| 1 Academic Unit of Primary Care, Cotham House, Cotham
Hill, Bristol BS6 6JL, UK
2 Department of Pharmacy and Pharmacology, University of Bath, UK
BMC Complementary and Alternative Medicine 2006, 6:37doi:10.1186/1472-6882-6-37
The electronic version of this article
is the complete one and can be found online at:
http://www.biomedcentral.com/1472-6882/6/37
Published: 13 November 2006
© 2006 Thompson and Weiss; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of
the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Abstract
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 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.
Background
Homeopathic medicine continues to attract attention in medical
journals and the media as a popular form of complementary medicine
(CM) whose proposed mechanism of action seems incompatible with
mainstream scientific thought and the research evidence for which
remains controversial. At the centre of clinical research in into
homeopathic medication lies the placebo controlled randomised clinical
trial (RCT). RCT findings for homeopathic medications are heterogeneous
and meta-analytical approaches have reached both positive [1] and
negative conclusions [2].
An assumption underlying RCT-based research is that homeopathic
medicines can be considered as a special class of pharmaceutical
agent with specific effects. When, as in the Shang et al meta-analysis,[2]
the therapy is presented as having no specific effects, it is considered
to be mediated by "non-specific" effects. An intervention
based solely on such effects is considered of little value –
the editor of the Lancet proposing that Shang's findings heralded
the "end of homeopathy". But despite these condemnations,
homeopathic care remains popular, a fact which some accord to the
empathic style of homeopathic practitioners.
The RCT model is only one possible way of approaching the riddle
of homeopathy – other include in vitro studies [3] and large-scale
observational studies [4-7]. In this study we consider it not as
a pharmaceutical intervention, but as a complex intervention and
have analysed its active ingredients using a framework proposed
by the UK Medical Research Council (MRC) [8]. This treatment is
justified because the homeopathic approach contains "a number
of components which may act both independently and interdependently"
– the criterion for the definition of a complex intervention.
For instance consultations involve the patient in an unusually detailed
exposition of their complaints, an attentive practitioner and a
process of matching between the patient's predicament and what is
known of a wide range of homeopathic medicines. Thus even on prima
facie grounds there are a number of potential factors at play.
The first stage of the MRC framework asks the investigator to explore
how a given intervention might, in theory, be beneficial. Here we
worked on the assumption that it is unlikely that the effects of
homeopathic care are conveyed by unique mechanisms. In other words,
broader psychological and anthropological theories of healing should
contribute to our understanding of homeopathy. We explored literature
on the placebo effect[9], universal anthropological models [10],
psychotherapeutic practices [11] and psychological models such as
disclosure theory [12]. We also took expert opinion from practitioners
in fields such as gestalt and narrative therapy [13]. We used this
knowledge to sensitise us to processes revealed in stage two of
the MRC framework, which involves the direct observation and modelling
in a real-world context. The purpose of this modelling is to "identify
the components of the intervention and underlying mechanims by which
they will influence outcome".
In this paper we present the findings of formal case series approach
to the study of 18 patients referred for care at Bristol Homeopathic
Hospital (BHH). This is the first time that the process of routine
homeopathic care has been the focus of systematic qualitative study.
By defining potential active ingredients in this way we hope to
shed important light on the concept of "non-specific"
effects and provide a more nuanced approach to the workings of homeopathy
than can be found in the RCT.
In summary, our objective was to identify and evalute potential
"active ingredients" of the homeopathic approach 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.
http://www.biomedcentral.com/1472-6882/6/37
|