Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial
Jing-Wen Yang,
Li-Wen Zhang,
Guang-Xia Shi,
Yi Du,
Jun Wang,
Jing-Jie Zhao,
Yan Cao,
Jian-Feng Tu,
Shuai Zhang,
Cheng Tan,
San-San Chen,
Cun-Zhi Liu
Affiliations
Jing-Wen Yang
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation
Li-Wen Zhang
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation
Guang-Xia Shi
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation
Yi Du
Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University
Jun Wang
Acupuncture and Moxibustion Department, Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine
Jing-Jie Zhao
Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University
Yan Cao
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation
Jian-Feng Tu
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation
Shuai Zhang
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation
Cheng Tan
Acupuncture and Moxibustion Department, Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine
San-San Chen
Acupuncture and Moxibustion Department, Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine
Cun-Zhi Liu
Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation
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.
