Research: FREI and co-authors,

Listed in Issue 142

Abstract

FREI and co-authors, Swiss Association of Homeopathic Physicians, Lucerne, Switzerland, have commented on methodological aspects of a randomized trial of homeopathy in children with ADHD.

Background

Treatment of patients with attention deficit hyperactivity disorder (ADHD) with homeopathy is difficult. The Swiss randomized, placebo controlled, cross-over trial in ADHD patients was designed with an open-label screening phase prior to the randomized controlled phase. During the screening phase, the response of each child to successive homeopathic medications was observed until the optimal medication was identified. Only children who reached a predefined level of improvement participated in the randomized cross-over phase. Although the randomized phase revealed a significant beneficial effect of homeopathy, the cross-over caused a strong carryover effect diminishing the apparent difference between placebo and verum treatment.

Methodology

This retrospective analysis explores the screening phase data with respect to the risk of failure to demonstrate a specific effect of a randomized controlled trial with randomization at the start of the treatment.

Results

During the screening phase, 84% (70/83) of the children responded to treatment and reached eligibility for the randomized trial after a median time of 5 months, with a median of 3 different medications (range 1-9). 13 children (16%) did not reach eligibility. 5 months after treatment start, the difference in Conners Global Index (CGI) rating between responders and non-responders became highly significant (p = 0.0006). Improvement in CGI was much greater following the identification of the optimal medication than in the preceding suboptimal treatment period (p < 0.0001).

Conclusion

It is generally necessary to identify an optimal medication before response to treatment can be expected. Therefore randomization at the start of treatment in a trial of homeopathy in ADHD children has a high risk of failure to demonstrate a specific treatment effect, particularly if the observation time is shorter than 12 months.

References

Frei H et al. Randomised controlled trials of homeopathy in hyperactive children: treatment procedure leads to an unconventional study design. Experience with open-label homeopathic treatment preceding the Swiss ADHD placebo controlled, randomised, double-blind, cross-over trial. Homeopathy: The Journal of the Faculty of Homeopathy 96 (1): 35-41, Jan 2007.

Comment

This very interesting study would appear to address many confounding problems in Homeopathic research.

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