A double-blind placebo-controlled randomized trial of oral saffron in the treatment of rheumatoid arthritis

Objective: Recently, saffron (Crocus sativus L. from the Iridaceae family) has been characterized by its antioxidant, anti-inflammatory and analgesic effects. This study aimed to evaluate the effect of saffron on disease activity in patients with rheumatoid arthritis (RA). Materials and Methods: This is a double-blind, placebo-controlled, randomized clinical trial (RCT) performed on ۵۵ newly- diagnosed RA patients without previous treatment, who were randomly divided into intervention (included ۲۸ cases) and control groups (consisted of ۲۷ individuals). Standard therapy including prednisolone, oral methotrexate, folic acid, vitamin D, calcium, and alendronate, was administered similarly in both groups.  Patients received a ۱۰۰ mg saffron pill/day (pure saffron powder) or placebo besides the standard protocol. The placebo had the same shape as the saffron pills. Follow up of DAS۲۸ESR disease activity score was done on the ۳۰th, ۴۵th and ۹۰th day of the study. Results: There was no difference between the intervention and control groups regarding to the DAS۲۸ESR at the end of the study. However, a significant decrease in DAS۲۸-ESR was observed in each group compared to the first visit (p=۰.۰۰۱). The results also showed no significant difference in the incidence of side effects in both groups. Conclusion: In summary, patients who received pure saffron pills (۱۰۰ mg/day) in addition to standard therapy did not have a significant difference in improvement of disease activity from the patients on standard therapy.

Keywords:

Crocus sativus L , Iridaceae family , Saffron , Rheumatoid arthritis , Clinical trial , RCT