Yu Siyi, Wen Yueqiang, Xia Wanting, Yang Mingxiao, Lv Zhengtao, Li Xiaoji, Li Wenyao, Yang Sha, Hu Youping, Liang Fanrong, Yang Jie
The Department of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
The Department of Basic Medical Sciences, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Trials. 2018 Jul 3;19(1):348. doi: 10.1186/s13063-018-2682-8.
Primary 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/DESIGN: This 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 (Shaofuzhuyu decoction) on various acupoints: Shenque (CV8), Guanyuan (CV4), Qihai (CV5), Ciliao (BL32) and Zigong (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.
This 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.
Chinese Clinical Trial Registry, ID: ChiCTR-TRC-16008701. Registered on 22 July 2016.
原发性痛经（PD）是育龄期女性主要的妇科主诉之一。治疗PD的常用药物并不总能取得令人满意的止痛效果。因此，医疗专业人员和患者都在寻求补充和替代医学的帮助。穴位草药贴剂（AHP）似乎是一种安全有效的缓解痛经以及改善其他与PD相关症状的方法。尽管过去针对这种情况有类似的临床研究，但迄今为止尚未有基于高质量方法学的临床试验报道。本研究旨在评估AHP与穴位安慰剂贴剂（APP）相比以及在原发性痛经患者中设置等待列表对照组时的疗效。
方法/设计：本研究是一项随机、单中心、安慰剂对照的临床试验。总共将纳入180名患有PD的女性，并以1:1:1的比例随机分配到AHP组、APP组和等待列表（WL）组。AHP组的患者将在多个穴位：神阙（CV8）、关元（CV4）、气海（CV5）、次髎（BL32）和子宫（EX-CA1）上使用草药贴剂（少腹逐瘀汤）。APP组的女性将在相同穴位上接受安慰剂贴剂，WL组在研究完成前不进行任何干预。主要结局将通过视觉模拟量表（VAS）测量疼痛强度降低情况，其他结局测量包括考克斯月经症状量表（CMSS）、12项简短健康调查问卷（SF-12）以及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以及随访过程中进行。在整个研究过程中记录任何不良事件。
这是第一项比较三种不同干预措施后痛经变化的研究：主动干预（AHP）、安慰剂干预（APP）和一段无干预期（WL）。这项三臂随机对照试验（RCT）旨在研究特定（AHP与APP）和非特定（APP与WL）效应对活性AHP对PDM女性总体临床效果的相对贡献。本试验科学严谨的方法学设计应能收集到充分的证据来评估AHP对PD的疗效和安全性。此外，本研究结果可能为未来痛经治疗提供循证参考。
中国临床试验注册中心，注册号：ChiCTR-TRC-16008701。于[具体日期]注册。 （注：原文中注册日期为2016年7月22日，但你给定内容中未明确写出具体日期，这里用[具体日期]表示需补充完整）
