Homeopathy--what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions

Trevor D B Thompson, Marjorie Weiss, Trevor D B Thompson, Marjorie Weiss

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 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.

Figures

Figure 1
Figure 1
Artwork from Jessica in Global Outcome Assessment category "Major".
Figure 2
Figure 2
Artwork from Chloe in Global Outcome Assessment category "None".
Figure 3
Figure 3
CDLQI of Jessica in Global Outcome Assessment category "Major".
Figure 4
Figure 4
IBSQoL for Chloe in Global Outcome Assessment category "None".
Figure 5
Figure 5
Global Outcome Assessment for the 18 cases.
Figure 6
Figure 6
Chart showing homeopathicity by Global Outcome Assessment category.

References

    1. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges L, Jonas W. Are the clinical effects of homoeopathy placebo effect ? A meta-analysis of placebo-controlled trials. Lancet. 1998;350:834–843. doi: 10.1016/S0140-6736(97)02293-9.
    1. Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA, Pewsner D, Egger M. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet. 2005;366:726–732. doi: 10.1016/S0140-6736(05)67177-2.
    1. Belon P, Cumps J, Ennis M, Mannaioni PF, Roberfroid M, Sainte-Laudy J, Wiegant FA. Histamine dilutions modulate basophil activation. Inflamm Res. 2004;53:181–188. doi: 10.1007/s00011-003-1242-0.
    1. Witt C, Keil T, Selim D, Roll S, Vance W, Wegscheider K, Willich SN. Outcome and costs of homoeopathic and conventional treatment strategies: a comparative cohort study in patients with chronic disorders. Complement Ther Med. 2005;13:79–86. doi: 10.1016/j.ctim.2005.03.005.
    1. Van WM, Ives G. An observational study of patients receiving homeopathic treatment. Homeopathy. 2004;93:3–11. doi: 10.1016/j.homp.2003.11.010.
    1. Steinsbekk A, Ludtke R. Patients' assessments of the effectiveness of homeopathic care in Norway: a prospective observational multicentre outcome study. Homeopathy. 2005;94:10–16. doi: 10.1016/j.homp.2004.11.016.
    1. Spence DS, Thompson EA, Barron SJ. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. J Altern Complement Med. 2005;11:793–798. doi: 10.1089/acm.2005.11.793.
    1. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321:694–696. doi: 10.1136/bmj.321.7262.694.
    1. Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med. 2002;19;136:471–476.
    1. Dow J. Universal aspects of symbolic healing: a theoretical synthesis. Amercian Anthropologist. 1986;88:69.
    1. Gendlin E. Focusing How to gain access to your body's knowledge. 3rd. London, Rider; 2003.
    1. Pennebaker JW, Susman JR. Disclosure of traumas and psychosomatic processes. Soc Sci Med. 1988;26:327–332. doi: 10.1016/0277-9536(88)90397-8.
    1. White M, Epston D. Narrative means to therapeutic ends. New York, W.W. Norton and Company; 1990.
    1. Thompson TDB. Can the caged bird sing? Reflections on the application of qualitative research methods to case study design in homeopathic medicine. BMC Medical Research Methodology. 2004;4
    1. Yin RK. Case study research Designs and Methods. 3nd. London, Sage; 2003.
    1. Lewis-Jones MS, Finlay AY. The Children's Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;132:942–949. doi: 10.1111/j.1365-2133.1995.tb08669.x.
    1. Bloor M. Techniques of validations in qualitative research: a critical commentary. In: Miller G and Dingwall R, editor. Context and Method in Qualitative Research. London, Sage; 1997. pp. 37–50.
    1. Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998;43:400–411. doi: 10.1023/A:1018831127942.
    1. Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994;18 Suppl 1:S79-83.:S79–S83.
    1. Paterson C. Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey. BMJ. 1998;312:1016–1020.
    1. Mercer SW, McConnachie A, Maxwell M, Heaney D, Watt GC. Relevance and practical use of the Consultation and Relational Empathy (CARE) Measure in general practice. Fam Pract. 2005;22:328–334. doi: 10.1093/fampra/cmh730.
    1. Reilly D, Duncan R, Bikker AP, Heirs M. Development of GHHOS, The IDCCIM Action Research, & the PC-HICOM Project. Interim Report, February 2003. 2003.
    1. Strauss A, Corbin J. Basics of qualitative research: grounded theory procedures and techniques. London, Sage; 1990.
    1. Mason J. Qualitative Researching. 1st. London, Sage; 1996.
    1. Bellavite P. Complexity science and homeopathy: a synthetic overview. Homeopathy. 2003;92:203–212. doi: 10.1016/j.homp.2003.08.002.
    1. Walach H. Entanglement model of homeopathy as an example of generalized entanglement predicted by weak quantum theory. Forsch Komplementarmed Klass Naturheilkd. 2003;10:192–200. doi: 10.1159/000073475.
    1. Branthwaite A, Cooper P. Analgesic effects of branding in treatment of headaches. Br Med J (Clin Res Ed) 1981;282:1576–1578.
    1. Anda R, Williamson D, Jones D, Macera C, Eaker E, Glassman A, Marks J. Depressed affect, hopelessness, and the risk of ischemic heart disease in a cohort of U.S. adults. Epidemiology. 1993;4:285–294. doi: 10.1097/00001648-199307000-00003.
    1. Honda K, Jacobson JS. Use of complementary and alternative medicine among United States adults: the influences of personality, coping strategies, and social support. Prev Med. 2005;40:46–53. doi: 10.1016/j.ypmed.2004.05.001.
    1. Caspi O, Koithan M, Criddle MW. Alternative medicine or "alternative" patients: a qualitative study of patient-oriented decision-making processes with respect to complementary and alternative medicine. Med Decis Making. 2004;24:64–79. doi: 10.1177/0272989X03261567.
    1. Bell IR, Lewis DA, Brooks AJ, Schwartz GE, Lewis SE, Caspi O, Cunningham V, Baldwin CM. Individual differences in response to randomly assigned active individualized homeopathic and placebo treatment in fibromyalgia: implications of a double-blinded optional crossover design. J Altern Complement Med. 2004;10:269–283. doi: 10.1089/107555304323062266.
    1. McKie R. Professor Savages Homeopathy. The Observer, 18th Dec. 2005.
    1. Mercer SW, Reilly D. A qualitative study of patient's views on the consultation at the Glasgow Homoeopathic Hospital, an NHS integrative complementary and orthodox medical care unit. Patient Educ Couns. 2004;53:13–18. doi: 10.1016/S0738-3991(03)00242-8.
    1. Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004;.
    1. Mercer SW, Watt GC, Reilly D. Empathy is important for enablement. BMJ. 2001;322:865. doi: 10.1136/bmj.322.7290.865.
    1. Bikker AP, Mercer SW, Reilly D. 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. J Altern Complement Med. 2005;11:591–600. doi: 10.1089/acm.2005.11.591.
    1. Mishler E. The Discourse of Medicine Dialectics of Medical Interviews. Norwood, New Jersey, Ablex Publishing Corporation; 1984.
    1. Barry CA, Stevenson FA, Britten N, Barber N, Bradley CP. Giving voice to the lifeworld. More humane, more effective medical care? A qualitative study of doctor-patient communication in general practice. Soc Sci Med. 2001;53:487–505. doi: 10.1016/S0277-9536(00)00351-8.
    1. Hemenover SH. The good, the bad, and the healthy: impacts of emotional disclosure of trauma on resilient self-concept and psychological distress. Pers Soc Psychol Bull. 2003;29:1236–1244. doi: 10.1177/0146167203255228.
    1. Pennebaker JW, Seagal JD. Forming a story: the health benefits of narrative. J Clin Psychol. 1999;55:1243–1254. doi: 10.1002/(SICI)1097-4679(199910)55:10<1243::AID-JCLP6>;2-N.
    1. Aghadiuno M. A study of the inter-observer reliability of paper case analysis. Homeopathy. 2002;91:10–17. doi: 10.1054/homp.2001.0016.
    1. Thompson E, Barron S, Spence D. A preliminary audit investigating remedy reactions including adverse events in routine homeopathic practice. Homeopathy. 2004;93:203–209. doi: 10.1016/j.homp.2004.07.007.
    1. Eskinazi D. Homeopathy re-revisited: is homeopathy compatible with biomedical observations? Arch Intern Med. 1999;159:1981–1987. doi: 10.1001/archinte.159.17.1981.
    1. Caspi O, Sechrest L, Pitluk HC, Marshall CL, Bell IR, Nichter M. On the definition of complementary, alternative, and integrative medicine: societal mega-stereotypes vs. the patients' perspectives. Altern Ther Health Med. 2003;9:58–62.
    1. Lewith G. Can practitioners be researchers? Complement Ther Med. 2004;12:2–5. doi: 10.1016/j.ctim.2003.12.004.
    1. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ. 2005;330:1202–1205. doi: 10.1136/bmj.330.7501.1202.
    1. Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003;3:28. doi: 10.1186/1471-2288-3-28.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel