A randomized, double-blind, clinical trial comparing the efficacy and safety of Crocus sativus L. with fluoxetine for improving mild to moderate depression in post percutaneous coronary intervention patients.
ShahmansouriN1 • Farokhn a M2 • Abbas SH3, Kassa an SE1 • Noorba a Tafti AA2, Gougo A2, Ye kehtaz H2, Forghani S4, Mahmoodan M1, Saroukhani S1 • Arjmand Beglar A1, Akhondzadeh s5.
OBJECTIVE: A significant correlation exists between coronary artery deseases and depresson. The aim of this trial was to compare the efficacy and safety of saffron versus fluoxetine in improving depressive symptoms of patients who were suffering from depression alter performing percutaneous coronary intervention (PCI).
METHODS: In this randomized double blind parallel group study 40 patients with a diagnosis of mild to moderate depression who had undergone PCI in the last six months were randomized to receive either fluoxetine (40mg/day) or saffron (30mg/day) capsule for six weeks. Participants were evaluated by Haminton depression rating scale (HDRS) at weeks 3 and 6 and the adverse events were systemically recorded.
RESULTS: By the study endpoint no significant difference was detected between two groups in reduction of HDRS scores (P=0.62). Remission and response rates were not significantly different as well (P=1 00 and P=0.67; respectively). There was no significant difference between two groups in the frequency of adverse events during this trial.
LIMTATIONS: Relatively small sample size and short observational period were the major limitations of this study
CONCLUSION: Short term therapy with saffron capsules showed the same antidepressant efficacy compared with fluoxetine in patients with a prior history of PCI who were suffering from depression.
©2013 Published by Esever B.V