Starch safety in resuscitation – when will we ever learn?

Recent trials have failed to demonstrate a survival benefit from the use of hydroxyethyl starches (HES) as a colloid in fluid resuscitation and have raised concerns of renal harm. In severe sepsis, there is a concerning signal of increased mortality. New high-quality systematic reviews consistently demonstrate a statistically non-significant relative risk of death of 1.08 - 1.10 and a significant 25% increased chance of requiring renal replacement therapy. The HES literature contains many industry-affiliated reviews of indifferent quality. Traditional efficacy confidence limits may warrant re-evaluation when considering these harms. Newer formulations of HES and more focused indications for use show benefit on surrogate endpoints, but these trials are currently underpowered to ensure safety

We are tired of 'adrenal fatigue'

There are numerous articles in the lay press discussing the existence and under-diagnosis of adrenal fatigue. Proponents of adrenal fatigue state that millions of people have under-active adrenal glands due to repeated stressors, resulting in numerous nonspecific symptoms such as fatigue, insomnia, joint pain and weight gain, among others. In studies to date, proposed methods to assess adrenal fatigue have produced conflicting results and the methodology for assessing the hypothalamic-pituitary-adrenal (HPA) axis has often been inappropriate. Furthermore, only a minority of studies have actually examined the HPA axis. Current evidence does not support the existence of adrenal fatigue or the usefulness of supplements to support adrenal function

The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 1. A legal vacuum

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). Stool banks are instrumental in enabling access to FMT for patients and clinicians and help to catalyse research in the microbiome. However, the regulatory landscape in SA remains unclear. 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

The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 2. Human stool as tissue?

Faecal microbiota transplantation (FMT) has been shown to be an effective treatment for recurrent Clostridioides difficile infection. The purpose of this article, the second of a series of three articles, is to explore the legal framework governing human FMT in South Africa (SA). FMT involves different modes of administration that require different regulatory considerations. The focus of this article is to explore the legal classification of human stool as tissue in terms of the National Health Act 61 of 2003, as well as the regulation of human stool banks as tissue banks. The article concludes with specific recommendations aimed at improving the current regulatory vacuum relating to the regulation of FMT in SA

Research on COVID-19 in South Africa: Guiding principles for informed consent

Research is imperative in addressing the COVID-19 epidemic, both in the short and long term. Informed consent is a key pillar of research and should be central to the conduct of COVID-19 research. Yet a range of factors, including physical distancing requirements, risk of exposure and infection to research staff, and multiple pressures on the healthcare environment, have added layers of challenges to the consent process in COVID-19 patients. Internationally, the recognition that consent for COVID-19 research may be imperfect has led to a range of suggestions to ensure that research remains ethical. Drawing on these guidelines, we propose a consent process for COVID-19 research in the South African context that combines individual consent with delayed and proxy consent for individuals who may be temporarily incapacitated, combined with key principles that should be considered in the design of a consent process for COVID-19 research.

Antibiotic prescribing practice and adherence to guidelines in primary care in the Cape Town Metro District, South Africa

Background. Knowledge of antibiotic prescribing practice in primary care in South Africa is limited. As 80% of human antibiotic use is in primary care, this knowledge is important in view of the global problem of antibiotic resistance.Objectives. To assess antibiotic prescribing in primary care facilities in the Cape Town Metro District and compare it with current national guidelines, and to assess the reasons why prescriptions were not adherent to guidelines.Methods. A retrospective medical record review was performed in April/May 2016. Records of all patients seen over 2 days in each of eight representative primary care facilities in the Cape Town Metro District were reviewed. The treatment of any patient who raised a new complaint on either of those days was recorded. Prophylactic antibiotic courses, tuberculosis treatment and patients with a non-infection diagnosis were excluded. Treatment was compared with the Standard Treatment Guidelines and Essential Medicines List for South Africa, Primary Healthcare Level, 2014 edition.Results. Of 654 records included, 68.7% indicated that an antibiotic had been prescribed. Overall guideline adherence was 45.1%. Adherence differed significantly between facilities and according to the physiological system being treated, whether the prescription was for an adult or paediatric patient, and the antibiotic prescribed. Healthcare professional type and patient gender had no significant effect on adherence. The main reasons for non-adherence were an undocumented diagnosis (30.5%), antibiotic not required (21.6%), incorrect dose (12.9%), incorrect drug (11.5%), and incorrect duration of therapy (9.5%).Conclusions. This study demonstrates poor adherence to guidelines. Irrational use of antibiotics is associated with increased antibiotic resistance. There is an urgent need to improve antibiotic prescribing practice in primary care in the Cape Town Metro District.