Triple Therapy vs. Amoxicillin Plus Omeprazole for Treatment of Helicobacter pylori Infection: A Multicenter, Prospective, Randomized, Controlled Study of Efficacy and Side Effects

Objective : this study compares the efficacy and side effects of the two commonly used treatment regimens for Helicobacter pylori infection. Methods : 118 patients with culture-proven H. pylori infection (61 with duodenal ulcer, 19 with gastric ulcer, three with both duodenal and gastric ulcer, and 35 with non-ulcer dyspepsia) were randomized to receive either triple therapy (tetracycline 250 mg, metronidazole 250 mg, colloidal bismuth subcitrate 120 mg, four times daily) for 14 days or amoxicillin 1000 mg and omeprazole 40 mg both twice daily for 14 days. The isolated H. pylori strain was metronidazole susceptible in 93%. Antral biopsy samples were taken for culture, urease testing, histology and, in most patients, for PCR at least 6 wk after treatment. A separate corpus sample was taken for culture. Eradication was defined as the absence of H. pylori in all specimens. In seven cases, when only histology was doubtfully positive, and all other tests including PCR were negative, a ¹³C-urea breath test was performed, the result of which was considered conclusive. Severity of the side effects was recorded by the patient on a semi-quantitative scale. Results: H. pylori was eradicated by triple therapy in 96.3% and by amoxicillin/omeprazole in 77.2% of the patients ( p = 0.008). Side effects occurred more often with triple therapy (72.7% vs. 50.8 %; p < 0.05) but were mild in most cases. Severe side effects occurred equally in both treatment groups. Conclusions : When the prevalence of metronidazole resistance is low, triple therapy is more effective than amoxicillin/omeprazole. Side effects occur more often in triple therapy but are mild in most cases.