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:
- Conception, development and manufacturing according to principles of Anthroposophic Medicine
- Long tradition of use on the European market
- Clinical (medical) experience [14,15]
- 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
- 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.
- 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
- 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.
- 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
- 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
- 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
- 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
- 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.
- 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.
- Jadad AR, Enkin MW. Randomized controlled trials: Questions, answers, and musings. Malden MA: Blackwell Publishing; 2007.
- 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
- Hamre HJ, Kiene H, Kienle GS. Clinical research in anthroposophic medicine. Altern Ther Health Med 2009 Nov;15(6):52-5.
- Kienle GS, Kiene H, Albonico HU. Anthroposophic medicine: effectiveness, utility, costs, safety. New York: Schattauer Verlag; 2006.
- 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
- 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: January 2021