Exploring acupuncture as a treatment for insomnia in perimenopausal women with stable angina pectoris: A protocol for a randomized, double-blind, placebo-controlled clinical trial

作者：Rui Shi, Wenyi Meng, Zhaozheng Liu, Wen Xue, Xingyu Chen, Yue Deng · 发表于：PLoS ONE · 年份：2024 · DOI：10.1371/journal.pone.0301827 · 被引用次数：3 · 研究领域：Acupuncture Treatment Research Studies、Sleep and related disorders、Cardiac Health and Mental Health

BACKGROUND: Insomnia has emerged as a major public health issue jeopardizing human wellbeing. Furthermore, insomnia and angina arise concomitantly and exert reciprocal effects. Multiple studies suggest that perimenopausal females are more prone to experiencing both angina and insomnia, consequently substantially compromising their quality of life.Credible evidence suggests that acupuncture exerts a beneficial impact in alleviating insomnia. Nevertheless, the exhaustive investigation into the potential of acupuncture for mitigating insomnia co-occurring with stable angina in perimenopausal females remains a realm yet to be traversed in the realm of randomized controlled trials. Hence, the primary intent of this research protocol was to evaluate the effectiveness and safety profile of acupuncture when administered to perimenopausal subjects grappling with concomitant conditions of stable angina and insomnia. METHODS: This study entails a single-center, randomized, double-blind, placebo-controlled clinical trial. A total of 110 patients exhibiting insomnia concomitant with stable angina in the perimenopausal period will be enlisted and randomized to either acupuncture or sham acupuncture. Participants in both arms will undergo 30-minute sessions thrice weekly over a 12-week intervention period, with a 12-week maximum follow-up. The primary outcome measure is the Pittsburgh Sleep Quality Index(PSQI). Secondary outcomes encompass the Health-Related Quality of Life Questionnaire (S...