Can conventional Research and Development methods align with traditional medicine?
A large number of modern-day therapies have had their documented origins in natural products. These include the popular antimalarial drugs, quinine and artemisinin from Cinchona and Artemisiaspecies respectively; the heart failure treatment, digoxin fromDigitalis species ; the important pain relief agents codeine and morphine from Paperver species; anticancer drugs vincristine and vinblastine from Catharanthus roseus and the pre-surgery medication, atropine from Atropa belladona 7.
At first blush, the conventional science-based approach to identifying new therapies seems incongruent with the process by which traditional medicine is practiced. African traditional medicine provides holistic treatment. The techniques often derive from the understanding of the aetiology of disease, as conceived by the practitioners: herbalists, traditional birth attendants, bone setters, diviners, faith healers and spiritualists. Their belief that diseases may be caused by spiritual and esoteric causes as well as physical and psychological causes8. Following diagnosis, a treatment usually consisting of a polyherbal remedy is prescribed. In some cases, individual compounds are responsible for the reputed pharmacological effect. However, in many cases, the observed pharmacological effects is due to a mixture of different compounds as well as the holistic approach of the practitioner.
As scientists, we recognize the benefit of traditional medicine but have been trained to seek standards, procedures and investigations that would provide confidence in short and long-term safety and efficacy claims that align with our own preconceptions of specific safety and efficacy metrics. This raises a number of questions to be considered:-
Can claims of efficacy be described with the scientific methods that are already available for conventional R&D? Could safety claims be under-written by the tests that are already available for new chemical entities? What could be the social, economic and political readiness if there is a need to strictly follow the procedures required by conventional science? What would be the impact on the established trust and usage by the communities who depend primarily on traditional medicine? How could orthodox and traditional healthcare practitioners mutually learn from each other to benefit their common patient base?
The integration of African natural products into the modern drug discovery process will require enhanced collaboration among different stakeholders including the pharmaceutical industry, academic research units, regulatory bodies, ethics review committees, local, regional, continental and international organizations. This aligns with the compromise process that some experts have promoted to facilitate the integration of traditional and orthodox medicine by recognizing claims of efficacy, and then attempting to collect as much clinical experience data as possible, while moving backwards through laboratory evaluations, preclinical experiments, and targeted clinical studies based on the learnings (see Table 1). We realize that these are big asks and suggest that assessments might be prioritized for those traditional therapies that are widely used or have popular support, and that the goal should be to support evaluation in clinical trials.
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We conducted an informal assessment of the COVID-19 clinical trials registered on https://www.covid-trials.org/ and noted that several traditional medicines are being examined in clinical trial settings across the world. The therapies under investigation comprised a diverse slate ranging from honey, plant products formulated into dosage forms through to a large number of Chinese Traditional Medicines. We were especially encouraged to note a trend towards study designs that would increase confidence in the study outcomes such as blinding processes and randomisation of participants to the interventions. However, we acknowledge that the rigour and requirements of clinical trials are likely to be unaffordable for most investigators and countries, but suggest that the approach outlined in Table 1, while expediting the process, might inform future research and future pandemic preparedness.