The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma


The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma
Thompson EA, Shaw A, Nichol J, Hollinghurst S, Henderson AJ, Thompson T, Sharp D


Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study examined the costs and patient outcomes of a homeopathy intervention plus usual care, compared with usual care, for children with moderate or severe asthma. The extra cost of homeopathic consultations was not offset by less health care use and there was no medical benefit, but some families reported benefits. The methods and results were mostly clear and comprehensive. The conclusions appear to be appropriate, but the study focused on the feasibility of a large trial and patient outcomes. Type of economic evaluation Cost-effectiveness analysis Study objective The aim was to examine the costs and effectiveness of usual care plus a personal homeopathy intervention. The population included children aged seven to 14 years, who were diagnosed with asthma that required hospital out-patient care, and who were on Step Two or more of the British Thoracic Society Asthma treatment steps. Interventions The homeopathy intervention plus usual care was compared with usual care alone. The intervention was an initial consultation of up to one hour, followed by four 20-minute visits over four to eight weeks. The homeopathic remedies were prescribed in tablet, granule, or liquid form and their potency was not restricted. Usual care consisted of the usual hospital respiratory clinician services. Location/setting UK/secondary care. Methods Analytical approach: The economic evaluation was based on a pilot study and published cost data. The authors stated that the perspective was that of the NHS in England, and patients and carers. The analytic time frame was 16 weeks. Effectiveness data: A pilot two-arm randomised controlled trial, conducted in Bristol, provided the effectiveness data. Sampling for variation in socio-demographic background and asthma severity was performed. The trial was open label, but the data analysts were blinded to group allocation. A total of 35 participants completed the trial, with 17 receiving the intervention and 18 receiving usual care; one family withdrew from the intervention and three from usual care. An intention-to-treat analysis was performed and qualitative interviews were undertaken with nine families. The main clinical effectiveness estimates were the asthma symptoms and their impact, which were measured on the Asthma Control Questionnaire (ACQ); the Paediatric Asthma Quality of Life Questionnaire (PAQLQ); the Medication Change Questionnaire (MCQ); patient diaries completed by parents; and the Outcome in Relation to Impact on Daily Living (ORIDL) questionnaire. Monetary benefit and utility valuations: Not relevant. Measure of benefit: The measure of benefit was asthma symptoms and impact as measured by the questionnaires. Cost data: Questionnaires completed by parents provided the patient and carer costs for travel to receive treatment and loss of earnings. The direct medical costs included the time of health professionals, homeopathic remedies, and medications. The unit costs were from national or NHS sources, such as the British National Formulary, and the hospital finance department. All costs were reported in UK pounds sterling (£). Analysis of uncertainty: None reported. Results At 16 weeks, the differences in the outcomes between the two groups were close to zero, with wide 95% confidence intervals. For example, patients receiving the homeopathic intervention had higher asthma control, measured on the ACQ, with a mean difference in change from baseline of 0.95 (95% CI -2.84 to 4.73). Clinically meaningful differences in peak flow or other measures could not be ruled out. From the NHS perspective, the mean costs per person over the previous 16 weeks were £937 (SD 913) for the homeopathy intervention versus £323 (SD 374) for usual care. The mean patient and carer costs per person were £108 (SD 271) for the homeopathy intervention versus £23 (SD 37) for usual care; the mean difference of £85 (95% CI -46 to 216) was not significant. Resource data were available for all 35 participants. Authors' conclusions The authors concluded that the extra cost of homeopathic consultations was not offset by less use of other health care resources and there was no medical benefit, but some families reported that they had benefited. The authors stated that a further trial of similar design was not possible due to its burden on the treatment timetables for families with severely asthmatic children. CRD commentary Interventions: The homeopathic and usual care strategies were well described and appropriate comparators. Homeopathic hospital care might be acceptable and feasible in other settings. Effectiveness/benefits: The effectiveness evidence was from an exploratory study, with a small sample. This study was mainly undertaken to assess the feasibility of the design for a larger trial. The methods of data collection were reported and a variety of outcomes for asthma symptoms and control were used and were patient focused. The outcome measures were not assessed as primary or secondary, because the study was designed to assess their suitability for a future trial; this was also why the benefit measures were disease specific. Costs: The perspective was clearly stated and it appears that all the cost categories relevant to this perspective were included. The approaches used to estimate the resource use, and the sources for the unit costs appear to have been appropriate. Discounting of costs was not necessary, but it was unclear if the costs were adjusted for inflation, which increases the uncertainty in the estimates. Analysis and results: The health outcomes and costs were not combined into incremental cost-effectiveness ratios; a cost-consequences analysis was performed. It was judged that a sample of between 50 and 80 participants could supply sufficient data to compare the two groups, but the actual sample was 35, which might have been insufficient to detect any differences. Sensitivity analyses were not undertaken to assess the impact of uncertainty in the data estimates on the results. The economic analysis was secondary to assessing the clinical outcomes and feasibility for a large trial. The authors discussed their results compared with those of other similar economic studies, which found cost savings from reduced medications, with homeopathic care. Concluding remarks: The methods and results were mostly clear and comprehensive. The conclusions appear to be appropriate, but the study focused on the feasibility of a large trial and patient outcomes. Funding Funded by the Avon Primary Care Research Collaborative. Bibliographic details Thompson EA, Shaw A, Nichol J, Hollinghurst S, Henderson AJ, Thompson T, Sharp D. The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma. Homeopathy 2011; 100(3): 122-130 PubMedID 21784328 DOI 10.1016/j.homp.2011.05.001 Original Paper URL http://www.journals.elsevierhealth.com/periodicals/yhomp/article/PIIS1475491611000403/abstract Indexing Status Subject indexing assigned by NLM MeSH Asthma /economics /therapy; Child; Child Health Services /organization & Feasibility Studies; Female; Great Britain; Homeopathy /economics /methods; Humans; Male; Materia Medica /economics /therapeutic use; Outcome Assessment (Health Care); Precision Medicine /economics /methods; Quality Assurance, Health Care /methods; Severity of Illness Index; Treatment Outcome; administration AccessionNumber 22011001331 Date bibliographic record published 20/10/2011 Date abstract record published 02/11/2011

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