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Effect of Samryungbaekchul-san Combined with Otilonium Bromide on Diarrhea-Predominant Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial.
J Clin Med. 2019 Sep 27; 8(10)JC

Abstract

Conventional and herbal drugs are frequently used together to treat many disorders. Samryungbaekchul-san (SRS, a herbal formula) and otilonium bromide (OB, an antispasmodic agent) are widely used to treat diarrhea-predominant irritable bowel syndrome (D-IBS) in Eastern Asian countries. However, there have been no studies on the co-administration of SRS and OB. Therefore, we aimed to preliminarily assess the feasibility of SRS combined with OB for D-IBS treatment in a pilot double-blind, four-arm, parallel-group, randomized controlled trial (RCT), including 80 patients diagnosed with D-IBS according to the Rome III criteria. The patients were randomly assigned to four treatment groups and were administered drugs for eight weeks after a two-week preparatory period. Follow-up was conducted four weeks after the administration period. The primary outcome was evaluated by using a global D-IBS symptom improvement score; no statistically significant difference was observed between the groups. However, multiple logistic regression analysis of primary outcome scores shows that SRS significantly improved D-IBS symptoms (p < 0.05). For secondary outcomes, better results were observed in the SRS + OB group, in terms of symptoms, including abdominal pain, discomfort, frequency of abdominal pain, and stool form than in OB alone or placebo groups (p < 0.05). In conclusion, the co-administration of SRS and OB might be an effective and safe strategy for the treatment of D-IBS. Large-scale RCTs are warranted to further confirm and clarify these findings.

Authors+Show Affiliations

Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon 22711, Korea. doolyjinhyun@empal.com.Future Medicine Division, Korea Institute of Oriental Medicine, Daejeon 34054, Korea. jikim@kiom.re.kr.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon 22711, Korea. baegmk@gmail.com.Iksoodang Korean Medical Clinic, Incheon 21425, Korea. 127501@hanmail.net.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon 22711, Korea. 545544@ish.ac.kr.Department of Korean Rehabilitation Medicine, Wonkwang University College of Korean Medicine, Iksan 54383, Korea. milpaso75@daum.net.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon 22711, Korea. gkimmhj@ish.ac.kr.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon 22711, Korea. cjs0123@ish.ac.kr.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon 22711, Korea. lmkjy7@gmail.com.Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Korea. csseo0914@kiom.re.kr.Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Korea. hkshin@kiom.re.kr.Herbal Medicine Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Korea. hkha@kiom.re.kr.Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon 22711, Korea. parktae9822@gmail.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31569833

Citation

Lee, Jin-Hyun, et al. "Effect of Samryungbaekchul-san Combined With Otilonium Bromide On Diarrhea-Predominant Irritable Bowel Syndrome: a Pilot Randomized Controlled Trial." Journal of Clinical Medicine, vol. 8, no. 10, 2019.
Lee JH, Kim JI, Baeg MK, et al. Effect of Samryungbaekchul-san Combined with Otilonium Bromide on Diarrhea-Predominant Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial. J Clin Med. 2019;8(10).
Lee, J. H., Kim, J. I., Baeg, M. K., Sunwoo, Y. Y., Do, K., Lee, J. H., Kim, H. J., Choi, J. S., Kim, J., Seo, C. S., Shin, H. K., Ha, H., & Park, T. Y. (2019). Effect of Samryungbaekchul-san Combined with Otilonium Bromide on Diarrhea-Predominant Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial. Journal of Clinical Medicine, 8(10). https://doi.org/10.3390/jcm8101558
Lee JH, et al. Effect of Samryungbaekchul-san Combined With Otilonium Bromide On Diarrhea-Predominant Irritable Bowel Syndrome: a Pilot Randomized Controlled Trial. J Clin Med. 2019 Sep 27;8(10) PubMed PMID: 31569833.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Samryungbaekchul-san Combined with Otilonium Bromide on Diarrhea-Predominant Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial. AU - Lee,Jin-Hyun, AU - Kim,Joong Il, AU - Baeg,Myong Ki, AU - Sunwoo,Yun-Young, AU - Do,Kwangsun, AU - Lee,Jung-Han, AU - Kim,Hye-Jung, AU - Choi,Ja Sung, AU - Kim,Jayoung, AU - Seo,Chang-Seob, AU - Shin,Hyeun-Kyoo, AU - Ha,Hyekyung, AU - Park,Tae-Yong, Y1 - 2019/09/27/ PY - 2019/07/29/received PY - 2019/09/21/revised PY - 2019/09/23/accepted PY - 2019/10/2/entrez PY - 2019/10/2/pubmed PY - 2019/10/2/medline KW - complementary medicine KW - functional bowel disorder KW - herbal extract KW - irritable bowel syndrome JF - Journal of clinical medicine JO - J Clin Med VL - 8 IS - 10 N2 - Conventional and herbal drugs are frequently used together to treat many disorders. Samryungbaekchul-san (SRS, a herbal formula) and otilonium bromide (OB, an antispasmodic agent) are widely used to treat diarrhea-predominant irritable bowel syndrome (D-IBS) in Eastern Asian countries. However, there have been no studies on the co-administration of SRS and OB. Therefore, we aimed to preliminarily assess the feasibility of SRS combined with OB for D-IBS treatment in a pilot double-blind, four-arm, parallel-group, randomized controlled trial (RCT), including 80 patients diagnosed with D-IBS according to the Rome III criteria. The patients were randomly assigned to four treatment groups and were administered drugs for eight weeks after a two-week preparatory period. Follow-up was conducted four weeks after the administration period. The primary outcome was evaluated by using a global D-IBS symptom improvement score; no statistically significant difference was observed between the groups. However, multiple logistic regression analysis of primary outcome scores shows that SRS significantly improved D-IBS symptoms (p < 0.05). For secondary outcomes, better results were observed in the SRS + OB group, in terms of symptoms, including abdominal pain, discomfort, frequency of abdominal pain, and stool form than in OB alone or placebo groups (p < 0.05). In conclusion, the co-administration of SRS and OB might be an effective and safe strategy for the treatment of D-IBS. Large-scale RCTs are warranted to further confirm and clarify these findings. SN - 2077-0383 UR - https://www.unboundmedicine.com/medline/citation/31569833/Effect_of_Samryungbaekchul_san_Combined_with_Otilonium_Bromide_on_Diarrhea_Predominant_Irritable_Bowel_Syndrome:_A_Pilot_Randomized_Controlled_Trial_ L2 - https://www.mdpi.com/resolver?pii=jcm8101558 DB - PRIME DP - Unbound Medicine ER -
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