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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.

Objective: To evaluate the course of symtoms and quality of life of migraine patients after treatment with traditional Chinese medicine. Design: Prospective observational study with 12 months follow-up. Patients: 138 consecutive patients diagnosed by a neurologist to have migraine headaches. Intervention: Complex in-patient treatment with traditional Chinese medicine including acupuncture and Chinese drug therapy. Outcomes: Number of days with headaches per month, number, intensity and duration of migraine attacks, concomitant symptoms, quality of life, global assessment and days off work. Results: The number of days with headaches per month decreased from 9 (median) at baseline to 4 at discharge and was 3 at 12 months. Also, for the other outcomes a clear improvement was seen with a slight wash-out tendency in follow-up. Conclusion: The observed patients with long-lasting migraines had a marked benefit from an in-patient treatment with traditional Chinese medicine.

Summary Background Homoeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homoeopathic remedies is equivalent to that reported for placebo. Methods We sought studies from computerised bibliographies and contacts with researchers, institutions, manufacturers, individual collectors, homoeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 186 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homoeopathy type, dilution, "remedy", population, and outcomes. Findings The combined odds ratio for the 89 studies entered into the main meta-analysis was 2·45 (95% CI 2·05, 2·93) in favour of homoeopathy. The odds ratio for the 26 good-quality studies was 1·66 (1·33, 2·08), and that corrected for publication bias was 1·78 (1·03, 3·10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2·03 (1·51, 2·74). Five studies on postoperative ileus had a pooled mean effect-size-difference of −0·22 standard deviations (95% Cl −0·36, −0·09) for flatus, and −0·18 SDs (−0·33, −0·03) for stool (both p Interpretation The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homoeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homoeopathy is clearly efficacious for any single clinical condition. Further research on homoeopathy is warranted provided it is rigorous and systematic.

Die randomisierte klinische Studie gilt als Methode der Wahl zur UberprUfung der Wirksamkeit medizinischer Massnahmen und wird fUr die komplementArmedizinische Forschung zum Teil vehement gefordert. Obwohl randomisierte Studien zweifelsfrei wUnschenswert sind, birgt eine unreflektierte Uberbetonung dieses Designs ein erhebliches Risiko, zu unsinnigen oder irrelevanten Ergebnissen zu gelangen. Anhand der Beispiele Johanniskraut bei Depression, Akupunktur bei Asthma, HomOopathie und komplexe naturheilkundliche Interventionen werden Funktion und Problematik randomisierter Studien diskutiert.

Ziel: Uberprufung immunmodulatorischer Effekte sowie von Sicherheits- und Vertraglichkeitsaspekten eines Thymushydrolysats. Design: Randomisierte placebokontrollierte Doppelblindstudie. Probanden: 24 gesunde mannliche Freiwillige. Intervention: Intramuskulare Injektion an 4 aufeinanderfolgenden Tagen von Thymushydrolysat oder Placebo. Zielkriterien: Primare Zielkriterien waren Leukozytenzahl, Lymphozytenzahl und CD4+/CD8+-Ratio. Weitere Immunparameter (einschliesslich Lymphozytensubpopulationen, Phagozytoseaktivitat) und verschiedene Sicherheitsparameter wurden monitorisiert. Bestimmungen erfolgten an 6 von 9 aufeinanderfolgenden Tagen; zusatzlich wurden an 2 Tagen mehrfach taglich Blutabnahmen vorgenommen. Ergebnisse: Zwar schwankten die dokumentierten Parameter je nach Tageszeit der Blutabnahme und zum Teil auch im Verlauf der 9tagigen Prufung, relevante Unterschiede zwischen den Gruppen wurden jedoch nicht beobachtet. In keinem Fall traten unerwunschte Begleiterscheinungen auf. Schlussfolgerungen: Immunmodulatorische Effekte, die im kausalen Zusammenhang mit der Prufmedikation stehen, konnten in dieser Studie an gesunden Probanden nicht belegt werden.

Objective: To investigate if extracts of Hypericum perforatum (St John9s wort) are more effective than placebo in the treatment of depression, are as effective as standard antidepressive treatment, and have fewer side effects than standard antidepressant drugs. Design: Systematic review and meta-analysis of trials revealed by searches. Trials: 23 randomised trials including a total of 1757 outpatients with mainly mild or moderately severe depressive disorders: 15 (14 testing single preparations and one a combination with other plant extracts) were placebo controlled, and eight (six testing single preparations and two combinations) compared hypericum with another drug treatment. Main outcome measures: A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group), and numbers of patients reporting and dropping out for side effects. Results: Hypericum extracts were significantly superior to placebo (ratio = 2.67; 95% confidence interval 1.78 to 4.01) and similarly effective as standard antidepressants (single preparations 1.10; 0.93 to 1.31, combinations 1.52; 0.78 to 2.94). There were two (0.8%) drop outs for side effects with hypericum and seven (3.0%) with standard antidepressant drugs. Side effects occurred in 50 (19.8%) patients on hypericum and 84 (52.8%) patients on standard antidepressants. Conclusion: There is evidence that extracts of hypericum are more effective than placebo for the treatment of mild to moderately severe depressive disorders. Further studies comparing extracts with standard antidepressants in well defined groups of patients and comparing different extracts and doses are needed. Key messages There is evidence from randomised trials that such extracts are more effective than placebo for the treatment of depressive disorders, but it is not known whether they are more effective for certain disorders than others Current evidence is inadequate to establish whether hypericum is as effective as other antidepressants and if it has fewer side effects Additional trials should be conducted to compare hypericum with other antidepressants in well defined groups of patients; to investigate long term side effects; and to evaluate the relative efficacy of different preparations and doses

Summary Quality assurance and related topics have become increasingly important in healthcare — a development which cannot be ignored in complementary medicine. This article discusses basic issues of quality assurance and management, and introduces the concept of scientific quality management as a new tool particularly useful for complementary medicine. Scientific quality management consists of two components: medical quality management, and attendent scientific research. Its intention is to evaluate and optimise the benefit from the patient's view as well as the costs and risks. The specific problems of scientific quality management in complementary medicine are discussed. Finally, objectives, methods, and the actual state of a scientific quality management project in a network of clinics in Germany (Klinikverbund ‘Munchener Modell’) are outlined.

Ziel: Erfassung allgemein beschreibender Merkmale, der Anwendung von komplementaren diagnostischen Testverfahren und Aspekten des therapeutischen Vorgehens von Mitghedern der Intern

Objective: To provide an overview of the evidence from randomized clinical trials about the efficacy and effectiveness of acupuncture in the treatment of asthma. Data Sources: Relevant articles were i

This article describes and discusses five placebo-controlled randomized studies investigating the immunomodulatory activity of preparations containing extracts of Echinacea in healthy volunteers. A total of 134 (18 female and 116 male) healthy volunteers between 18 and 40 years of age were studied. Two studies tested intravenous homeopathic complex preparations containing Echinacea angustifolia D1 (study 1) and D4 (study 5). Two studies (2 and 3a) tested oral alcoholic extracts of roots of E. purpurea, one study an extract of E. pallida roots (study 3b), and one study an extract of E. purpurea herb (study 4). Test and placebo preparations were applied for four (study 5) or five (studies 1-4) consecutive days. The primary outcome measure for immunomodulatory activity was the relative phagocytic activity of polymorphonuclear neutrophil granulocytes (PNG), measured in studies 1 and 2 with a microscopic method and in studies 3, 4, and 5 with two different cytometric methods. The secondary outcome measure was the number of leukocytes in peripheral venous blood. Safety was assessed by a screening program of blood and other objective parameters as well as by documentation of all subjective side effects. In studies 1 and 2 the phagocytic activity of PNG was significantly enhanced compared with placebo [maximal stimulation 22.7% (95% confidence interval 17.5-27.9%) and 54.0% (8.4-99.6%), respectively], while in the other studies no significant effects were observed. Analysis of intragroup differences revealed significant changes in phagocytic activity during the observation periods in five test and three control groups. Leukocyte number was not influenced significantly in any study. Side effects due to the test preparations could not be detected. Our studies provide evidence for immunomodulatory activity of the homeopathic combination tested in study 1 and the E. purpureae radix extract tested in study 2. The negative results of the other three studies are difficult to interpret due to the different methods for measuring phagocytosis, the relevant changes in phagocytic activity within most placebo and treatment groups during the observation period, and the small sample sizes. Future studies should be performed on patients rather than healthy volunteers and use standardized or chemically defined monopreparations of Echinacea.

Grundzuge der Weiterbildungssituation in Naturheilverfahren fur Arzte im europaischen Raum werden exemplarisch anhand der Lander Deutschland, Frankreich und Spanien beschrieben. Konsensusbildung uber

Ziel: Beurteilung der vorliegenden Evidenz zur Wirksamkeit Echinacea-haltiger PrAparate im Indikationsbereich Immunmodulation. Suchmethoden: Online-Suchen in

Three ways to enhance acceptance and publication of clinical trials in homoeopathy and confirmatory laboratory studies on serially agitated dilutions are proposed. First, we recommend the use of methodology and presentation checklists to increase the quality of original papers on research. Second, we recommend to prepare an extensive report available to interested persons if a published report does not include all relevant details. Third, we recommend establishing a preregistration data base for all confirmatory projects of research in homoeopathy.

Im Rahmen des Hochschulprojektes «Munchener Modell» – einem Modellversuch zur Integration von Naturheilverfahren in Forschung und Lehre an der LMU Munchen – sollen in einem Verbund von Spezialkliniken Naturheilverfahren erprobt werden. Hier steht nicht die Durchfuhrung kontrollierter klinischer Studien im Vordergrund, sondern die Erfassung einer Struktur-, Prozess- und Ergebnisqualitat der beteiligten Kliniken. Neben der allgemeinen Beschreibung der Qualitatssicherung als Instrument fur Wissenschaft, Organisation und Wettbewerb wird auf die charakteristischen Eigenschaften und Besonderheiten von Naturheilverfahren hin-gewiesen, die bei der Qualitatssicherung zu berucksichtigen sind. Schwerpunkt des Qualitatssicherungs-Vorhabens «Munchener Modell» bildet die Ermittlung der Ergebnisqualitat, die den patientenorientierten Nutzen (Abbau der Beschwerdeintensitat, Zugewinn an Lebensqualitat), die Kosten und das Risiko der stationaren Intervention unter Erhalt der ganzen Komplexitat der therapeutischen Situation umfassen soil. Zielsetzung ist, die Ergebnisse der Qualitatssicherung der einzelnen klinischen Einrichtungen miteinander zu vergleichen. Abschliessend werden der Aufbau der medizinischen Dokumentation, das Arbeitsprogramm und die administrative Realisation des Vorhabens erlautert.

Systematische Ubersichtsarbeiten kontrollierter klinischer Studien gewinnen auch in der KomplementArmedizin in den letzten Jahren zu-nehmend an Bedeutung. Im vorliegenden Artikel werden Durc

The present study aimed to assess the effectiveness of clinical hypnosis on the symptoms and disease activity of Rheumatoid Arthritis (RA). Sixty six RA patients participated in a controlled group design. Twenty six patients learnt the hypnosis intervention, 20 patients were in a relaxation control group and 20 patients were in a waiting-list control group. During hypnosis, patients developed individual visual imagery aimed at reducing the autoimmune activity underlying the RA and at reducing the symptoms of joint pain, swelling and stiffness. Subjective assessments of symptom severity and body and joint function, using standardised questionnaires and visual analogue scales, were obtained. Objective measures of disease activity via multiple blood samples during the therapy period and at the two follow-ups were also taken. These measurements were of erythrocyte sedimentation rate. C-reactive protein, haemoglobin and leukocyte total numbers. Results indicate that the hypnosis therapy produced more significant improvements in both the subjective and objective measurements. above relaxation and medication. Improvements were also found to be of clinical significance and became even more significant when patients practised the hypnosis regularly during the follow-up periods.

The TLC-chromatograms of Sophora flavescens root extract samples except of some quantitative deviation show a rather uniform zone pattern when detected with vanillin-sulphuric acid reagent. The Sophora tonkinensis sample did not contain the characteristic flavanones, chalcones and pterocarpan but showed only a small amount of the alkaloid Oxymatrine. Glycyrrhiza pallidiflora was devoid of both classes of compounds. In the HPLC-fingerprints of all Sophora flavescens extract samples 1–6 the characteristic flavanones, chalcones and pterocarpan were detectable at 210 and 365 nm. Neither Sophora tonkinensis nor Glycyrrhiza pallidiflora extract showed any relevant peaks which could be used for the authentity proof. For the HPLC-analysis of the alkaloids of Sophora flavescens another extraction procedure and HPLC-system has to be used.

The fingerprints of Pericarpium Citri reticulatae can be very well authenticated by TLC and especially by HPLC. The “European” fruits of Pericarpium Citri limonis and Pericarpium Citri aurantii as falsifications or adulterations can be easily distinguished from each other in TLC as well as in HPLC.

The TLC- and HPLC-fingerprint analysis has confirmed that in both processed Aconitum roots the extremely toxic alkaloid Aconitine was strongly degraded. Therefore the demand of the Chinese Pharmacopoeia seems to be fulfilled. However, since neither the processing methods used are standardized nor safe limits were stipulated for the toxic Aconitine, Mesaconitine and the other main alkaloids, it is compulsory to work out reliable, quantitative HPLC-methods to guarantee the safety of processed Aconitum species for prescription and the preparations of decoctions. It is also compulsory to perform toxicity studies to asses how safety limits(3) can be achieved without simultaneous loss of the medicinal potential. If this aim cannot be guaranteed all unprocessed and processed Aconitum drugs should be banned from the Pharmacopoeias and excluded from the market.

The authenticity of Fructus Tribuli can be very well characterized in TLC- and in HPLC-fingerprint by the presence of the characteristic flavonolglycosides and saponins.

The lipophilic ether soluble tanshinones and the water soluble phenol/caffeoyl carboxylic acids of Salvia miltiorrhiza which both contribute to the cardiovascular, antiischemic, antihyperlipidemic and antidiabetic activity of Salvia miltiorrhiza root can be best separated and evaluated using two different TLC- and HPLC-fingerprint analytical methods for the tanshinones and the phenol/caffeoyl carboxylic acids. A fast detection of both fractions can be achieved with the same MeOH-extract (Fig. 3a). The characteristic marker compounds for Salvia miltiorrhiza are Tanshinone IIA and Salvianolic acid B.