Evolution of drug proving in Homoeopathy

Dr Maby James

INTRODUCTION:
Provings are the pillars upon which Homoeopathic practice stands. Without the accurate proving all prescribing indications are bound to be vague guesses at best and pure fiction at work.

Dr. Hahnemann says in the Organon of Medicine “Therefore, we have only to rely on the morbid phenomena which the medicines produce in the healthy body as the sole possible revelation of their in dwelling curative power”.

While translating “A TREATISE ON MATERIA MEDICA” by WILLIAM CULLEN, Dr. Samuel Hahnemann was not happy with the sentence that Cinchona Bark cures Malaria because of its bitter property. Hahnemann having this idea in mind he began his exploration by his simple and rational experiment with Cinchona bark in 1970;

• Took cinchona juice himself, (4 drachms twice daily for several days) started developing symptoms of malaria, reconfirmed it even by proving it on others.
• Came to the conclusion that the drug having capacity to produce set of symptoms is capable of curing the same in disease.
• Hahnemann, also well known as the Father of Experimental Pharmacology, has tested 99 drugs on himself, his family and his colleagues to discover the peculiar effects of drugs in human health.

NEW BEGINNING
Dr. Samuel Hahnemann examined carefully every method that had been proposed for ascertaining the action of drugs. His main aim was to test the medicines singly and alone on the healthy body. He started searching all the medicinal records for 6 years and found the pure action of drug therapeutically and also the hazardous effects as in the accounts of cases of poisoning by various medical substances. He questioned if these accounts of poisonings will suffice to guide him in the selection of the remedies for the disease he encountered with.

In medical record he found the poisonous effect of Arnica – Nausea, Uneasiness, Headache, Oppression of Stomach, Empty Eructation, Cutting in Bowels. During that period in Autumn Season –an Epidemic Dysentery started, which presented the symptoms of Arnica. So, he tested the therapeutic effect of Arnica. He gave 4 to 14 grains of Arnica according to the age of the patient. Arnica proves itself specific and cures the disease without the aid of any other medicine.

Another patient came with symptoms of anxious feeling on the stomach region, tightness of chest to complete loss of breath, suffocation of larynx (swallowing solid liquid difficult) and symptoms like hopeless, suicidal thought tremors till 10 o clock. When he falls to sleep all the symptoms disappear. In this case –he recalls from the record book- the effect of veratrum in case of poisoning. So, he gave a few grains of it every morning to cure this complaint at the earliest. Going about this path ahead, he made way making lucky prescription. The symptoms he found from the cases of poisoning were so vague and infinite. He never arrived at a conclusion but was always in doubt. Most of which had been disturbed and deranged by the administrations of equally violent so-called antidotes.

From this, he saw clearly that there was nothing for it but to test each medicine individually on human body. So, Hahnemann decided for proving by inducing a number of medical brethren to join in testing on their healthy bodies. He thought –from a Medical Man arise well known curative tools. Acting of this thought, he wrote some essays in Hufelands journal. No one responded as they were perfectly satisfied with the traditional system. Again and again, Hahnemann appealed to them, again and again did he received the same answer.  This very opposition of his colleagues made him more resolute in his determination to carry out the experiments. His only aim was – Perfect Healing Art.

He had ascertained by experiment on himself, his family and few friends. 1805-He published –positive powers of medicine on human body

• He says: Every simple medicinal substance causes a peculiar specific disease.
• Every species of plant differs in some ways from every other species of plant.
• Every mineral and salt differ from every other mineral and salt.

So, they all differ among themselves in their medicinal properties. So, each of these substance effects an alteration in our state of health in a peculiar determinate manner.

First Proving Guidelines

• Administer these medicines experimentally to the weaker as well as stronger.
• Each medicine administered singly and un-combined to the healthy individuals.
• Less powerful medicinal agents – give only one pretty strong dose to the healthy person.
• Best is to be given as solution.
• Note down the symptoms as they occur precisely in the order which they occur.
• The more obvious and striking symptoms must be recorded.
• Nothing like guess work.
• Should be noted down as truth.
• We may give to another person or the same individual.
• But only to the latter after the lapse of several days/ when the action of 1^st dose is fully over.
• The stronger medicine develops their action sooner than the weaker or robust individuals in small doses.
• Weaker medicine must give in larger dose, in order to that we make acquainted with their powers.

Formed new criteria

• Proving medicines are genuine and unaltered.
• Indigenous plants should be taken in the form of fresh juice and mix with alcohol.
• Exotic veg substance as powder.
• Salt and gum should merely be dissolving in water just before being taken.
• If we get plant dry and it be weak, we should take it in the form of infusion –swallowing it while warm.
• The diet of experimenter should be regulated, all medicinal and stimulating beverages avoided.
• Avoid over exertion of mind.
• Both male and females are required for experiment.
• From this he experienced many things, then again, he changed the criteria.
• Medicine do not exhibit their actions to all their provers when given in crude state. But that they do so when duly triturated and succussed.
• The best plan of proving medicine is to give it to the experimenter on an empty stomach daily, four or six very small globule of the 30^th dilution of the substance.
• Continue this for several days until an effect is proved.

For many years system of Homoeopathy Followed the same rules for proving the drugs.

ERA OF HUMAN PATHOGENETIC TRAIL
In 1996, Flavio Dantas coined the new term for drug proving – Human Pathogenetic Trial. It is a systematic experimental approach to detect changes in healthy volunteers after exposure to the drug.

Drug proving –initiated by the Homoeopathic Research Committee (formed in 1963). Since the inception of CCRH the proving programme has been continuing and is one of the most important research programmes of the council.

Three basic components of HPT

• The Test Substance
• The Proving Team
• The Methodology

The substance is tested singly as our system is based on Law of Simplex.

At CCRH Headquarters

• Principal investigator – Director General, CCRH
• Coordinator & Co-investigator(s)-Designated officers of CCRH

At Research Centre

• Site investigator –DO of CCRH function Homoeopathic medical college premises.
• Site Co –Investigator(s) – DO of Homoeopathic medical college premises where the proving program is being conducted.

Three major steps

• Pre-Proving protocol
• Proving protocol
• Post proving protocol

Pre –proving protocol

• Study settings
• Eligibility criteria
• Sample size

Proving Protocol

• Proving process
• Dietary and life style guidelines for provers

Post proving protocol

• When and how to withdraw the provers
• Study duration

Pre –proving protocol: Eligibility criteria

• eligibility for study: age- 18-60 year
• Gender – both Male / Female
• Health status – Good state of health – somatic and psychologically
• Sample size – each drug minimum 30 participants (include 30 % control)

Inclusion Criteria:

• Healthy individuals with no apparent disease and normal routine laboratory parameters during screening.
• Healthy individuals identified as fit for proving by experts.
• Intelligent enough to record carefully the facts, subjective and objective symptoms generated by the IPS during proving.
• Able to be informed of the nature of the study and willing to give written informed consent.

Exclusion Criteria:

• Any disease or condition which might compromise the Hematopoietic, Renal, Endocrine, Pulmonary, Central Nervous System, Cardiovascular, Immunological, Dermatological, Gastro-Intestinal or any other body system .
• Persons with colour blindness.
• Persons who have undergone surgery in last two months.

Proving Process

• Screening of volunteers: Applications from interested volunteers will be invited.
• Written Voluntary Informed Consent: this will be obtained from each selected volunteer.
• Screening of Participants: Volunteers identified as healthy will be enrolled as participants.
• Pre –trial medical Examination.
• Enrollment of provers.
• Coding/randomization.
• Blinding

Study Medication

• Drugs -Pharmacopeial standards from GMP compliant manufacturers.
• The alcohol to be used as placebo will also be purchased from GMP compliant pharmaceutical firm approved by the Council.
• The IPS will be prepared in the form of globules of size 30.
• packed in the form of 1 dram glass bottles.
• labeled with serial number, prover’s code and date of packaging. The placebo will be prepared similarly.

Data Recording

• The prover -to make a daily record of the date and time of intake of study medication NEW PROVING –INTERVAL- 3DAYS
• RE-PROVING – INTERVAL- 7DAYS
• Route and method of administration of IP/Placebo: Orally as globules.

Run – in period

• The time period between completion of PME and receipt of medicine batches by the provers at the research.
• During – 3days/ 7 days study medication intake period, the prover will report to the investigator daily.

Washout period:

• After symptoms have disappeared, a period of further 30 days symptom free period will be maintained as a wash out period.

Post –Trial (Terminal) Medical examination

• After all the batches of the study medication are consumed and a subsequent washout period of 30 days, the provers are examined again as in the PME, and the process is called ‘Terminal Medical Examination’ (TME).
• The TME must be completed within two weeks after the completion of the washout period.
• When and how to withdraw the provers.
• A prover may be discontinued from the study in case of the occurrence of serious adverse event(s) or serious inter-current illness.

Sketch out of Human Pathogenic Trial

Reference.

1. Dudgeon RE. Lectures on the theory and practice of homoeopathy. B. Jain Publishers; 2003.
2. Partha MP, Mandal B. A Text Book of Homoeopathic Pharmacy. B. Jain Publishers; 2001.
3. Goel S. Art and Science of Homoeopathic Pharmacy: A Textbook and Reference Work for Homoeopaths and Homoeopathic Student’s. Indian Books & Periodicals Publishers; 2014.
4. Central council for research in homoeopathy drug proving protocol.2014

Dr. Maby James
PG Scholar
Department of Homoeopathic Pharmacy
Father Muller Homoeopathic Medical College and Hospital, Mangalore, Karnataka.
Under The Guidance of Dr Prennie Vidiera, B.H.M.S, M.D (Hom)
Assistant Professor, Dept. Of Homoeopathic Pharmacy