Gong Cuicui, Li Huakang, Li Qiang, Gu Pengxuan, Xiao Qi, Jia Yunjing, Xiao Qian, Mi Yuanzhen, Wei Shanshan, Wu Ziliang, Lin Bing, Zhang Zhonglin
School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Department of Oncology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Front Neurol. 2025 Apr 30;16:1524412. doi: 10.3389/fneur.2025.1524412. eCollection 2025.
Insomnia (difficulty falling or staying asleep) is a common issue among breast cancer survivors, significantly impacting their quality of life. Current treatments, primarily pharmacological and psychological, have limitations: the former often causes side effects, while the latter faces accessibility barriers. Long-snake moxibustion (LSM), a traditional Chinese medicine (TCM) technique, involves applying moxibustion along the governor vessel, which is an important meridian in TCM that plays a key role in regulating brain function. LSM is characterized by its minimal side effects, ease of application, and cost-effectiveness, with preliminary studies supporting its potential for treating insomnia. This study aims to further investigate the therapeutic effectiveness of LSM in alleviating insomnia among breast cancer survivors and to explore its underlying mechanisms.
This single-center, rater-masked, randomized controlled trial will enroll 100 breast cancer survivors with chronic insomnia, who will be randomly assigned in a 1:1 ratio to either the LSM group or a waitlist control group. During the 4-week treatment period, all participants will receive standard care, with the LSM group additionally receiving LSM treatment twice a week. The primary efficacy outcome is the change in Insomnia Severity Index (ISI) score at the end of the intervention. Secondary outcomes include changes in hypnotic medication use, Pittsburgh Sleep Quality Index (PSQI) scores, Piper Fatigue Scale (PFS) scores, and Functional Assessment of Cancer Therapy-Breast (FACT-B) scores. Mechanistic evaluations will assess serum biochemical markers, gut microbiota composition, and metabolomic profiles.
If proven effective, this trial will provide critical clinical evidence supporting LSM as a viable and accessible treatment for insomnia among breast cancer survivors. The findings could influence clinical practice by offering a non-pharmacological treatment option, improving patient outcomes, and reducing dependence on pharmacological interventions. Furthermore, exploring the underlying mechanisms may enhance our understanding of how LSM works, paving the way for future research.
http://itmctr.ccebtcm.org.cn/, identifier ITMCTR2024000578.
失眠（入睡困难或睡眠维持困难）是乳腺癌幸存者中的常见问题，严重影响其生活质量。目前的治疗方法主要是药物治疗和心理治疗，但都存在局限性：前者常引起副作用，而后者存在可及性障碍。长蛇灸是一种中医疗法，沿着督脉进行艾灸，督脉是中医的一条重要经络，在调节脑功能方面起关键作用。长蛇灸具有副作用小、操作简便、成本效益高的特点，初步研究支持其治疗失眠的潜力。本研究旨在进一步探讨长蛇灸缓解乳腺癌幸存者失眠的治疗效果，并探索其潜在机制。
这项单中心、评估者盲法、随机对照试验将招募100名患有慢性失眠的乳腺癌幸存者，他们将按1:1的比例随机分配到长蛇灸组或等待名单对照组。在为期4周的治疗期间，所有参与者都将接受标准护理，长蛇灸组每周额外接受两次长蛇灸治疗。主要疗效指标是干预结束时失眠严重程度指数（ISI）评分的变化。次要指标包括催眠药物使用的变化、匹兹堡睡眠质量指数（PSQI）评分、派珀疲劳量表（PFS）评分以及癌症治疗功能评估-乳腺（FACT-B）评分。机制评估将评估血清生化标志物、肠道微生物群组成和代谢组学谱。
如果被证明有效，本试验将提供关键的临床证据，支持长蛇灸作为乳腺癌幸存者失眠的一种可行且可及的治疗方法。这些发现可能会影响临床实践，提供一种非药物治疗选择，改善患者预后，并减少对药物干预的依赖。此外，探索潜在机制可能会增进我们对长蛇灸作用方式的理解，为未来的研究铺平道路。
