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Open Access Highly Accessed Study protocol

Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial

Gajin Han1, Seok-Jae Ko1, Jae-Woo Park1, Jinsung Kim1, Inkwon Yeo2, Hyejung Lee3, Song-Yi Kim3 and Hyangsook Lee3*

Author Affiliations

1 Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, Kyung Hee dae-ro 26, Dongdaemun-gu, Seoul 130-701, Republic of Korea

2 Department of Statistics, Sookmyung Women’s University, Cheongpa-ro 47-gil 100, Youngsan-gu, Seoul 140-742, Republic of Korea

3 Acupuncture and Meridian Science Research Center, College of Korean Medicine, Kyung Hee University, Kyung Hee dae-ro 26, Dongdaemun-gu, Seoul 130-701, South Korea

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Trials 2014, 15:89  doi:10.1186/1745-6215-15-89

Published: 22 March 2014

Abstract

Background

Functional dyspepsia (FD) is a common health problem currently without any optimal treatments. Acupuncture has been traditionally sought as a treatment for FD. The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD.

Methods/design

A two-center, randomized, waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms. Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals. They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group. The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks. The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period. The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index, EQ-5D, FD-related quality of life, Beck’s depression inventory, state-trait anxiety inventory questionnaire, and level of ghrelin hormone. The protocol was approved by the participating centers’ Institutional Review Boards.

Discussion

Results of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work.

Trial registration

ClinicalTrials.gov Identifier: NCT01921504.

Keywords:
Acupuncture; Functional dyspepsia; Ghrelin; Randomized controlled trial; Waitlist