Acupuncture Research Center, Beijing University of Chinese Medicine, Beijing, China.
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
Acupunct Med. 2020 Oct;38(5):301-309. doi: 10.1177/0964528419900911. Epub 2020 Feb 7.
Evidence for treating postprandial distress syndrome with acupuncture is limited.
We aimed to evaluate the feasibility of verum acupuncture versus sham acupuncture in patients with postprandial distress syndrome.
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.
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%; = 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); = 0.04). No serious adverse events occurred.
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.
目前针对餐后不适综合征采用针刺治疗的证据有限。
旨在评估真针刺与假针刺治疗餐后不适综合征患者的可行性。
共纳入 42 例符合条件的患者，按照 1:1 的比例随机分配至真针刺组或假针刺组。每位患者接受 4 周、共 12 次的治疗。主要结局指标为随机分组后 4 周的总治疗效果（OTE）应答率。次要结局指标包括消化不良症状严重程度和不良事件。
每组各有 19 例（91.5%）患者完成研究。根据 OTE，真针刺组有 13 例（61.9%）患者和假针刺组有 7 例（33.3%）患者被归类为应答者（差异率 28.6%； = 0.06）。治疗结束时，真针刺组和假针刺组的消化不良症状严重程度也存在显著差异（5.9 单位比 3.7 单位；组间差异 2.2（95% CI，0.2-4.2）； = 0.04）。未发生严重不良事件。
4 周的针刺治疗可能是餐后不适综合征的一种潜在治疗方法。本试验中使用的治疗方案和结局测量指标是可行的。由于这是一项初步研究，针刺的疗效仍需要更大规模、充分效能的试验来确定。
