Recent Advances in Homoeopathic Pathogenetic Trials
DrA B Ram Jyothis.
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
- Austrian provings
Methodological flaws in Hahnemannian Drug provings
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|
|Adverse ReactionReporting. Survey/Sampling
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).
- The Test Substance
- The Proving Team
- The Methodology
The Proving Team:
- Project Director
- Advisor / Expert
- Proving Supervisors
Methodology of Proving:
- The Pre-proving Protocol
- The Proving
- The Post Proving Protocol
- Study of Test substance.
- Selection of Supervisors
- Selection of Provers
- Primary coding of remedy.
The Proving Protocol
- Multicentric Trials
- Nature of Trials
- Double Blind
- Cross Over
Recording of Proving
- Log book
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
- Theming into Materia Medica
- Double blind, placebo – controlled, randomized, four period cross – over design.
- Triple blinding.
- Revised proving time – line.
- Symptom selection criteria: 9 item pathogenetic index.
- Rating of Symptoms: Four point scale.
- Meta – analysis of HPT: Methodological quality Index.
- Concept of PPR Entanglement.
Dr.A.B.Ram Jyothis.M.D (Hom)
Department of Pharmacy
Fr.Muller Homeopathic Medical College. Mangalore
Email : [email protected]