Clinical trial: a randomized controlled cross-over study of flupenthixol + melitracen in functional dyspepsia.
BACKGROUND
Functional dyspepsia is a prevalent condition associated with diminished quality of life (QoL) and high economic burden.


OBJECTIVE
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.
Hashash
J G
JG
Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. as08@aub.edu.lb
Abdul-Baki
H
H
Azar
C
C
Elhajj
I I
II
El Zahabi
L
L
Chaar
H F
HF
Sharara
A I
AI
D000328:Adult; D000873:Anthracenes / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D005475:Flupenthixol / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D013223:Statistics as Topic
D000873:Anthracenes; D014150:Antipsychotic Agents; C005100:melitracene; D005475:Flupenthixol