[Controlled clinical study on the efficacy of tiropramide hydrochloride in the treatment of irritable colon: comparison with octylonium bromide]

Abstract

The effectiveness of a new calmodulin-independent spasmolytic, tiropramide hydrochloride, and octylonium bromide, an antispasmodic calmodulin-antagonist drug, was compared in a controlled trial performed in 60 patients with irritable bowel syndrome with spastic pattern. The effect of treatments was assessed according to the score reduction of following symptoms: abdominal pain, constipation, bloating and dyspepsia. Tiropramide hydrochloride administered at the daily dose of 300 mg for 30 days induced a faster and higher improvement than that observed during the administration of 120 mg daily of octylonium bromide. On 3rd and 5th day, treatment with tiropramide induced the relief of abdominal pain in a significantly greater percentage of patients (p less than 0.05). Besides, in the group of subjects treated with this drug the "pain" score was more markedly decreased. Furthermore, at the end of the study 88% of subjects treated with tiropramide and 47% with octylonium bromide had normal bowel habits. This difference was statistically significant (p less than 0.05). Both treatments are effective in reducing dyspeptic symptoms and bloating. We can conclude that tiropramide--having a significant antispasmodic effect combined with a regulating effect on bowel habits--besides eliminating spasm, would act by synchronizing and therefore normalizing the intestinal motility.