Efficacy and safety of saffron as adjunctive therapy in adults with attention-deficit/hyperactivity disorder: A randomized, double-blind, placebo-controlled clinical trial

Abstract

ObjectiveAround 30% of patients with Attention-Deficit/Hyperactivity Disorder (ADHD) do not respond to Ritalin or cannot tolerate its side effects, which necessitates the consideration of alternative options. Previous studies have shown the beneficial effects of Crocus sativus (saffron) in children with ADHD. However, its potential therapeutic effects in adults with ADHD is unknown. This study aimed to evaluate the efficacy and safety of saffron as an adjuvant to Ritalin for improving symptoms in adults with ADHD. DesignThis was a randomized, double-blind, placebo-controlled clinical trial. MethodsFifty-six patients diagnosed with ADHD were assigned into two parallel groups to receive Ritalin (30 mg/day) plus placebo or Ritalin plus saffron (15 mg twice daily) for six weeks. The patients were assessed with Conners' Adult ADHD Rating Scales (CAARS) and the Adult ADHD Self-Report Scale (ASRS) at baseline, week 3 and week 6. ResultsForty-four patients completed the trial. GLM repeated-measure analysis demonstrated significant time × treatment interaction effect for ASRS (df=2, F=3.455, and P-value=0.036) and CAARS (df=1.584, F=3.939, and P-value=0.033) score from baseline to the study endpoint. We found a significantly greater reduction in ASRS scores in the saffron group compared with the placebo group from baseline to the study endpoint (week 6) (P-value=0.024). However, the change score from baseline to week 3 was not significantly different between trial groups (P-value=0.269). There was no significant difference in the improvement of CAARS scores between saffron and placebo from baseline to week 3 or 6 (P-value=0.564 and 0.089, respectively). There was no significant difference between the two groups in baseline parameters and frequency of side effects. ConclusionsSaffron combination therapy with Ritalin can effectively improve symptoms of patients with ADHD. However, further studies with larger sample sizes and longer follow-up treatment are needed to confirm our findings.This trial was registered with the Iranian Registry of Clinical Trials (www.irct.ir; No IRCT20090117001556N111).