The potential contribution other research designs could make to understanding the topic

The three trials which have been included within this article were all RCTs which had been adapted to account for the complexities of the homeopathic method.  RCTs are deemed the ‘gold standard’ of evidence based medicine (EBM) in the current medical era (Bowling, 1997).  However, the intricacies of homeopathy are not easily measured using this form of research, as RCTs are typically used to evaluate a single component of a treatment method.  Lewith et al. (2002) believe that RCTs can render research a success when the most important outcome measure is agreed upon, the disease and its potential outcomes are easily defined and measured, and the intervention is simple, short and content based.  Unfortunately the complex nature of the homeopathic intervention often confounds the RCT’s strict rules, leading to research results which often are conflicting and controversial (Bell and Koithan, 2006).

RCTs are designed to answer a simple question about the specificity of an intervention.  Homeopathy, however, is not a simple intervention.  The philosophy of homeopathy is founded upon the treatment of the whole person, rather than the specific disease (Roy, 1999).  Therefore, during treatment a homeopath aims for improvement in many areas of a patient’s life, not just for the presenting complaint.

The high internal validity of RCTs which is essential in providing high quality trials often reduces the meaning of the research results in terms of ‘real world’ situations or external validity (Lewith et al., 2002).  In two of the trials examined, although individual homeopathy was prescribed to patients, freedom to prescribe potencies of choice was curtailed, thus not reflecting the ‘real world’ situation of homeopathic prescribing where a practitioner bases the prescription on numerous factors, such as the length of duration of disease, the ‘energy’ of the patient, and whether allopathic medicine is currently used (Vithoulkas, 1980).  Outcome measures in all three trials were narrow and specific, rather than patient-centred and multi-dimensional thus not reflecting the dynamic nature and ‘real world’ practice of homeopathy (Bell, 2003).  The length of the trials was also not a true reflection of homeopathic practice.  The treatment of chronic disease where patients are and have been taking conventional medicine for a number of years is often reflected in the time taken for homeopathy to have significant effect on the presenting complaint although non-specific mental and emotional improvements may occur previous to the improvement of physical problems (Grossinger, 1993).  Homeopathic practitioners observe changes in the positive dimensions of a patient’s health, not merely improvement in the disease (Bell, 2003).

One reasonable suggestion which may provide important qualitative evidence for the use of homeopathy in RA is the large scale outcome study (Lewith et al., 2002).  For conditions such as RA, where the natural course of the disease is known, and the prognosis can be estimated, documentation of the effects of homeopathic treatment for a longer time would provide important information about the usefulness of homeopathy in such a chronic condition.  Lewith et al. (2002) suggest that in conditions such as RA, where there may often be a history of ineffective treatment, both doctors and patients are often desperate for interventions whether specific or non-specific, which may improve patient’s quality of life.

Bell (2003) suggests that the homeopathic profession currently has a paucity of systematic qualitative and observational data especially in the treatment of chronic conditions, and that large scale observational studies of such conditions could direct the future design of homeopathically orientated RCTs.  She proposes a three stage research programme for homeopathy.  Each stage would move the research process forwards culminating in the development of homeopathic research standards which could be implemented in large scale, multi-site controlled clinical trials.  This specific longitudinal research design would be especially useful for chronic conditions providing a focus for the translation of homeopathic remedy effects into measurable changes in the holistic dynamics of a patient.

Mixed methods research may provide a suitable solution for research into homeopathy and RA.  Hailed as a third paradigm in research, this method entails the integration of quantitative and qualitative data collection and analysis in a single study (Cresswell et al., 2004).  The provision of quantitative data analysing physical changes using measurements such as grip strength, and qualitative data which would concentrate on subjective data such as improvements in general well-being, would afford a more holistic research agenda for RA (Bell, 2003).  Acupuncture research, already published using mixed methods research, has demonstrated the phenomenon of ‘emergence’ where patients describe multi-dimensional changes in their health, occasionally omitting to mention the state of their initial complaint (Paterson, 2006).  This type of research may allow researchers to develop techniques which may precisely represent ‘real world’ homeopathy, ensuring external validity but also honouring internal validity by employing more precise and less subjective quantitative data collection techniques.

Another development in homeopathic research which Bell and Kothian (2006) suggest is the utilisation of homeopathic theories such as Hering’s Law of Cure, which is considered during homeopathic consultations to ascertain whether healing has occurred.  As Hering’s Law of Cure follows a traceable distinct pattern in patients, it could be applied in a research situation to assess whether healing in certain chronic diseases follows the same sequence.  Thus the utilisation of a specific homeopathic theory could provide the basis for a theory-driven outcome for controlled research.  This type of research would identify patterns of healing in a whole system, rather than reducing the analysis of a specific point in time to a specific outcome.  The outcomes would be probabilistic not certain, as whole systems react differently to interventions and by their very nature are non-reductionist.

Conclusion

Homeopathy does not profess to act with local specificity, but rather on the whole system.  Therefore, research, such as RCTs, which measure specific effects, are not truly reflective of the homeopathic system, and therefore often produce contentious results.  Although RCTs have historically been viewed as the ‘gold standard’ of research into conventional medical interventions, it is time that homeopathic research truly reflected the uniqueness of its delivery, allowing homeopathy to be more accurately examined, thus enabling its true value to be revealed.

Whole systems research seems to provide a distinct way forward in homeopathic research since it would provide a more holistic form of research.  According to homeopathic understanding of disease and health, many patients express illness not only in their physical body, but also mentally and emotionally.  Therefore when assessing the action of homeopathic treatment, not only should changes in physical symptoms be evaluated, but also changes in the mental and emotional state (Vithoulkas, 1980).

References

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Appendix 1

Good Prescribing Symptoms (‘R’ patients)

Onset of symptoms following-

• a sudden fright
• bereavement
• physical injury
• profound emotional or physical trauma

Complaint affected by-

• climatic conditions e.g. damp or dry weather, heat, frost or wind
• other factors such as movement, rest or time of day

• marked craving or aversion to certain foods

For female patients -

• physical, emotional, mental changes during or after the menstrual period

Other anomalies -

• Marked mental or emotional peculiarities e.g. extreme tidiness, fear of heights or unusual reactions to sympathy

(Gibson et al., 1980)

Appendix 2

Medical Tests conducted during the trial

(Andrade et al., 1991)

Appendix 3

Weaknesses in Baseline Demographics

(Andrade et al.,1991)

Appendix 4

American College of Rheumatology

Classification of Global Functional Status in Rheumatoid Arthritis

Class I              Completely able to perform usual activities of daily living (self-care, vocational, and avocational

Class II             Able to perform usual self-care and vocational activities, but limited in avocational activities

Class III             Able to perform usual self-care activities, but limited in vocational and avocational activities

Class IV            Limited in ability to perform usual self-care, vocational and avocational activities

Usual self-care activities include dressing, feeding, bathing, grooming and going to the toilet.  Avocational (recreational and/or leisure) and vocational (work, school, homework) activities are patient-desired and age- and sex-specific.