The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualised homeopathic treatment
Received10 October 2003
revised15 April 2004
accepted07 June 2004
19 December 2017 (online)
The authors’ experience of conducting clinical trials in homeopathy and analysing data from these has drawn attention to a fundamental problem with the interpretation of results from placebo controlled trials in homeopathy: It is not reasonable to assume that the specific effects of homeopathic medicine and the non-specific effects of consultations are independent of each other—specific effects of the medicine (as manifested by patients’ reactions) may influence the nature of subsequent consultations and the non-specific effects of the consultation may enhance or diminish the effects of the medicine.
For clinical trials of homeopathy to be accurate representations of practice, we need modified designs that take into account the complexity of the homeopathic intervention. Only with such trials will the results be generalisable to homeopathic practice in the real world. The authors propose that comparative trials are a meaningful way of evaluating the effectiveness of homeopathic treatment.
- 1 Kessler R.C, Davis R.B, Foster D.F. et al. Long-term trends in the use of complementary and alternative medical therapies in the United States. Ann Internal Med 2001; 135: 262-268.
- 2 Thomas K.J, Nicholl J.P, Coleman P. Use and expenditure on complementary medicine in England a population based survey Complement Ther Med. 2001; 9: 2-11.
- 3 House of Lords Select Committee on Science and Technology Complementary and Alternative Medicine. London: Stationery Office, 2000 (6th. Report).
- 4 Angell M., Kassirer J.P. Alternative medicine, the risks of untested and unregulated remedies. N Engl J Med 1998; 339: 839-841.
- 5 Haynes R.B. Commentary. a warning to complementary medicine practitioners: get empirical or else. BMJ 1999; 319: 1629
- 6 Mason S., Tovey P., Long A.F. Evaluating complementary medicine. methodological challenges of randomised controlled trials. BMJ 2002; 325: 832-834.
- 7 Linde K., Melchart D. Randomized controlled trials of individualized homeopathy. a state-of-the-art review. J Altern Complement Med 1998; 4: 371-388.
- 8 Linde K., Clausius N., Ramirez G., Melchart D., Eitel F., Hedges L.V. et al. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350: 834-843.
- 9 Labrecque M., Audet D., Latulippe L.G., Drouin J. Homoeopathic treatment of plantar warts. Can Med Assoc J 1992; 146: 1749-1753.
- 10 Leaman A.M., Gorman D. Cantharis in the early treatment of minor burns. Arch Emergency Med 1989; 6: 259-261.
- 11 Bignamini M., Saruggia M., Sansonetti G. Homoeopathic treatment of anal fissures using Nitricum acidum. Berl J Res Hom 1991; 1: 286-287.
- 12 Jacobs J., Jimenez L.M., Gloyd S.S., Gale J.L., Crothers D. Treatment of acute childhood diarrhea with homeopathic medicine. a randomized clinical trial in Nicaragua. Pediatrics 1994; 93: 719-725.
- 13 Chapman E.H., Angelica J., Spitalny G., Strauss M. Results of a study of the homeopathic treatment of P.M.S.. J Am Inst Hom 1997; 87: 14-21.
- 14 Andrade L., Ferraz M.B., Atra E., Castro A., Silva M.S.M. A randomized controlled trial to evaluate the effectiveness of homoeopathy in rheumatoid arthritis. Scand J Rheumatol 1991; 20: 204-208.
- 15 Gibson R.G., Gibson S., MacNeill A.D., Watson Buchanan W. Homoeopathic therapy in rheumatoid arthritis. evaluation by double-blind clinical therapeutical trial. Br J Clin Pharmacol 1980; 9: 453-459.
- 16 Weatherley-Jones E., Nicholl J.P., Thomas K.J. et al. A randomised controlled triple-blind study of the efficacy of homeopathic treatment for chronic fatigue syndrome. J Psychosomatic Med 2004; 56: 189-197.
- 17 Thompson E, Douglas D, Montgomery A, Reilly D, A pilot randomised double-blind placebo controlled trial of individualised homeopathy for symptoms of oestrogen withdrawal in breast cancer survivors, 2004, submitted for publication.
- 18 Kleijnen J., de Craen A.J., van Everdingen J., Krol L. Placebo effect in double-blind clinical trials. a review of interactions with medications. Lancet 1994; 344: 1347-1349.
- 19 Di Blasi Z., Harkness E., Ernst E., Georgiou A., Kleijnen J. Influence of context effects on health outcomes. a systematic review. Lancet 2001; 357: 757-762.
- 20 Jacobs J., Springer D.A., Crothers D. Homeopathic treatment of acute otitis media in children. a preliminary randomized placebo-controlled trial. Ped Infectious Dis J 2001; 20: 177-183.
- 21 Jacobs J., Jimenez L.M., Malthouse S., Chapman E., Crothers D., Masuk M. et al. Homeopathic treatment of acute childhood diarrhea results from a clinical trial in Nepal. J Altern Complement Medi 2000
- 22 Balzarini A., Felisi E., Martini A., De Conno F. Efficacy of homeopathic treatment of skin reactions during radiotherapy for breast cancer. a randomised double-blind clinical trial. Br Hom J 2000; 89: 8-12.
- 23 Hahnemann S. Organon of Medicine, 6th ed. (translated by Boericke). Boericke and Tafel, 1922.
- 24 Hahnemann S. In: Dudley P (ed), Tafel LH (translator). Chronic Diseases: Their Peculiar Nature and Their Homeopathic Cure. Homeopathic Book Service, 1998.
- 25 Thomas K., Fitter M. Evaluating complementary therapies for use in the National Health Service “Horses for courses”.. Part 2: alternative research strategies. Complement Ther Med 1997; 5: 94-98.
- 26 Reilly D. Randomised controlled trials for homoeopathy. When is useful improvement a waste of time? Double positive paradox of negative trials. Letter BMJ 2002; 325: 41
- 27 Fitter M., Thomas K. Evaluating complementary therapies for use in the National Health Service “Horses for courses”.. Part: 1 the design challenge. Complement Ther Med 1997; 5: 90-93.
- 28 Bell I.R., Caspi O., Schwartz G.E., Grant K.L., Gaudet T.W., Rychener D. et al. Integrative medicine and systemic outcomes research. Arch Internal Med 2002; 162: 133-140.