Indian Journal of Research in Homeopathy

ORIGINAL ARTICLE
Year
: 2020  |  Volume : 14  |  Issue : 2  |  Page : 80--89

Proposed checklist for standardising homoeoprophylaxis interventions


Isaac Golden 
 Human Research and Ethics Committee, National Institute of Integrative Medicine, Melbourne, Australia

Correspondence Address:
Dr. Isaac Golden
PO Box 695, Gisborne, Victoria 3460
Australia

Abstract

Background: Results from large homoeoprophylaxis (HP) interventions support the effectiveness of HP, but their variable methodology means that meaningful summaries of the combined data are difficult to produce. Objective: The aim of this article is to develop possible ways of standardising and improving the quality of data from HP interventions. Methods: Evidence collected from some large HP interventions is summarised. A previously suggested pre- and post-intervention checklist intended to help standardise the evidence from HP interventions is critically examined. Results: A summary of HP evidence from large interventions shows that there is a growing body of data suggesting a level of HP effectiveness between 85% and 90%. However, the type and quality of the evidence is variable. A previously developed checklist for researchers to use is modified and examples are given from actual interventions. Conclusion: There is a growing body of evidence supporting claims that HP interventions are effective. The evidence base needs to be improved in a range of ways. Requiring a standardised checklist to be completed by researchers before and after an intervention offers one method to improve the quality and consistency of evidence collected. HP has much to offer governments, health officials and citizens globally. It is safe, relatively effective, flexible, easily delivered and highly cost-effective. Yet, it is supported by very few governments. The quantity of evidence is growing, but the onus is on proponents to strengthen the quality of the evidence base supporting HP to the point where the inevitable critics of Homoeopathy are silenced.



How to cite this article:
Golden I. Proposed checklist for standardising homoeoprophylaxis interventions.Indian J Res Homoeopathy 2020;14:80-89


How to cite this URL:
Golden I. Proposed checklist for standardising homoeoprophylaxis interventions. Indian J Res Homoeopathy [serial online] 2020 [cited 2020 Aug 7 ];14:80-89
Available from: http://www.ijrh.org/text.asp?2020/14/2/80/285284


Full Text



 Introduction



Hahnemann wrote passionately about his preference for infectious disease prevention (homoeoprophylaxis [HP]) over treatment: 'Who can deny that the perfect prevention of infection from this devastating scourge, and the discovery of a means whereby this divine aim may be surely attained, would offer infinite advantages over any mode of treatment, be it of the most incomparable kind soever so ever? The remedy capable of maintaining the healthy uninfectable by the miasm of scarlatina, I was so fortunate as to discover'.[1]

If the reader substitutes 'COVID-19' for 'scarlatina', his statement stands as a goal for 2020. Already HP interventions are being used in India and Cuba. However, the proponents of HP have an obligation to produce high-quality evidence of effectiveness.

Respondents to a 2014/15 international survey of homoeopaths regarding HP were asked to: grade their confidence from 0 (none) to 10 (very strong) in the evidence available to homoeopaths describing the safety and effectiveness of HP. High confidence (confidence ranked 8, 9 or 10) was: high confidence in HP safety: 69.4% and high confidence in HP effectiveness: 49.3%.[2]

Pharmaceutical advocates would have even less confidence in the evidence base of HP, given the current dogma that Homoeopathy in general is ineffective.

Homoeopathic opponents of HP such as the Brazillian academic, Dr M Texiera, make extravagant claims against practitioners who use HP. Texiera claimed that users of HP 'transgress the bioethical principles of beneficence and non-maleficence'. He also claimed that 'In spite of promoting global use of so-called dynamized isoprophylaxis, Golden reports rates of adverse effects higher than 10% in children subjected to this method – similar to those of conventional vaccination'.[3] In fact, Golden's reported reaction rate per dose was 2%, whereas the per-dose reaction rate for vaccines can be as high as 82.84%.[4]

Hence, there is a clear need to build confidence in HP, and this will require a stronger evidence base. We have a growing body of data from real-world interventions using HP, so the task of researchers is to continue to improve the quality of evidence so that the findings will be more widely accepted.

 Methods



Two publications in 2019 described 17 substantial HP interventions over 34 years in just three countries. There was no attempt to list every HP intervention around the world – an impossible task. However, this small sample examined the use of HP in over 250 million people on an annualised basis – similar to 250 million prescriptions, except that many prescriptions were not just a single remedy given once, but a series of remedy administrations over time.[5],[6]

In 2018, the author suggested using a pre- and post-intervention checklist to improve the quality and standardisation of results. This is shown in [Table 1].[7]{Table 1}

It was decided to change the order of some items in the checklist, and then use two well-known epidemic HP interventions and the author's analysis of endemic HP to test to see how the pre- and post-intervention checklist would look.

 Results



Interested readers who wish to study the full results from the interventions cited are directed to the original articles, but [Table 2] shows that the HP interventions studied were a mix of non-randomised and controlled/not-controlled methodologies. The figures show the number of interventions in each category and the number of years for which the interventions ran.{Table 2}

[Table 3] shows the references to the articles referred to in [Table 2].{Table 3}

An analysis[6] showed that there was consistency when these results were summarised in different ways, as shown in [Table 4].{Table 4}

[Table 5] shows the definitions of bias used in the following analysis. Different authors use terms differently.{Table 5}

A few examples of what a post-intervention checklist might look like are presented below. The first example [Table 6] uses the author's study of long-term/endemic HP in Australia,[20] the second [Table 7] examines the leptospirosis intervention in Cuba in 2008[21] and the third example [Table 8] examines the meningococcal meningitis intervention in Brazil in 1998.[8] Another two examples are from studies conducted in India: one on Japanese Encephalitis (JE)[22] in Andhra Pradesh and Telangana states [Table 9] and another on Chikungunya[23] [Table 10]. These examples assume the intervention has been completed and the researchers have filled in the form.{Table 6}{Table 7}{Table 8}{Table 9}{Table 10}

 Discussion



The practical circumstances of each HP intervention will determine the most appropriate data collection methods to use, remembering that most HP interventions are not academic research studies, but practical attempts to save lives and prevent suffering in at-risk populations.

Schunemannet al. argued that while RCTs should generate data having the greatest internal validity (and lowest risk of bias), evidence should first be direct (or applicable), and that 'direct evidence from NRS (non-randomised studies) can provide equivalent (or potentially higher) confidence (i.e., quality) compared with indirect evidence from RCTs.'[24]

In many cases, when the entire population is intervened, then randomisation is not possible, and not needed. However, the establishment of direct or an indirect control group is of great importance, especially to allow measures of the effectiveness of the intervention.

A well-constructed, non-randomised study can produce reliable results, especially if researchers focus on developing a strong control and minimising the effect of confounders and biases. The three examples presented show that the suggested checklists allow a ready identification of biases as well as encourage a more consistent response and the calculation of meaningful measure of effectiveness.

 Conclusion



The use of HP to prevent the spread of targeted infectious diseases is well established in Homoeopathy, being first used by Dr Hahnemann in 1798. However, the HP evidence base needs to be improved to increase confidence in its effectiveness among homoeopaths, health officials, politicians and citizens. It is suggested that a pre- and post-intervention checklist will assist that goal and allow more effective analysis of the overall effectiveness of this safe, adaptable, timely and cost-effective method.

Financial support and sponsorship

Nil.

Conflicts of interest

Isaac Golden has supplied homoeoprophylaxis (HP) programmes to patients since 1985.

References

1Hahnemann S. The cure and prevention of scarlet fever. In: Hahnemann's Lesser Writings. New Delhi: B Jain Publishers (P) Ltd.; 2007.
2Golden I, Stranieri A, Al Nuaimat A. Attitudes towards and use of homoeoprophylaxis: Findings of two international surveys. Int J High Dilution Res 2015;14:38-53.
3Texiera M. Homeopathy: A preventive approach to medicine? Int J High Dilution Res 2009;8:155-72.
4GlaxoSmithKline Inc. Product Monograph Infanrix Hexa. 2018. p. 10 (Irritability any Grade). Available from: https://ca.gsk.com/media/537989/infanrix-hexa.pdf. [Last accessed on 2020 Feb 18].
5Golden I. Large homoeoprophylaxis: Brief and long-term interventions. Am J Homeopathic Med 2019;112:31-6.
6Golden I. Large Homoeoprophylaxis Interventions by Government Institutions. Similia 2019;31:14-9.
7Golden I. Observational research in homeopathy: Improving HP research outcomes. Homeopathic Links 2018;31:71-4.
8Castro D, Nogueira GG. Use of the nosode Meningococcinum as a preventative against meningitis. J Am Institute Homeopathy 1975;68:211-9.
9Mronisnski C. Adriano E. Mattos G. Meningococcinum: Its protective effect against meningococcal disease. Homeopathic Links 2001;14:230-4.
10Rejikumar R, Dinesh RS. Study on the Prophylactic Efficacy of Homoeopathic Preventive Medicine Against Chikungunya Fever. Available from: http://www.similima.com/pdf/efficacy-chiunguna-kerala.pdf. [Last accessed on 2020 Feb 18].
11Protective Efficacy of “Genus Epidemicus” (Homeopathic Preventative) Administered During Epidemic Fever in Kerala. Available from: http://www.homoeopathy.kerala.gov.in/docs/jan2011/raech_report.pdf. [Last accessed on 2020 Feb 18].
12Bracho G, Golden I. A brief history of homeoprophylaxis in cuba, 2004-2014. Homeopathic Links 2016;29:128-34.
13Marino R. Homeopathy and collective health: The case of dengue epidemics. Int J High Dilution Res 2008;7:179-85.
14De Souza Nunes LA. Contribution of homeopathy to the control of an outbreak of dengue in Macaé, Rio de Janeiro. Int J High Dilution Res 2008;7:186-92.
15Dengue and Homeopathy: A Successful Experience from Macae. Available from: http://www.ecomedicina.com.br/site/conteudo/entrevista22.asp. [Last accessed on 2020 Feb 18].
16Gadugu S, Nyapati SR, Sastry GL. An open observational study on efficacy of miasmatic prescription in the prevention of Japanese Encephalitis. Homeopathy 2014;103:78-9.
17Rastogi DP. Sharma VD. Study of homoeopathic drugs in encephalitis epidemic (1991) in Uttar Pradesh (India). CCRH Quarterly Bulletin 1992;14:1-11.
18CCRH. Dengue Epidemic – Scientific Activities of Council. CCRH News 1996-97;23:10.
19The Hindu: Homeopathy to Fight Dengue Fever; 14 August, 2012. Available from: https://www.thehindu.com/todays-paper/tp-national/tp-andhrapradesh/homeopathy-to-fight-dengue-fever/article3767663.ece. [Last accessed on 2020 May 02].
20Golden I. The Potential Value of Homœoprophylaxis in the Prevention of Infectious Diseases, and the Maintenance of General Health in Recipients. Melbourne: Swinburne University Press; 2005.
21Bracho G, Golden I. A re-evaluation of the effectiveness of homoeoprophylaxis against leptospirosis in Cuba in 2007 and 2008. J Evidence Based Comp Alt Med 2014;19:155-60.
22Oberai P, Varanasi R, Padmanabhan M, Upadhyaya A, Singh S, Singh SP. Effectiveness of Homeopathic Medicines as Addon to Institutional Management Protocol for Acute Encephalitis Syndrome in Children: An Open-Label Randomized PlaceboControlled Trial. Homeopathy. 2018; 107(3):161-171.
23Nair KR, Gopinadhan S, Kurup TN, Bonthu SJ, Aggarwal A, Varanasi R,et al. Homoeopathic Genus Epidemicus ′Bryonia alba′ as a prophylactic during an outbreak of Chikungunya in India: A cluster -randomised, double -blind, placebo- controlled trial. Indian J Res Homoeopath. 2014;8(3):160–5.
24Schünemann HJ, Tugwell P, Reeves BC, Akl EA, Santesso N, Spencer FA,et al. Non-randomized studies as a source of complementary, sequential or replacement evidence for randomized controlled trials in systematic reviews on the effects of interventions. Res Synth Methods 2013;4:49-62.