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 -