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

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.