Mapping Clinical Evidence of Herbal Medicine for Translation to Clinical Practice in Nigeria: The Case of Anti-Malarial Herbal Medicines

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Authors : Orgah Adikwu, Emmanuel, Orgah O, John

Abstract:

There has been an astronomical rise in the cost of developing drugs in the last four decades. This has had a resultant effect on public health and Nigeria is particularly negatively affected. As the world spends more money on drugs’ R&D, the volume of innovative synthetic drugs dwindles. This trend points to the necessity for a paradigm shift in drug development strategy.

Although herbal medicines offer a wide diversity of medicinal properties and have proven to be a boom for therapies, its clinical evidence mapping is largely lacking and thus cannot be integrated into Nigerian public health structures. Also, there is a high incidence ranking of malaria in Nigeria, and clinical evidence mapping of herbal anti-malarias might be the innovation to improve malaria control and elimination programs.

Few or no studies have illustrated methods to engage herbal medicine clinics in Africa and perhaps none in Nigeria on ways to describe and evaluate clinical use of herbal medicines as anti-malarial in patients. Observational clinical studies could be carried out to estimate the efficacy and toxicities of herbal anti-malarias in clinical protocols and thus document any adverse effects. This should provide the needed opportunity to measure patient outcome in malaria patients exposed to the herbal drug in a clinical setting. This paper discuses the challenges to drug development in weak and fledgling economies, the dearth of clinical research on herbal anti-malarial therapies and the prospects of herbal clinical research to malaria control and public health in Nigeria.

Key words: Herbal anti-malaria, Malaria, Herbal medicines’ clinical evidence research, Drug development and Public health

References:

[1]. Berger, M. L., Dreyer, N., Anderson, F., Towse, A., Sedrakyan, A., Normand, SL., (2012) Prospective Observational Studies to Assess Comparative Effectiveness: The ISPOR Good Research Practices Task Force Report. value in health; 1 5, 2 1 7 – 2 3 0

[2]. Booth B, Zemmel R. (2004). Prospects for productivity. Nature Reviews Drug Discovery; 3(5): 451-456.

[3]. Bunnage M.E. Getting pharmaceutical R&D back on target. Nature Chemical Biology 2011; 7(6):335-339.

[4]. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. Journal of Health Economics 2003; 22(2):151-185.

[5]. DiMasi JA. Risks in new drug development: approval success rates for investigational drugs. Clinical Pharmacology and Therapeutics 2001; 69(5): 297-307.

[6]. Dondrop AM, Nosten F, Yi P, Das D, Phy AP, Taming J, et al. (2009). Artemisinin Resistance in Plasmodium falciparum malaria. N.Engl. J. Med. 361:455-67

[7]. Graz, B., Elisabetsky, E., and Falquet, J., (2007). Beyond the myth of expensive clinical study: Assessment of traditional medicines Journal of Ethnopharmacology 113 382–386

[8]. Graz, B. Falquet J. Diallo, D. Willcox, M. Giani S., (2005) Letter to the Editor: Screening of traditional herbal medicine: First, do a retrospective study, with correlation between diverse treatments used and reported patient outcome Journal of Ethnopharmacology101 338–339

[9]. Graza B., Falquet J., Elisabetsky, E., (2010). Ethnopharmacology, sustainable development and cooperation: The importance of gathering clinical data during field surveys Journal of Ethnopharmacology 130 (2010) 635–638

[10]. Graz B., Willcox, M. L., Diakite, C., Falquet, J., Dacku, F., Sidibe, O., Giani, S., Diallo, D., (2009). Argemone mexicana decoction versus artesunate-amodiaquine for the management of malaria in Mali: policy and public-health implications. Trans R Soc Trop Med Hyg doi:10.1016/j.trstmh.2009.07.005

[11]. Maiers, M., McKenzie, E., Evans, R., and McKenzie, M. (2009). The Development of a Prospective Data Collection Process in a Traditional Chinese Medicine Teaching Clinic; The Journal Of Alternative And Complementary Medicine, 15(3), 2009, pp. 305–320. DOI: 10.1089/acm.2008.0224

[12]. Medical Research Council. (MRC ; 2000). A Framework for the Development and Evaluation of RCTs for Complex Interventions to Improve Health . London.

[13]. Osterbauer P, McKenzie M, McKenzie E, Evans R. (2004). Patient Characteristics in the Edith Davis Acupuncture and Oriental Medicine Teaching Clinic. 10-1-2004. San Francisco, CA: Society for Acupuncture Research.

[14]. The Pharmaceutical Research and Manufacturers of America, (PhRMA, 2011). 2011 profile: pharmaceutical industry http://www.phrma.org/sites/default/fi les/159/phrma_profile_2011_final.pdf, (April 2011).

[15]. Takala-Harrison S, Jacob CG, Arze C, Cummings MP, Silva JC, Dondrop AM, et al. (2014). Independent emergence of Arteminisin resistance mutations among Plasmodium falciparum in Southeast Asia. J. Infect Dis. Epub ahead of print.

[16]. Taylor, S. M., Parobek, C. M., DeConti, D. K., Kayentao, K., Coulibaly, S. O., Greenwood, B. M., Tagbor, H., Williams, J., Bojang, K., Njie, F., Desai, M., Kariuki, S., Gutman, J., Mathanga, D. P., Mårtensson, A., Ngasala, B., Conrad, M. D., Rosenthal, P. J., Tshefu, A. K., Moormann, A. M., Vulule, J. M. Doumbo, O. K., ter Kuile, F. O., Meshnick, S. R. Bailey, J. A. and Juliano, J. J.; (2014)** Absence of Putative Artemisinin Resistance Mutations Among Plasmodium falciparum in Sub-Saharan Africa: A Molecular Epidemiologic Study. The Journal of Infectious Diseases 2015; 211:680–688. DOI: 10.1093/infdis/jiu467 **(The Author 2014; Published by Oxford University Press on behalf of the Infectious Diseases Society of America).

[17]. WHO, (2000). Severe falciparum malaria. Transactions of the Royal Society of Tropical Medicine and Hygiene, 94(Suppl. 1):1–90.

[18]. WHO, (2003). Traditional Medicine; Fact sheet no.134, revised 2003

[19]. WHO (2010). World Health Organization, Geneva. WHO World Malaria Report, 2010

[20]. WHO (2014). World Health Organization, Geneva. WHO World Malaria Report, -Nigeria Health profile-WHO, 2014)

[21].WHO (2015) Q&A on artemisinin resistance http://www.who.int/malaria/media/artemisinin_resistance_qa/en/

[22].WHO (Ed.). (2013). WHO traditional medicine strategy, 2014-2023. Geneva: World Health Organization (WHO).

[23].Willcox M. L. (1999). A clinical trial of ‘AM’, a Ugandan herbal remedy for malaria. Journal of Public Health Medicine; 21(3), pp. 318–324

[24].Willcox, M. L., Graz, B., Falquet, J., Diakite, C., Giani, S., Diallo, D., (2011). A “reverse pharmacology” approach for developing an anti-malarial phytomedicine; Malaria Journal, 10(Suppl 1):S8 http://www.malariajournal.com/content/10/S1/S8

[25].Woodcock J, Woosley R. The FDA critical path initiative and its influence on new drug development. Annual Review in Medicine 2008; 59:1-12.

[26].Xing, M., Long A.F., (2006). A retrospective survey of patients at the University of Salford Acupuncture Clinic; Complement Ther Clin Pract 2006;12:64–71.