Hypericum perforatum (St John's Wort) for attention-deficit/hyperactivity disorder in children and adolescents -: A randomized controlled trial

Context Stimulant medication can effectively treat 60% to 70% of youth with attention-deficit/ hyperactivity disorder ( ADHD). Yet many parents seek alternative therapies, and Hypericum perforatum ( St John's wort) is 1 of the top 3 botanicals used. Objective To determine the efficacy and safety of H perforatum for the treatment of ADHD in children. Design, Setting, and Participants Randomized, double- blind, placebo-controlled trial conducted between March 2005 and August 2006 at Bastyr University, Kenmore, Washington, among a volunteer sample of 54 children aged 6 to 17 years who met Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition) criteria for ADHD by structured interview. Intervention After a placebo run- in phase of 1 week, participants were randomly assigned to receive 300 mg of H perforatum standardized to 0.3% hypericin ( n= 27) or a matched placebo ( n= 27) 3 times daily for 8 weeks. Other medications for ADHD were not allowed during the trial. Main Outcome Measures Performance on the ADHD Rating Scale - IV ( range, 0- 54) and Clinical Global Impression Improvement Scale ( range, 0- 7), and adverse events. Results One patient in the placebo group withdrew because of an adverse event. No significant difference was found in the change in ADHD Rating Scale - IV scores from baseline to week 8 between the treatment and placebo groups: inattentiveness improved 2.6 points ( 95% confidence interval [ CI], - 4.6 to - 0.6 points) with H perforatum vs 3.2 points ( 95% CI, - 5.7 to - 0.8 points) with placebo ( P=. 68) and hyperactivity improved 1.8 points ( 95% CI, - 3.7 to 0.1 points) with H perforatum vs 2.0 points ( 95% CI, - 4.1 to 0.1 points) with placebo ( P=. 89). There was also no significant difference between the 2 groups in the percentage of participants who met criteria for improvement ( score <= 2) on the Clinical Global Impression Improvement Scale ( H perforatum, 44.4%; 95% CI, 25.5%- 64.7% vs placebo, 51.9%; 95% CI, 31.9%- 71.3%; P=. 59). No difference between groups was found in the number of participants who experienced adverse effects during the study period ( H perforatum, 40.7%; 95% CI, 22.4%- 61.2% vs placebo, 44.4%; 95% CI, 25.5%- 64.7%; P=. 78). Conclusion In this study, use of H perforatum for treatment of ADHD over the course of 8 weeks did not improve symptoms. Trial Registration clinicaltrials. gov Identifier: NCT00100295.