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. 2019 Jan 18;20(1):65.
doi: 10.1186/s13063-018-3051-3.

Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial

Ya-Quan Hou  1 , Xin Zhang  1 , Jian-Feng Tu  2 , Yang Zheng  2 , Jing-Wen Yang  1 , Mirim Kim  1 , Hui Hu  1 , Li-Qiong Wang  1 , Jing-Jie Zhao  3 , Wei Zhou  4 , Jun Wang  5 , Xuan Zou  1 , Yu Wang  2 , Guang-Xia Shi  2 , Cun-Zhi Liu  6
Affiliations

Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial

Ya-Quan Hou et al. Trials. .

Abstract

Background: 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.

Discussion: 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.

Trial registration: ISRCTN Registry, ISRCTN12511434 . Registered on 31 March 2017.

Keywords: Acupuncture; Functional dyspepsia; Postprandial distress syndrome; Randomized controlled trial; Sham acupuncture.

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Conflict of interest statement

Ethics approval

Research Ethical Committees of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Dongzhimen Hospital, Beijing Friendship Hospital, Huguosi Hospital of Chinese Medicine and Dongfang Hospital. Written informed consent will be obtained from patients prior to enrolment in the study.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram
Fig. 2
Fig. 2
Locations of acupoints and non-acupoints
Fig. 3
Fig. 3
Schedule of enrollment, intervention, and assessments of this study protocol. AFT after the first treatment, w week
See this image and copyright information in PMC

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