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首页> 外文期刊>Trials >Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial
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Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial

机译：手动针刺不同频率对功能性消化不良（FD）患者的上腹痛综合征（EPS）的疗效和安全性：一项随机对照试验的研究方案

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Background Manual acupuncture (MA) manipulations are one of the key factors influencing acupuncture effects in traditional Chinese medicine theory. Different MA manipulations contain different stimulating parameters, thus generating different acupuncture responses or effects. Evidence has demonstrated that acupuncture is effective for functional dyspepsia (FD). However, the effects of different stimulating parameters of MA manipulations on FD remain unclear. Methods/design This study is a randomized controlled trial with a four-arm, parallel-group structure. Patients with FD with epigastric pain syndrome (EPS) will be included and randomly allocated into four groups: three MA manipulation groups (separately treated with a frequency of 1 Hz, 2 Hz, or 3 Hz) and a control group. All groups will receive omeprazole as a basic treatment and acupuncture: in the MA manipulation groups, the needles will be manipulated manually with three different frequencies on the basis when de qi is reached, while in the control group, the needles will be inserted without any manipulation. All patients will receive acupuncture treatment of five consecutive sessions per week for 2 weeks and be followed up at 4, 8, and 12 weeks. The primary outcomes of the study include patients’ response to the treatment. The secondary outcomes include dyspeptic symptoms, quality of life, mental status, fasting serum gastrin, motilin, and ghrelin concentrations, and adverse events. The protocol was approved by the Ethics committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (2016-K-057-01). Discussion The aim of this study is to evaluate the efficacy and safety of MA manipulations with different stimulating parameters (different frequencies) on EPS in patients with FD. Trial registration Chinese Clinical Trial Registry, ChiCTR-IOR-16008189 . Registered on 30 March 2016.
机译：背景技术手动针灸（MA）操作是影响中药理论中针灸作用的关键因素之一。不同的MA操作包含不同的刺激参数，从而产生不同的针灸反应或效果。有证据表明，针灸对功能性消化不良（FD）有效。但是，尚不清楚MA操作的不同刺激参数对FD的影响。方法/设计本研究是具有四臂平行组结构的随机对照试验。患有上腹痛综合征（EPS）的FD患者将被随机分为四组：三个MA操作组（分别以1 Hz，2 Hz或3 Hz的频率治疗）和对照组。所有组均将接受奥美拉唑作为基本治疗和针灸：在MA操纵组中，将在达到de qi的基础上以三种不同的频率手动操纵针头，而在对照组中，将不使用任何针头将其插入操纵。所有患者将接受每周五次连续针灸治疗，持续2周，并在4、8和12周进行随访。该研究的主要结果包括患者对治疗的反应。次要结果包括消化不良症状，生活质量，精神状态，空腹血清胃泌素，胃动素和生长素释放肽浓度以及不良事件。该方案已获得浙江中医药大学附属第一医院伦理委员会批准（2016-K-057-01）。讨论本研究的目的是评估具有不同刺激参数（不同频率）的MA操作对FD患者EPS的有效性和安全性。试验注册中国临床试验注册中心，ChiCTR-IOR-16008189。 2016年3月30日注册。

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