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.

• Authors: J G Hashash, H Abdul-Baki, C Azar, I I Elhajj, L El Zahabi, H F Chaar, A I Sharara
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 27 Issue 11 Pg. 1148-55 (Jun 01 2008) ISSN: 1365-2036 [Electronic] England
• PMID: 18331614 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Anthracenes
• Antipsychotic Agents
• melitracene
• Flupenthixol

Topics

• Adult
• Anthracenes (therapeutic use)
• Antipsychotic Agents (therapeutic use)
• Cross-Over Studies
• Drug Therapy, Combination
• Dyspepsia (drug therapy)
• Female
• Flupenthixol (therapeutic use)
• Humans
• Male
• Statistics as Topic