Facilitating a pragmatic comparative trial of the clinical and cost effectiveness of homeopathic treatment for ADHD

Abstract

Introduction: ADHD is a common and growing problem. There are concerns about current treatments and they are not leading to improved long term outcomes. It is associated with many negative outcomes and a drain on resources across nationally funded support agencies such as education, criminal justice, social work and health care. Any new intervention would need to show clinical and cost effective improvements to these departments and demonstrate improvements in areas of unmet need including: the management of emotion (especially anger); treatment of ADHD in ASD; safety and side effects; and long term effectiveness. Current RCT evidence for homeopathy and ADHD has tested the efficacy of homeopathic medicines prescribed in a variety of unusual or inappropriate ways, but not the effectiveness of the intervention as experienced in real life. Homeopathy is considered to be a complex intervention, but these trials are not following MRC (Medical Research Council) recommendations for complex interventions, there are tensions concerning internal and external validity and information from such trials is not relevant to stakeholders. Methods: A pragmatic RCT, evaluating the comparative clinical and cost effectiveness of treatment by a homeopath, compared to usual care and other interventions is suggested. This design is proposed as being appropriate to answer questions of interest to stakeholders, address internal and external validity issues and provide robust evidence. The cmRCT design will be used. A large cohort of children with a diagnosis of ADHD will first be recruited and their outcomes measured regularly. A random selection of children fulfilling inclusion criteria will subsequently be offered homeopathic treatment for one year each. Their outcomes will be compared with those of eligible children in the cohort not offered treatment. Results: Key elements of the design include: the retention of the totality of homeopathic treatment; comparison with other effective treatments and standard care; sample size of adequate power; random distribution of groups; groups representative of the ADHD population; homeopathic treatment by several homeopaths in several locations; evaluation of clinical and cost effectiveness using measurements reflecting stakeholder requirements; objective outcome measurement; and allowance of sufficient trial time to demonstrate long term effectiveness. Conclusion: This will be the first comparative pragmatic study to be conducted into the effectiveness of treatment by homeopaths for ADHD.