IS THE EFFECT OF HOMOEOPATHIC MEDICINE DIFFERENT FROM THE EFFECT OF PLACEBO IN HEALTHY INDIVIDUALS? – A RANDOMIZED, BLINDED, CONTROLLED, THREE ARMED HOMOEOPATHIC PATHOGENETIC TRIAL ON ELECTRO-PHOTONIC IMAGE CHANGES.
“A RANDOMISED, BLINDED, PLACEBO-CONTROLLED, THREE ARMED PARALLEL STUDY ON ELECTROPHOTONIC IMAGE CHANGES DURING HOMOEOPATHIC PATHOGENETIC TRIAL USING MOLECULAR AND ULTRA-MOLECULAR DOSES - A REPROVING OF BELLADONNA” ABSTRACT: Background: Homoeopathic drug proving is the process of understanding the pathogenetic powers of the dynamised Homoeopathic drugs on healthy human beings. In homoeopathic drug proving due to the biomimicry of production of disease symptoms, there are tremendous chances for the altered electron communication which may produce changes in the Electro-photonic Emission. Although controversies exist on the action of Belladonna in the healthy human provers (Good year et al (1998), H. Wallah et al (2001), S Brien et al(2003)). This study takes up the challenge to re-evaluate the efficacy of Belladonna in homoeopathic pathogenetic trial in the molecular and ultra-molecular doses. Method: Randomised, blinded, placebo-controlled three-armed (Belladonna6C, Belladonna200C and Placebo) parallel study (n = 150) conducted in National Institute of Homoeopathy, India. The study design was framed as a four-week protocol consisting of Pre-Intervention period, Intervention Period, Post Intervention period for each participant. Primary and Secondary Outcome Measures are Twelve parameters of Electro Photonic Imaging [EPI] technique and Q-Form-02 (30 items, Likert scale questionnaire) respectively. Result: The analysis showed a statistically significant difference in eight parameters (P-value <0.05,) out of twelve parameters and the Form Coefficient parameter (P-value <0.001) revealed the effect of placebo during the run-in phase. The questionnaire Q-Form-02 analysis revealed a significant difference among the three groups. The post hoc analysis showed the number of symptoms and the scores among groups depicted the trend: Belladonna 6C > Belladonna 200C > Placebo. Conclusion: We may conclude that the Electro Photonic Emissions from the human body may serve as a parameter to differentiate the placebo effect from the Homoeopathic medicine effect in the Homoeopathic Pathogenetic Trial [Trial Registration: CTRI/ 2018/03/012290].
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The parameters in the EPI-0 represents the Baseline data, EPI-1 represents the Run-in period data & EPI -2 represents the Drug administration period data. All the 12 parameters of the EPI were analysed for each data set. Three-way analysis approach had been adopted to find out the differences in the primary outcome parameters. The three-way analysis were Direct analysis, Derived analysis and Gender analysis. ‘Direct analysis’ involves analyzing the direct values of the parameters recorded. Derived analysis was done to make the analysis more rigorous and to sort out the effect of Homoeopathic medicine from the placebo. In the ‘Derived Analysis’ approach, the Placebo effect and the Drug effect has been derived from the existing direct values of the parameters. For determining the Placebo effect (X), the Baseline parameter values have been subtracted from the Run-in period parameter values [X = EPI 1 – EPI 0]. For finding the Drug effect (Y), the Baseline parameters have been subtracted from the Drug administration phase parameter. [Y = EPI 2 – EPI 0]. On account of finding the difference between the Placebo effect and the Drug effect (Z), the values of the parameters in the Run in Period had been subtracted from the values of the parameters in the Drug administration period[Z = EPI 2 - EPI 1]. The ‘Gender Analysis’ has been done to find out the gender predominance of action of the Belladonna. The test statistics applied in the analysis of Primary outcome was one-way ANOVA and Kruskal Wallis based on the normality and the equality of the variances, whereas 5 parameters of the ‘Q Form-2’ of the secondary outcome was analysed using one-way ANOVA because the parameters were normally distributed. The p-value less than 0.05 was considered as statistically significant for the moderate effect size 0.5. Bio well camera is an Electro-Photonic Imaging [EPI] device and it is based on Gas Discharge Visualisation [GDV] technology13,14. Bio- well camera has CE, EU and FDA certification. EPI technique is based on the coronal electrical discharge surrounding the object when exposed to the electrical field. The characteristics of this electric field are high voltage of 10 kV at a frequency of 1024 Hz and low current that is in micro-Amperes. In particular, the fingertips are placed on a dielectric glass plate of the instrument and when such voltage characteristics are applied to the underside of the glass plate to generate a high electrical field, collision of electrons take place in the surrounding air molecules around the fingertips. These wrenched out electrons induce ionization of the air molecules and produce a glow around the finger. Further, this process is captured as a snapshot by a charged coupled device camera placed underneath the glass plate and then registered in a form of an EPI image