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Research and the Goal of Improving Patient Care. 改善病人护理的研究与目标。
Q Medicine Pub Date : 1998-01-01 DOI: 10.1159/000057330
Edwards

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.

本文的目的是提出与我们的研究方法的基本假设以及传统医疗保健和补充和替代医疗保健中健康/疾病的本质相关的问题。从随机对照试验和结局研究两方面讨论了不同类型的疗效。不同受众对研究结果的需求表明,研究人员需要在知识状态的背景下仔细指定研究问题。研究设计的适当匹配,疾病的性质,治疗的性质和已知的东西是设计和实施研究的关键,这些研究实际上可以改善病人的护理。
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引用次数: 2
The Use and Abuse of Placebo in Clinical Trials. 临床试验中安慰剂的使用和滥用。
Q Medicine Pub Date : 1998-01-01 DOI: 10.1159/000057332
Kleijnen

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.

这篇文章特别关注了当标准药物已经可用时,在新药评估中使用安慰剂的利弊。安慰剂使盲法成为可能,从而有助于在评估试验结果时控制测量偏差。在决定是否使用安慰剂时,需要考虑几个因素。有法律方面、注册要求、商业利益、医疗问题和科学方面。当患者的病情不危及生命,并且安慰剂治疗没有不可逆转的后果时,即使有标准药物可用,也可以而且应该在所有研究中使用安慰剂,但显然只有在知情同意之后。如果在评估新药与标准药物时忽略安慰剂组,则证据不足。显然,这会导致伦理方面和科学方面的冲突,但如果不使用安慰剂组,它将减缓医学的发展,减少治疗的可能性。
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引用次数: 5
Zur Eigenheit von homöopathischen Arzneimitteln und ihrer Wirkung aus naturwissenschaftlicher Sicht. 从科学的观点来看,顺势医学药品的特性和效果。
Q Medicine Pub Date : 1998-01-01 DOI: 10.1159/000021114
Dittmann, Weingärtner, Harisch

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.

从科学的角度看顺势疗法的特点和功效这项工作的目的是介绍顺势疗法的具体特点,正如物理学家所看到的那样,并通过应用生化方法解释它们的作用表现。2. 物理方法被认为对顺势疗法效力的特殊特性的研究是足够的。由于逻辑上的原因,这些方法目前只能是理论性的。实质上,增强过程的基本假设与顺势疗法效力的治疗活性成分(= TAI)必须具有的必要品质的需求有关。提出了一个理论模型,该模型应该通过制定TAI传递的学习过程来实现潜能和TAI之间的联系。3.利用生物化学的方法,可以研究顺势疗法的功效。根据体内和体外试验的结果,发展了它们的作用展示模型。
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引用次数: 0
Pragmatic Randomised Controlled Trials for Complex Therapies. 复杂疗法的实用随机对照试验。
Q Medicine Pub Date : 1998-01-01 DOI: 10.1159/000021089
Resch

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.

为了能够“预测”干预成功的程度或可能性,了解暴露和效果之间的因果关系至关重要。随机对照临床试验(RCT)通常被认为是确定因果关系的黄金标准。除了伦理限制或罕见疾病,很少不可能进行随机对照试验。然而,有时,由于患者或治疗师不愿参与、缺乏资金、组织限制或无法获得提供治疗的技术技能,随机对照试验可能不可行(至少乍一看)。为了克服这些问题,已经提出了多种设计方案,如临床首选治疗、单同意设计、双同意随机设计、预随机化、集群随机化和响应适应设计(“玩赢家”)。对于复杂的(“联合模式”)治疗,研究整个治疗方案对患者的影响而不是单个成分的价值似乎是合理的。改为开放标签或可选交叉允许在随机对照试验框架内进行“个体化治疗”和“个体化结果”。对于临床医生和研究人员来说,把重点放在寻找适合他们当前问题的合适设计上,而不是人为地将他们的研究调整为一个尴尬的标准设计(甚至放弃寻找一个开放问题的答案的想法),这似乎是明智的:存在的选择比人们想象的要多得多。
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引用次数: 1
Das Resonanzphänomen. 共振现象。
Q Medicine Pub Date : 1998-01-01 DOI: 10.1159/000057102
Thurneysen

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.

在顺势疗法的病例处理过程中,人们可以观察到一种强烈的动态互动,在此过程中,患者通常会体验到一种最终被感知和被认真对待的感觉。因此,他会开始告诉更多不被问到的细节。通过本草知识的联想链接使顺势疗法医生甚至间接地接近尚未发现的领域。面谈越随性,就越有可能释放病人的中心关键点。在这种情况下,会产生一种特殊的感觉,作者称之为共振现象;这种感觉很难用语言表达出来,但却非常明显——在作者的例子中是在太阳神经丛区域。在这一刻,病人和顺势疗法医生立即意识到病人的历史达到了一个非常重要的点。这一要点的思想、本质、问题或性质,绝对必须由后一种规定的补救办法予以涵盖。由于这种现象是不可测量的,所以导致这种现象发生的条件是否只是一种安慰剂效应,这个问题仍然没有得到解答。
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引用次数: 1
The Therapeutic Alliance in Randomized Controlled Clinical Trials. 随机对照临床试验中的治疗联合。
Q Medicine Pub Date : 1998-01-01 DOI: 10.1159/000057105
Kossoy, Wilner

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.

对于那些治疗患者和进行临床试验的人来说,治疗联盟是熟悉的,许多人认为在研究中是一种非特异性效应。治疗联盟的概念源于医患关系,并在心理动力学心理治疗的背景下被广泛讨论。研究表明,联盟的强度是心理治疗结果的一个强有力的预测因素,并强调了它在确保药物治疗依从性方面的重要性。然而,在随机对照临床试验中,很少有实证研究检验治疗联盟对患者依从性和保留性的影响。此外,一些人认为治疗联盟是临床试验的必要和积极组成部分,而另一些人则认为这是一个混淆变量,两者之间存在紧张和争论。那些认为这是一个混淆变量的人认为,这种联盟可能会影响患者的参与,并使治疗效果的评估变得困难。我们报告了我们对一项成人精神分裂症患者的观察结果,他们参加了一种新的抗精神病药物的临床试验。我们假设,在治疗联盟的强度和随后的依从性和保留参加临床药物试验的患者之间存在关联。这些构念之间的关系可以通过经验检验,治疗联盟与临床反应评估之间的关系也可以通过经验检验。
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引用次数: 1
Theorie und Erfahrung in der Medizin: Orthodoxe Wissenschaft und ganzheitliche Kybernetik. 理论和医学经验:正统科学及整体认知学
Q Medicine Pub Date : 1998-01-01 DOI: 10.1159/000057109
Zycha

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.

医学理论与实践:正统科学与综合控制论当今卫生保健系统的问题需要彻底改变观点。随着现代唯物主义-还原论自然科学的定位,大学研究的重点从主观的可确定的治疗转向了客观的物理和化学方法可测量的发病机制。自然科学研究对各种疾病及其病因所表现出的不同病理变化特别感兴趣,而不是对一个痊愈的人的持续相似的正常状态感兴趣。这导致了一种观点,即所调查的因果链的逆转等于愈合;治愈和疾病被认为是对立的。这种思维方式导致了越来越多的问题,这是由于因果原则的可疑性质,从日常思维转移到微观世界。这些因果链中的每一个都代表了复杂的自然相互关系的人为线性化,此外,永远无法跟进其结果。这种还原论思维的无限倒退只能被不太可能的假设人为地阻止,这些假设导致了错过治愈的成功和现代疗法的多种副作用——导致了理论与经验之间的差异。今天,控制论以一种整体精神的观点向我们展示了一条新的道路。控制论导致了对生命过程的基本假设自由的洞察和对疾病的科学合理的定义:疾病和治疗不应该被认为是相反的,因为治疗已经在发病机制中奠定了!控制论尤其会带来人们期待已久的顺势疗法的科学证据,除此之外,还会证明顺势疗法的治疗原理是整个医学领域所有成功疗法的普遍自然原理。
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引用次数: 7
Der Patient als Experte. 病人是专家
Q Medicine Pub Date : 1998-01-01 DOI: 10.1159/000057326
Dubs

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.

当卫生经济和质量管理在处理成本效益关系时,对效益的描述、计算和评估在很大程度上是缺失的。对因果关系的讨论不会超出发病机制(病因-病理-表现)和器官水平(ICD)的描述模型。只有国际缺陷、残疾和残障分类(ICIDH)作为对器官、个人和社会水平上的疾病表现的单独估计,才能阐明这种益处。病人才是决定自己需要什么、想要什么、能做什么的专家,从而在个人层面上评估自己能力的丧失。ICIDH被认为是慢性病管理的关键。慢性疾病的特点需要健康发生的整合和需求层次的考虑。特别开发的MARA模型,以MARA曲线(平均年龄相关能力)为伦理准则,作为能力变化描述已实施和未实施干预的效益的实用基础。在质量界,以ICIDH、需求层次和健康发生为基础的MARA模型可以为效益评估提供以患者为导向的讨论基础,并在实用上促进循证医学的引入。通过从具有多因素方面的器官水平到可以将能力理解为单一因素的个人水平的观点转变,在保健服务的讨论中,几个参与者之间有可能达成高度共识。
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引用次数: 2
期刊
Forschende Komplementarmedizin
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