Randomized controlled study of efficacy and safety of drotaverine hydrochloride in patients with irritable bowel syndrome.

BACKGROUND: This study aimed to assess the efficacy and safety of drotaverine hydrochloride (DHC) in Chinese patients with irritable bowel syndrome (IBS). METHODS: Totally, 144 patients with IBS were included and randomly divided into treatment group and placebo group in a 1:1 ratio. Patients received either DHC or placebo 80-mg tablet, 3 times daily for a total of 4 weeks. The primary outcome included abdominal pain, measured by the visual analog scale (VAS), and weekly stool frequency. The secondary outcomes were measured by the Bristol scale, and the 36-item short form health survey (SF-36), as well as the adverse events recorded during the treatment period. All those outcomes were measured at the end of 4-week treatment. RESULTS: The total and different types of IBS in VAS, stool frequency, and Bristol score were significantly better in the treatment group than those in the placebo group at the end of 4-week treatment. However, no significant difference was found in quality of life, measured by SF-36 scale between 2 groups. Additionally, no serious and significant differences in adverse events were found in and between both groups. CONCLUSION: The findings suggest that DHC has promising efficacy to enhance symptoms of IBS in Chinese population.