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      Herbal Medicine Today: Clinical and Research Issues

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          Abstract

          Herbal medicine is the use of medicinal plants for prevention and treatment of diseases: it ranges from traditional and popular medicines of every country to the use of standardized and tritated herbal extracts. Generally cultural rootedness enduring and widespread use in a Traditional Medical System may indicate safety, but not efficacy of treatments, especially in herbal medicine where tradition is almost completely based on remedies containing active principles at very low and ultra low concentrations, or relying on magical-energetic principles.

          In the age of globalization and of the so-called ‘plate world’, assessing the ‘transferability’ of treatments between different cultures is not a relevant goal for clinical research, while are the assessment of efficacy and safety that should be based on the regular patterns of mainstream clinical medicine.

          The other black box of herbal-based treatments is the lack of definite and complete information about the composition of extracts. Herbal derived remedies need a powerful and deep assessment of their pharmacological qualities and safety that actually can be realized by new biologic technologies like pharmacogenomic, metabolomic and microarray methology. Because of the large and growing use of natural derived substances in all over the world, it is not wise to rely also on the tradition or supposed millenarian beliefs; explanatory and pragmatic studies are useful and should be considered complementary in the acquisition of reliable data both for health caregiver and patients.

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          What are pragmatic trials?

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            Research into complementary and alternative medicine: problems and potential.

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              Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research.

              Policy and clinical management decisions depend on data on the health and cost impacts of psychiatric treatments under usual care, i.e., effectiveness. Clinical trials, however, provide information on treatment efficacy under best-practice conditions. An understanding of the design, analysis, and conventions of both efficacy and effectiveness studies can lead to research that better informs clinical and societal questions. This paper contrasts the strengths and limitations of clinical trials and effectiveness studies for addressing policy and clinical decisions. These research approaches are assessed in terms of outcomes, treatments, service delivery context, implementation conventions, and validity. Clinical trials and effectiveness research share problems of internal and external validity despite more attention to internal validity in clinical trials (e.g., randomization, blinding, standardized protocols) and to external validity in effectiveness studies (e.g., community-based treatments, representative samples). To develop research at the interface of clinical trials and effectiveness studies, research goals must be redefined, and methods, such as cost-utility and econometric analyses, must be shared and developed. Development of hybrid designs that combine features of efficacy and effectiveness research will require separation of conventions such as frequency of follow-up, intensity of measurement, and sample size from the central scientific issues of aims and validity.
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                Author and article information

                Journal
                Evid Based Complement Alternat Med
                ecam
                ecam
                Evidence-based Complementary and Alternative Medicine : eCAM
                Oxford University Press
                1741-427X
                1741-4288
                September 2007
                : 4
                : Suppl 1 , ETM 2007 EUROPEAN TRADITIONAL MEDICINE International Congress VINCI, ITALY -October 4-6, 2007
                : 37-40
                Affiliations
                Center of Natural Medicine, S.Giuseppe Hospital, Empoli, Italy
                Author notes
                For reprints and all correspondence: Fabio Firenzuoli, MD, Center of Natural Medicine, Director S. Giuseppe Hospital, Via Paladini 40 – 50053 Empoli, Italy. Tel: +39-0571-702601; Fax: +39-0571-702639; E-mail: f.firenzuoli@ 123456usl11.toscana.it
                Article
                10.1093/ecam/nem096
                2206236
                18227931
                a1eba503-91cf-42f5-9507-fbbaf6096b32
                © 2007 The Author(s).

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Categories
                Original Articles

                Complementary & Alternative medicine
                traditional medicine,traditional medical system,explanatory trials,herbal medicine,phytotherapy,evidence based medicince,mainstream medicine,pragmatic trials

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