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

BMC Complementary and Alternative Medicine

Study Protocol

Laurie Dimisko¹  Jae-Woo Park²  Jinsung Kim²  Seok-Jae Ko²  Junhee Lee³  Inkwon Yeo⁴  Jungtae Leem⁵  Braden Kuo⁶  Vitaly Napadow⁷  Jessica Gerber⁷  Ted J. Kaptchuk⁸ 

[1] BioMEMS Resource Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA;Department of Gastroenterology, College of Korean Medicine, Kyung Hee University, 26 Kyung Heedae-ro, Dongdaemun-gu, 02447, Seoul, Republic of Korea;Department of Sasang Constitutional Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, 02447, Seoul, Republic of Korea;Department of Statistics, Sookmyung Women’s University, 100 Cheongpa-ro 47-gil, Yongsan-gu, 04310, Seoul, Republic of Korea;DongShin Korean Medicine Hospital, 351, Omok-ro, Yangcheon-gu, 07999, Seoul, Republic of Korea;Gastroenterology Unit, Massachusetts General Hospital, Harvard Medical School, Blake 4, 55 Fruit St, 02114, Boston, MA, USA;Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Medical School. Boston, Harvard, MA, USA;Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, 02215, Boston, MA, USA;

关键词: Functional dyspepsia;    Acupuncture;    Randomized controlled trial;    Augmented interaction;    Limited interaction;   

DOI  :  10.1186/s12906-017-1869-y

 received in 2017-02-23, accepted in 2017-07-04,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundIn 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.MethodsPatients 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.DiscussionThis study will evaluate the influence of the patient-practitioner interaction on clinical effects of acupuncture in patients with functional dyspepsia.Trial registrationCRIS Identifier: (KCT0002229).

【 授权许可】

CC BY   
© The Author(s). 2017