The methodology of research in Traditional Medicine
الموضوعات : مجله گیاهان داروییمجید آویژگان 1 , مائده محب نسب 2
1 - استاد بیماریهای عفونی و گرمسیری، بخش عفونی و مرکز تحقیقات طب سنتی ایرانی، دانشگاه علوم پزشکی اصفهان، اصفهان، ایران
2 - دکتری حرفه ای پزشکی، مرکز تحقیقات طب سنتی ایرانی ، دانشگاه علوم پزشکی اصفهان، اصفهان ،ایران
الکلمات المفتاحية: Medicinal Plants, Methodology, Ethnomedicine, Botany,
ملخص المقالة :
In countries having traditional medicine (TM), one of the main challenges for any researcher is research methodology. Current methodologies are different with what was in past. The main purpose of this article is to present the steps (herbs, claims and methodology) of research in TM fields.1. Assessment of herbsHistory, method of study, quality assessment, efficacy, safety, toxicity and therapeutic effect are included in this part.2. Efficacy and safety of herbsBotany, therapeutic effect, toxicology methods, how to study toxicity will be explained in this part.3. Assessment of TM productsThis part contains herb identification, certification, standardization, claims for therapeutic effect, confirmation of safety of herb.4. Claims for efficacy of herbsIt includes various claims, concept, features, base, importance, and evidence to confirm these claims.5. Method of studyThis includes for in vitro/in vivo studies (observational and interventional). In addition, the role of Meta analysis will be discussed.6. Ethical committeeEthics in research, ethical committee, their activity, check list of committee for any study will be explained.
Anonymous. 1999. Guidance for industry: significant scientific agreement in the review of health claims for conventional foods and dietary supplements issued 22 December 1999 by the USA Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Special Nutritionals, Federal building 8, 200 C Street, SW, Washington, DC 20204, USA.
Anonymous. 2000. Guidelines for levels and kinds of evidence to support claims for therapeutic goods produced by the Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia, in April 2000.
Hasselblad, V., Mosteller, F., Littenberg, B., Chalmers, T.C., Hunick, M.G., Turner, A. et al. 1995. A survey of current problems in meta- analysis. Discussion from the Agency for Health Care Policy and Research Inter-PORT Work Group on Literature Review/ Meta-Analysis. Med Care. 33: 202 - 220.
ICH Harmonized tripartite guideline: guideline for Good Clinical Practice issued by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, International Federation of Pharmaceutical Manufacturers Associations, PO Box 9, 1211 Geneva, Switzerland. Recommended for adoption on 1 May 1996 by the ICH Steering Committee.
Sacks, H.S. 1998. Meta-analyses of clinical trials. In: Perman JA, Rey J, eds. Clinical Trials in Infant Nutrition, Nestle Nutrition Workshop Series, Vol 40, pp. 85 - 99. Philadelphia, PA: Vevey/ Lippincott-Raven Publishers, 1998.
Sacks, H.S., Berrier, J., Reitman, D., Pagano, D. and Chalmers, T.C. 1992. Meta-analysis of randomized con- trolled trials: an update. In: Balder WC, Mosteller F, eds. Medical Uses of Statistics, 2 ed, pp. 427- 442. Boston" MA: NEJM Books.
Sacks, H.S., Berries, J., Reitman, D., Ancona-Berk, V.A. and Chalmers, T. 1957. Meta-analyses of randomized controlled trials. New Engl J Med. 34d: 450-455.
WHOQOL user manual, Geneva, World Health Organization: an, 1998: 61 - 71 (unpublished document WHO/ MNH/ MHP/ 98. 3; available on request from Programme on Mental Health, World Health Organization, 1211 Geneva 27, Switzerland.
World Health Organization Regional Office for the Western Pacific. 1993. Research guidelines for evaluating the safety and efficacy of herbal medicines. Manila, World Health Organization Regional Office for the Western Pacific.
World Health Organization. 1990. Report of a WHO Consultation on traditional medicine and AIDS: clinical evaluation of traditional medicines and natural products. Geneva, 26-28 September 1990. Geneva, World Health Organization, pp. 5-7
World Health Organization. 1993. Research guidelines for evaluation the safety and efficacy of herbal medicines. Manila, World Health Organization Regional Office for the Western Pacific. 35-40.
World Health Organization. 1995. The use of essential drugs. Eighth list. Geneva, World Health Organization, pp. 106-107; 108-110 (WHO Technical Report Series, No. 85.
World Health Organization. 1998. Quality control methods for medicinal plant materials. Geneva, World Health Organization.
World Health Organization. 1998. Regulatory situation of herbal medicines: a worldwide review. Geneva, World Health Organization, 1998 (unpublished document WHO/TRMI 98. 1; available on request from Traditional Medicine (TRM/EDM/HTP), World Health Organization, 1211 Geneva 27, Switzerland.
World Health Organization. 1999. Guidelines on basic training and safety in acupuncture. Geneva, World Health Organization, (unpublished document WHO/ EDM/TRM/ 99. 1; available on request from Traditional Medicine (TRM/ EDM/ HTP), World Health Organization, 1211 Geneva 27, Switzerland.
World Health Organization. 1999. WHO monographs on selected medicinal plants. Vol. I. Geneva, World Health Organization.
