Another point of view for the homeopathic trials and meta-analyses
by Prof. George Vithoulkas
The already published research on homeopathy in the last ten years, in its majority, has followed wrong lines and therefore is causing and will continue to cause confusion and uncertainties within the medical profession. The problem was created from peer-reviewers who obviously were not eligible to peer review such a new subject.
Yet, homeopathy is growing in the preferences of the patients. Therefore, research should be the first step in a series of decisions, for putting an order to the anarchistic way that this therapeutic modality is developing at the moment. If the medical community wants to see the real effect and also the limits of homeopathy should aim in having good research. If this crucial problem is not understood and solved, mainly by the prestigious medical journals, then homeopathy will continue to expand unbelievably but haphazardly while the medical profession will pretend that such a thing does not exist.
Most of the papers published on homeopathic trials till today are confused and confusing. In homeopathy, there is no such thing as giving a remedy for a specific ailment or disease. The idea of double blind research is valid for conventional medicine but not for homeopathy which is based on the principle of giving a remedy for a totality of symptoms of an individual and not only for his single ailment, disease or pathology. If such papers continue to be published then the real homeopathic community, the practitioners who apply homeopathy in everyday practice will never accept this type of research.
Therefore I believe, the following comments will help to clarify a lot of issues that are causing and will continue to cause confusing remarks concerning the efficacy of homeopathy.
Out of six homeopathic meta--analysis 1-6 published in medical journals four 1-4 were somewhat positive and two 5-6 negative, compared with placebo, but all of them wrongly conceived and inaccurately evaluated from the aspect of homeopathy.
The latest fashion of meta-analysis applied to homeopathic trials is coming to a climax, but from a homeopathic point of view without guiding lines, and without the possibility of reaching ever a final and definite conclusion concerning the effectiveness of homeopathy. I would like to show why such meta-analyses will prove to be useless, unreliable and misleading, whether the outcome be positive or negative, if it continues to take in to account the kind of trials existing till this day.
The main pillar of meta-analysis is that it should be based on reliable trials. Are the bulk of the trials reviewed in these meta-analyses reliable?
The answer is a clear "no" 1-10. My objection is that all these trials were not structured according to the well established principles of homeopathy.
Homeopathy demands individualisation of the cases in order to show its best therapeutic effect. But in almost all the trials reviewed in the 6 meta-analysis studies these critical parameters were obviously ignored.
I will take as an example the Lancet paper Klaus Linde @ et al 1. I will only comment on two trials within this meta-analysis, though all of the papers included will not withstand any serious scrutiny from the homeopathic point of view:
1. The Shipley, Jenkins et al, trial 11 that was the most negative for homeopathy:
Rhus-tox D6 was tested in osteoarthritis and found to have no effect.
Rhus -tox. as every homeopath knows is almost never indicated in osteoarthritis cases (is useful perhaps in some cases of fibrositis or in rheumatic complains). Other remedies like the Causticum, the Kali salts the Calcarea salts or the Natrum salts could have been tried for this pathology under a specific protocol, but never the Rhus-tox.
This research was similar to testing antibiotics in. . . anxiety neurosis and finding that they do not work, we arrived at the conclusion that all conventional medicine is useless. I consider this paper the worst type of homeopathic trials, though many others in the same meta-analysis have similar problems.
2. On the Hariveau, et al trial 12 that was the most positive for homeopathy:
The remedy Cuprum were tested and found very effective in reducing cramps.
Though Cuprum is effective in some cases for cramps, yet is not as effective as this trial tried to show. Mossinger's similar trials 13 that did not show such a dramatic effect confirm this point of mine.
The bulk of the rest of the trials in this meta-analysis have very little to do with testing the effectiveness of homeopathy. They were conceived according to conventional way of thinking (a remedy for a specific disease) This is not homeopathy as I explained above. The only conclusion one could draw from these trials is that highly diluted substances can still have an effect upon the human organism.
Therefore, the homeopathic community should not accept research that does not comply and does not respect the homeopathic principles.
Which are these principles:
- That homeopathy does not treat diseases, but only diseased individuals. Therefore every case may need a different remedy though suffering with the same pathology. This rule was violated by almost all trials in all the meta-analysis, even in those trials that were coined as classical. An exception was the trials that attempted to be closer to the idea of the homeopathic principles as well. P. Fisher et al 14 Jacobs et al 15 and Schwab 16. These trials showed excellent results in spite of the fact they did not follow a process of complete individualisation of the cases.
There is usually an initial aggravation after the first prescription, especially in chronic cases that should be considered as a positive sign. That factor has been totally ignored. Also that sufficient time should be given in the design of the trial, in order to overcome the aggravation period.
In a recent study published in Cephalalgia 17 the aggravation period was evaluated as a negative sign and the homeopathic group was pronounced worse than the placebo. Cephalalgia refused to publish my objections to the study. 18
- In severe chronic conditions the homeopath may need to prescribe a second or a third remedy before any sign of improvement is apparent. Such prescription should take place only after evaluating the results by the previous remedy. This rule has also been ignored in all studies.
- Research should take in to consideration the length of time and the severity of the case. The prognosis of a chronic condition (the possible time after which an amelioration sets in through homeopathic treatment) differs according to the length of time the disease is active and the severity of the case.
In concluding these remarks allow me to suggest:
a. All the above parameters for homeopathy should have been discussed with expert homeopaths before researchers undertake to design homeopathic trials, and Medical Journals should provide more knowledgeable peer-reviewers for clinical trials on homeopathy.
b. There is a need for at least one standardized protocol for clinical trials that will respect both: the double blind parameters but also some of the homeopathic principles. Only then such trials could be acceptable by both the homeopathic and the conventional medicine. With some of my colleagues we are in the final stage of completing such a protocol.
- Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV et al. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350: 834-43.
- Cucherat M, Haugh MC, Gooch M, Boissel JP, for the HMRAG group. Evidence of Clinical efficacy of homeopathy. A meta-analysis of clinical trials. Eur J Clin Pharmacol 2000; 56: 27.
- Barnes J, Resch KL, Ernst E. Homeopathy for post operative ileus? A meta - analysis. J Clin Gastroenterol 1997 Dec; 25 (4): 628-33.
- Kleijnen J, Knipschild P, ter Riet G. Clinical trials of Homeopathy. BMJ 1991 Feb 9; 302(6772):316-23.
- Scheen A, Lefebvre P. Is homeopathy superior to placebo?Controversy apropo of a meta-analysis of controlled studies. Bull Mem Acad R Med Belg 1999; 154 (7-9); 295-304; discussion 304-7.
- Linde K, Scholz M, Ramirez G, Clausius N, Melchart D, Jonas WB. Impact of study quality on outcome in placebo- controlled trials of homeopathy. J Clin Epidemiol 1999 July; 52(7):631-6
- Vandenbroucke JP, Homeopathic trials :going nowhere. Lancet 1997; 350:824.
- Langman MJS. Homeopathy trials: reasons for good ones but are they warranted ? Lancet 1997 350:825
- Ernst E, Barnes J. Are homeopathic remedies effective for delayed onset muscle soreness? A systematic review of placebo-controlled trials. Perfusion 1998; 11: 4-8
- Dean M. Out of step with the Lancet homeopathy meta-analysis: more objections than objectivity? J Altern Complement Med 1998 Winter; 4(4): 389-98.
- Shipley M, Berry H, Broster G, Jenkins M, Clover A, Williams I. Controlled trial of homeopathic treatment of osteoarthritis Lancet;1983, i: 97-98.
- Hariveauv, et al recherche clinique a L'Institut Boiron Homeopathie 1987;5:55-58.
- Mossinger P. Misslungene Wirksamkeitsnachweise. Allg homopath Ztg 1976; 221: 26-31
- Fisher P, Greenwood A, Huskisson EC et al. Effect of homoeopathic treatment on fibrositis (primary fibromyalgia). BMJ 1989; 299: 365-366
- Jacobs J, Jiminez LM, Gloyds SS et al Homoeopathic treatment of acute childhood diarrhea: a randomized clinical trial in Nicaragua. Br Hom Journal 1993; 82: 83--86
- Schwab G. Lsst sich eine Wirkung homopathischer Hochpotenzen nachweisen? Karlsruhe: Deutsche Homopathische Union; 1990.
- Walach H, W. Haeusler T Lowes, D Mussbach, U Schamell, W Springer et al Classical Hom. Treatm. of Chronic Headaches Cephalalgia 1997;17: 119-26
- Vithoulkas G. Unpublished Critical Review of Class. Hom. Treatm. of Chronic Headaches in Cephalagia Oct 1997 sent to Cephalalgia and their respond.