Efficacy of Saffron as an Adjunct to Methylphenidate in Treating ADHD in Children Aged 6-12: A Randomized Clinical Trial.

Abstract

Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a common childhood disorder often managed with stimulant medications such as methylphenidate. Around 30% of patients with ADHD do not respond to treatment or cannot tolerate its side effects, which necessitates the consideration of alternative options. This study evaluated the effectiveness of adding the saffron extract to methylphenidate on ADHD symptoms and working memory in children aged 6-12.

Method: In a randomized clinical trial, 58 children diagnosed with ADHD were randomized into two groups: a methylphenidate (0.5-1 mg/kg/day, divided into 2-3 doses)/saffron (20-30 mg/day based on weight: 20 mg for <30 kg, 30 mg for >30 kg) group and a control group receiving only methylphenidate (0.5-1 mg/kg/day, divided into 2-3 doses) for six weeks. The severity of ADHD was evaluated using subjective (Conners' Parent Rating Scale-revised) and objective (Corsi block-span task and continuous performance test) tests at the start and end (in the sixth week) of the study.

Results: 22 participants in the methylphenidate/saffron group and 21 in the control group completed the study. The changing trend of total ADHD scores (p = 0.002, Cohen's d = 0.85), hyperactivity score (p = 0.024, d = 0.62), impulsivity score (p = 0.031, d = 0.58), and attention score (p = 0.001, d = 0.92) was significantly different between groups based on subjective parent reports. However, no significant differences were found in impulsivity, inattention, or sustained attention on the CPT, though reaction time improved significantly (p = 0.023, d = 0.45). Scores on the Corsi Block Span Task indicated no significant changes in working memory between groups. The combination treatment was well-tolerated, with no reports of severe adverse effects.

Conclusion: The findings suggest that the combination of saffron with methylphenidate may enhance subjective reports of ADHD symptoms, particularly hyperactivity and impulsivity; however, objective cognitive measures showed limited changes. Given the favorable safety profile of saffron and study limitations, this supports its potential role as a complementary option, pending confirmation in placebo-controlled trials with larger samples and long-term evaluations.