Results

Thompson was able to identify various ‘ingredients’ of the homeopathic intervention as well as comment on their relative importance, regardless of whether the individual case treatment was successful or not. As reported, one third of cases experienced major global health improvement, one third some, and one third none.  This enabled relative evaluations. For example, patient expectation was uniform, so therefore did not correlate with actual improvement.

In order to identify these ‘ingredients’, data from patient interviews was coded separately and blindly by both investigators, and analysed by computer, according to pre-existing and emerging themes.  By doing so, a number of key issues were addressed regarding challenges to homeopathy, i.e. that success in homeopathy is due to placebo effect (Shang et al 2005) or the empathic consultation²⁴.

Non-specific ‘ingredients’ would refer to components acting as beneficial, independently of the SAHD given:

• Patient expectation of benefit

This did not correlate with outcome in every case. Patients who did not improve held the same expectations as those who did.

• Patient openness to the mind-body connection

Generally this did appear to correspond to good outcome in most cases. This supports the idea that there are ‘alternative patients’ as well as alternative therapies²⁵.

• Consultational empathy

This appeared to be necessary for good outcome, but with no direct correlation between empathy level and outcome.

• Disclosure

The theory of disclosure maintains that by disclosing trauma, the person is enabled to gain self-insight and repair damaged self-perception²⁶.  In this study, only one case is cited in which this may have mediated marked health gains.

• Narratology

Results led to the conclusion that deep probing in consultation was not necessary for therapeutic benefit. In two of the cases of major global improvement, no deep ‘life-world’ was revealed.

The two ‘ingredients’ specific to homeopathy are intrinsically linked:

• Homeopathicity

‘Homeopathicity’ is a process whereby therapist matches patient with the most suitable SAHD (remedy). Accuracy of match between patient and remedy is the goal of the consultation and is dependent on practitioner skill.  Clarity of this match as correlated with major health changes was analysed and determined retrospectively.  All cases with no improvement were categorised as unclear match. Twice the number of improved cases were clear-match than unclear.  Interestingly, the homeopathic skill of practitioner was not measured in any other way.

• The remedy

Various phenomena suggested evidence of the remedy as specifically active. One patient receiving more than one remedy could accurately document which was most effective, through both narrative and measurement profiles.  This phenomenon contradicts the notion that homeopathic medicines act as placebo.

Other research designs that would contribute to this topic

Having identified the ‘active ingredients’ in a prospective case-series study, retrospective observational studies or large scale observational studies could focus on patient openness to the mind-body connection, patient expectations and practitioner role.

RCTs incorporating a holistic model are also possible, as Frei et al have shown, in a trial of homeopathic treatment of ADHD in which the optimal medication for the patient (child) was determined before the placebo-controlled, cross-over trial began²⁷.

Medical Anthropology may provide interesting models for qualitative studies to investigate the mechanism and meaning of healing in homeopathy.

Conclusion

The paradigm of whole systems research enables homeopathy as a therapeutic intervention to be investigated within the real-life setting of the clinic. Thompson and Weiss have conducted an innovative, ground-breaking and rigorously designed study which goes beyond the limitations of RCTs . They have identified a number of therapeutic components which can form the basis for further investigations, either through observational retrospective or further prospective case-series studies. Many more pragmatic trials are needed to overturn the view that homeopathy is a non-specific placebo effect.

References

1.  Walach, H., Jonas, W.B. (2002a) Ch.14 Homeopathy pp. 229-245, in George Lewith, Wayne B. Jonas and Harald Walach (2002) Clinical Research in Complementary Therapies London: Churchill Livingstone

2.  Shang, A., Huwiler-Muntener, K., Nartey, L., Juni, P., Dorig,S., Sterne, J.A., Powsner, D., Egger, M. (2005) Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy Lancet 366 pp.726-732

3.  Bell, I.R., and Kothian, M. (2006) Models for the Study of Whole Systems Integrative Cancer Therapies 5(4) pp.293-307

4.  Weatherley-Jones, E., Thompson, E.A., Thomas, K.J. (2004) The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualised homeopathic treatment Homeopathy 93, pp.186-189

5.  Campbell, D., and Fitzgerald, M. (2007) Royals’ favoured hospital at risk as homeopathy backlash gathers pace The Observer Sunday April 8, 2007  located via Internet  http://observer.guardian.co.uk/uk_news/story/0,,2052505,00.html)

6.  Verhoef, M.J., Casebeer, A.L., Hilsden, R.J. (2002) Assessing Efficacy of Complementary Medicine: Adding Qualitative Research Methods to the “Gold Standard” The Journal of Alternative and Complementary Medicine Vol. 8, number 3, pp.275-281

7. Mason, S. Tovey, P Long, A.F. (2002) Evaluating Complementary Medicine: methodological challenges of randomised controlled trials. BMJ 2002; 325 832-834

8.  Verhoef, M.J., Lewith, G., Ritenbaugh, C., Boon, H., Fleishman, S., Leis, A. (2005) Complementary and alternative medicine whole systems research: Beyond identification of inadequacies of the RCT Complementary Therapies in Medicine vol.13 pp. 206-212

9.  Thompson, T.D.B., and Weiss, M., (2006) Homeopathy – what are the active ingredients? An exploratory study using the UK Medical Research Council’s framework for the evaluation of complex interventions BMC Complementary and Alternative Medicine vol. 6:37

10.  Thompson, T. (2004) Can the caged bird sing? Reflections on the application of qualitative research methods to case study design in homeopathic medicine BMC Medical Research Methodology 4:4

11.  Jonas, W.B.,  Lewith, G., Walach, H. (2002) Ch.1: Balanced Research Strategies for complementary and alternative medicine, pp. 3-27, in George Lewith, Wayne B. Jonas and Harald Walach (2002) Clinical Research in Complementary Therapies London: Churchill Livingstone

12.  Walach, H., Jonas, W.B., Lewith, G. (2002b) Ch.2: The role of outcomes research in evaluating complementary and alternative medicine pp. 29-45, in George Lewith, Wayne B. Jonas and Harald Walach (2002) Clinical Research in Complementary Therapies London: Churchill Livingstone

13.  http://dictionary.reference.com/browse/synergy

14. Capra, F. (1996) The Web of Life Great Britain, Harper Collins

15.  Greenhalgh, T. (1997) How to read a paper: Assessing the methodological quality of published papers   BMJ 1997;315:305-308 (2 August)

16.  http://dictionary.reference.com/browse/ingredient

17. Bar-Yam, Y. (2000) Concepts in Complex Systems, from the website of New England Complex Science Institute http://necsi.org/guide/concepts/reductionism.html

18. Macpherson, G. Ed. (2002) Black’s Medical Dictionary 40^th edition A&C Black, London

19. Eizayaga, F. (1991) Treatise on Homoeopathic Medicine Buenos Aires Ediciones Marecel

20.  Datta, A.K., (2003) Chronic diarrhea cured with Natrum Sulphuricum Homeopathic Links vol.16 Winter, pp. 215

21.  Gujjar, B. (2003) My child will become a criminal Homeopathic Links vol.16 Winter, pp. 210-211

22.  http://www.bath.ac.uk/e-learning/gold/glossary.html#N1980

23.  Bell, I.R., Caspi, O., Schwartz, G.E.R., Grant, K.L., Gaudet, T.W., Rychener, D., Maizes, V., Weil, A. (2002) Integrative Medicine and Systemic Outcomes Research Arch Intern Med vol.162 pp.133-140

24. Bikker, A.P.,  Mercer, S.W., Reilly, D. (2005) Empathy is crucial for enablement: A Pilot Prospective Study on the Consultation and Relational Empathy, Patient Enablement, and Health Changes over 12 Months in Patients Going to the Glasgow Homoeopathic Hospital The Journal of Alternative and Complementary Medicine Vol. 11, No. 4 pp.591-600

25.  Caspi, O.,  Koithan, M., Kriddle, M. (2004) Alternative Medicine or “Alternative Patients”: A Qualitative Study of Patient-Oriented Decision-Making Processes With Respect to Alternative and Complementary Medicine  Medical Decision Making MO-MO 2004

26.  Pennebaker JW, Susman JR. (1988) Disclosure of traumas and psychosomatic processes. Social Science Medicine 26(3):327-32. (abstract)

27.  Frei, H., Everts, R., von Ammon, K.,  Kaufmann, F., Walther, D., Hsu Schmitz, SF., Collenberg, M., Steinlin, M., Lim, C., Thurneysen, A. (2007) Randomised controlled trials of homeopathy in hyperactive children: treatment procedure leads to an unconventional study design; Experience with open-label homeopathic treatment preceding the Swiss ADHD placebo controlled, randomised, double-blind, cross-over trial  Homeopathy 96 pp. 35-41

APPENDIX I   Outcome measurements scales references

CARE

Consultation and Relational Empathy Measure:  The Consultation and Relational Empathy Measure has been developed as a tool for assessing the patients’ perceptions of relational empathy in the consultation. Relevance and practical use of the Consultation and Relational Empathy (CARE) Measure in general practice. Mercer SW, McConnachie A, Maxwell M, Heaney D, Watt GC. Fam Pract. 2005 Jun;22(3):328-34. Epub 2005 Mar 16.

CDLQI

Childrens Dermatological Life Quality Index:  developed in 1995 by research dermatologists The Children’s Dermatology Life Quality Index aims to measure the impact of skin disease on children’s quality of life. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=7662573&dopt=Abstract

FIS

The Fatigue index scale was initially developed in 1994 to improve understanding of the effects of fatigue on quality of life. FIS items reflect perceived impact on cognitive, physical, and psychosocial functioning.  http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8148458&dopt=Citation

GHHOS

Glasgow Homeopathic Hospital Outcome Scale; specifically developed for homeopathy treatment at GHH  http://www.adhom.com

IBS QoL

Validity and reliability demonstrated in a report published in 1997 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9218081&dopt=Abstract

MYMOP

BMJ 1996;312:1016-1020 (20 April) MYMOP Measure Your Medical Outcome Profile has been developed as a patient generated generic instrument to evaluate one’s health status, and is sensitive to improvement or deterioration, in both specific symptoms and global quality of life assessment