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

High blood pressure – making sense of the noise

This week, I examined a few newly diagnosed hypertension patients, who expressed frustration at the conflicting information on the net, specifically with diets that should be followed – whats good for you, what prevents high blood pressure, etc.

The problem with browsing the net is that many opinions are published without scientific proof. I always advise my patients to first check if the article is talking about anecdotal evidence, or scientific evidence.

When it comes to food products and hypertension, we can see a few published articles that can give us some direction. This will also guide you on how to recognise quality articles.

A recent article showed that the use of Whey protein for 8 weeks lowered ambulatory blood pressure and other risk factors for cardio-vascular disease (Whey protein decreases blood pressure). Another article investigated the effects of daily dairy consumption in Chinese adults (Dairy food intake decreases the risk of hypertension)- over 37 000 adults where investigated over many years, and the authors concluded that the amount of dairy consumed had an inverse relationship with the risk of high blood pressure. The final food related article I have investigated a group of Taiwanese adults, and found that vegetarians had a 34% reduced risk of developing hypertension when compared to non-vegetarians (Vegetarian diet reduces the risk of hypertension).

I want to conclude the article review with a mention of exercise on blood pressure. GA Kelly evaluated over 700 adult woman and found that aerobic exercise reduced systolic and diastolic resting blood pressures (Aerobic exercise and blood pressure) – it reminds me of 2 of my previous posts – Dancing your high blood pressure away, and Tai Chi – its effects on blood pressure, weight and quality of life.

That’s all for now. Please feel free to comment or share this if you feel that it may benefit others.

Dr Essack Mitha

E-Cigarette safety – Up in Smoke?!?

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So this week, while going through the many medical updates and research articles in my inbox, I had the misfortune of seeing 2 articles published on the same topic, with 2 completely different conclusions.

The first article, published in Annals of Internal Medicine, looked at the long term safety findings of E-cigarettes (E-Cigarettes: Long term safety findings). The article made me look twice, I must admit. An extract is below:

Conclusion:

Former smokers with long-term e-cigarette–only or NRT-only use may obtain roughly similar levels of nicotine compared with smokers of combustible cigarettes only, but results varied. Long-term NRT-only and e-cigarette–only use, but not dual use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes.

The first thing that struck me was that the author compared groups of smokers of cigarettes against smokers of e-cigarettes. There is no duration of study, or number of participants included in the abstract. This begs the question of scientific validity. While I have reviewed only the abstract, I would have preferred to see a comparison of e-cigarette users compared to non-smokers, to determine long term safety. I would rather compare e-cigarettes to NO cigarettes.

The second article was published in JAMA Cardiology, looked at the cardiovascular risk associated with e-cigarette users against non-users (Thank you!!). The sample size was small (42 patients), but the author chose to look at specific risk factors of cardiovascular stress. Their conclusion:

Conclusions and Relevance  In this study, habitual e-cigarette use was associated with a shift in cardiac autonomic balance toward sympathetic predominance and increased oxidative stress, both associated with increased cardiovascular risk.

You can also view my previous e-cigarette articles here – E-Cigarettes negatively effect attempts to quit smoking, and E-Cigarettes and Alcohol use.

I have a few patients that claim that e-cigarettes help to give up smoking. I always tell them that there is still nicotine in e-cigarettes, and it may not be too long before they need to give up e-cigarettes too. For those wishing to quit, read about this innovative method Cigarette Crushing App helps you kick the habit.

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

Dr Essack Mitha

 

Diabetes – why is it so difficult to manage?

I have seen many patients over the last few years, who have been on treatment for diabetes at various health centres, with uncontrolled glucose levels. The patients sometimes did not even have yearly HbA1C measurements done, and management was usually only based on a fasting plasma glucose.

The more serious anecdotal finding, was that approximately 10% of these patients had some form of renal dysfunction, and they did not even suspect it.

Besides the usual investigations that should be done, patients in South Africa tend to leave decision making entirely to the health care provider. I always try to educate my patients on the causes, investigation and management of diabetes. Usually, this goes a long way in making patients more complaint with medication and management of their conditions.

We also need to look at other factors that make management of diabetes more difficult. A study published in The Lancet in November 2016 looked at the prevalence of Diabetes in Sub-Saharan Africa (Diabetes prevalence in Sub-Saharan Africa) . It found the median prevalence of diabetes was 5% and the median prevalence of overweight or obesity was 27%. With values so high, it was very encouraging to note that the South African government was considering imposing a sugar tax (see my previous post A tax on sugar)-as expected, the soft drink manufacturers were quick to try and prove no correlation between their drinks sugar content and the diseases it is accused of causing. However, an article published in September 2016 by Al Saint Jacques clearly shows a direct link between the consumption of fructose and the onset of diabetes.

Another way to improve management is to have less invasive and easier to use medications. Ask any diabetic of the most distressing part of treatment, and most will speak about injecting themselves with Insulin. Well, a newly developed delivery method called Cholestosome may make it possible too have a really effective oral Insulin pill (I discussed another oral insulin pill here An easy pill to swallow?). Watch out for this one – it may be a few years away, but t will definitely have an impact.

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

Dr Essack Mitha