Electroacupuncture versus Sham Acupuncture for Perimenopausal Insomnia: A Randomized Controlled Clinical Trial

Abstract

Objective

To evaluate the short- and long-term effects of acupuncture on perimenopausal insomnia (PMI) and quality of life.

Patients and Methods

We designed a semi-standardized, patient-blinded, randomized placebo-controlled trial. A total of 84 patients were recruited, all of whom met the criteria for diagnosis of PMI. Either acupuncture therapy or a noninvasive placebo acupuncture therapy designed to treat insomnia was implemented 18 times over the course of 8 weeks (3 times per week for 4 weeks, twice per week for 2 weeks, once per week for 2 weeks). The primary outcome was the change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to the end of treatment, week 8. Secondary outcomes included climacteric symptoms and quality of life measured by the Menopause Quality of Life (Men-QoL), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), sleep parameters recorded in the actigraphy and adverse events. The PSQI and Men-QoL were assessed at weeks 0, 4, 8, 12 and 20. Other assessments were performed at week 0 and week 8.

Results

The participants were randomly assigned to either acupuncture (n=42) or sham acupuncture (n=42) groups. The mean difference from baseline of PSQI score at the end of treatment between real acupuncture and sham acupuncture group was −2.38 (95% CI, −3.46 to −1.30; P<0.001). The acupuncture group was associated with significantly lower scores than the sham acupuncture group at week 12 and during the 20-week follow-up visits (all P <0.001). Acupuncture was also associated with significantly higher quality of life in vasomotor and other physical dimensions (all P <0.001). At the end of treatment, researchers found a significantly higher total sleep time (TST), sleep efficiency (SE) and lower number of average awakenings (AA) (P =0.007 0.023 and 0.011, respectively) in the acupuncture group than in the sham acupuncture group. No severe adverse events were reported.

Conclusion

The findings suggest that acupuncture may be a safe and effective treatment for PMI and improving quality of sleep in patients with menopause and could have a long-lasting effect.

Trial Registration

Chinese Clinical Trial Registry (ChiCTR); Trial ID: ChiCTR1800018645. URL: http://www.chictr.org.cn/showproj.aspx?proj=31482.

Keywords:

• acupuncture
• perimenopausal insomnia
• randomized controlled trial

Abbreviations

PMI, perimenopausal insomnia; PSQI, Pittsburgh Sleep Quality Index; Men-QoL, Menopause Quality of Life; ISI, Insomnia Severity Index; SAS, Self-Rating Anxiety Scale; SDS, Self-Rating Depression Scale; TST, total sleep time; SE, sleep efficiency; AA, average awakenings; ChiCTR, Chinese Clinical Trial Registry; HRT, hormone replacement therapy; SSRIs, selective serotonin reuptake inhibitors; ICSD-3, International Classification of Sleep Disorders; PI, principal investigator; AE, adverse events; CRF, case report form; LOCF, Last observation carried forward; ITT, intention-to-treat; SNS, sympathetic nerves; HPA, hypothalamus-pituitary-adrenal axis; RVLM, reduced rostral ventrolateral medulla; FSH, follicle-stimulating hormone; LH, luteinizing hormone.

Data Sharing Statement

The data that support the findings of this study are available from the corresponding author (Shifen Xu) upon reasonable request. Also, the individual deidentified participant data is available after contacting the corresponding author via email ([email protected]). The data will be available immediately following publication without an end date.

Acknowledgments

The authors thank Prof. Ruiping Wang from Shanghai University of Traditional Chinese Medicine for the statistical guidance; Dr. Jing Chen and Jian Xu from Shanghai Municipal Hospital of Traditional Chinese Medicine for referring proper participants; Prof. Xiao Huang from Department of Neurology and Department of Psychological Medicine, Zhongshan Hospital, Fudan University for providing expert opinions on the treatment protocol; we also thank Dr. Zonya Christine Crossno and Dr. Philippa Hazlewood from the International Education College, Shanghai University of Traditional Chinese Medicine, for editorial support of manuscript, and all other project staff, as well as the trial participants.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

The study was partly supported by grants from the National Natural Science Foundation of China (No 81973943), Shanghai Municipal Health Commission (2019LJ06), and sponsored by grants from Shanghai Committee of Science and Technology, China (No. 18401905200). The funding body has no role in study design, data collection, data analysis, data interpretation, or writing of the report.