Simple treatment – the way all medication should be

In recent years, i have been very excited to be part of clinical trials that aim to simplify treatment for various medical conditions.

My top picks would include:

  • Anti-Diabetic injections – we first compared a 3 times per week injection with the usual daily injection, and then trialed a once per week injection with the daily injection. The drug developer hopes to make this a once per month injection
  • Asthma treatment that is delivered as a once per month injection.
  • ARV treatment that is delivered as a once per month injection.
  • Osteo-arthritis treatment that is delivered as a once per month injection.

These treatment options, when they come to market, will surely be out of the price range of most of my patients, but in time, this will change.

I was excited to learn of another new medication that was launched by Shinogi & Co.

Baloxavir marboxil (S-033447) treats influenza A and B in one day, with one dose, reports Shionogi & Co.

So what is Baloxavir marboxil? It is currently approved and being developed in Japan under the name Xofluza. It is the most exciting development in recent years in the battle against influenza.

Most people would be aware of Tamiflu (Oseltamivir) and the developement of Tamiflu resistance. Not only those Xofluza provide an alternative treatment option, it is also a very simple treatment regime – just one tablet! That’s it.

Xofluza is an endonuclease enzzyme blocker that was shown to stop viral shedding within 24 hours, when compared with Oseltamivir’s 72 hours. So, instead of being knocked out for 5 days, taking Tamiflu morning and night during this period, Influenza sufferers will be treated with one tablet and recover a lot faster. The add-on benefits to those that have co-existant medical conditions have not been investigated but it should be profound.

I do hope that we see this medication in our neck of the woods. If last years flu season was anything to go by, it will be sorely needed.

Please feel free to comment or share this if you feel that it may benefit others.

Dr Essack Mitha

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Listeriosis

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Listeriosis is in the news – the South African minister of health today announced that 727 confirmed cases had been identified since early 2017 in South Africa.

I have been getting lots of queries about Listeriosis, so here is a quick guide on what you need to know:

Listeriosis is caused by eating foods contaminated with a bacteria called Listeria monocytogenes.

The bacteria are found in soil and water. The result is that the bacteria can be found in vegetables, meat and dairy products, processed foods and cold-cut meats, unpasteurized milk and soft cheeses (feta, brie, camembert, etc).

Listeriosis does not spread from person to person (except in the case of a pregnancy). It is usually caused by the ingestion of food that is contaminated.

Contaminated food will continue to grow bacteria even if the food is refrigerated. Cooking food thoroughly will kill off any bacteria present.

Signs and symptoms are fairly non-specific – these include fever, nausea, vomiting, diarrhoea, muscle pains and flu-like illness. In severe cases, patients can present with neck stiffness and other CNS symptoms.

Diagnosis is based on history and examination, but will only be confirmed by the culture of the bacteria in blood and cerebrospinal fluid.

Most people will spontaneously clear the infection with no treatment. However, patients considered high-risk should be treated with antibiotics (Ampicillin is the drug of choice). High risk individuals include patients who are elderly, newborn babies, pregnant patients and those with reduced immunity (e.g. HIV, TB, diabetes, organ transplant, cancer patients).

Preventative tips include:

  • Do not drink raw milk (unpasteurized) or eat food with unpasteurized milk in them
  • Wash all fruit and vegetables thoroughly under running water before consuming
  • Wash all raw meat thoroughly and refrigerate immediately
  • If eating left-over food, reheat it thoroughly until it is steaming
  • If in doubt, throw it out
  • Wash your hands, utensils and counter tops immediately before and after handling food
  • Consume ready to eat and perishable foods as soon as possible
  • Listeria can contaminate other foods due to spills in your refrigerator. Store food securely and clean your fridge often

If you are in doubt, please consult your usual healthcare provider.

For interests sake, lets look at the recent “outbreak” discovered in USA in March 2016. Part of the investigations included testing frozen vegetables sold in retail stores and found that one particular supplier had products that tested positive for the bacteria. Targeted action resulted in the reduction of the outbreak. Read the article here.

Please feel free to comment or share this if you feel that it may benefit others.

Dr Essack Mitha

Strenous exercise and gut disorders

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A new article published in Alimentary Pharmacology and Therapeutics by Costa analysed various studies and assessed the impact of strenous exercise on gastro-intentinal (GI) function.

A section of the results read as follows:

Exercise stress of ≥2 hours at 60% VO2max appears to be the threshold whereby significant gastrointestinal perturbations manifest, irrespective of fitness status. Gastrointestinal symptoms, referable to upper- and lower-gastrointestinal tract, are common and a limiting factor in prolonged strenuous exercise. While there is evidence for health benefits of moderate exercise in patients with inflammatory bowel disease or functional gastrointestinal disorders, the safety of more strenuous exercise has not been established.

The theory is that exercise-induced gastrointestinal syndrome are driven down two pathways: (1) a circulatory-gastrointestinal pathway involving redistribution of blood flow to working muscle and (2) a neuroendocrine-gastrointestinal pathway involving an increase in sympathetic activation, reducing overall gastrointestinal functional capacity. The combination of these two paths leads to a cascade of events that may result in gastrointestinal symptoms.

Associated effects include changes in gastrointestinal motility, with potential to slow gastric emptying. GI symptoms, such as bloating, belching and regurgitation are commonly reported by people partaking in strenuous exercise, and these appear to be exacerbated if foods and fluids are consumed whilst exercising. Other syptoms include epigastric pain, heartburn, flatulance, nausea and abnormal defecation. There is also evidence that strenous exercise can lead to malabsorption. Malabsorption of carbohydrates consumed during exercise is commonly seen after endurance running.

Understanding the effect of prolonged strenuous exercise on GI motility is important since the consumption of foods/fluids during exercise is usually encouraged to prevent fatigue and enhance exercise performance. However, consumption during a period when GI motility is compromised may create a problem, owing to reduced gastric empting rates,  and malabsorption.

Lets first look at what type of exercise is found to be problemtaic. Most articles seemed to find a cut-off of > 70% VO2 Max. Anything less that this seemed to have no effect on the GI system. Duration of less that an hour also seemed to have no effect. So if you are an endurance athlete, performing for more than 1 hour at a power level > 70% VO2 Max, you may need to take some preventative steps. In fact, the type of exercise showed that runners are more susceptable compared to cyclists, and woman are more prone to experience symptoms that men. Exercising in hot confitions also increased GI symptoms.

Below, are some of the recommended steps to prevent exercise induced GI syndrome:

1 Maintenance of euhydration

There is evidence that dehydration may exacerbate GI disturbances. Acute body mass loss of 2.7%, via sauna exposure, prior to cycling exercise (70% VO2max) has been shown to impair gastric emptying and increase GI symptoms, including nausea, compared with starting exercise in a euhydrated state. It therefore appears that starting exercise euhydrated and maintaining euhydration throughout would decrease GI symptoms.

2 Consumption of carbohydrate during exercise

Frequent and consistent consumption of carbohydrate during exercise is a protective strategy against exercise-induced GI symptoms.  The authors observed an abolition of intestinal injury, reduced intestinal permeability, and improved endotoxin and cytokine profile with the consumption of 15 g of carbohydrate pre-exercise and every 20 minutes during running at 60% VO2max in 35°C, compared with water alone. Such quantities of carbohydrate (45 g/h) appeared to be well tolerated. However, higher rates (up to 90 g/h) of multiple-transportable carbohydrate intake during running appear to be less tolerable, despite their recommended intake. It would therefore be advised to identify yur personal carbohydrate intake tolerance levels (ie, quantity and quality) during exercise, and consume carbohydrates evenly and more frequently throughout exercise.

3 Avoidance of NSAIDs

It is well established that NSAIDs are gastrointestinal irritants, impacting stomach gastric secretions, and erosion of the mucosal lining along the GI tract. The administration of NSAIDs prior to exercise can markedly increase intestinal injury in response to exercise so avoidance of NSAIDs prior to exercise would be recommended to minimise exercise-associated GI damage.

4 Dietary supplementation

It has been proposed that certain dietary supplements (e.g. anti-oxidants, glutamine, L-arginine, L-citrulline, bovine colostrum and probiotics) may contribute to the prevention of exercise-induced GI syndrome. It is thought that anti-oxidant supplementation can prevent further epithelial damage in the period after exercise. L-citrulline and L-arginine are precursors for nitric oxide production, which is a potent vasodilator, potentially enhancing blood flow into the intestinal microvasculature reducing exercise-induced hypoperfusion. Glutamine and bovine colostrum have been proposed to enhance the expression of heat shock proteins (ie, proteins that protect cellular membrane under period of stress), which may protect the intestinal enterocytes, reduce intestinal permeability, and attenuate the development of local inflammatory pathways. However, due to discrepancy in outcomes, the evidence for the use of a single supplement for the prevention and management of exercise-induced GI syndrome is not clear, and needs further investigation.

The concept that probiotics might exert favourable effects on intestinal epithelial integrity has led to three cross-over and blinded controlled laboratory studies and the results showed that probiotics may not be beneficial in preventing or attenuating exercise-induced GI syndrome and may actually contribute as an exacerbating factor.

So, to my my cycling and running friends out there – if you experience GI symptoms while on your long ride or run, consider some of the suggestions above.

Please feel free to comment or share this if you feel that it may benefit others.

Dr Essack Mitha

Medical Research Publication – A hot topic!

Medical Research Publication – A hot topic!

I base all of my medical opinions on Evidence Based Medicine, which involves review of published articles in reputable journals.

I have tried to educate family, friends and patients on the ways to evaluate written articles – just type in any search in Google, and you are likely to find hundreds of articles, usually with conflicting views. So, as an example, you could find that the good old “Green Chilli” has numerous health benefits…or none at all – depending on which article you read. While this may not be a HOT topic on its own, the underlying dynamics in research publication is causing some researchers to develop a fiery burn in the tummy.

Let’s immediately dispel those articles that are published with anecdotal evidence, or even evidence not based on a randomised control trials (RCT). So, if a green chilli is proven by a RCT to assist with lower back pain, I will take notice. But if an article published by a random organisation in the back of a monthly magazine claims that green chillies are good for impotence…I would take a limp view of it.

The main focus of this article, though, is to highlight the concerns recently, of biased medical reporting and even non-reporting of trial data. There has been a trend in some pharma circles, that will see a company not publish results if they show that their medication is not as effective as once thought. The concern is that non-publishing of data or selective reporting of data could even lead to safety issues being hidden from the public.

It is with this background that I welcome the initiatives by a group of experts that plan to tackle the “questionable integrity” of medical evidence. Experts from BMJ and the Oxford University’s  Centre for Evidence Based Medicine set out the steps required to develop trustworthy evidence.

Too many research studies are poorly designed or executed, argues Professor Carl Heneghan, editor in chief of the journal Evidence Based Medicine, in an editorial with The BMJ’s editor in chief, Dr Fiona Godlee, and colleagues.

Too much of the resulting research evidence is withheld or disseminated only piecemeal, they add, and as the volume of clinical research activity has grown, the quality of evidence has often worsened, which has compromised medicine’s ability to provide affordable, effective, high-value care for patients.

The manifesto aims to solve these issues. Developed by people engaged at all points in the research process, patients and the public, it identifies nine steps towards more trustworthy evidence.

They include expanding the role of patients, health professionals and policy makers in research, reducing questionable research practices, bias and conflicts of interests, ensuring drug and device regulation is robust, transparent and independent, and producing better usable clinical guidelines.

You can read the full article here. Hopefully, this gathers momentum and will lead to higher quality medical data, and ultimately to a healthier world.

Metformin and Victoza – my 2 favourite diabetes meds

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Diabetes, according to the World Health Organisation, affected 422 million people in 2014. That is more than 4 times more than 36 years ago, when it affected 108 million people globally.

In America, diabetes is currently the 7th leading cause of death. In South Africa, it is estimated that 7% of adults have diabetes. And its growing – as we are a rapidly urbanising country, with greater access to high calorie foods, more sedentary lifestyles, etc.

It was with interest then, that I came across the American College of Physicians updated guidelines for the management of diabetes. The reason for the update is due to the number of new oral therapies approved for use by the FDA. The College, therefore, needed to present the most up to date guideline which deals with all classes of approved drugs.

The new guidelines recommend metformin as first-line treatment of type 2 diabetes. A sulfonylurea, thiazolidinedione, SGLT-2 inhibitor, or DPP-4 inhibitor as add-on to metformin is recommended as second-line treatment.

Let’s bring this more local – and explore the most recent guidelines for South Africa, published by the Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA) – the 2012 guidelines.

These guidelines also regard Metformin is first line therapy, while Sulphonylureas, Alpha glucosidase inhibitors, DPP4 inhibitors and GLP-1 agonists all have a place as add-on therapy. Thiazolidendiones don’t long like they have a role to play as Pioglitazone has been removed from the 2012 treatment Algorithm and Rosiglitazone is no longer available in South Africa. There is currently no recommendations for SGLT-2 inhibitors.

Metformin still is a first line drug of choice for me, as it is effective and affordable. The major contra-indication for metformin use will be in patients with severe renal dysfunction (eGFR < 30). However, SEMDSA will need to publish an update soon, as there are more options available for treatment in South Africa.

Another favourite diabetic treatment has to be Liraglutide (Victoza) – probably because of its effect on weight loss. Most of my diabetic patients are overweight, and Liraglutide would be started a lot earlier in these patients – if they could afford it. It’s such a pity that a medication that could have such a profound effect on diabetes and weight management be put out of reach of the many patients that would benefit from it.

There has been a study published recently claiming that Liraglutide decreases the incidence of diabetes by 80% when used in overweight individuals, however, I wonder if the reduction in diabetes is directly attributable to Liraglutide, or could it be as a positive side effect of weight loss. It would be best to study Liraglutide, versus other conventional forms of weight loss, to truly determine if the reduction is due to Liraglutide.

So while Metformin represents an effective and affordable first line choice for diabetes, Victoza remains out of reach for the average patient. Let’s hope that Novo Nordisk recoups their R&D costs, so that the price can be made more affordable for the man on the street.

Read some of my previous articles on Diabetes and Liraglutide here (Diabetes – why is it so difficult to manage?, Liraglutide assists with weight loss in non-diabetic patients.). Please feel free to comment or share this if you feel that it may benefit others.

Dr Essack Mitha

POST BLOG NOTE: SEMDA has indeed published their new guidelines – in fact, i believe it was published today. See the SEMDA 2017 guidelines here. The guidelines estimated the South African national prevalence of diabetes (based on HbA1c) in persons older than 15 years was 9.5% in 2012, which is higher than previously estimated. The guideines are quite comprehensive and gives details into what equipment a diabetic centre should have, what assessments should be done, and the time interval for these assessments to be repeated. Sulphonyureas, Pioglitozone and DPP4 inhibitors are recommended as add-on therapy with Metformin. SGLT2 inhibitors are recommended as 2nd line or 3rd line agents, while GLP1 agonists are described as 3rd agents.

I like these guidelines, and will spend the next few days going through it in detail.

Asthma – ease the wheeze

Asthma – ease the wheeze

This time of the year, i start seeing more patients with poorly controlled asthma – probably due to the cold winter setting in.

Invariably, i have patients and worried parents trying to get to the bottom of their asthma attack, and what had caused the asthma in the first place. It is a very difficult question to answer sometimes, especially when there are many anecdotal reports documented on Google.

It is true that Asthma risk can be higher if mothers consume certain foods while pregnant. But that does not imply that every Asthma trigger should be engaged when a woman is pregnant. In fact, data from more than 60 000 pregnancies was evaluated specifically looking at the consumption of fish and any resultant protective effect on Childhood Asthma. The results showed that there was no evidence of a protective association of fish and seafood consumption during pregnancy with symptoms of  asthma and allergic rhinitis in offspring.

Asthma control in children has serious implications for other areas of health. There were 2 studies recently published that evaluated difficult to control asthma in children, with levels of overweight and obesity. The first study showed  a significant association between severe persistent difficult-to-control asthma and obesity and the second study showed that many children with persistent asthma are overweight or obese, have limited opportunity for activity, and experience activity limitations. It is therefore important to assess asthma management in children with a view to weight management as well – children with asthma should have a plan to keep active when their asthma is well managed.

For patients whose asthma is controlled and who have a low risk for future  exacerbation, current guidelines recommend gradually stepping down treatment to identify the lowest dose needed to maintain control. A recent article showed that adding Immunotherapy at this stage will assist in managing asthma in patients who are classified as moderate asthmatics. A bit more research is needed here – but it provides some hope when it comes to down-titrating asthma medication.

Remember to assess asthma every 6 months with Spirometry measurements – its the best way to ensure control, in my opinion.

Read some of my previous articles on Asthma here (asthma updates, assessment of asthma, aerobic exercise and asthma). Please feel free to comment or share this if you feel that it may benefit others.

Dr Essack Mitha

Breakfast – the most important meal of the day

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It is surprising to see how many people skip breakfast these days. Reasons vary from not having time in the mornings, to skipping a meal altogether to aid weight loss. Well, there have been some interesting studies published recently that emphasise why breakfast should not be missed. We also look at some of the regular “breakfast items” that we consume.

There have been a few studies going around in the last few years, investigating the cognitive benefits of breakfast. A recent article did an analysis of these studies, and found that healthy adults that consume breakfast displayed a small but robust improvement in cognition, specifically memory. Another study published in the Journal of Behavioural Medicine investigated a group of people that had enrolled in an Obesity Treatment program. Data confirmed that those who had breakfast, and also decreased the number of meals consumed in the day had a better weight loss outcome (compared to those that skipped breakfast and decreased daily meal frequency).

Ok, so we have confirmed that breakfast is important – but what should we be having? My favourite is always a cup of coffee…and its justified by an article in Clinical Nutrition, that found that patients who had 1-2 cups of coffee per day had a decreased incidence of cognitive dysfunction. As I write this, I am having my second cup…

While we are at it, another article in the European Journal of Nutrition found that the regular consumption of green/roasted coffee blends have positive effects on blood pressure, glucose and triglyceride levels. The authors suggest that this could be a recommendation to lower the risk of metabolic syndrome in healthy adults. I have also previously written about coffee – Caffeine consumption reduces risk of erectile dysfunction and Coffee – the healthy drink!

For those of you who enjoy your coffee, and add in some low-cal sweeteners instead of regular sugar – read this! A recent study evaluated adults who used low-cal sweeteners for a long period of time (mean 10 years), comparing them to non-users. They found that the users of low-cal sweeteners had an increased BMI (0,8kg/m2), a 2,6cm larger waist circumference and a 53% higher incidence of abdominal obesity. These findings are quite alarming, and results were adjusted for age, sex, race, dietary intake, physical activity and diabetes.

The authors quite correctly summarised the research by saying “These findings underscore that weight management strategies should be rooted in understanding how the human body responds to certain types of food instead of merely considering the theoretical caloric content.”

Lets end up this piece with a review of research on dairy consumption that was published in Annals of Epidemiology. The authors evaluated results from 17studies on total dairy products, and 16 studies on milk, specifically looking at the risk of obesity. The authors concluded that the risk of obesity decreased by 16% for every 200g/day increment of milk consumption.

That’s all for now – I would like to finish that cup before it gets too cold! Please feel free to comment or share this if you feel that it may benefit others.

Dr Essack Mitha