symptoms with cimetidine: an international multicentre collaborative study

Abstract

In this double-blind multicentre trial, 127 patients on non-steroidal anti-inflammatory drugs (NSAIDs) who experienced gastrointestinal symptoms significant enough to warrant endoscopic evaluation, but without endoscopic evidence of mucosal damage, were randomized to receive cimetidine 400 mg b.d. or placebo for 4 weeks. Non-steroidal anti-inflammatory drug therapy was maintained at pre-trial doses for the duration of the study. After 4 weeks, 72% of cimetidine-treated patients experienced complete symptom resolution, as defined by a global symptom score of zero, compared with 49% on placebo. Complete disappearance of upper abdominal pain was achieved in 72% of the cimetidine-treated patients as opposed to 47% on placebo. Relief of heartburn was experienced by 87% of patients on cimetidine compared with 60% on placebo. Throughout treatment, the proportion of cimetidine-treated patients with nausea was consistently lower than in patients on placebo, while the two groups were similar with respect to disappearance of vomiting. At the completion of acute treatment, 27% of placebo-treated patients but only 12% of those on cimetidine were ineligible to continue maintenance due to persisting gastrointestinal symptoms. Patients who were symptom-free and required continuation of NSAID therapy were followed for 6 months during which they were re-randomized to receive cimetidine 400 mg nocte or placebo. Of the 105 patients included in this maintenance treatment phase of the study, 11% of the cimetidine-treated patients and 10% of those on placebo experienced relapse of symptoms. However, the mean time to relapse was 120 days with cimetidine compared with 35 days with placebo.(ABSTRACT TRUNCATED AT 250 WORDS)