H Zheng1, J Xu1, X Sun2, F Zeng1, Y Li1, X Wu1, J Li1, L Zhao1, X-R Chang3, M Liu3, B Gong4, X-Z Li4, F-R Liang1. 1. Acupuncture & Tuina College/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China. 2. Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, China. 3. Acupuncture College, Hunan University of Traditional Chinese Medicine, Changsha, Hunan, China. 4. Traditional Chinese Medicinal College, Chongqing Medical University, Chongqing, China.
Abstract
BACKGROUND: To test the efficacy of electroacupuncture for patients with refractory functional dyspepsia (FD). METHODS: A 24-week, 2-arm, single-blind, randomized controlled trial was conducted at three hospitals in China. Patients with refractory FD were randomly assigned to receive 20 sessions of authentic or sham electroacupuncture in a treatment duration of 4 weeks. The primary outcome was complete absence of dyspeptic symptoms at 16 weeks after initiation of acupuncture (week 16). The secondary outcomes included adequate relief of dyspeptic symptoms, Leeds Dyspepsia Questionnaire (LDQ), Nepean Dyspepsia Index (NDI), and adverse events. Intention-to-treat analysis was performed. KEY RESULTS:Two hundred patients were included, of which 196 (98%) completed follow-up data at week 24. At week 16, 17 (17%) patients in the authentic electroacupuncture group vs 6 (6%) patients in the sham group achieved the primary outcome (P = .014). Sixty-two (62%) patients had adequate relief in the authentic electroacupuncture group, as compared to 22 (22%) in the sham group (P = .001). The scores of LDQ and NDI were significantly improved in both groups at week 16, and patients in the authentic electroacupuncture group have more improvements (LDQ, mean difference, -2.2, 95% confidence interval, -2.3 to -2.1, P < .001; NDI, -7.3, -10.5 to -4.2, P < .001). Results were similar for all the outcomes assessed at week 24. No serious adverse events were reported in both groups. CONCLUSION:Acupuncture efficaciously improves dyspeptic symptoms in patients with refractory FD.
RCT Entities:
BACKGROUND: To test the efficacy of electroacupuncture for patients with refractory functional dyspepsia (FD). METHODS: A 24-week, 2-arm, single-blind, randomized controlled trial was conducted at three hospitals in China. Patients with refractory FD were randomly assigned to receive 20 sessions of authentic or sham electroacupuncture in a treatment duration of 4 weeks. The primary outcome was complete absence of dyspeptic symptoms at 16 weeks after initiation of acupuncture (week 16). The secondary outcomes included adequate relief of dyspeptic symptoms, Leeds Dyspepsia Questionnaire (LDQ), Nepean Dyspepsia Index (NDI), and adverse events. Intention-to-treat analysis was performed. KEY RESULTS: Two hundred patients were included, of which 196 (98%) completed follow-up data at week 24. At week 16, 17 (17%) patients in the authentic electroacupuncture group vs 6 (6%) patients in the sham group achieved the primary outcome (P = .014). Sixty-two (62%) patients had adequate relief in the authentic electroacupuncture group, as compared to 22 (22%) in the sham group (P = .001). The scores of LDQ and NDI were significantly improved in both groups at week 16, and patients in the authentic electroacupuncture group have more improvements (LDQ, mean difference, -2.2, 95% confidence interval, -2.3 to -2.1, P < .001; NDI, -7.3, -10.5 to -4.2, P < .001). Results were similar for all the outcomes assessed at week 24. No serious adverse events were reported in both groups. CONCLUSION: Acupuncture efficaciously improves dyspeptic symptoms in patients with refractory FD.
Authors: Lucas Wauters; Ram Dickman; Vasile Drug; Agata Mulak; Jordi Serra; Paul Enck; Jan Tack; Anna Accarino; Giovanni Barbara; Serhat Bor; Benoit Coffin; Maura Corsetti; Heiko De Schepper; Dan Dumitrascu; Adam Farmer; Guillaume Gourcerol; Goran Hauser; Trygve Hausken; George Karamanolis; Daniel Keszthelyi; Carolin Malagelada; Tomislav Milosavljevic; Jean Muris; Colm O'Morain; Athanassos Papathanasopoulos; Daniel Pohl; Diana Rumyantseva; Giovanni Sarnelli; Edoardo Savarino; Jolien Schol; Arkady Sheptulin; Annemieke Smet; Andreas Stengel; Olga Storonova; Martin Storr; Hans Törnblom; Tim Vanuytsel; Monica Velosa; Marek Waluga; Natalia Zarate; Frank Zerbib Journal: United European Gastroenterol J Date: 2021-04 Impact factor: 4.623