Healing of Benign Gastric Ulcer with Low-Dose Antacid or Cimetidine: A Double-Blind, Randomized, Placebo-Controlled Trial

J. I. Isenberg, W. L. Peterson, J. D. Elashoff, M. A. Sandersfeld, T. J. Reedy, A. F. Ippoliti, G. M. Van Deventer, H. Frankl, G. F. Longstreth, D. S. Anderson

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Abstract

We conducted a 12-week, double-blind, randomized, placebo-controlled trial to determine whether cimetidine (300 mg with meals and at bedtime) or a convenient, liquid aluminum–magnesium antacid regimen (15 ml one hour after meals and at bedtime) would expedite healing or relief of symptoms in patients with benign gastric ulcer. Of the 101 patients who completed the trial according to protocol, 32 received the antacid, 36 cimetidine, and 33 placebo. At 4, 8, and 12 weeks after entry, ulcers had healed in a larger percentage of patients treated with cimetidine than of those treated with placebo: 53, 86, and 89 per cent of the cimetidine group versus 26, 58, and 70 per cent of the placebo group (P = 0.02, 0.01, 0.05), respectively. Healing at the three intervals had occurred in 38,70, and 84 per cent, respectively, of the antacid-treated patients. Neither cimetidine nor antacid was more effective than placebo in relieving symptoms. The presence or absence of symptoms during the fourth and eighth treatment weeks was a poor predictor of the presence or absence of an ulcer crater. We conclude that cimetidine significantly hastens the healing of benign gastric ulcer. (N Engl J Med 1983; 308:1319–24.) The majority of studies evaluating cimetidine or antacid have shown these drugs to be superior to placebo in promoting the endoscopic healing of duodenal ulcer.1 2 3 4 5 6 However, there is no clear consensus that either antacid7,8 or cimetidine9 10 11 12 13 hastens healing of gastric ulcer. For example, although two placebo-controlled trials have reported improvements in gastric-ulcer healing with cimetidine,9,10 three others have not.11 12 13 One large study showed that gastriculcer healing was similar with a regimen of “highdose” liquid antacid or cimetidine,14 but because no placebo group was included, it was not clear that either treatment was superior to placebo. This study was designed to.

Original languageEnglish (US)
Pages (from-to)1319-1324
Number of pages6
JournalNew England Journal of Medicine
Volume308
Issue number22
DOIs
StatePublished - Jun 2 1983

ASJC Scopus subject areas

  • Medicine(all)

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    Isenberg, J. I., Peterson, W. L., Elashoff, J. D., Sandersfeld, M. A., Reedy, T. J., Ippoliti, A. F., Van Deventer, G. M., Frankl, H., Longstreth, G. F., & Anderson, D. S. (1983). Healing of Benign Gastric Ulcer with Low-Dose Antacid or Cimetidine: A Double-Blind, Randomized, Placebo-Controlled Trial. New England Journal of Medicine, 308(22), 1319-1324. https://doi.org/10.1056/NEJM198306023082203