Effect of Acupuncture on Pregnancy-Related Insomnia and Melatonin: A Single-Blinded, Randomized, Placebo-Controlled Trial

Abstract

Objective

The aim of the current study is to evaluate the efficacy and safety of acupuncture on sleep quality and overnight melatonin secretion, measured as urinary 6-sulfatoxymelatonin, in pregnant women.

Patients and Methods

This randomized, parallel, single-blinded (participant), controlled trial was conducted on 72 pregnant women with insomnia. Study participants were randomly assigned to either the intervention, 10 sessions of acupuncture treatment over a 3-week period, or control group by block randomization (1:1). Patients in both groups were evaluated at baseline and post-treatment (third week) using the Pittsburgh Sleep Quality Index (PSQI) score (as the primary outcome) and urinary 6-sulfatoxymelatonin.

Results

Fifty-five of 72 participants completed the study. There was no statistically significant difference regarding PSQI score and 6-sulfatoxymelatonin level between intervention and control groups at the baseline (P=0.169 and P=0.496). At the end of the study period, treatment with acupuncture significantly improved the PSQI score (P<0.001) with a large effect size of 3.7, as well as 6-sulfatoxymelatonin level (P=0.020) with a medium effect size of 0.6 as compared to the control group. No adverse effects were noted during acupuncture sessions and follow-up visits.

Conclusion

Acupuncture was shown to significantly improve the sleep quality in pregnant women, possibly through increasing melatonin secretion, and could be recommended as a low-cost and low-risk alternative treatment to pharmacological therapies.

Keywords:

• acupuncture
• pregnancy
• insomnia
• melatonin

Data Sharing Statement

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

Acknowledgments

This article was extracted from the thesis written by Saeede Foroughinia for a degree of Obstetrics and Gynecology, and was financially supported by the Shiraz University of Medical Sciences.

Author Contributions

All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

The authors declare that they have no conflicts of interest.

Additional information

Funding

The project was financed by Vice Chancellor for Research of the Shiraz University of Medical Science, Shiraz, Iran. The funding organization played no role in the study design, data collection, analysis, and interpretation of data.