The effects of alcoholic extract of saffron (Crocus satious L.) on mild to moderate comorbid depression-anxiety, sleep quality, and life satisfaction in type 2 diabetes mellitus: A double-blind, randomized and placebo-controlled clinical trial

Depression and anxiety are major health problems throughout the world. Metabolic changes in type 2 diabetes mellitus induces and aggravates mental disorders, such as depression and anxiety. Saffron as a therapeutic herb may attenuate Comorbid Depression- Anxiety (CDA). So, this trial is designed to investigate the effect of saffron alcoholic extract on symptoms of CDA in type 2 diabetic patients.Fifty-four outpatients suffered from mild to moderate CDA diagnosed by using Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV), were assessed by Hamilton Depression and anxiety measurements, the Pittsburgh Sleep Quality Index (PSQI), and the Satisfaction with Life Scale (SWLS). The participants of this double-blind, placebo-controlled, single center and randomized trial were randomly assigned to intake 30 mg/day saffron or placebo capsules for 8 weeks.After the intervention, mild to moderate CDA, anxiety and sleep disturbance, but not depression alone, were relieved significantly in the saffron group (P < 0.05), whereas, the changes were not significant in the placebo group. Anthropometric measures and blood pressure parameters of the patients in either groups did not change significantly (P > 0.05) during the intervention. Moreover, dietary intake and physical activity did not differ during the study in the two groups. Changes in the life satisfaction were not significant.The results indicate the beneficial effect of saffron on the mild to moderate CDA in type 2 diabetic patients.