Long-term effects of homeopathic treatment in children suffering from attention deficit disorder with and without hyperactivity
AbstractObjective: To evaluate clinical and cost-effectiveness of individualised homeopathic treatment of children diagnosed with attention deficit hyperactivity disorder (ADHD) between age 6 and 16 during 10 years. Methods: Public lectures made families with inattentive or hyperactive children children getting interested in a randomized, double blind, placebo controlled trial (RCT), embedded in a prospective observational study. After diagnostic screening and a primary run-in phase of homeopathic treatment, crossover RCT was followed by open-label long-term follow-up and cost-effectiveness evaluation. At diagnosis, beginning of, and after each crossover period, and at yearly intervals during long-term follow-up, parents reported Connersâ€™ Global Index (CGI, 10 items, rated 0-3 points each; primary variable) by questionnaire or telephone interview. Results: A total of 140 children was recruited, 43 were excluded by a screening questionnaire, another 14 did not meet strict diagnostic criteria (according to DSM-IV), resulting in 83 children treated with individually prescribed homeopathic remedies. As 13 patients did not improve at least 50% in CGI values (RCT inclusion criterion), the remaining 62 children (84%) participated in, and 58 finished the double-blind cross-over RCT phase. After ten years of open-label therapy, 56/62 children were eligible for follow-up (90%). According to ITT-analysis, 38/62 (62%) children were without any homeopathic (HOM) or medical treatment. In the remaining children, successful results were achieved in 6 with HOM, 9 with methylphenidate (MPH) and 3 with both, HOM and MPH. During cross-over RCT, CGI values detected clinically and statistically significant differences in verum and placebo phase, respectively. Cost-effectiveness evaluation demonstrated non-inferiority of homeopathic treatment compared to stimulant treatment, even in the first year including case-taking and repertory analysis. Discussion: The innovative design of this study enabled both, to show clinical and cost-effectiveness of integrated homeopathic treatment in children dignosed with ADHD, and to detect a specific effect of the individual homeopathic remedy. The clinical result is comparable to conventional stimulant treatment. This again raises the question about the mode of action of homeopathically potentized substances. Conclusion: In children with ADHD, individualized homeopathic therapy and conventional stimulant treatment have comparable both, clinically significant, and specific effects persistent over ten years.