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. 1999 Dec;81(8):1356–1362. doi: 10.1038/sj.bjc.6690457

Prospective, double-blind, placebo-controlled randomized trial of cimetidine in gastric cancer

M J S Langman 1, J A Dunn 2, J L Whiting 3, A Burton 2, M T Hallissey 3, J W L Fielding 3, D J Kerr 2
PMCID: PMC2362962  PMID: 10604733

Abstract

Cimetidine is thought to inhibit suppressor T-lymphocyte function and preliminary evidence from a randomized trial indicated that it might prolong survival for patients with operable and inoperable gastric cancer. The British Stomach Cancer Group conducted a randomized, double-blind, placebo-controlled trial examining the effects of cimetidine (400 mg or 800 mg twice a day) on the survival of patients with early (stages I, II and III: n = 229) and advanced (stages IVa and IVb: n = 201) gastric cancer. The primary end point was death. A total of 442 patients were randomized by 59 consultants in 39 hospitals between February 1990 and March 1995. Log-rank survival analysis was used to assess differences between the groups. Three hundred and forty patients died during the study: 166 (49%) in the cimetidine treatment groups and 174 (51%) in the placebo groups. Median survival for patients receiving cimetidine was 13 months (95% confidence interval (CI) 9–16 months) and 11 months in the placebo arm (95% CI 9–14 months). There was no significant difference in survival between the two treatment groups (P = 0.42) or between different doses of cimetidine tablets (P = 0.46). Five-year survival of those patients randomized to cimetidine was 21% compared to 18% for those patients randomized to placebo. Cimetidine at a dose of 400 mg or 800 mg twice a day does not have a significant influence on the survival of patients with gastric cancer compared to placebo. © 1999 Cancer Research Campaign

Keywords: cimetidine, gastric cancer, randomized, clinical trial, H2-antagonists

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Selected References

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