The goal of this article is to raise issues associated with the underlying assumptions of our research approaches and the nature of health/disease in conventional medical care and complementary and alternative medical care. Different types of efficacy are discussed in terms of randomized controlled trials and outcomes research. The demands of different audiences for research results suggest that researchers need to carefully specify the research question in the context of the state-of-the-knowledge. Appropriate matching of the study design, the nature of the disease, the nature of the treatment and what is known is essential to designing and implementing research that actually could improve patient care.
{"title":"Research and the Goal of Improving Patient Care.","authors":"Edwards","doi":"10.1159/000057330","DOIUrl":"https://doi.org/10.1159/000057330","url":null,"abstract":"<p><p>The goal of this article is to raise issues associated with the underlying assumptions of our research approaches and the nature of health/disease in conventional medical care and complementary and alternative medical care. Different types of efficacy are discussed in terms of randomized controlled trials and outcomes research. The demands of different audiences for research results suggest that researchers need to carefully specify the research question in the context of the state-of-the-knowledge. Appropriate matching of the study design, the nature of the disease, the nature of the treatment and what is known is essential to designing and implementing research that actually could improve patient care.</p>","PeriodicalId":54318,"journal":{"name":"Forschende Komplementarmedizin","volume":"5 Suppl S1 ","pages":"116-120"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000057330","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20799646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This article particularly looks at the advantages and disadvantages of the use of placebos in the evaluation of new drugs when a standard drug is already available. Placebos make blinding possible and in that way help to control measurement bias when assessing the outcome of a trial. Several considerations need to be made when deciding whether to use a placebo. There are legal aspects, registration requirements, commercial interests, medical issues and scientific aspects. A placebo can and should be used in all research when the condition of the patient is not life-threatening and when there are no irreversible consequences of placebo treatment, even if a standard drug is available, but obviously only after informed consent. Insufficient evidence is provided if a placebo group is omitted when assessing a new drug versus standard drug. Obviously, this causes a conflict between the ethical aspects on one hand and the scientific aspects on the other, but if placebo groups are not used it will slow developments in medicine and reduce therapeutic possibilities.
{"title":"The Use and Abuse of Placebo in Clinical Trials.","authors":"Kleijnen","doi":"10.1159/000057332","DOIUrl":"https://doi.org/10.1159/000057332","url":null,"abstract":"<p><p>This article particularly looks at the advantages and disadvantages of the use of placebos in the evaluation of new drugs when a standard drug is already available. Placebos make blinding possible and in that way help to control measurement bias when assessing the outcome of a trial. Several considerations need to be made when deciding whether to use a placebo. There are legal aspects, registration requirements, commercial interests, medical issues and scientific aspects. A placebo can and should be used in all research when the condition of the patient is not life-threatening and when there are no irreversible consequences of placebo treatment, even if a standard drug is available, but obviously only after informed consent. Insufficient evidence is provided if a placebo group is omitted when assessing a new drug versus standard drug. Obviously, this causes a conflict between the ethical aspects on one hand and the scientific aspects on the other, but if placebo groups are not used it will slow developments in medicine and reduce therapeutic possibilities.</p>","PeriodicalId":54318,"journal":{"name":"Forschende Komplementarmedizin","volume":"5 Suppl S1 ","pages":"125-127"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000057332","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20799648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Characteristics and Efficiency of Homoeopathics from a Scientific Point of View 1. This work aims at the presentation of the specific peculiarities of homoeopathics as physics see it and at the explanation of their display of action by application of biochemical methods. 2. Physical methods are considered to be adequate for the investigation of specific peculiarities of homoeopathic potencies. For logical reasons these methods have to be of theoretical nature for the present. In substance basic assumptions of the potentisation procedure are linked to the demand for necessary qualities which a Therapeutically Active Ingredient (= TAI) of homoeopathic potencies has to have. A theoretical model is proposed which should enable the link between potentisation and the TAI by working out learning processes for the transmission of the TAI. 3. By use of methods of biochemistry it is rendered possible to investigate the efficiency of homoeopathics. From the results of in vivo and in vitro trials a model for their display of action is evolved.
{"title":"Zur Eigenheit von homöopathischen Arzneimitteln und ihrer Wirkung aus naturwissenschaftlicher Sicht.","authors":"Dittmann, Weingärtner, Harisch","doi":"10.1159/000021114","DOIUrl":"https://doi.org/10.1159/000021114","url":null,"abstract":"<p><p>Characteristics and Efficiency of Homoeopathics from a Scientific Point of View 1. This work aims at the presentation of the specific peculiarities of homoeopathics as physics see it and at the explanation of their display of action by application of biochemical methods. 2. Physical methods are considered to be adequate for the investigation of specific peculiarities of homoeopathic potencies. For logical reasons these methods have to be of theoretical nature for the present. In substance basic assumptions of the potentisation procedure are linked to the demand for necessary qualities which a Therapeutically Active Ingredient (= TAI) of homoeopathic potencies has to have. A theoretical model is proposed which should enable the link between potentisation and the TAI by working out learning processes for the transmission of the TAI. 3. By use of methods of biochemistry it is rendered possible to investigate the efficiency of homoeopathics. From the results of in vivo and in vitro trials a model for their display of action is evolved.</p>","PeriodicalId":54318,"journal":{"name":"Forschende Komplementarmedizin","volume":"5 5","pages":"236-243"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000021114","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20798803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In order to be able to 'predict' the extent or likelihood of success of an intervention, it is essential to know that exposure and effect are causally related. The randomised controlled clinical trial (RCT) is commonly referred to as the golden standard to establish causality. Apart from ethical constraints or rare diseases it is rarely impossible to do an RCT. Sometimes, however, RCTs may not be feasible (at least at first glance) due to e. g. patients' or therapists' reluctance to participate, lack of funding, organisational limitations, or because technical skills to deliver a therapy are not available. A variety of design alternatives have been proposed to overcome these problems, e. g. clinician-preferred treatment, single consent design, double consent randomised design, prerandomisation, cluster randomisation, and response-adaptive designs ('play the winner'). For complex ('combined modality') therapies it seems reasonable to study the effect of the whole treatment package on the patient rather than the value of individual components. Change to open label or optional cross-over allow 'individualized treatment' as well as 'individualized outcome' within the framework of the RCT. For clinicians and researchers it seems wise to put more emphasis on the search for a suitable and appropriate de-sign for their current problem rather than to artificially tailor their study to an awkward standard design (or even abandon the idea to seek an answer to an open question): Much more alternatives exist than one would imagine.
{"title":"Pragmatic Randomised Controlled Trials for Complex Therapies.","authors":"Resch","doi":"10.1159/000021089","DOIUrl":"https://doi.org/10.1159/000021089","url":null,"abstract":"<p><p>In order to be able to 'predict' the extent or likelihood of success of an intervention, it is essential to know that exposure and effect are causally related. The randomised controlled clinical trial (RCT) is commonly referred to as the golden standard to establish causality. Apart from ethical constraints or rare diseases it is rarely impossible to do an RCT. Sometimes, however, RCTs may not be feasible (at least at first glance) due to e. g. patients' or therapists' reluctance to participate, lack of funding, organisational limitations, or because technical skills to deliver a therapy are not available. A variety of design alternatives have been proposed to overcome these problems, e. g. clinician-preferred treatment, single consent design, double consent randomised design, prerandomisation, cluster randomisation, and response-adaptive designs ('play the winner'). For complex ('combined modality') therapies it seems reasonable to study the effect of the whole treatment package on the patient rather than the value of individual components. Change to open label or optional cross-over allow 'individualized treatment' as well as 'individualized outcome' within the framework of the RCT. For clinicians and researchers it seems wise to put more emphasis on the search for a suitable and appropriate de-sign for their current problem rather than to artificially tailor their study to an awkward standard design (or even abandon the idea to seek an answer to an open question): Much more alternatives exist than one would imagine.</p>","PeriodicalId":54318,"journal":{"name":"Forschende Komplementarmedizin","volume":"5 Suppl S1 ","pages":"136-139"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000021089","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20799650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The Resonance Phenomenon In the course of homoeopathic case-taking one can observe an intensive dynamic interaction, during which the patient will mostly experience a feeling of being eventually perceived and taken seriously. Therefore, he will start to tell further unasked details. The associative link through Materia medica knowledge enables the homoeopath to approach even indirectly yet uncovered fields. The more the interview is spontaneous, the greater the chance arises that central key points of the patient can be freed. In such situations a specific sensation can happen, which the author calls resonance phenomenon; it is hard to put into words, but is very clearly felt - in the author&'s case in the region of the solar plexus. At thismoment, the patient as well as the homoeopath realise immediately that a very important point of the patient's history is reached. The idea, essence, problem or character of this key-point has absolutely to be covered by the later prescribed remedy. As this phenomenon is not measurable, there remains the unanswered question whether the conditions which allow its happening are just a placebo effect.
{"title":"Das Resonanzphänomen.","authors":"Thurneysen","doi":"10.1159/000057102","DOIUrl":"https://doi.org/10.1159/000057102","url":null,"abstract":"<p><p>The Resonance Phenomenon In the course of homoeopathic case-taking one can observe an intensive dynamic interaction, during which the patient will mostly experience a feeling of being eventually perceived and taken seriously. Therefore, he will start to tell further unasked details. The associative link through Materia medica knowledge enables the homoeopath to approach even indirectly yet uncovered fields. The more the interview is spontaneous, the greater the chance arises that central key points of the patient can be freed. In such situations a specific sensation can happen, which the author calls resonance phenomenon; it is hard to put into words, but is very clearly felt - in the author&'s case in the region of the solar plexus. At thismoment, the patient as well as the homoeopath realise immediately that a very important point of the patient's history is reached. The idea, essence, problem or character of this key-point has absolutely to be covered by the later prescribed remedy. As this phenomenon is not measurable, there remains the unanswered question whether the conditions which allow its happening are just a placebo effect.</p>","PeriodicalId":54318,"journal":{"name":"Forschende Komplementarmedizin","volume":"5 Suppl S1 ","pages":"15-17"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000057102","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20799252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The therapeutic alliance, familiar to those who treat patients and conduct clinical trials, is considered by many to be a non-specific effect in research studies. The concept of the therapeutic alliance has its roots in the doctor-patient relationship and has been discussed extensively in the context of psychodynamic psychotherapy. Research has demonstrated that the strength of the alliance is a strong predictor of outcome in psychotherapy and has emphasized its importance in ensuring compliance in pharmacotherapy. However, little empirical research has been conducted which examines the impact of the therapeutic alliance on patient compliance and retention in randomized controlled clinical trials. Moreover, tension and debate exist between those who see the therapeutic alliance as both a necessary and positive component of a clinical trial and those who view it as a confounding variable. Those who view it as a confounding variable argue that this alliance may serve to influence patients' participation and make difficult the assessment of treatment effects. We report our observations from one study of adults with schizophrenia who were enrolled in a clinical trial of a new antipsychotic medication. We hypothesize that there is an association between the strength of the therapeutic alliance and subsequent compliance and retention of patients enrolled in clinical drug trials. The relationship among these constructs could be tested empirically as could the association between the therapeutic alliance and the assessment of clinical response.
{"title":"The Therapeutic Alliance in Randomized Controlled Clinical Trials.","authors":"Kossoy, Wilner","doi":"10.1159/000057105","DOIUrl":"https://doi.org/10.1159/000057105","url":null,"abstract":"<p><p>The therapeutic alliance, familiar to those who treat patients and conduct clinical trials, is considered by many to be a non-specific effect in research studies. The concept of the therapeutic alliance has its roots in the doctor-patient relationship and has been discussed extensively in the context of psychodynamic psychotherapy. Research has demonstrated that the strength of the alliance is a strong predictor of outcome in psychotherapy and has emphasized its importance in ensuring compliance in pharmacotherapy. However, little empirical research has been conducted which examines the impact of the therapeutic alliance on patient compliance and retention in randomized controlled clinical trials. Moreover, tension and debate exist between those who see the therapeutic alliance as both a necessary and positive component of a clinical trial and those who view it as a confounding variable. Those who view it as a confounding variable argue that this alliance may serve to influence patients' participation and make difficult the assessment of treatment effects. We report our observations from one study of adults with schizophrenia who were enrolled in a clinical trial of a new antipsychotic medication. We hypothesize that there is an association between the strength of the therapeutic alliance and subsequent compliance and retention of patients enrolled in clinical drug trials. The relationship among these constructs could be tested empirically as could the association between the therapeutic alliance and the assessment of clinical response.</p>","PeriodicalId":54318,"journal":{"name":"Forschende Komplementarmedizin","volume":"5 Suppl S1 ","pages":"31-36"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000057105","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20799255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Theory and Practice in Medicine: Orthodox Science and Comprehensive Cybernetics The problems of today's health care system require a radical change of view. With its orientation towards the modern materialistic-reductionistic natural science, the focus of university research moved from a subjective ascertainable healing towards pathogenesis, which is objectively measurable by physical and chemical methods. Natural science research is especially interested in the distinct pathological changes expressed by the various diseases and their causes, but not in the constantly similar normal condition of a healed person. This led to the idea that the reversal of the investigated causal chain equals healing; healing and disease are considered as opposites. This way of thinking led to growing problems, which result from the dubious nature of a causal principle, that is transferred from everyday thinking into the micro world. Each of those causal chains represents an artificial linearization of complex natural interrelations and, additionally, can never be followed up to its ends. This infinite regress of reductionistic thinking can only artificially be stopped by unlikely hypotheses, which are responsible for missing healing success and the manifold side effects of modern therapies - for the discrepancy between theory and experience. With an holistic-spiritual view of nature today cybernetics shows us a new route. Cybernetics leads to a lergely hypothesis-free insight into life's processes and to a scientifically sound definition of disease: Disease and healing should not be considered as opposite, as healing is already laid down in the pathogenesis! Cybernetics will especially lead to the long-awaited scientific proof of homoeopathy and, apart from this, will prove that the healing principle of homoeopathy is the general natural principle of all successful therapies in the whole field of medicine.
{"title":"Theorie und Erfahrung in der Medizin: Orthodoxe Wissenschaft und ganzheitliche Kybernetik.","authors":"Zycha","doi":"10.1159/000057109","DOIUrl":"https://doi.org/10.1159/000057109","url":null,"abstract":"<p><p>Theory and Practice in Medicine: Orthodox Science and Comprehensive Cybernetics The problems of today's health care system require a radical change of view. With its orientation towards the modern materialistic-reductionistic natural science, the focus of university research moved from a subjective ascertainable healing towards pathogenesis, which is objectively measurable by physical and chemical methods. Natural science research is especially interested in the distinct pathological changes expressed by the various diseases and their causes, but not in the constantly similar normal condition of a healed person. This led to the idea that the reversal of the investigated causal chain equals healing; healing and disease are considered as opposites. This way of thinking led to growing problems, which result from the dubious nature of a causal principle, that is transferred from everyday thinking into the micro world. Each of those causal chains represents an artificial linearization of complex natural interrelations and, additionally, can never be followed up to its ends. This infinite regress of reductionistic thinking can only artificially be stopped by unlikely hypotheses, which are responsible for missing healing success and the manifold side effects of modern therapies - for the discrepancy between theory and experience. With an holistic-spiritual view of nature today cybernetics shows us a new route. Cybernetics leads to a lergely hypothesis-free insight into life's processes and to a scientifically sound definition of disease: Disease and healing should not be considered as opposite, as healing is already laid down in the pathogenesis! Cybernetics will especially lead to the long-awaited scientific proof of homoeopathy and, apart from this, will prove that the healing principle of homoeopathy is the general natural principle of all successful therapies in the whole field of medicine.</p>","PeriodicalId":54318,"journal":{"name":"Forschende Komplementarmedizin","volume":"5 Suppl S1 ","pages":"52-59"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000057109","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20800349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Patients as Experts: Determining Benefit by Using Assessments of Ability (ICIDH)When health economy and quality mangement are dealing with the cost-benefit relationship, to this day description, calculation, and assessment of the benefit are missing to a great extent. Deliberations in terms of cause and effect do not go beyond the model of pathogenesis (etiology - pathology - manifestation) and descriptions on the organ level (ICD). Only the international classification of impairments, disabilities, and handicaps (ICIDH) as a separate estimation of the resulting manifestations of illness on the levels of organ, individual, and society is capable to elucidate this benefit. It is the patient who is the expert to decide what he needs, what he wants, and what he can do, thus, evaluating on an individual level his loss of capability. The ICIDH is regarded as the key for the management of chronic diseases. The characteristics of being chronically ill require the integration of salutogenesis and the consideration of the hierarchy of needs. The specially developed MARA model serves as pragmatic basis for the description of the benefits of carried out and omitted interventions as changes of abilities by using the MARA curve (mean age-related ability) as ethical guideline. In quality circles the MARA model, which is based on ICIDH, hierarchy of needs and salutogenesis, can offer apatient-oriented basis of discussion for benefit assessments, and, in a pragmatical way, it can facilitate the introduction of evidence-based medicine. By the change of view from the organ level with multifactorial aspects to the individual level, in which the abilities can be understood as a monofactor, a high consensus potential between several participants of discussion in health service is possible.
{"title":"Der Patient als Experte.","authors":"Dubs","doi":"10.1159/000057326","DOIUrl":"https://doi.org/10.1159/000057326","url":null,"abstract":"<p><p>Patients as Experts: Determining Benefit by Using Assessments of Ability (ICIDH)When health economy and quality mangement are dealing with the cost-benefit relationship, to this day description, calculation, and assessment of the benefit are missing to a great extent. Deliberations in terms of cause and effect do not go beyond the model of pathogenesis (etiology - pathology - manifestation) and descriptions on the organ level (ICD). Only the international classification of impairments, disabilities, and handicaps (ICIDH) as a separate estimation of the resulting manifestations of illness on the levels of organ, individual, and society is capable to elucidate this benefit. It is the patient who is the expert to decide what he needs, what he wants, and what he can do, thus, evaluating on an individual level his loss of capability. The ICIDH is regarded as the key for the management of chronic diseases. The characteristics of being chronically ill require the integration of salutogenesis and the consideration of the hierarchy of needs. The specially developed MARA model serves as pragmatic basis for the description of the benefits of carried out and omitted interventions as changes of abilities by using the MARA curve (mean age-related ability) as ethical guideline. In quality circles the MARA model, which is based on ICIDH, hierarchy of needs and salutogenesis, can offer apatient-oriented basis of discussion for benefit assessments, and, in a pragmatical way, it can facilitate the introduction of evidence-based medicine. By the change of view from the organ level with multifactorial aspects to the individual level, in which the abilities can be understood as a monofactor, a high consensus potential between several participants of discussion in health service is possible.</p>","PeriodicalId":54318,"journal":{"name":"Forschende Komplementarmedizin","volume":"5 Suppl S1 ","pages":"90-95"},"PeriodicalIF":0.0,"publicationDate":"1998-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000057326","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20800355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}