Commentary on “Serious mistakes in meta-analysis of homeopathic research” by Dr. George Vithoulkas
To the Editor,
This paper raises important points to be considered when conducting trials for assessing the efficacy of homoeopathy . However, the points raised by the author were already addressed more specifically and extensively in the paper by Mathie et al (2015)  under the domains to be assessed for model validity of homoeopathic treatment, under the RedHot guidelines proposed by Dean et al (2007)  to report data regarding the homoeopathic treatment, and under the criteria proposed by Saha et al (2014)  while reporting about individualization during reporting of trials of individualized homoeopathy.
Dr. Vithoulkas points out the following shortcomings in the trials selected for meta-analyses:
- Most notably individualization and other homoeopathic principles are often ignored in the selected trials.
- Specific remedies are often used for specific pathology, which is again against homoeopathic principles.
- Improvement is assessed and understood differently conventionally and in homoeopathy. An initial aggravation of existing symptoms is often expected as a favorable response during homoeopathic treatment. A ‘symptom shift’ and consequently change of remedy due to change in guiding symptoms may also often require series of remedies in dealing successfully with chronic cases. Evaluation during initial aggravation may be misleading.
The raised points as mentioned above are addressed further in this paper.
- Homoeopathy does not treat diseases, but only diseased individuals. Therefore, every case may need a different remedy although the individuals may be suffering from the same pathology.
Why this problem occurs? Lack of knowledge or faulty application of principles of homoeopathy or vested interest
Solution: Qualified homoeopathic practitioners should be consulted before beginning the trial and the rationale behind remedy selection for each case of disease must be reported.
RedHot: Under the checklist for RedHot, reporting the information requested under Item 1 (Rationale section) and Item 5 (Practitioners section) may bring more clarity.
Model validity: The assessment of Domains – Domain I (Rationale), Doman II (Intervention) and Domain III (Practitioner) before a trial is undertaken can address the issue.
Quality of individualization: Criteria 1-6 enhances detailed and transparent reporting of how the individualization was done in terms of selection of medicine and dose.
- In the homeopathic treatment of serious chronic pathology, if the remedy is correct usually a strong initial aggravation takes place. Such an aggravation may last from a few hours to a few weeks and even then we may have a syndrome-shift and not the therapeutic results expected. If the measurements take place in the aggravation period, the outcome will be classified negative. Sufficient time should be given in the design of the trial, in order to account for the aggravation period.
Homoeopathic principle: The aggravation period can be initial – when using centesimal potency (§157-160 5th edition), or the aggravation can occur at the end of treatment of chronic disease – with 50 millesimal potency (§161 6th edition)]. The aggravation occurring in a case has to be assessed whether it is due to the progress of disease or due to excess of homoeopathic medicine (caused by either improper dose or too frequent repetition of the medicine). Due to excess of medicine, either homoeopathic aggravation [considered a favorable sign, no new symptoms arise but an increase in intensity of existing symptoms (§157) occur along with other signs of improvement such as feeling of well-being (§253)] or medicinal aggravation [new symptoms appearing which are not due to progress of disease pathology but due to excess of homoeopathic medicine (§248 6th edition)].
Why this problem occurs? Conventional assessment of improvement differs from homoeopathic assessment of improvement. The commencement of improvement after taking the homoeopathic medicine can also vary depending on the disease, the individual suffering from the disease, the medicine used and its potency.
Solution: Chronic and acute cases have to be approached differently as per homoeopathic principles. Transparent criteria should emerge enabling differentiation among different types of aggravations (and adverse events) . Before measurement of outcome during follow-up period, the prescribed potency should always be considered, i.e., whether it was centesimal or 50 millesimal as the aggravation periods are expected to be different. Disease specific quality of life questionnaire and non-specific general ones should be given equal importance, provided sufficient attention has been paid to availability of validated, reliable and cross-culturally adaptable questionnaire in local languages.
RedHot: Attention to the following three items of the RedHot when constructing the protocol may help – Item 2 (Participants – Knowledge condition, baseline health definition in proving), Item 3 (Medications – Potency and scale, Dosage – Dose, timing, form), and Item 8 (Adverse events – Aggravations)
Model validity: Addressing the following three domains under Model validity also provides a solution to this problem in general – Domain IV (Outcome measure), Domain V (Outcome sensitivity) Domain VI (Follow-up).
Quality of individualization: Criteria 4 and 5 seek meticulous and comprehensive reporting about dose selection.
- In severe chronic conditions, the homoeopath may need to correctly prescribe a series of remedies before the improvement is apparent. Such a second or third prescription should take place only after evaluating the effects of the previous remedies.
Homoeopathic principle: The chronic cases very often require series of remedies (§171). The change in totality of symptoms should guide the selection of next required medicine (§169) only after the previous medicine has stopped producing further improvement in the case (§183) (§248, 5th edition). This symptom shift cannot be predicted beforehand and requires fresh examination and prescription of new remedy according to the totality of symptoms. It must be assessed before prescribing the next remedies that whether the previous remedy is still acting. If it is still acting beneficially, then it should not be disturbed by repeating the prescription or prescribing a new remedy. However, if the previous remedy has caused harm or unpleasant aggravation, it needs to be antidoted (§249). Medicines can have differences in their action in acute and chronic cases (§161 fn1).
Why this problem occurs? Lack of knowledge or faulty application of principles of homoeopathy
Solution: Qualified homoeopathic practitioners’ inputs are necessary into the trial and the rationale behind remedy selection and change of remedy for the case of disease should be reported.
RedHot: Item 1 (Rationale section) and Item 5 (Practitioners section)
Model validity: The assessment of Domains – Domain I (Rationale), Doman II (Intervention) and Domain III (Practitioner) before a trial is undertaken.
Quality of individualization: Criteria 1-6 necessitate inputs from qualified homoeopathic practitioners.
- As the prognosis of a chronic condition and the length of time after which any amelioration sets in may differ from one to another case, the treatment and the study-design respectively should take into consideration the length of time the disease was active and also the severity of the case.
Homoeopathic principle: Same as given under point 3
Proper consideration of all domains of model validity for homoeopathic treatment, all the items of RedHot guidelines, and all the criteria for reporting quality of individualization when designing the protocol can help with this.
- In our experience, homoeopathy has its best results in the beginning stages of chronic diseases, where it might be possible to prevent the further development of the chronic state and this is its most important contribution. Examples of pathologies to be included in such RCTs trials are ulcerative colitis, sinusitis, asthma, allergic conditions, eczema, gangrene rheumatoid arthritis as long as they are within the first six months of their appearance.
Comment: Though it sounds interesting, still its feasibility is questionable. Though this criterion may increase homogeneity of the study sample, but using it as one inclusion criteria may make achieving desired sample size more challenging.
- Another novel point raised by Dr. Vithoulkas is that medical journals should invite more knowledgeable peer-reviewers who understand the principles of homoeopathy. Only those researches which properly follow homoeopathic principles should be considered as justifiably evaluating the efficacy of homoeopathy.
Conclusion: By considering the domains and items mentioned in model validity, RedHot and quality of individualization before beginning a trial, the need to bridge clinical research methodology with adherence to homoeopathic principles might be addressed sufficiently. With the passage of time since the demise of Hahnemann, many schools of thought have sprung up which claim to be homoeopathy, but differ very much from the principles given by Hahnemann. The principles as laid down by Hahnemann should be considered as the sole basis for any homoeopathic treatment. Just as the CONSORT is supplemented by RedHot, similarly, the SPIRIT guidelines  should have a supplement from homoeopathic perspective, so that the proposed recommendations for conducting trials of individualized homoeopathy may be incorporated during the phase of protocol development and thus generating meaningful results.
- Vithoulkas G. Serious mistakes in meta-analysis of homeopathic research. J Med Life. 2017;10:47-49.
- Mathie RT, Van Wassenhoven M, Jacobs J, Oberbaum M, Roniger H, Frye J, et al. Model validity of randomised placebo controlled trials of individualized homeopathic treatment. Homeopathy. 2015;104:164-169.
- Dean ME, Coulter MK, Fisher P, Jobst K, Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. Homeopathy. 2007;96:42-45.
- Saha S, Koley M, Ganguly S, Rath P, Roy Chowdhury P, Hossain SI. Developing the criteria for evaluating quality of individualization in homeopathic clinical trial reporting: a preliminary study. J Integr Med. 2014;12:13-19.
- Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200-207.
- Stub T, Salamonsen A, Alraek T. Is it possible to distinguish homeopathic aggravation from adverse effects? A qualitative study. Forsch Komplementmed. 2012;19:13-19.
Dept. of Organon of Medicine & Homoeopathic Philosophy
National Institute of Homoeopathy
Govt. of India
Champsara, Baidyabati, Hooghly
West Bengal, India
West Bengal, India
|Cite this article as: Michael J, Koley M, Saha S. Commentary on “Serious mistakes in meta-analysis of homeopathic research” by Dr. George Vithoulkas. National Homoeo Recorder 2018;14(4):60-63.
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