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Effect of Triple Therapy (Antibiotics plus Bismuth) on Duodenal Ulcer Healing: A Randomized Controlled Trial

David Y. Graham, MD; Ginger M. Lew, PA-C; Dolores G. Evans, PhD; Doyle J. Evans Jr., PhD; and Peter D. Klein, PhD
[+] Article and Author Information

Grant Support: In part by the Department of Veterans Affairs, by grant DK 39919 from the National Institute of Diabetes and Digestive and Kidney Diseases, by the U. S. Department of Agriculture/Agricultural Research Service Children's Nutrition Center, and by Hilda Schwartz. The ranitidine was supplied by Glaxo and the Pepto-Bismol tablets by Procter and Gamble.

Requests for Reprints: David Y. Graham, MD, Veterans Affairs Medical Center (111D), 2002 Holcombe Boulevard, Houston, TX 77030.

Current Author Addresses: Drs. Graham, Evans, Evans, and Ms. Lew: Veterans Affairs Medical Center (111D) 2002 Holcombe Boulevard, Houston, TX 77030.

Dr. Klein: Children's Nutrition Research Center, 1100 Bates Street, Houston, TX 77030.


Ann Intern Med. 1991;115(4):266-269. doi:10.7326/0003-4819-115-4-266
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Objective: To determine whether antimicrobial therapy for Helicobacter pylori infection accelerates the healing of duodenal ulcers.

Design: Single-blind, randomized, controlled trial.

Setting: Veterans Affairs hospital.

Participants: One hundred and five patients with endoscopically verified duodenal ulcers.

Intervention: Patients received either ranitidine, 300 mg/d, or ranitidine, 300 mg/d, plus "triple therapy" (2 g/d of tetracycline, 750 mg/d of metronidazole, and 5 or 8 bismuth subsalicylate tablets per day). Triple therapy was administered for only the first 2 weeks of ulcer treatment.

Measurements: Videoendoscopic assessment of ulcer status was done until ulcer healing was complete. Evaluations were done after 2, 4, 8, 12, and 16 weeks of therapy.

Main Results: Ulcer healing was more rapid in patients receiving ranitidine plus triple therapy than in patients receiving ranitidine alone (P < 0. 01). The cumulative percentages of patients with healed ulcers in the group receiving ranitidine plus triple therapy and in the group receiving ranitidine alone were as follows: 37% and 18% after week 2; 74% and 53% after week 4; 84% and 68% after week 8; 96% and 80% after week 12; and 98% and 84% after week 16.

Conclusion: Combined therapy with anti-H. pylori agents and ranitidine was superior to ranitidine alone for duodenal ulcer healing. Our results indicate that H. pylori plays a role in duodenal ulcer disease.

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