Submitting a Monograph

Guidelines for Homeopathic Drug Provings

Approved April 2015

1. Foreword

The following guidelines are presented to help monograph sponsors for homeopathic medicines design and conduct a Proving for their monograph submission that will meet the standards for approval; and to help guide reviewers who examine monograph submissions to ensure that expected standards of quality are being upheld. Published literature on homeopathic provings was considered in the development of these guidelines.(1-8) A glossary is placed at the end of this document to provide definitions of terms used within these guidelines. Periodic review and revision of these guidelines will occur as needed. Please use the online version as the current reference.

These guidelines contain two specific types of criteria: standard requirements and best practice recommendations. Standard requirements are recognized by language that is definitive, such as “should” or “will include”, while best practice recommendations will use more permissive qualifiers such as “is recommended”. For monograph approval, the submitted Proving must meet all standard requirements. Deviations from best practice recommendations are permitted, but should be accompanied by an explanation by the sponsor. If a monograph sponsor expects their proving to deviate from these guidelines, questions for clarification may be submitted in writing to the Editor (HPCUS).

Monograph reviewers are instructed to ensure the following criteria are met for Provings:

• Compliance with the Proving design & execution requirements (Sections 2–6)
• Proper analysis to evaluate the sufficiency of the Proving results (Section 7)
• Compliance with all legal, ethical, and publication requirements (Section 8–9)

Standard = A requirement that must be met for approval of the monograph. Non-compliance with these requirements will likely cause non-approval of a monograph. Any proposed deviation from these requirements must be approved by the PRC prior to initiation of Proving. Standards may be periodically updated as needed. Standards contained within these guidelines for Provings are recognizable by language that implies a required element, placement in the left column of the document, and appearance in the text as regular font.

Best Practice Recommendation = Suggested method or practices or particular point that will need to be considered when conducting a Proving. Elements of Provings that comply with current best practice recommendations will be considered within compliance standards. Elements of a Proving that fall outside of current best practice recommendations, while not immediately disqualifying, should be accompanied by the reasoning for such a departure to help expedite the monograph review process. Best practices will be updated as community research standards continue to evolve. Best practice recommendations contained within these guidelines for Provings are recognizable by language describing the element as “recommended”, placement in the right column of the document, and appearance in the text as italicized font.

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(1) Belon P. Provings: Concept and methodology. British Homoeopathic Journal, Volume 84, Issue 4, October 1995, Pages 213-217.
(2) Brien S, Lewith G. Assessing homeopathic proving using questionnaire methodology: consideration and implications for future studies. Forsch Komplementarmed Klass Naturheilkd. 2005 Jun;12(3):152-8. Epub 2005 Jun 23. Review.PMID:15985780.
(3) Riley D. Entanglement in Provings. Homeopathy, Volume 94, Issue 1, January 2005, Page 69.
(4) Riley D. Proving methodology. British Homoeopathic journal, Volume 85, Issue 2, April 1996, Pages 122-123.
(5) Walach H. The Pillar of Homoeopathy: Homoeopathic Drug Provings in a Scientific Framework. British Homoeopathic journal, Volume 86, Issue 4, October 1997, Pages 219-224.
(6) Walach H. Information Value of Proving. British Homoeopathic journal, Volume 84, Issue 1, January 1995, Page 64.
(7) Walach H. Provings: The Method and Its Future. British Homoeopathic journal, Volume 83, Issue 3, July 1994, Pages 129-131.
(8) Teut M, Hirschberg U, Luedtke R, Schnegg C, Dahler J, Albrecht H, Witt C, Protocols for a phse 1 homeopathic drug proving trial. Trials. 2010 Jul 22;11:80. doi: 10.1186/1745-6215-11-80.