J Neurogastroenterol Motil.
2014 Jan;20(1):113-121.
Efficacy and Safety of Tiropramide in the Treatment of Patients With Irritable Bowel Syndrome: A Multicenter, Randomized, Double-blind, Non-inferiority Trial, Compared With Octylonium
- Affiliations
-
- 1Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea. leeoy@hanyang.ac.kr
- 2Department of Internal Medicine, Catholic University College of Medicine, Seoul, Korea.
- 3Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 4Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea.
- 5Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea.
- 6Department of Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, Korea.
- 7Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
- 8Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 9Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- 10Department of Internal Medicine, Soonchunhyang University College, Seoul, Korea.
- 11Department of Internal Medicine, Ajou University College of Medicine, Suwon, Gyeonggi-do, Korea.
- 12Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
- 13Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Korea.
- 14Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea.
- 15Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
- 16Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
- 17Department of Internal Medicine, Pusan University College of Medicine, Busan, Korea.
- 18Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.
- 19Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.
Abstract
- BACKGROUND/AIMS
Antispasmodics such as octylonium are widely used to manage irritable bowel syndrome (IBS) symptoms. However, the efficacy and safety of another antispasmodic, tiropramide, remain uncertain. We aimed to evaluate the efficacy and safety of tiropramide compared with octylonium in patients with IBS.
METHODS
In this multicenter, randomized, non-inferiority trial, 287 patients with IBS (143 receiving tiropramide and 144 octylonium) were randomly allocated to either tiropramide 100 mg or octylonium 20 mg t.i.d (means 3 times a day) for 4 weeks. Primary endpoint was the mean change of abdominal pain from baseline assessed by visual analogue scales (VAS) score after 4 weeks of treatment. Secondary endpoints were the changes in abdominal pain from baseline at week 2 and in abdominal discomfort at weeks 2 and 4, using VAS scores, patient-reported symptom improvement including stool frequency and consistency, using symptom diaries, IBS-quality of life (IBS-QoL), and depression and anxiety, at week 4.
RESULTS
The VAS scores of abdominal pain at week 4, were significantly decreased in both tiropramide and octylonium groups, but the change from baseline did not differ between the 2 groups (difference,-0.26 mm; 95% CI,-4.33-3.82; P = 0.901). Abdominal pain and discomfort assessed using VAS scores, diaries, and IBS-QoL were also improved by both treatments, and the changes from baseline did not differ. The incidence of adverse events was similar in the 2 groups, and no severe adverse events involving either drug were observed.
CONCLUSIONS
Tiropramide is as effective as octylonium in managing abdominal pain in IBS, with a similar safety profile.
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