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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial

Authors: Jing-Wen Yang, Li-Wen Zhang, Guang-Xia Shi, Yi Du, Jun Wang, Jing-Jie Zhao, Yan Cao, Jian-Feng Tu, Shuai Zhang, Cheng Tan, San-San Chen, Cun-Zhi Liu

Published in: Trials | Issue 1/2017

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Abstract

Background

Postprandial distress syndrome (PDS) is referred to as meal-related functional dyspepsia (FD) and causes a reduced quality of life (QoL) for patients. Several randomized controlled trials (RCTs) have suggested that acupuncture is an effective treatment for FD, but few studies were particularly for PDS. This pilot study was designed to determine the feasibility and efficacy of acupuncture in patients with PDS characterized by postprandial fullness and early satiation according to the Rome III criteria.

Methods

This is a multi-center, two-arm, blinded (participants), pilot RCT. Forty-two participants who meet the inclusion criteria will be randomly assigned to the verum acupuncture group or minimal acupuncture group in a 1:1 ratio. Both treatments consist of 12 sessions of 20 min duration over four weeks (three sessions per week). The primary outcome measurement is the proportion of persons who improve as assessed using the global outcome by the overall treatment effect (OTE) at end-of-treatment (EOT) (four weeks after randomization). Global assessment at weeks 8 and 16 after randomization is one of the secondary outcomes. The other secondary outcomes including symptoms, disease-specific QoL, and depression and anxiety will be assessed at weeks 4, 8, and 16 after randomization.

Discussion

This pilot study will help determine the feasibility and efficacy of acupuncture in patients with PDS.

Trial registration

ISRCTN Registry, ISRCTN18135146. Registered on 7 July 2016.
Appendix
Available only for authorised users
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Metadata
Title
Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial
Authors
Jing-Wen Yang
Li-Wen Zhang
Guang-Xia Shi
Yi Du
Jun Wang
Jing-Jie Zhao
Yan Cao
Jian-Feng Tu
Shuai Zhang
Cheng Tan
San-San Chen
Cun-Zhi Liu
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2285-9

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