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The Journal of Alternative and Complementary Medicine Vol. 24, No. 5, pp. 422-430 (2018)

Development of Software for Automatic Analysis of Intervention in the Field of Homeopathy

Rajesh Kumar Jain (1), Shagun Goyal (2), Sushma N. Bhat (2), Srinath Rao (3), Vivek Sakthidharan (4), Prasanna Kumar (5), Kannanaikal Rappayi Sajan (6), Sameer Kumar Jindal (7), and Ghanshyam D. Jindal (8)

1 Electronics Division, Bhabha Atomic Research Centre (BARC), Mumbai, India .
2 Under Board of Research in Nuclear Sciences (BRNS), Electronics Division, Bhabha Atomic Research Centre (BARC), Mumbai, India.
Departments of 3 Materia Medica, 4 Homeopathic Pharmacy, and 6 Organon of Medicine, Father Muller Homoeopathic Medical College, Mangalore, India.
5 Dr. Prasanna Homoeopathic Clinic, Medicare Centre, Mangalore, India.
7 Sanjeevani Homeopathic Clinic, Navi Mumbai, India.
8 Department of Bio-Medical Engineering, MGM’s College of Engineering and Technology (MGMCET), Navi Mumbai, India.

Abstract

Objective: To study the effect of homeopathic medicines (in higher potencies) in normal subjects, Peripheral Pulse Analyzer (PPA) has been used to record physiologic variability parameters before and after administration of the medicine/placebo in 210 normal subjects.
Methods: Data have been acquired in seven rounds; placebo was administered in rounds 1 and 2 and medicine in potencies 6, 30, 200, 1 M, and 10 M was administered in rounds 3 to 7, respectively. Five different medicines in the said potencies were given to a group of around 40 subjects each. Although processing of data required human intervention, a software application has been developed to analyze the processed data and detect the response to eliminate the undue delay as well as human bias in subjective analysis. This utility named Automatic Analysis of Intervention in the Field of Homeopathy is run on the processed PPA data and the outcome has been compared with the manual analysis. The application software uses adaptive threshold based on statistics for detecting responses in contrast to fixed threshold used in manual analysis.
Results: The automatic analysis has detected 12.96% higher responses than subjective analysis. Higher response rates have been manually verified to be true positive. This indicates robustness of the application software. The automatic analysis software was run on another set of pulse harmonic parameters derived from the same data set to study cardiovascular susceptibility and 385 responses were detected in contrast to 272 of variability parameters. It was observed that 65% of the subjects, eliciting response, were common.
Conclusion: This not only validates the software utility for giving consistent yield but also reveals the certainty of the response. This development may lead to electronic proving of homeopathic medicines (e-proving).

https://www.liebertpub.com/doi/abs/10.1089/acm.2017.0157

Excerpts:

“Homeopathic system of medicine was introduced by Dr Samuel Hahnemann around the year 1790 and since then it has been helping the ailing patients consistently. In this system of medicine, the medicinal substance is ultradiluted (1 g of medicinal substance in 99 g of solvent) in a predefined manner. Thus not even a single molecule of medicinal substance remains in the preparation after 12th dilution (commonly known as 12th potency on centesimal scale) as the concentration of medicinal substance reduces to 1.0 ×10^-24 g...This has not only resulted in paucity of pharmacological data but has also raised possibility of placebo effect of homeopathic medicine in the mind of rational thinkers.

“Experiments performed by several researchers in the field during the past 50 years have failed to give any conclusive explanation. Although clinical evidence exists about the disease cure in patients in the past 200 years, practitioners have started documenting the efficacy of this system of medicine with the help of noninvasive techniques such as ultrasonography and impedance plethysmography (IPG) during the past 50 years.2 A breakthrough research was published in 19883 describing observations of basophil degranulation in the absence of any anti-IgE molecule in antigen–antibody reaction. This suggested the necessity of a hydroxyl group in the solvent for carrying forward the medicinal properties. However, results of these experiments could not be reproduced for unknown reasons.4

“In 2010, researchers detected nanoparticles in homeopathic preparations,5 but its elemental analysis has shown peaks of other impurity elements also. This hypothesis has the advantage of explaining the presence of a medicinal substance in higher potencies (since nanoparticles reside on the surface and do not obey Avogadro's law). Scientific acceptance of this hypothesis depends upon multicentric trials and compliance with test of reproducibility.

“Bhabha Atomic Research Centre (BARC) developed a medical analyzer for recording variability in heart rate, blood flow, or stroke volume from a single data acquisition in a subject.6 This instrument, also known as Peripheral Pulse Analyzer (PPA) (Fig. 1), is based on the principle of IPG and records instantaneous electrical impedance (Z) of a body segment and derives change in impedance (delta Z[t]) and rate of change of impedance (dZ/dt) as a function of time. Since blood is a good conductor of electricity, these impedance signals can be used to derive blood flow in real time and estimate physiologic parameters such as heart rate, blood flow index, stroke volume, and morphology index (of the peripheral pulse).7 The beat-to-beat parameters, thus obtained, can be used to find variability spectrum of heart rate, blood flow, and morphology index as follows.

“Array of these parameters is interpolated to obtain their periodic values (in place of the existing rhythmic values) for a span of 256 sec. The interpolated array of data is subjected to Fourier transform to obtain power spectral density (PSD) of the variations, commonly known as Variability Spectrum. PSD depicts the contribution of various rhythms causing variability in the said physiologic parameters.”

“PSD thus obtained reveals the input contribution of different body systems to autonomic nervous system (ANS).10"

“Several studies6,12–15 have shown the manifestation of several diseases on the variability spectra as summarized in Table 1.  As a natural extension of these observations, authors recorded HRV and blood flow variability (BFV) in normal subjects before and after administration of sulfur 1 M (typical response shown in Fig. 2), Gelsemium 10 M, and phosphorus 30.16"

“On test days, post-15 min of initial rest, with the subject in supine position, five readings each for a duration of 5 min have been recorded before and after the administration of placebo/medicine without any significant break. Placebo was administered in round 1 and round 2 and termed as anxiety and placebo intervention, respectively. Medicine was administered in round 3 to round 7 in potencies 6C, 30C, 200C, 1000C (1 M), and 10,000C (10 M), respectively. However, in round 3 to round 7, placebo was administered in place of medicine to 10–12 subjects for every medicine to isolate unstable parameters. Five different medicines (M1: Apis Mel., M2: Calcarea Carb., M3: Cocculus Indica, M4: Lycopodium, and M5: sulfur) were administered, in the mentioned potencies, to each subgroup of 40–44 subjects as given in Table 3.”

“Raw data acquired using PPA were then processed for obtaining HRV, peripheral BFV (PBFV), and morphology index variability (MIV) parameters in an Excel sheet...If the value of a parameter increased after intake of medicine to >1.5 times of the highest value or less than half of the lowest value during anxiety, placebo, and premedicine round, the response was said to be present.”

“In the past years, as the analysis was manual, it highly depended on the dexterity of the person analyzing the results. This also led to delay in analysis due to nonavailability of the analysis experts. The outcome was certainly not free from subjective bias of the analyzing expert. This is the first time a complete analysis process has been automated explicitly for this purpose. However, processing of data files still requires manual edits as per the task force recommendation10 and automation efforts are deemed necessary in this direction for wider acceptance of this modality.”

“In the past, some scientific studies have conclusively indicated that homeopathic medicines have only placebo effects.19 This aspect is negated by this study since 65% of the subjects showing response are common to PPA and PHA analyses. Since both the systems are detecting response, it demonstrates the susceptibility of these responsive subjects to the homeopathic medicines. It is also important to mention that homeopathic medicines were administered to normal subjects and, therefore, responses observed by PPA or PHA exhibit proving aspect of homeopathic medicines.

“It is necessary to explain why only 43 out of 210 control subjects have responded to administration of homeopathic medicine. Except feasibility experiments, in ED BARC (Table 2), this number has not gone beyond 29% in any of the previous studies...A retrospective analysis of all studies suggests that the hypothesis of detecting response within 30 min of administration of the medicine is empirical and needs serious review. What is the ideal time? Homeopathy, being a system more dependent on individual sensitivity and susceptibility, it is very difficult to define an ideal time to observe a response. It may be few seconds in one case or a few days in another. Since protocol needs strict definition, it is difficult to specify variable elapsed time. In view of the mentioned, it is reasonable to consider the instant of appearance of symptoms, to be proving in a subject as the correct time for observing e-response. In such cases, changes observed in PPA or PHA parameters can be classified in specific templates for different medicines. As an illustration, depressed activity in LF and HF regions shown in Figure 2 can be considered as electronic proving (e-proving) of sulfur. Any such template observed in a patient will indicate corresponding medicine for treatment, provided it is prospectively confirmed in an appropriate treatment population.”

“Pre- and postintervention variability/harmonic study is able to detect and objectively demonstrate action of homeopathic medicines in higher potencies wherein medicinal material does not exist as per Avogadro's law, thus paving the way for e-proving of homeopathic medicines...It is likely that some medicines have decided affinity for vegetative sphere and they can be better studied with the help of PPA parameters. Therefore, automatic processing of PPA data should be undertaken at priority. For improving the response yield of e-proving, the study protocol may include recording of objective data on appearance of symptoms during proving.”

“Acknowledgments

“The authors are grateful to the Board of Research in Nuclear Sciences, Department of Atomic Energy, Government of India, for financially sponsoring research projects at Father Muller Homeopathic Medical College...”