Improved Traditional Medicines in Mali

Mali is unusual in enjoying a high level of government support for research and development of traditional medicines. The Department for Traditional Medicine, within the National Institute for Research on Public Health (part of the Ministry of Health), was founded in 1968 (originally as the National Institute of Phytotherapy and Traditional Medicine), and in 2005 moved to new purpose-built premises. Since 1979, one of its aims has been the development of standardized “Medicaments Traditionnels Ameliores” (MTAs, or improved traditional medicines). The “improvement” lies in the pharmacologic evidence of safety and efficacy, the standardized dose and quality control. In order to obtain marketing authorization, a dossier of information on the remedy's safety and efficacy must be submitted to the Commission Nationale d'Autorisation de Mise sur le Marche of the Ministry of Health. Malian regulations categorize traditional medicines as shown in Table 1.1 The requirements for the dossier vary according to the category (Table 2). Most MTAs are of category 2, for which clinical trials are not an absolute requirement. Table 1. Categories of Traditional Medicines in Malian Law1 Table 2. Components of the Brochure for Requesting a Marketing Authorization for a Traditional Herbal Medicine in Mali1 Since 1990, MTAs have been included on the Essential Drugs List of Mali, are included in the Malian National Formulary2 alongside conventional drugs, and are distributed through pharmacies. There are currently seven approved MTAs in the formulary2 (Table 3), and more are under development. They are intended to be a safe and effective, but locally produced and less expensive, alternative to imported medicines. This article is a systematic review of the preclinical and clinical literature on the safety and efficacy of these medicines. Voucher specimens of all these plants have been deposited at the herbarium of the Departement de Medecine Traditionnelle (Table 3). Monographs for all these plants are available online at: http://portal.ics.trieste.it/MAPs/MedicinalPlants_Country.aspx#Mali Table 3. The Seven Official “Improved Traditional Medicines” in Mali Balembo syrup (Crossopteryx febrifuga) Crossopteryx febrifuga Benth. (Rubiaceae) is a small tree 5–6 m high with small round fruit, which become black when ripe (Fig. 1). They are rich in flavonoids and polysaccharides. The seeds have anti-inflammatory properties.3 FIG. 1. Crossopteryx febrifuga (Rubiaceae) black fruits are used to make a cough syrup. Photo © Merlin Willcox. Color images available online at www.liebertonline.com/acm The fruits are boiled in water to produce a syrup, which was the most effective of several antitussive remedies tested,4 and is nontoxic when given orally.5 There was very low toxicity at the dose of 30 g/kg administrated orally in mice. In the model of cough in guinea pigs provoked by nebulized citric acid, it reduced the number of coughs by 63% at a dose of 250 mg/kg, and by 77% at a dose of 1 g/kg (compared to 76% by codeine at 10 mg/kg). The lower dose of 50 mg/kg was not effective.6 The remedy (at an oral dose of 1 g/kg) also reduced antigen-induced bronchoconstriction in guinea pigs by 54%, compared to a reduction of 78% by disodium cromoglicate (at a dose of 10 mg/kg). However, it had no effect on histamine-induced bronchoconstriction, and aqueous extracts were not active against bacteria that commonly cause respiratory infections.7 A clinical trial in 32 patients with cough showed improvement after 7 days,* and a sedative effect.5† Now Balembo syrup is the most frequently prescribed MTA; it is prescribed by up to 76% of biomedical health workers in Mali, and is also the most widely known by patients.8