Abstract
Purpose
Due to concerns regarding the side effects of hormone therapy, many studies have focused on the development of non-hormonal agents for treatment of hot flashes. The aim of this study was to evaluate the efficacy and safety of saffron (stigma of Crocus sativus) in treatment of major depressive disorder associated with post-menopausal hot flashes.
Methods
Sixty women with post-menopausal hot flashes participated in this study. The patients randomly received either saffron (30 mg/day, 15 mg twice per day) or placebo for 6 weeks. The patients were assessed using the Hot Flash-Related Daily Interference Scale (HFRDIS), Hamilton Depression Rating Scale (HDRS) and the adverse event checklist at baseline and also at the second, fourth, and sixth weeks of the study.
Results
Fifty-six patients completed the trial. Baseline characteristics of the participants did not differ significantly between the two groups. General linear model repeated measures demonstrated significant effect for time × treatment interaction on the HFRDIS score [F (3, 162) = 10.41, p = 0.0001] and HDRS score [F (3, 162) = 5.48, p = 0.001]. Frequency of adverse events was not significantly different between the two groups.
Conclusions
Results from this study revealed that saffron is a safe and effective treatment in improving hot flashes and depressive symptoms in post-menopausal healthy women. On the other hand, saffron, with fewer side effects, may provide a non-hormonal and alternative herbal medicine option in treatment of women with hot flashes.
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Acknowledgements
This Study was part of thesis of Dr. Farzaneh Eftekhari for MD., degree at Tehran University of Medical Sciences under supervision of Prof. Shahin Akhondzadeh.
Funding
This study was supported by a Grant (Grant no.: 30324) from Tehran University of Medical Sciences.
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Contributions
LK and SA, principal investigator and data Management from March 2016 to March 2017, SE, FE, HS and EMZ, data collection and manuscript writing from March 2016 to March 2017; SS, TF and FE, data collection and data management from March 2016 to March 2017
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The authors declare that they have no conflict of interest.
Ethical approval
All procedures performed in the current study were approved by the institutional review board of Tehran University of Medical Sciences (Approval number: 30324) and were in accordance with the 1964 Helsinki declaration and its later amendments in Brazil, 2013.
Informed consent
Informed consent was obtained from all individual participants included in the study.
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Kashani, L., Esalatmanesh, S., Eftekhari, F. et al. Efficacy of Crocus sativus (saffron) in treatment of major depressive disorder associated with post-menopausal hot flashes: a double-blind, randomized, placebo-controlled trial. Arch Gynecol Obstet 297, 717–724 (2018). https://doi.org/10.1007/s00404-018-4655-2
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DOI: https://doi.org/10.1007/s00404-018-4655-2