Effect of Saffron (Crocus Satious L.) as an Add-On Therapy to Sertraline in Mild to Moderate Generalized Anxiety Disorder: A Double Blind Randomized Controlled Trial

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.