Efficacy and safety of lansoprazole combined with flupentixol-melitracen for functional dyspepsia: A randomized, double-blinded, placebo-controlled clinical trial
Abstract
BACKGROUND
Psychosocial factors play a major role in the pathogenesis of functional dyspepsia (FD); however, there is a paucity of evidence from randomized controlled trials supporting the use of neuromodulators in FD.
AIM
To evaluate the efficacy and safety of lansoprazole (LPZ) combined with flupentixol-melitracen (FM) in FD.
METHODS
This was a single-center, double-blind, randomized, placebo-controlled trial enrolling patients aged 18-80 years who met the Rome IV diagnostic criteria for FD. Patients with a positive Helicobacter pylori test or abnormal upper gastrointestinal endoscopy/abdominal ultrasound were excluded. Participants completed the Leuven Postprandial Distress Scale, Short Form Nepean Dyspepsia Index (SF-NDI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorders-7, and Pittsburgh Sleep Quality Index. Patients were randomized 1:1 to receive LPZ (30 mg once daily) combined with FM (flupentixol 0.5 mg + melitracen 10 mg) or matched placebo for 2 weeks, followed by a 4-week follow-up. The primary endpoint was clinical response rate in the intention-to-treat population, defined as a reduction of at least 0.7 in the postprandial discomfort syndrome (PDS) score at the end of treatment among patients with a baseline PDS score of ≥ 1.
RESULTS
Between March 5 and August 10, 2025, 183 patients were randomized to receive LPZ + FM (n = 92) or LPZ + placebo (n = 91). At week 2, the clinical response rate was higher in the LPZ + FM group than in the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 92 participants or records.
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