Zhaoqin Wang1, Manwen Xu2, Zheng Shi3, Chunhui Bao4, Huirong Liu5, Cili Zhou6, Yilu Yan7, Chunye Wang8, Guona Li9, Wei Zhang10, Anqi Gao11, Huangan Wu12. 1. Department of Aeronautics and Astronautics, Shanghai Key Laboratory of Acupuncture Mechanism and Acupoint Function, Fudan University, Shanghai, 200433, China. Electronic address: wangzhaoqin@fudan.edu.cn. 2. Department of Integrated Traditional Chinese and Western Medicine, Huashan Hospital, Fudan University, Shanghai, 200040, China. Electronic address: merelyric_white@163.com. 3. Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: shizhengmm@163.com. 4. Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: baochunhui789@126.com. 5. Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: lhr_tcm@139.com. 6. Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: zhoucili2010@126.com. 7. Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China; Yueyang Hospital of Integrative Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. Electronic address: 18001861046@163.com. 8. Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China; Yueyang Hospital of Integrative Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. Electronic address: Daisywang666@163.com. 9. Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China; Yueyang Hospital of Integrative Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. Electronic address: liguonaaa@163.com. 10. Department of Biostatistics, School of Public Health, Fudan University, Shanghai, 200032, China. Electronic address: weizhang@shmu.edu.cn. 11. Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China; Yueyang Hospital of Integrative Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China. Electronic address: 13817206183@163.com. 12. Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. Electronic address: wuhuangan@126.com.
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE: Moxibustion therapy is a traditional Chinese medicine external treatment method, which involves crushing dried herb Artemisia argyi H. Lév. & Vanio and rolling it into a long cigarette-like strip, igniting it and using its warmth to stimulate specific acupuncture points for a certain period of time. It is often used in Asia to treat various diseases, especially abdominal pain. Clinical reports suggest that acupuncture and moxibustion are the effective treatment for Irritable Bowel Syndrome with Diarrhea (IBS-D). However, there is no placebo-controlled study to prove its safety and efficacy. OBJECTIVE: To evaluate the effects of mild moxibustion (MM) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) through comparisons with those of placebo moxibustion. PATIENTS AND METHODS: This was a single-site, randomized controlled trial was conducted at Shanghai Research Institute of Acupuncture and Meridian in China and enrolled 76 participants who met the Rome IV diagnostic criteria for IBS-D between May 2017 and December 2019. 76 participants were randomized to either mild moxibustion (MM) or placebo moxibustion group (PM) in a 1:1 ratio. 18 sessions of MM or PM were implemented over the course of 6 weeks (3 times per week). The primary outcome was adequate relief after 6 weeks of treatment. RESULTS: Of 76 patients with IBS-D who were randomized (38 in the MM group and 38 in the PM group) were included in the intention-to-treat (ITT) analysis set. After treatment at week 6, the response rate was significantly higher in the MM group than the PM group (81.58% vs. 36.84%) with an estimated difference of 44.74 (95% CI, 23.46 to 66.02, P < 0.001). No participant reported severe adverse effects. CONCLUSION: The findings suggest that mild moxibustion may be more effective than placebo moxibustion for the treatment of IBS-D, with effects lasting up to 12 weeks. TRIAL REGISTRATION: ChiCTR, ChiCTR2100046852. Registered 29 May 2021 - Retrospectively registered, URL: http://www.chictr.org.cn/showproj.aspx?proj=127000.
ETHNOPHARMACOLOGICAL RELEVANCE: Moxibustion therapy is a traditional Chinese medicine external treatment method, which involves crushing dried herb Artemisia argyi H. Lév. & Vanio and rolling it into a long cigarette-like strip, igniting it and using its warmth to stimulate specific acupuncture points for a certain period of time. It is often used in Asia to treat various diseases, especially abdominal pain. Clinical reports suggest that acupuncture and moxibustion are the effective treatment for Irritable Bowel Syndrome with Diarrhea (IBS-D). However, there is no placebo-controlled study to prove its safety and efficacy. OBJECTIVE: To evaluate the effects of mild moxibustion (MM) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) through comparisons with those of placebo moxibustion. PATIENTS AND METHODS: This was a single-site, randomized controlled trial was conducted at Shanghai Research Institute of Acupuncture and Meridian in China and enrolled 76 participants who met the Rome IV diagnostic criteria for IBS-D between May 2017 and December 2019. 76 participants were randomized to either mild moxibustion (MM) or placebo moxibustion group (PM) in a 1:1 ratio. 18 sessions of MM or PM were implemented over the course of 6 weeks (3 times per week). The primary outcome was adequate relief after 6 weeks of treatment. RESULTS: Of 76 patients with IBS-D who were randomized (38 in the MM group and 38 in the PM group) were included in the intention-to-treat (ITT) analysis set. After treatment at week 6, the response rate was significantly higher in the MM group than the PM group (81.58% vs. 36.84%) with an estimated difference of 44.74 (95% CI, 23.46 to 66.02, P < 0.001). No participant reported severe adverse effects. CONCLUSION: The findings suggest that mild moxibustion may be more effective than placebo moxibustion for the treatment of IBS-D, with effects lasting up to 12 weeks. TRIAL REGISTRATION: ChiCTR, ChiCTR2100046852. Registered 29 May 2021 - Retrospectively registered, URL: http://www.chictr.org.cn/showproj.aspx?proj=127000.