EFFECT OF TRIPLE THERAPY (ANTIBIOTICS PLUS BISMUTH) ON DUODENAL-ULCER HEALING - A RANDOMIZED CONTROLLED TRIAL

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.