A Comparison of Methylphenidate (MPH) and Combined Methylphenidate with Crocus sativus (Saffron) in the Treatment of Children and Adolescents with ADHD: A Randomized, Double-blind, Parallel-Group, Clinical Trial

Abstract

Background: Attention-deficit/hyperactivity disorder (ADHD) is characterized by behavioral and neurodevelopmental problems. It is estimated that 3 - 7% of children and adolescents suffer from this problem. Apart from synthetic drugs, other effective types of medication like herbal medicines are of great importance. Objectives: This study aimed to evaluate the effectiveness of methylphenidate (MPH) and its combination with Crocus sativus (saffron) in the treatment of children suffering from ADHD. Methods: The sample included 70 children aged between 6 and 16 years who had been diagnosed with ADHD. The patients were randomly assigned into two equal groups (n = 35 in each group). While both groups received 20 or 30 mg/d of MPH (20 and 30 mg/d for < 30 and > 30, respectively), one of them also received 20 or 30 mg/d of saffron in a capsule based on BMI (20 and 30 mg/d for < 30 and > 30, respectively). To collect data, parents and teachers completed Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV). Also, for analyzing the data, the repeated measures analysis of variance (RMANOVA) was used. Results: The results of general linear model (GLM) repeated measures indicated that in both groups, the patients had less symptoms after eight weeks of treatment. However, after four weeks, the average score assigned by the parents and teachers in the MPH with saffron group was lower than the average total score in the MPH group (P < 0.05). Conclusions: Using MPH combined with saffron proved to be more effective in the treatment of patients suffering from ADHD compared to separate treatments. It seems that the duration of therapy can be reduced and the effectiveness be improved by prescribing proposed combined treatment.

Effectivity of Saffron Extract (Saffr’Activ) on Treatment for Children and Adolescents with Attention Deficit/Hyperactivity Disorder (ADHD): A Clinical Effectivity Study

“…This is in keeping with the recent literature. Several recent clinical trials examined the efficacy and safety of saffron extract to treat ADHD symptoms [ 20 , 21 , 22 ]. All three of them found that saffron is an effective and safe treatment for ADHD.…”

“…Baziar et al [ 20 ] showed a similar effect for saffron and methylphenidate in children. Khaksarian et al [ 21 ] showed that combining saffron with methylphenidate was more effective for treating ADHD symptoms in children than methylphenidate alone. Pazoki et al [ 22 ] found a similar boosting effect in adults.…”

“…Similar to previous studies [ 20 , 21 ], we used raw scores of several subjective measures. Moreover, we also used a performance-based task to objectively measure executive function.…”

“…Recently, three clinical trials tested saffron’s efficacy to treat ADHD symptoms in adolescents and adults [ 20 , 21 , 22 ]. All three of them showed, in general terms, the efficacy of saffron.…”

“…All three of them showed, in general terms, the efficacy of saffron. Baziar et al [ 20 ] did not find significant differences between treatment with methylphenidate and saffron, whereas Khaksarian et al [ 21 ] found an added effect of saffron and methylphenidate compared to the effect of methylphenidate alone. Pazoki et al [ 22 ] reported that a combination of methylphenidate and saffron better improved ADHD symptoms compared with methylphenidate alone.…”