A Multi-Criteria Decision Analysis Model to Assess the Safety of Botanicals Utilizing Data on History of Use
Keywords:Botanicals, Brahmi, history of safe use, multi multi-criteria decision analysis, safety assessment, similarity score
AbstractBotanicals (herbal materials and extracts) are widely used in traditional medicines throughout the world. Many have an extensive history of safe use over several hundreds of years. There is now a growing consumer interest in food and cosmetic products, which contain botanicals. There are many publications describing the safety assessment approaches for botanicals, based on the history of safe use. However, they do not define what constitutes a history of safe use, a decision that is ultimately a subjective one. The multi-criteria decision analysis (MCDA), is a model that has been developed, which assesses the safety of botanical ingredients using a history of use approach. The model evaluates the similarity of the botanical ingredient of interest to its historic counterpart – the comparator, the evidence supporting the history of use, and any evidence of concern. The assessment made is whether a botanical ingredient is as safe as its comparator botanical, which has a history of use. In order to establish compositional similarity between the botanical ingredient and its comparator, an analytical ‘similarity scoring' approach has been developed. Applicability of the model is discussed with an example, Brahmi (Bacopa monnieri). This evolution of the risk assessment of botanicals gives an objective, transparent, and transferable safety assessment approach.
WHO. Traditional Medicine (Pamphlet). Geneva: WHO; 2003.
Mukherjee P K, Wahile A. Integrated approaches towards drug development from Ayurveda and other Indian system of medicines. J Ethnopharmacol 2006;103:25-35.
Xue T, Roy R. Studying Traditional Chinese Medicine. Science 2003;300:740-1.
Schilter B, Andersson C, Anton A, Constable A, Kleiner J, O'Brien J, et al. Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements. Food Chem Toxicol 2003;41:1625-49
Bast A, Chandler RF, Choy PC, Delmulle LM, Gruenwald J, Halkes SB, et al.Botanical health products, positioning and requirements for effective and safe use. Environ Toxicol Pharmacol 2002;12:195-211.
Kroes R, Walker R. Safety issues of botanicals and botanical preparations in functional foods. Toxicology 2004;198:213-20.
EFSA Scientific Cooperation (ESCO) Working Group on Botanicals and Botanical Preparations; Advice on the EFSA guidance document for the safety assessment of botanicals and botanical preparations intended for use as food supplements, based on real case studies on request of EFSA. EFSA J 2009;7:280.
Conto A. A new approach for the safety assessment of botanicals intended for use as ingredients in food supplements. Agro Food Industry Hi Tech 2009;20:3.
French S, Maule J, Papamichail N. Decision Behaviour, Analysis and Support. Chapter 7. Cambridge, England: Cambridge University Press; 2009.
Stermitz FR, Lorenz P, Tawara JN, Zenewicz LA, Lewis K. Synergy in a medicinal plant: Antimicrobial action of berberine potentiated by 5'-methoxyhydnocarpin, a multidrug pump inhibitor. Proc Natl Acad Sci U S A 2000;97:1433-7.
Linkov I, Satterstrom FK, Kiker G, Seager TP, Bridges T, Gardner KH, et al. Multicriteria decision analysis: A comprehensive decision approach for management of contaminated sediments. Risk Analysis 2006;26:61-78.
Semenzin E, Critto A, Rutgers M, Marcomini A. Integration of bioavailability, ecology and ecotoxicology by three lines of evidence into ecological risk indexes for contaminated soil assessment. Sci Total Environ 2007;389:71-86
Kelly L. International Symposium on Quality of Traditional Chinese medicine with Chromatographic Fingerprint. Guangzhou; 2001. p. i4-1.
Technical request about fingerprint technology of injection of traditional medicine. Chinese Traditional Patent Medicine. Vol. 22. China: State Drug Administration of China; 2002. p. 671.
WHO. World Health Organisation, Guidelines for the assessment of Herbal Medicines (Conference proceedings) Munich. Geneva: WHO; 1991.
Liang YZ, Xie P, Chan K. Quality control of herbal medicines. J Chromatogr B Analyt Technol Biomed Life Sci 2004;812:53-70.
Khan IA. Issues related to botanicals. Life Sci 2006;78:2033-8.
Walker R. Criteria for risk assessment of botanical food supplements. Toxicol Lett 2004;149:187-95.
Bhandari P, Kumar N, Singh B, Kaul VK. Cucurbitacins from Bacopa monnieri. Phytochemistry 2007;68:1248-54.
Sivaramakrishna C, Rao CV, Trimurtulu G, Vanisree M, Subbaraju GV. Triterpenoid glycosides from Bacopa monnieri. Phytochemistry 2005;66:2719-28.
Calabrese C, Gregory WL, Leo M, Kraemer D, Bone K, Oken B. Effects of a standardized Bacopa monnieri extract on cognitive performance, anxiety, and depression in the elderly: a randomized, double-blind, placebo-controlled trial. J Altern Complement Med 2008;4:707-13.
Stough C, Downey LA, Lloyd J, Silber B, Redman S, Hutchison C, et al. Examining the nootropic effects of a special extract of Bacopa monniera on human cognitive functioning: 90 Day double-blind placebo-controlled randomized trial. Phytotherapy Res 2008;22:1629-34.