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Methodology and Case Reporting

Methodology of clinical research has been a focus in Anthroposophic medicine. Besides using well established methods, innovative methods were developed: For instance combined bias suppression in single arm therapy studies (1) and the systematic comparison of the order of magnitude of single-arm cohorts with corresponding cohorts (2).

Other research has gone into single case methodologies (3,4):
Medicine is built of single cases.  Individual patients – single cases – are the essence of what medicine is dealing with. Every patient is important and every case can be a lesson. Case reports have an important place in medicine and present relevant information complementing data from clinical trials. As „cornerstones of medical progress“ (5) they often are the first presentation of discoveries: new conditions, novel therapies, new perspectives in pathogenesis, inventive diagnostic procedures. Their publication often provokes others to try to reproduce the observation and thus to either confirm or refute the initial hypothesis. A recent example is the discovery of beneficial effects of propranolol in severe hemangiomas of infancy, which found its way into routine application after the publication of just a few case reports. Another domain is side effects. The Thalidomide tragedy came to light by a courageous pediatrician and geneticist analyzing and presenting numerous cases. About 40% of all side effects are uncovered by case reports. (6) They can test the applicability of clinical guidelines in clinical practice, and they can also help to implement them. Many disciplines find themselves represented mainly in case reports.

Medical education and the development of connoisseurship and expertise also depends on learning from cases; even hazard ratios from randomized controlled trials and meta-analyses need to be hooked on stories in order to be memorizable. (7,8)

However, quality and transparency of case reports are often insufficient. This is why recommendations for training and publication have been published. Furthermore, an international group of researchers, medical editors and clinicians have gathered to develop consensus-based publication guidelines for writing case reports.(9-14) Also the epistemologic basis for judging therapeutic causality in individual patients has been analysed. (3,4,15,16)

Many case reports on Anthroposophic Medicine, particularly with mistletoe treatment, have been written according to these recommendations. (examples: (17-28))

Read more ... Exemplary literature

March 2017

Dr. med. Gunver S. Kienle
IFAEMM Freiburg at the Witten Herdecke University
Center for Complementary Medicine, Medical Center, University of Freiburg, Germany

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(1) Hamre HJ, Glockmann A, Kienle GS, Kiene H. Combined bias suppression in single-arm therapy studies. J EvalClin Pract. 2008;14(5):923-929.2.

(2) Hamre HJ, Glockmann A, Troger W, Kienle GS, Kiene H. Assessing the order of magnitude of outcomes in single-arm cohorts through systematic comparison with corresponding cohorts: an example from the AMOS study. BMC Med ResMethodol. 2008;8:11.3

(3) Kiene H. Komplementäre Methodenlehre der klinischen Forschung. Cognition-based Medicine. Berlin, Heidelberg, New York: Springer-Verlag; 2001.

(4) Kiene H. Was ist Cognition-based Medicine? Zeitschrift für ärztliche Fortbildung und Qualitätssicherung im Gesundheitswesen. 2005;99 301-306.

(5) Vandenbroucke JP. In defense of case reports and case series. Annals of Internal Medicine. 2001;134 330-334.

(6) Aronson JK. Adverse drug reactions and the role of case reports. Presented at "Celebrating case reports and stories in health care" at the Royal College of Physicians, London, UK. 15-5-2009. . 2009.

(7) Kienle GS. Why Medical Case Reports? Glob Adv Health Med. 2012;1(1):8-9.

(8) Kienle GS, Kiene H. Clinical Judgement and the Medical Profession. Journal of Evaluation in Clinical Practice. 2011;17(4):621-627.

(9) Gagnier JJ, Riley D, Altman D, et al. The CARE Guidelines: Consensus-based Clinical Case Report Guideline Development. Dtsch Arztebl. 2013;110(37): 603-8

(10) Gagnier JJ, Kienle G, Altman DG, et al. The CARE guidelines: consensus-based clinical case report guideline development. Journal of Clinical Epidemiology. 2014;67(1):46-51.

(11) Abbing AC, Ponstein AS, Kienle GS, Gruber H, Baars E. The CARE-AAT Guideline: Development and Testing of a Consensus-based Guideline for Case Reports in Anthroposophic Art Therapy. The International Journal of Art Therapy. 2016.

(12) Kienle GS, Hamre HJ, Portalupi E, Kiene H. Improving the quality of therapeutic reports of single cases and case series in oncology - criteria and checklist.  Alternative Therapies in Health and Medicine. 2004;10:68-72.

(13) Kienle GS, Kiene H. Kriterien für die Erstellung therapeutischer Einzelfallberichte in der Onkologie. Der Merkurstab. 2003;56(1):2-5.

(14) Kienle GS, Kiene H. Zur Qualitätssicherung von Einzelfallberichten und Fallserien in der Onkologie. Dtsch Z Onkol. 2006;38 (2):62-65.

(15) Kiene H, Hamre HJ, Kienle GS. In Support of Clinical Case Reports: A System of Causality Assessment. Glob Adv Health Med. 2013;2(2):28-39.

(16) Kiene H, Sch”n-Angerer T. Single-case causality assessment as a basis for clinical judgment. Alternative Therapies in Health and Medicine. 1998;4(1):41-47.

(17) Kienle GS, Meusers M, Quecke B, Hilgard D. Patient-centered Diabetes Care in Children: An Integrated, Individualized, Systems-oriented, and Multidisciplinary Approach. Glob Adv Health Med. 2013;2(2):12-19.

(18) Werthmann PG, Helling D, Heusser P, Kienle GS. Tumour response following high-dose intratumoural application of Viscum album on a patient withadenoid cystic carcinoma. BMJ Case Reports. 2014:doi: 10.1136/bcr-2013-203180.

(19) Werthmann PG, Sträter G, Friesland H, Kienle GS. Durable Response of Cutaneous Squamous Cell Carcinoma Following High-dose Peri-lesional Injections of Viscum album Extracts - A Case Report. Phytomedicine. 2013;20:324-327.

(20) Wode K, Schneider T, Lundberg I, Kienle GS. Mistletoe treatment in cancer-related fatigue: a case report. Cases Journal. 2009;2:77.

(21) Orange M, Fonseca M, Lace A, von Laue HB, Geider S. Durable tumourresponses following primary high-dose induction with mistletoe extracts: Two case reports. Eur J Integr Med. 2010;2:63-69.

(22) Orange M, Lace A, Fonseca M, von Laue HB, Geider S, Kienle GS. Durable Regression of Primary Cutaneous B-cell Lymphoma following Fever-inducing Mistletoe Treatment - Two Case Reports. Glob Adv Health Med. 2012;1(1):16-23.

(23) von Schoen-Angerer T, Goyert A, Vagedes J, Kiene H, Merckens H, Kienle GS. Disappearance of an advanced adenomatous colon polyp after intratumoural injection with Viscum album (European mistletoe) extract: a case report. J Gastrointestin Liver Dis. 2014;23(4):449-452.

(24) von Schoen-Angerer T, Helmschmidt E, Madeleyn R, et al. A General Pediatrics and Integrative Medicine Approach to Pervasive Refusal Syndrome: A Case Report. Perm J. 2016;20(4):112-115.

(25) von Schoen-Angerer T, Madeleyn R, Kiene H, Kienle GS, Vagedes J. Improvement of Asthma and Gastroesophageal Reflux Disease With Oral Pulvis stomachicus cum Belladonna, a Combination of Matricaria recutita, Atropa belladonna, Bismuth, and Antimonite: A Pediatric Case Report. Glob Adv Health Med. 2016;5(1):107-111.

(26) von Schoen-Angerer T, Madeleyn R, Kienle G, Kiene H, Vagedes J. Viscum Album in the Treatment of a Girl With Refractory Childhood Absence Epilepsy. J Child Neurol. 2015;30(8):1048-1052.

(27) von Schoen-Angerer T, Wilkens J, Kienle GS, Kiene H, Vagedes J. High-Dose Viscum album Extract Treatment in the Prevention of Recurrent Bladder Cancer: A Retrospective Case Series. Perm J. 2015;19(4):76-83.

(28) Deckers B, von Schoen-Angerer T, Voggenreiter B, Vagedes J. External Nursing Applications in the Supportive Management of Prolonged Postoperative Ileus: Description of Interventions and Case Report. Holist Nurs Pract. 2016;30(4):216-221