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.
Author(s): Shahmansouri N(1), Farokhnia M(2), Abbasi SH(3), Kassaian SE(1), Noorbala Tafti
AA(2), Gougol A(2), Yekehtaz H(2), Forghani S(4), Mahmoodian M(1), Saroukhani
S(1), Arjmandi-Beglar A(1), Akhondzadeh S(5).
Affiliation(s): Author information:
(1)Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
(2)Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical
Sciences, Tehran, Iran.
(3)Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran; Family
Health Research Center, Iranian Petroleum Industry Health Research Institute,
Tehran, Iran.
(4)Razi Vaccine and Serum Research Institute, Karaj, Iran.
(5)Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical
Sciences, Tehran, Iran. Electronic address: s.akhond@neda.net.
Publication date & source: 2014, J Affect Disord. , 155:216-22
OBJECTIVE: A significant correlation exists between coronary artery diseases and
depression. 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 after 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 fluoexetine (40mg/day) or saffron
(30mg/day) capsule for six weeks. Participants were evaluated by Hamilton
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.
LIMITATIONS: 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.
|