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

Kang Nyeong Lee, 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 ParkIn Kyung Sung

Research output: Contribution to journalArticle

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)113-121
Number of pages9
JournalJournal of Neurogastroenterology and Motility
Volume20
Issue number1
DOIs
Publication statusPublished - 2014 Jan 1

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Irritable Bowel Syndrome
Abdominal Pain
Visual Analog Scale
Safety
Parasympatholytics
Therapeutics
octylonium
tiropramide
Anxiety
Quality of Life
Depression
Incidence
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Clinical Neurology
  • Gastroenterology

Cite this

Lee, Kang Nyeong ; Lee, Oh Young ; Choi, Myung Gyu ; Sohn, Chong Il ; Huh, Kyu Chan ; Park, Kyung Sik ; Kwon, Joong Goo ; Kim, Nayoung ; Rhee, Poong Lyul ; Myung, Seung Jae ; Lee, Joon Seong ; Lee, Kwang Jae ; Park, Hyojin ; Lee, Yong Chan ; Choi, Suck Chei ; Jung, Hye Kyung ; Jee, Sam Ryong ; Choi, Chang Hwan ; Kim, Gwang Ha ; Park, Moo In ; Sung, In Kyung. / 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. In: Journal of Neurogastroenterology and Motility. 2014 ; Vol. 20, No. 1. pp. 113-121.
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title = "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",
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.",
author = "Lee, {Kang Nyeong} and Lee, {Oh Young} and Choi, {Myung Gyu} and Sohn, {Chong Il} and Huh, {Kyu Chan} and Park, {Kyung Sik} and Kwon, {Joong Goo} and Nayoung Kim and Rhee, {Poong Lyul} and Myung, {Seung Jae} and Lee, {Joon Seong} and Lee, {Kwang Jae} and Hyojin Park and Lee, {Yong Chan} and Choi, {Suck Chei} and Jung, {Hye Kyung} and Jee, {Sam Ryong} and Choi, {Chang Hwan} and Kim, {Gwang Ha} and Park, {Moo In} and Sung, {In Kyung}",
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language = "English",
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Lee, KN, Lee, OY, Choi, MG, Sohn, CI, Huh, KC, Park, KS, Kwon, JG, Kim, N, Rhee, PL, Myung, SJ, Lee, JS, Lee, KJ, Park, H, Lee, YC, Choi, SC, Jung, HK, Jee, SR, Choi, CH, Kim, GH, Park, MI & Sung, IK 2014, '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', Journal of Neurogastroenterology and Motility, vol. 20, no. 1, pp. 113-121. https://doi.org/10.5056/jnm.2014.20.1.113

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. / Lee, Kang Nyeong; Lee, Oh Young; Choi, Myung Gyu; Sohn, Chong Il; Huh, Kyu Chan; Park, Kyung Sik; Kwon, Joong Goo; Kim, Nayoung; Rhee, Poong Lyul; Myung, Seung Jae; Lee, Joon Seong; Lee, Kwang Jae; Park, Hyojin; Lee, Yong Chan; Choi, Suck Chei; Jung, Hye Kyung; Jee, Sam Ryong; Choi, Chang Hwan; Kim, Gwang Ha; Park, Moo In; Sung, In Kyung.

In: Journal of Neurogastroenterology and Motility, Vol. 20, No. 1, 01.01.2014, p. 113-121.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of tiropramide in the treatment of patients with irritable bowel syndrome

T2 - A multicenter, randomized, double-blind, non-inferiority trial, compared with octylonium

AU - Lee, Kang Nyeong

AU - Lee, Oh Young

AU - Choi, Myung Gyu

AU - Sohn, Chong Il

AU - Huh, Kyu Chan

AU - Park, Kyung Sik

AU - Kwon, Joong Goo

AU - Kim, Nayoung

AU - Rhee, Poong Lyul

AU - Myung, Seung Jae

AU - Lee, Joon Seong

AU - Lee, Kwang Jae

AU - Park, Hyojin

AU - Lee, Yong Chan

AU - Choi, Suck Chei

AU - Jung, Hye Kyung

AU - Jee, Sam Ryong

AU - Choi, Chang Hwan

AU - Kim, Gwang Ha

AU - Park, Moo In

AU - Sung, In Kyung

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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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