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:
- Project Director
- Advisor / Expert
- Proving Supervisors
- 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:
- 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 : pharmakon@rediffmail.com
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