Clinical trial: a randomized controlled cross‐over study of flupenthixol + melitracen in functional dyspepsia

• Published in: Alimentary pharmacology & therapeutics 2008-06, Vol.27 (11), p.1148-1155
• Main Authors: HASHASH, J. G., ABDUL‐BAKI, H., AZAR, C., ELHAJJ, I. I., EL ZAHABI, L., CHAAR, H. F., SHARARA, A. I.
• Format: Article
• Language: English
• Subjects: Adult; Anthracenes - therapeutic use; Antipsychotic Agents - therapeutic use; Biological and medical sciences; Cross-Over Studies; Digestive system; Drug Therapy, Combination; Dyspepsia - drug therapy; Female; Flupenthixol - therapeutic use; Gastroenterology. Liver. Pancreas. Abdomen; Helicobacter pylori; Humans; Male; Medical sciences; Other diseases. Semiology; Pharmacology. Drug treatments; Statistics as Topic; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2008.03677.x

Summary 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.