• Jing-Wen Yang, Li-Qiong Wang, Xuan Zou, Shi-Yan Yan, Yu Wang, Jing-Jie Zhao, Jian-Feng Tu, Jun Wang, Guang-Xia Shi, Hui Hu, Wei Zhou, Yi Du, and Cun-Zhi Liu.
• School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).
• Ann. Intern. Med. 2020 Jun 16; 172 (12): 777-785.

BackgroundPostprandial distress syndrome (PDS) is the most common subtype of functional dyspepsia. Acupuncture is commonly used to treat PDS, but its effect is uncertain because of the poor quality of prior studies.ObjectiveTo assess the efficacy of acupuncture versus sham acupuncture in patients with PDS.DesignMulticenter, 2-group, randomized clinical trial. (ISRCTN registry number: ISRCTN12511434).Setting5 tertiary hospitals in China.ParticipantsChinese patients aged 18 to 65 years meeting Rome IV criteria for PDS.Intervention12 sessions of acupuncture or sham acupuncture over 4 weeks.MeasurementsThe 2 primary outcomes were the response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms: postprandial fullness, upper abdominal bloating, and early satiation after 4 weeks of treatment. Participants were followed until week 16.ResultsAmong the 278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16. The estimated response rate from generalized linear mixed models at week 4 was 83.0% in the acupuncture group versus 51.6% in the sham acupuncture group (difference, 31.4 percentage points [95% CI, 20.3 to 42.5 percentage points]; P < 0.001). The estimated elimination rate of all 3 cardinal symptoms was 27.8% in the acupuncture group versus 17.3% in the sham acupuncture group (difference, 10.5 percentage points [CI, 0.08 to 20.9 percentage points]; P = 0.034). The efficacy of acupuncture was maintained during the 12-week posttreatment follow-up. There were no serious adverse events.LimitationLack of objective outcomes and daily measurement, high dropout rate, and inability to blind acupuncturists.ConclusionAmong patients with PDS, acupuncture resulted in increased response rate and elimination rate of all 3 cardinal symptoms compared with sham acupuncture, with sustained efficacy over 12 weeks in patients who received thrice-weekly acupuncture for 4 weeks.Primary Funding SourceBeijing Municipal Science and Technology Commission.

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