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Date posted: June 16, 2012

Dr.A.B.Ram Jyothis.MD (Hom) Pharm.

Background:
Homoeopathy is a unique form of drug therapy which is capable of stimulating the body’s own power of self healing in a special way. In order to understand what symptoms potential Homoeopathic medicines can provoke in healthy individual, Homoeopaths conduct ‘Drug proving or Human pathogenetic Trials .They are the pillars of Homoeopathy. Hahnemann was one of the first to give medicines to healthy people in order to understand its effects in the sick. He was not the first, however to have had the idea. Albrecht von Haller, a Swiss doctor advocated it in1771 and Anton Storck, Head of a Viennese Hospital experienced with pharmaceutical substances on himself. But what was unique about Hahnemann was his systematic approach.  In the beginning, Hahnemann used mainly mother tinctures and low potencies for drug proving, he later switched on to centesimal Potencies and many of his followers did the same. In modern HPTs, the substances have been given in the form of ultra high succussed dilution, avoiding any risk of toxicity. The question of whether HPTs using ultra high succussed dilution, yield symptoms which differ from placebo is unresolved.

Considering the great importance of Human pathogenetic Trials in Homoeopathic theory and practice, it is surprising to see that very little scientific work has been done on the particular subject. This is a weak point in research which has already taken up by critics of Homoeopathy. The debate has to focus on the weakness of traditional proving methods and steps to reform it.  

HPT versus Clinical trials:HPTs have certain similarities to phase I trials for new pharmaceutical products, they are conducted on healthy volunteers, but there are key differences. HPTs are clinical trials designed to investigate the effect of the exposure of human volunteers, good in health, to potentially toxic or pathogenetic substances, diluted and serially agitated according to homoeopathic pharmacopoeial methods.    

Necessity of placebo controls:
For more than 100 years proving have been done without placebo control. The Placebo control in a HPT is only useful, if introduced as an intra – individual control, i.e, a crossover design. Parallel – group designs are of no value in HPT. There are so many variables which govern the variance of individual symptoms that in parallel – group designs only very large numbers ( several 100 or so) may give a chance of controlling them by randomization. But if we use intra – individual control, we have to be aware of carry over effects. If there are carry over effects, the design is compromised, and only the first half of the experimental period can be used. So the crossover design with all its inherent difficulties remains the candidate of choice, but it is vital to control the carry-over effect either by a washout period. (1)

Methodological Quality Index for HPTs:
A Methodological Quality Index is introduced to assess the reliability of HPTs. It is based on key components of methodological quality including internal and external validity items. The MQI includes aspects such as randomisation, inclusion and exclusion criteria, blinding and criteria for selection of pathogenetic effects with values ranging from 1 to 4 for each component, giving arrange from 4 to 16.Scoreweredivided into 4 methodological classes, where class I is the worst and class IV is the best, with arbitrary cutoff points (< 6 for class I, 7-10 for class II, 11-13for class III, > 14 for class IV). 

Statistical methods:
Spearman correlation coefficients (rs) are used to verify relationships between validity and reliability of information from HPTs, including association between Methodological Quality Index and subjective judgments by reviewers. Kappa statistics are used to evaluate agreement between reviewers on judging methodological quality components and to estimate the disagreement on global judgments of quality.

The application of Quantitative Techniques adopts a scientific approach to Human Pathogenetic Trials. The use of proving data in a systematic manner and constructing it into a Materia medica for future use is major function Human Pathogenetic Trials. This processing and manipulating of raw data into meaningful information is the heart of scientific analysis. The aim of the quantitative methods is to improve detected symptoms and gain a finer resolution of observed symptoms by implementing the proving method developed by Hahnemann and his followers. We should combine this phenomenologically accurate method with rigorous methodological standards.

Dr.A.B.Ram Jyothis.MD (Hom) Pharm.
Department of Homoeopathic Pharmacy,
Fr.Muller Homoeopathic Medical College
Derelakatte, Mangalore

 Download full article : www.similima.com/pdf/human-pathogenetic-trials-homeopathy.pdf

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