Electroacupuncture treatment of primary dysmenorrhea: A randomized, participant-blinded, sham-controlled clinical trial protocol.
Electroacupuncture treatment of primary dysmenorrhea: A randomized, participant-blinded, sham-controlled clinical trial protocol.
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原发性痛经的电针治疗：一种随机的，参与者的盲目对照临床试验方案。
DOI：
10.1371/journal.pone.0282541
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发表时间：
2023
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
--
作者：
女性原发性痛经是一种常见且严重的公共卫生问题，具有心理和生理影响。止痛药有不良反应，如耐受性、成瘾性、刺激消化道和肝、肾损害。电针已被用作替代疗法，虽然没有（非轶事）有效性的证据。本研究旨在为电针治疗原发性痛经的可行性和有效性提供依据。此外，本研究将借由观察血清及尿液代谢物的变化，探讨电针治疗原发性痛经的可能机制。这项多中心、随机、参与者设盲、假对照的临床试验包括336名原发性痛经妇女，正在中国的三家医院中心进行，包括12周治疗和3个月随访。女性将接受电针（n = 168）或假针灸（n = 168），从月经前7天开始，每天一次，直到月经。每个月经周期等于一个疗程，我们将评估总共三个疗程。关注的主要结局是治疗前后视觉模拟量表评分的变化。次要结局包括数字评定量表、考克斯精神症状量表、中医症状、焦虑自评量表、抑郁自评量表和36项简表问卷评分的变化，以及安全性评价。此外，我们还将对电针与原发性痛经病理学关系的代谢组学机制进行初步探讨。我们的目的是找到一个合适的非药物替代原发性痛经治疗，以减少对非甾体抗炎药的依赖。中国临床试验注册中心：ChiCTR 2100054234; http://www.chictr.org.cn/。
Primary dysmenorrhea in women is a common and serious public health problem with psychological and physical effects. Painkillers have adverse effects, such as tolerance, addiction, irritation of the digestive tract, and liver and kidney damage. Electroacupuncture has been used as alternative therapy, although with no (non-anecdotal) evidence of effectiveness. This study aims to provide evidence for the feasibility and efficacy of electroacupuncture in the treatment of primary dysmenorrhea. Moreover, by observing changes in serum and urine metabolites, we will evaluate the putative mechanisms mediating electroacupuncture effects in primary dysmenorrhea. This multicenter, randomized, participant-blinded, sham-controlled clinical trial including 336 women with primary dysmenorrhea is being conducted at three hospital centers in China and consists of a 12-week treatment and a 3-month follow-up. Women will undergo electroacupuncture (n = 168) or sham acupuncture (n = 168), beginning 7 days before their menstruation, once per day, until menstruation. Each menstrual cycle equals one course of treatment, and we will evaluate a total of three courses of treatment. The primary outcome of interest is the change in visual analogue scale scores before and after treatment. The secondary outcomes include changes in the numeric rating scale, Cox Menstrual Symptom Scale, traditional Chinese medicine symptoms, the Self-Rating Anxiety Scale, Self-Rating Depression Scale, and 36-Item Short Form questionnaire scores, and a safety evaluation. Moreover, we will preliminarily investigate the metabolomics mechanism as a potential mediator of the association between electroacupuncture and primary dysmenorrhea symptomology. We aim to find a suitable non-medicinal alternative for primary dysmenorrhea treatment to reduce reliance on non-steroidal anti-inflammatory drugs. Chinese Clinical Trial Registry: ChiCTR2100054234; http://www.chictr.org.cn/.
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影响因子：
2.5
作者：
Chen CX;Carpenter JS;Ofner S;LaPradd M;Fortenberry JD
通讯作者：
Fortenberry JD
影响因子：
12.4
作者：
Yang NN;Yang JW;Ye Y;Huang J;Wang L;Wang Y;Su XT;Lin Y;Yu FT;Ma SM;Qi LY;Lin LL;Wang LQ;Shi GX;Li HP;Liu CZ
通讯作者：
Liu CZ
影响因子：
9.3
作者：
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通讯作者：
Coen M
DOI：
10.1073/pnas.2022857118
发表时间：
2021-09-14
影响因子：
11.1
作者：
Teruya T;Chen YJ;Kondoh H;Fukuji Y;Yanagida M
通讯作者：
Yanagida M
DOI：
10.1016/j.cimid.2021.101711
发表时间：
2021-10-01
影响因子：
2
作者：
Daldaban, Fadime;Bekdik, Ilknur Karaca;Arslan, Korhan
通讯作者：
Arslan, Korhan