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Effect of herbal extract granules combined with otilonium bromide on irritable bowel syndrome with diarrhoea: a study protocol for a randomised controlled trial.
BMJ Open 2017; 7(11):e018362BO

Abstract

INTRODUCTION

Irritable bowel syndrome (IBS), known as a functional and organic gastrointestinal disorder, is a collection of symptoms that occur together and generally include pain or discomfort in the abdomen and changes in bowel movement patterns. Due to the limitations of conventional treatments, alternative IBS treatments are used by many patients worldwide. Samryungbaekchulsan (SRS), a herbal formula, has long been used for alleviating diarrhoea-predominant IBS (D-IBS) in traditional Korean medicine. Otilonium bromide (OB) is an antimuscarinic compound used to relieve spasmodic pain in the gut, especially in IBS. Although herbal formulae and Western drugs are commonly coadministered for various diseases in Korea, few clinical studies have been conducted regarding the synergic effects of these treatments for any disease, including D-IBS.

METHODS AND ANALYSIS

This trial is a randomised, double-blinded, placebo-controlled, double-dummy, four-arm, parallel study. After a 2-week preparation period, 80 patients with D-IBS will be randomly assigned to one of four treatment groups consisting of SRS (water extract granules, 5 g/pack, three times a day) with OB (tablet form, one capsule three times a day) or their placebos, with treatment lasting for 8 weeks. Post-treatment follow-up will be conducted 4 weeks after the end of treatment. The primary outcome is the finding obtained using the Subject's Global Assessment of Relief method. The secondary outcomes are the severity of symptoms related to D-IBS, determined using a 10-point scale, and the change in symptoms.

ETHICS AND DISSEMINATION

This trial has full ethical approval of the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS15MISV0033) and the Korean Ministry of Food and Drug Safety (30769). The results of the study will be disseminated through a peer-reviewed journal and/or conference presentations.

TRIAL PROTOCOL VERSION

IS15MISV0033 version 4.0 (25 July 2016).

TRIAL REGISTRATION NUMBER

KCT0001621 (approval date: 10 August 2015).

Authors+Show Affiliations

Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Wonkwang University, Iksan, Jeonbuk, Republic of Korea.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Wonkwang University, Iksan, Jeonbuk, Republic of Korea.K-herb Research Center, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29196484

Citation

Kim, Joong Il, et al. "Effect of Herbal Extract Granules Combined With Otilonium Bromide On Irritable Bowel Syndrome With Diarrhoea: a Study Protocol for a Randomised Controlled Trial." BMJ Open, vol. 7, no. 11, 2017, pp. e018362.
Kim JI, Kim P, Lee JH, et al. Effect of herbal extract granules combined with otilonium bromide on irritable bowel syndrome with diarrhoea: a study protocol for a randomised controlled trial. BMJ Open. 2017;7(11):e018362.
Kim, J. I., Kim, P., Lee, J. H., Kim, Y. J., Yang, N. R., Baeg, M. K., ... Park, T. Y. (2017). Effect of herbal extract granules combined with otilonium bromide on irritable bowel syndrome with diarrhoea: a study protocol for a randomised controlled trial. BMJ Open, 7(11), pp. e018362. doi:10.1136/bmjopen-2017-018362.
Kim JI, et al. Effect of Herbal Extract Granules Combined With Otilonium Bromide On Irritable Bowel Syndrome With Diarrhoea: a Study Protocol for a Randomised Controlled Trial. BMJ Open. 2017 Dec 1;7(11):e018362. PubMed PMID: 29196484.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of herbal extract granules combined with otilonium bromide on irritable bowel syndrome with diarrhoea: a study protocol for a randomised controlled trial. AU - Kim,Joong Il, AU - Kim,Pumsoo, AU - Lee,Jin-Hyun, AU - Kim,Yoo-Jin, AU - Yang,Na-Rae, AU - Baeg,Myong Ki, AU - Choi,Ja Sung, AU - Kim,Hye-Jung, AU - Kim,Jayoung, AU - Sunwoo,Yun-Young, AU - Lee,Jung-Han, AU - Ha,Hyekyung, AU - Park,Tae-Yong, Y1 - 2017/12/01/ PY - 2017/12/3/entrez PY - 2017/12/3/pubmed PY - 2018/7/22/medline KW - clinical trial protocol KW - irritable bowel syndrome KW - otilonium bromide KW - randomized controlled study KW - samryungbaekchulsan SP - e018362 EP - e018362 JF - BMJ open JO - BMJ Open VL - 7 IS - 11 N2 - INTRODUCTION: Irritable bowel syndrome (IBS), known as a functional and organic gastrointestinal disorder, is a collection of symptoms that occur together and generally include pain or discomfort in the abdomen and changes in bowel movement patterns. Due to the limitations of conventional treatments, alternative IBS treatments are used by many patients worldwide. Samryungbaekchulsan (SRS), a herbal formula, has long been used for alleviating diarrhoea-predominant IBS (D-IBS) in traditional Korean medicine. Otilonium bromide (OB) is an antimuscarinic compound used to relieve spasmodic pain in the gut, especially in IBS. Although herbal formulae and Western drugs are commonly coadministered for various diseases in Korea, few clinical studies have been conducted regarding the synergic effects of these treatments for any disease, including D-IBS. METHODS AND ANALYSIS: This trial is a randomised, double-blinded, placebo-controlled, double-dummy, four-arm, parallel study. After a 2-week preparation period, 80 patients with D-IBS will be randomly assigned to one of four treatment groups consisting of SRS (water extract granules, 5 g/pack, three times a day) with OB (tablet form, one capsule three times a day) or their placebos, with treatment lasting for 8 weeks. Post-treatment follow-up will be conducted 4 weeks after the end of treatment. The primary outcome is the finding obtained using the Subject's Global Assessment of Relief method. The secondary outcomes are the severity of symptoms related to D-IBS, determined using a 10-point scale, and the change in symptoms. ETHICS AND DISSEMINATION: This trial has full ethical approval of the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS15MISV0033) and the Korean Ministry of Food and Drug Safety (30769). The results of the study will be disseminated through a peer-reviewed journal and/or conference presentations. TRIAL PROTOCOL VERSION: IS15MISV0033 version 4.0 (25 July 2016). TRIAL REGISTRATION NUMBER: KCT0001621 (approval date: 10 August 2015). SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/29196484/Effect_of_herbal_extract_granules_combined_with_otilonium_bromide_on_irritable_bowel_syndrome_with_diarrhoea:_a_study_protocol_for_a_randomised_controlled_trial_ L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=29196484 DB - PRIME DP - Unbound Medicine ER -