A double-blind randomized trial evaluated the efficacy of trimebutine maleate and demonstrated that the trimebutine maleate is effective and safe in the management of dyspepsia.

A study was conducted to determine the efficacy and safety of trimebutine maleate (TM) as monotherapy for the management of functional dyspepsia.

A total of 211 patients with functional dyspepsia patients were enrolled in this multicenter, randomized, double-blind, and placebo-controlled, prospective study. The study participants were categorized into two groups: the TM group (n=108) and the placebo group (n=103). The patients were randomized to receive TM 300 mg twice per day or placebo BID for 4 weeks. The primary endpoint is the relief of dyspepsia symptoms using the Glasgow Dyspepsia Severity Score (GDSS) questionnaire. Gastric emptying (GE) evaluated using a 99mTc-Tin Colloid Semi Solid Meal Scintigraphy test was the secondary endpoint.

Among the 211 patients, 185 (97 in the TM group and 88 in the placebo group) completed the study. There were no differences in study groups related to demographic and medical history data. At the first (2-week) and final (4-week) visit, a statistically significant reduction in GDSS scores was determined in the TM group.

A significant increase was observed in GE obtained at 50 min in the TM group (median emptying 75.5%) compared to the placebo group (median emptying 66.6%) after the 99 mTc-Tin Colloid Semi Solid Meal Scintigraphy testing as shown in the following figure:

Adverse effects were reported in 11 (42.3%) patients in the TM group and 15 (57.7%) patients in the placebo group, as represented in the following figure:

Adverse events were found to be of low to moderate severity.

TM monotherapy appears to yield satisfactory results in the management of functional dyspepsia; however, further studies are needed to confirm these findings.