Coffee is one of the world’s most widely consumed beverages, and previous research has linked its consumption to a lower risk of conditions such as type 2 diabetes and cardiovascular disease. However, the biological mechanisms behind these benefits remain unclear. A new Finnish study links habitual coffee consumption to healthier body composition and metabolic markers, while revealing distinct associations with sex hormones in men and women.
The study, conducted at the University of Oulu, analysed data from 2264 participants aged 46 in the Northern Finland Birth Cohort 1966. Researchers examined how habitual coffee consumption was associated with circulating metabolites, cardiometabolic risk markers and sex hormones.
Despite having a similar body mass index (BMI), individuals with higher coffee consumption had lower total and visceral fat and greater skeletal muscle mass than those who consumed less coffee.
In both men and women, higher coffee consumption was correlated with lower circulating levels of branched-chain amino acids, biomarkers that have previously been linked to insulin resistance and an increased risk of type 2 diabetes when chronically elevated.
The strongest sex-specific associations were observed in men. Higher coffee consumption was linked to a more favourable glucose–insulin profile, higher concentrations of total and bioavailable testosterone, and increased levels of sex hormone-binding globulin (SHBG). At the same time, free testosterone and the free androgen index were modestly lower. In women, hormonal associations were more limited and were primarily characterised by higher SHBG and lower measures of free androgens.
“Coffee is consumed by millions of people every day, yet we still know surprisingly little about how it relates to our metabolism and hormones. What stood out in our findings was a distinct hormonal signature that didn’t disappear even after we took into account BMI and lifestyle factors, with several of these associations differing between men and women,” says Luca Verroest, lead author of the study and Doctoral Researcher at the University of Oulu.
The results suggest that hormonal pathways may partly explain the relationship between coffee consumption and metabolic health. However, as this was an observational study, the findings demonstrate associations rather than cause-and-effect relationships.
The study is particularly relevant in Finland, one of the world’s highest coffee-consuming countries, where annual consumption averages around 11.8 kilograms per person.
The researchers say the findings provide a foundation for future studies aimed at determining whether coffee itself drives these biological changes and identifying the compounds responsible. These questions are currently being investigated in animal models, with the long-term goal of progressing to human intervention studies. Further research will be needed before the findings could inform dietary recommendations.
GLP-1 receptor agonists and dual agonists have transformed the treatment of obesity and other metabolic diseases, and a new editorial co-authored by Dr Steven Heymsfield of LSU’s Pennington Biomedical Research Center and Dr Adam Gilden of the University of Colorado examines what scientists are learning as these medications reach millions of people.
“Most of the unanticipated side effects of GLP-1 receptor agonists have been positive,” the authors wrote.
The researchers highlight evidence suggesting GLP-1 medications may reduce inflammation and lower the risk of certain cardiovascular and musculoskeletal conditions. Emerging studies also suggest the medications may reduce alcohol consumption and the risk of certain substance use disorders, although additional clinical trials are needed to confirm these effects.
At the same time, questions remain about the medications’ effects on lean body mass and nutritional health. Weight loss associated with GLP-1 medications can include reductions in lean mass, including muscle, making it important to understand how to preserve muscle through exercise and appropriate nutrition. Reduced appetite may also increase the risk of micronutrient deficiencies in some patients.
“GLP-1 receptor agonists have already transformed the practice of medicine in the United States, and this change will continue as more medications come onto the market,” the authors wrote.
The researchers identify three key priorities for future GLP-1 research:
Understanding the mechanisms behind potential reductions in inflammation,
Conducting randomised trials to better understand changes in lean body mass and ways to preserve muscle,
Conducting larger randomised trials to determine whether these medications can reduce alcohol use disorders.
Despite the remaining questions, the authors conclude that the evidence available to date supports a favourable overall risk-benefit profile for GLP-1 receptor agonists and dual agonists.
We usually think of bodily sensations as information the brain receives. What if the way we attend to those sensations can feed back and change the biological response itself?
Attention is already known to shape how bodily sensations are perceived. Focusing away from pain or itch, for example, can make these sensations feel less intense. A new study from the lab of Dr Liron Rozenkrantz at Bar-Ilan University’s Azrieli Faculty of Medicine, published in Nature Human Behaviour, shows that attention can also influence the body’s inflammatory response.
When people voluntarily focused their attention on sensations arising from a small area of inflammation in their arm, the inflammatory response was smaller and showed faster recovery dynamics than when their attention was directed away from those sensations.
The study, led by Dr Nofar Mizrachi and conducted in collaboration with Prof Menachem Rottem, a clinical immunologist, involved 57 healthy volunteers across three preregistered experiments. Participants underwent a standardised procedure that produced a small, temporary inflammatory response in the skin. They were then instructed either to focus on sensations from the affected area or to direct their attention elsewhere. The researchers measured the inflammatory response for 20 minutes as it unfolded, along with physiological measures such as heart-rate variability, skin temperature and autonomic activity.
The effect was substantial and highly consistent: nearly 90% of participants showed a smaller inflammatory response when they focused on the affected area, with responses approximately 1.5-fold smaller under internal attention compared with distraction. Differences emerged within minutes, with the response also showing faster return toward baseline.
“What was particularly striking was that directing attention toward the inflamed area changed not only what participants experienced, but the inflammatory response itself,” said Dr Rozenkrantz. “This raises the possibility that our subjective experience of what is happening in the body is not only a passive process, but may be actively contributing to how physiological responses are regulated.”
The researchers identified two complementary pathways that contributed to the effect. One involved sensory signals coming from the inflamed tissue. The other was a top-down mechanism through which attention continued to influence inflammation even when sensory signals were reduced using a local anesthetic.
Together, the findings suggest that attention can influence inflammation through both sensory and top-down pathways. More broadly, they suggest that the way the brain prioritises signals from the body may have consequences for how the body regulates itself.
The experiments involved healthy volunteers and a controlled model of acute skin inflammation. Whether the same mechanisms apply to chronic inflammation, autoimmune disease, wound healing or other conditions remains to be determined. The team’s next step is to identify the precise brain and immune pathways involved and determine whether similar effects occur in other physiological systems.
Growing evidence links higher consumption of ultra-processed foods (UPFs) to a range of health problems. Research has identified several potential biological pathways through which UPFs may contribute to cancer. These include metabolic disruption, inflammation, oxidative stress, and changes to the gut microbiome. However, data are sparse about whether men who consume high amounts of UPFs have greater risks of prostate cancer.
Now, new research from Florida Atlantic University’s Charles E. Schmidt College of Medicine provides evidence that men with higher consumption of UPFs have increased risks of prostate cancer. Published in The American Journal of Medicine, the study analyses a large and nationally representative survey from 17 024 US adults males from 2003 through 2023. Researchers used two 24-hour dietary recalls to calculate the percentage of daily calories participants consumed from UPFs. Using the validated and widely used NOVA classification system, they divided participants into four groups, ranging from less than about 20% of calories from UPFs to more than 44%.
Men in the three higher-consumption groups of UPFs had a 29% greater risk of prostate cancer, while those in the two highest-consumption groups had a 30% greater risk, compared to those in the lowest consumption group. After adjustments for age, race and ethnicity, smoking, and poverty status, the increased risk remained significant, ranging from 24% to 31%. Men with the highest UPF intake alone had a possible 34% higher risk, although the finding did not reach statistical significance, potentially reflecting the smaller number of prostate cancer cases in that group.
“Among adult men in this nationally representative US population, those who consumed higher amounts of UPFs had significantly higher risks of the subsequent development of prostate cancer,” said Charles H. Hennekens, MD, FACPM, FACC, senior author and the First Sir Richard Doll Professor of Medicine and Preventive Medicine in the Department of Medicine and the Department of Population Health at FAU’s College of Medicine. “These findings add to emerging evidence that UPFs have major adverse health effects and underscore the need for large-scale observational studies and randomised trials to adequately test the hypothesis.”
Previous studies have shown that people who consume larger amounts of UPFs have higher risks of overweight and obesity, metabolic disease, markers of inflammation, cardiovascular disease, principally heart attacks and strokes, as well as premature death.
This original research adds to the armamentaria of a major battle in which the priorities of the food industry do not align with the needs of the U.S. public. The authors opine that just as the dangers of tobacco began to emerge during the middle of the prior century, decades passed before the preponderance of evidence and the efforts of forward-thinking health officials prompted policy changes to discourage cigarette use. The authors believe that this is likely to be a similar path for UPFs.
“Reducing consumption of UPFs is a complex public health challenge, particularly given how prevalent and accessible these products are,” said co-author Timothy De Ver Dye, PhD, professor and chair of FAU’s Department of Population Health. “Healthcare providers should recognise that many patients face barriers to accessing and affording healthier food options. Addressing these challenges will require efforts that extend beyond individual choices to support greater access to nutritious, minimally processed foods.”
According to the International Agency for Research on Cancer, nearly 1.5 million men worldwide were diagnosed with prostate cancer in 2022, and nearly 400 000 died from the disease.
“All healthcare professionals should encourage patients to adopt healthy lifestyle practices and evidence-based therapies, while also helping them reduce their consumption of ultra-processed foods,” Hennekens said. “Patients and their healthcare providers should consider this finding as part of broader efforts to promote healthier dietary choices.”
Study co-authors are FAU medical students Hunter Scott and John Dunn as well as Yanna Willett, a doctoral student at the University of Oxford in the United Kingdom.
Increased risk of amyotrophic lateral sclerosis (ALS) associated with herbicides, insecticides Men exposed to these chemicals may be twice as likely to develop ALS as unexposed men
Photo by Arjun Mj on Unsplash
Workplace exposure to pesticides (herbicides and insecticides) is linked to a 60-70% heightened risk of the most common form of motor neuron disease – amyotrophic lateral sclerosis, or ALS for short, finds a synthesis of the available evidence, published online in Occupational & Environmental Medicine.
Men who have been exposed to these chemicals may be twice as likely to develop the condition as those who haven’t been, the analysis indicates.
Although still relatively rare, the incidence of ALS – a progressive and rapidly fatal neurodegenerative disease for which there is no cure – has increased in recent years, note the researchers.
White the short term neurotoxic effects of pesticides, particularly insecticides, have been known for decades, there’s not a great deal of evidence on their potential long term neurotoxicity, they add.
In a bid to strengthen the evidence base, the researchers scrutinised research databases for relevant studies, including peer reviewed theses and scientific reports, on workplace exposure to pesticides and ALS, published between 1990 and 2025.
Eight case-control studies involving a total of 1734 cases of ALS, and 3 studies involving 457 cases of unspecified motor neuron disease, were retained for pooled data analysis from 767 initially screened articles.
This showed that compared with no exposure, any workplace exposure to pesticides was associated with a 60% heightened risk of ALS, based on the pooled data from 6 studies.
And based on the results of 3 studies, any exposure to high levels of pesticides was associated with a near tripling in risk compared with no pesticide exposure, whereas any exposure to lower levels was associated with a doubling in risk.
Compared with no exposure, exposure to herbicides was associated with a 70% heightened risk of developing the disease; exposure to either insecticides or fungicides was associated with a 60% heightened risk.
In studies that reported risk estimates stratified by sex, the pooled data analysis showed that exposed men were twice as likely as unexposed men (3 studies) to develop ALS.
But no increased risk was apparent in women who had been exposed to pesticides compared with those who hadn’t been.
The researchers highlight various limitations to their findings: the small number of available primary studies and their crude assessment of exposure, generally based on answers to a few limited questions.
“To strengthen the evidence on risk factors for ALS, primary studies particularly need methodological improvements on exposure assessment, on the selection of reference groups, and on adjustment for potential confounders, including analysis for interactions between risk factors,” they emphasise.
But they conclude: “The findings of this review add to the evidence that occupational exposure to pesticides may increase the risk of ALS and should encourage the implementation of interventions aimed at reducing exposure during occupational pesticide use.”
People who have survived intensive care unit admission with sepsis don’t respond to vaccines in the same way as those who haven’t had sepsis, according to new clinical trial results. The findings suggest that more work is needed to understand why the vaccine-related immune response is altered in sepsis survivors, so that vaccination programmes can be tailored to reduce sepsis survivors’ risk of infections and improve long-term health outcomes.
Sepsis survivors can have a weakened or altered immune system, which can increase the risk of new infections and death. Fifteen per cent of sepsis survivors die within a year of leaving hospital, with a further six to eight per cent dying every year over the next five years.
The VACIRiSS trial, led by King’s College London and Guy’s and St Thomas’ NHS Foundation Trust and funded by the National Institute for Health and Care Research (NIHR), found that a vaccine that helps protect against serious illnesses like pneumonia and meningitis in the general population did not reduce the risk of future infections or re-hospitalisations in adults who had survived sepsis.
The long-term health impacts of sepsis survivors may not be receiving enough attention in health care. In the UK, one in three sepsis survivors are re-hospitalised within 90 days, with the majority of these re-hospitalisations from infections, and one in six patients are no longer alive at the end of the first year after recovering from sepsis. Despite this, there is no routine long-term follow up care for sepsis survivors in the NHS.
Professor Manu Shankar-Hari, Professor of Critical Care Medicine at King’s College London and Principal Investigator on the trial
Sepsis, a misfiring of immune responses to infection, can cause failure of vital organs and death if not treated quickly. Globally, it’s estimated that there are about 166 million sepsis cases and 21 million deaths from sepsis each year. Those who survive (approximately 145 million patients globally every year) are at increased risk of long-term ill health, including from recurrent infections.
While sepsis survivors may receive vaccinations as part of established vaccination programmes (such as flu or pneumonia vaccinations for older adults), vaccinations are not part of standard of care for sepsis survivors.
In the trial, 214 sepsis survivors were randomly assigned to receive a vaccine, called PCV13, or a placebo injection. Participants were followed up for a year to see whether the vaccine reduced their risk of re-hospitalisation with infection or death.
Overall, the vaccine did not reduce re-hospitalisation with infection or death in sepsis survivors. While blood tests showed that many participants did produce immune responses to the vaccine, the responses varied widely from person to person. The differences in vaccine responses were linked to factors such as age, body weight, sex, and levels of altered immune system before vaccination.
The findings suggest that established vaccination programmes may need to be modified to provide better protection to sepsis survivors. However, more needs to be done to understand the varied responses in sepsis survivors to inform what changes are needed.
In a thoughtfully designed, adaptive clinical trial, University of Pittsburgh School of Medicine physician-scientists demonstrated that the United States could triple to quadruple the supply of platelets available to help save bleeding patients of all ages and extend the life-saving therapy into rural regions and community hospitals. Platelets are the component of blood that encourage clotting, plugging cuts and tears in blood vessels and stemming blood loss.
Of the 2.5 million room-temperature platelet units collected per year in the United States, roughly 10% to 20% are wasted due to the short shelf life, costing hospitals $300 million, according to recent research in the journal Hematology.
“Our findings could result in major international public health benefits,” said lead author Philip Spinella, professor of surgery and of critical care medicine in Pitt’s School of Medicine and codirector of Pitt’s Trauma and Transfusion Medicine Research Center. “This is incredibly transformative and will dramatically improve the availability of platelets while also reducing waste, allowing hospitals that aren’t in major cities to afford to keep this life-saving blood product on hand for bleeding patients.”
Currently, donated platelets are conventionally stored at room temperature with a five- to seven-day shelf life. Early studies conducted half a century ago in healthy volunteers led regulators to believe that refrigerating platelets to extend their shelf life made them less effective.
Recent preclinical studies indicated the opposite, though, so Spinella and colleagues designed CHIPS to safely test using refrigerated platelets stored for increasing amounts of time up to 21 days. The trial enrolled 1000 paediatric and adult patients undergoing cardiac surgery at 27 sites in the United States and Australia from December 2021 to March 2025.
The patients were randomised to receive either standard, room-temperature platelets stored for less than seven days or chilled platelets. At every 200 participants treated, independent data analysts looked at the results. If the chilled platelets were performing just as well as room temperature, they’d add up to another five days to the age of the chilled platelets used and enrol another 200 participants, up to a maximum of 21 days.
The research team discovered that platelets refrigerated for up to three weeks were just as effective at treating bleeding as room-temperature platelets stored for up to one week. Since it can take two days for blood banks to process donations, the finding holds the potential to extend the lifespan of platelets for use in controlling bleeding by almost four-fold.
“Rural and community hospitals, for the most part, simply cannot justify keeping room temperature platelets in stock – they don’t see enough severely bleeding patients, so the waste would far exceed the benefit, something our nation’s fragile blood supply chain cannot accommodate,” said coauthor Michael Boisen, cardiothoracic anaesthesiologist and medical director of the UPMC Patient Blood Management Program, who served as principal investigator for UPMC’s CHIPS trial site. “So, if we can safely extend the shelf life of platelets and reduce the waste, imagine how many more people we could help.”
More than 97% of platelets are donated through apheresis, where a donor’s blood runs from a tube in their arm to a machine that collects the platelets and returns the rest of the blood back to the donor–a time-consuming process. The age of platelet donors has steadily increased over the past decade and younger donors are not replacing the aging donor base fast enough to keep up with demand, according to data from Vitalant, which supplied the platelets for the study and is one of the nation’s largest nonprofit blood and biotherapies services providers.
“About 15% of hospitals can experience one or more delayed platelet transfusions within any given month due to supply shortages,” said Ralph Vassallo, Vitalant’s chief medical and scientific officer. “A 21-day shelf life for cold-stored platelets will reduce outdate rates and ensure platelets are available on hospital shelves when a surge in need occurs.”
In addition to the civilian applications, the findings could also benefit military personnel by making it more feasible to have platelets available in conflict areas, said Spinella, who is also associate medical director of Pitt’s Center for Military Medicine Research.
A unique facet of the trial is that it included children and babies from the start. Usually, clinical trials that aren’t specific to paediatric populations will exclude children.
“I believe it is unethical not to include children in a trial when there isn’t a rational biological reason to exclude them,” Spinella said. “Of the 1,000 participants in our trial, roughly a third were children—which makes sense because it is the very young who bleed the most from cardiac surgery and most frequently benefit from platelets. Our trial will hopefully motivate others to include children in their trials.”
Additional authors are listed in the JAMA article.
Real-world study reveals the precise level associated with patient prognosis.
Credit: Darryl Leja National Human Genome Research Institute National Institutes Of Health
After treatment for metastatic prostate cancer, a drop in prostate-specific antigen (PSA) levels in the blood is an indicator that the treatment is working. A recent real-world study indicates that reaching a PSA level below 0.2 ng/mL is an indicator of improved patient survival. The study is published by Wiley online in CANCER, a peer-reviewed journal of the American Cancer Society.
Multiple phase 3 clinical trials have shown that a PSA level below 0.2 ng/mL is the best cut-off for determining a patient’s prognosis. Real-world data are lacking, however, and physicians often use other metrics, such as percentage of PSA decline, to assess treatment response. To determine whether there is a PSA response target associated with the most favourable outcome in community-dwelling adults with metastatic prostate cancer, investigators analysed Veterans Health Administration data on 4890 patients who received testosterone deprivation therapy with or without other treatments in 2018–2023 for metastatic hormone-sensitive prostate cancer.
Over a median follow-up of approximately 2 years, 896 patients died. Patients whose PSA levels dropped below 0.2 ng/mL within 9 months of starting treatment were 54% less likely to die than patients whose levels did not drop this low, whether their PSA levels also decreased by at least 90% or not. Patients who had at least a 90% PSA decline but did not achieve a PSA of less than 0.2 ng/ml had no improvement in survival. The findings suggest that patients who do not experience a PSA drop below 0.2 ng/mL could be candidates for more aggressive treatments. Also, patients who received testosterone deprivation therapy plus another drug to further block testosterone were more likely to reach a PSA below 0.2 ng/mL.
“These data show that we need to target a PSA below 0.2 ng/ml as our metric of success to optimize outcomes for our patients with metastatic prostate cancer,” said corresponding author Stephen J. Freedland, MD, professor of Urology at Cedars-Sinai and Staff Physician at the Durham VA Medical Center.
#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)
By Dr Andy Gray for Spotlight
The regulation of complementary and alternative medicines in South Africa has been hotly contested in recent decades, including in court rooms. In his latest column for Spotlight, Dr Andy Gray unpacks the legal background and the current state of this still unfolding regulatory saga.
Multivitamin and mineral supplements are commonly found in many South African retail outlets, from pharmacies to health shops and supermarkets. Some outlets will stock a wider range of medicines, perhaps on shelves marked as “complementary”, or among other non-prescription medicines available for self-service.
Are these medicines regulated in the same way as other medicines, including those available on prescription?
The concept of a “call-up notice”
When South Africa’s medicines legislation was first passed in 1965, there were already many medicines on the local market which had not been assessed for safety, efficacy or quality. As all such medicines could not be immediately “called up” for registration, a stepwise approach had to be followed.
Between 1967 and the mid-1980s, medicines were identified for registration by pharmacological classification. The remnant of that approach is still evident in section 14(1) and (2): of the Medicines and Related Substances Act, 1965:
(1) Save as provided in this section or sections 21 and 22A, no person shall sell any medicine, … which is subject to registration by virtue of a declaration published in terms of subsection (2) unless it is registered.
(2) (a) The Authority may from time to time determine that a medicine, …, or class or category of medicine, … or part of any class or category of medicine, … mentioned in the declaration, shall be subject to registration in terms of this Act.
(b) Any such declaration may also relate only to medicines, … which were available for sale in the Republic immediately prior to the date on which it comes into operation in terms of paragraph (c) or only to medicines, … which were not then so available.
The declaration that a category or class of medicine is subject to registration is referred to colloquially as a “call-up notice”. A notice could be applied to those medicines already marketed, or only to those not yet marketed. Medicines which were already marketed but exempted from a full registration process were then regulated as “old medicines”. They are still subject to control according to their scheduling status and their production still needs to be in accordance with Good Manufacturing Practice. In time, new brands of some of the “old medicines” have been registered.
By the mid-1980s, the process of working through the pharmacological classifications was concluded. Thereafter, every new medicine would need to be registered before being marketed. In other words, a manufacturer or importer would need to provide sufficient evidence of the medicine’s safety, efficacy and quality to justify registration.
However, an important exception was created in 1986, which exempted homeopathic medicines from the full registration process. Two important restrictions were included. Firstly, no medical claims could be made for the medicine. Secondly, the following wording was to be included on the label of such medicine: “Homeopathic Medicine” and “WARNING: Use only as directed by a medical practitioner, pharmacist or homeopath”. The provision applied to homeopathic mother substances and so-called “minute-dose forms” made in accordance with homeopathic principles.
Broadening the scope of complementary medicines
Homeopaths are one of several complementary and traditional health professions regulated by the Allied Health Professions Council of South Africa. Medicines legislation has been amended to accommodate this wider range of complementary and traditional medicines.
A separate South African Health Products Regulatory Authority (SAHPRA) web site is dedicated to what are termed Category D medicines, also known as complementary medicines.
The General Regulations issued in terms of the Medicines Act includes a definition of complementary medicines which has two components: health supplements and medicines used in accordance with a “discipline as determined by the Authority”. The pharmacological classifications listed in Annexures 1 (human) and 2 (veterinary) medicines list the “disciplines” as Aromatherapy, Homeopathy, Phytotherapy, Traditional Chinese Medicine, Unani Medicine, Western Herbal Medicine, Combination Products and Other Herbal. The Annexures also list the types of health supplements, including amino acids, mineral, probiotics and vitamins. Two elements are important here – the nature of the substance included in the complementary medicine and the claims made in relation to that medicine.
Since 2013, the intention has been to progressively bring all complementary medicines under effective regulation, using a risk-based approach to identify those requiring registration and full assessment of safety, efficacy and quality data. The first pharmacological classifications identified were those claiming antiviral properties, and those intended to treat diabetes, cardiac conditions and cancer. However, no complementary medicines have yet been registered and the initial “call-up notices” have been repealed.
Like much of South Africa’s medicines regulatory space, this process has been affected by litigation. A challenge of the complementary medicines regulatory scheme by the Alliance of Natural Health Products (South Africa) was finally decided by the Supreme Court of Appeal in 2022. The court confirmed the finding that SAHPRA should have no regulatory power over substances and preparations that did not meet the definition of a medicine. A preparation that seeks to supplement a diet or provide a nutritional benefit is not a medicine, but a foodstuff. Draft amendments to the 2017 General Regulations, informed by the court judgment, were published for comment in March 2023, but have yet to be issued in final form.
Not a total lack of regulation
The hiatus in finalising regulations does not mean, however, that there is no regulatory control over complementary or Category D medicines. The initial “roadmap” outlined in the 2013 regulations has been replaced by a series of guidelines. The progressive, developmental approach to the regulation of complementary medicines remains in place, albeit delayed and as yet incomplete.
The overall roadmap was updated in 2021. All manufacturers, wholesalers or distributors of complementary medicines are required to be licensed by SAHPRA, but this process relies on an applicant’s “attestation of compliance with minimum requirements at the time of application and the payment of the required licence application, and desktop evaluation fees”, rather than the full Good Manufacturing Practice inspection applied to manufacturers of other medicines. However, SAHPRA reserves the right to conduct inspections where warranted. A similar approach is applied to the regulation of medical devices and diagnostic tests.
In the meantime, while no complementary or alternative medicines have been registered by SAHPRA, there is relatively strict regulation of what companies can say about the unregistered complementary medicines that they market in South Africa.
As with the 1986 exclusion for homeopathic products, all category D products which have not been registered have to include the following statement on the label: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”. The guideline also distinguishes between low risk and high-risk claims, in either labelling or advertising. Low risk claims are those for general health enhancement without any reference to specific diseases; health maintenance; or the relief of minor symptoms (not related to a disease or disorder).
The guideline is specific about a widely used wording: “Unregistered complementary medicines making use of the terms “Clinically proven” or any similar expression … shall also be considered to be HIGH RISK and may be subject to individual call-up in terms of section 14(2) of the Medicines Act.” Examples of acceptable low risk claims are provided, such as “Helps enhance/promote joint health”. Further guidance on the evidence to be relied upon for low risk and high-risk claims has been provided for the discipline-specific complementary medicines.
Manufacturers and importers of health supplements are only allowed to make low risk claims, and the relevant guideline provides Annexures (from Annexure A to O), showing the allowable levels and claims for each type of supplement. For example, a single component vitamin B3 (nicotinamide) product sold for adults may not contain more than 500mg per dose, and can only make a claim of “Helps to metabolise carbohydrates, fats and proteins”, “Contributes to normal growth and development” or “A factor in the maintenance of good health”.
A key document is the current guideline on the regulation of discipline-specific complementary medicines. An additional guideline was updated in 2022, which provides guidance on caffeine, menthol, camphor and cannabidiol. Low-dose cannabidiol can be sold as either a discipline-specific complementary medicine or a health supplement. At a dose not exceeding 20mg per day or 600mg per pack, it can be sold as a Schedule 0 product.
As no complementary medicines have yet been registered, none have as yet been specifically included in any of the Schedules, and they are therefore assumed to be controlled as Schedule 0 products, which can be sold in any retail outlet. One exception would be any injectable product, as those are automatically included in Schedule 3 and are prescription-only.
Important sources of information
The SAHPRA complementary medicines website provides a crucial resource which can be accessed by the public. The list of licensed complementary medicines manufacturers, importers and exporters is accessible here. There are currently 117 entries on the list. Each entry also provides a list of the products provided by that licensed entity, with details of ingredients, recommended doses and intended uses, whether discipline-specific or health supplement. The entire database is also searchable.
The site also enables anyone to lodge a complaint about a complementary medicine, including anonymous complaints.
Gaps in the system
While some progress has been made, the regulatory scheme for complementary medicines remains incomplete. Apart from finalising the regulations after the court challenge, a risk-based “call-up” process still needs to commence. Moving from an attestation process to confirmation that every manufacturer has met current Good Manufacturing Practice standards is still necessary.
Currently, the proprietary (brand) names used for complementary medicines are not pre-approved by SAHPRA, and many are in contravention of the naming guidelines applied to other medicines.
Effective oversight of advertising and marketing practices remains elusive, not only in respect of complementary medicines.
The dictum traditionally applied to consumer goods of “let the buyer beware” (in Latin, “caveat emptor”) is no longer considered appropriate. The Consumer Protection Act, 2008 seeks to protect the public against unsafe products and unfair marketing. Medicines are treated as a special category of goods, deserving closer regulatory control. The remaining gaps in the medicines regulatory system need to be plugged. One very particular gap, which has never been adequately addressed, is the regulation of African traditional medicines, which are not currently captured in the definition of Category D medicines.
– Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice.
Disclosure: Gray serves on three technical advisory committees at the South African Health Products Regulatory Authority.
Children are NOT small adults. They experience and express illness and injury very differently from adults. Which is why paediatric diagnostic imaging is a highly specialised field of medical imaging and is specifically designed for children, from birth to adolescence.
Dr Ebrahim Banderker, a paediatric radiologist at Red Cross War Memorial Children’s Hospital (RXCH), explains why children need a different approach to imaging and the role of radiology in children. He also talks about the success of a public-private initiative with SCP Radiology where he is a consulting radiologist.
Why is paediatric imaging so important?
Children are often unable to, or struggle to describe the nature of their discomfort, pain or symptoms clearly. Imaging helps doctors understand what is happening inside the body, when language and understanding are limited.
When we diagnose early, we are often preventing future pain, disability or developmental issues as well as reducing the anxiety of the family.
What should parents know or understand about paediatric radiology?
Paediatric imaging is designed with the needs, safety and the specific conditions of children in mind. It is a tool for clarity, reassurance and early care. Our goal is to care for the child in their imaging journey and provide their doctors and families with clear answers they can trust.
How is paediatric radiology different from adult radiology?
The choice of the method of imaging is primarily based on how safe it is. The effects of radiation from X-rays and CT scans have a greater risk for a child than an adult – so ultrasound and MRI are preferred where possible.
Children are often afraid, unsettled because of pain and anxiety and may require sedation or anaesthesia to make them comfortable during the imaging process.
Paediatric imaging equipment, anaesthetic apparatus, monitoring and emergency equipment have to be adapted to children of different ages.
Do paediatric radiologist work directly with children and their parents?
Paediatric radiologists interact with the child and their caregivers far more often than adult radiologists interact with their patients. It is one of the most rewarding aspects of our work. Parents are generally more involved and can help the radiologist by confirming the history and symptoms. The radiologist in turn can reduce parent anxiety, explain the procedure and obtain consent where needed.
Please can you talk about radiation and safety in children – we know that one of the issues both parents and other adults have is safety and radiation?
Children have rapidly developing cells and tissues, often tightly packed together in small bodies and are considered to be 10-15 times more sensitive to radiation.
The guiding principle of all radiation safety is ‘ALARA,’ which stands for ‘As Low As Reasonably Achievable’ or as we say, ‘when benefit clearly outweighs the risk.’ Ultrasound and MRI do not use radiation and these should be used where possible.
What injuries are commonly seen in children that require imaging?
Common injuries include those from motor vehicle accidents and particularly pedestrian accidents, fractures from falls or playing sport and unfortunately, increasingly from child abuse which is sometimes first identified by the radiologist.
Children’s bones are different from adults and have areas where the bone is still growing. These are called growth plates. Injuries to the growth plates require special care because they can affect how a bone develops and this impacts the overall growth of the child.
Outside of injuries, paediatric imaging also looks at chest infections, abdominal pain, appendicitis, urinary tract problems and hip development in infants. Brain imaging may be used for seizures, headaches or developmental concerns. In essence, imaging can help us rule out serious causes quickly, which brings enormous reassurance to families.
Even for adults, radiology can be stressful and frightening – for children it must be worse. How are children supported during scans?
Radiographers and radiologists are trained to work gently and calmly with children and parents are encouraged to be involved and ask questions. For example, when a child needs to be sedated for an MRI, the parent will stay with them until they are asleep. When children feel safe, the scan is quicker, easier and more accurate. The team ensures the child is warm and comfortable and the environment is child friendly with toys and reading material to distract patients and to keep them happy and engaged.
What developments in paediatric radiology do you feel are the most important – especially over the 5 years?
Digital radiography allows for digital manipulation of images improving image quality and accuracy. Retakes are reduced so there is less radiation involved
Ultrasound machines have improved in-depth visualisation of body parts, disease processes and blood vessels
CT scanners are faster and offer lower radiation dose options. There are scanners which can scan the entire body of a child in less than a second. There is not even time to wriggle…
MRI imaging is developing at a galloping pace with faster scanning techniques and finer image detail
Functional MRI and the ability to do tissue sampling in cancer imaging, is opening many exciting new avenues.
The scope of interventional radiology techniques (treating not just diagnosing) is expanding rapidly to make less invasive treatment possible, with less complications for patients and much shorter recovery times. Paediatric radiology increasingly includes minimally invasive procedures (image-guided drainages, biopsies, nephrostomies, angiography), which can shorten hospital stays and reduce surgical burden.
