Author/Authors :
Ghorbani Zeinab نويسنده Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Science, Tehran, IR Iran , Manayi Azadeh نويسنده Medicinal Plants Research Center, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. Manayi Azadeh , Razeghi Jahromi Soodeh نويسنده Sina Hospital, Multiple Sclerosis Research Center- Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran AND Shefa Neuroscience Research Center, Tehran, Iran. Razeghi Jahromi Soodeh , Jafarnia Nasibe نويسنده Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran , Nokhostin Morteza نويسنده Psychiatry Department, Shahid Ansari Hospital, Guilan University of Medical Sciences, Rasht, Iran , Nourimajd Saeedeh نويسنده Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran
Abstract :
[Background]Generalized anxiety disorder (GAD) is known as the most prevalent anxiety disorder. Saffron has been previously approved as an effective adjuvant therapy in depression and might alleviate GAD symptoms.[Methods]In the current double blind randomized controlled trial, 40 patients with mild to moderate GAD, diagnosed according to the diagnostic and statistical manual of mental disorders-V (DSM-V) and received sertraline were randomly assigned to the saffron receiving group (450 mg, n = 20) or placebo taking patients (n = 20). Interventions were administered as an add-on therapy to sertraline on a daily bases for 6 weeks. In addition to assessing anthropometric, demographic data, and dietary intakes of patients, a 14-item Hamilton anxiety rating scale (HAM-A) was used to assess the effect of treatment.[Results]The mean (SD) of age was 29.65 (8.45) and 32.40 (6.74) years in the Saffron and placebo groups, respectively. Applying ANCOVA models adjusted for age, baseline energy intake,HAM-A total score, and weight changes from baseline to the 6th week, showed that at the end of the 6th week, saffron treated patients had a significantly lower mean HAM-A score compared to placebo group (2.95 vs. 5.05; P value = 0.005). Furthermore, within the group analysis it was shown that the total HAM-A score significantly declined in both groups (P value ≤ 0.000). Measuring changes in the HAM-A total score, relative to the baseline, following adjustment of ANCOVA models, showed that saffron was more effective than the placebo in reducing the mean HAM-A score of patients (-17.25 ± 2.67 vs. -15.35 ± 2.30; P value = 0.029). The side effects were tolerable and did not result in discontinuation of the supplementation.[Conclusions]Saffron as a sertraline add-on therapy may attenuate GAD symptoms. However, more randomized clinical trials with a larger sample size and longer duration of follow-up are needed to confirm this effect.