Acupuncture therapy for vasomotor symptoms in breast cancer: Protocol for a prospective, multicenter, case registry study

IF 1.9 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

European Journal of Integrative Medicine Pub Date : 2025-02-01 DOI:10.1016/j.eujim.2025.102429

Jia-Shan Li , Zi-Yan Li , Xing-Fang Pan , Zhuo-Xin Yang , Jia Liu , Xin Wang , Hong-Jiao Li , Lin Luo , Bo Chen , Bao-Yan Liu , Yi Guo , Li-Yun He , Tian-Yi Zhao

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引用次数: 0

Abstract

Introduction

Adjuvant endocrine therapy for breast cancer has advantages such as reducing the incidence of recurrence. However, adjuvant endocrine therapy may cause adverse vasomotor symptoms. Although randomized controlled trials (RCTs) have shown that acupuncture therapy is an effective treatment for vasomotor symptoms in patients with breast cancer, a practical real-world acupuncture regimen has yet to be established. Therefore, there is an urgent need for a case registry study that provides real-world evidence for the effectiveness of acupuncture therapy in treating vasomotor symptoms. This article presents the protocol for a case registry study that aims to provide an overview of the acupuncture therapy for managing vasomotor symptoms in patients with breast cancer.

Methods

The study cohort will comprise patients with breast cancer with vasomotor symptoms who are aged between 18 and 70 years and are undergoing adjuvant endocrine therapy. Patients will be recommended to receive acupuncture therapy, without excluding other treatments. The primary outcome is the patient-reported change in the hot flashes score. Electronic case report forms will be used to record patient demographic characteristics, information about interventions, and information about medical personnel from week 1 to 8, with a subsequent follow-up period of 24 weeks. At least 250 patients will be recruited from six medical hospitals. Adverse events will be monitored and recorded. An appropriate mixed model will be used to analyze the factors potentially influencing the effects of acupuncture therapy.

Discussion

This multicenter, prospective, observational, case registry study will bridge the gap between the clinical practices of acupuncture therapy and the evidence established through RCTs and systematic reviews. The findings will provide knowledge to better inform regulatory decision-making.

Conclusion

The findings of this case registry study will identify subgroups of patients with breast cancer that will benefit from acupuncture therapy for vasomotor symptoms.

Registration

This study was registered in the Chinese Clinical Trial Registry (ChiCTR2400081274)

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针刺治疗乳腺癌血管舒缩症状：一项前瞻性、多中心、病例登记研究方案

乳腺癌辅助内分泌治疗具有降低复发率等优点。然而，辅助内分泌治疗可能引起不良的血管舒缩症状。虽然随机对照试验（rct）已经表明针灸疗法是治疗乳腺癌患者血管舒缩症状的有效方法，但实际的针灸治疗方案尚未建立。因此，迫切需要一项病例登记研究，为针灸治疗血管舒缩症状的有效性提供现实证据。本文介绍了一项病例登记研究的方案，旨在概述针灸治疗对乳腺癌患者血管舒缩症状的管理。方法研究队列将包括年龄在18 ~ 70岁之间并接受辅助内分泌治疗的伴有血管舒缩症状的乳腺癌患者。建议患者接受针灸治疗，不排除其他治疗方法。主要结果是患者报告的潮热评分的变化。从第1周到第8周，将使用电子病例报告表记录患者人口统计学特征、干预措施信息和医务人员信息，随后的随访期为24周。将从6家医院招募至少250名患者。对不良事件进行监测和记录。适当的混合模型将用于分析可能影响针灸治疗效果的因素。这项多中心、前瞻性、观察性、病例登记的研究将弥合针灸治疗的临床实践与通过随机对照试验和系统评价建立的证据之间的差距。这些发现将为更好地为监管决策提供信息。结论：这项病例登记研究的结果将确定乳腺癌患者亚组，这些患者将受益于针灸治疗血管舒缩症状。本研究已在中国临床试验注册中心注册（ChiCTR2400081274）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.