Classical Homeopathic Provings in a Highly regulated Environment: Reflections on a Recent Proving of Galium mollugo

Introduction: The evolution of a distinctly South African proving research milieu, characterized by formal academic review and independent research ethics board approval, has an almost 25-year history. Over the past 11 of these, there have been additional pressures to align an overtly classical proving methodology, implementation, and analysis to a range of international and local regulatory guidelines imperatives. These include the Homeopathic Pharmacopoeial Convention of the United States (HPCUS) Proving Guidelines, the International Committee for Harmonisation (ICH) and South African Good Clinical Practice (SA-GCP) Guidelines, and formal review processes for approval by the Clinical Trials Committee of the South African Health Products Regulatory Authority (SAHPRA).

The Proving of Galium mollugo: The recently completed double-blind placebo-controlled proving of Galium mollugo is to the authors’ knowledge the first classical homeopathic proving to have been reviewed and approved by a national (conventional) regulatory authority as a quasi-Phase 1 clinical trial. In pursuing this proving within a clinical trial milieu it was necessary to negotiate a critical balance between the essential components of a subtle and nuanced qualitative experimental methodology and the objective rigour and ‘scientific’ imperatives of the mainstream paradigm.

Results: The proving yielded a rich and nuanced materia medica of Galium mollugo that demonstrated clear internal coherence, several clinically useful generalities and peculiarities, and clear relationship to related substances at genus (Galium) and family (Rubiaceae) levels.

Conclusions: Some have argued that the highly subjective, artistic, and somewhat ephemeral nature of homeopathic provings is anathema to the harsh objectivity and rigour of objective regulatory review, placebo comparison and operational clinical trial imperatives. In this paper the authors will reflect upon the veracity of this position, and outline the critical considerations in reference to methodology, the supervisory team, prover training and accountable data analysis within a highly regulated environment.

Keywords: Provings, clinical trial, medicines regulation

Publication History

Article published online:
30 January 2024