Clinical Trials in Homeopathy
What Are We Looking For?
G. Vithoulkas, S. Kivellos
One of the main fields of scientific research in Homeopathy, is clinical studies according to the standards of Medical Science. A lot of effort and progress has been done in this field recently. Many clinical studies for homeopathy have been published in homeopathic and mainstream medical journals. Even meta-analyses have been published, in order to determine if those studies have given clinical results in favor or against Homeopathy. Nevertheless, every homeopathic doctor who practices classical homeopathy, knows that the results of clinical studies demonstrate poorer therapeutic results than those experienced in everyday clinical practice. Even for chronic diseases such as asthma and cephalalgia, where patients respond well to homeopathic treatment, clinical studies have failed, so far, to reproduce these positive therapeutic results. We can assume that the reproducibility failure of therapeutic results in clinical studies indicates a severe deficiency in the studies' protocols.
The main reason is that, in conventional research protocols there are certain rules (patho-physiologicals, pathologo-anatomicals, biochemicals, statisticals, epidemiologicals) for studying disease, but no laws or principles for studying the patient. On the contrary, in homeopathic research protocols there are definite laws (similia, totality, infinitesimal, Hering's law) for studying the patient, and uncertain rules (appropriate remedy, consequence of remedies, repetition, potencies, wait or act) for studying disease.
In order to indicate the main reasons for all of the above, we have to define again the laws that govern classical homeopathic treatment, understand their action upon modern, mostly chemically treated chronic diseases, and embody them in clinical study protocols. The suggested triptych includes:
1- reference back to theory of classical homeopathy,
2- embodiment of it in modern pathology of chronic diseases and
3- adjustment of medical clinical protocols to it and not the opposite, as has been mostly done.
Topics of main importance, while drawing up and conducting a medical clinical protocol concerning homeopathic treatment, are:
The choice of disease and treatments under comparison.
The parameter of time including follow ups and final evaluation.
Homeopathic prescription including potency and repetition.
Management of homeopathic aggravation.
Management of acute diseases during treatment of chronic diseases.
Management of reappearance of old predispositions.
Final evaluation with statistical analysis including topics 4,5 and 6.
Evaluation of the accuracy of the homeopathic prescription.
Management of patients suffering from modern chronic diseases, most of them under chemical treatment (currently or in the past), is the most difficult part and major challenge of medical homeopathy.
Every parameter of homeopathic treatment, including those important for clinical protocols above mentioned, is differentiated according to the patient's level of health. Prof G.Vithoulkas' contribution to the introduction of the laws of classical homeopathy into medical pathology, has led to the upgraded theory of levels of health. Information derived from this theory is used to draw up and conduct medical clinical protocols, which can then establish the real therapeutic effects of classical homeopathy.?? Talking about therapeutic results as both medical doctors and homeopaths, it is important to define the difference between suppression of symptoms with a treatment and "cure".
Curing patients with classical homeopathy, presupposes the respect for certain laws, almost unfamiliar to our conventional colleagues. Cure means the dynamic condition of freedom not only from the patients' symptoms, but from the disease's pathology. Furthermore, "homeopathic cure" means a lot more. It means freedom from the patient's pathological symptoms, and from the acquired predisposition that allowed the disease to be expressed.
The definition of health should be wonderfully upgraded by G.Vihoulkas' definition of health.
Patients and doctors both anticipate certain therapeutic results. In chronic diseases it is not uncommon that a classical homeopath will expect different reactions from the patient, than a conventional medical doctor would. For instance, homeopathic aggravation, reappearance of acute diseases from the past and reappearance of the immunological ability to achieve a high fever. A homeopath also hopes for a more recognizable homeopathic "picture" with clearer symptoms and signs, indicating a stronger and more stable neuro-endocrine-immuno balance. Last but not least, he expects a true healing, proceeding according to Hering's law.
It is not uncommon to see a patient's symptoms improved from the perspective of one conventional specialist (e.g. suppression of acne symptoms after oral retinoid treatment prescribed by a dermatologist) while other more severe symptoms appear according to another specialists' point of view (suicidal tendency as a long term side effect of oral retinoids, detected by a psychiatrist). This misinterpretation of what "therapy" or "cure" means is one of the main communicative problems between conventional medicine and Homeopathy.
It sometimes seems to be a severe compatibility problem between homeopaths as well. ??In the clinical practice of classical homeopathy, on the first monthly follow up of the patient after taking the homeopathic remedy, we are looking for evidence that the remedy has started to have a therapeutic effect.
This evidence does not necessarily mean the improvement of the patient's symptoms. On the contrary, the homeopath expects the possibility of the worsening of the patients' symptoms during the first days under homeopathic treatment – the phenomenon of therapeutic crisis-aggravation. These may included noteworthy changes of symptoms of the mental and emotional level of the patient, the reappearance of past predispositions or infections the patient has had (e.g. the reappearance of past dermatitis, or herpes on the lips), and finally, noteworthy changes in the particular physical symptoms of the patient (e.g. patients with migraines, often experience changes in the characteristics of the pain).
In cases of chronic cephalalgia, where the patient has taken conventional medication for a long time, the symptoms, signs and peculiarities (key-notes) which would normally lead the homeopathic doctor to conclude he had chosen the correct remedy (the simillimum), may have been suppressed. In these situations the following have to be taken into account, when evaluating the results of a clinical trial.
Firstly, it is not expected that this patient will be fully cured by one homeopathic remedy, but rather with a series of homeopathic remedies, prescribed gradually over a long time period.
Secondly, if a patient shows immediate improvement without the indication of therapeutic crisis, or the reappearance of former predispositions, then the homeopathic remedy might not be the most correct remedy, but a remedy that just palliates the patient's symptoms without substantially curing him.
In this case, the response of the patient is not due to a placebo effect, but rather the close (but not absolute) similarity of the remedy with the symptoms.??In every clinical trial with conventional medicine, the action of a medicine on the cellular and biochemical level has been studied in vitro or in animals. On the contrary, in classical homeopathy the homeopathic pathogenic trials (proving), have been undertaken on healthy human volunteers who presented a sensitivity to the specific natural substance. In other words, healthy individuals developing the appearance of symptoms indicates the effects of the specific substance and also that these individual have a sensitivity to the substance.
Theoretically, the specific homeopathic remedy would be one of the remedies advisable at some stage of their life. In the same way, the response of a patient to homeopathic treatment, is dependent on the idiosyncratic sensitivity to the specific remedy at the time of prescription.
If the wrong remedy is prescribed, the following may occur. The prescription of the absolute wrong homeopathic remedy, resembles the prescription of an inactive remedy and its reaction resembles the action of placebo.
The prescription of a somewhat similar but wrong homeopathic remedy, resembles the prescription of conventional medication, because it suppresses the symptoms without provoking the reaction of the human organism. This translated at a clinical level, means that it palliates the patient without curing him. ??For these reasons, according to G.Vithoulkas' Theory of levels of health, in cases of chronic disease, where patients have been under conventional treatment for a long time and may have a low level of health, it is important to know if the patient received placebo or not and if he received a well selected remedy, and whether it has been antidoted. This is essential for the effectiveness of clinical trials on chronic diseases, in which the possibility of the patient having a clear picture, with clear key-notes, is somewhat less. Without knowledge of these details, it is quite difficult for the homeopathic doctor to determine if he gave the correct homeopathic remedy, or how to proceed from there.
In conducting a classical double blind trial, Dr. Menachem Oberbaum believes it is legitimate that the physician choose the patients he thinks are treatable, provided that it is done before randomization. This means that the physician may say "for this patient I have enough symptoms and he can be included in the study" and for another patient he may say "for this patient I do not have enough symptoms and he can't be included in the study". After collecting suitable patients, they will be randomized blind into a treatment and placebo group.
The above is essential for the statistical analysis of the study, as the prescription of the incorrect homeopathic remedy resembles the action of placebo, and the prescription of a close but incorrect remedy (similar) resembles the action of a conventional medicine (palliation).
Summarizing the guidelines for classical homeopathic clinical studies protocols :
1. There should not be any restrictions on the homeopathic prescription. The doctor should always be able to prescribe whichever of the 3500 homeopathic remedies he believes is appropriate in order to achieve the highest individualization of the patient's treatment.
2. There homeopathic doctor should be able to choose patients he thinks are treatable according to his knowledge and the patient's clear picture of symptoms. This procedure in a clinical protocol is essential, especially regarding chronic diseases under conventional treatment.
3. There should be allowance for recording a patient's therapeutic aggravation phenomenon, which is remarkable in individualized Homeopathic treatment. If this is not foreseen by the protocol, then one will conclude falsely, that the results of the remedy are negative.
4. There should be allowance for recording the reappearance of predispositions of the past medical history of a patient (ex. reappearance of acute sinusitis) , also for treating them exclusively with Homeopathy, so that the treatment is concluded without the intervention of other medicine. If this is not foreseen by the protocol, then, different therapeutic interventions may antidote homeopathic treatment.
5. There should be a long period of following the patients under study, especially the ones with chronic diseases who were under conventional treatment, because classical drugs weaken the homeopathic medicine's effect. Certain effects will start to occur strongly, only after having gradually reduced classical medicines. Only then will the patient's initial symptoms reappear. Then he may be prescribed a second homeopathic medicine that corresponds to his/her initial symptoms which are now more obvious (ex. topography, period of time, modifying factors of pain). It is estimated from experience that a patient with a ten year headache history, that was regularly treated by conventional medicine, will need ten months of Homeopathic treatment in order for those clearer symptoms to appear. In that case it one could compare the time frame to a patient who has followed Homeopathic treatment from the first.
Finally, we should emphasize that the results of a study on Homeopathy compared to one on conventional treatment or placebo, will depend on the Homeopathic doctor's ability to find the patient's individual drug, and apply the homeopathic rules of therapy. This qualification is completely unnecessary in conventional trials.