Original paperThe feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma
Introduction
The debate continues about provision of homeopathy in the National Health Service (NHS).1 The use of homeopathy and other complementary therapies is increasing, with a reported prevalence of 14.5% among asthma patients (adults and children) in a recent primary care survey.2 Data from the UK homeopathic hospitals indicate that childhood asthma is one of the ten most common reasons for referral.3, 4 The prevalence of asthma in children has increased over the past ten years and it constitutes a significant burden to children, their families and Health Services. Motivating factors for use of complementary and alternative medicine (CAM) vary but include parents’ wish to minimise use of steroids5 yet asthma remains a potentially life threatening condition where the use of regular conventional treatments is strongly recommended. Research into the role of homeopathy in this context is essential for patients to make informed and safe choices for their children’s health care.
Some in-vitro models of high homeopathic dilutions have yielded reproducible positive results.6 One study showed that low dose cytokines which have undergone ‘sequential kinetic activation’ were active in a mouse asthma model.7 A Cochrane review of homeopathy for asthma concluded available evidence was inconclusive and that, as well as randomised trials, there is a need for observational data to document the different methods of homeopathic prescribing.8 Observational data from clinical practice suggests that homeopathy can improve asthma for children.3, 9 Clinical trials in asthma have mainly centred around the use of isopathic homeopathic medicines, for example, an ultra molecular dilution of house dust mite to desensitise allergic triggers.10, 11
In routine clinical homeopathic practice individualised homeopathic prescriptions are considered more effective treatment because the body is viewed as a whole system to which the medicine is matched: symptoms of the mind and body are synthesised and a single remedy chosen. One trial of individualised homeopathy included a high proportion of children with very mild asthma and it was therefore difficult, due to floor and ceiling effects, to demonstrate a benefit of the intervention.12, 13 We therefore tested the feasibility of a possible future pragmatic randomised trial design in children with more severe asthma, who were at Step 2 or above on the British Thoracic Guidelines (BTG)14 and required secondary care input for their asthma management.
This study was designed to:
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Establish whether we could successfully recruit and retain patients from this target population, whether randomisation was acceptable and other aspects of a larger trial.
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Pilot the acceptability of outcome measures to study participants and explore between-group differences.
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Explore patients’ and health professionals’ views and experiences of living with asthma, the research process and homeopathic treatment.
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Pilot the feasibility of an economic evaluation using resource use questionnaires.
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Enable a power calculation for a definitive trial.
Section snippets
Design
Following the Medical Research Council’s guidelines on the evaluation of complex interventions,15 this was a mixed methods study using both quantitative and qualitative research to investigate the research content and process. We used a pragmatic parallel randomised controlled trial design of ‘A versus [A + B]’, where A is usual care (UC) and B is homeopathic care (HC). The study was approved by the Oxfordshire Ethics Committee (05/Q1605/126 November 2005) and had approval from the Medicines and
Patient recruitment, retention and the acceptability of the research process
Figure 1 describes the participant flow through the study. The diagram includes information on the interventions received, outcome measures sent out and received and the number of patients actively followed up at different times during the trial. Recruitment was slow and a second recruitment site (SMH) was added following ethics approval. Despite aiming for a total sample size of 50–80, out of 226 potential families identified, 67 showed an interest in taking part and were sent the first pack
Discussion
This feasibility study was carried out to determine the best design for a future study to investigate whether a package of HC as delivered routinely in practice could safely and cost effectively improve asthma symptoms and quality of life in children with severe asthma. Findings suggested the complexity of the disease within the family context appeared to challenge the trial process and the homeopathic process. Qualitative and quantitative data highlighted poor asthma control in both groups and
Conclusion
From this pilot study of a pragmatic parallel group randomised controlled trial design to compare UC with UC plus individualised homeopathy, in children requiring secondary care for their asthma management, we conclude that a future trial of similar design is not feasible. Difficulties are predicted at various stages of the research process in this particular population of children. Quantitative data suggest that integrating homeopathy into existing conventional care would not confer additional
Acknowledgements
We thank all the children and adults who gave their time to this study and Dr Huw Thomas and the respiratory team of doctors and nurses at both recruiting sites and the Avon Primary Care Research Collaborative who funded the study. We thank Alan Montgomery for his help in the design and analysis of this study.
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