Experience of Health professionals in the implementation of Clinical trials of Traditional Herbal Medicines: A cross-sectional study in Mali
Abstract
Objective: The objective of this study was to determine the experience of health professionals in clinical trials of traditional herbal medicines in Mali.
Material and methods: This was a cross-sectional study conducted from June to December 2022 among healthcare professionals in three randomly selected localities: the district of Bamako and the regions of Koulikoro and Sikasso. Data were collected by direct interview using an anonymous questionnaire. The Chi-square (χ2) test was used to assess factors associated with participation in clinical trials of traditional medicines.
Results: The involvement of healthcare professionals in clinical trials of traditional medicines was low (3.5%) and was associated with age (p=0.021). The obstacles to conducting these trials reported by healthcare professionals were lack of funding and failure to take account of the specificities of traditional medicines in clinical trial regulations. Some healthcare professionals suggest ethnomedical evaluation of recipes proposed by traditional practitioners and the use of reverse pharmacology as alternatives.
Conclusion: Research into traditional medicines could be given greater impetus by the long-term funding of clinical trials and by less costly alternatives such as the ethnomedical evaluation of recipes proposed by traditional healers and reverse pharmacology.
Keywords:
Traditional herbal medicines (THMs), clinical trials, healthcare professionals, Mali, World Health Organization (WHO), Sampling
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References
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http://www.ncbi.nlm.nih.gov/pubmed/26681895 DOI:10.4103/0975-7406.168035
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23. Sanogo R, Haïdara M, Dénou A. Improved traditional medicine for infectious disorders in Mali. In: Medicinal Plants as Anti-Infectives. Academic Press; 2022. p. 479–99. DOI:10.1016/B978-0-323-90999-0.00004-5
24. Sanogo R. Pteolopsis suberosa Engl. et Diels (Combretaceae): a plant with anti-ulcer and anti-Helicobacter pylori activity. Hegel. 2014 Apr 1;N° 2(2):148–53.
DOI:10.3917/heg.042.0148
25. Touré I. Evaluation of the therapeutic efficacy of an improved traditional recipe 'Gastrosédal' in the treatment of gastritis [Internet]. 1989 [cited 2024 Mar 30]. Available from: https://bibliosante.ml/bitstream/handle/123456789/9831/89M37.pdf?sequence=1&isAllowed=y
26. Mariko MD. Study of the activity of 'TERENIFOU' trunk bark of Pteleopsis suberosa engl. et diels (Combretaceae) in the treatment of peptic ulcers [Internet]. Bibliosante; 1989 [cited 2024 Mar 30]. Available from:
https://bibliosante.ml/bitstream/handle/123456789/9842/89M51.pdf?sequence=1&isAllowed=y
27. Douaré I. Contribution to the clinical study of a traditional preparation using the roots of Entada africana 'Samanere' for the treatment of viral hepatitis B [Internet]. Bibliosante; 1992 [cited 2024 Mar 30]. Available from:
https://bibliosante.ml/bitstream/handle/123456789/9960/92M40.pdf?sequence=1&isAllowed=y
28. Traoré B. Contribution to research into a traditional treatment for Eczema - Preliminary study on the feasibility of a clinical trial protocol [Internet]. 1995 [cited 2024 Mar 30]. Available from:
https://bibliosante.ml/bitstream/handle/123456789/10034/95M25.pdf?sequence=1&isAllowed=y
29. Willcox ML, Graz B, Diakite C, Falquet J, Dackouo F, Sidibe O, et al. Is parasite clearance clinically important after malaria treatment in a high transmission area? A 3-month follow-up of home-based management with herbal medicine or ACT. Trans R Soc Trop Med Hyg. 2011 Jan;105(1):23–31.
DOI:10.1016/j.trstmh.2010.10.003
30. Sangho A, Kaloga A, Sangho O, Kouboura Teguera R, Sangho F, Maïga S, et al. Overview of the regulation of clinical trials in Mali. Mali Médical. 2022;37(3):23–9.
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32. Ministry of Health. Statistical Yearbook of the Local Health Information System of Mali; 2020. p.18–20.
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https://www.cairn.info/revue-sante-publique-2019-2-page-297.htm
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https://sgg-mali.ml/JO/2017/mali-jo-2017-13.pdf
36. Dori D, Ganfon H, Gbaguidi F, Evrard B, Quetin-Leclercq J, Semde R. Overview of regulations on medicines derived from traditional Pharmacopoeia in Benin and Burkina Faso. Int J Drug Regul Aff. 2019 Dec 18;7(4):8–13.
DOI:10.22270/ijdra.v7i4.361
37. Graz B, Houriet J, Willcox M, Csajka C. RTO-COVID-19" survey: Our care, our actions, their effects. Rev Med Suisse. 2020 Aug 26;16(703):1522–3.
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38. Simoes-Pires C, Hostettmann K, Haouala A, Cuendet M, Falquet J, Graz B, et al. Reverse pharmacology for developing an anti-malarial phytomedicine. The example of Argemone mexicana. Int J Parasitol Drugs Drug Resist. 2014 Dec 1;4(3):338–46.
DOI:10.1016/J.IJPDDR.2014.07.001
39. Willcox ML, Graz B, Falquet J, Diakite C, Giani S, Diallo D. A ‘reverse pharmacology’ approach for developing an anti-malarial phytomedicine. Malar J. 2011 Mar 15;10 Suppl 1:S8.
DOI:10.1186/1475-2875-10-S1-S8
40. Kitalong C, Nogueira RC, Benichou J, Yano V, Espangel V, Houriet J, et al. ‘DAK’, a traditional decoction in Palau, as adjuvant for patients with insufficient control of diabetes mellitus type II. J Ethnopharmacol [Internet]. 2017 Jun 9 [cited 2024 Jan 19];205:116–22. Available from:
https://pubmed.ncbi.nlm.nih.gov/28478093/ DOI:10.1016/J.JEP.2017.05.003
41. Seck SM, Doupa D, DIa DiG, DIop EA, Ardiet DL, Nogueira RC, et al. Clinical efficacy of African traditional medicines in hypertension: A randomized controlled trial with Combretum micranthum and Hibiscus sabdariffa. J Hum Hypertens [Internet]. 2017 Dec 1 [cited 2024 Jan 19];32(1):75–81. Available from:
https://pubmed.ncbi.nlm.nih.gov/29311704/ DOI:10.1038/S41371-017-0001-6
42. Kroa E, Diaby B, Ahoussou EM, Yao GHA, Coulibaly GS, Kouassi D. Analysis of collaboration between traditional and modern medicine in the Sud Bandama region (Ivory Coast). Pharmacopée Médecine Tradit Africaine [Internet]. 2014 [cited 2024 Mar 11];17(1):21–7. Available from:
http://publication.lecames.org/index.php/pharm/article/view/237/137
43. Oseni Z, Shannon G. The relationship between Indigenous and allopathic health practitioners in Africa and its implications for collaboration: a qualitative synthesis. Glob Health Action. 2020 Dec 31;13(1):1838241.
DOI:10.1080/16549716.2020.1838241
44. Ouoba K, Lehmann H, Zongo A, Amari ASG, Semdé R, Pabst JY. Compliance to the legal and ethical requirements for the practice of traditional medicine: A cross-sectional study among traditional health practitioners in Burkina Faso. Eur J Integr Med. 2022 Dec 1;56:102189.
DOI:10.1016/J.EUJIM.2022.102189
https://iris.who.int/bitstream/handle/10665/67313/WHO_EDM_TRM_2002.1_fre.pdf?sequence=1&isAllowed=y
2. WHO. WHO strategy for traditional medicine 2014-2023 [Internet]. WHO;2013 [cited 2024 Mar 26]. p. 1–75. Available from:
https://apps.who.int/iris/bitstream/handle/10665/95009/9789242506099_fre.pdf;jsessionid=2F717520616C4BB2873E3C57A4CBEC9A?sequence=1
3. African Intellectual Property Organization. Initiative for the protection and promotion of African inventions relating to medicines [Internet]. OAPI; 2002 [cited 2024 Mar 26]. p. 26. Available from:
http://www.oapi.int/Ressources/Actes_OAPI/Initiative_Libreville.pdf
4. Sofowora A, Cepleanu F, Hostettmann K. Medicinal plants and traditional medicine in Africa. Karthala, editor. Swiss Academy of Natural Sciences; 2010. p.1–79.
5. WHO. National policy on traditional medicine and regulation of herbal medicines : Report of a WHO global survey [Internet]. WHO; 2005 [cited 2024 Mar 17]. Available from:
https://apps.who.int/iris/bitstream/handle/10665/43229/9241593237.pdf
6. Okoye TC, Uzor PF, Onyeto CA, Okereke EK. Safe African Medicinal Plants for Clinical Studies. Toxicol Surv African Med Plants. 2014 Jan 1;535–55.
DOI:10.1016/B978-0-12-800018-2.00018-2
7. Okaiyeto K, Oguntibeju OO. African Herbal Medicines: Adverse Effects and Cytotoxic Potentials with Different Therapeutic Applications. Int J Environ Res Public Health. 2021 Jun 2;18(11):5988.
DOI:10.3390/ijerph18115988
8. Byard RW, Musgrave I, Maker G, Bunce M. What risks do herbal products pose to the Australian community? Med J Aust [Internet]. Wiley; 2017 Feb 1 [cited 2024 Jan 20];206(2):86–90. Available from:
https://onlinelibrary.wiley.com/doi/full/10.5694/mja16.00614 DOI:10.5694/MJA16.00614
9. Xu Y, Patel DN, Ng SLP, Tan SH, Toh D, Poh J, et al. Retrospective study of reported adverse events due to complementary health products in Singapore from 2010 to 2016. Front Med. 2018 Jun 1;5(JUN):167.
DOI:10.3389/FMED.2018.00167/BIBTEX
10. Ouoba K, Lehmann H, Semde R, Pabst JY. Review of the literature on pharmacovigilance of medicines derived from traditional pharmacopoeias. Part I: identification of risks. Ann Pharm Françaises; 2021 Dec 14
DOI:10.1016/J.PHARMA.2021.11.008
11. Ouoba K, Lehmann H, Pabst JY, Semde R. Review of the literature on pharmacovigilance of medicines derived from traditional pharmacopoeias. Part II: risk assessment and prevention. Ann Pharm Françaises; 2021 Dec 9.
DOI:10.1016/J.PHARMA.2021.11.007
12. Kambugu A. Challenges of clinical trials in resource limited settings: Perspectives from uganda. Vox Sang [Internet]. Embase; 2019 Jun 7 [cited 2024 Mar 26];114(S1):5–240. Available from:
https://www.embase.com/records?subaction=viewrecord&rid=23&page=1&id=L628679913 DOI:10.1111/vox.12792
13. Graz B, Elisabetsky E, Falquet J. Beyond the myth of expensive clinical study: Assessment of traditional medicines. J Ethnopharmacol. 2007 Sep 25;113(3):382–6. DOI:10.1016/J.JEP.2007.07.012
14. WHO. General methodological principles for research and evaluation relating to traditional medicine [Internet]. 2000 [cited 2024 Ma4 26]. p. 79. Available from:
https://apps.who.int/iris/bitstream/handle/10665/68476/WHO_EDM_TRM_2000.1_fre.pdf?sequence=1&isAllowed=y
15. Willcox M. Clinical trials of herbal medicines: Lessons learned and future priorities. Planta Med. 2014 Oct 30;80(16).
DOI:10.1055/S-0034-1394478
16. Kamagaté M, Die-Kacou H, Balayssac E, Yavo JC, Daubret PT, Kacou KA, et al. Clinical trials of herbal medicinal products: a review of the literature. Therapies. 2005 Jul 1;60(4):413–8.
DOI:10.2515/THERAPIE:2005060
17. Sangho A, Ouoba K, Sanogo R, Semdé R. Ethical and regulatory frameworks for clinical trials of traditional herbal medicines: Review of the literature. J Africain Technol Pharm Biopharmacie. 2023 Apr 6;1(2):1–11. DOI:10.57220/jatpb.v1i2.37
18. West African Health Organisation (WAHO). Traditional medicine practices and development of medicines from traditional pharmacopoeia in ECOWAS Member States. [Internet]. 2013 [cited 2024 Mar 27]. Available from:
https://www.wahooas.org/web-ooas/sites/default/files/publications/2186/pratiques-de-la-medecine-traditionnelleok.pdf
19. Chippaux, Jean-Philippe. Clinical trial practice in Africa. IRD. Paris, France; 2004.p. 321.
20. Parveen A, Parveen B, Parveen R, Ahmad S. Challenges and guidelines for clinical trial of herbal drugs. J Pharm Bioallied Sci [Internet]. NCBI; 2015 Oct 1 [cited 2024 MaR 12];7(4):329–33. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/26681895 DOI:10.4103/0975-7406.168035
21. Siegfried N, Hughes G. Herbal medicine, randomised controlled trials and global core competencies. South African Med J. 2012;102(12):912–3.
DOI:10.7196/SAMJ.6392
22. Sanogo R. Development of Phytodrugs from Indigenous Plants: The Mali Experience. In: Novel Plant Bioresources: Applications in Food, Medicine and Cosmetics. Wiley Blackwell; 2014. p. 191–203.
DOI:10.1002/9781118460566.CH15
23. Sanogo R, Haïdara M, Dénou A. Improved traditional medicine for infectious disorders in Mali. In: Medicinal Plants as Anti-Infectives. Academic Press; 2022. p. 479–99. DOI:10.1016/B978-0-323-90999-0.00004-5
24. Sanogo R. Pteolopsis suberosa Engl. et Diels (Combretaceae): a plant with anti-ulcer and anti-Helicobacter pylori activity. Hegel. 2014 Apr 1;N° 2(2):148–53.
DOI:10.3917/heg.042.0148
25. Touré I. Evaluation of the therapeutic efficacy of an improved traditional recipe 'Gastrosédal' in the treatment of gastritis [Internet]. 1989 [cited 2024 Mar 30]. Available from: https://bibliosante.ml/bitstream/handle/123456789/9831/89M37.pdf?sequence=1&isAllowed=y
26. Mariko MD. Study of the activity of 'TERENIFOU' trunk bark of Pteleopsis suberosa engl. et diels (Combretaceae) in the treatment of peptic ulcers [Internet]. Bibliosante; 1989 [cited 2024 Mar 30]. Available from:
https://bibliosante.ml/bitstream/handle/123456789/9842/89M51.pdf?sequence=1&isAllowed=y
27. Douaré I. Contribution to the clinical study of a traditional preparation using the roots of Entada africana 'Samanere' for the treatment of viral hepatitis B [Internet]. Bibliosante; 1992 [cited 2024 Mar 30]. Available from:
https://bibliosante.ml/bitstream/handle/123456789/9960/92M40.pdf?sequence=1&isAllowed=y
28. Traoré B. Contribution to research into a traditional treatment for Eczema - Preliminary study on the feasibility of a clinical trial protocol [Internet]. 1995 [cited 2024 Mar 30]. Available from:
https://bibliosante.ml/bitstream/handle/123456789/10034/95M25.pdf?sequence=1&isAllowed=y
29. Willcox ML, Graz B, Diakite C, Falquet J, Dackouo F, Sidibe O, et al. Is parasite clearance clinically important after malaria treatment in a high transmission area? A 3-month follow-up of home-based management with herbal medicine or ACT. Trans R Soc Trop Med Hyg. 2011 Jan;105(1):23–31.
DOI:10.1016/j.trstmh.2010.10.003
30. Sangho A, Kaloga A, Sangho O, Kouboura Teguera R, Sangho F, Maïga S, et al. Overview of the regulation of clinical trials in Mali. Mali Médical. 2022;37(3):23–9.
31. Willcox M, Siegfried N, Johnson Q. Capacity for clinical research on herbal medicines in Africa. J Altern Complement Med. 2012 Jun 1;18(6):622–8.
DOI:10.1089/acm.2011.0963
32. Ministry of Health. Statistical Yearbook of the Local Health Information System of Mali; 2020. p.18–20.
33. Yaméogo PA, D’Alessandro E, Soubeiga AK. Natural remedies" without scientific proof! Ethnography of the rationales structuring the prescription of herbal medicines by doctors in Burkina Faso | Cairn.info. Public Health (Paris) [Internet]. 2019 [cited 2023 Feb 10];31(2):297–304. Available from:
https://www.cairn.info/revue-sante-publique-2019-2-page-297.htm
DOI:10.3917/spub.192.0297
34. General Secretariat of the Government. Official Journal of the Republic of Mali [Internet]. 2010 [cited 2024 Mar 29]. p. 83–6. Available from:
https://sgg-mali.ml/JO/2010/mali-jo-2010-03.pdf
35. General Secretariat of the Government. Official Journal of the Republic of Mali. Decree n°2017-0245/P-RM setting the terms and conditions for the application of Law n°09-059 of 28 December 2009 governing biomedical research on human beings [Internet]. 2017 [cited 2024 Mar 13]. Available from:
https://sgg-mali.ml/JO/2017/mali-jo-2017-13.pdf
36. Dori D, Ganfon H, Gbaguidi F, Evrard B, Quetin-Leclercq J, Semde R. Overview of regulations on medicines derived from traditional Pharmacopoeia in Benin and Burkina Faso. Int J Drug Regul Aff. 2019 Dec 18;7(4):8–13.
DOI:10.22270/ijdra.v7i4.361
37. Graz B, Houriet J, Willcox M, Csajka C. RTO-COVID-19" survey: Our care, our actions, their effects. Rev Med Suisse. 2020 Aug 26;16(703):1522–3.
DOI:10.53738/REVMED.2020.16.703.1522
38. Simoes-Pires C, Hostettmann K, Haouala A, Cuendet M, Falquet J, Graz B, et al. Reverse pharmacology for developing an anti-malarial phytomedicine. The example of Argemone mexicana. Int J Parasitol Drugs Drug Resist. 2014 Dec 1;4(3):338–46.
DOI:10.1016/J.IJPDDR.2014.07.001
39. Willcox ML, Graz B, Falquet J, Diakite C, Giani S, Diallo D. A ‘reverse pharmacology’ approach for developing an anti-malarial phytomedicine. Malar J. 2011 Mar 15;10 Suppl 1:S8.
DOI:10.1186/1475-2875-10-S1-S8
40. Kitalong C, Nogueira RC, Benichou J, Yano V, Espangel V, Houriet J, et al. ‘DAK’, a traditional decoction in Palau, as adjuvant for patients with insufficient control of diabetes mellitus type II. J Ethnopharmacol [Internet]. 2017 Jun 9 [cited 2024 Jan 19];205:116–22. Available from:
https://pubmed.ncbi.nlm.nih.gov/28478093/ DOI:10.1016/J.JEP.2017.05.003
41. Seck SM, Doupa D, DIa DiG, DIop EA, Ardiet DL, Nogueira RC, et al. Clinical efficacy of African traditional medicines in hypertension: A randomized controlled trial with Combretum micranthum and Hibiscus sabdariffa. J Hum Hypertens [Internet]. 2017 Dec 1 [cited 2024 Jan 19];32(1):75–81. Available from:
https://pubmed.ncbi.nlm.nih.gov/29311704/ DOI:10.1038/S41371-017-0001-6
42. Kroa E, Diaby B, Ahoussou EM, Yao GHA, Coulibaly GS, Kouassi D. Analysis of collaboration between traditional and modern medicine in the Sud Bandama region (Ivory Coast). Pharmacopée Médecine Tradit Africaine [Internet]. 2014 [cited 2024 Mar 11];17(1):21–7. Available from:
http://publication.lecames.org/index.php/pharm/article/view/237/137
43. Oseni Z, Shannon G. The relationship between Indigenous and allopathic health practitioners in Africa and its implications for collaboration: a qualitative synthesis. Glob Health Action. 2020 Dec 31;13(1):1838241.
DOI:10.1080/16549716.2020.1838241
44. Ouoba K, Lehmann H, Zongo A, Amari ASG, Semdé R, Pabst JY. Compliance to the legal and ethical requirements for the practice of traditional medicine: A cross-sectional study among traditional health practitioners in Burkina Faso. Eur J Integr Med. 2022 Dec 1;56:102189.
DOI:10.1016/J.EUJIM.2022.102189
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SANGHO, A., D. Dori, K. Ouoba, O. Sangho, A. Kaloga, R. Sanogo, and R. Semdé. “Experience of Health Professionals in the Implementation of Clinical Trials of Traditional Herbal Medicines: A Cross-Sectional Study in Mali”. International Journal of Drug Regulatory Affairs, Vol. 12, no. 2, June 2024, pp. 8-14, doi:10.22270/ijdra.v12i2.659.
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