Chinese Traditional Herbal Medicine Volume I Diagnosis and Treatment
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It is based on the wholistic principle which recognizes the link between mind, emotions and the body. This first volume of the series focuses on the theory, principles, diagnostic methods and treatment modalities that are an essential part of the practice of Traditional Chinese Medicine. It is intended to not only provide the background and theoretical framework for the reader to understand the viewpoint from which TCM starts in its understanding of human health, but also gives the reader systemic insight and practical information to permit meaningful application of these principles.
The diagnostic method known as the Four Diagnosis is described. This method includes interrogation, observation, palpitation and listening. The underlying attempt to gain an insight and understanding into the state of the Qi the flow of energy within and outside of the body of the patient and discover what can be done to bring it back into balance and harmony.
Tierra does an immense service in revealing, ina clear and comprehensive way, the valuable system of health and healing known as TCM. In volume two he goes on to provide and extensive Materia Medica and herbal resource organized and developed for the Western practitioner.
Chinese Traditional Herbal Medicine Volume I
After developing the Materia Medica the book goes on to indicate the use of Chinese herbal formulas and the treatment of specific disease conditions. The book also provides a number of useful index listings, including Latin name, Chinese name, and Chinese Herbal formulas, as well as a general index. International herbal medicine research must use outcome measures that accurately capture the effects conferred by herbal medicines. While it is generally agreed that all human subjects research must maintain valid study designs, questions arise about the characteristics of a valid research design.
Two extreme positions are often defended. At one extreme, some researchers trained in biomedical methods of clinical investigation argue that the only valid source of knowledge regarding clinical efficacy must come from one type of research design, the randomized double blind, placebo-controlled trial. They argue that any deviations from this gold standard of scientific validity amount to worthless science.
At the other extreme, critics of biomedical research conducted on traditional medicines charge that attempts to evaluate traditional therapies with biomedical methodologies may fail to generate true knowledge, since that knowledge itself depends on a scientific vocabulary that only makes sense from within the concepts of biomedicine.
Research on herbal medicines should typically employ experimental research designs such as the RCT. Even if research tools including the RCT are imperfect, 25 they are thus far the best methods we have for furthering our knowledge. Despite these complexities, investigators have successfully adapted double-blind RCT designs to complex individually tailored Chinese herbs.
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Bensoussan et al. In other instances, cluster RCTs can allow for practitioner variability, while still rigorously testing the efficacy of a therapeutic approach. In cross-cultural settings, researchers cannot merely adopt alternative designs in an ad hoc manner, but must reflect on and refine their research question, and find a design that best answers the research question within the given cultural context.
In recent years, growing attention has been paid to a group of additional important ethical issues surrounding publication bias, financial conflicts of interest, and clinical trial registries.
In the arena of traditional herbal medicine, these same issues apply, and when cross-cultural differences exist in the definitions of valid science, as is the case in traditional herbal medicine research, these questions compound. For instance, until recently, there was a tendency to see only positive studies published in China. It is, therefore, critically important to the long-term scientific credibility of international traditional herbal medicine research that, at the outset, partners agree about the standards of scientific conduct, the disclosure of financial relationships, registration of clinical trials, and adequate reporting of trial results.
In international herbal medicine research, several practical challenges arise in making accurate risk—benefit determinations. Typically, in American pharmaceutical development, a step-wise process of drug testing occurs — a compound is isolated, tested in tissue cultures and animals, and then investigated in phase 1, 2 and 3 clinical trials.
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However, herbal medicines are already in widespread use, are often used in combination, and are drawn from plant sources with their own variability in species, growing conditions and biologically active constituents. They often come into use by a process of trial and error, or over centuries.
Accordingly, in clinical herbal medicine research there is rarely a strong preclinical basis for dosing, and there are significant looming questions about product purity, quality, chemical stability and active constituents at the time herbal medicine trials are proposed. Initiating large-scale research trials in such circumstances raises questions about whether the risks and benefits of research participation can be accurately ascertained.
Those reviewing protocols should factor in the uncertainty associated with product variability in determining whether a herbal medicine trial has a favourable risk—benefit ratio. However, protocol reviewers i.
While researchers should provide such information in protocol materials, reviewers must remain aware of the role their own lack of familiarity may play in their ultimate judgements of risks and benefits of the research. Researchers increasingly agree that it is important to establish a rational basis for dosing and standardization of biologically active compounds before conducting large-scale treatment trials. Likewise, more rigorous monitoring of adverse events and standardized reporting of research results for both safety and efficacy data will improve long-term efforts to enhance risk—benefit ratio determination for trial participation.
Cultural factors also may influence judgements of the risks and benefits in herbal medicine research. For instance, a cultural familiarity with many traditional Chinese herbal medicines in China may promote a familiarity bias, accepting a widespread cultural assumption of safety, based on the historical use of herbal medicines.
In order for international collaborative herbal medicine research to achieve its objectives, it will be important to establish standards of evidence for demonstration of safety before conducting large-scale clinical trials evaluating the efficacy of herbal medicines. How can international collaborative herbal medicine trials achieve the ethical requirements outlined above?
Collaborative partnership, the first requirement for international research ethics, provides both the rationale and the context for achieving appropriate application of the other ethical requirements.
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Partners in these collaborations must share vocabulary for all the requirements, especially for social value, scientific validity, and favourable risk—benefit ratio. How can agreed-upon language be achieved? As illustrated here, these challenges are significant. In the case presented earlier, investigators should have reservations about implementing a large-scale clinical trial for Africa Flower.
Nevertheless, the local interest in this substance may be valid and deserve some additional preliminary investigation. Collaborative partnership displays a commitment by all parties in international research agreements to work together for common language and goals. To achieve collaborative partnership, parties can engage in structured methods of democratic deliberation to devise shared language and concepts for research.
These methods have been used to bring different parties together in a safe and collegial process of decision-making. Furthermore, sustainable collaborative research partnerships would benefit from robust and independent adverse-event reporting systems for herbal medicines so that the risk—benefit ratio for herbal medicine research can be more clearly defined.
Ethical challenges in international traditional herbal medicine call for a comprehensive framework.
Addressing these challenges requires collaborative partnership that implements sound research designs. So envisioned, international herbal medicine research can contribute to global health. Franklin G Miller and Jack Killen generously read and offered helpful suggestions on earlier versions of this paper. Health Topics. World Health Statistics. About Us. Skip to main content. Herbal medicine research and global health: an ethical analysis Jon C Tilburt a , Ted J Kaptchuk b Introduction Traditional herbal medicines are naturally occurring, plant-derived substances with minimal or no industrial processing that have been used to treat illness within local or regional healing practices.
Ethical framework Cases like these present challenging questions related to the role of traditional herbal medicines in public health. Table 1. A comprehensive framework for research ethics html, 3kb Social value All research should hold the potential to achieve social value. Scientific validity Part of ensuring the social value of research includes devising and implementing sound science. Balancing internal and external validity Building a valid basis for knowledge in herbal medicine will require balancing two aspects of scientific validity: internal and external validity.
Chinese Traditional Herbal Medicine, Vol I, by Michael and Lesley Tierra
Inclusion and exclusion criteria To ensure that research results are externally valid, the inclusion and exclusion criteria for research participation should fit with existing diagnostic categories in the target population specified by the research question. Valid outcome measures International herbal medicine research must use outcome measures that accurately capture the effects conferred by herbal medicines.
Determining research design While it is generally agreed that all human subjects research must maintain valid study designs, questions arise about the characteristics of a valid research design. Favourable risk—benefit ratio In international herbal medicine research, several practical challenges arise in making accurate risk—benefit determinations. Improving science through collaborative partnership How can international collaborative herbal medicine trials achieve the ethical requirements outlined above?
Competing interests: None declared. References SARS.