A double-blind, randomized, placebo-controlled trial of saffron stigma (Crocus sativus L.) in mothers suffering from mild-to-moderate postpartum depression

Phytomedicine. 2017 Dec 1;36:145-152. doi: 10.1016/j.phymed.2017.10.005. Epub 2017 Oct 7. . Tabeshpour J1, Sobhani F2, Sadjadi SA3, Hosseinzadeh H4, Mohajeri SA5, Rajabi O6, Taherzadeh Z7, Eslami S4. Author information 1 Department of pharmacodynamy and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran; Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran. 2 Targeted Drug Delivery Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 3 Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 4 Pharmaceutical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 5 Pharmaceutical research center, Mashhad University of Medical Sciences, Mashhad, Iran. 6 Department of Pharmaceutical Control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. 7 Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: taherzadehzh@mums.ac.ir. Abstract INTRODUCTION: Numerous adverse effects of antidepressants as well as the attitudes of breastfeeding mothers, who prefer to consume herbal medicine rather than chemical drugs, encouraged us to assess the effects of saffron (Crocus sativus L.) on mothers suffering from mild-to-moderate postpartum depressive disorder. METHODS: A double-blind, randomized, and placebo-controlled trial was conducted on 60 new mothers who had a maximum score of 29 on the Beck Depression Inventory-Second Edition (BDI-II). They were randomly assigned to the saffron (15 mg/Bid) or placebo group. The primary outcome was a change in the BDI-II scores 8 weeks after treatment compared to the baseline. The response and remission rates were considered to be secondary outcome measures. RESULTS: Saffron had a more significant impact on the BDI-II scores than the placebo. The mean BDI-II scores decreased from 20.3 ± 5.7 to 8.4 ± 3.7 for the saffron group (p < .0001) and from 19.8 ± 3.2 to 15.1 ± 5.4 for the placebo group (p < .01). In the final assessment, 96% of the saffron group were in remission compared to 43% of the placebo group (p < .01). The complete response rates were 6% for the placebo group and 66% for the saffron group. CONCLUSION: When administered to treat minor PPD in breastfeeding mothers, saffron had a more significant impact on the BDI-II than the placebo. Copyright © 2017 Elsevier GmbH. All rights reserved. KEYWORDS: Beck depression inventory-second edition; Breastfeeding mothers; Postpartum depression; Saffron stigma