顺势疗法——其活性成分是什么?一项使用英国医学研究理事会复杂干预评估框架的探索性研究。
Homeopathy--what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions.
作者信息
Thompson Trevor D B, Weiss Marjorie
机构信息
Academic Unit of Primary Care, Cotham House, Cotham Hill, Bristol BS6 6JL, UK.
出版信息
BMC Complement Altern Med. 2006 Nov 13;6:37. doi: 10.1186/1472-6882-6-37.
BACKGROUND
Research in homeopathy has traditionally addressed itself to defining the effectiveness of homeopathic potencies in comparison to placebo medication. There is now increasing awareness that the homeopathic consultation is in itself a therapeutic intervention working independently or synergistically with the prescribed remedy. Our objective was to identify and evalute potential "active ingredients" of the homeopathic approach as a whole, in a prospective formal case series, which draws on actual consultation data, and is based on the MRC framework for the evaluation of complex interventions.
METHODS
Following on from a theoretical review of how homeopathic care might mediate its effects, 18 patients were prospectively recruited to a case series based at Bristol Homeopathic Hospital. Patients, who lived with one of three index conditions, were interviewed before and after a five visit "package of care". All consultations were recorded and transcribed verbatim. Additional data, including generic and condition-specific questionnaires, artwork and "significant other" reports were collected. Textual data was subject to thematic analysis and triangulated with other sources.
RESULTS
We judged that around one third of patients had experienced a major improvement in their health over the study period, a third had some improvement and a third had no improvement. Putative active ingredients included the patients' "openness to the mind-body connection", consultational empathy, in-depth enquiry into bodily complaints, disclosure, the remedy matching process and, potentially, the homeopathic remedies themselves.
CONCLUSION
This study has has identified, using primary consultation and other data, a range of factors that might account for the effectiveness of homeopathic care. Some of these, such as empathy, are non-specific. Others, such as the remedy matching process, are specific to homeopathy. These findings counsel against the use of placebo-controlled RCT designs in which both arms would potentially be receiving specific active ingredients. Future research in homeopathy should focus on pragmatic trials and seek to confirm or refute the therapeutic role of constructs such as patient "openness", disclosure and homeopathicity.
背景
顺势疗法的研究传统上致力于确定顺势疗法药力与安慰剂药物相比的有效性。现在人们越来越意识到,顺势疗法咨询本身就是一种治疗干预措施,它可以独立发挥作用,也可以与所开的药物协同发挥作用。我们的目标是在一个前瞻性正式病例系列中,识别并评估整个顺势疗法方法的潜在“活性成分”,该病例系列借鉴实际咨询数据,并基于医学研究委员会(MRC)评估复杂干预措施的框架。
方法
在对顺势疗法护理可能如何介导其效果进行理论综述之后,前瞻性地招募了18名患者进入布里斯托尔顺势疗法医院的一个病例系列。患有三种索引病症之一的患者在接受五次“护理套餐”前后接受了访谈。所有咨询都进行了录音并逐字转录。还收集了其他数据,包括通用和特定病症问卷、病历以及“重要他人”报告。文本数据进行了主题分析,并与其他来源的数据进行了三角验证。
结果
我们判断,在研究期间,约三分之一的患者健康状况有了重大改善,三分之一有一定改善,三分之一没有改善。假定的活性成分包括患者“对身心联系的开放态度”、咨询中的同理心、对身体不适的深入询问、信息披露、药物匹配过程以及可能的顺势疗法药物本身。
结论
本研究通过初次咨询和其他数据,确定了一系列可能解释顺势疗法护理有效性的因素。其中一些因素,如同理心,是非特异性的。其他因素,如药物匹配过程,则是顺势疗法特有的。这些发现不建议使用安慰剂对照随机对照试验设计,因为在这种设计中,两组可能都在接受特定的活性成分。顺势疗法未来的研究应侧重于务实试验,并试图证实或反驳诸如患者“开放性”、信息披露和顺势疗法特性等概念的治疗作用。
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