Acupuncture for perimenopausal insomnia: A systematic review and meta-analysis protocol

This article presents a systematic review and meta-analysis protocol on the use of acupuncture to treat perimenopausal insomnia, registered with PROSPERO under number CRD42018092917. The protocol was developed following the PRISMA-P guidelines to ensure methodological quality.

Perimenopausal insomnia is a very common condition that significantly affects women's quality of life. Prevalence varies among populations: 51-55% in China, 40% in Caucasian women, 31-42% in the United States, 28% in Japan, and 15.9% in Korea. This condition not only impacts mental health but also increases cardiometabolic and neurocognitive morbidity and mortality, raising healthcare costs.

The pathophysiology of perimenopausal insomnia is related to the hormonal changes characteristic of this period. Studies show that lower estradiol levels and higher luteinizing hormone levels are significantly correlated with insomnia. According to Traditional Chinese Medicine, the condition results from Liver and Kidney deficiency, preventing the mind from being properly nourished during the attenuation of reproductive function.

The protocol establishes rigorous search criteria across ten major databases, including MEDLINE, Cochrane Library, Web of Science, EMBASE, Springer, WHO ICTRP, and Chinese databases such as CNKI, Wanfang, CBM, and VIP. The search will be limited to studies in English and Chinese, focusing exclusively on randomized controlled trials (RCTs) that evaluate different acupuncture modalities, including manual acupuncture, auricular acupuncture, electroacupuncture, and other related techniques.

Primary outcomes will be sleep quality measures, while secondary outcomes will include biochemical indicators such as hormone levels, adverse effects of acupuncture, Insomnia Severity Index total scores, and changes in Traditional Chinese Medicine symptoms. The methodology will include risk-of-bias assessment using Cochrane tools and the STRICTA checklist, along with the Jadad scale for methodological quality.

Statistical analysis will be performed using RevMan 5.3, with mean differences for continuous data and risk ratios for dichotomous data. Heterogeneity will be assessed by the chi-square test and I² value, with fixed-effects or random-effects models applied as appropriate. Subgroup analyses will be conducted considering different forms of acupuncture, participant conditions, and controls.

The importance of this review lies in the need for high-quality evidence on acupuncture for perimenopausal insomnia. Although acupuncture is widely used in China for this condition because of fewer side effects compared with hormone therapy, robust evidence is still lacking to convince physicians worldwide of its efficacy and safety.

This protocol represents an important step in consolidating scientific knowledge about a promising non-pharmacological intervention for a condition that affects millions of women globally.