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.


METHODS
Single-blind, randomized, controlled trial.


METHODS
Veterans Affairs hospital.


METHODS
One hundred and five patients with endoscopically verified duodenal ulcers.


METHODS
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.


METHODS
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.


RESULTS
Ulcer healing was more rapid in patients receiving ranitidine plus triple therapy than in patients receiving ranitidine alone (P less than 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.


CONCLUSIONS
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.
Graham
D Y
DY
Baylor College of Medicine, Houston, Texas.
Lew
G M
GM
Evans
D G
DG
Evans
D J
DJ
Klein
P D
PD
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001729:Bismuth; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage*; D011899:Ranitidine / Q000008:administration & dosage; D012459:Salicylates / Q000008:administration & dosage*; D016037:Single-Blind Method; D013752:Tetracycline / Q000008:administration & dosage*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D012459:Salicylates; D008795:Metronidazole; C015715:bismuth subsalicylate; D011899:Ranitidine; D013752:Tetracycline; D001729:Bismuth