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

Aims, tasks and prerequisites

ESCAMP aims to develop the scientific basis for a permanent regulatory framework for anthroposophic medicinal products (AMPs) in Europe. This includes the following tasks:

  1. Development of methods and standards for the scientific assessment of efficacy/effectiveness, safety and cost-effectiveness of AMPs.
  2. Elaboration of appropriate categories and criteria for regulatory assessment of AMPs, which could be implemented in a draft law for registration of AMPs in Europe.
  3. Implementation of the these methods and regulatory criteria in registration documents and product monographs.

Foundations for this work have been developed during the past 10 years:

  • the Anthroposophic Pharmaceutical Codex [1]
  • a growing body of clinical research and reviews on Anthroposophic Medicine (e. g. mistletoe reviews, AMOS study, IIPCOS study [2-7])
  • the first comprehensive review of clinical studies of Anthroposophic Medicine in a health technology assessment report [8]
  • the pharmacovigilance network EvaMed (Evaluation of Anthroposophic Medicine) [9]
  • the concept of Cognition-based Medicine [10]
  • the Vademecum of Anthroposophic Medicines [11]

Reference List

  1. Anthroposophic Pharmaceutical Codex APC. Dornach: The International Association of Anthroposophic Pharmacists IAAP; 2005, 2nd ed. 2007.
  2. Kienle GS, Kiene H. Die Mistel in der Onkologie - Fakten und konzeptionelle Grundlagen [Mistletoe in oncology - Facts and concepts]. Stuttgart: Schattauer Verlag; 2003.
  3. Kienle GS, Kiene H. Complementary cancer therapy: a systematic review of prospective clinical trials on anthroposophic mistletoe extracts. Eur J Med Res 2007 Mar 26;12(3):103-19.
  4. Kienle GS, Glockmann A, Schink M, Kiene H. Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research. J Exp Clin Cancer Res 2009;28:79.
  5. Kienle GS. Mistletoe therapy: Scientific informations. Physicians' Association for Anthroposophic Medicine in Germany 2010 May http://wissenschaft.mistel-therapie.de/?lang=1
  6. Hamre HJ, Becker-Witt C, Glockmann A, Ziegler R, Willich SN, Kiene H. Anthroposophic therapies in chronic disease: The Anthroposophic Medicine Outcomes Study (AMOS). Eur J Med Res 2004 Jul 30;9(7):351-60.
  7. Hamre HJ, Fischer M, Heger M, Riley D, Haidvogl M, Baars E, et al. Anthroposophic vs. conventional therapy of acute respiratory and ear infections: a prospective outcomes study. Wien Klin Wochenschr 2005 Apr;117(7-8):256-68.
  8. Kienle GS, Kiene H, Albonico HU. Anthroposophic medicine: effectiveness, utility, costs, safety. Stuttgart, New York: Schattauer Verlag; 2006. Update: Kienle GS, Glockmann A, Grugel R, Hamre HJ, Kiene H: Klinische Forschung zur Anthroposophischen Medizin – Update eines "Health Technology Assessment"-Berichts und Status Quo. Forsch Komplementmed 2011;18, DOI: 10.1159/000331812.
  9. Jeschke E, Ostermann T, Tabali M, Bockelbrink A, Witt CM, Willich SN, et al. Diagnostic profiles and prescribing patterns in everyday anthroposophic medical practice - a prospective multi-centre study. Forsch Komplementmed 2009 Oct;16(5):325-33.
  10. Kiene H. Komplementäre Methodenlehre der klinischen Forschung. Cognition-based Medicine [Complementary methodology for clinical research. Cognition-based medicine]. Berlin - Heidelberg - New York: Springer-Verlag; 2001.
  11. Vademecum of Anthroposophic Medicines. First English edition. Filderstadt: Medical Section of the School of Spiritual Science; International Federation of Anthroposophic Medical Associations (IVAA); Association of Anthroposophic Physicians in Germany (GAÄD); 2009.

Last update: February 2012