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

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单位: [1]Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China. [2]Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China. [3]Acupuncture and Moxibustion Department, Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine, Beijing, China.
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关键词: Postprandial distress syndrome Functional dyspepsia Acupuncture Randomized controlled trial Minimal acupuncture

摘要:
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.

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出版当年[2016]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
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出版当年[2015]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2015版] 出版当年五年平均[2011-2015] 出版前一年[2014版] 出版后一年[2016版]

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第一作者单位: [1]Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, No. 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China.
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