Jian-Feng Tu1,2, Jing-Wen Yang1, Li-Qiong Wang1, Yang Zheng3, Li-Wen Zhang3, Yong-Ting Li1, Xin Zhang3, Guang-Xia Shi1, Jun Wang4, Jing-Jie Zhao5, Yi Du5, San-San Chen4, Lu Cheng4, Cun-Zhi Liu1,2. 1. Acupuncture Research Center, Beijing University of Chinese Medicine, Beijing, China. 2. School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China. 3. Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China. 4. Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China. 5. Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Abstract
BACKGROUND: Evidence for treating postprandial distress syndrome with acupuncture is limited. AIM: We aimed to evaluate the feasibility of verum acupuncture versus sham acupuncture in patients with postprandial distress syndrome. METHODS:A total of 42 eligible patients were randomly allocated to either verum acupuncture or sham acupuncture groups in a 1:1 ratio. Each patient received 12 sessions over 4 weeks. The primary outcome was the response rate based on the overall treatment effect (OTE) 4 weeks after randomization. Secondary outcomes included dyspepsia symptom severity and adverse events. RESULTS: In each group, 19 patients (91.5%) completed the study. Thirteen patients receivingverum acupuncture and seven patients receiving sham acupuncture were classified as responders according to OTE (61.9% vs 33.3%; rate difference 28.6%; p = 0.06). Dyspepsia symptom severity at the end of treatment also differed significantly between verum acupuncture and sham acupuncture groups (5.9 units vs 3.7 units; between-group difference 2.2 (95% CI, 0.2-4.2); p = 0.04). No serious adverse events occurred. CONCLUSION: Four weeks of acupuncture may represent a potential treatment for postprandial distress syndrome. The treatment protocol and outcome measures used in this trial were feasible. Since this was a pilot study, the efficacy of acupuncture still needs to be determined by a larger, adequately powered trial.
RCT Entities:
BACKGROUND: Evidence for treating postprandial distress syndrome with acupuncture is limited. AIM: We aimed to evaluate the feasibility of verum acupuncture versus sham acupuncture in patients with postprandial distress syndrome. METHODS: A total of 42 eligible patients were randomly allocated to either verum acupuncture or sham acupuncture groups in a 1:1 ratio. Each patient received 12 sessions over 4 weeks. The primary outcome was the response rate based on the overall treatment effect (OTE) 4 weeks after randomization. Secondary outcomes included dyspepsia symptom severity and adverse events. RESULTS: In each group, 19 patients (91.5%) completed the study. Thirteen patients receiving verum acupuncture and seven patients receiving sham acupuncture were classified as responders according to OTE (61.9% vs 33.3%; rate difference 28.6%; p = 0.06). Dyspepsia symptom severity at the end of treatment also differed significantly between verum acupuncture and sham acupuncture groups (5.9 units vs 3.7 units; between-group difference 2.2 (95% CI, 0.2-4.2); p = 0.04). No serious adverse events occurred. CONCLUSION: Four weeks of acupuncture may represent a potential treatment for postprandial distress syndrome. The treatment protocol and outcome measures used in this trial were feasible. Since this was a pilot study, the efficacy of acupuncture still needs to be determined by a larger, adequately powered trial.