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.
- Author:
Kang Nyeong LEE
1
;
Oh Young LEE
;
Myung Gyu CHOI
;
Chong Il SOHN
;
Kyu Chan HUH
;
Kyung Sik PARK
;
Joong Goo KWON
;
Nayoung KIM
;
Poong Lyul RHEE
;
Seung Jae MYUNG
;
Joon Seong LEE
;
Kwang Jae LEE
;
Hyojin PARK
;
Yong Chan LEE
;
Suck Chei CHOI
;
Hye Kyung JUNG
;
Sam Ryong JEE
;
Chang Hwan CHOI
;
Gwang Ha KIM
;
Moo In PARK
;
In Kyung SUNG
Author Information
1. Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea. leeoy@hanyang.ac.kr
- Publication Type:Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Irritable bowel syndrome;
Antispasmodic;
Octylonium;
Rome III criteria;
Tiropramide
- MeSH:
Abdominal Pain;
Anxiety;
Depression;
Humans;
Incidence;
Irritable Bowel Syndrome*;
Parasympatholytics;
Weights and Measures
- From:Journal of Neurogastroenterology and Motility
2014;20(1):113-121
- CountryRepublic of Korea
- Language:English
-
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.
