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Re: Inappropriate outcomes and flooring/ ceiling effects invalidate study conclusion

Dear Editor

The efficacy and clinical effectiveness of homeopathy engenders considerable debate; it is therefore essential that clinical trials are accurately interpreted and reported. The recent publication by White et al.[1] has highlighted this issue.

The study, assessing classical homeopathy as an adjunctive treatment for childhood asthma concluded that, based on the primary outcome (the active quality of living subscale of the Childhood Asthma Questionnaire) classical homeopathy was not superior to placebo. We disagree with this conclusion. The scale used to assess the primary outcome was inappropriate [it does not distinguish between asthmatics and non-asthmatics [2] and is more suitable as a cross-sectional measure rather than a longitudinal outcome; and the ability to identify any therapeutic improvement was severely reduced due to ceiling/flooring effects in both the primary and some secondary outcome data. For example, baseline scores identified that the study population had good quality of life, and that two of the three age groups studied had mild asthma. Therefore, any therapeutic improvement would be hard to identify let alone quantify.

Other design issues were apparent, e.g. no data was reported on homeopathic exacerbations (an indicator of the healing response), and the security of blinding was not assessed. Yet despite these limitations, some encouraging therapeutic effects were apparent. For example, a clinically relevant improvement in asthma severity (unadjusted scores) was seen in two of the three groups and a favourable pattern in the days off school/days attended was seen in the homeopathic treated children (although no data was presented).

We suggest that a balanced and accurate conclusion to this data would be that no definitive conclusions could be drawn but that further investigation is needed. We therefore hope that the authors’ inaccurate conclusions neither dampens future research, nor bias future systematic reviews.[3]

References

(1) White A, Slade P, Hunt C, Hart A and Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma ;a randomised placebo controlled trial. Thorax 2003: 58:317-321.

(2) French DJ, Christie MJ, Snowden AJ. The reproducibility of the childhood asthma questionnaires: measures of aulity of life fro children with asthma aged 4-16 years. Quality of Life Research 1994;3:215-224.

(3) White, P, Lewith G, Berman B and Birch S. Reviews of acupuncture for chronic neck pain : pitfalls in conduting systematic reviews. Rheumatology 2002;41:1224–1231.

Send letter to journal:
Re: Author's reply to Robert Leckridge

Dear Editor

Dr Leckridge[1] is correct to state that the children in the study had mild to moderate symptoms of asthma at the time of recruitment. Children with more severe symptoms were excluded at the request of the Ethics Committee, because of the risks that could arise if they stopped their conventional medication. Our study tested homeopathy as an adjunct to standard medical management, not an alternative.

We expected that children given homeopathy might be able to reduce their conventional medication by standard guidelines, but could not find any evidence that this occurred. We acknowledged that there were trends in favour of the homeopathy group in some measures, but not in the primary measure, which was recommended by the questionnaire’s author as the most sensitive to change. We were careful not to over-generalise from our study, and certainly did not claim that homeopathy is ineffective in different samples of patients with asthma, for example those with more severe symptoms.

Reference

Send letter to journal:
Re: Homeopathy and childhood asthma

Dear Editor

This study of quality of life in children with asthma treated with homeopathy is fatally flawed.[1] The Childhood Asthma Quality of Life instrument used was validated in a study by French et al.[2] The children entered into White’s study had scores consistent with those of normal children who don’t have asthma. For a statistically significant improvement to occur in this score, the treated group would have to develop scores of around 100% ie better than normal, non-asthmatic children. This is clearly highly unlikely. In addition, a similar “ceiling effect” applies to the PEFR readings – again, at entry they were 100.4% and 96.9% of expected for the verum and placebo groups, respectively.

This is a very poor quality trial which does absolutely nothing to further our understanding of the potential value of homeopathic treatment in children with asthma. In fact, the press release from the journal has been picked up by the media and used to support a headline of “Homeopathy of no use in Asthma”.

Publishing this quality of research at best does not improve our necessary evidence base, and, at worst, contributes to the denial of services which may indeed be of value to patients. A close analysis of the study shows that the treatment group had a trend to better outcomes than the placebo group. If this were a pilot study, it would be indicating that there is indeed a potential benefit to asthmatic children from homeopathy which should be investigated with a proper trial of good methodological quality.

References

(1) A White, P Slade, C Hunt, A Hart, and E Ernst. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax 2003; 58:317-321.

(2) French DJ, Christie MJ, Sowden AJ. The reproducibility of the childhood asthma questionnaires: measures of quality of life for children with asthma aged 4–16 years. Qual Life Res 1994;3:215–24.