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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

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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 Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2017-018362 on 1 December 2017. Downloaded from Effect of herbal extract granules combined with otilonium bromide on irritable bowel syndrome with diarrhoea: a study protocol for a randomised controlled trial Joong Il Kim,1 Pumsoo Kim,1 Jin-Hyun Lee,2 Yoo-Jin Kim,1 Na-rae Yang,1 Myong Ki Baeg,1 Ja Sung Choi,1 Hye-Jung Kim,1 Jayoung Kim,1 Yun-Young Sunwoo,1 Jung-Han Lee,2 Hyekyung Ha,3 Tae-Yong Park1 To cite: Kim JI, Kim P, ABSTRACT Strengths and limitations of this study Lee J-H, et al. Effect of herbal Introduction Irritable bowel syndrome (IBS), known extract granules combined as a functional and organic gastrointestinal disorder, with otilonium bromide on ► This randomised controlled trial is the first Korean irritable bowel syndrome is a collection of symptoms that occur together and clinical trial approved by the Korean Ministry of with diarrhoea: a study generally include pain or discomfort in the abdomen Food and Drug Safety to investigate the efficacy protocol for a randomised and changes in bowel movement patterns. Due to and safety of Samryungbaekchulsan (SRS; herbal controlled trial. BMJ Open the limitations of conventional treatments, alternative formula) and otilonium bromide (OB; Western drug) 2017;7:e018362. doi:10.1136/ IBS treatments are used by many patients worldwide. in diarrhoea-predominant irritable bowel syndrome bmjopen-2017-018362 Samryungbaekchulsan (SRS), a herbal formula, has (D-IBS). ► Prepublication history for long been used for alleviating diarrhoea-predominant ► To evaluate the therapeutic effect and safety of this paper is available online. IBS (D-IBS) in traditional Korean medicine. Otilonium the coadministration of SRS and OB, this study is To view these files, please visit bromide (OB) is an antimuscarinic compound used proposed as a double-blind, double-dummy, four- the journal online (http:// dx. doi. to relieve spasmodic pain in the gut, especially in arm, parallel-group randomised controlled trial. org/ 10. 1136/ bmjopen- 2017- IBS. Although herbal formulae and Western drugs are ► The primary outcome is the improvement in the 018362). commonly coadministered for various diseases in Korea, patient’s symptoms according to the Subject’s http://bmjopen.bmj.com/ JIK and PK contributed equally. few clinical studies have been conducted regarding the Global Assessment of Relief, and the secondary synergic effects of these treatments for any disease, outcome is the severity of D-IBS symptoms. Received 23 June 2017 including D-IBS. ► This study is conducted with a small sample size Revised 2 November 2017 Methods and analysis This trial is a randomised, (four arms, 20 participants per group), so further Accepted 10 November 2017 double-blinded, placebo-controlled, double-dummy, clinical trials with powerful sample sizes will be required to more adequately determine the four-arm, parallel study. After a 2-week preparation effectiveness of SRS and/or OB in D-IBS. period, 80 patients with D-IBS will be randomly assigned to one of four treatment groups consisting of SRS (water on September 25, 2021 by guest. Protected copyright. extract granules, 5 g/pack, three times a day) with OB Trial registration number KCT0001621 (approval date: (tablet form, one capsule three times a day) or their 10 August 2015). placebos, with treatment lasting for 8 weeks. Post- 1Institute for Integrative treatment follow-up will be conducted 4 weeks after the end of treatment. The primary outcome is the finding Medicine, Catholic Kwandong INTRODUCTION University International St. obtained using the Subject’s Global Assessment of Relief Irritable bowel syndrome (IBS), a chronic Mary’s Hospital, Incheon, method. The secondary outcomes are the severity of Republic of Korea symptoms related to D-IBS, determined using a 10-point gastrointestinal (GI) disease and functional 2Department of Rehabilitation scale, and the change in symptoms. bowel disorder, is characterised by abnormal Medicine of Korean Medicine, bowel habits and abdominal pain without College of Korean Medicine, Ethics and dissemination This trial has full Wonkwang University, Iksan, ethical approval of the Ethics Committee of Catholic structural, morphological and histological Jeonbuk, Republic of Korea Kwandong University International St. Mary’s Hospital abnormalities. It affects approximately 20% of 3K-herb Research Center, Korea (IS15MISV0033) and the Korean Ministry of Food and the population worldwide, according to popu- 1–6 Institute of Oriental Medicine, Drug Safety (30769). The results of the study will be lation-based studies. In addition, recent Daejeon, Republic of Korea disseminated through a peer-reviewed journal and/or evidence suggests that IBS is not only a func- Correspondence to conference presentations. tional disease but also an organic disease with Dr Tae-Yong Park; Trial protocol version IS15MISV0033 version 4.0 (25 a complex of symptoms, including infection, parktae9822@ gmail. com July 2016). immune activation, serotonin dysregulation, Kim JI, et al. BMJ Open 2017;7:e018362. doi:10.1136/bmjopen-2017-018362 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2017-018362 on 1 December 2017. Downloaded from Figure 1 Flow chart of trial. D-IBS, diarrhoea-irritable bowel syndrome; FM, family medicine; GIIM, gastrointestinal internal http://bmjopen.bmj.com/ medicine; OB, otilonium bromide; P, placebo; SRS, Samryungbaekchulsan. bacterial overgrowth, central dysregulation, brain–gut SRS has been shown to have antiacetylcholine and anti- interaction and genetics.4–8 Based on their predominant barium chloride effects and to suppress gastric secretion bowel habits, patients with IBS can be divided into diar- and small intestine motility.13 However, no clinical trials rhoea-predominant IBS (D-IBS), constipation-predom- have evaluated the efficacy of SRS for IBS when coadmin- inant IBS or mixed IBS.2 6 9 Recently, smooth muscle istered with a conventional drug. relaxants, bulking agents and antidiarrhoeal agents have Otilonium bromide (OB) is widely used for the preven- on September 25, 2021 by guest. Protected copyright. been used in the treatment of IBS.10 However, these tion and reduction of symptoms in patients with IBS.7 8 OB methods are often not effective, and many patients with has been shown to inhibit L-type and T-type calcium chan- IBS also use complementary treatments, such as herbal nels, muscarinic receptors and tachykininergic responses medicine, acupuncture, psychological treatment and life- in human cultured smooth muscle cells and rat colon style correction.2 11 12 strips.19–21 According to a recent randomised controlled Samryungbaekchulsan (SRS; Shenlingbaizhu-san in trial (RCT), OB (40 and 80 mg) is more effective for traditional Chinese medicine; Jinryobyakujutsu-san in treating IBS than placebo, not only for the reduction of Kampo medicine), which was introduced in the famous bloating and abdominal pain but also for protection from classical compendium of herbal formulae ‘Formulary of relapse owing to its long-lasting effect.22 23 Peaceful Benevolent Dispensary’, consists of 10 herbs According to the guidelines of the Korean Society of (Atractylodes rhizoma Alba, Poria sclerotium, Dioscoreae Gastroenterology, antispasmodic agents are recommended rhizoma, Glycyrrhizae radix et rhizoma, Coicis semen, for the treatment of D-IBS (grade 1B),24 and SRS is the Nelumbinis semen, Platycodonis radix, Dolichoris semen, preferred drug for diarrhoea treatment in Korean medi- Amomi fructus and Ginseng radix). In traditional Korean cine.18 Recently, several studies have been conducted to and Chinese medicine, this herbal formula has been evaluate the therapeutic effect of the coadministration used to treat GI disease, and various studies have been of herbal formulae and conventional drugs for IBS in published regarding the treatment of IBS with SRS.13–18 China.25 26 However, there has been no such clinical study 2 Kim JI, et al. BMJ Open 2017;7:e018362. doi:10.1136/bmjopen-2017-018362 Open Access BMJ Open: first published as 10.1136/bmjopen-2017-018362 on 1 December 2017. Downloaded from in Korea, even though both herbal medicine and conven- four separate arms of the trial. The trial will be conducted tional drugs are widely used for IBS treatment in the clinical at Catholic Kwandong University International St. Mary’s field. Therefore, there is a need to evaluate the efficacy and Hospital, Incheon, South Korea. safety of SRS, OB and the coadministration of both drugs. The study subjects will be required to participate in a In this study, we expect that the combined administra- 2-week preparation period (weeks −2 to 0) and an 8-week tion of OB and SRS will result in synergistic effects that drug-administration period (weeks 0–8). The patients improve D-IBS symptoms, including abdominal pain, will visit four times, on weeks 0, 4, 8 and 12. The primary discomfort (the main effect of OB) and diarrhoea-like outcome measurement will be evaluated at weeks 2, 4, 6, stool patterns (the main effect of SRS). 8 and 12, and the secondary outcome measurement will be evaluated at weeks 0, 2, 4, 6, 8 and 12. Participants will be assessed for efficacy and safety of the treatment METHODS AND ANALYSIS through visits (0, 4, 8 and 12 weeks) and telephone Objectives questionnaires (2 and 6 weeks). In addition, laboratory The purpose of this study is to evaluate the efficacy and tests will be conducted at 0, 4 and 8 weeks. According to safety of the coadministration of SRS and OB to patients with D-IBS. the intervention protocols, the clinical research coordi- nator (CRC) will encourage patients and participants to Necessity of the trial complete follow-up at every visit. Recently, herbal medicines and Western drugs have During the drug-administration period, SRS or its been coadministered for various medical therapies. This placebo will be given as one pack of water extract gran- is particularly true in Korea, where approximately 76% ules three times a day, 30 min before each meal.
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