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.
OBJECTIVE
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.
Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
Kang Nyeong
KN
Lee
Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
Oh Young
OY
Lee
Department of Internal Medicine, Catholic University College of Medicine, Seoul, Korea.
Myung-Gyu
MG
Choi
Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Chong Il
CI
Sohn
Department of Internal Medicine, Konyang University College of Medicine, Daejeon, Korea.
Kyu Chan
KC
Huh
Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea.
Kyung Sik
KS
Park
Department of Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, Korea.
Joong Goo
JG
Kwon
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Nayoung
N
Kim
Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Poong-Lyul
PL
Rhee
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Seung-Jae
SJ
Myung
Department of Internal Medicine, Soonchunhyang University College, Seoul, Korea.
Joon Seong
JS
Lee
Department of Internal Medicine, Ajou University College of Medicine, Suwon, Gyeonggi-do, Korea.
Kwang Jae
KJ
Lee
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Hyojin
H
Park
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
Yong Chan
YC
Lee
Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Korea.
Suck Chei
SC
Choi
Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea.
Hye-Kyung
HK
Jung
Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
Sam Ryong
SR
Jee
Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Chang Hwan
CH
Choi
Department of Internal Medicine, Pusan University College of Medicine, Busan, Korea.
Gwang Ha
GH
Kim
Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.
Moo In
MI
Park
Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.
In Kyung
IK
Sung
Antispasmodic; Irritable bowel syndrome; Octylonium; Rome III criteria; Tiropramide