How traditional healers diagnose and treat diabetes mellitus in the Pretoria Mamelodi area and how do these purported medications comply with complementary and alternative medicine regulations

Introduction Medicine regulation and control is not an option but a necessity for national health programmes. In South Africa, a new amended regulation required a review of complementary and alternative medicine (CAMs) call-up for registration in November 2013, this impacted traditional healers (THs)’ compliance with the regulatory authorities’ on the good manufacturing practice. In return, affected the public’s access to CAMs. Regarding THs patients, cases of diabetes mellitus will be investigated. This investigation embraces methods, in the Mamelodi area of Pretoria, TH use to diagnose metabolic disorder diabetes mellitus and identify the purported medication prescribed. The study assesses what these purported medications comprise of as well as the purported medication labels for compliance with complementary and alternative medicine regulation. It is essential to understand the functioning of the newly amended regulations of the South African Health Products Regulatory Authority (SAHPRA). Regulations surrounding the registration and post-marketing control of complementary and alternative medicines are crucial. This study’s findings will be available to assist the SAHPRA to improve regulating complementary and alternatives medicines. The study will help create awareness among traditional healers concerning new regulations, requirements, and procedures for supplying complementary and alternatives medicine to their patients. Methods The study comprises a survey with administered questionnaires, distributed amongst 75 THs to gain knowledge on how they diagnose diabetes mellitus in their patients and establishing Complementary and Alternative Medicines used in treating this condition. The study also includes visits, with a non-structured survey, focussing on traditional health shops and pharmacies in the Mamelodi area; to identify and assess those with diabetes mellitus and complementary and alternative medicines compliance with the South African Health Products Regulatory Authority (previous Medicines Control Council(MCC)) regulations. Results and Discussion According to the questionnaires, traditional healers do not use any medical materials or laboratory tests to diagnose patients. They make use of skeletal bones and prayers, sometimes followed by physicians’ medical reports along with traditional healer’s assessment questions. They have an understanding regarding safety, quality control, and pharmacovigilance. Traditional healer’s self-provided treatment list for diabetes mellitus displays 20 different active ingredients in various CAM therapies. The most common treatment is plant/ herbal-based called Muti. Records show the most prevalent is the Oz (1 ounce/28.35 g) mixture (Oz First flush, Oz lily herbs, Oz flower of Ypres, Oz mulch root and Oz Makasan) followed by Mukwere kwere Euclea undulata), Bitter leave plants, known as Uhlunguhlungu (Brachylaena elliptica) and other (Brachylaena ilicifolia), Ndoleh (Vernonia amygdalina), Bitter bossie (Vernonia oligocephala) all along with herbs, such as Escobilla (Schkuhria pinnata). The overall purported medications do not comply with SAHPRA regulation. Pharmacies provided CAMs that are used by traditional healers only as complementary medicines. Most of them had a disclaimer on the label when not evaluated by the MCC/SAHPRA. Only two medicines were recorded as being registered by the MCC/SAHPRA known as ‘Manna blood sugar support’ and ‘Super Moringa’. Conclusion The diagnosis of diabetes by THs in the Mamelodi area is mostly by divination. THs know the importance of drug monitoring with regards to safety, efficacy, and effectiveness of the medication. They are still complaining of not being understood but rather dictated to by the health regulatory bodies in terms of regulation. Although their purported medication seems successful according to themselves and their patients’ feedback. Further investigation is demanded regarding glycaemic control of the 1 ounce (Oz) mixture to identify active ingredient molecules for potential drug discovery and development. This project impacts the South African Health Products Regulatory Authority and traditional healers. The project increases the public’s knowledge and signifies an advantage regarding the safety and trust of complementary and alternative medication.Dissertation (MSc)--University of Pretoria, 2019.PharmacologyMScUnrestricte