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Date posted: June 6, 2012

Recent Advances in Homoeopathic Pathogenetic Trials
DrA B Ram Jyothis
.

The Background
Pioneers in Human Drug Proving:
Albrecht von Haller (1708-1777)
Anton Storck (1731 – 1803)
Samuel Hahneman (1755-1843) 

Post – Hahnemannian Drug Provings:

  • Johann Christian Jorg
  • Hartlaub & Trinks
  • Nennings
  • Stapf
  • Austrian provings 

Methodological flaws in Hahnemannian Drug provings 

    Methodological flaws

           Consequences

Absence of control group.

Prover’s symptoms + Random symptoms + Medicine symptoms.

Use of well known friends as provers.

Placebo effect to please master prover.

Provers were informed about medicine.

Expectancy + conditioning effect.

Recording all symptoms & signs.

Medicine symptoms + Naturally occurring symptoms.

          

Absence of masking provers & supervisors. Selective perception + Investigators effect.
Close supervision & Daily recording of symptoms. Hawthorne effects.
Sudden prohibition of tea, coffee etc. Effects of abstinence & Surfacing of hidden symptoms.
Vague definition of healthy provers. Symptoms related to prior & current disease.

New Drug Development 

Pre- ClinicalR&D      ClinicalR&D   NDA Review  Post – MarketingSurveillance
Initial Synthesis&Characterization  

Animal Testing

Phase1Phase 2 

Phase 3

Adverse ReactionReporting. Survey/Sampling

Testing. 

HPT vs. Phase I trials -Similarities

  •  Non- patient volunteers.
  • Observation of Subjective & Objective changes.
  • Multiple or more specific end-points.
  • Controlled experiments.
  • Small number of subjects (20-100).  

HPT vs. Phase I trial- Differences

          HPT Phase I clinical trial
Use of ultramolecular doses of drugs. Use of defined pharmacological dose.
Expecting more subjective & Objective symptoms. Close monitoring of objective changes.((Lab tests)
The more reliable symptoms, the better. The fewer symptoms, the better.
High level of detail for every reported symptom. Raw symptoms.
Tendency to produce type -B reactions, but without potential serious effects. Apt to produce type – A reactions.

Sources of Current Proving Protocols

  • The development of proving methods since Hahnemann (Demarque, 1987).
  • Provings – planning & protocol (Nagpaul, 1987).
  • The Dynamics & Methodology of Homoeopathic Proving (Jeremy Sherr, 1994).
  • A Protocol for provings (Sankaran.S,1995). 

Current Protocol

  • The Test Substance
  • The Proving Team
  • The Methodology 

The Proving Team:

  1. Project Director
  2. Advisor / Expert
  3. Proving Supervisors
  4. Provers 

Methodology of Proving:

  • The Pre-proving Protocol
  • The Proving
  • The Post Proving Protocol  

Pre-proving protocol

  • Study of Test substance.
  • Selection of Supervisors
  • Selection of Provers
  • Primary coding of remedy. 

The Proving Protocol

  • Multicentric Trials
  • Nature of Trials
  • Randomized
  • Double Blind
  • Cross Over 

Recording of Proving

  • IMRP
  • Log book
  • RMP 

Criteria for Including Symptoms

  • New symptoms, unfamiliar to the prover.
  • Usual or current symptoms those are intensified.
  • Current symptoms modified or altered.
  • Old symptoms that have not occurred for at least one year.
  • Present symptoms that have disappeared during the proving.
  • If a symptom is in doubt, it is included in brackets. 

Post Proving Protocol

  • Extraction
  • Collation
  • Analysis
  • Theming into Materia Medica
  • Repertorising 

Recent Advances

Sensitive designs:

  1. Double blind, placebo – controlled, randomized, four period cross – over design.
  2. Triple blinding.
  3. Revised proving time – line.
  4. Symptom selection criteria: 9 item pathogenetic index.
  5. Rating of Symptoms: Four point scale.
  6. Meta – analysis of HPT: Methodological quality Index.
  7. Concept of PPR Entanglement.

Dr.A.B.Ram Jyothis.M.D (Hom)
Department of Pharmacy
Fr.Muller Homeopathic Medical College. Mangalore
Email : pharmakon@rediffmail.com

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