Working to develop the scientific basis for a permanent regulatory framework for anthroposophic medicinal products in Europe

Appropriate criteria and categories for regulatory assessment

When developing scientifically based licensing categories, three issues must be taken into account: the existing licensing categories for herbal products, the scientific discussion on evidence hierarchies, and the special features of AMPs.

For herbal products two special licensing categories exist: "well-established use" and "traditional use". The most important requirements for "well-established use" are a 10-year tradition of use and one randomised trial, and for "traditional use" a 30-year tradition of use, thereof 15 years in the EU [1]. For the acceptance of a legislation system for AMPs it is probably necessary to have a similar number of licensing categories.

To date, evidence hierarchies for efficacy/effectiveness have randomised studies and meta-analyses thereof on top. Presently the GRADE system (Grading of Recommendations Assessment, Development and Evaluation) [2-5] is being implemented worldwide. The GRADE system perpetuates this hierarchisation but not the absolutely rigid separation of randomised trials and observational studies: An upgrading of particularly convincing evidence from observational studies is possible, as well as a down-grading of weak evidence from randomised trials. The current discussion [6-11] goes even further and includes the notion of randomised trials and observational studies as complementary designs of equal value. This viewpoint is also discussed by distinguished proponents of evidence-based medicine [10,11].

Compared to herbal medicine, AMP therapy has some special features: the large number of individual products, often used in individualised combinations; the frequent prescription by physicians; the medical use also in severe disease; the variety of dosage forms including injections; and the difficulties in conducting randomized trials in settings of Anthroposophic Medicine, because of therapy preference and disturbance of the physician-patient relationship from randomization [12,13].

For regulatory hierarchisation of AMPs four criteria have been proposed:

  1. Conception, development and manufacturing according to principles of Anthroposophic Medicine
  2. Long tradition of use on the European market
  3. Clinical (medical) experience [14,15]
  4. Clinical studies

These four criteria need to be formalised (e. g. minimum requirements for a valid clinical study) and can be combined into perhaps two or three licensing categories.

Reference List

  1. Guideline on the assessment of clinical safety and efficacy in the preparation of community herbal monographs for well-established and of community herbal monographs/entries to the community list for traditional herbal medicinal products/substances/preparations. Doc. Ref. EMEA/HMPC/104613/2005. London: Committee On Herbal Medicinal Products (HMPC), European Medicines Agency; 2006.
  2. Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, et al. Grading quality of evidence and strength of recommendations. BMJ 2004 Jun 19;328(7454):1490. doi 10.1136/bmj.328.7454.1490
  3. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, onso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008 Apr 26;336(7650):924-6.
  4. Guyatt GH, Oxman AD, Kunz R, Falck-Ytter Y, Vist GE, Liberati A, et al. GRADE: going from evidence to recommendations. BMJ 2008 May 10;336(7652):1049-51. doi 10.1136/bmj.39489.470347.AD
  5. Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schunemann HJ. What is "quality of evidence" and why is it important to clinicians? BMJ 2008 May 3;336(7651):995-8. doi 10.1136/bmj.39490.551019.BE
  6. Heusser P. Kriterien zur Beurteilung des Nutzens von komplementärmedizinischen Methoden [Criteria for assessing benefit with complementary medical methods]. Forsch Komplementärmed Klass Naturheilkd 2001 Feb;8(1):14-23. doi 10.1159/000057190
  7. Leichsenring F. Randomized controlled versus naturalistic studies: a new research agenda. Bull Menninger Clin 2004;68(2):137-51. doi 0.1521/bumc.68.2.137.35952
  8. Kiene H, Ollenschlager G, Willich SN. Pluralismus der Medizin – Pluralismus der Therapieevaluation? [Pluralism in medicine - pluralism or therapeutic evaluation?] Z aerztl Fortb Qual sich 2005;99(4-5):261-2.
  9. Kienle GS. Gibt es Gründe für pluralistische Evaluationsmodelle? Limitierungen der randomisierten klinischen Studie [Is there a rationale for pluralistic evaluation models? Limitations of randomized clinical trials]. Z aerztl Fortb Qual sich 2005;99(4-5):289-94.
  10. Jadad AR, Enkin MW. Randomized controlled trials: Questions, answers, and musings. Malden MA: Blackwell Publishing; 2007.
  11. Rawlins M. De Testimonio: on the evidence for decisions about the use of therapeutic interventions. Clin Med 2008 Dec;8(6):579-88. doi 10.1016/S0140-6736(08)61930-3
  12. Hamre HJ, Kiene H, Kienle GS. Clinical research in anthroposophic medicine. Altern Ther Health Med 2009 Nov;15(6):52-5.
  13. Kienle GS, Kiene H, Albonico HU. Anthroposophic medicine: effectiveness, utility, costs, safety. New York: Schattauer Verlag; 2006.
  14. Kienle GS, Kiene H: Clinical Judgement and the Medical Profession. J Eval Clin Pract 2011;17(4):621-7. doi 10.1111/j.1365-2753.2010.01560.x
  15. Kiene H, Heimpel H, Fischer G, Girke M, Hahn EG, Hoppe HD, et al. Professional treatment in the context of medical pluralism. European Journal of Integrative Medicine 2010;2(2):53-6.

Last update: March 2017