Healing of Benign Gastric Ulcer: Comparison of Cimetidine and Placebo in the United States

doi:10.1059/0003-4819-102-5-573

Healing of Benign Gastric Ulcer: Comparison of Cimetidine and Placebo in the United States

Houston and Temple, Texas; New Orleans, Louisiana; Salt Lake City, Utah; Albuquerque, New Mexico; Jackson, Mississippi; St. Paul, Minnesota; Richmond, Virginia; Rochester, New York; Philadelphia, Pennsylvania; and Hines, Illinois

Abstract

Recently the Food and Drug Administration approved cimetidine for the treatment of benign gastric ulcer. Approval was based in part on the results of our large multicenter trial involving 172 patients with benign gastric ulcer between 0.5 and 2.5 cm in diameter: 87 were randomly assigned to receive cimetidine (300 mg four times daily) and 85 to receive placebo. Cimetidine treatment resulted in significantly more rapid healing than placebo; after 2 and 6 weeks of therapy, 10.0% and 44.8% of patients receiving placebo were healed, as compared to 22.6% and 65.1% receiving cimetidine. The results of our study were compared with the time-response curve previously published (0, 4, and 8 weeks of therapy). The combined data yielded linear healing rates for the first 8 weeks of therapy (r > 0.99 for both cimetidine and placebo). These studies can be used to define expectations for healing of benign gastric ulcer, and we recommend follow-up intervals of 8 and, if unhealed, 16 weeks.

Article and Author Information

▸From the Veterans Administration Medical Center, Houston, Texas; Tulane University School of Medicine, New Orleans, Louisiana; Scott and White Memorial Hospital, Temple, Texas; Veterans Administration Medical Center, Salt Lake City, Utah; University of New Mexico Hospital, Albuquerque, New Mexico; University of Mississippi Medical Center, Jackson, Mississippi; St. Paul Gastroenterology, Ltd., St. Paul, Minnesota; Medical College of Virginia, Richmond, Virginia; University of Rochester, Rochester, New York; Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; and the Veterans Administration Hospital, Hines, Illinois.
▸Requests for reprints should be addressed to David Y. Graham, M.D.; Room 612, Building 1A, Veterans Administration Medical Center, 2002 Holcombe Boulevard; Houston, TX 77211.