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Summary of the Study: "Crocus sativus L. Versus Methylphenidate in Treatment of Children with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Pilot Study"

Objective

This study investigated the safety and efficacy of Crocus sativus (saffron) compared to methylphenidate in treating children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Methods

The trial was conducted over 6 weeks with 54 children aged 6–17 who met the ADHD criteria according to the DSM-5. Participants were randomized to receive either saffron capsules or methylphenidate, dosed based on their weight. The effects of the treatments were measured using the ADHD Rating Scale-IV filled out by teachers and parents at the start, week 3, and week 6.

Results

Out of 54 participants, 50 completed the study. The statistical analysis revealed no significant differences in ADHD symptom improvement between the saffron and methylphenidate groups according to both parents and teachers’ ratings. Side effects were similarly mild and tolerable in both groups.

Conclusion

Saffron showed comparable efficacy to methylphenidate in the short-term treatment of ADHD among children, with similar rates of side effects. However, the study recommends larger, controlled trials with longer durations to fully assess saffron’s therapeutic potential and safety over time.

Clinical Significance

Given its similar efficacy and safety profile, saffron could be considered as an alternative treatment for ADHD, especially for patients who are looking for non-stimulant options or those who have adverse reactions to traditional ADHD medications. However, more extensive research is necessary to validate these findings before widespread clinical application.

Authors:

Sara Baziar, MD, Ali Aqamolaei, MD, Ebrahim Khadem, PhD, Seyyed Hosein Mortazavi, MD, Sina Naderi, MD, Erfan Sahebolzamani, MD, Amirhosein Mortezaei, MD, Shakiba Jalilevand, MD, Mohammad-Reza Mohammadi, MD, Mahsa Shahmirzadi, PharmD, and Shahin Akhondzadeh, PhD

Published:

3 April 2019 / Journal of Child and Adolescent Psychopharmacology