South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde
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The legal regulation of faecal microbiota transplantation (FMT) in South Africa (SA) is currently unclear. The purpose of this article, the first of three in a series, is to explore the nature, role and clinical application of FMT in SA in order to determine, from a legal perspective, the appropriate regulatory pathways governing FMT as a procedure that may combine approaches for the treatment of drugs, human tissue for transplantation, or clinical treatment as part of the practice of medicine. FMT has been shown to be a novel, safe and effective treatment for recurrent Clostridioides difficile infection (CDI). ⋯ Microbial therapies such as FMT are necessary, especially in a time of rising microbiome-associated inflammatory diseases and increasing resistance to traditional antibiotics. FMT is now considered as part of the standard of care for recurrent CDI overseas, but is currently only being used for research purposes in a minority of clinical cases of CDI in SA. This article, which lays the foundation for consideration of this question in three parts, suggests that the relevant regulatory system would depend on the categorisation of human stool as tissue, the exact composition of the FMT, how it is administered to patients, and the relevant levels of manipulation of the stool for FMT-derived products.
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Smoking cessation is a complex process influenced by factors such as smokers' nicotine dependence levels, socioeconomic status (SES) and other lifestyle behaviours. Little is known about these relationships in South Africa (SA). ⋯ Most adult smokers in SA have low nicotine dependence. However, the association of HND with high SES in this study suggests that although cessation treatment based on an integrated lifestyle behavioural intervention package may suffice for most smokers, a more intense cessation treatment package is needed for smokers of higher SES.