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

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. 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. 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. 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.