Capacity for Clinical Research on Herbal Medicines in Africa

Willcox, Merlin; Siegfried, Nandi; Johnson, Quinton

doi:10.1089/acm.2011.0963

Cited by 25 publications

(18 citation statements)

References 6 publications

(7 reference statements)

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“…80 Accompanying this is a rising commitment to develop the African traditional medicine as part of integrated healthcare in Africa, including the production of a new class of standardized African herbal medicines. 81 As companies and researchers move in this direction, key legal parameters will need to be observed and enforced. In this context, the case of P. africana stands as stark testimony to the consequences of a failure of ethics and enforcement in the development of Africa's medicinal plants and the traditional knowledge of their use for human health.…”

Section: Discussionmentioning

confidence: 99%

Prunus africana (Hook.f.) Kalkman: The Overexploitation of a Medicinal Plant Species and Its Legal Context

BodekerGerard

KloosterCharlotte²,

WeisbordEmma

2014

The Journal of Alternative and Complementary Medicine

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The linkage between herbal medicines and the sustainability of medical plants from which they are manufactured is increasingly being understood and receiving attention through international accords and trade labeling systems. However, little attention is paid to the fair trade aspects of this sector, including the issue of benefit-sharing agreements with traditional societies whose knowledge and resources are being exploited for commercial herbal medicine development and production.This article examines the case of Prunus africana (Hook.f.) Kalkman, from equatorial Africa. While the conservation and cultivation dimension of the trade in P. africana has been much discussed in literature, no research appears to have focused on the traditional resource rights and related ethical dimensions of this trade in traditional medicine of Africa. Serving as a cautionary tale for the unbridled exploitation of medicinal plants, the history of P. africana extraction is considered here in the context of relevant treaties and agreements existing today. These include the Nagoya Protocol, a supplementary agreement to the Convention on Biological Diversity, the Trade-Related Aspects of Intellectual Property Rights agreement from the World Trade Organization, and two African regional frameworks: the Swakopmund Protocol and the Organisation Africaine de la Propriété Intellectuelle Initiative.In the context of strengthening medicinal plant research in Africa, a novel international capacity-building project on traditional medicines for better public health in Africa will be discussed, illustrating how access and benefit sharing principles might be incorporated in future projects on traditional medicines.

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Section: Discussionmentioning

confidence: 99%

Prunus africana (Hook.f.) Kalkman: The Overexploitation of a Medicinal Plant Species and Its Legal Context

BodekerGerard

KloosterCharlotte²,

WeisbordEmma

2014

The Journal of Alternative and Complementary Medicine

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“…Faradin®, is a liquid polyherbal (three herbal plants) that have been found anecdotally to be effective for treatment of SCD (and with no reported toxicity) in Nigeria and few other West African countries. However, very little investigation has been conducted or published on Faradin [10][11][12]. It was approved by the Nigerian Agency for Food and Drug Administration and Control (NAFDAC) as a supplement (Certificate number 4-0077L).…”

Section: Complementary and Alternative Medicinesmentioning

confidence: 99%

Evaluation of an Undocumented Polyherbal (Faradin®) Used for the Treatment of Sickle Cell Disease in West Africa. Part I: Phytochemistry and Ex-vivo Anti-sickling Study

Adeyeye¹,

Gbadero²,

Farayola³

et al. 2017

BJPR

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Background: An undocumented complementary and alternative medicine (CAM)-Faradin® -was screened for its phytochemicals, anti-sickling effect using a clinical protocol, and toxicity. Faradin is a polyherbal made up of Zanthoxylum zanthoxyloides, Alnus glutinosa and Alchornea cordofolia. Adeyeye et al.; BJPR, 17(1): 1-14, 2017; Article no.BJPR.33605 2 Methods: The polyherbal and the individual components (coded V, M, and F) were separately screened for phytochemicals such as alkaloids, phenols, flavonoids, sterols and coumarins, using standard tests. Institutional Review Board approved clinicalprotocolinvolving4 female de-identified sickle cell patients was used for the ex-vivo anti-sickling evaluation. The negative control was phosphate-buffered saline (PBS)-washed erythrocytes treated with 2% sodium metabisulfite (SMB) to cause a hypoxic state and result in HBSS polymerization or sickling. As positive control, 2% w/v p-hydroxy benzoic acid (PHBA) solution was used. The anti-sickling effect was studied by incubating the washed erythrocytes in various concentrations of Faradin -Faradin: water v/v ratios (2.5:1 -10:1) -for 4 hours followed by further incubation with SMB for 1½ hrs. The respective samples were examined under an optical microscope and the number of sickled cells counted. Cell viability to Faradin was also done using human primary hepatocytes (HPP) and Cell Titer-Glo Luminescent assay. Results: Faradin tested positive for flavonoids, phenols, coumarins, alkaloids and antioxidants. The V component tested positive for coumarins, alkaloids and antioxidants. The M component was positive for phenols, alkaloids and antioxidants while the F component tested positive for flavonoids, phenols and antioxidants. For the anti-sickling study, the negative control (SMB treated erythrocytes) showed 20-28% increase in sickling relative to the PBS-washed. The positive control caused a reversal of sickling by decreasing the percent sickled cells from 21% to 8%. There was a dose-dependent decrease in percent sickled cells; the highest dose reduced the percent sickled cells from 21% to 2%. The activity was likely due to the phenols, polyphenols, flavonoids and antioxidants in the CAM. Cell viability of Faradin® was greater than 85%. Conclusions: Thecombined phytochemicals in the polyherbal contributed to the reversal of sickling that is similar to the positive control. Faradin has a high potential for clinical effectiveness in the management of SCD. Original Research Article

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“…This convergence of international partnerships and the Botswana government’s investment to support research has created a unique opportunity to not only do clinical trials, but also to study the conduct of RCTs in Botswana. Previous studies have primarily focused on the need for improved quality management systems and resource constraints in the region [ 12 , 13 ]. This study aims to provide a qualitative account from individuals who are involved in the day-to-day conduct of trials in Botswana.…”

Section: Introductionmentioning

confidence: 99%

Lessons from the field: the conduct of randomized controlled trials in Botswana

Bonsu

Frasso

Curry

2017

Trials

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BackgroundThe conduct of randomized controlled trials (RCTs) in low-resource settings may present unique financial, logistic, and process-related challenges. Middle-income countries that have comparable disease burdens to low-income countries, but greater availability of resources, may be conducive settings for RCTs. Indeed, the country of Botswana is experiencing a rapid increase in the conduct of RCTs. Our objective was to explore the experiences of individuals conducting RCTs in Botswana to gain an understanding of the challenges and adaptive strategies to their work.MethodsWe conducted in-depth interviews with 14 national and international individuals working on RCTs in Botswana. Participants included principal investigators, research coordinators, lab technicians, research assistants, and other healthcare professionals. Interviews were audiotaped, transcribed verbatim, and coded for thematic analysis.ResultsFive primary themes were identified: ethics board relationships (including delays in the process); research staff management (including staff attrition and career development); study recruitment and retention (including the use of reimbursements); resource availability (including challenges accessing laboratory equipment); and capacity-building (including issues of exporting locally sourced samples). These themes were explored to discuss key challenges and adaptive strategies.ConclusionsThis study offers a first-hand account of individuals engaged in conducting RCTs in Botswana, a nation that is experiencing a rapid increase in research activities. Findings provide a foundational understanding for researchers in Botswana and trial managers in similar settings when planning RCTs so that the conduct of research does not outpace the ability to manage, support, and regulate it.

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Capacity for Clinical Research on Herbal Medicines in Africa

Cited by 25 publications

References 6 publications

Prunus africana (Hook.f.) Kalkman: The Overexploitation of a Medicinal Plant Species and Its Legal Context

Prunus africana (Hook.f.) Kalkman: The Overexploitation of a Medicinal Plant Species and Its Legal Context

Evaluation of an Undocumented Polyherbal (Faradin®) Used for the Treatment of Sickle Cell Disease in West Africa. Part I: Phytochemistry and Ex-vivo Anti-sickling Study

Lessons from the field: the conduct of randomized controlled trials in Botswana

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