Kashani Ladan, Esalatmanesh Sophia, Eftekhari Farzaneh, Salimi Samrand, Foroughifar Tahereh, Etesam Farnaz, Safiaghdam Hamideh, Moazen-Zadeh Ehsan, Akhondzadeh Shahin
Infertility Ward, Arash Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, 13337, Iran.
Arch Gynecol Obstet. 2018 Mar;297(3):717-724. doi: 10.1007/s00404-018-4655-2. Epub 2018 Jan 13.
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.
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.
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.
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.
由于对激素疗法副作用的担忧，许多研究聚焦于开发用于治疗潮热的非激素药物。本研究的目的是评估藏红花（番红花柱头）治疗与绝经后潮热相关的重度抑郁症的疗效和安全性。
60名有绝经后潮热的女性参与了本研究。患者被随机给予藏红花（30毫克/天，每天两次，每次15毫克）或安慰剂，为期6周。在基线以及研究的第2、4和6周，使用潮热相关日常干扰量表（HFRDIS）、汉密尔顿抑郁量表（HDRS）和不良事件清单对患者进行评估。
56名患者完成了试验。两组参与者的基线特征无显著差异。一般线性模型重复测量显示，时间×治疗交互作用对HFRDIS评分[F(3, 162) = 10.41, p = 0.0001]和HDRS评分[F(3, 162) = 5.48, p = 0.001]有显著影响。两组不良事件的发生率无显著差异。
本研究结果表明，藏红花是改善绝经后健康女性潮热和抑郁症状的一种安全有效的治疗方法。另一方面，藏红花副作用较少，可能为治疗潮热女性提供一种非激素的替代草药选择。
