[Efficacy of fenoverine and trimebutine in the management of irritable bowel syndrome: multicenter randomized double-blind non-inferiority clinical study]
| Autor: | Il Hyun Baek, Sung Joon Lee, Rok Seon Choung, Jeong Seop Moon, Seong Hee Kang, Yang Seo Koo, Jong Jae Park, Suck Chei Choi, Sung Chul Park, Yoon Tae Jeen, Seung Yeong Kim, Jong Hun Lee, Ja Seol Koo, You Sun Kim, Kyoung Oh Kim |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Diarrhea Male Abdominal pain medicine.medical_specialty Constipation Fenoverine Gastroenterology Severity of Illness Index Drug Administration Schedule law.invention Irritable Bowel Syndrome Randomized controlled trial Double-Blind Method law Phenothiazines Internal medicine medicine Clinical endpoint Humans Irritable bowel syndrome business.industry Trimebutine Parasympatholytics General Medicine Middle Aged medicine.disease Abdominal Pain Treatment Outcome Tolerability Female medicine.symptom business medicine.drug |
| Zdroj: | The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi. 62(5) |
| ISSN: | 2233-6869 |
| Popis: | Background/aims Antispasmodic agents have been used in the management of irritable bowel syndrome. However, systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome. Fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium. We compared fenoverine with trimebutine for the treatment of patients with IBS. Methods A multicenter, randomized, double-blind, non-inferiority clinical study was conducted to compared fenoverine with trimebutine. Subjects were randomized to receive either fenoverine (100 mg three times a day) or trimebutine (150 mg three times a day) for 8 weeks. A total of 197 patients were analyzed by the intention-to-treat approach. The primary endpoint was the proportion of patients who had 30% reduction in abdominal pain or discomfort measured by bowel symptom scale (BSS) score at week 8 compared to the baseline. The secondary endpoints were changes of abdominal bloating, diarrhea, constipation, overall and total scores of BSS, and overall satisfaction. Results At week 8, fenoverine was shown to be non-inferior to trimebutine (treatment difference, 1.76%; 90% CI, -10.30-13.82; p=0.81); 69.23% (54 of 78 patients) of patients taking fenoverine and 67.47% (56 of 83 patients) of patients taking trimebutine showed 30% reduction in abdominal pain or discomfort compared to the baseline. There results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group. Conclusions Fenoverine is non-inferior to trimebutine for treating IBS in terms of both efficacy and tolerability. |
| Databáze: | OpenAIRE |
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