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A Comprehensive Study for Harmonization of Methodology of Homoeopathic Pathogenetic Trial of CCRH, LMHI, HPUS , ECH and ECCH

Biswajit Basu
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A Comprehensive Study for Harmonization of Methodology of Homoeopathic Drug Provings

Introduction: Hippocrates, Paracelsus and etc. mentioned the ‘Law of Similia’ before Hahnemann, but none of them proceeded systematically to offer an experimental proof. Dr. Hahnemann established experimental human pharmacology by proving drugs on healthy human beings. He obtained data on the pure effects of drugs which he recorded in his ‘Chronic Diseases’ and in the ‘Materia Medica Pura’. The human Drug-Proving (pathogenetic trial) is not  conducted to such an extent that it would produce irreversible pathological changes.  The pathological data/symptoms  recorded in Homoeopathic Materia Medica  chiefly belong to  clinical observations, supported by reports of accidental poisoning and a few valued animal proving. Thus Homoeopathic Materia Medica is essentially a register of human functional pathology made by man for humans.

 

remediesThe objectives of a homoeopathic pathogenetic trial, in other words  ‘Drug proving’  is to find out the pathogenetic effects of a drug on healthy human beings, and what Hahnemann referred to as pathogenetic effects,  i.e phenomena of  homoeopathic medicines. [Ref -2, §109, FN 93/p-191, ]   Hahnemann  asserted in his Lesser Writings in the article ‘ Medicine of experience’ …[ p- 517],  “In the action of simple medicines on the healthy human body there occur, in the first place, phenomena and symptoms, which may be termed the positive disease, to be expected from the specific action of the medicinal substance.’

In order to enhance symptoms of Materia Medica and /or confirm existing symptoms with its amplitude, drug proving is one of the fundamental tools in the homoeopathic field. Since the inception of Homoeopathy, considerable  manpower was used in different countries, including India to conduct or participate in human pathogenetic trials. From daily experiences drug proving protocol has been modified accordingly from time to time.  In the relevant perspective comparison has been made and a comprehensive table is given below for ready references.

Nomenclature/reference used in the table  as follows,-

1- CCRH- Central Council for Research in Homoeopathy, India; Updated on August 2010

2-LMHI- International Homoeopathic Medical league, Geneva , Switzerland, Updated on April 2013

3-HPUS-  Updated on April 2013

4-ECH- European Committee for Homeopathy, Version 1.1, updated on June 2011

5- ECCH- 2nd Edition, updated on April 2009

 

 

A Comprehensive Comparison Table

of Homoeopathic Pathogenetic Trial of  CCRH, LMHI, HPUS , ECH, ECCH

Title/Subtitle

1-CCRH

2-LMHI

3-HPUS

4-ECH

5- ECCH

Sample size

15 to 20 volunteer,   each centre, multicentric*1 [minimum  30]

12 to 15, volunteer   each centre

20 volunteer withdrawal >10%

12 to 15 volunteer

10 to 20, volunteer

Age *2

18 yrs and above

18 to 60 yrs

18 to 75 yrs

Over 18 yrs

Over 18 yrs

Controls *3

30%

20%

20%

10%

10 to 30%

Potency *4

6C, 30C, 200C

Not mentioned

Not <12 C & > 30 C

12 C to 30 C

2-3 potencies

Categorization*5 of Symptoms

Not detail

Given

Given

Given

Given

Adverse event*6

Not  mentioned

Mentioned  and Defined

 Mentioned  and Defined

Mentioned and reporting

observation period mentioned

Adverse Drug Reaction [ADR] / effect *7

Not mentioned

Unusal in Homoeopathic drug  proving

Unusal in Homoeopathic drug  proving

Reporting

Not mentioned

Statistical procedure

Not mentioned

Given

Not mentioned

Given

Not mentioned

Assessment procedure

 Visual analogue scale  and social desirability scale

Not mentioned

Not mentioned

Not mentioned

Not mentioned

Rules to stop proving *8

3 or > 3 provers develop serious adverse proving symptoms

Not mentioned

Not mentioned

Not mentioned

Not mentioned

 

Discussion:

[*1] Locations of the study- Should be multi centric in plane, sea coast and mountain/hilly area to eliminate or include circumstantial influences on developing pathogenetic effects.

 [*2] Age – Above 18 years of age. The prover must be young .[Ref -2, §145, FN 106,p-212] ;.[Ref -4,p-200]  between 18 to 40 , to avoid bodily degeneration due to aging factor.

[* 3] Controls – Among above said authorities CCRH is holding provision for 30% control which is very much justified from a statistical analysis point of view. In a CCRH protocol regarding control, it is noted under criteria for selection of symptoms as ‘same symptoms to be discarded keeping in view appearance in number of controls vis-a-vis verum group’. Sometimes it may happen that control groups are also narrating some symptoms and it is better that it not be discarded but will be listed separately and kept in a different category, mentioning them as developed in control group for further retrospective study .

[*4] Potency and Dose- Regarding potency, Richard Hughes in his book A Cyclopedia of Drug Pathogenesy stated that “ IX- Include symptoms reported as coming from attenuation above the 12th decimal only …” . [Ref -5, p-xiii] Any potency above 12th Decimal is justified for all practical purposes.

The proving of drugs is not hurtful to provers if the vital force is not overwhelmed by too massive doses or too frequent repetition of the dose. [Ref -2, §114, ,p-193]

 ‘ 4 to 6 small globules of  drug to be moistened with a little water or dissolved in more or less water and thoroughly mixed and let him continue for several days. [Ref -2, §128, ,p-201]

     ‘ ….even though the experimenter had observed, a considerable time previously, the spontaneous occurrence of similar phenomena in himself. The reappearance of these during the trial of the medicine only show that this individual is by virtue of his peculiar constitution, particularly disposed to have such symptoms excited in him. In this case they are the effect of the medicine; the symptoms do not arise spontaneously while the medicine that has been taken is exercising an influence over the health of the whole system, but are produced by the medicine. [Ref -2, §138, ,p-207].

      So apart from the development of new symptoms, if anything happens like above, that may be noted and counted as the pathogenetic effect of that medicine.

Single dose administration of chronic medicine may produce symptoms to sensitive provers; for that we have to observe the phenomena. ‘if the first dose administered shall have been sufficiently strong, the prover express the symptoms in such a way, the order of succession of the symptoms and can note down accurately , the Genius of the medicine’[Ref -2, §130, ,p-202-203]. ‘Same medicine for successive dosage may produce several symptoms but we do not ascertain Genius….’ [Ref -2, §131, ,p-203]  . So, during experiment one quota may be sacrificed to have the genius symptom of medicines if it develops in any prover.

Consideration should also be given regarding selection of homoeopathic medicine for trial with regard to short acting and deep acting chronic and  potency. [Ref -4,p-199]

[*5] Categorization of Symptoms- In the CCRH protocol regarding this point Title is ‘Criteria for selection of symptoms’. Instead of that Categorization of Symptoms is a more appropriate term that may be coined.

After qualifying PME, participants should begin to take notes about any deviation of health both in mental and physical level seven days prior to taking medicine. Some drug symptoms appear with tolerably uniform regularity in each of the several provers, others appear rarely and with only isolated provers.

Mental symptoms : The range of enquiry is not desirable in the perspective of a predetermined field, but all symptoms in the realms of mind, intellect and body are to be noted and documented  .  Apart from Form G, a separate elaboration sheet (Form) for noting mental symptoms  is necessary.

A comparative study of developed signs and symptoms between verum group and control group is to be made to elicit the true picture. Effects with similar magnitude may be listed separately for further investigation if needed, but not be excluded. Selection of symptoms on the basis of comparison (both intra prover and inter prover) with controls (Exactly same symptoms to be discarded keeping in view appearance in number of controls vis-à-vis verum group

  1. 1.                As per the appearance of Symptoms , the symptoms which appeared last in the proving are of the great value’- Hering, confirmed by Boenninghausen [Ref -1 ,p- 185]  these symptoms to be categorized , and may be taken into consideration for clinical verification with priority.
  2. Categorization  of symptoms in volunteers may be done as follows,-
    1.                             i.               (RS)- Recent symptoms i.e. a symptom that you are suffering from now, or have been suffering from in the last year.
    2.                           ii.               (NS)- Symptoms which are experienced as new, never experienced before.
    3.                        iii.               (OS)- Old symptom. State when the symptom occurred previously.
    4.                        iv.               (AS)- Alteration in present or old symptom. (e.g. used to be left side, now on the right side)
    5.                           v.               (US)- An unusual symptom for you.
  • Some drugs may produce alternating symptoms and may be noted as [ALS] which is very rare and characteristic of the drug  [ALS] and should not be confused with alternating side of affection from left to right as stated in existing CCRH protocol noting (AS).
  • Rare, unusual symptoms are to be noted with mark of (US)
  • As through PME, the prover has to be selected, recent symptoms(RS) that anyone suffering for a long time does not arise [vide exclusion criteria], likewise as there was no existing symptoms, so chances of cure are not relevant (CS) during proving.
  • During proving any old symptoms may reappear for several reasons  and may be noted with (OS) separately with detail of their progress and cessation. If retrospective anamnesis reveals that OS is the result of the phenomena that has taken place during proving, that should be noted as reactive power (RPM) of the medicine under trial.
  • Rare, peculiar symptoms developed rarely in very sensitive idiosyncratic prover are to be noted as (IRS), and may have qualitative value in clinical application.

[*6] Adverse event [AE]-  Any untoward medical occurrence in a volunteer administered a proving substance and which does not necessarily have a causal relationship with the action of the substance. An adverse event (AE) can therefore be any unfavourable and unattended sign, symptom or disease temporally associated with the administration of a proving substance, whether or not related to it. If it took place that is to be noted in a separate page as AE .

About the author

Biswajit Basu

Biswajit Basu

Dr. Biswajit Basu , BHMS(Hons),Gold Medalist; MD(Hom) is Chairman of The Bengal Academy of Applied Homoeopathy Kolkata, West Bengal; Teaching faculty both in UG and P.G level and a Member in Research Committee at D.N.De. Homoeopathic Medical College Hospital, Govt. of West Bengal Kolkata, India. Guest PG faculty & Guide , PG Hom , Hahnemann College of Homoeopathy , London, U.K Member as one of the resource persons for ‘Compilation of Materia Medica on Indian Drugs’ conducted by Central Council For Research in Homoeopathy, Ministry of Health & Family Welfare, Dept. of AYUSH, Govt. of India.

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