Thompson E A, Shaw A, Nichol J, Hollinghurst S, Henderson A J, Thompson T, Sharp D
Bristol Homeopathic Hospital, University Hospitals Bristol Foundation Trust, Cotham Hill, Bristol BS6 6JU, England, UK.
Homeopathy. 2011 Jul;100(3):122-30. doi: 10.1016/j.homp.2011.05.001.
To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial.
In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences.
226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process.
A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma.
通过一项结合经济评估与嵌套式定性研究的实用试验设计，比较常规护理（UC）与UC加个体化顺势疗法，用于需要二级护理的哮喘儿童，检验该设计的可行性。这包括招募与保留、结局指标的可接受性、患者及医护人员的观点与经验以及一项确定性试验的功效计算。
在一项实用平行组随机对照试验（RCT）设计中，符合英国胸科学会哮喘指南（BTG）第2步或以上的儿童被随机分配至UC组或UC加五次顺势疗法护理（HC）套餐组。结局指标包括朱尼珀哮喘控制问卷、生活质量问卷和资源使用问卷。采用定性访谈获取家庭和医护人员的观点与经验。
从医院诊所和相关患者数据库中识别出226名儿童。67名表示有参与兴趣，39名儿童被随机分组，18名分到HC组，21名分到UC组。缺乏支持辅助顺势疗法治疗的证据。经济评估表明，额外咨询的成本并未被顺势疗法药物成本的降低以及顺势疗法组儿童初级护理使用的减少所抵消。定性数据揭示了研究过程中家庭和医护人员的不同观点。
采用该设计的未来研究不可行，对顺势疗法在哮喘管理中潜在作用的进一步研究或许在病情较轻的哮喘儿童初级护理中进行效果更佳。
