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Efficacy and safety of lansoprazole combined with flupentixol-melitracen for functional dyspepsia: A randomized, double-blinded, placebo-controlled clinical trial
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DOI：10.3748/wjg.v32.i13.117115.png)
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Abstract
En 中文
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 placebo group (63.0% vs 46.2%; relative risk = 1.42, 95% confidence interval: 1.04-1.93). LPZ + FM resulted in greater reductions in PDS, SF-NDI, PHQ-9, Generalized Anxiety Disorders-7, and Pittsburgh Sleep Quality Index scores. Improvements in PDS, SF-NDI, and PHQ-9 persisted through follow-up. Adverse events were mild and occurred in 32.6% of patients receiving LPZ + FM and 23.1% receiving placebo, with no serious adverse events reported. CONCLUSION Short-term, low-dose FM combined with LPZ is an effective and safe treatment for FD.
Keywords:
Flupentixol-melitracen
Functional dyspepsia
Lansoprazole
Anxiety
Deanxit
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