Research: FREI and colleagues,

Listed in Issue 145

Abstract

FREI and colleagues, Swiss Association of Homeopathic Physicians, Lucerne, Switzerland,  heiner.frei@hin.ch, have conducted a randomized trial of homeopathy in hyperactive children.

Background

The aim of this study was to demonstrate successful treatment of children with attention deficit hyperactivity disorder (ADHD) with homeopathy by introducing a screening phase prior to the randomization phase of the trial.

Methodology

The Swiss randomized, placebo controlled, cross-over trial in ADHD patients was designed with an open-label screening phase prior to the randomised 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. The retrospective analysis explores the screening phase data with respect to the risk of failure to demonstrate a specific effect of a randomized controlled trial (RCT) 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 randomised trial after a median time of 5 months (range 1-18), with a median of 3 different medications (range 1-9). Thirteen children (16%) did not reach eligibility. Five 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

Because of the necessity of identifying an optimal medication before response to treatment can be expected, randomization at the start of treatment in an RCT of homeopathy in ADHD children has a high risk of failure to demonstrate a specific treatment effect, 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.

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