Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial.
Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial.
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穴位草药膏治疗原发性痛经：随机对照试验研究方案
DOI：
10.1186/s13063-018-2682-8
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发表时间：
2018-07-03
期刊：
影响因子：
2.5
通讯作者：
Yang J
中科院分区：
文献类型：
--
作者：
Yu S;Wen Y;Xia W;Yang M;Lv Z;Li X;Li W;Yang S;Hu Y;Liang F;Yang J
【摘要】：背景原发性痛经(PD)是育龄妇女主要的妇科疾病之一。治疗帕金森病的常用药物并不总能达到令人满意的疼痛缓解效果。因此，卫生专业人员和患者都在寻求补充和替代医学的帮助。穴位草药膏（AHP）似乎是一种安全有效的缓解经期疼痛以及改善其他帕金森病相关症状的方法。尽管过去针对这种情况进行了类似的临床研究，但迄今为止尚未报道基于方法的高质量临床试验。本研究旨在评估 AHP 与穴位安慰剂膏药 (APP) 相比，并被纳入等待名单对照组对原发性痛经患者的疗效。 方法/设计本研究是一项随机、单中心、安慰剂对照临床试验。总共 180 名患有 PD 的女性将被纳入，并以 1:1:1 的比例随机分配到 AHP、APP 和等待名单 (WL) 组。 AHP组的患者将在神阙穴(CV8)、关元穴(CV4)、气海穴(CV5)、磁髎穴(BL32)和自宫穴(EX-CA1)上贴膏药(少腹逐瘀汤)。 APP 组的女性将在相同的穴位上接受安慰剂膏药，并且在研究完成之前不会对 WL 组进行任何干预。主要结果是通过视觉模拟量表 (VAS) 测量的疼痛强度减轻，其他结果测量包括考克斯月经症状量表 (CMSS)、12 项简短健康调查 (SF-12) 和参与者总体变化印象 (PGIC)。所有评估将在基线、治疗过程中的每个月经周期和后续过程中进行。整个研究过程中将记录任何不良事件。讨论这是第一项比较三种不同干预措施后经痛变化的研究：主动干预（AHP）、安慰剂干预（APP）和一段时间不干预（WL）。这项三组随机对照试验 (RCT) 旨在调查特异性（AHP 与 APP）和非特异性（APP 与 WL）效应对主动 AHP 对 PDM 女性的总体临床效果的相对贡献。本试验科学严谨的方法学设计，为评价层次分析法治疗帕金森病的疗效和安全性提供了良好的证据。此外，本研究结果可为今后经痛的治疗提供循证参考。试验注册中国临床试验注册中心，编号：ChiCTR-TRC-16008701。注册日期：2016 年 7 月 22 日。
BackgroundPrimary dysmenorrhea (PD), is one of main gynecological complaints in women of child-bearing age. Common medications for PD do not always achieve satisfactory outcome of pain relief. Hence, both health professionals and patients are seeking help from complementary and alternative medicine. The acupoint herbal plaster (AHP), which appears to be a safe and effective way to alleviate menstrual pain, as well as to improve other PD-related symptoms. Despite similar clinical studies for this condition in the past, no high-quality methodology-based clinical trial has been reported to date. The current study aims to assess the efficacy of the AHP compared with the acupoint placebo plaster (APP) and being placed on a waiting-list control group in patients with primary dysmenorrhea.Methods/designThis study is a randomized, single-center, placebo-controlled clinical trial. A total of 180 women with PD will be included and randomly allocated to the AHP, APP and waiting-list (WL) groups in a 1:1:1 ratio. Patients in the AHP group will be provided with herbal plasters (Shaofuzhuyudecoction) on various acupoints:Shenque(CV8),Guanyuan(CV4),Qihai(CV5),Ciliao(BL32) andZigong(EX-CA1). Women in the APP group will receive placebo plasters on the same acupoints, and no intervention will be given to the WL group until completion of the study. The primary outcome will be pain intensity reduction measured by a Visual Analog Scale (VAS), with other outcome measurements including the Cox Menstrual Symptom Scale (CMSS), the 12-Item Short Form Health Survey (SF-12) and the Participant Global Impression of Change (PGIC). All assessments will be performed at baseline, each menstrual cycle during the treatment course and the follow-up course. Any adverse events will be recorded throughout the study.DiscussionThis is the first study to compare the changes in menstrual pain after three different interventions: the active intervention (AHP), the placebo intervention (APP), and a period of no intervention (WL). This three-arm randomized controlled trial (RCT) aims to investigate the relative contributions of the specific (AHP vs. APP) and non-specific (APP vs. WL) effects to the overall clinical effects of the active AHP on women with PDM. The scientific and rigorous methodology design of this trial should gather good evidence to assess the curative effects and safety of the AHP on PD. Moreover, the results of this study may provide evidence-based references for the treatment of menstrual pain in future.Trial registrationChinese Clinical Trial Registry, ID: ChiCTR-TRC-16008701. Registered on 22 July 2016.
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DOI：
10.1093/ecam/neq009
发表时间：
2011
期刊：
Evidence-based complementary and alternative medicine : eCAM
影响因子：
--
作者：
Irnich D;Salih N;Offenbächer M;Fleckenstein J
通讯作者：
Fleckenstein J
影响因子：
3.6
作者：
Bourion-Bédès S;Schwan R;Laprevote V;Bédès A;Bonnet JL;Baumann C
通讯作者：
Baumann C
DOI：
10.1196/annals.1429.007
发表时间：
2008-01-01
期刊：
MENSTRUAL CYCLE AND ADOLESCENT HEALTH
影响因子：
--
作者：
Harel, Zeev
通讯作者：
Harel, Zeev
影响因子：
2.7
作者：
Grandi G;Ferrari S;Xholli A;Cannoletta M;Palma F;Romani C;Volpe A;Cagnacci A
通讯作者：
Cagnacci A
DOI：
10.1016/s0005-7916(00)00012-4
发表时间：
2000-06-01
影响因子：
1.8
作者：
Devilly, GJ;Borkovec, TD
通讯作者：
Borkovec, TD