Hou Ya-Quan, Zhang Xin, Tu Jian-Feng, Zheng Yang, Yang Jing-Wen, Kim Mirim, Hu Hui, Wang Li-Qiong, Zhao Jing-Jie, Zhou Wei, Wang Jun, Zou Xuan, Wang Yu, Shi Guang-Xia, Liu Cun-Zhi
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Dongcheng District, Beijing, China.
Trials. 2019 Jan 18;20(1):65. doi: 10.1186/s13063-018-3051-3.
Postprandial distress syndrome (PDS) has a considerable impact on quality of life. Our previous pilot trial suggested that acupuncture might be a potential treatment option for PDS. We will conduct this large trial to determine the efficacy of acupuncture versus sham acupuncture for PDS.
METHODS/DESIGN: A total of 280 eligible patients who meet the Rome IV criteria for PDS will be randomly allocated to either the acupuncture group or the sham acupuncture group. Each patient will receive 12 sessions over four weeks. The primary outcomes will be the response rate of overall treatment effect (OTE) and the elimination rate of all three cardinal symptoms (postprandial fullness, upper abdominal bloating, and early satiation) at four weeks after randomization. Secondary outcomes will include assessments of the severity of dyspepsia symptoms and disease-specific quality of life at weeks 4, 8, and 16 after randomization. All patients who receive randomization will be included in the intent-to-treat analysis.
The finding of this trial will provide high-quality evidence on the efficacy of acupuncture for treatment of PDS. Results of this research will be published in peer-reviewed journals.
ISRCTN Registry, ISRCTN12511434 . Registered on 31 March 2017.
餐后不适综合征（PDS）对生活质量有相当大的影响。我们之前的试点试验表明，针灸可能是PDS的一种潜在治疗选择。我们将进行这项大型试验，以确定针灸与假针灸治疗PDS的疗效。
方法/设计：总共280名符合PDS罗马IV标准的合格患者将被随机分配到针灸组或假针灸组。每位患者将在四周内接受12次治疗。主要结局将是随机分组后四周时总体治疗效果（OTE）的缓解率和所有三种主要症状（餐后饱胀、上腹胀气和早饱）的消除率。次要结局将包括随机分组后第4、8和16周时消化不良症状严重程度和疾病特异性生活质量的评估。所有接受随机分组的患者将纳入意向性分析。
本试验的结果将为针灸治疗PDS的疗效提供高质量证据。本研究结果将发表在同行评审期刊上。
ISRCTN注册库，ISRCTN12511434。于2017年3月31日注册。
