A randomised clinical trial comparing the efficacy of a herbal preparation STW 5 with the prokinetic drug cisapride in patients with dysmotility type of functional dyspepsia

Abstract

Aim: To compare the efficacy of the herbal preparation STW 5 (Iberogast ((R))) and the research preparation STW 5-II with cisapride for treatment of patients with dysmotility type of functional dyspepsia.

Patients and methods: After a diagnostic work-up and 7 days wash-out, 186 patients with dysmotility type of functional dyspepsia were randomly assigned in a double-blind, double-dummy study to one of three treatment arms (STW 5/cisapride-placebo; STW 5-II/cisapride-placebo; cisapride/STW-placebo) for four weeks. Main outcome variable was the improvement of a dyspepsia-specific gastrointestinal symptom score. Symptoms were assessed three times during treatment and after six months follow-up. Hypothesis of non-inferiority was tested. Secondary endpoints were efficacy and tolerability assessments, recurrences and safety parameters.

Results: 137 patients were included in the confirmatory analysis. The lower limit of the confidence interval for both herbal preparations was above the pre-defined lower limit of the equivalence border and hypothesis of non-inferiority was proven for STW 5 and STW 5-II. There were no statistical significant differences for the secondary endpoints.

Conclusion: In this study STW 5 and the research preparation STW 5-II showed equivalent efficacy to cisapride for the treatment of patients with functional dyspepsia of dysmotility type.