Clinical Research on Traditional Drugs and Food Items - The Potential of Comparative Effectiveness Research for Interdisciplinary Research.
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Luisenstr. 57, 10117 Berlin, Germany. Electronic address: . Journal of ethnopharmacology
(Impact Factor: 3).
02/2013; 147(1). DOI: 10.1016/j.jep.2013.02.024
In the traditional context, herbs are often used as herbal whole system therapies, however, most clinical trials included highly selected patients and applied standardized treatment protocols with the aim to exclude as much bias as possible. These studies have contributed important information on the efficacy of herbal medicine extracts; however, their results are only marginally helpful to understand the value of herbal medicine and food items in a more traditional usual care context.
The new development of comparative effectiveness research (CER) will be introduced and synergies with ethnopharmacology will be outlined.
CER provides great opportunities for guiding researchers and clinicians in improving management of disease. CER compares two or more health interventions in order to determine which of these options works best for which types of patients in settings that are similar to those in which the intervention will be used in practice. CER uses a broad spectrum of methodologies including randomized pragmatic trials that can also be applied to herbal whole system therapies. Ethnopharmacological research can provide highly relevant information for CER including data on characteristics of typical patients as well as traditional usage including methods of collection, extraction, and preparation. Recommendations for future research on traditional herbal medicine and food items are (1) a systematic cooperation between ethnopharmacology and clinical researchers and (2) a call for more CER on traditional herbal medicines and food items.
Multiple stakeholders, including ethnopharmacologists, should cooperate to identify relevant study questions as well share their knowledge to determine the optimal placement of a clinical trial in the efficacy-effectiveness-continuum.
Available from: Laura Casu
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ABSTRACT: The ethnopharmacological approach toward the understanding and appraisal of traditional and herbal medicines is characterized by the inclusions of the social as well as the natural sciences. Anthropological field-observations describing the local use of nature-derived medicines are the basis for ethnopharmacological enquiries. The multidisciplinary scientific validation of indigenous drugs is of relevance to modern societies at large and helps to sustain local health care practices. Especially with respect to therapies related to aging related, chronic and infectious diseases traditional medicines offer promising alternatives to biomedicine. Bioassays applied in ethnopharmacology represent the molecular characteristics and complexities of the disease or symptoms for which an indigenous drug is used in "traditional" medicine to variable depth and extent. One-dimensional in vitro approaches rarely cope with the complexity of human diseases and ignore the concept of polypharmacological synergies. The recent focus on holistic approaches and systems biology in medicinal plant research represents the trend toward the description and the understanding of complex multi-parameter systems. Ethnopharmacopoeias are non-static cultural constructs shaped by belief and knowledge systems. Intensified globalization and economic liberalism currently accelerates the interchange between local and global pharmacopoeias via international trade, television, the World Wide Web and print media. The increased infiltration of newly generated biomedical knowledge and introduction of "foreign" medicines into local pharmacopoeias leads to syncretic developments and generates a feedback loop. While modern and post-modern cultures and knowledge systems adapt and transform the global impact, they become more relevant for ethnopharmacology. Moreover, what is traditional, alternative or complementary medicine depends on the adopted historic-cultural perspective.
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ABSTRACT: Western herbal medicine (WHM) is a complex healthcare system that uses traditional plant-based medicines in patient care. Typical preparations are individualized polyherbal formulae that, unlike herbal pills, retain the odor and taste of whole herbs. Qualitative studies in WHM show patient-practitioner relationships to be collaborative. Health narratives are co-constructed, leading to assessments, and treatments with personal significance for participants. It is hypothesized that the distinct characteristics of traditional herbal preparations and patient-herbalist interactions, in conjunction with the WHM physical healthcare environment, evoke context (placebo) effects that are fundamental to the overall effectiveness of herbal treatment. These context effects may need to be minimized to demonstrate pharmacological efficacy of herbal formulae in randomized, placebo-controlled trials, optimized to demonstrate effectiveness of WHM in pragmatic trials, and consciously harnessed to enhance outcomes in clinical practice.
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