3 research outputs found
Trimebutine maleate monotherapy for functional dyspepsia: A multicenter, randomized, double-blind placebo controlled prospective trial
Background and Objectives:Functional dyspepsia (FD) is one of the most
common functional gastrointestinal disorders; it has a great impact on
patient quality of life and is difficult to treat satisfactorily. This
study evaluates the efficacy and safety of trimebutine maleate (TM) in
patients with FD.Materials and Methods: A multicenter, randomized,
double-blind, placebo controlled, prospective study was conducted,
including 211 patients with FD. Participants were randomized to receive
TM 300 mg twice per day (BID, 108 patients) or placebo BID (103
patients) for 4 weeks. The Glasgow Dyspepsia Severity Score (GDSS) was
used to evaluate the relief of dyspepsia symptoms. Moreover, as a pilot
secondary endpoint, a substudy (eight participants on TM and eight on
placebo) was conducted in to evaluate gastric emptying (GE), estimated
using a 99mTc-Tin Colloid Semi Solid Meal Scintigraphy test.Results: Of
the 211 patients enrolled, 185 (87.7\%) (97 (52.4\%) in the TM group and
88 (47.6\%) in the placebo group) completed the study and were analyzed.
The groups did not differ in their demographic and medical history data.
Regarding symptom relief, being the primary endpoint, a statistically
significant reduction in GDSS for the TM group was revealed between the
first (2-week) and final (4-week) visit (p-value = 0.02). The 99 mTc-Tin
Colloid Semi Solid Meal Scintigraphy testing showed that TM
significantly accelerated GE obtained at 50 min (median emptying 75.5\%
in the TM group vs. 66.6\% in the placebo group,p= 0.036). Adverse
effects of low to moderate severity were reported in 12.3\% of the
patients on TM.Conclusion: TM monotherapy appears to be an effective and
safe approach to treating FD, although the findings presented here
warrant further confirmation