Drug Proving is the systematic process of acquiring knowledge of the instruments intended for the cure of the natural diseases. In other wards we can say that it is the systematic process of investigating the pathogenetic power of drug by administering the same in to the healthy individuals of different age and both the sax.
Hahnemann was not the first clinician who noted that the drug selected on the basis of their similarity to the disease to reach to cure. He cites previous experiences of clinicians like Hippocrates, Paracelsus and Stahl(1738) in whose writings he found that the most definite statement of Law of Similars. But, none of these proceeded systematically to offer an experimental proof.
While he was translating Cullen’s Materia Medica from English to German, he came across with cullen’s remark on the curative power of Cinchona –bark in marsh-ague and decided for testing its positive effects on himself. He was surprised to note that the similarity of the symptoms of ague with that produced by Cinchona-bark, then he formed a tentative hypothesis in his mind that the specific curative power of a drug lies in its power of producing similar symptoms in a healthy individual i.e. disease producing power is the disease curative power. He then continued his researches and experiments from 1790 to 1796 and wrote about fifty drugs which specifically cured the diseased conditions, the similar pictures of which they produced when administered to healthy individuals. He then suggested a new way of ascertaining the specific curative powers of drug. It was published as an article in Hufeland’s journal with the title “ An Essay on a New Principle for Ascertaining the Curative powers of Drug”
Drug cure by virtue of their capacity to induce changes, which are similar to those, brought about by disease. Hahnemann set about collecting data pertaining to disease and the drugs. He then had to determine the criteria for establishing similarity between the two. After this was done, he had to administer the drug and to observe accurately the result so produced. Organon of Medicine gives us the details of the great therapeutic experiment in a highly systematized manner stretching over fifty years.
Drugs are the substances which have the capacity to affect the development of disease and / or its expression through systems. For acquiring the knowledge about drug-effects, experiments have been made on the healthy human being through the process of Drug Proving.
In conduction of Drug Proving the physician (Proving master) must have the knowledge of genuineness of unimpaired strength of drug so that he can rely upon the therapeutic powers drug. Substances belonging to the Animal and Vegetable kingdom possess their medicinal qualities most perfectly in their raw state.
Indigenous plants are collected in fresh state to possess powers in the most complete and certain manner and by mixing their freshly expressed juice immediately with equal parts of spirits of wine of strength, which is sufficient to burn in lamp. Then it kept for a day and a night (24 hours) in a close stoppered bottled. The fibrionus and aluminous matter are deposited, the clear superincumbent fluid is then decanted off for medicinal use. All fermentation of the vegetable juice will be at once checked by the spirits of wine mixed with it and rendered impossible for the future, and the entire medicinal power of the vegetable juice is thus retained (perfect & uninjured) for ever by keeping the preparation in well-corked bottle, further protected with wax to prevent evaporation and excluded from the sun’s light.
The exotic plants, barks, seeds and roots that cannot be obtained in the fresh state, the sensible physician will never take in the pulverized form on trust, but will first convince himself of their genuineness in their crud, entire state before making any medicinal employment of them.
|The pre-requisites for the prover, drug & the physician are as under:-|
|· Must be healthy physically and mentally.· Should be honest, lover of truth that he can narrate symptoms exactly.· Should have the capacity to express symptoms in exact manner.
· Should be keen observer.
· Should be intelligent
· Should be introspective that can look within himself.
· Should be conscientious.
· Must avoid all sorts of dissipation and disturbing passions.
|· Must be pure.· Must be genuine.· Must be of known origin.
· Should be full of energy.
· Indigenous drug procured fresh juice should be mixed with alcohol then should be given.
· Exotic drug should be procured fresh, made into tincture of dry powder, to be taken with equal volume of water.
· Gum and resin, salts should be dissolved in water then to be given.
· Medicines obtained in dry form are made into powder should mixed with hot water and taken as infusion.
|· Should be unprejuidiced· Should give full attention to the prover.· Should be a person of sound sense.
· Should have fedility to his prover.
· Should be tactful
· Should be Circumspective
· Should have patients of an eminent degree.
· Must take causion during enquiry.
· Should have knowledge of human nature.
· Should have the capacity of proper judgement.
· Should have clear knowledge about narcotic, alternating action, idiocyncrasy, surrogate.
Dr. Hahnemann established experimental human pharmacology by Proving Drugs on healthy human beings, obtained data on the pure effects of drugs which he recorded in his ‘Chronic Diseases’ and in the ‘Materia Medica Pura’. He arranged all the datas according to a scheme of locations and presented in a systematic manner. He ensured complete objectivity by faithful recording the effects as experienced by the provers, retaining their language as far as possible. In his introductory remarks his personal comments and observations have been recorded separately. Even today his directions are rigidly adhered to in the Homoeopathic Pharmacopoeia.
In our Materia Medica, symptoms of many drugs have been recorded, based only on the symptoms of poisoning and not as the effects of drugs provings. These toxicological symptoms may have their value but they should be kept apart as very often it is not advisable to take them into account in medical prescriptions.
The effects of medicines can be ascertained from different sources, including :
o Proving on healthy human being
o Toxicological studies in animals
o Clinical experiences
The human Drug-Proving could not be done to the extent of producing irreversible pathological changes. The pathological data owe their origin chiefly to clinical observations, supported by reports of accidental poisoning and a few animal provings that were conducted. Thus Homoeopathic Materia Medica is essentially a record of human functional pathology.
It is known to all that certain substances which is inert in crude state, acquire remarkable powers to influence susceptibility when they are prepared as per direction in homoeopathic pharmacopoeia and administered according to definite plan as has done in well conducted provings.
In a proving, a drug is administered till it meets the susceptibility and evoke the response. Further stimulation is then suspended, otherwise, clarity of response tends to get blurred. The specific capacity of the drug to affect health acts on the susceptibility in a prover to give rise to the final picture in a drug proving. General experience indicates that a sensitive and gracile subject is extremely susceptible; where as, the coarse type requires repeated stimulations through the lower potencies. Not all provers manifest susceptibility to lower potency. Some of the finer indications have been obtained by provings conducted with the 30th potency and beyond. Inert substances require considerable release of energy through 30th potency and beyond before they affect susceptibility.
In Homoeopathic Drug Provings on healthy subjects, volunteers (provers) receive the medicinally active substances over a definite period of time. All striking changes and symptoms affecting the body or psyche are than carefully recorded and evaluated and described in detail e.g. intensity of individual symptoms, their variation at different times of day, associated circumstances and modifying influences. All newly occurring symptoms, in this context, are taken as symptoms, which systematically collected to form the picture of the drug substances being proved.
After thorough physical and clinical examinations provers (volunteers) of both male and female are selected, and consent is taken from each prover before the drug trial. The provers are divided into two groups (control and active).
The details of physical and clinical examinations along with constitutional features (mental
and physical attributes) are recorded in a ‘Pre-trial Medical Report Proforma’. This proforma is reserved throughout the period of proving and even after the trial is over, for reference, as and when required.
In India the authority has adopted the methodology of proving is based on Drysdale’s Double Blind Method. General instructions and directions given by the Indian authority is as under :-
1) The Drug Proving study is to be undertaken on persons who are reasonably healthy and selected on the basis of biological, environmental, social and nutritional variations. As no one is perfectly healthy in the true sense, a very careful record of the individual’s present state of health including symptoms, if any, be maintained together with reports of various laboratory tests such as blood, stool, urine, etc.
2) Persons selected must be between the age group of 18-45 yrs, as-
i) they are intelligent enough to understand the seriousness of the experiment and able to record the subjective symptoms properly.
ii) the natural bodily degenerative changes which come with age will not be present.
3) The prover must be well acquainted with Homoeopathic Methodology and have good knowledge of symptomatology found in Materia Medica so that the particular deviations which may manifest during the experiment are fully appreciated.
4) The persons who are hysterical or displaying enxieties and emotionally disturbed stated should not be included in the proving trials, as, such individuals display a high incidence of “Placebo effect”.
5) Persons suffering from allergic manifestations particularly pertaining to respiratory system and skin should not be included.
6) Pathological, Biochemical and serological tests are required to be performed to facilitate correlation between the subjective and objective changes as far as possible.
The drug is administered, in doses of 4-6 globules, four times a day for 14 days. In case of Mother Tincture, a dose is 5 minims in a tablespoon of water, three times a day. The drugs are proved in ascending or descending order of potencies. As stated by Dunham, it is better to start first with higher potencies so that susceptible prover may be known right from the beginning as they will give us finer and more detailed symptoms. If there is no response, then lower potency or mother tincture may be employed. Once a prover develops any signs/symptoms, administration of drug is stopped immediately and is not re-administered till the sign(s) and symptoms (s) persist. Disappearance of sign(s) and symptom(s) is followed by a washout (drug free) period of 7 days and in case of no recurrence of sign(s) and symptom(s), the drug is re-administered, till the completion of one quota. Next quota is administered after a washout period of seven days.
During the course of proving, use of any other medication is restricted. The provers are also instructed not to make any major change in their daily routine and his lifestyle, specifically food habits, sleep, exercise etc. Those who are habitual for tobacco chewing, smoking, tea, coffee, alcohol etc. are advised to minimize the use of such stimulants. These can, however, be withdrawn if the prover does not suffer from any ill-effects from the withdrawl of these habits or stimulants and beverages. Use of other drugs and medicaments, especially of camphor is to be prohibited during the proving and also the use of table condiments and highly spiced and seasoned food.
Provers should note down all the symptoms they observe during the course of proving in the Prover’s Day Book Proforma, report to the physician everyday and hand over the recorded Proforma. The physician should take care to ascertain and record environmental changes, alteration in daily routine and lifestyle of the provers, if any, to ensure a true and realistic evolution of drug pathogenesis. The physician should interrogates the provers with regard to their symptomatic presentation and records them and his own observation in respect of location, sensation, modalities, concomitants, extension (if any) and duration of each reported symptom in the “Symptom Elaboration Sheet”. During the period of the trial the clinical, laboratory and radiological investigations are also to be recorded.
After completion of all the quotas of the drug under trial, the provers are required again a thorough physical and clinical examination. The observations recorded need to be compared with the preliminary medical examination recorded earlier. Any variation in pre and post trial findings is also to be recorded.
The data of the drug collected from different provers gathered centrally for final compilation. At the conclusion of the provings, all the record books which is in the form of a Diary, the progress and all the details of each proving with all the particulars as to the dose and days when the prover should be examined by any special examiner, and the latter’s report upon his special examination, have to be collected centrally. Finally a summary of each proving is to be made as a whole, which will incorporate the observations of the special examiner. These must be presented in a narrative form rather than in a schematic form so that the sequence, continuity and the characteristic grouping of the symptoms may not be lost. A final summary should be prepared from the general Summaries of the individual’s proving.
[ Reference taken from Organon of Medicine (5th & 6th edition), Literatures of Central Council of Research in Homoeopathy, Principles & Practice of Homoeopathy by Dr.M.L.Dhawale and an article of Dr.Jugal Kishore namely Scientific Provings in Homoeopathy and Technique. ]
Dr.Ashis Datta, M.D(Hom)
E-Mail – firstname.lastname@example.org
* Author of “ Science & Art of Homoeopathic Case-Taking ”
* Former Member of Teaching Faculty of Nagpur College of Homoeopathy and approved by Nagpur University.
* Approved as P.G. Guide for Poona University, Bharti Vidyapeeth University, Utkal University and Dr. B.B.A University, Agra, B.A.Bihar University, Maharashtra University of Health Sciences and West Bengal University of Health Sciences.
* Recipient of “Appreciation award-2006 ” from Board of Homoeopathic System of Medicine. Govt. of NCT of Delhi
* Recipient of “Life time achievement award – 2007” from Board of Homoeopathic System of Medicine. Govt. of NCT of Delhi
* Presently Asstt. Secretary (Tech.) to Central Council of Homoeopathy (Govt. of India), New Delhi.