Acupuncture for uterine fibroids: A protocol for a randomized controlled trial comparing segmental electroacupuncture, manual acupuncture, and sham acupuncture

IF 1.7 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
Elham Hooshyarazar , Parvaneh layegh , Leili Hafizi , Maliheh Dadgarmoghaddam , Sandro Graca , Amir Hooman Kazemi , Seyed Kazem Farahmand , Farnoosh Bidouee , Hoda Azizi
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引用次数: 0

Abstract

Introduction

Uterine fibroids are prevalent among women of reproductive age. They have a negative impact on females' private and social life. As surgical and non-surgical approaches lead to some shortcomings such as reproduction failure, recurrence, and adverse effects of medications, complementary and integrative treatments have gained attention. Acupuncture is used for uterine fibroids in practice; however, the evidence is limited. This study aims to compare the effects of segmental electroacupuncture, manual acupuncture, and sham acupuncture on symptoms, mass size, and Doppler indices of uterine arteries in patients with uterine fibroids.

Methods

This study is a three-arm, sham-controlled, parallel-group, single-blinded, randomized clinical trial. Seventy-two cases with uterine fibroids type 1-6 according to the International Federation of Gynecology and Obstetrics classification will enter the study. They will be randomized into 3 groups, segmental electroacupuncture, manual traditional acupuncture and sham acupuncture and undergo an eight-week intervention, then will be followed up for 8 weeks. Fibroid size, uterine arteries’ resistance index, pulsatility index, and diameter; Uterine Fibroid Symptoms and Health-Related Quality of Life (UFS-QOL) questionnaire scores, and adverse events will be compared before and immediately after the intervention, and after 8 weeks follow-up. The outcomes will be reported as statistically significant at a probability level of P value < 0.05.

Results

The results of this protocol will be published in peer-reviewed journals.

Conclusion

This clinical trial will be the first to provide substantial evidence regarding the safety and efficacy of acupuncture in the treatment of uterine fibroids, while also suggesting a mechanism through the analysis of uterine artery indices. Moreover, evaluating the differences in efficacy between segmental and traditional manual acupuncture will further facilitate the optimization of acupuncture methods for uterine fibroids.
针刺治疗子宫肌瘤:一项比较分段电针、手针和假针的随机对照试验方案
子宫肌瘤在育龄妇女中普遍存在。他们对女性的私人和社会生活产生了负面影响。由于手术和非手术治疗方法存在生殖失败、复发和药物不良反应等缺点,因此补充和综合治疗已引起人们的关注。针刺治疗子宫肌瘤在实践中应用较多;然而,证据是有限的。本研究旨在比较节段性电针、手针和假针对子宫肌瘤患者症状、肿块大小和子宫动脉多普勒指数的影响。方法采用三组、假对照、平行组、单盲、随机临床试验。72例根据国际妇产科联合会分类的1-6型子宫肌瘤患者将进入研究。随机分为分段电针、手工传统针刺和假针刺3组,进行为期8周的干预,并随访8周。肌瘤大小、子宫动脉阻力指数、搏动指数、直径;比较干预前、干预后即刻及随访8周后的子宫肌瘤症状及健康相关生活质量(UFS-QOL)问卷评分、不良事件。结果将以P值为0.05的概率水平报告为统计学显著。研究结果将发表在同行评议的期刊上。结论本临床试验将首次为针灸治疗子宫肌瘤的安全性和有效性提供实质性证据,并通过对子宫动脉指标的分析提示其作用机制。此外,评估节段针刺与传统手工针刺的疗效差异,将进一步促进子宫肌瘤针刺方法的优化。
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来源期刊
European Journal of Integrative Medicine
European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
4.70
自引率
4.00%
发文量
102
审稿时长
33 days
期刊介绍: The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.
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