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Randomized Controlled Trial
. 2017 Jul 14;17(1):363.
doi: 10.1186/s12906-017-1869-y.

Influence of the patient-practitioner interaction context on acupuncture outcomes in functional dyspepsia: study protocol for a multicenter randomized controlled trial

Seok-Jae Ko  1 , Jae-Woo Park  1 , Jungtae Leem  2 , Ted J Kaptchuk  3 , Vitaly Napadow  4 , Braden Kuo  5 , Jessica Gerber  4 , Laurie Dimisko  6 , Inkwon Yeo  7 , Junhee Lee  8 , Jinsung Kim  9
Affiliations
Randomized Controlled Trial

Influence of the patient-practitioner interaction context on acupuncture outcomes in functional dyspepsia: study protocol for a multicenter randomized controlled trial

Seok-Jae Ko et al. BMC Complement Altern Med. .

Abstract

Background: In the treatment of functional dyspepsia, the placebo effect has been reported to be high, and the influence of the patient-practitioner relationship may be a major component of this effect. The specific and non-specific effects of acupuncture cannot be easily distinguished, and the patient-practitioner relationship may influence the total therapeutic effect in clinical practice. There have been no studies that investigate the influence of patient-practitioner relationship on acupuncture treatment for patients with functional dyspepsia.

Methods: Patients with postprandial distress syndrome, a functional dyspepsia subtype, will be recruited at three hospitals (two in Korea and one in USA) for an international, multi-center, randomized, patient/assessor-blinded, clinical trial. The total anticipated sample size is 88. The participants will be randomly allocated into two groups: an augmented interaction group and a limited interaction group. Acupuncture, with total 12 acupoints, will be performed twice weekly for 4 weeks in both groups. Trained practitioners will provide an "augmented" or "limited" interaction context, as determined by random allocation. The primary outcome measure is the proportion of responders, the proportion of participants who answer "yes" to more than half of the adequate relief questions during the study. Secondary outcome measures include questionnaires for quality of life and symptoms of dyspepsia, and maximum tolerable volume of nutrient drink test. Data will be collected at baseline and following 4 weeks of acupuncture.

Discussion: This study will evaluate the influence of the patient-practitioner interaction on clinical effects of acupuncture in patients with functional dyspepsia.

Trial registration: CRIS Identifier: ( KCT0002229 ).

Keywords: Acupuncture; Augmented interaction; Functional dyspepsia; Limited interaction; Randomized controlled trial.

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Conflict of interest statement

Ethics approval and consent to participate

This trial will be carried out according to the standards of the International Committee on Harmonization on Good Clinical Practice and the Declaration of Helsinki. Medical Ethics Committee at KyungHee University Hospital at Gangdong (approval number is KHNMCOH 2016-04-007-001), Kyung Hee University Medical Center (No. KOMCIRB – 150914 – HR - 040), and Massachusetts General Hospital (No. 2016P001981/PHS) have approved this protocol. Informed consent will be gained from all participants before commencing the trial.

Consent for publication

Not applicable.

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 chart of the study
See this image and copyright information in PMC

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References

    1. Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006;130:1377–1390. doi: 10.1053/j.gastro.2006.03.008. - DOI - PubMed
    1. Lacy BE, Talley NJ, Locke GR 3rd, Bouras EP, DiBaise JK, El-Serag HB, et al. Review article: current treatment options and management of functional dyspepsia. Aliment Pharmacol Ther. 2012;36(1):3–15. - PMC - PubMed
    1. Ouyang H, Chen JD. Review article: therapeutic roles of acupuncture in functional gastrointestinal disorders. Aliment Pharmacol Ther. 2004;20:831–841. doi: 10.1111/j.1365-2036.2004.02196.x. - DOI - PubMed
    1. Kaptchuk TJ. Powerful placebo: the dark side of the randomized controlled trial. Lancet. 1998;351:1722–1725. doi: 10.1016/S0140-6736(97)10111-8. - DOI - PubMed
    1. Hrobjartsson A. What are the main methodological problems in the estimation of placebo effects. J Clin Epidemiol. 2002;55:430–435. doi: 10.1016/S0895-4356(01)00496-6. - DOI - PubMed

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