School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China (J.Y., L.W., X.Z., G.S.).
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China (S.Y.).
Ann Intern Med. 2020 Jun 16;172(12):777-785. doi: 10.7326/M19-2880. Epub 2020 May 12.
BACKGROUND: Postprandial 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. OBJECTIVE: To assess the efficacy of acupuncture versus sham acupuncture in patients with PDS. DESIGN: Multicenter, 2-group, randomized clinical trial. (ISRCTN registry number: ISRCTN12511434). SETTING: 5 tertiary hospitals in China. PARTICIPANTS: Chinese patients aged 18 to 65 years meeting Rome IV criteria for PDS. INTERVENTION: 12 sessions of acupuncture or sham acupuncture over 4 weeks. MEASUREMENTS: The 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. RESULTS: Among 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]; < 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]; = 0.034). The efficacy of acupuncture was maintained during the 12-week posttreatment follow-up. There were no serious adverse events. LIMITATION: Lack of objective outcomes and daily measurement, high dropout rate, and inability to blind acupuncturists. CONCLUSION: Among 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 SOURCE: Beijing Municipal Science and Technology Commission.
背景：餐后不适综合征（PDS）是功能性消化不良最常见的亚型。针灸常用于治疗 PDS，但由于先前研究质量较差，其疗效尚不确定。
目的：评估针刺与假针刺治疗 PDS 患者的疗效。
设计：多中心、2 组、随机临床试验。（ISRCTN 注册号：ISRCTN85250403）。
设置：中国 5 家三级医院。
参与者：符合 Rome IV 标准的 18 至 65 岁中国 PDS 患者。
干预措施：4 周内进行 12 次针刺或假针刺。
测量：2 个主要结局是基于整体治疗效果的反应率和所有 3 个主要症状（餐后饱胀、上腹胀满和早饱）的消除率：治疗 4 周后。参与者随访至第 16 周。
结果：在 278 名随机分配的参与者中，有 228 名（82%）在第 16 周完成了结局测量。广义线性混合模型估计的第 4 周时的反应率在针刺组为 83.0%，在假针刺组为 51.6%（差异，31.4 个百分点[95%CI，20.3 至 42.5 个百分点]；<0.001）。针刺组 3 个主要症状的总消除率为 27.8%，假针刺组为 17.3%（差异，10.5 个百分点[CI，0.08 至 20.9 个百分点]；=0.034）。针刺治疗的疗效在 12 周的治疗后随访中得以维持。无严重不良事件。
局限性：缺乏客观结局和日常测量、高脱落率和无法对针灸师进行盲法。
结论：在 PDS 患者中，与假针刺相比，针刺可提高整体反应率和所有 3 个主要症状的消除率，在接受每周 3 次、连续 4 周针刺治疗的患者中，疗效可持续 12 周。
主要资金来源：北京市科学技术委员会。
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