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

Abstract

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.

Efficacy of psychotropic drugs in functional dyspepsia: systematic review and meta-analysis

“…In the trial by Braak et al 45 seven (10.3%) of 68 screening failures were due to a mood disorder. Among the other studies, three reported reasons for screening failure and none were due to a mood disorder,25 42 44 and two did not report these data. Detailed characteristics of individual RCTs are provided in table 1.…”

“…We successfully contacted original investigators to seek clarification on study methodology, and hence reduce risk of bias, or to obtain supplementary dichotomous data for nine trials 25 32 33 42–46 48. Three trials used antipsychotic drugs,27 40 41 three trials 5-HT 1A receptor agonists,25 43 44 two trials TCADs,45 46 one trial SSRIs,32 one trial tetracyclic antidepressants,48 one trial serotonin-norepinephrine reuptake inhibitors (SNRIs),33 one trial SSRIs or TCADs,47 and one trial a combination of an antipsychotic drug and a TCAD 42. Ten of the RCTs were at low risk of bias (see online supplementary table S1).…”

“…Six trials screened for, and excluded, individuals with coexistent mood disorders 25 42 44 45 47 48. In the trial by Braak et al 45 seven (10.3%) of 68 screening failures were due to a mood disorder.…”

“…For five studies, these were obtained by direct contact with the original investigators 25 32 42 44 48. There were 118 (21.9%) of 538 patients assigned to psychotropic drugs experiencing any adverse event, compared with 73 (16.7%) of 436 allocated to placebo.…”

Review: Evaluation and management of dyspepsia

“…Hashash and associates in a double-blind crossover study in 25 patients found that a combination of flupenthixol (antipsychotic) and melitracen (tricyclic antidepressant) significantly improved symptoms of functional dyspepsia (symptom relief in 71% of the treatment group compared to 24% of control) [Hashash et al 2008]. This study excluded patients with a history of depression or use of antidepressants, thus benefits were due to improvement of the dyspepsia.…”