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There are only few experimental studies that assess the hypothesis that placebo analgesia is mediated by endogenous opioids. One of these studies [Grevert P, Albert LH, Goldstein A: Partial antagonism of placebo analgesia by naloxone. Pain 1983;16:129-143] had a rather complicated design and data presentation. In this commentary we attempt to clarify the experimental design of that study. Based on a clearer understanding of the study procedures and data analysis we ropose some alternative interpretations of the results.

Disease is a fact of nature. Diagnosis is an artefact constructed by human beings. The core concept of disease is a bodily abnormality. Literally, the term 'disease' denotes a demonstrable lesion of cells, tissues, or organs; metaphorically, it may be used to denote any kind of malfunctioning, of individuals, groups, economies. Classic nosology was descriptive, based on somatic pathology. The diagnostician sought to anticipate and approximate the pathologist's findings at autopsy, that is, identify the patients's bodily lesion/disease and its material cause (etiology). For example, the term 'pneumococcal pneumonia' identifies the organ affected, the lungs, and the cause of the illness, infection with the pneumococcus. Contemporary nosology is strategic, based on economic, legal, social, and other interests (unrelated to disease as somatic pathology). The diagnostician seeks to secure reimbursement for medical services, legitimize treatment, justify defining undesirable behavior as disease, and so forth. For example, diagnosis-related groups provide bureaucratic rationale for reimbursing medical services by third-party payers; psychiatric diagnoses provide legal-scientific rationale for treating mental diseases as if they were brain diseases; and so forth. Formerly, diagnoses encoded the objectively verifiable condition of the patient's body (diseases). Today, diagnoses rationalize the health-care policy of the body politic (methods of controlling costs and compensating physicians). We are witnessing the transformation of nosology from the medical-scientific classification of disease as somatic pathology, into the medicalized justification of social policy as 'health care' or 'treatment'.

The Place of Randomisation in Clinical TrialsRandomised clinical trials are nowadays the accepted gold standard for treatment comparisons. However, controversies still exist concerning the possibility to perform randomised trials or the adequacy and the ethical appropriateness of randomisation. Randomisation is sometimes credited with advantages it does not possess, and an extremely negative view or even a categorical rejection of non-randomised trials is found. This attitude may be comprehensible from a historical, pragmatic or educational viewpoint, but is not well-founded on epistemological grounds. This article argues that non-randomised clinical trials are needed, clarifies the role of randomisation in clinical trials and analyses the arguments raised against the validity of results from observational studies. It is shown that it has not been demonstrated up to now that well-designed and analysed observational studies would have yielded results that are distinct or even qualitatively different from results of similar randomised clinical trials. Although one is well advised to randomise whenever possible, there is still room for a considerable improvement of observational studies: Randomisation itself should be the only difference between observational studies and randomised clinical trials.

Autogenic Training - Qualitative Meta-Analysis of Controlled Clinical Studies and Relation to NaturopathyAutogenic training is a relaxation technique based on autosuggestions and practice in the perception of 'natural' relaxating processes of the body with an increasing calm basic attitude. The psycho-physiological changes that occur after periodical exercises can be explained by a plausible model which has been empirically proved in many of its aspects. With regard to methodological aspects the present study deals with the qualitative meta-analysis of 64 controlled clinical studies from 1952 to 1997. The clinical effect of autogenic training on the main symptoms as exclusive or at least central psychotherapeutic intervention (partly in combination with a somatic basic therapy) was evaluated. It was proved that autogenic training has positive effects on psychosomatic disorders (hypertension, asthma, intestinal diseases, 'vegetative dystonia', glaucoma, atopic eczema), on preparation for childbirth, sleep disorders and anxiety disorders. A positive effect can also be expected in case of headaches and Raynaud's disease, however, other relaxation techniques seem to be superior in these cases. Moreover, positive effects on the mood (e. g. depressive symptoms) and the general subjective condition (e. g. 'quality of life') have been proved by many studies. Hence indications can be derived according to the basic rules of evidence-based medicine. Nevertheless there are contraindications, for instance regarding exogenous, acute schizophrenic or affective psychosis. Beyond that the preparedness to therapy of many patients can be improved if the therapeutic offers are enlarged by autogenic training as a 'low level' offer. Autogenic training is an effective and useful component of preventive, rehabilitative or therapeutic interventions and can last but not least be part of therapeutic interventions which include naturopathy.

Placebo from a Biosemiotic Point of View The rise and success of modern science, first in physics, later in medicine, was based on a mechanic linear model of causality. Its only category of explanation of natural processes is the mechanical machine. As human beings using and processing signs we cannot recognize ourselves in this reductionistic model. As all living creatures we perceive, interpret and answer the stimuli of the environment. To explain the behaviour of organisms we need a semiotic-circular causality. Semiotics, the study of signs, can be subdivided in semantics, the theory of meaning of signs, in syntax, the theory of the forms and the arrangement of signs, and in pragmatics, the theory of the contextual rules of communication. Semiotics is not exclusively concerned with language, but helps as so-called biosemiotics also to explain the network of communication of a living organism. The 'Denkstil' of established pharmacology is likewise restricted to mechanistic causality. One of the consequences is the fact that theplacebo effect is defined as 'non-specific' or 'non-characteristic'. Such negative definitions exclude concrete questions of investigation. We have to accept a biosemiotic view in pharmacology, to see drugs as signs consisting of a physical vehicle equipped with meaning. The therapy with drugs must be seen in a broader treatment context investigated by pharmacopragmatics. The semiotic expansion of pharmacology does not invalidate the achievements of classic pharmacology, but elucidates in addition a view of the pragmatic components and makes the scientific integration of the placebophenomenon into drug therapy possible. The placebo effect loses its inconsistency.

Every treatment, in classical no less than in unorthodox medicine, includes a so-called 'placebo' component. Such ingredients are more accurately described as non-specific factors (NSF), for several reasons, including the fact that they are not invariably pleasing. The purpose of the title of this contribution is to provoke a discussion of NSF, leading to their classification and the description of a quantitative method (based on Judgment Analysis) of estimating the amount of 'placebo-ness', or 'non-specificity', attributable to any treatment, whether surgical or intercessory prayer.

Best-Case Analyses of 4 Current Unconventional Therapies in OncologyBest-case analyses are - under certain circumstances - a useful method to decide on the tumor-specific efficacy of unconventional treatments, without performing formal clinical studies and with limited expenditure. As part of the activities of the 'Arbeitsgruppe Biologische Krebstherapie', sponsored by the 'Deutsche Krebshilfe', an analysis and second-opinion judgement (according to internationally accepted standards) of their 'best cases' was offered to 36 manufacturers and users of unconventional cancer drugs and methods, who in public propagated these as effective cancer therapies. Only few of the approached offerers were both willing to cooperate and able to provide significant documentation for such an analysis. Therefore, only four best-case analyses could be performed completely. The work-up of the available documentation was not very convincing in all four cases, especially when considering that a positive selection from hundreds or even thousands of applications had taken place. The results of the analyses did not reveal any well-founded evidence for a tumor-specific effectiveness of the corresponding applications. The discrepancy between the offerers and the working group's judgements results especially from the circumstance that the majority of the treatments were not performed on patients with advanced tumor disease without any other conventional therapies, but additionally to established therapies or as an adjuvant treatment protocol. Other reasons were the obvious misjudgement of findings, the assessment of unimportant or unsuitable parameters, the misinterpretation of the probably normal development as a treatment success or also documentation inappropriate for evaluation.

OBJECTIVE: Evalution of low-intensity laser irradiation on the healing of bone affections and gangrene in patients suffering from diabetic microangiopathy. DESIGN: Case-report study. PATIENTS: Two consecutive diabetic male patients with gangrene, osteomyelitis, and bone fractures. INTERVENTION: Helium-neon laser irradiation (36 J/cm2 ) 50 min/day. MAIN OUTCOME PARAMETER: Healing of gangrene and corticalis lesion as well as remineralisation of bone affections. RESULTS: Within a mean period of 14 weeks not only a complete healing of the diabetic gangrenes but also a radiographically determined reestablishment of corticalis and remineralisation of preexisting bone affections could be achieved. CONCLUSION: We therefore conclude that low-intensity laser irradiation should be further tested as an additional beneficial therapeutic modality for the healing of gangrene and bone affections in diabetic patients.

Reliability of Mandel's Energy Emission Analysis (EEA) in Sick PersonsOBJECTIVE: Is the Energy Emission Analysis (EEA) according to Mandel a reliable diagnostic instrument in severely diseased patients? PATIENTS: 30 patients of the Stauferklinik Schwäbisch Gmünd, Germany, suffering from a great variety of diseases. STUDY DESIGN: At regular intervals of 10-15 min 4 Kirlian photos of fingers and toes were taken from each patient. An experienced rater blindly assessed all photos according to the EEA sectors with respect to remarkable phenomena. Additionally he defined the most affected circles of functions of Traditional Chinese Medicine (TCM). RESULTS: The circles of functions of kidney/bladder and spleen/pancreas/stomach appeared to be the most affected in nearly all photos, the reliability is estimated by a rather low intraclass-kappa of 0.14 (95% CI: 0.00-0.29, p = 0.0279. Reliabilities of single EEA sectors also are low and similar to those of healthy persons. CONCLUSIONS: The reasons for the moderate reliability may be attributed to fluctuations of Chi, increasing regulation rigidity of diseased persons or simply to technical limitations of the method.Possibly new realtime Kirlian devices can provide additional information.