Summary: | Saeedeh Foroughinia,1 Kamran Hessami,2,3 Nasrin Asadi,3 Leila Foroughinia,4 Mohammadjavad Hadianfard,5 Azadeh Hajihosseini,5 Najmeh Pirasteh,5 Mehrdad Vossoughi,6 Homeira Vafaei,3 Azam Faraji,3 Maryam Kasraeian,3 Mehrnoosh Doroudchi,7 Mohammad Rafiee Monjezi,8 Shohreh Roozmeh,3 Khadije Bazrafshan3 1Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran; 2Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; 3Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; 4Box Hill Hospital, FRANZCOG, Eastern Health, Victoria, Australia; 5Physical Medicine and Rehabilitation Department, Shiraz University of Medical Sciences, Shiraz, Iran; 6Oral and Dental Disease Research Center, Department of Dental Public Health, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran; 7Department of Immunology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; 8Shiraz Institute for Cancer Research, Shiraz University of Medical Sciences, Shiraz, IranCorrespondence: Nasrin AsadiMaternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, IranTel +98-71-36128257Fax +98-71-362128257Email nasadi2012@yahoo.caObjective: 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
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