Homeopathy in Healthcare – Effectiveness, Appropriateness, Safety, Costs: An HTA report on homeopathy as part of the Swiss Complementary Medicine Evaluation Programme

237 Pages·2011·2.083 MB·English

by  Prof. Peter F. Matthiessen MD, PhD (auth.), Gudrun Bornhöft MD, Prof. Peter F. Matthiessen MD, PhD (eds.)

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
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V
Table of Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Peter F. 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
2 Chapter 1 · Introduction
The present HTA report on homeopathy, now published in book format, was part of the ‘Com-
1
plementary Medicine Evaluation Programme’ (PEK1) which was set up following a decision by
the Swiss government in 1998 to ‘provisionally’ include the complementary medical disciplines
– anthroposophic medicine, homeopathy, traditional Chinese medicine, phytotherapy and neu-
ral therapy – in the list of services covered by the national statutory health insurance.
HTA is short for Health Technology Assessment, an established scientific procedure which,
in contrast to the meta-analyses and systematic reviews specified by the Cochrane Collabora-
tion Standards, examines not only the efficacy of a particular intervention, but especially also
its ‘real-world effectiveness’, its appropriateness, safety and economy. HTAs are therefore much
wider in scope and politically more informative. They include material that is ‘normally’ not
taken into consideration, such as observational studies, good case series and longitudinal cohort
studies.
The specialities named were to be examined for their real-world effectiveness, appropriate-
ness and cost-effectiveness, and the result was intended to inform the decision regarding their
future within primary health care (cf. Chap. 2 of this book and Wolf 2006).
The motivation for the project and how it evolved reflect the polarities and diverging streams
that are now ubiquitous in many countries with regard to complementary and alternative med-
icines (CAM) while also elucidating institutional processes:
The PEK programme was prompted by the high demand and widespread use and accept-
ance of complementary medical treatment, as well as by the political hope for its economic and
preventive use. At the same time, mainstream medicine frequently expressed its concern that
complementary medical treatment was ineffective, if not harmful. The question was: how could
one arrive at a decision that would satisfy society while meeting the requirements of scientific
medicine?
Following a 5-year preparation phase, the evaluation project was split into a practical com-
ponent (field study), as part of which special trials were conducted on parameters relevant for
practitioners and patients, and a literary component (HTA reports) to assess international
publications for evidence of the (real-world) effectiveness, appropriateness, safety and economy
of the treatments. The latter was extended by a smaller sub-project that encompassed a quanti-
tative analysis of the quality of clinical trials in the CAM disciplines mentioned above compared
with those of conventional medicine.
After the above-mentioned 5-year preparation phase, less than 2 years remained for the
completion of the projects.
Before the overall project was finalized, the results of the smaller quantitative sub-study,
which – contrary to the implicit intention of an HTA – had evaluated only experimental trials
(randomized double-blind trials), became known out of context. While the overall conclusion
was that studies of homeopathy and phytotherapy were of better quality than comparable stud-
ies of conventional medicine, the subsidiary meta-analysis of the qualitatively best trials (ac-
cording to internal validity criteria) demonstrated efficacy for the interventions of conven-
tional medicine and phytotherapy but no significant difference to placebo for homeopathic
treatment. (Concerning the problem of reducing qualitative evaluations to purely internally
valid criteria cf. Chaps. 5 and 13.)
The ‘negative result’ for homeopathy caused a massive furore prior to conclusion of the PEK
project and following its subsequent publication (Shang et al. 2005), culminating in the unfor-
tunately titled Lancet editorial ‘The end of homeopathy’ (editorial 2005).
1 PEK – Programm Evaluation Komplementärmedizin