Yuanyuan Wang1, Heng Fan2, Xiao Qi3, Yaoliang Lai4, Zhixiang Yan5, Baiwen Li6, Min Tang7, Dawei Huang4, Zhen Li1, Hongjing Chen1, Qingping Zhu1, Chao Luo1, Xuan Chen1, Jin Fen1, Zhengyan Jiang1, Liang Zheng1, Xingxing Liu2, Qing Tang2, Dongmei Zuo2, Jingyi Ye8, Yongqiang Yang8, Huisuo Huang8, Zongxiang Tang7, Weimin Lu9, Jun Xiao10. 1. Department of Gastroenterology, the Second Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Provincial Second Hospital of Chinese Medicine. 23 Nanhu Rd., Nanjing, 210017, China. 2. Department of Integrated Traditional Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. 1277 Liberty Rd., Wuhan, 430022, China. 3. Washington University School of Medicine. 660 S Euclid Ave, St. Louis, MO 63110, the United States. 4. Department of Gastroenterology, Beijing Xuanwu Hospital of Chinese Medicine. 8 Wanming Rd., Beijing 100050, China. 5. The Institute of Chinese Medical Sciences, the University of Macau, Av. Padre Tomás Pereira, Taipa, Macao, SAR, China. 6. Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, 100 Haining Rd. Hongkou, Shanghai 200280, China. 7. The State Key Laboratory Cultivation Base for TCM Quality and Efficacy, the School of Medicine and Life Sciences, Nanjing University of Chinese Medicine, 138 Xianlin Road, Nanjing 210023, China. 8. The Macrohard Institute of Health. 231 North Ave. Battle Creek, MI 49017, USA. 9. Department of Internal Medicine, Jiangsu Province Hospital of Chinese Medicine, the Affiliated Hospital of Nanjing University of Chinese Medicine. 155 Hanzhong Rd., Nanjing, 210029, China. Electronic address: wmlu@163.com. 10. The Macrohard Institute of Health. 231 North Ave. Battle Creek, MI 49017, USA. Electronic address: jxiao@macrohardinstitute.org.
Abstract
OBJECTIVES: To examine the efficacy and safety ofpersonalized tongxie formulas; to decrease type II errors to minimum. METHODS: Patients were randomized (1:1:1) into three groups given tongxie, placebo, or pinaverium 3 times daily for 4 weeks. Patients in the tongxie group were treated with personalized formulas based on TCM differential diagnosis, i.e., basic type of IBS, IBS due to liver depression and qi stagnation, excess heat in the liver, deficient spleen function, deficient kidney function, and others (groups 1-6). Primary endpoints were significantly greater reductions in abdominal pain and Bristol stool score. Secondary endpoints were reductions in pain and stool frequencies and abdominal discomfort and its frequency. RESULTS: There were significantly more patients whose stool consistencies were improved than pains were relieved in the entire population (p < 0.001), but there was no significantly difference in subpopulation group 3 (p > 0.05). There were significantly more patients whose stool frequencies were reduced than pain frequencies were reduced in the entire population (p < 0.001), but there were no significantly difference in the subpopulation Groups 1, 3, 4, and 6 (p > 0.05). Multiple active ingredients and their mechanisms of actions to relieve IBS symptoms were identified. CONCLUSION: The outcomes in subpopulations may be different from those of the entire population, indicating that personalized formulas are important to achieve optimal outcomes; the active ingredients and innovative mechanisms identified in this study can be the candidates for developing new IBS drugs, and used to manage IBS, respectively. TRIAL REGISTRATION: NCT01641224 (www.ClinicalTrials.gov).
RCT Entities:
OBJECTIVES: To examine the efficacy and safety ofpersonalized tongxie formulas; to decrease type II errors to minimum. METHODS:Patients were randomized (1:1:1) into three groups given tongxie, placebo, or pinaverium 3 times daily for 4 weeks. Patients in the tongxie group were treated with personalized formulas based on TCM differential diagnosis, i.e., basic type of IBS, IBS due to liver depression and qi stagnation, excess heat in the liver, deficient spleen function, deficient kidney function, and others (groups 1-6). Primary endpoints were significantly greater reductions in abdominal pain and Bristol stool score. Secondary endpoints were reductions in pain and stool frequencies and abdominal discomfort and its frequency. RESULTS: There were significantly more patients whose stool consistencies were improved than pains were relieved in the entire population (p < 0.001), but there was no significantly difference in subpopulation group 3 (p > 0.05). There were significantly more patients whose stool frequencies were reduced than pain frequencies were reduced in the entire population (p < 0.001), but there were no significantly difference in the subpopulation Groups 1, 3, 4, and 6 (p > 0.05). Multiple active ingredients and their mechanisms of actions to relieve IBS symptoms were identified. CONCLUSION: The outcomes in subpopulations may be different from those of the entire population, indicating that personalized formulas are important to achieve optimal outcomes; the active ingredients and innovative mechanisms identified in this study can be the candidates for developing new IBS drugs, and used to manage IBS, respectively. TRIAL REGISTRATION: NCT01641224 (www.ClinicalTrials.gov).
Authors: Rong Tang; Xiaoqing Peng; Xiaohong Zhou; Zhimin Zheng; Jiayu Yin; Hong Liu Journal: Evid Based Complement Alternat Med Date: 2022-04-01 Impact factor: 2.629