Involving Voters and Consumers in Decision-Making about the Health Care System - The Swiss Case: A Review.

BACKGROUND: Behind the principle of involving users and voters directly in decision-making about the health care system are ideas relating to empowerment. This implies a challenge to the traditional view that scientific knowledge is generally believed to be of higher value than empirical knowledge, as it is the case with CAM. The objectives of this review are (a) to show that this assumption disregards the fact that CAM is as scientific as conventional medicine but has different basic assumptions what the world is being made of and consequently uses different/adapted scientific methods; (b) to demonstrate how a perspective of the history of medicine and science as well as direct democracy mechanisms such as stipulated in the Swiss constitution can be used to achieve the acceptance of CAM in a modern medical health care system. A public health care system financed by levies from the population should also reflect the widely documented desire in the population for medical pluralism (provided that therapeutical alternatives are not risky). Otherwise, the problem of social inequality arises because only people with a good financial background can afford this medicine. SUMMARY: From the perspective of scientific theory and the history of science, the answer to the question of whether complementary medicine and conventional medical procedures must provide proof of efficacy according to a uniform scientific is quite controversial according to epistemologically oriented studies on this issue. KEY MESSAGES: This review found strong evidence for involving voters and consumers directly in decision-making about the provision of CAM in the health care system. It also seems necessary to step back in the debate on evidence-based medicine, taking a history of medicine and science perspective, as the role which the proper method occupies and plays in medicine is defined by the scientific nature of the world view.Hinter dem Grundsatz, Nutzer und Wähler direkt in die Entscheidungsfindung über das Gesundheitssystem einzubeziehen, stehen Vorstellungen von Empowerment. Dies impliziert eine Infragestellung der traditionellen Ansicht, dass wissenschaftliches Wissen im Allgemeinen als wertvoller angesehen wird als empirisches Wissen und erprobte Erfahrung, wie es bei der Komplementärmedizin der Fall ist. Die Ziele dieser Übersichtsarbeit sind: (a) zu zeigen, dass diese Annahme die Tatsache außer Acht lässt, dass die Komplementärmedizin ebenso wissenschaftlich ist wie die Schulmedizin, aber von anderen Grundannahmen ausgeht, wie die Welt beschaffen ist, und folglich andere/angepasste wissenschaftliche Methoden anwendet; (b) aufzuzeigen, wie eine medizin- und wissenschaftsgeschichtliche Perspektive sowie Mechanismen der direkten Demokratie, wie sie in der Schweizer Verfassung vorgesehen sind, genutzt werden können, um die Akzeptanz der Komplementärmedizin in einem modernen medizinischen Gesundheitssystem zu erreichen. Ein öffentliches, durch Abgaben der Bevölkerung finanziertes Gesundheitssystem sollte auch dem vielfach dokumentierten Wunsch der Bevölkerung nach medizinischem Pluralismus Rechnung tragen (sofern die therapeutischen Alternativen nicht riskant sind). Andernfalls stellt sich das Problem der sozialen Ungleichheit, weil sich nur Menschen mit einem guten finanziellen Hintergrund diese Medizin leisten können.

Herbal medicinal products - Evidence and tradition from a historical perspective.

BACKGROUND: Aside from the fully licensed herbal medicines there are products on the European pharmaceutical market which are registered by virtue of their longstanding traditional use. The normal registration procedure does not apply to them because presently they do not meet the legal requirements for a full license as set out in the relevant European Union Directive. One of these requirements, "proof of tradition", has so far been dealt with in different ways and fails to meet the criteria of good practice. METHOD: This analysis is based on a selective literature search in PubMed and in databases of medical and pharmaceutical history, interviews with licensing experts, a consensus meeting attended by researchers with a background in general medicine, phytotherapy, medical and pharmaceutical history, biometry, ethnopharmacology, pharmacognosy and the pharmaceutical industry. RESULTS AND DISCUSSION: The 2004 EU Directive, which governs the registration of Traditional Herbal Medicinal Products and demands proof of tradition, is a regulatory construct and, above all, the outcome of a political process that has ended in a pragmatic compromise. The concept of tradition applied in the Directive does not sufficiently reflect the semantic breadth of the term. The only condition defined is that a specific commercial preparation needs to have been on the market for 30 years (15 of them inside the EU). Such an approach does not make full scientific use of the evidence available because the information excerpted from historical sources, if adequately processed, may yield valuable insights. This applies to indications, modes of application, efficacy and product safety (innocuousness). Such criteria should enter in full into the benefit-risk-analysis of applied preparations, in the registration process as well as in the therapeutic practice. CONCLUSION: When registering Traditional Herbal Medicinal Products the criterion of evidence-based medicine will only be met if all the facts available are assessed and evaluated, over and above the formally stipulated regulatory provisions (30 years, product reference). To this end, the scientific methods (from among the natural, life or cultural sciences), which are recognized as authoritative in each case, must be applied.

[Naturheilkunde und Komplementärmedizin in medizinischen Leitlinien - können europäische Normen Leitlinien für Naturheilkunde und Komplementärmedizin verdrängen?].

Leitlinien machen in der Komplementärmedizin, wie das Beispiel der Naturheilkunde zeigt, durchaus Sinn. Sie ergänzen zum Wohle des Patienten und zur besseren Orientierung des Therapeuten die bislang, auch auf europäischer Ebene, bereits bestehenden Leitlinien, die ständig weiterentwickelt werden. Diese Ergänzung ist dringend notwendig, weil die meisten der vorliegenden Leitlinien einzelner Fachgesellschaften die Forschungsergebnisse der Komplementärmedizin, die zum Teil beachtlich und auch evidenzbasiert sind, zum Nachteil des Patienten ignorieren. Es ist bedauerlich, dass einige Richtungen der Komplementärmedizin jedoch meinen, dass eine europäische Norm, wie sie beispielsweise Osteopathen und Homöopathen mithilfe des europäischen Normungsinstituts (CEN) durchzusetzen hoffen, sie in ihrem Kampf um Anerkennung weiterbringen wird. Der Patient, der auf eine individuelle und bestmögliche Behandlung wert legt, wird jedenfalls davon nicht profitieren.

Using the framework of corporate culture in "mergers" to support the development of a cultural basis for integrative medicine - guidance for building an integrative medicine department or service.

BACKGROUND: An increasing number of clinics offer complementary or integrative medicine services; however, clear guidance about how complementary medicine could be successfully and efficiently integrated into conventional health care settings is still lacking. Combining conventional and complementary medicine into integrative medicine can be regarded as a kind of merger. In a merger, two or more organizations - usually companies - are combined into one in order to strengthen the companies financially and strategically. The corporate culture of both merger partners has an important influence on the integration. PURPOSE: The aim of this project was to transfer the concept of corporate culture in mergers to the merging of two medical systems. METHODS: A two-step approach (literature analyses and expert consensus procedure) was used to develop practical guidance for the development of a cultural basis for integrative medicine, based on the framework of corporate culture in "mergers," which could be used to build an integrative medicine department or integrative medicine service. RESULTS: Results include recommendations for general strategic dimensions (definition of the medical model, motivation for integration, clarification of the available resources, development of the integration team, and development of a communication strategy), and recommendations to overcome cultural differences (the clinic environment, the professional language, the professional image, and the implementation of evidence-based medicine). CONCLUSION: The framework of mergers in corporate culture provides an understanding of the difficulties involved in integrative medicine projects. The specific recommendations provide a good basis for more efficient implementation.

Hahnemann and placebo.

Samuel Hahnemann (1755-1843) known today as the founder of homoeopathy, was - as far as we know - the first physician who administrated placebos to his patient on a systematic and regular basis. This study is based upon unpublished documents (e.g. patients' letters) in the Archives of the Institute for the History of Medicine of the Robert Bosch Foundation in Stuttgart. It also profited from the critical edition of Hahnemann's case journals and the editorial comments which have also been published in this series. Hahnemann differentiated clearly between homeopathic drugs and pharmaceutical substances which he considered as sham medicine (e.g. milk sugar). A close look at Hahnemann's case journals reveals that the percentage of placebo prescriptions was very high (between 54 and 85 percent). In most instances Hahnemann marked placebos with the paragraph symbol (§). The rationale behind this practice was that Hahnemann had encountered the well-known problem that patients were used to taking medicine on a daily basis as it was typical for the age of heroic medicine. The main reason for giving placebo was therefore to please the impatient patient who was used to frequent medications in allopathic medicine, not only every day but sometimes also hourly.

The placebo effect and its ramifications for clinical practice and research. Villa La Collina at Lake Como, Italy, 4-6 May 2012.

INTRODUCTION: The purpose of this workshop was to further explore the implications of the placebo effect for both research and clinical practice from a variety of angles with a group of selected experts. METHOD/APPROACH: The use of placebos in both clinical practice and research was explored in depth from a historical, methodological, ethical, legal and cultural point of view. The current state of knowledge regarding the placebo effect was established, knowledge gaps were identified, and the implications for both clinical research and practice were discussed in depth. KEY MESSAGES: • Placebos have been consciously used in clinical practice since the 18th century, but only emerged as a research topic in the western world in the second half of the 20th century. • The placebo response consists of the placebo effect plus the natural course of the disease, and is a meaningful part of all medical treatments. • A variety of not fully understood individual, context and cultural factors contribute to the placebo response and interact in a non-linear way with the specific effects of medicines. • The assessment of a therapeutic effect in placebo-controlled RCTs is often difficult due to a strong placebo response, e.g. in Central Nervous System (CNS) indications like major depression or in Irritable Bowel Syndrome. • Placebo effects occur, and can affect the validity and appropriateness of placebo controlled trials in conventional as well as Complementary and Alternative Medicine (CAM) research. • It may be impossible to fully disentangle the verum and sham effects of both CAM and conventional medical procedures such as for instance acupuncture and surgery. • Context/meaning effects, including doctor empathy, are highly relevant and under-researched in both conventional and complementary medicine. • The use of 'impure placebos' (non-indicated/ineffective medicines) in clinical practice may be common, but little reliable data is available due to complexities around the definition of impure placebos and underreporting. • The assumption that placebo effects do not occur in veterinary research is likely to be incorrect, e.g. owner empathy and vet expectations can affect outcomes. • Various innovative trial designs that better deal with the placebo issue are available, but only as partial solutions. • Patient treatment will benefit from better understanding and appropriately utilising meaning/context effects. CONCLUSIONS: There are many remaining knowledge gaps with regard to the placebo response. The evolving knowledge challenges the paradigm of the placebo controlled RCT as a gold standard for demonstrating benefit of treatments. There are a number of pointers towards alternative research designs and paradigms worthy of further exploration. The evolving knowledge can contribute to the further development of a 'meaning orientated' and patient centred healthcare system.

The early history of the placebo.

In the late 18th century the term "placebo" became part of medical jargon. In contrast to the prevailing opinion that it was the Scottish physician and pharmacologist William Cullen (1710-1790) who introduced this expression into medical language in 1772, the credit must be given to another English physician, Alexander Sutherland (born before 1730 - died after 1773). The main reason for administering placebos in late 18th-century medical practice was to satisfy the patient's demand and his expectations. Another reason was obstinancy of the patient: the motivation behind such prescriptions may be summarized as prescribing inert drugs for the satisfaction of the patient's mind, and not with the view of producing any direct remedial effect. In most cases these 18th century physicians did not administer "pure" placebos but resorted to any kind of medicine which they thought simple, feeble, or altogether powerless, non-perturbing medicines. Today we make the distinction between pure placebos (substances with no pharmacological effect, e.g. sugar pills) and impure placebos (substances with pharmacological effect but not on the condition being treated). In the 18th century those physicians who prescribed placebo usually thought of drugs which were considered not very effective in the particular case, e.g. a mild ointment. At the same time, only very few brilliant minds came up with the ingenious idea of using inert substances as placebo. An alternative to milk sugar used as placebo in homeopathy was breadpills. Recent research suggests that expectancy is an integral part of the placebo effect. As early as 1775 the English bishop John Douglas (1721-1807) anticipated the findings of modern research on the placebo effect.

O papel da homeopatia na Alemanha Nazista: uma avaliação histórica / Role of homeopathy in Nazi Germany: a historical assessment

Uma das questões ainda polêmicas diz respeito da relação entre homeopatia e os homeopatas e o nazismo. O presente artigo representa resultados parciais de uma pesquisa em andamento, abordando vários dos tópicos em debate. Além da menção dos casos específicos de homeopatas perseguidos pelo sistema e aspectos controversos sobre a experimentação de medicamentos, particularmente em humanos, discorre-se sobre o contexto histórico: inicialmente a conjuntura político-social favoreceu as medicinas ditas alternativas, marginalizadas até essa época pela medicina oficial. Destaca-se que a palavra “homeopatia” não aparece nem uma única vez nos registros dos processos médicos de Nuremberg. (AU)

A still polemical issue concerns the relationship between homeopathy and homeopaths and Nazism. This article represents partial results of an ongoing research and addresses some of the topics under debate. Besides a discussion the specific instance of homeopaths pursued by the regime and controversial aspects on experimentation of remedies, particularly on human beings, it elaborates on the historical context: initially, the political and social conjuncture favored so-called alternative medicines, which had been marginalized until that moment by conventional medicine. It is highlighted that there is not one only mention to the word “homeopathy” in the records of Nurnberg´s medical trials.

A review of the use and role of low potencies in homeopathy.

BACKGROUND: The issue of potency choice in homeopathy has always been controversial. In "high" potencies there are no molecules of the starting substance remaining and in low potencies (including tinctures) the line between homeopathy and herbal medicine is blurred. METHOD: The literature on potency selection is reviewed, including the use of low potencies and their effects on organ physiology. This article attempts to examine the overlapping boundaries between homeopathy and herbal medicine in clinical practice and basic research. FINDINGS: Both low and high potencies are utilized in all areas of homeopathy ranging from prescribing for acute or chronic diseases to constitutional treatment. Low dilutions play a role in homeopathic prescribing, and are particularly prominent in systems of homeopathy focusing on the organotropic effects of homeopathic medicinal products integrated with conventional medicine diagnosis and treatment. (Mother) tinctures may be employed in homeopathy as well as in herbal medicine. The distinction between the two is based on the clinical context, the rationale behinds its use, and the production method of the tincture. Data available from basic research on low and high potencies do not suggest a superiority of low potencies over high potencies or vice versa. CONCLUSION: Low potency homeopathic medications (with detectable concentrations of the starting material) and high potency homeopathic medications (with no detectable amount of the starting material in the finished product) have been available since the beginning of homeopathy. Given that both groups of homeopathic medications have shown effectiveness in clinical trials and in the absence of a definitive mechanism of action for homeopathy (including the possibility that there may be multiple mechanisms of action present) this wide of range of potencies for homeopathic medicines should be maintained, ranging from mother tinctures to homeopathic medicinal products with no measurable concentration.

The longue durée of contraceptive methods.

Medical history has so far paid hardly any attention to the longue durée, a history in which, according to Braudel, 'all change is slow'. It is therefore one of the challenges of the emerging field of the social history of medicine to work audaciously across time as well as across space. An interesting subject, for example, is the history of contraception. Throughout history, there has been almost nothing people have worried about more than having sex without fear of consequence. At first sight, the story of contraception seems to be one of progress, from the Ancient Egyptian crocodile-dung pessary to the modern-day condom and contraceptive pill. A closer look, however, shows a pattern of remarkable continuities in the reproductive behaviour of men and women over the last two thousand years. In this paper, I shall attempt to show why traditional male-dominated contraceptive methods still linger on despite the sexual revolution brought about by the invention of the 'pill' in the late 1950s.

The historiography of homoeopathy in Germany.

Homoeopathy originated in Germany. The same applies, by the way, to many other branches of alternative medicine, e.g. mesmerism, homoeopathy, hydropathy, anthroposophical medicine. This historical fact provides more than just an excuse to start with a survey of the historiography of homeopathy in German-speaking countries. The first part of the paper focuses on 19th-century attempts at a history of homoeopathy, reflecting the wish to establish a corporate identity among the adherents of the new art of healing. Early examples are books by prominent homoeopathic doctors on the origins and recent history of homoeopathy in German lands. A look at their motives will give us a notion of the response of the fringe medicine to a wide ranger of attacks of orthodox physicians and medical historians who saw progress in the field of the new "scientific" medicine only and who shared the values and ideologies of the medical establishment. The second part of the paper - which covers the period from the turn of the century to the end of World War II - examines the first attempts by professional medical historians as well as amateurs to write about the rise and fall of homeopathy in Germany. The third part is then centred on recent medical historiography on this subject.

Case taking in homoeopathy in the 19th and 20th centuries

There has been a lack of research into the effect alternative medicine's comprehensive taking of patient histories has had on practice. Significant practitioners who influenced homoeopathic case taking are discussed and the continuity and tradition of taking patient histories emphasised. (AU)