Abstract
OBJECTIVE: This study was designed to evaluate the efficacy and safety of short-term flupentixol-melitracen in adult patients with aerophagia through a single-center parallel randomized controlled trial. METHODS: Eligible patients were randomly divided into three groups based on the order of subjects. Each group consisted of 30 patients (15F/15M) who received 2 weeks of treatment. Groups 1, 2, and 3 were treated with itopride hydrochloride, flupentixol-melitracen, and the combination of two medicines, respectively. The mean scores of aerophagia symptom relief measured by the visual analogue scale (VAS) after treatment were used as the endpoints. RESULTS: A total of 90 patients were eligible for the study, of which 76 completed the 2-week treatment period. The scores indicating improvement of aerophagia by VAS showed significant improvement in Group 2 compared with Group 1 (6.92 ± 2.96 vs. 4.58 ± 4.08, p = 0.016) and Group 3 compared with Group 1 (7.34 ± 3.12 vs. 4.58 ± 4.08, p = 0.006). There was no significant difference between Group 2 and Group 3 (6.92 ± 2.96 vs. 7.34 ± 3.12, p = 0.618). The percentage of patients exhibiting scores indicating improvement of aerophagia by VAS ≥ 5 in Group 2 and Group 3 was significantly higher than Group 1 (p = 0.020, p = 0.007). The three groups had similar baseline characteristics and experienced similar non-serious adverse effects during the treatment period. CONCLUSION: The findings suggest that short-term treatment with flupentixol-melitracen, with or without a prokinetic benzamide derivative, is likely to improve symptoms of aerophagia in adults without significant adverse effects. Trial Registration: ClinicalTrials.gov identifier: ChiCTR-IPR-15006869.