Homoeopathic management of attention deficit hyperactivity disorder: A randomised placebo-controlled pilot trial

Abstract

1Central Council for Research in Homoeopathy, India; 2Central Research Institute (Homoeopathy), India Objective: To evaluate the effectiveness of individualized homoeopathic medicines in LM potencies in children with Attention Deficit Hyperactivity Disorder (ADHD) and secondarily to deduce feasibility of study design and to calculate sample size for a definitive study. Materials and Methods: A multicentric single blind randomized placebo controlled pilot trial was carried out to evaluate the efficacy of individualized homoeopathic therapy in the management of Attention Deficit Hyperactivity Disorder (ADHD), under Central Council for Research in Homoeopathy. Sixty one children aged 6 years to 15 years, fulfilling DSM-IV criteria for ADHD were enrolled (H:30, P:31) were blinded and received either individualized homoeopathic medicines in LM potency or placebo. Severity of disease was rated on Conner’s Parent Rating Scale-Revised (CPRS-R, procured from Multi-Health Systems Inc., New York) and Clinical global impression scale, at the time of enrolment and on each subsequent follow-up visits for one year. Results: Out of 61 children enrolled, 54 patients (Homeopathy=27, placebo=27) were analyzed under mITT. All patients in Homeopathy group showed better outcome in baseline adjusted GLM repeated measures ANCOVA for oppositional, cognition problems, Hyperactivity and ADHD Index (domains of CPRS-R) and CGI-IS at T3,T6,T9 and T12 (p= 0.0001). The mean baseline-adjusted treatment difference between groups at month 12 from baseline for all individual outcome measures favored homeopathy group; Oppositional (-16.4, 95% CI -20.5 to -12.2, p=0.0001), Cognition problems (-15.5, 95% CI -19.2 to -11.8, p=0.0001), Hyperactivity (-20.6, 95% CI -25.6 to -15.4, p=0.0001), ADHD I (-15.6, 95% CI -19.5 to -11.6, p=0.0001), Academic performance14.4%, 95% CI 8.3 to 20.5, p=0.0001), CGISS (-1.6, 95% CI-1.9 to -1.2, p=0.0001), CGIIS (-1.6, 95%CI -2.3 to -0.9, p=0.0001). Conclusion: This pilot study provides evidence to support the therapeutic effect of individually selected homeopathic medicines in children with ADHD. However the results need to be validated in a larger multicenter prospective randomized double blind placebo controlled clinical trial. abstracts ICCMR2013 no 438 blz 32