Subscribe to RSS
DOI: 10.1055/s-0040-1701439
Five Years of Practical Experience Using the Revised Proving Guidelines of the Homœopathic Pharmacopœia Convention of the United States
Abstract
The Homœopathic Pharmacopœia of the United States (HPUS) is one of the three officially recognized compendia of medical drugs in the United States. A well-conducted homeopathic proving is one pathway to entry into the HPUS. In 2013, guidelines for homeopathic drug provings were updated to better assess the methodology of provings and improve the confidence in the outcomes generated. In addition, the team who developed the revised guidelines included a pragmatic approach to assess the quality of proving outcomes in terms of their usefulness in determining the therapeutic profile. The monograph review team, composed of homeopathic clinicians and researchers, has evaluated 25 new homeopathic medicines for monograph purposes. The team has noted that the guidelines have helped frame and standardize the monograph review process. The revised structure for monograph reporting has enhanced the reviewer's ability to ascertain the therapeutic profile for a new substance. Sponsors have stated that the new guidelines have helped increase their conformance with Good Clinical Practices, helped improve the reporting and transparency of their provings, and may help safeguard provings as a valid research method. Similar harmonized guidelines have been adopted by the European Committee for Homeopathy and the Liga Medicorum Homœopathica Internationalis.
Publication History
Received: 11 October 2019
Accepted: 20 December 2019
Article published online:
15 March 2020
The Faculty of Homeopathy
-
References
-
1 Federal Food, Drug, and Cosmetic Act. United States Code Title 21. Chapter 9. Subchapter II. Section 321 (g) Definitions. Accessed June 13, 2019 at: http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim
-
2 The Homœopathic Pharmacopœia of the United States. Legal Status of Homeopathy in the United States. Available at: http://hpus.com/legal-status.php
- 3 Belon P. Provings: concept and methodology. Br Homeopath J 1995; 84: 213-217
- 4 Brien S, Lewith G. Assessing homeopathic proving using questionnaire methodology: consideration and implications for future studies. Forsch Komplementarmed Klass Naturheilkd 2005; 12: 152-158
- 5 Riley D. Proving methodology. Br Homeopath J 1996; 85: 122-123
- 6 Walach H. Provings: the method and its future. Br Homeopath J 1994; 83: 129-131
- 7 Walach H. The pillar of homoeopathy: homœopathic drug provings in a scientific framework. Br Homeopath J 1997; 86: 219-224
- 8 Herscu P. Provings (Vol. 1). Amherst, MA: NESH Press; 2002: 351
- 9 Sherr J. Dynamics and Methodology of Homeopathic Provings. West Malvern, England: Dynamis Books; 1994: 136
-
10
Mcguire DJ.
Report of the Directors of Provings. Transactions of the Thirty-Eighth Session of the American Institute of Homeopathy. St. Louis;, June 2–5, 1885. Accessed December 20, 2019 at: http://www.wholehealthnow.com/homeopathy_pro/placebo.html
- 11 Kaptchuk TJ. Early use of blind assessment in a homeopathic scientific experiment. JLL Bulletin: Commentaries on the history of treatment evaluation. 2004 . Accessed June 13, 2019 at: https://www.jameslindlibrary.org/articles/early-use-of-blind-assessment-in-a-homeopathic-scientific-experiment/
-
12 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practices Guidelines, finalized June 1996. Integrated addendum E6 (R2) 2016. Accessed December 20, 2019 at: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
-
13 World Health Organization. WHO Technical Report Series, No. 850, 1995, Annex 3; Guidelines for good clinical practice (GCP) for trials on Pharmaceutical Products. Accessed June 13, 2019 at: http://apps.who.int/medicinedocs/pdf/whozip13e/whozip13e.pdf
-
14 Protecting Personal Health Information in Research. Understanding the HIPAA Privacy Rule. U.S. Department of Health and Human Services. NIH Publication Number 03–5388. Accessed June 13, 2019 at: http://privacyruleandresearch.nih.gov/pdf/HIPAA_Privacy_Rule_Booklet.pdf
-
15 Proving Guidelines HPCUS. Section 6.1. April 15, 2013 revised April 15, 2015. Accessed February 7, 2020 at: www.hpus.com
-
16 United States Food and Drug Administration. Guidance for Industry and Investigators. Safety Reporting Requirements for INDs and BA/BE. 21CFR312.32. Revised April 01, 2011. Accessed June 13, 2019 at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf
-
17 United States Food and Drug Administration MedWatch. The FDA Safety Information and Adverse Event Reporting Program. Accessed June 13, 2019 at: http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm
- 18 Teut M, Hirschberg U, Luedtke R. et al. Protocol for a phase 1 homeopathic drug proving trial. Trials 2010; 11: 80
- 19 United States Food and Drug Administration. The Drug Development Process. Step 3: Clinical Research. 2018 . Accessed June 13, 2019 at: https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
-
20 ICH Harmonized Tripartite Guideline Maintenance of the ICH Guideline on Clinical Safety Data Management. Data Elements for Transmission of Individual Case Safety Reports E2B(R2) Current Step 4 version dated 5 February 2001. Accessed February 1, 2020 at: https://admin.ich.org/sites/default/files/inline-files/E2B_R2_Guideline.pdf
- 21 Riley D. Extracting symptoms from homœopathic drug provings. Br Homeopath J 1997; 86: 225-228
-
22 Universal Declaration on Bioethics and Human Rights adopted by the United Nations Educational, Scientific, and Cultural Organization (UNESCO) in October 2005. Accessed June 13, 2019 at: http://unesdoc.unesco.org/images/0014/001461/146180E.pdf
-
23 Code of Federal Regulations Title 21 Food and Drug Administration Part 50 Protection of Human Subjects. Accessed June 13, 2019 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1
-
24 Code of Federal Regulations Title 21 Food and Drug Administration PART 54 Financial Disclosure by Clinical Investigators. Accessed June 13, 2019 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54&showFR=1