Comparison of Saffron versus Fluoxetine in Treatment of Mild to Moderate Postpartum Depression: A Double-Blind, Randomized Clinical Trial.
Introduction:Postpartum depression is a common mental health problem that is associated with maternal suffering. The aim of this double-blind clinical trial was to compare safety and efficacy of saffron and fluoxetine in treatment of mild to moderate postpartum depression.Methods:This was a 6-week, double-blind, randomized clinical trial. Subjects were women aged 18-45 years with mild to moderate postpartum depression who had Hamilton Depression Rating Scale (HDRS 17-item) score≤18. Eligible participants were randomized to receive either a capsule of saffron (15 mg capsule) or fluoxetine (20 mg capsule) twice daily for 6 weeks. The primary outcome measure was to evaluate efficacy of saffron compared to fluoxetine in improving depressive symptoms (HDRS score).Results:There was no significant effect for time×treatment interaction on HDRS score [F (4.90, 292.50)=1.04, p=0.37] between the 2 groups. 13 (40.60%) patients in the saffron group experienced complete response (≥50% reduction in HDRS score) compared with 16 (50%) in the fluoxetine group and the difference between the 2 groups was not significant in this regard (p=0.61). Frequency of adverse events was not significantly different between the treatment groups.Discussion:The results of this study may suggest that saffron is a safe alternative medication for improving depressive symptoms of postpartum depression. Nevertheless, it should be mentioned that the trial is not well powered and should be considered a preliminary study. Therefore, large clinical trials with longer treatment periods and comparison with placebo group would be appropriate for future studies.
Arash Hospital, Infertility Ward, Tehran University of Medical Sciences, Tehran, Iran.
L
L
Kashani
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
S
S
Eslatmanesh
Yas Women General Hospital, Tehran University of Medical Sciences, Tehran, Iran.
N
N
Saedi
Yas Women General Hospital, Tehran University of Medical Sciences, Tehran, Iran.
N
N
Niroomand
Yas Women General Hospital, Tehran University of Medical Sciences, Tehran, Iran.
M
M
Ebrahimi
Trauma Nursing Research Center, Kashan University of Medical Sciences, Kashan, Iran.
M
M
Hosseinian
Baharloo Hospital, Tehran University of Medical Sciences, Tehran, Iran.
T
T
Foroughifar
Baharloo Hospital, Tehran University of Medical Sciences, Tehran, Iran.
S
S
Salimi
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
S
S
Akhondzadeh
D000293:Adolescent; D000328:Adult; D027622:Crocus; D019052:Depression, Postpartum / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D010936:Plant Extracts; D005473:Fluoxetine