Gudrun Bornhöft, Peter F. Matthiessen (eds) Homeopathy in Healthcare – Effectiveness, Appropriateness, Safety, Costs Gudrun Bornhöft, Peter F. Matthiessen (eds) Homeopathy in Healthcare – Effectiveness, Appropriateness, Safety, Costs An HTA report on homeopathy as part of the Swiss Complementary Medicine Evaluation Programme Translated from the German by Margot M. Saar 123 Prof. Peter F. Matthiessen Zentrum für Integrative Medizin der Universität Witten/Herdecke gGmbH Gerhard-Kienle-Weg 6 58313 Herdecke, Germany Dr. med. Gudrun Bornhöft Reußstr. 1 38640 Goslar, Germany ISBN-13 978-3-642-20638-2 Springer-Verlag Berlin Heidelberg New York Bibliographic information Deutsche Bibliothek The Deutsche Bibliothek lists this publication in Deutsche Nationalbibliographie; detailed bibliographic data is available in the internet at <http://dnb.ddb.de>. This work is subject to copyright. 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Matthiessen, Gudrun Bornhöft 2 Background and objectives of HTA . . . . . . . . . . . . . . . . . . . . . . . 5 Stefanie Maxion-Bergemann, Gudrun Bornhöft 2.1 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 2.2 Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3 Introduction to the speciality of homeopathy – principles and definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Marco Righetti, Klaus v. Ammon, Peter Mattmann, André Thurneysen 3.1 Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.2 The principle of similarity or ‘Law of Similars’ . . . . . . . . . . . . . . . . . . . 10 3.3 Homeopathic pharmacology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.4 The homeopathic examination and remedy selection . . . . . . . . . . . . . 11 3.5 Medicines: their manufacture, application and mode of action . . . . . . . 11 3.6 The concept of disease in homeopathy and conventional medicine . . . . 12 3.7 Indications and limitations of homeopathy . . . . . . . . . . . . . . . . . . . . 13 3.8 Other therapies known as homeopathy . . . . . . . . . . . . . . . . . . . . . . . 13 3.9 Homeopathy research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 3.10 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 4 Homeopathy: Research and Research Problems (preclinical and clinical) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Marco Righetti, Stephan Baumgartner, Klaus v. Ammon 4.1 Introduction and Research Problems . . . . . . . . . . . . . . . . . . . . . . . . 16 4.2 Preclinical Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 4.2.1 Fundamental physico-chemical research . . . . . . . . . . . . . . . . . . . . . . . 17 4.2.2 Botanical studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 4.2.3 Animal studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 4.2.4 In vitro studies with human cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 4.2.5 Conclusion: fundamental preclinical research . . . . . . . . . . . . . . . . . . . . 19 4.3 Clinical trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 4.3.1 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 4.3.2 An outline of clinical trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 4.3.3 Future research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 4.3.4 Summary clinical studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 4.4 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 5 General problems with clinical trials in research . . . . . . . . . . . . . 27 Peter F. Matthiessen, Gudrun Bornhöft 5.1 The Problems with Randomized Clinical Trials . . . . . . . . . . . . . . . . . . 28 5.2 The Risk of Bias in Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 VI Table of Contents 5.3 Problems with the Formal Evaluation of Clinical Trials in Meta-analyses . 39 5.4 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 6 HTA Homeopathy: Methods and Material . . . . . . . . . . . . . . . . . . 47 Stefanie Maxion-Bergemann, Gudrun Bornhöft, Ursula Wolf 6.1 Project Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 6.2 Methods: Systematic Literature Search . . . . . . . . . . . . . . . . . . . . . . . 49 6.2.1 Selection of data sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 6.2.2 Data sources used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 6.2.3 Systematic literature search: general search strategy and article selection . . . 54 6.2.4 Systematic literature search for individual HTA aspects: search strategy and article selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 6.3 Data Extraction and Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 6.3.1 Extraction and evaluation of data / procedure . . . . . . . . . . . . . . . . . . . . 56 6.3.2 Extraction and evaluation of data . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 6.3.3 Evaluation categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 6.4 Data Synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 6.5 Publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 6.5.1 Database research ‘Homeopathy’ . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 6.5.2 Special search: URTI (Upper Respiratory Tract Infection) . . . . . . . . . . . . . . 62 6.5.3 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 6.5.4 Cost-effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 6.6 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 7 International Utilisation of Complementary Medical Approaches 67 René Gasser, Ursula Wolf, Martin Wolf, Klaus v. Ammon, Gudrun Bornhöft, Stefanie Maxion-Bergemann 7.1 Introduction and Research Questions . . . . . . . . . . . . . . . . . . . . . . . . 68 7.2 Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 7.3 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 7.3.1 Outline of studies used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 7.3.2 Study design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 7.3.3 CAM definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 7.3.4 Profile of CAM users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 7.3.5 Frequency of CAM use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 7.3.6 Estimation of satisfaction with CAM and CAM effectiveness . . . . . . . . . . . . 83 7.3.7 Reasons for using CAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 7.3.8 Use of CAM compared with conventional medicine . . . . . . . . . . . . . . . . . 86 7.4 Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 7.5 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 7.6 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 8 CAM Conditions and Use in Switzerland . . . . . . . . . . . . . . . . . . . 91 Ursula Wolf, Martin Wolf, Klaus v. Ammon 8.1 Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 8.2 The Use of Complementary Medicine in Switzerland: Prevalence, Effectiveness, Acceptance and the Views of Patients and Physicians . . . . 94 8.2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 VII Table of Contents 8.2.2 Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 8.2.3 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 8.2.4 Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 8.2.5 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 8.2.6 List of study numbers (referred to in the diagrams) . . . . . . . . . . . . . . . . . 98 8.3 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 9 Overview of Systematic Reviews on the Clinical Efficacy of Homeopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Gudrun Bornhöft, Klaus v. Ammon 9.1 Introduction: Systematic Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 9.2 Literature Search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 9.3 Presentation of the Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 9.3.1 Reviews on general effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 9.3.2 Reviews on special indications: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 9.3.3 Reviews on special interventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 9.3.3 Reviews on special indications with special intervention . . . . . . . . . . . . . . 108 9.4 Evaluation of the Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 9.4.1 Research question . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 9.4.2 Selection of studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 9.4.3 Selection and evaluation of data/information . . . . . . . . . . . . . . . . . . . . 113 9.4.4 Data synthesis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114 9.5 Discussion and Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 9.6 List of Excluded Studies with Reasons for Exclusion . . . . . . . . . . . . . . . 118 9.7 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124 10 Clinical Studies on the Effectiveness of Homeopathy for URTI/A (Upper Respiratory Tract Infections and Allergic Reactions) . . . . 127 Stefanie Maxion Bergemann, Gudrun Bornhöft, Denise Bloch, Christina Vogt-Frank, Marco Righetti, André Thurneysen 10.1 Selection of Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 10.2 Outcome of Literature Search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 10.3 Summary of Studies: Data Extraction, Internal and External Validity, Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 10.3.1 Population, study design and implementation . . . . . . . . . . . . . . . . . . . . 140 10.3.2 Intervention and control therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 10.3.3 Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 10.3.4 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 10.3.5 Side effects, initial aggravation, adverse effects . . . . . . . . . . . . . . . . . . . 143 10.4 Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143 10.5 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156 11 Safety of Homeopathic Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 Klaus v. Ammon, André Thurneysen 11.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 11.2 Responses to Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 11.3 Interaction of Substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 11.4 Safety of Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 VIII Table of Contents 11.5 Scientific Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 11.6 Safety: Summary and Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 11.7 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 12 Cost-effectiveness of Homeopathy . . . . . . . . . . . . . . . . . . . . . . . 163 Klaus v. Ammon, René Gasser, Gudrun Bornhöft, Stefanie Maxion-Bergemann 12.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 12.2 Methods of Health Economics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166 12.3 Use of CAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 12.4 Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168 12.5 Cost-effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168 12.6 Reimbursement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169 12.7 Data and Studies for Homeopathy . . . . . . . . . . . . . . . . . . . . . . . . . . 169 12.8 Data and Projects from Switzerland . . . . . . . . . . . . . . . . . . . . . . . . . 171 12.8.1 NFP 34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171 12.8.2 Further data from Switzerland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 12.9 International CAM Studies and Surveys: Patients . . . . . . . . . . . . . . . . 173 12.10 International CAM Studies and Surveys on: Physicians/Providers . . . . . . 174 12.11 Pilot Projects in Germany . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174 12.12 Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177 12.12.1 Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177 12.12.2 Cost-effectiveness of complementary medical methods . . . . . . . . . . . . . . 177 12.12.3 Homeopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 12.13 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 13 Full discussion of the HTA results . . . . . . . . . . . . . . . . . . . . . . . . 193 Gudrun Bornhöft, Klaus v. Ammon, Marco Righetti, André Thuneysen, Peter F. Matthiessen 13.1 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203 14 Synopsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205 14.1 Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206 14.2 Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206 14.3 Studies on the Indication Upper Respiratory Tract Infection/Allergy (URTI/A) 207 14.4 Appropriateness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208 14.4.1 Estimation of Demand/Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208 14.4.2 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208 14.5 Economy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208 15 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211 15.1 Data Extraction Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212 15.1.1 Sample questionnaires: systematic reviews and meta-analyses, also for HTA . 212 15.1.2 Sample questionnaires: clinical studies . . . . . . . . . . . . . . . . . . . . . . . . 218 15.1.3 Sample questionnaire: demand/cost-effectiveness . . . . . . . . . . . . . . . . . 224 15.2 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227 15.3 Conflict of interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230 15.4 Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230 1 Introduction Peter F. Matthiessen, Gudrun Bornhöft G. Bornhöft, P. F. Matthiessen (eds), Homeopathy in Healthcare – Effectiveness, Appropriateness, Safety, Costs, DOI 10.1007/978-3-642-20638-2_1, © Springer-Verlag Berlin Heidelberg 2011