Skip to main content
SpringerLink
Log in

Pharmacovigilance of Herbal Medicines

The Potential Contributions of Ethnobotanical and Ethnopharmacological Studies

  • Current Opinion
  • Published:
Drug Safety Aims and scope Submit manuscript

Abstract

Typically, ethnobotanical/ethnopharmacological (EB/EP) surveys are used to describe uses, doses/dosages, sources and methods of preparation of traditional herbal medicines; their application to date in examining the adverse effects, contraindications and other safety aspects of these preparations is limited. From a pharmacovigilance perspective, numerous challenges exist in applying its existing methods to studying the safety profile of herbal medicines, particularly where used by indigenous cultures. This paper aims to contribute to the methodological aspects of EB/EP field work, and to extend the reach of pharmacovigilance, by proposing a tool comprising a list of questions that could be applied during interview and observational studies. The questions focus on the collection of information on the safety profile of traditional herbal medicines as it is embedded in traditional knowledge, as well as on identifying personal experiences (spontaneous reports) of adverse or undesirable effects associated with the use of traditional herbal medicines. Questions on the precise composition of traditional prescriptions or ‘recipes’, their preparation, storage, administration and dosing are also included. Strengths and limitations of the tool are discussed. From this interweaving of EB/EP and pharmacovigilance arises a concept of ethnopharmacovigilance for traditional herbal medicines: the scope of EB/EP is extended to include exploration of the potential harmful effects of medicinal plants, and the incorporation of pharmacovigilance questions into EB/EP studies provides a new opportunity for collection of ‘general’ traditional knowledge on the safety of traditional herbal medicines and, importantly, a conduit for collection of spontaneous reports of suspected adverse effects. Whether the proposed tool can yield data sufficiently rich and of an appropriate quality for application of EB/EP (e.g. data verification and quantitative analysis tools) and pharmacovigilance techniques (e.g. causality assessment and data mining) requires field testing.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Notes

  1. The latter two EP studies were approved by the Ethics Committee of the Federal University of São Paulo (UNIFESP’s Ethics Committee on Research n. 056/00). The biological resources and traditional knowledge associated with biodiversity (TK) referred to in this article are protected under the terms of the United Nations Convention on Biological Diversity (CBD), in force internationally since December 1993. Any individual or public or private entity who wishes to carry out scientific or technological investigations on the biological resources and TK referred to shall observe the requirements set forth by Articles 8 (j) and 15 of the CBD, as well as, in the case of Brazilian biological resources and TK, the requirements set forth by the Provisional Measure no. 2.186-16/2001, which regulates access to genetic resources, protection and access to TK and the sharing of benefits arising from the use of Brazilian TK and biological resources. The unauthorized use of these resources is an act of misappropriation, and subjects violators to administrative, civil and criminal penalties in Brazil.

References

  1. Barnes J. Pharmacovigilance of herbal medicines: a UK perspective. Drug Saf. 2003;26(12):829–51.

    Article  PubMed  Google Scholar 

  2. World Health Organization. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. Geneva: World Health Organization; 2004.

    Google Scholar 

  3. Uppsala Monitoring Centre. Uppsala Reports 2012 Oct; 59: 6–7 [online]. Available from URL: http://www.who-umc.org/graphics/27165.pdf. Accessed 12 Nov 2012.

  4. World Health Organization. WHO traditional medicine strategy 2002–2005. Geneva: World Health Organization; 2002.

    Google Scholar 

  5. Farah MH, Edwards IR, Lindquist M, et al. International monitoring of adverse health effects associated with herbal medicines. Pharmacoepidemiol Drug Saf. 2000;9(2):105–12.

    Article  PubMed  CAS  Google Scholar 

  6. Lanini J, Duarte-Almeida JM, Nappo S, et al. “Natural and therefore free of risks”: adverse effects, poisonings and other problems related to medicinal herbs by “raizeiros” in Diadema/SP, Brazil. Rev Bras Farmacogn. 2009;19:121–9.

    Article  Google Scholar 

  7. Heinrich M, Barnes J, Gibbons S, et al. Fundamentals of pharmacognosy and phytotherapy. 2nd ed. Edinburgh: Churchill Livingstone; 2012.

    Google Scholar 

  8. Cotton CM. Ethnobotany: principles and applications. Chicester: Wiley; 1996.

    Google Scholar 

  9. Bruhn JG, Holmstedt B. Ethnopharmacology: objectives, principles and perspectives. In: Reinhard E, Beal JL, editors. Natural products as medicinal agents. Stuttgart: Hippokrates; 1981. p. 405–30.

    Google Scholar 

  10. Holmstedt B, Bruhn JG. Ethnopharmacology: a challenge. In: Schultes RE, Von Reis S, editors. Ethnobotany: evolution of a discipline. Portland: Timber Press; 1995. p. 338–42.

    Google Scholar 

  11. Edwards SE, Nebel S, Heinrich M. Questionnaire surveys: methodological and epistemological problems for field-based ethnopharmacologists. J Ethnopharmacol. 2005;100(1–2):30–6.

    Article  PubMed  Google Scholar 

  12. Rodrigues E, Carlini EA. Plants with possible action on the central nervous system used by a quilombola group in Brazil. Phytother Res. 2004;18(9):748–53.

    Article  PubMed  Google Scholar 

  13. Rodrigues E, Tabach R, Galduróz JC, et al. Plants with possible anxiolytic action indicated by three Brazilian cultures (Indians, Afro-descendants and river-dwellers). In: Atta-ur-Rahman FRS, editor. Studies in natural product chemistry. Amsterdam: Elsevier Science; 2008. 35:549–95.

  14. International code of botanical nomenclature [online]. Available from URL: http://ibot.sav.sk/icbn/main.htm. Accessed 12 Nov 2012.

  15. International classification of diseases [online]. Available from URL: http://apps.who.int/classifications/icd10/browse/2010/en. Accessed 16 Nov 2012.

  16. Raza M. A role for physicians in ethnopharmacology and drug discovery. J Ethnopharmacol. 2006;104(3):297–301.

    Article  PubMed  Google Scholar 

  17. Bourbonnais-Spear N, Awad R, Merali Z, et al. Ethnopharmacological investigation of plants used to treat susto, a folk illness. J Ethnopharmacol. 2007;109(3):380–7.

    Article  PubMed  Google Scholar 

  18. Thomas E, Vanderbroek I, Semo L, et al. Susto etiology and treatment according to Bolivian Trinitario people: a “masters of the animal species” phenomenon. Med Anthropol Q. 2009;23:298–319.

    Article  PubMed  Google Scholar 

  19. Houghton PJ. Traditional plant medicines as a source of new drugs. In: Evans WC, editor. Trease and Evans Pharmacognosy. 15th ed. Edinburgh: W.B. Saunders; 2002. p. 131.

    Google Scholar 

  20. Tang W, Eisenbrand G. Chinese drugs of plant origin: chemistry, pharmacology and use in traditional and modern medicine. Berlin: Springer; 1992.

    Book  Google Scholar 

  21. Adamolekun B. Neurological disorders associated with cassava diet: a review of putative etiological mechanisms. Metab Brain Dis. 2011;26(1):79–85.

    Article  PubMed  CAS  Google Scholar 

  22. Lim WC, Seo JM, Lee CI, et al. Stimulative and sedative effects of essential oils upon inhalation in mice. Arch Pharm Res. 2005;28(7):770–4.

    Article  PubMed  CAS  Google Scholar 

  23. Gorinsky C, Luscombe DK, Nicholls PJ. Neuromuscular blocking and local anaesthetic activities of warifteine hydrochloride, an alkaloid isolated from Cissampelos ovalifolia D.C. J Pharm Pharmacol. 1972;24:147–8.

    Google Scholar 

  24. Rodrigues E. Plants of restricted use indicated by three cultures in Brazil (caboclo-river dweller, Indian and Quilombola). J Ethnopharmacol. 2007;111(2):295–302.

    Article  PubMed  Google Scholar 

  25. Williamson EM, Driver S, Baxter K, editors. Stockley’s herbal medicines interactions. London: Pharmaceutical Press; 2009.

    Google Scholar 

  26. Schultes RE, Hofmann A. Plantas de los dioses: origenes del uso de los alucinógenos. Cidade do México: Fondo de Cultura Económica; 1993.

    Google Scholar 

  27. Rodrigues E. Ethnopharmacology in the Jaú National Park (JNP), state of Amazonas, Brazil. Phytother Res. 2006;20(5):378–91.

    Article  PubMed  Google Scholar 

  28. Rodrigues E, Carlini EA. A comparison of plants utilized in ritual healing by two Brazilian cultures: Quilombolas and Indians. J Psychoactive Drugs. 2006;38(3):285–95.

    Article  PubMed  Google Scholar 

  29. Gollin LX. Subtle and profound sensory attributes of medicinal plants among the Kenyah Leppo’Ke of east Kalimantan, Borneo. J Ethnobiol. 2004;24:173–201.

    Google Scholar 

  30. Brett JA. Medicinal plant selection criteria: the cultural interpretation of chemical senses. J Appl Bot. 1998;72:70–4.

    Google Scholar 

  31. Leonti M, Sticher O, Heinrich M. Medicinal plants of the Popoluca, México: organileptic properties as indigenous selection criteria. J Ethnopharmacol. 2002;81(3):307–15.

    Article  PubMed  Google Scholar 

  32. Shepard GH Jr. A sensory ecology of medicinal plant therapy in two Amazonian societies. Am Anthropol. 2004;106:252–66.

    Article  Google Scholar 

  33. Morales S, Ladio A. Chemosensory perception and medicinal plants for digestive ailments in a Mapuche community in NW Patagonia, Argentina. J Ethnopharmacol. 2009;123(3):397–406.

    Article  Google Scholar 

  34. Peyrots des Gachons C, Beauchamp GK, Stern RM, et al. Bitter taste induces nausea. Curr Biol 2001; 21(7):R247–8.

    Google Scholar 

  35. Sipiora ML, Murtaugh MA, Gregoire MB, et al. Bitter taste perception and severe vomiting in pregnancy. Physiol Behav. 2000;69:259–67.

    Article  PubMed  CAS  Google Scholar 

  36. Dworacek B, Rupreht J. Physostigmine: short history and its impact on anaesthesiology of present days. Int Congr Ser. 2002;1242:87–93.

    Article  Google Scholar 

Download references

Acknowledgements

We thank all the interviewees who participated in the EB/EP studies described in this paper and in doing so contributed to knowledge of the adverse effects of plants. We also thank two anonymous referees for their helpful suggestions in improving this paper. Eliana Rodrigues also thanks the FAPESP-Fundação de Apoio à Pesquisa do Estado de São Paulo and CAPES-Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, for financial support. We are also thankful for the support given by Dr. Elisaldo A. Carlini, who provided some of the field works. The authors declare no conflicts of interest.

Author information

Authors and Affiliations

  1. Department of Biological Sciences, Center for Ethnobotanical and Ethnopharmacological Studies (CEE), Universidade Federal de São Paulo (UNIFESP), Rua Arthur Riedel, Diadema, SP, 275-09972-270, Brazil

    Eliana Rodrigues

  2. School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand

    Joanne Barnes

Authors
  1. Eliana Rodrigues
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Joanne Barnes
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Eliana Rodrigues.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Rodrigues, E., Barnes, J. Pharmacovigilance of Herbal Medicines. Drug Saf 36, 1–12 (2013). https://doi.org/10.1007/s40264-012-0005-7

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40264-012-0005-7

Keywords

Search

Navigation