[A randomized and case-control clinical study on trimebutine maleate in treating functional dyspepsia coexisting with diarrhea-dominant irritable bowel syndrome].

Objective: To observe the efficacy and adverse drug reaction of trimebutine maleate in treating patients with functional dyspepsia (FD) coexisting with diarrhea dominant irritable bowel syndrome (IBS-D).

Methods: 129 patients were enrolled in this randomized, case-control and prospective study and divided into 3 groups. Group A was treated with trimebutine maleate and bacillus licheniformis, Group B with trimebutine maleate and Group C with bacillus licheniformis. The symptoms of the patients were described with grading score and efficacy of treatment assessed according to the changes of grading score of symptoms.

Results: There was a significant decrease in the scores of postprandial fullness (4.55 +/- 0.85, 1.26 +/- 0.52; 4.36 +/- 0.66, 1.48 +/- 0.61), early satiation (4.05 +/- 0.96, 1.01 +/- 0.51; 3.89 +/- 0.81, 1.25 +/- 0.76), abdominal pain (9.26 +/- 0.68, 0.68 +/- 0.43; 9.57 +/- 1.60, 0.76 +/- 0.54) and total symptom score (20.00 +/- 1.25, 3.06 +/- 0.91; 19.05 +/- 2.28, 3.89 +/- 2.12) before and after treatment in Group A and B (P < 0.05), but there was no such significance in Group C (P > 0.05). There was a significant decrease in diarrhea score before and after treatment in the 3 groups (A: 4.78 +/- 0.76, 0.65 +/- 0.53; B: 4.13 +/- 0.65, 1.25 +/- 0.62; C: 4.65 +/- 0.88, 1.45 +/- 0.70) (P < 0.05). After treatment for 4 weeks, there was significant difference in the scores of postprandial fullness, early satiation, abdominal pain and total symptom score as well as the effective rate of every symptom and total effective rate between Group A or B and Group C (P < 0.05). The ratio of cost and effect was 4.07, 1.19 and 6.65 in Group A, B and C respectively, the Group B being the best. The rate of adverse drug reaction was 22.9% and 23.7% in Group A and B, and the main adverse drug reactions were mild thirst and constipation.

Conclusions: In treating patients with functional dyspepsia coexisting with diarrhea dominant irritable bowel syndrome, trimebutine maleate has the advantage of high efficacy, low cost and few adverse reactions.