Complementary Medicine Research

Schmidt, J.G.

doi: 10.1159/000057098pmid: N/A

doi: 10.1159/000057099pmid: N/A

Sánchez-Araujo, M.

doi: 10.1159/000057100pmid: 9892823

Objective: To establish whether the choice of the placebo treatment used may influence the outcomes of clinical trials on acupuncture or not. Design: A meta-analysis of outcomes according to the choice of the placebo. Attention was focused on the placebo design of 117 clinical, controlled trials found after an extensive search. Studies comparing acupuncture to no treatment or a reference treatment were discarded from the analysis. A set of 90 publications could be classified into one of two groups: i) Clinical studies with sham acupuncture as placebo, which consists of needling outside the meridian, but near to classical acupoints. This group of 45 trials was classified as energetic placebo model (EPM). ii) 45 studies using a placebo treatment consisting of needling within a segmental zone far enough away from the active points were classified as neurophysiological or metameric placebo model (MPM). In both groups of studies the proportions of significant results and the distribution of outcomes characterized by nonsignificant results with improvements greater than 35% in both groups of patients were assessed by the chi-square test. Results: The proportion of meaningful results was significantly higher in the MPM group [73.33% (33/45)], while only 33.33% (15/45) of such results were found in the EPM group (p < 0.03). In the EPM group 24/30 studies showed nonsignificant results with improvements greater than 35% in both groups of patients, while in the MPM group only 20% (6/30) of studies with this outcome could be observed (p < 0.05). Conclusion: Studies using EPM as placebo failed more frequently to show any differences between real acupuncture and placebo treatment than those using MPM as placebo. On the other hand, sham acupuncture appears almost as active as ‘real’ acupuncture. These results suggest that the design and the way of performing the placebo procedure determine the outcome, i. e. success or failure of a clinical trial in obtaining differences among the patients groups, in case they actually exist.

ter Riet, G.; de Craen, A.J.M.; de Boer, A.; Kessels, A.G.H.

doi: 10.1159/000057101pmid: N/A

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.

Thurneysen, A.

doi: 10.1159/000057102pmid: 9892825

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.

Schönbächler, G.

doi: 10.1159/000057103pmid: N/A

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.

Bügel, P.

doi: 10.1159/000057104pmid: 9892827

Physicians throughout medical history knew three possible ways to explain the association between treatment and cure: 1. the beneficial effect of the treatment itself, 2. the healing power of nature, and 3. the placebo effect. In the modern definition by Grünbaum, a treatment is a placebo when the effect cannot be explained by the theory that describes its activity. In clinical practice the placebo phenomenon is commonly misunderstood. Placebos are given to prove the patient wrong or to punish him. Nevertheless, most clinical pain can be reduced to at least half of its intensity by placebos. Also cough, headaches, asthma and other ailments can thus be relieved. Explanatory theories are often much narrower in focus than the phenomenon they seek to explain. A Meaning Model could offer new possibilities, as it includes the doctor-patient relationship, belief systems, social support, and feelings of mastery over the symptoms. One way to make such a model visible is the exploration of the deep-seated cultural assumptions about illness in different countries.

Kossoy, A.; Wilner, P.J.

doi: 10.1159/000057105pmid: 9892828

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.

doi: 10.1159/000057106pmid: N/A

Szasz, T.

doi: 10.1159/000057107pmid: N/A

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’.