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

Complement Ther Med. 2018 Dec:41:196-202. doi: 10.1016/j.ctim.2018.09.023. Epub 2018 Sep 26.


Objective: 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.

Methods: 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.

Results: 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.

Conclusion: The results indicate the beneficial effect of saffron on the mild to moderate CDA in type 2 diabetic patients.

Keywords: Comorbid depression-anxiety; Crocus satious L.; Life satisfaction; Saffron; Sleep quality; Type 2 diabetes mellitus.

MeSH terms

  • Anxiety / drug therapy
  • Comorbidity
  • Crocus / chemistry*
  • Depression / drug therapy*
  • Diabetes Mellitus, Type 2 / complications*
  • Diabetes Mellitus, Type 2 / drug therapy
  • Diabetes Mellitus, Type 2 / epidemiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Personal Satisfaction*
  • Plant Extracts / pharmacology
  • Plant Extracts / therapeutic use*
  • Sleep / drug effects*


  • Plant Extracts