Evidenced-based Research in Classical Homeopathy
Exciting New Study – December 2022:
After two years of work, we just had another successful study published: Safety and Evaluation of the Immune Response of Coronavirus Nosode (BiosimCovex) in Healthy Volunteers: A Preliminary Study Extending the Homeopathic Pathogenetic Trial.
We aimed to develop a bridge study between homeopathic pathogenetic trials (“provings”) and the modern regulatory drug discovery language of clinical trials. The primary purpose of this study was to evaluate the safety of a nosode developed from clinical samples of a COVID-19 patient. Result: there were no serious or fatal adverse events during the study. The secondary objectives were to explore whether a nosode may elicit laboratory signals worthy of further exploration. If the nosode was to be examined particularly for its prophylactic potential during a pandemic, it is reasonable to expect an immune response during the trial. In this study, the mild elevation of IL-6 in all the subjects may be linked to an immune response, as there were no corresponding clinical signs and symptoms of inflammatory or pathological response. A larger placebo-controlled bridge study is needed to explore the induction of biochemical changes that may occur by ingestion of the nosode.
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The New England School of Homeopathy is dedicated to investigating objective trial data and promoting reliable testing and research that focuses on Classical Homeopathy. To facilitate the scientific exploration of classical homeopathy, to answer the question in a scientific manner of whether classical homeopathy is an effective treatment modality, it is necessary to develop evidenced-based research standards in classical homeopathy. There are several enormous and ongoing misconceptions of what classical homeopathy is or is not, leading to errors in study design. As a result, studies designed to evaluate classical homeopathy erroneously include those that are deeply flawed, leading to meta-analyses that have very little to do with classical homeopathy. Conceptually, this project is designed to assist scientists to explore classical homeopathy only, with the following criteria:
Classical homeopathy trial design acknowledges the fundamental primacy of the concept of similimum, where subjects are enrolled based upon a symptom complex found in provings and clinical experience.
The first nine specific steps operationalizing this project include:
- Collect and segregate all published trials which fit the above concept of similimum.
- Describing the methodologies used in collected trials:
- Was the trial blinded or not?
- Was there a placebo arm or not?
- Head to head. Was the trial a head to head trial with conventional medical interventions?
- Was the trial well controlled?
- Instruments of measure. Did the trial methodology incorporate accepted instruments of measure used at the time of the trial?
- Once collected, create and publish a list of all published trials fitting the above criteria.
- For new trials, develop a clinical trial design variable checklist.
- For new trials, assist in high quality clinical trial design to fulfill the abovementioned standards. The main research goal is to reproduce the standardized elements of conventional drug trials that are applicable to homeopathic studies of similar focus, and to innovate and update trial design that is outdated, inappropriate or reflects a lack of understanding of the tenets of classical homeopathy.
- Expand the clinical trial list developed in steps 1-3, above.
- Conduct meta-analyses incorporating data from this trial list.
- Publish meta-analyses results of this data.
- Create approval process of new trials, mentioned in steps 4,5, and 7.
We know we are achieving our very specific goal if we have a complete list of past studies of classical homeopathy and are able to assist in designing acceptable, reproducible trials that allow researchers to assess classical homeopathy efficacy and effectiveness.
Here are some published articles we wanted to share:
Herscu, P, Talele, G, Vaidya, S, Shah, R. Safety and Evaluation of the Immune Response of Coronavirus Nosode (BiosimCovex) in Healthy Volunteers: A Preliminary Study Extending the Homeopathic Pathogenetic Trial. Medicines. 2022 December 30
Talele G, Vaidhya S, Chowdhary A, Herscu P, Shah R. Randomized Double-Blind, Placebo-Controlled Feasibility Study, Evaluating the Efficacy of Homeopathic Medicines in the Prevention of COVID-19 in a Quarantined Population. Homeopathy. 2021 Sep 30
Kirkby R, Herscu P. Homeopathic Trial Design in Influenza Treatment. Homeopathy. 2010 Jan;99(1):69-75.
Kirkby R, Calabrese C, Kaltman L, Monnier J, Herscu P. Methodological Considerations for Future Controlled Influenza Treatment Trials in Complementary and Alternative Medicine. Journal of Complementary and Alternative Medicine. 2010 Mar;16(3):275-83.
Homeopathy in the treatment of depression: a systematic review
Click here for additional Clinical Trial Studies Published by the Herscu Laboratory.