Individualised homeopathy as an adjunct in the treatment of childhood asthma: A randomised placebo controlled trial

Complementary Medicine, Peninsula Medical School, University of Exeter, Exeter EX2 4NT, UK.
Thorax (Impact Factor: 8.29). 05/2003; 58(4):317-21. DOI: 10.1136/thorax.58.4.317
Source: PubMed


Homeopathy is frequently used to treat asthma in children. In the common classical form of homeopathy, prescriptions are individualised for each patient. There has been no rigorous investigation into this form of treatment for asthma.
In a randomised, double blind, placebo controlled trial the effects of individualised homeopathic remedies were compared with placebo medication in 96 children with mild to moderate asthma as an adjunct to conventional treatment. The main outcome measure was the active quality of living subscale of the Childhood Asthma Questionnaire administered at baseline and follow up at 12 months. Other outcome measures included other subscales of the same questionnaire, peak flow rates, use of medication, symptom scores, days off school, asthma events, global assessment of change, and adverse reactions.
There were no clinically relevant or statistically significant changes in the active quality of life score. Other subscales, notably those measuring severity, indicated relative improvements but the sizes of the effects were small. There were no differences between the groups for other measures.
This study provides no evidence that adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.

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Available from: Edzard Ernst
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    • "Thirdly, our selected 'main outcome measure'—and thus our calculated OR—differs for three of the eight previously analysed trials of individualised homeopathy. Fourthly, our group of three RCTs with 'reliable evidence' is founded on a more exacting standard than for Shang's 'trials of higher methodological quality': indeed, by Shang's explicit criteria for domains IV, V and VI, we would label five of our 'non-reliable' trials [20,25262728 as 'higher methodological quality'. A notable finding from sub-group analysis is that our 14 newly examined trials do not differ in 'effect size' from the eight that were included in previous 'global' meta-analysis by Shang et al. [8], disputing suggestions that the evidence base in homeopathy is weakening with time [29] . "

    Full-text · Article · Feb 2016
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    • "However, the 'homeopathicity' [12] of the therapeutic modality and of the clinical outcome measure/s used (i.e. the key characteristics of model validity) have never been formally accounted for in the assessment of trial quality. Some homeopathy trials have been broadly criticised for their lack of acceptable model validity, e.g.: homeopathic complex medication in female infertility [13,14]; individualised homeopathic treatment of childhood asthma [15,16]; isopathic treatment of hay fever [17,18]. Recognising that the characteristics of the homeopathic intervention and outcome measures are important seems a prerequisite for developing the most refined and relevant approaches to systematic review in this field of clinical research. "
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    ABSTRACT: A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity.
    Full-text · Article · Apr 2012 · BMC Medical Research Methodology
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