The current state of evidence based medicine

and the implications for research in homeopathy.

When inconvenient research emerges, manipulative tactics which manufacture doubt and create uncertainty are implemented to influence, stifle and silence independent science to better serve corporate interests,¹ corrupting the premise and practice of evidence based medicine.²

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First published in Similia - the Australian Journal of Homeopathic Medicine, Vol 35 No 2, December 2022 & elsewhere without permission...

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Perfectly illustrative of this gross process is the Gartlehner et al.,³ conclusion that outcome reporting bias (ORB) in homeopathy ‘affects the validity of the body of evidence of homeopathic literature and may overestimate the true treatment effect.’ This meta-analysis literally breezed past the fact that ORB affects all disciplines of medical research and is prevalent in Randomized Controlled Trials (RCT),⁴ Systematic reviews, and Cochrane protocols,⁵⁶⁷ and failed to mention that their finding of ORB in 25% of published homeopathy trials is almost equal to the 23% ORB found in Cochrane systematic review groups(5). The Homeopathy Research Institute⁸ noted this study actually showed that in regard to scientific and ethical standards ‘homeopathy is out-performing conventional medicine in this respect, with lower levels of reporting bias.’

Debasement of medical research integrity is not a new phenomenon, former editors of The New England Journal of Medicine and the British Medical Journal have published books on the subject.⁹¹⁰¹¹ Much of today’s evidence based medicine is said to be questionable¹² with a Stanford study revealing just 7% of 60,000 clinical studies were of high quality and clinically relevant to patients.¹³

Systematic reviews and meta-analysis of homeopathic treatment¹⁴¹⁵ show a low quality and unclear body of evidence. To develop a robust evidence base well designed RCTs with the inclusion of the different possible reactions necessary to correctly evaluate remedy effect must be conducted.¹⁶¹⁷ Van Haselen¹⁸ concludes that it is possible to quantitatively investigate aspects of individualized homeopathic treatment alongside carefully designed and executed RCT.

Although low in the hierarchy of evidence and classified as a weak indicator of causality¹⁹ case reports, documenting clinical experiences and scrutinizing principles, have advanced homeopathy for two centuries and profoundly influence and expand medical literature in general.²⁰²¹ Case reports, when correctly recorded, impart healthcare insights,²²²³ can contribute, sometimes significantly, to the establishment of a causal link,²⁴ and may inform clinical research.(19)

Adherence to HOM-CASE guidelines²⁵ is recommended to improve the quality, reliability, accuracy, and transparency of homeopathic case reports(19) which, while not suited to investigate therapeutic efficacy,²⁶ may assess how likely causal attribution is to the final clinical outcome via inclusion of the Modified Naranjo Criteria for Homeopathy (MONARCH) score.²⁷²⁸²⁹³⁰³¹

Serious homeopaths are encouraged to become familiar with the case reports and series of the International Academy of Classical Homeopathy,³² the only institute publishing the use of homeopathy for a variety of difficult to manage conditions in reputable medical journals, and perhaps by doing so partially mitigate misrepresentation of our inconvenient medical science.  

1. Reed et al., The disinformation playbook: how industry manipulates the science-policy process-and how to restore scientific integrity. Journal of Public Health Policy [Internet]. 2021 Dec [cited 2022 Aug 19].;42(4):622-634. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8651604/

2. Jureidini J, McHenry LB. The illusion of evidence based medicine. British Medical Journal (Clinical research edition) [Internet]. 2022 Mar [cited 2022 Aug 21]. 16;376:o702. Available from: https://www.bmj.com/content/376/bmj.o702.long

3. Gartlehner et al., Assessing the magnitude of reporting bias in trials of homeopathy: a cross-sectional study and meta-analysis. British Medical Journal; Evidence Based Medicine [Internet]. 2022 Mar [cited 2022 Aug 20];15:bmjebm-2021-111846. Available from: https://ebm.bmj.com/content/early/2022/05/08/bmjebm-2021-111846.long

4. Dwan et al., Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One [Internet]. 2008 Aug [cited 2022 Aug 19];28;3(8):e3081. Available from: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0003081

5. Shah Outcome reporting bias in Cochrane systematic reviews: a cross-sectional analysis. British Medical Journal open [Internet]. 2020 Mar [cited 2022 Aug 23].  16;10(3):e032497. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076244/

6. Kirkham et al., The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. British Medical Journal [Internet]. 2010 Feb [cited 2022 Aug 20]. 15;340:c365. Available from: https://www.bmj.com/content/340/bmj.c365.long

7. Kirkham Bias due to changes in specified outcomes during the systematic review process. PLoS One [Internet]. 2010 Mar [cited 2022 Aug 22]. 22;5(3):e9810. Available from: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0009810

8. Homeopathy Research Institute (HRI). HRI comment on BMJ article assessing reporting bias in trials of homeopathy. Kensington, London [Internet]. 2022  [cited 2022 Aug 20]. Available from: https://www.hri-research.org/2022/03/homeopathy-research-institute-hri-comment-on-bmj-article-assessing-reporting-bias-in-trials-of-homeopathy/

9. Angell, M. 2005. The Truth About the Drug Companies: How They Deceive Us and What to Do About It. Random House Trade Paperbacks.

10. Kassirer, J. On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health. Oxford University Press. 2005.

11. Smith, R. The Trouble with Medical Journals. Routledge. 2006.

12. Heneghan et al., Evidence based medicine manifesto for better healthcare. British Medical Journal [Internet]. 2017 Jun [cited 2022 Aug 20];20;357:j2973. Available from: https://www.bmj.com/content/357/bmj.j2973

13. Ioannidis et al., How to survive the medical misinformation mess. European Journal of Clinical Investigation [Internet]. 2017 Nov [cited 2022 Aug 20];47(11):795-802. Available from: https://onlinelibrary.wiley.com/doi/full/10.1111/eci.12834 

14. Mathie et al., Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Systematic Reviews [Internet]. 2014 [cited 2022 Aug 24]3, 142. Available from: https://pubmed.ncbi.nlm.nih.gov/25480654/

15. Mathie et al., Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis. Systematic Reviews [Internet]. 2017 [cited 2022 Aug 24]. 6 (1), 63. Available from: https://pubmed.ncbi.nlm.nih.gov/28340607

16. Vithoulkas, G. Levels of Health, The second volume of the Science of Homeopathy. Revised edition. Alonissos: International Academy of Classical Homeopathy. 2017.

17. Oberbaum et al., Clinical trials of classical homeopathy: reflections on appropriate research designs. Journal of Alternative and Complementary Medicine [Internet]. 2003 Feb [cited 2022 Aug 25].;9(1):105-11. Available from: https://www.liebertpub.com/doi/10.1089/107555303321222982?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed 

18. van Haselen R. Development of a Prognostic Factor Prediction Model in Patients with Musculoskeletal Pain Treated with Homeopathy: An Individual Patient Data Meta-Analysis of Three Randomized Clinical Trials. Complementary Medicine Research [Internet]. 2021 [cited 2022 Aug 20];28(1):46-55. Available from: https://www.karger.com/Article/FullText/508716

19. Lamba et al., Evaluation of the Modified Naranjo Criteria for Assessing Causal Attribution of Clinical Outcome to Homeopathic Intervention as Presented in Case Reports. Homeopathy [Internet]. 2020 Nov [cited 2022 Aug 22];109(4):191-197. Available from:  https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0040-1701251#JR1900046-10

20. Teut et al., Case Reporting in Homeopathy-An Overview of Guidelines and Scientific Tools. Homeopathy [Internet]. 2022 Feb [cited 2022 Aug 22].;111(1):2-9. Available from: https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0041-1731313

21. Murad et al., Methodological quality and synthesis of case series and case reports. British Medical Journal; Evidence Based Medicine [Internet]. 2018 Apr [cited 2022 Aug 24].;23(2):60-63. Available from: https://ebm.bmj.com/content/23/2/60.long

22. Gagnier et al., CARE Group. The CARE guidelines: consensus-based clinical case reporting guideline development. BMJ Case Reports [Internet]. 2013 Oct [cited 2022 Aug 19];23;2013:bcr2013201554. Available from:  https://pubmed.ncbi.nlm.nih.gov/24155002/

23. Crowe et al., The case study approach. BMC Medical Research Methodology [Internet]. 2011 Jun [cited 2022 Aug 19];27;11:100. Available from: https://pubmed.ncbi.nlm.nih.gov/21707982/

24. van Haselen RA. Towards improving the reporting quality of clinical case reports in complementary medicine: assessing and illustrating the need for guideline development. Complementary Therapies in Medicine [Internet]. 2015 Apr [cited 2022 Aug 21];23(2):141-8. Available from: https://www.sciencedirect.com/science/article/abs/pii/S0965229915000102?via%3Dihub   

25. van Haselen RA. Homeopathic clinical case reports: Development of a supplement (HOM-CASE) to the CARE clinical case reporting guideline. Complementary Therapies in Medicine [Internet]. 2016 Apr [cited 2022 Aug 20];25:78-85. Available from: https://www.sciencedirect.com/science/article/abs/pii/S0965229915300406?via%3Dihub

26. Teut et al., Recommendations for Designing, Conducting and Reporting Observational Studies in Homeopathy. Homeopathy [Internet]. 2020 Aug [cited 2022 Aug 25];109(3):114-125. Available from: https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0040-1708045 

27. Prusty AK, Bhandari P. A Co-morbid Condition of Warts and Vitiligo Treated with Individualized Homeopathy: An Evidence-Based Case Report. Homeopathy [Internet]. 2022 May [cited 2022 Aug 26].;111(2):139-146. Available from: https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0041-1733975

28. Ramanan VE, Sathyanandhan S. A Case Report of Idiopathic OAT Syndrome, Associated with Necrospermia and Hypospermia, Reversed with Individualized Homeopathy. Homeopathy [Internet]. 2022 Feb [cited 2022 Aug 26]. 7. Available from: https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0041-1739396

29. Rudakova E, Mahesh S, Vithoulkas G. Syringomyelia Managed with Classical Homeopathy: A Case Report. Annals of Neuroscience [Internet]. 2021 Jul [cited 2022 Aug 26].;28(3-4):170-178. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8948329/

30. Mahesh et al., Appearance of Acute Inflammatory State Indicates Improvement in Atopic Dermatitis Cases Under Classical Homeopathic Treatment: A Case Series. Clinical Medicine Insights, Case Reports [Internet]. 2021 [cited 2022 Aug 23]. 11;14:1179547621994103. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7882755/

31. Mahesh et al., Appearance of Acute Inflammatory State Indicates Improvement in Atopic Dermatitis Cases Under Classical Homeopathic Treatment: A Case Series. Clinical Medicine Insights, Case Reports [Internet]. 2021 [cited 2022 Aug 23]. 11;14:1179547621994103. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7882755/

32. International Academy of Classical Homeopathy (IACH). Clinical Cases [Internet]. 2016 [cited 2022 Aug 21]. Available from: https://www.vithoulkas.com/research/clinical-cases