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

Trials

Cheng Tan¹  San-San Chen¹  Jun Wang¹  Shuai Zhang²  Guang-Xia Shi²  Li-Wen Zhang²  Jian-Feng Tu²  Jing-Wen Yang²  Yan Cao²  Cun-Zhi Liu²  Yi Du³  Jing-Jie Zhao³ 

[1] Acupuncture and Moxibustion Department, Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine;Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation;Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University;

关键词: Postprandial distress syndrome;    Functional dyspepsia;    Acupuncture;    Randomized controlled trial;    Minimal acupuncture;   

DOI  :  10.1186/s13063-017-2285-9

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown