Dataset Information

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

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.

SUBMITTER: Yang JW

PROVIDER: S-EPMC5683366 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Yang Jing-Wen JW Zhang Li-Wen LW Shi Guang-Xia GX Du Yi Y Wang Jun J Zhao Jing-Jie JJ Cao Yan Y Tu Jian-Feng JF Zhang Shuai S Tan Cheng C Chen San-San SS Liu Cun-Zhi CZ

Trials 20171113 1

<h4>Background</h4>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 ...[more]

PMID: 29132415

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Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

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