Enhancing compliance not a prerequisite for effective eradication of Helicobacter pylori: the HelP study

Abstract

OBJECTIVE: The aim of this study was to compare cure rates of Helicobacter pylori ( H. pylori) infection, compliance, and side effects in patients given 10 days of omeprazole 20 mg b.d., amoxycillin 500 mg t.d.s., and metronidazole 400 mg t.d.s. (OAM) or 10 days OAM plus compliance enhancing measures. METHODS: A total of 119 H. pylori-positive patients were prospectively randomized to receive either 10 days OAM or 10 days OAM plus compliance enhancing measures (medication in a dose dispensing unit, medication chart, an information sheet about H. pylori treatment, and phone call 2 days after starting therapy). H. pylori eradication was assessed by 13C-UBT at least 4 wk after cessation of therapy, compliance by phone interview on the last day of therapy and returned pill count, and side effects by phone interview and returned side effects form. RESULTS: In 113 patients attending 13C-UBT H. pylori was eradicated in 51 of 57 patients (89.5%) after 10 days OAM and in 48 of 56 (85.7%) after 10 days OAM plus compliance enhancing measures ( p = 0.54). In both groups 97% of medications were taken. Side effects were common (82% of patients). Both side effects ( p = 0.001) and ulcer versus nonulcer at endoscopy ( p = 0.016) were independent predictors of treatment failure; side effects also predicted noncompliance ( p = 0.02). CONCLUSIONS: Ten days of OAM was effective for H. pylori eradication in our clinical population. Patient compliance was excellent and attempts to increase compliance had no impact on outcome or compliance. Side effects were very common and were significantly associated with treatment failure and decreased compliance.