St. John's Wort does not show benefit for ADHD in short trial

Abstract

Question Among children with attention-deficit/hyperactivity disorder (ADHD), is Hypericum perforatum efficacious and safe? Design Randomized, double-blind, placebo-controlled trial. Setting Bastyr University, Kenmore, WA. Participants Volunteer sample of 54 children (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. Outcomes Performance on the ADHD Rating Scale-IV (range, 0-54) and Clinical Global Impression Improvement Scale (range, 0-7), and adverse events. Main Results 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 versus 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 versus 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). Conclusions In this study, use of H perforatum for treatment of ADHD over the course of 8 weeks did not improve symptoms. Commentary This is not only the first study of St. John's wort in children and adolescents with ADHD, but it is also an excellent example of a high-quality randomized controlled trial (RCT). The study's meticulous attention to true double-blinding of participants and investigators, concealed randomization allocation method, objective standardized outcome measures, intention to treat analysis, and full disclosure of prerandomization exclusions, as well as postrandomization withdrawals are all hallmarks of a rigorous RCT. Among RCTs of complementary and alternative therapies, this study also stands out in how it addresses the common problem of high placebo response and the stability of botanical compounds. Although this short trial does not support the use of St. John's wort for treatment of ADHD, it does illustrate how rigorously complementary and alternative medicine therapies can and should be studied. Both parents and providers should understand that even “natural” therapies may have side effects and interactions with prescribed medications, and thus deserve the same level of scrutiny as pharmaceuticals. Clinical Research Abstracts for PediatriciansThe Journal of PediatricsVol. 153Issue 5PreviewEDITOR'S NOTE: Journals reviewed for this issue: Archives of Disease in Childhood, Archives of Pediatrics and Adolescent Medicine, British Medical Journal, Journal of the American Medical Association, Journal of Pediatrics, The Lancet, New England Journal of Medicine, Pediatric Infectious Diseases Journal, and Pediatrics. Gurpreet K. Rana, BSc, MLIS, Taubman Medical Library, University of Michigan, contributed to the review and selection of this month's abstracts. Full-Text PDF