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

List of authors.
  • Jon I. Isenberg, M.D.,
  • Walter L. Peterson, M.D.,
  • Janet D. Elashoff, Ph.D.,
  • Mary Ann Sandersfeld, R.T., G.I.A.,
  • Terry J. Reedy, Ph.D.,
  • Andrew F. Ippoliti, M.D.,
  • Gary M. Van Deventer, M.D.,
  • Harold Frankl, M.D.,
  • George F. Longstreth, M.D.,
  • and Daniel S. Anderson, M.D.

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.)

Funding and Disclosures

Supported by a grant (AM 17328) from the National Institute of Arthritis, Diabetes, and Digestive and Kidney Diseases to the Center for Ulcer Research and Education; the Veterans Administration; the William H. Rorer Laboratories; and the Smith Kline and French Laboratories.

We are indebted to the fellows and staff of the participating hospitals for enrollment and care of our patients; to Inger Pearce, Jim Haines, and Cora Barnett for expert technical assistance; and especially to John Fordtran, M.D., and the late Morton Grossman, M.D., for advice and counsel.

Author Affiliations

From the Center for Ulcer Research and Education, San Diego, Los Angeles, and Dallas; the Departments of Internal Medicine, University of California at San Diego and Los Angeles; the Department of Internal Medicine, University of Texas Health Science Center, Dallas; the San Diego, Wadsworth, and Dallas Veterans Administration Medical Centers; the Kaiser–Permanente Medical Centers, San Diego and Los Angeles; and the Balboa Naval Hospital, San Diego. Address reprint requests to Dr. Peterson at Gastroenterology (111B1), Dallas VA Medical Center, 4500 S. Lancaster Rd., Dallas, TX 75216.

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