From medical tradition to traditional medicine: A Tibetan formula in the European framework.

ETHNOPHARMACOLOGICAL RELEVANCE: The increasing prevalence of complex multi-factorial chronic diseases and multimorbidity reveals the need for an enlargement of the therapeutic options. Potent multicompound herbal formulations from traditional medicine systems such as Tibetan Medicine might meet the requirements. With its practice over the centuries Tibetan Medicine is one of the important medical heritages of the world. In the 20th century Tibetan formulas came to Switzerland, where the formula Gabur-25 was then registered as medicine in 1977 (Padma 28, Swissmedic No 35872). The new European directive 2004/24/EC opened the avenue for traditional herbal medicinal products and registrations followed in Austria (HERB-00037) and the UK (39568/0001). The aim of this review was to analyse not only the critical points and hazards but also chances that occur in the endeavour of bringing a ethnopharmacological based preparation to the market within a modern Western medical and regulatory framework and to discuss the necessary transformation steps from a traditional herbal formula towards a modern pharmaceutical product with the example of the Tibetan formula Gabur-25. METHODS: The historic transformation process from the 19th to the 21st century is analysed, using the registration documents and other material from the library of Padma AG, Hinwil, Switzerland. RESULTS: The transformation of a traditional formula into a modern traditional herbal medicinal product according to the present EU regulations is a multi faceted process. The modern indication represents only a small part of the possible traditional indications. Quality and product labelling has to be adopted to modern standards. The formula, once registered, is a fixed combination of herbal and mineral ingredients. Contrary to this the concept of Asian medical tradition allows a certain flexibility in the composition of an herbal formula. The ingredients are constantly adapted to local conditions, availability of raw material and therapeutic situation. CONCLUSIONS: The example shows that in principle complex herbal formulas from Asian medicine can meet the requirements of the European regime of traditional herbal medicinal products. A structured process of transformation from a traditional herbal formula to a modern medicinal product has to include selection of a suitable formula, development of an analytic concept and selection of a suitable indication with regard to the empirical set of possible indications. To extend the range of high quality medicinal products from other medical traditions within the European context the European legislators have to re-evaluate the imposed restrictions given in directive 2004/24/EC. Without amendment of the prerequisite of 15 years documented use in the EU and the limitation of indications for traditional herbal medicinal products, European citizens will be excluded from access to high quality medical traditions with their accumulated empirical knowledge.

[Tibetan formulas as pleiotropic signatures--application of network medicines in multimorbidity]. / Tibetische Rezepturen als pleiotrope Signaturen--Einsatz von Netzwerk-Arzneien bei Multimorbidität.

In the context of the network model of the organism, multimorbid states (≥ 2 chronic diseases at the same time) can be considered as a complex disease pattern which can be mapped as characteristic signatures. From the perspective of system theory, living systems such as the human body are viewed as networks of interacting parts. These in turn can themselves be subnetworks assigned to different complexity levels. They range, e.g., from the gene to the transcriptome, proteome, metabolome, and epigenome up to the network of the entire molecular interactions, the so-called interactome. In multimorbidity, the disease signature affects different networks at all levels, e.g., cell systems, organs, and functional systems. Based on this semiotics, certain signatures of effectiveness and profiles of action can be assigned to each drug. A drug signature represents the physicochemical stimuli that cause a reaction by the system, as well as the cross-links by which the entire connected system is affected at all levels. Phytotherapeutics, which chemically represent multi-component mixtures, have especially complex signatures. As multi-target medicines with a pleiotropic effect profile, they therapeutically affect different levels of the network, which is why they are also referred to as network medicines. Herbal formulas from traditional medicine systems such as Tibetan Medicine are an example for phytotherapeutics with a particularly complex pleiotropic signature. Also from the traditional point of view, a disease signature is set in relation with a corresponding drug signature. However, in this case, it is based on the traditional energetic understanding of diseases. Modern research results clearly indicate a widely diversified signature range of Tibetan Medicines and thus provide a rationale for their use in integrative treatment approaches for diseases with complex signatures, e.g. in multimorbidity. The system-theoretical approach discussed here represents a method to enable a connectivity of traditional methods from complementary and alternative medicine to the other disciplines of modern medicine.

[Early encounters of German-language explorers with the Tibetan medicine in Siberia in the modern era]. / Frühe neuzeitliche Begegnungen deutschsprachiger Forscher mit der tibetischen Medizin in Sibirien.

The spreading of Tibetan Buddhism and with it the Tibetan medicine in the region east of Lake Baikal, goes back to the 17th century. At the beginning of the 18th century, German speaking scholars were among the first to undertake scientific expeditions through Siberia. As such they were amongst the first scientists of the modern era who encountered the traditions, concepts, and therapeutic methods of Tibetan medicine. The aim of this article is to describe and analyze these first encounters with Tibetan medicine by the example of selected men of science of the 18th and 19th century. This work is based on extensive studies of sources in archives and libraries in Russia and Switzerland. We found documents related to the following scientists: Daniel Gottlieb Messerschmidt (1685-1735), Johann Georg Gmelin (1709-1755), Erik Laxmann (1737-1796), Friedrich Adelung (1768-1843), and Joseph Rehmann (1779-1831). They mentioned the distribution of Tibetan medicine within Russia, the use of medicinal plants and formulas as well as therapeutic techniques. For the scientific community of the time these first encounters of Europeans with practitioners of Tibetan medicine could not lift Tibetan medicine out of other exotic context in the field of ethnography. For today's researchers, these encounters are an important evidence for more than 300 years of development of Tibetan medicine on the vast territory of Siberia. The practice and the scientific examination of Tibetan medicine in Siberia is an active endeavor until today. The present work shows that it is possible and rewarding to follow up the historic and cultural connections from Europe to Asia via the Siberian link.

Unique aspects of herbal whole system research.

INTRODUCTION: Whole systems of healthcare offer unique methodological and theoretical challenges for researchers. Herbalism has its own set of methodological and philosophical research issues that are beyond those presented for whole system research in general. It was our objective to explore various conceptual and methodological issues surrounding whole system herbal research. METHODS: An International Society for Complementary Medicine Research workshop, Challenges in Herbal Whole System Research, was presented. Starting from a definition of herbalism, the most important challenges to herbal whole system research were elicited with inputs from both the workshop presenters and the audience. RESULTS: Five major challenges unique to herbal whole system research were identified: (1) defining herbalists and herbalism, (2) the role of the natural products industry in herbal research, (3) designing placebos and delivering active herbal treatments as given by herbalists, (4) researching the herb as a living entity, and (5) designing trials to investigate and develop multicomponent herbal therapies. CONCLUSIONS: Unique methods and theoretical frameworks are required to design studies of herbalism. Solutions to these methodological challenges need to be addressed to conduct research that examines herbal systems of medicine versus conducting trials on individual herbs given out of their original therapeutic context.

[Tibetan medicine in Europe: historical, practical and regulatory aspects]. / Tibetische Arzneimittel in Europa: Historische, praktische und regulatorische Aspekte.

Being one of the great medicine systems of the world, Tibetan Medicine developed in the 8th century AD and spread throughout central Asia over the intervening centuries. The first European contact with Tibetan remedies started around 1850 in Russia. By and by, they made their way as far a Switzerland where, in the meantime, they have been produced for more than 30 years and licensed by the health authorities. During the last years, comprehensive clinical and experimental research material has been generated on several formulas, especially on Padma 28 and Padma Lax. At the same time, a genuine European pool of experience was gained. Tibetan remedies are multicomponent mixtures. Special requirements on quality assessment, efficacy and safety arise on the path to a modern Tibetan multicompound. The production of such elaborately formulated com-positions has to take into account modern demands of GMPas well as traditional sources. In recent years, a rising popularity of Asian medicine can be observed. This need of patients, physicians and therapists also demands answers from the regulatory part. Aspects such as the justification of the composition (rationale of combination) and certain quality standards have to be newly defined by the authorities in this context. Only with adapted regulatory frameworks Tibetan medicines can find their place in Europe and, together with other medical traditions and biomedical research, integratively enrich the arsenal of intervention and prevention of Western industrial societies.

Spontaneous ultraweak photon emission from biological systems and the endogenous light field.

Still one of the most astonishing biological electromagnetic phenomena is the ultraweak photon emission (UPE) from living systems. Organisms and tissues spontaneously emit measurable intensities of light, i.e. photons in the visible part of the electromagnetic spectrum (380-780 nm), in the range from 1 to 1,000 photons x s-1 x cm-2, depending on their condition and vitality. It is important not to confuse UPE from living systems with other biogenic light emitting processes such as bioluminescence or chemiluminescence. This article examines with basic considerations from physics on the quantum nature of photons the empirical phenomenon of UPE. This leads to the description of the non-thermal origin of this radiation. This is in good correspondence with the modern understanding of life phenomena as dissipative processes far from thermodynamic equilibrium. UPE also supports the understanding of life sustaining processes as basically driven by electromagnetic fields. The basic features of UPE, like intensity and spectral distribution, are known in principle for many experimental situations. The UPE of human leukocytes contributes to an endogenous light field of about 1011 photons x s-1 which can be influenced by certain factors. Further research is needed to reveal the statistical properties of UPE and in consequence to answer questions about the underlying mechanics of the biological system. In principle, statistical properties of UPE allow to reconstruct phase-space dynamics of the light emitting structures. Many open questions remain until a proper understanding of the electromagnetic interaction of the human organism can be achieved: which structures act as receptors and emitters for electromagnetic radiation? How is electromagnetic information received and processed within cells?