Linda L D Zhong1, Chung-Wah Cheng1, Wai Kun1, Liang Dai1, Dong-Dong Hu1, Zi-Wan Ning1, Hai-Tao Xiao1, Cheng-Yuan Lin1, Ling Zhao1, Tao Huang1, Ke Tian1, King-Hong Chan2, Ting-Wa Lam3, Xiao-Rui Chen2, Chi-Tak Wong2, Min Li1, Ai-Ping Lu1, Justin C Y Wu4, Zhao-Xiang Bian5. 1. Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China. 2. Department of Family Medicine & General Out-patient Clinics, Kowloon Central Cluster, Hospital Authority, Kowloon City, Hong Kong, P. R. China. 3. Department of Medicine, Queen Elizabeth Hospital, Hospital Authority, Hong Kong, P. R. China. 4. Institute of Digestive Disease, Faculty of Medicine, The Chinese University of Hong Kong, P. R. China. Electronic address: justinwu@cuhk.edu.hk. 5. Hong Kong Chinese Medicine Study Centre, Hong Kong Baptist University, Hong Kong, P. R. China. Electronic address: bzxiang@hkbu.edu.hk.
Abstract
BACKGROUND & AIMS: The Chinese herbal medicine, MaZiRenWan (MZRW), has been used for more than 2000 years to treat constipation, but it has not been tested in a randomized controlled trial. We performed a trial to evaluate the efficacy and safety of MZRW, compared with the stimulant laxative senna or placebo, for patients with functional constipation (FC). METHODS: We performed a double-blind, double-dummy, trial of 291 patients with FC based on Rome III criteria, seen at 8 clinics in Hong Kong from June 2013 through August 2015. Patients were observed for 2 weeks and then assigned randomly (1:1:1) to groups given MZRW (7.5 g, twice daily), senna (15 mg daily), or placebo for 8 weeks. Patients were then followed for 8 weeks and evaluated at baseline and weeks 4, 8 (end of treatment), and 16 (end of follow up). Participants recorded information on stool form and frequency, feeling of complete evacuation, and research medication taken. Data on individual bowel symptoms, global symptom improvement, and adverse events were collected. A complete response was defined as an increase ≥1 complete spontaneous bowel movement (CSBM)/week from baseline (the primary outcome). Secondary outcomes included response during the follow-up period, colonic transit, individual and global symptom assessments, quality of life measured with 36-item short form Chinese version, and adverse events. RESULTS: Although there was no statistically significant difference in proportions of patients with a complete response to MZRW (68%) vs. senna (57.7%) (P = .14) at week 8, there was a statistically significant difference vs. placebo (33.0%) (P < .005). At the 16-week timepoint (after the 8-week follow-up period), 47.4% of patients had a complete response to MZRW, 20.6% had a complete response to senna, and 17.5% had a complete response to placebo (P < .005 for MZRW vs. placebo). The group that received MZRW group also had significant increases in colonic transit and reduced severity of constipation, straining, incomplete evacuation, and global constipation symptoms compared with the groups that received placebo or senna in (P < .05 for all comparisons). CONCLUSIONS: In a randomized controlled trial of 291 patients with FC, we found MZRW to be well-tolerated and effective in increasing CSBM/week. MZRW did not appear to be more effective than senna and might be considered as an alternative to this drug. ClincialTrials.gov no: NCT01695850.
RCT Entities:
BACKGROUND & AIMS: The Chinese herbal medicine, MaZiRenWan (MZRW), has been used for more than 2000 years to treat constipation, but it has not been tested in a randomized controlled trial. We performed a trial to evaluate the efficacy and safety of MZRW, compared with the stimulant laxative senna or placebo, for patients with functional constipation (FC). METHODS: We performed a double-blind, double-dummy, trial of 291 patients with FC based on Rome III criteria, seen at 8 clinics in Hong Kong from June 2013 through August 2015. Patients were observed for 2 weeks and then assigned randomly (1:1:1) to groups given MZRW (7.5 g, twice daily), senna (15 mg daily), or placebo for 8 weeks. Patients were then followed for 8 weeks and evaluated at baseline and weeks 4, 8 (end of treatment), and 16 (end of follow up). Participants recorded information on stool form and frequency, feeling of complete evacuation, and research medication taken. Data on individual bowel symptoms, global symptom improvement, and adverse events were collected. A complete response was defined as an increase ≥1 complete spontaneous bowel movement (CSBM)/week from baseline (the primary outcome). Secondary outcomes included response during the follow-up period, colonic transit, individual and global symptom assessments, quality of life measured with 36-item short form Chinese version, and adverse events. RESULTS: Although there was no statistically significant difference in proportions of patients with a complete response to MZRW (68%) vs. senna (57.7%) (P = .14) at week 8, there was a statistically significant difference vs. placebo (33.0%) (P < .005). At the 16-week timepoint (after the 8-week follow-up period), 47.4% of patients had a complete response to MZRW, 20.6% had a complete response to senna, and 17.5% had a complete response to placebo (P < .005 for MZRW vs. placebo). The group that received MZRW group also had significant increases in colonic transit and reduced severity of constipation, straining, incomplete evacuation, and global constipation symptoms compared with the groups that received placebo or senna in (P < .05 for all comparisons). CONCLUSIONS: In a randomized controlled trial of 291 patients with FC, we found MZRW to be well-tolerated and effective in increasing CSBM/week. MZRW did not appear to be more effective than senna and might be considered as an alternative to this drug. ClincialTrials.gov no: NCT01695850.
Authors: Tao Huang; Ling Zhao; Cheng-Yuan Lin; Lin Lu; Zi-Wan Ning; Dong-Dong Hu; Linda L D Zhong; Zhi-Jun Yang; Zhao-Xiang Bian Journal: Front Pharmacol Date: 2020-01-23 Impact factor: 5.810
Authors: Chung-Wah Cheng; Hoi-Fung Mok; Cora W S Yau; Jasmine T M Chan; Yu-Chen Kang; Pui-Yan Lam; Linda L D Zhong; Chen Zhao; Bacon F L Ng; Annie O L Kwok; Doris M W Tse; Zhao-Xiang Bian Journal: Chin Med Date: 2022-03-02 Impact factor: 5.455