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Clinical trial: a randomized controlled cross‐over study of flupenthixol + melitracen in functional dyspepsia
Author(s) -
HASHASH J. G.,
ABDULBAKI H.,
AZAR C.,
ELHAJJ I. I.,
EL ZAHABI L.,
CHAAR H. F.,
SHARARA A. I.
Publication year - 2008
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2008.03677.x
Subject(s) - medicine , placebo , anxiety , quality of life (healthcare) , depression (economics) , randomized controlled trial , gastroenterology , anxiolytic , antidepressant , physical therapy , psychiatry , alternative medicine , nursing , pathology , economics , macroeconomics
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.