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
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ÀÌ°³ç(Lee Kang-Nyeong) - Hanyang University College of Medicine Department of Internal Medicine
ÀÌ¿À¿µ(Lee Oh-Young) - Hanyang University College of Medicine Department of Internal Medicine
ÃÖ¸í±Ô(Choi Myung-Gyu) - Catholic University College of Medicine Department of Internal Medicine
¼ÕÁ¤ÀÏ(Sohn Chong-Il) - Sungkyunkwan University School of Medicine Department of Internal Medicine
Çã±ÔÂù(Huh Kyu-Chan) - Konyang University College of Medicine Department of Internal Medicine
¹Ú°æ½Ä(Park Kyung-Sik) - Keimyung University School of Medicine Department of Internal Medicine
±ÇÁß±¸(Kwon Joong-Goo) - Catholic University of Daegu School of Medicine Department of Internal Medicine
±è³ª¿µ(Kim Na-Young) - Seoul National University Bundang Hospital Department of Internal Medicine
ÀÌdz·Ä(Rhee Poong-Lyul) - Sungkyunkwan University School of Medicine Kangbuk Samsung Hospital Department of Internal Medicine
¸í½ÂÀç(Myung Seung-Jae) - University of Ulsan College of Medicine Department of Internal Medicine
ÀÌÁؼº(Lee Joon-Seong) - Soonchunhyang University College of Medicine Department of Internal Medicine
À̱¤Àç(Lee Kwang-Jae) - Ajou University College of Medicine Department of Internal Medicine
¹ÚÈ¿Áø(Park Hyo-Jin) - Yonsei University College of Medicine Gangnam Severance Hospital Department of Internal Medicine
ÀÌ¿ëÂù(Lee Yong-Chan) - Yonsei University College of Medicine Department of Internal Medicine
ÃÖ¼®Ã¤(Choi Suck-Chei) - Wonkwang University College of Medicine Department of Internal Medicine
Á¤Çý°æ(Jung Hye-Kyung) - Ewha Womans University College of Medicine Department of Internal Medicine
Áö»ï·æ(Jee Sam-Ryong) - Inje University College of Medicine Department of Internal Medicine
ÃÖâȯ(Choi Chang-Hwan) - Korea Chung-Ang University College of Medicine Department of Internal Medicine
±è±¤ÇÏ(Kim Gwang-Ha) - Pusan National University Postgraduate School of Medicine Department of Internal Medicine
¹Ú¹«ÀÎ(Park Moo-In) - Kosin University College of Medicine Department of Internal Medicine
¼ºÀΰæ(Sung In-Kyung) - Konkuk University School of Medicine Department of Internal Medicine
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 tir-opramide 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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Irritable bowel syndrome, Antispasmodic, Octylonium, Rome III criteria, Tiropramide
KMID :
0812020140200010113
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