Clinical trial: A randomized controlled cross-over study of flupenthixol + melitracen in functional dyspepsia

Abstract

Background: Functional dyspepsia is a prevalent condition associated with diminished quality of life (QoL) and high economic burden. Aim: To study the efficacy of a combination of flupenthixol and melitracen (F + M) with anxiolytic and antidepressant properties in functional dyspepsia using a randomized controlled cross-over design. Methods: Patients met the Rome III criteria for functional dyspepsia and a validated questionnaire was used to exclude those with anxiety or depression. Moreover, patients had to have failed a trial of acid-suppressive therapy and Helicobacter pylori eradication when positive. End points included subjective global symptom relief and QoL assessed by the Nepean Dyspepsia Index (NDI). Results: Twenty-five patients (14 females, 11 males; mean age = 34.3 ± 9.9 years) were enrolled and 24 completed the 8-week study. There was a significant improvement in subjective global symptom relief with F + M vs. placebo (ITT: 73.9% vs. 26.1%, P = 0.001) and a significant drop in the NDI score vs. placebo (ITT: -9.0 ± 11.9 vs. -2.4 ± 8.9, P = 0.03). No difference was noted whether the initial treatment was F + M or placebo. No significant side effects were noted. Conclusions: A combination of F and M is safe and effective in the short-term treatment of functional dyspepsia. F + M is associated with significant improvement in QoL independent of the presence of anxiety or depression. © 2008 The Authors.