No evidence sugar-free soft drinks aid weight loss – study

Soft drinks made with artificial sweeteners, such as diet colas, do not help people lose weight and may be as big a part of the obesity problem as the full-sugar versions, academics have said.

A paper by researchers at Imperial College London and two universities in Brazil contends that artificially sweetened beverages, often called diet drinks, are just as big a problem as those containing sugar. There is no evidence they help people lose weight, they say, possibly because people assume they can eat more because their drinks are low in sugar.

The report says the combined factors of what goes into artificially sweetened drinks, how they are consumed, and their environmental impact mean that “far from helping to solve the global obesity crisis [they are] a potential risk factor for highly prevalent chronic diseases”.

Sugar-sweetened drinks, including sports beverages, have been identified as one of the major causes of obesity. Many countries, including Mexico and France, have introduced sugar taxes to try to reduce consumption, and the UK plans to do so next year.

Many manufacturers are looking to boost sales of drinks containing artificial sweeteners in order to escape the levy. Such products already account for 25% of the global soft drinks market.

Prof Christopher Millett, senior investigator at Imperial’s School of Public Health, said: “A common perception, which may be influenced by industry marketing, is that because ‘diet’ drinks have no sugar they must be healthier and aid weight loss when used as a substitute for full-sugar versions. However, we found no solid evidence to support this.”

The paper, published in the journal PLoS Medicine, is a commentary on the research done so far into artificially sweetened beverages promoted as healthier alternatives and the impact on weight.

It says the evidence does not suggest they help with weight loss, although they probably do not cause people to put on weight. Some studies show no weight loss; others show a small loss, but those studies were not always well done and were often funded by the soft drinks industry, the authors say.

Maria Carolina Borges, the first author of the study, from the Federal University of Pelotas, in Brazil, said: “The lack of solid evidence on the health effects of ASBs [artificially sweetened beverages] and the potential influence of bias from industry-funded studies should be taken seriously when discussing whether ASBs are adequate alternatives to SSBs [sugar-sweetened beverages].”

The paper argues that “given their negligible nutritional benefits and potential detrimental health impacts”, the environmental impact of manufacturing artificially sweetened drinks should be taken into account. It takes 150-300 litres of water to make one litre of drink, it says, and there is considerable solid waste and cumulative chemical pollution.

Prof Carlos Monteiro, a co-author, from the University of São Paulo, said: “Taxes and regulation on SSBs and not ASBs will ultimately promote the consumption of diet drinks rather than plain water, the desirable source of hydration for everyone.”

The British Soft Drinks Association dismissed the paper. Its director general, Gavin Partington, said: “Contrary to the claims made in this article, scientific research shows that low-calorie sweeteners, such as those found in diet drinks, help consumers manage their weight as part of a calorie-controlled diet.

“At a time when we are trying to encourage people to reduce their overall calorie intake it is extremely unhelpful that products that contain no sugar, let alone calories, are demonised without evidence.”

He added: “It’s worth bearing in mind that the UK soft drinks sector is the only category in which sugar is consistently falling year on year – over 17% since 2012.”

Global beverage companies have been investing in soft drinks, flavoured water, juices and ready-to-drink tea and coffee containing artificial sweeteners in response to the obesity crisis and the outcry over sugar. The World Health Organisation has said sugar should not be more than 10% of people’s energy intake, and preferably lower than 5%.

On Tuesday the supermarket chain Sainsbury’s announced a 13% cut in the sugar content of its own-brand cereals.

The government has asked food manufacturers to reduce the sugar content of their products by 5% by the end of this year. Sainsbury’s said it had also removed all illustrated characters from its cereal boxes as part of a commitment to responsible marketing to children.

No evidence sugar-free soft drinks aid weight loss – study

Doctor wins appeal over shaken baby syndrome trials evidence

A doctor barred from practising over evidence she gave in criminal trials involving so-called shaken baby syndrome has had her licence reinstated.

Dr Waney Squier, a consultant paediatric neuropathologist, won a high court appeal battle when a judge cleared her of dishonesty on Thursday.

Squier, who worked at John Radcliffe hospital in Oxford, had her name removed from the medical register at a medical practitioners tribunal service in March.

The tribunal concluded she gave deliberately misleading and dishonest evidence for the defence in trials between 2007-10 regarding four babies and a 19-month-old who died after sustaining deliberate head injuries.

On Thursday, Mr Justice Mitting overturned the decision, saying it was flawed because her views were not misleading. However, he said she had failed to work “within the limits of her competence, to be objective and unbiased and pay due regard to the views of other experts”.

A spokeswoman for the General Medical Council, which brought the case against Squier, said: “Mr Justice Mitting has confirmed that this case was not about scientific debate and the rights and wrongs of the scientific evidence, but the manner in which Dr Squier gave evidence.

“The ruling makes clear that she acted irresponsibly in her role as an expert witness on several occasions, acted beyond her expertise and lacked objectivity, and sought to cherry-pick research which it was clear did not support her opinions.”

Doctor wins appeal over shaken baby syndrome trials evidence

The evidence of an NHS weekend effect is shaky | Letter from Neena Modi, David Owen, Robert Winston, Stephen Hawking and others

We call on Theresa May to act in the public’s interest and take immediate action over freshly disputed evidence surrounding a “weekend effect”. Department of Health documents leaked to the Guardian and Channel 4 News revealed NHS policy concerns from Jeremy Hunt’s own civil servants. His repeated claim about thousands of patients dying unnecessarily because of poor weekend hospital care “has not been helpful” in justifying new seven-day services. The internal briefing document proposed other means to vindicate his policy, but repeats the assertion that “eight independent studies have set out the evidence for a ‘weekend effect’ – unacceptable variation in care across the week”.

The evidence for these claims is not supported by reliable research. Of the eight “studies” cited by Hunt, only four are independently peer-reviewed, yet peer-review is essential. Three use data from the same population and are not independent, with just two from the last decade. The remainder are not peer-reviewed medical literature, being opinion pieces, the lowest form of clinical evidence. Critically, when his claims began, at least 13 independent, peer-reviewed papers were available to the secretary of state that refute his definition of a weekend effect.

Hunt has cherrypicked research, causing a devastating breakdown of trust between government and the medical profession. In making these claims without faithfully representing the evidence, he has obstructed fact and misled parliament and the public.

We call on Theresa May to commission an independent inquiry into the process behind these policies. It is wrong to waste precious resources, or lives, because of bad evidence. Like NHS treatments, health policy should be evidence-based to demonstrate clinical and cost-effectiveness. Additionally, we call for a pause on any policies or contractual reform driven by this evidence until it can be examined objectively and with rigour.

Dr Taha Nasser
Dr Ben White
Dr Hugo Farne
Dr Antonio De Marvao
Dr Rachel Clarke
Dr Margaret McCartney
Dr Philippa Whitford MP
Dr Phil Hammond Vice-president, Patients’ Association
Professor Alistair Hall Epidemiologist
Professor Trisha Greenhalgh Evidence-based practice
Professor Neena Modi President RCPCH
David Owen House of Lords
Professor Robert Winston House of Lords
Professor Stephen Hawking

• Join the debate – email guardian.letters@theguardian.com

The evidence of an NHS weekend effect is shaky | Letter from Neena Modi, David Owen, Robert Winston, Stephen Hawking and others

New Study Provides First Evidence That Natural Essential Oils Counteract Inflammation Caused By Polluted Air

Certain ingredients in essential oils made from plants could provide a natural treatment of liver and lung conditions caused by air pollution.  They may also help in counteracting inflammation.

This recent study evaluated the value of using specific essential oil compounds — like fennel, anise, ylang ylang, and cloves — to treat inflammation caused by the fine particles found in hazy, polluted air known to be carcinogenic.

This new study is the first of its kind.

Different Organic Compounds in Essential Oils

Plants naturally contain a variety of essential oils that consist of different compounds. Some of these compounds have antioxidant value.  They may also be able to fight inflammation.

The essential oils in some plants have a group of organic compounds called phenylpropanoids — possible anti-inflammatory substances.  A few of these substances are estragole (found in basil), eugenol (which occurs in clove bud oil), trans-anethole, (a flavor component of anise and fennel), and isoeugenol (contained in ylang ylang).

Laboratory Tests Discover Essential Oil

Lead author of this new study, Miriana Kfoury and her team of researchers, collected air pollutant samples containing fine particles.  Laboratory test samples were then introduced to human cell cultures of cancer derived hepatic cells and normal bronchial epithelial cells.

The fine particle matter induced inflammation in the cells.  They started to secrete the pro-inflammatory cytokines IL-6 and IL-8 — substances that are secreted during infections and tissue damage. Cytokin levels normally increase when our body’s immune system fights specific infections.

Next, the researchers established that the trans-anethole, estragole, eugenol, and isoeugenol all have cytotoxicity — which means that they might cause cell death when exposed to comparatively high concentrations.

Evaluation of Oil Compound Properties

In their evaluation, the researchers were able to determine the level of cytotoxicity of these oil compounds. This was important in order to establish the maximum dose that should be selected in the next step — specifically, the assessment for anti-inflammatory properties.

In the second round of laboratory testing, the researchers introduced the four compounds to the combination of cell lines and air pollutants to see whether the natural essential oil compounds could protect lung and liver cells damaged by fine particles found in air pollution.

The researchers discovered that the essential oil compounds tested decrease the levels of the two types of cytokines in the samples. The levels of cytokine IL-6 decreased up to 96 percent, and the levels of cytokine IL-8 by 87 percent.

First Evidence of Essential Oils Counteracting Inflammation

Lead author Miriana Kfoury, of the Unité de Chimie Environnementale et Interactions sur le Vivant, Université du Littoral Côte d’Opale in France and the Lebanese University in Lebanon, offers a brief comment about this new study’s findings.

“The findings provide the first evidence that natural essential oil components counteract the inflammatory effects of particulate matter, such as that contained in polluted air.”

Kfoury and her colleagues published their recent study titled, “Essential oil components decrease pulmonary and hepatic cells inflammation induced by air pollution particulate matter,” in Springer’s journal Environmental Chemistry Letters

New Study Provides First Evidence That Natural Essential Oils Counteract Inflammation Caused By Polluted Air

Why Tea Is So Excellent For You? See What the Evidence Says

It is a so popular drink all in excess of the planet, and it’s loaded with so a lot of rewards for health, most importantly, tea does not looks to produce any adverse perceptions this kind of as coffee or other drinks.

The helpful results of tea on general wellness have been proven by plenty of scientific studies:

No.one:

A finding (one) published in 2008 showed folks who drank tea have been much less very likely to have liver issues, including liver steatosis, liver cirrhosis and chronic liver illness.

No.two:

Scientific studies (2) have identified that consume 3 cups of tea day-to-day could decrease the risk of getting depression.

No.three:

Tea has been established to be ready to minimize the chance of stroke and heart condition(three), and individuals who drank at least three cups a day obtaining a 21% reduced risk than individuals who drank significantly less than a cup per day.

No.four:

Consume tea routinely may lessen the chance of creating type two diabetes, in accordance to a meta-evaluation published in 2014. (4)

No.5:

Drinking one particular cup of green tea a day could decrease the danger of endometrial cancer by 11 %. Green tea was also connected with reduced threat of prostate cancer. (5)

No.six:

A 2001 research (6)showed drinking tea can support to avert the blindness and enhance eyesight successfully, this is also thanks to the higher ranges of antioxidants tea contains.

Apart from these advantages, consuming tea regularly is good for your wellness in numerous other techniques:

one. Tea consists of antioxidants, which safeguard your entire body from the ravages of aging and improve your skin.

two. Tea only contains about 1/three of caffeine than coffee, an 8-ounce cup of tea consists of only thirty-forty mg caffeine, even though coffee includes about 135 mg, implies consuming tea rather of coffee has significantly less likelihood to outcome in headaches, indigestion or issues with sleep.

three. A examine showed people who drank tea for a lot more than ten years had far more stronger bones than non-drinkers, implies tea protects your bones.

4. Tea helps your entire body fight off disease by boosting the immune system. In a analysis, individuals who drank five cups of tea per day for a month had higher immune system activity in the blood of the tea drinkers than these who drink coffee alternatively.

5. Energetic compounds in tea aids to decrease the amounts of irritation, thus avoiding numerous ailments, this kind of as arthritis, depression as properly as cardiovascular condition.

six. Tea is a calorie-totally free beverage and it tends to make you feel content. If you want to shed excess weight effortlessly, then drink some cups of green tea each day, it has been proven to boost your metabolic process and support you burn up additional calories.

Some Healthy Sorts Tea You Need to Be Consuming

one. Black

According to a examine, (seven)consuming three or more cups of black tea per day can minimize the threat of stroke by 21 %. And black tea also includes antioxidants, such as  thearubigins and theaflavins, which have been proven to reduce cholesterol ranges. (eight)

2. Green

Green tea has been so common because extended time for its medicinal properties: Promotes fat reduction, prevents diabetes, prevents heart condition, minimizes the risk of cancers, prevents Alzheimer’s and Parkinson’s, prevents substantial blood strain and it also advantages to skin.

three. Oolong

Oolong tea is a great unwanted fat burner, and it also includes niacin, tends to make it an superb drink to detoxify the body.

four. White

White tea consists of catechins, which helps battle cancers, in accordance to American Cancer Society, drinking white tea often may support minimize the risk of cancer recurrence for breast cancer survivors.

five. Chamomile

The antioxidants in chamomile tea may avert diabetes and kidney ailment.

six. Echinacea

Drinking Echinacea tea typically assists to avert infections and fight off numerous illnesses.

Sources: (one) (2) (3) (4) (five) (six) (seven) (8) (9)

Also By Writer:

How to Use Honey and Cinnamon Combination for Bodyweight Loss

8 Very good Factors to Drink Apple Ginger Kombucha (With Recipe)

Detoxing Cleanse Water With Lemon and Cayenne Pepper – Why You Ought to Drink It Every Day

Why Tea Is So Excellent For You? See What the Evidence Says

Far more Evidence That Sugar May Be Poor For The Brain

A new study suggests that sugar-sweetened beverages could be dangerous to the brain – especially the establishing brain. The thought itself is not a shock: Earlier research have surely hinted that sugar may have a detrimental result on brain cells, in the way of memory impairment and cognitive difficulties. The new research finds that, at least if you are an adolescent rat, consuming drinks sweetened with higher-fructose corn syrup (HFCS) might impede maze-studying, which is a good check of cognitive perform for rats. No matter whether the findings hold accurate for human youngsters is nevertheless up for debate, but the researchers say there’s convincing evidence that it is.

“It’s no secret that refined carbohydrates, particularly when consumed in soft drinks and other beverages, can lead to metabolic disturbances,” mentioned study author Scott Kanoski, of the University of Southern California. “However, our findings reveal that consuming sugar-sweetened drinks is also interfering with our brain’s capability to perform generally and bear in mind crucial data about our atmosphere, at least when consumed in extra ahead of adulthood.”

(Photograph credit score: Bev Goodwin)

It’s essential to stage out that the review has not but been published in a peer-reviewed journal, so it should be regarded preliminarily. It will be presented at the Yearly Meeting of the Society for the Examine of Ingestive Habits this week.

In their examine, the researchers fed adolescent and adult mice lower-fat lab chow, water, and yet another beverage, consisting of both eleven% sucrose or eleven% high-fructose corn syrup (a control group just got a lot more water) for 30 days. They examined the rats’ memory by possessing them do a Barne’s maze task, which issues them to uncover a aim by remembering exactly where they’ve already been.

The adult rats faired Ok, irrespective of what variety of beverage they’d been drinking. But the adolescent rats carried out worse on the process when they’d been offered the HFCS-sweetened drinks, in contrast to the sucrose-sweetened drinks.

If HFCS truly influences brain function, what mechanism may be behind the effect? Inflammation in the brain’s extended-term memory center, the hippocampus, might be accountable, the authors propose. They found higher ranges of pro-inflammatory cytokines IL-six and IL1-b in the adolescent rats who’d consumed HFCS-sweetened beverages, but did not locate the same increase in other groups of rats.

“This could,” explained Kanoski, “result from peripheral insulin resistance, which was existing in the adolescent rats that consumed SSB [sugar-sweetened beverages], and has been previously linked with neuroinflammation.” He adds that it is attainable that sugary drink consumption might also degrade the blood-brain barrier, which has been hinted at in previous scientific studies, but wants to be confirmed.

Possibly an equally critical question is whether or not the findings are applicable to human teenagers who could be taking in a whole lot of sugar in the way of soda, juice, and power drinks. Kanoski says they completely are. “The relevance to human teens, in my opinion, is based on the truth that one) in our research we utilised sugar-sweetened drinks with sugar concentrations that are comparable to those commonly consumed by people, and two) sugar-sweetened beverages consumption in the U.S. has risen dramatically in the previous 30 many years (specifically in kids), and three) rodents are an exceptional model for human feeding behavior.”

There is tons of evidence, he says, that not only are our metabolisms equivalent, but the same memory circuits in rodents also exist in the human brain. The hippocampus is an spot of the brain that is delicate to numerous different chemical substances – sugar, apparently, amongst them – in both species. It is identified to govern finding out and memory, and plays roles in depression, cognitive decline, and Alzheimer’s illness. “In several approaches this region is a canary in the coal mine,” says Kanoski, “as it is specifically sensitive to insult by numerous environmental aspects, which includes consuming meals that are higher in saturated body fat and processed sugar.”

A lot more investigation will be needed to tease it all apart, but you may well want to lower back on the sugary stuff, especially if you’re a teenager. Diet soda may not be a lot healthier for the brain, of course, so select your poison. Or at least drink soda as you would consume something else with an eye toward overall health — in moderation.

Adhere to me @alicewalton or locate me on Facebook.

Far more Evidence That Sugar May Be Poor For The Brain

Statins advice to GPs is a victory for vested interests more than evidence | Kailash Chand

Statins could be prescribed to more men and women, with a smaller sized risk of heart condition, right after the NHS medicines watchdog lowered the bar for prescriptions.

Good (the National Institute for Overall health and Care Excellence) has issued advice that proposes lowering the cardiovascular primary prevention chance threshold – the degree of danger at which statins can be prescribed – from 20% to 10%.

Several believe that such advice would not have the self-confidence of the pros charged with its implementation. In Could a nationwide conference of general practitioners passed a unanimous movement calling for Good to recommend such adjustments only on the basis of a complete disclosure of trial information. This was followed in June by an unprecedented open letter to Wonderful from a variety of senior medical doctors and academics expressing four major areas of concern: medicating wholesome folks non-disclosed side-result information relying on market-funded statins trials and conflicts of curiosity within Good.

Nice is basing this advice on an examination of market-sponsored trials that might have exaggerated benefits whilst under-reporting harm. Most statins data is presented employing relative chance, which inflates benefit. For example, the heart safety review claimed a forty% reduction in mortality from cardiovascular disease, but the reduction in overall mortality was .3% per yr.

Concomitantly, the side-result information has been declared commercially out of bounds, leaving medics and individuals unable to evaluate the cost-advantage of these drugs.

I have been a GP for more than thirty years and prescribed statins with little concern, right up until I took statins myself for in excess of two years. I developed side-results like myalgia, backache and rest disturbance. I stopped taking statins and my signs and symptoms largely disappeared.

An intervention trial evaluating rosuvastatin unveiled that one particular in one hundred females taking a statin risked building type 2 diabetes at one.9 years. For these individuals the chance of contracting diabetes is roughly the same as the likelihood of keeping away from a non-fatal heart attack. For individuals with a minimal danger of cardiovascular illness, 130 men and women require to get statins for a 12 months to avoid just one undesired overall health outcome.

Wonderful describes itself as follows: “We offer independent, authoritative and proof-based advice on the most successful methods to avoid, diagnose and deal with ailment and unwell health …”

The health care occupation should hence assume Great to base its findings on full data disclosure and independently evaluated cost-benefit of statins. Nevertheless, it transpires that eight out of twelve people on the Wonderful guideline improvement group have ties to the drug organizations, and Wonderful is recommending this guideline on the basis of the Cholesterol Therapy Trialists Collaboration drug-business-funded trials. Nice simply asserting that is independent seems unconvincing.

At existing, it is estimated that about 7 million individuals in the United kingdom consider statins. If Great guidance is followed the number could enhance by numerous million. The evidence for the benefit in major prevention – ie preventing cardiovascular condition in men and women who do not have any diagnosed cardiovascular ailment – is weak.

Three-quarters of people having a 1st heart assault, for instance, have standard cholesterol amounts. According to the Planet Well being Organisation, 80% of cardiovascular illness is caused by smoking, inactivity, an unhealthy diet regime, and other way of life variables. Statins give the illusion of protection to numerous individuals who would be significantly much better served by merely strolling more and staying away from processed food.

Excellent medicine ought to usually be proof based and offered to the correct patient at the proper time. Statins have an important position in patients who have an current heart illness or have had a heart assault. Sufferers should be wary of these guidelines, and engage in meaningful dialogue with their medical doctor, just before deciding regardless of whether or not to medicate. If growing numbers of folks without having heart condition consider statins it will be a victory for vested interests more than proof.

Statins advice to GPs is a victory for vested interests more than evidence | Kailash Chand

New Evidence Fuels Concerns About The Security Of Niacin

The string of failures– for HDL therapies in general and for niacin in particular– continues unabated.  The publication of the main results of the HPS2-THRIVE trial, along with new information from the AIM-HIGH trial, provide no evidence of a beneficial effect for niacin but do fuel concerns that it may cause serious adverse effects.

In HPS2-THRIVE, published in the New England Journal of Medicine, the combination of extended-release niacin and laropiprant (Tredaptive, Merck) was compared to placebo in more than 25,000 high risk patients already receiving statin therapy. Patients in the treatment group had significant reductions in LDL cholesterol (10 mg/dL), significant increases in HDL  (6 mg/dL), and significant reductions in triglycerides (33 mg/dL). But there was no difference in the rate of major vascular events (13.2% for niacin-laropiprant versus 13.7% for placebo, RR 0.96, CI 0.90 – 1.03, p=0.29).  There was also no significant difference in an exploratory analysis of patients with low HDL and high triglyceride levels who might be expected to benefit the most from niacin therapy.

There were signs of harm associated with niacin-laropiprant. Serious adverse events occurred more often in the combination group (55.6% versus 52.7%, p < 0.001). Diabetes complications were especially concerning. Among patients who had diabetes at the start of the trial, serious complications related to diabetes occurred in 11.1% of patients in the treatment group versus 7.5% of patients in the control group, a 55% increase. Among patients who did not have diabetes at the start of the trial, there was a 32% increase in the diagnosis of diabetes in the treatment group (5.7% versus 4.3%).

Niacin therapy was also associated with significant increases in infections (8% versus 6.6%, p< .001) and bleeding (2.5% versus 1.9%, p < 0.001). These findings came as a surprise to the investigators. There were also significant increases in other, previously known adverse effects of niacin, including gastrointestinal, musculoskeletal, and skin-related adverse events.

The troubling findings of HPS2-THRIVE were not contradicted, and were at least partially confirmed, by a new analysis from the AIM-HIGH trial published in the correspondence section of NEJM. The trial randomized more than 3,400 patients with stable coronary artery disease to extended-release niacin (Niaspan, AbbVie) or placebo in addition to simvastatin and, if needed, ezetimibe. The trial was stopped early for lack of efficacy.

In their new analysis the AIM-HIGH investigators report a significant increase in serious infections (8.1% versus 5.8%, p=0.008) and a nonsignificant increase in serious bleeding events (3.4% versus 2.9%, p=0.36). But there was also a significant increase in all bleeding events in AIM-HIGH (10.1% versus 8.1%%, p=0.04).

The AIM-HIGH authors were reluctant to conclude that the new adverse effects seen in HPS2-THRIVE were also a genuine problem in AIM-HIGH. The findings, they wrote, “should be considered to be provisional and exploratory.” But the HPS2-THRIVE authors were more certain:

In light of the consistency of the results with those from previous trials of niacin alone, we believe that the findings from HPS2-THRIVE are likely to be generalizable to all high-dose niacin formulations. Although niacin might still be relevant for particular patient groups (e.g., patients at high risk for vascular events who have high levels of LDL cholesterol), any potential benefits should be considered in the context of the observed hazards.

Much of the initial discussion about HPS2-THRIVE revolved around the relative importance of the niacin and laropiprant components of the drug. In an accompanying editorial, Donald-Lloyd Jones writes that  ”the consistency of the overall findings with earlier trials of niacin alone suggest that niacin is the major problem.”

What now should we make of niacin and the HDL cholesterol causation hypothesis? On the basis of the weight of available evidence showing net clinical harm, niacin must be considered to have an unacceptable toxicity profile for the majority of patients, and it should not be used routinely.

The failure of the niacin trials, as well as other HDL-related trials, “lends further credence to the notion that HDL cholesterol is unlikely to be causal.”

Sanjay Kaul said that because the results of these trials have been known the lack of efficacy “is not surprising.” The safety findings, however, are “noteworthy.”

The increase in adverse events, including infections and bleeding, observed in HPS2-THRIVE likely represents an underestimate given that only about 50% of those screened were enrolled in the trial (one-third withdrawals on active drug). I do not agree with the AIM-HIGH investigators assertion that the significantly increased risk of infection and numerical excess in serious bleeding should be considered provisional and exploratory. AIM-HIGH, like most other lipid lowering trials, was powered for efficacy and not safety assessments. Lack of a significant difference in safety outcomes in inadequately powered studies should not be viewed as reassuring. Instead, safety should be assessed by examining the 95% CI and ruling out unacceptable harm. The difference in serious bleeding of 3.4% vs 2.9% results in a risk ratio of 1.19 (0.82, 1.73). In absence of any efficacy outcome benefit, I would argue that not being able to rule out a 73% increase in serious bleeding is unacceptable and points to an unfavorable benefit-risk balance. One has to also take into consideration that an absolute difference in the serious bleeding rate of 0.55% was observed in about 1/8th the number of patients enrolled in HPS2-THRIVE (difference in bleeding risk was 0.7%). Had AIM-HIGH enrolled as many patients as were enrolled in HPS2-THRIVE, this difference would have been statistically significant. If one were to count bleeding events of any severity in AIM-HIGH, the increase in risk would be statistically significant: 174 vs 137, risk ratio 1.25 (1.01, 1.55), p=0.04.

Bottom line, given the undesirable benefit-risk balance of extended release niacin, it is hard to make a case for it as frontline therapy in patients evaluated in these trials.

Another interesting observation is lack of efficacy in patients with mixed dyslipidemia (elevated TG and low HDL) in HPS2-THRIVE. In contrast, a beneficial effect was observed in AIM-HIGH. This could be related to different cutoffs for elevated TG or low HDL used in the 2 studies. Alternatively, the positive finding in AIM-HIGH might be spurious (false positive) given the overall null result!

New Evidence Fuels Concerns About The Security Of Niacin

New Evidence Fuels Issues About The Safety Of Niacin

The string of failures– for HDL therapies in general and for niacin in particular– continues unabated.  The publication of the main results of the HPS2-THRIVE trial, along with new information from the AIM-HIGH trial, provide no evidence of a beneficial effect for niacin but do fuel concerns that it may cause serious adverse effects.

In HPS2-THRIVE, published in the New England Journal of Medicine, the combination of extended-release niacin and laropiprant (Tredaptive, Merck) was compared to placebo in more than 25,000 high risk patients already receiving statin therapy. Patients in the treatment group had significant reductions in LDL cholesterol (10 mg/dL), significant increases in HDL  (6 mg/dL), and significant reductions in triglycerides (33 mg/dL). But there was no difference in the rate of major vascular events (13.2% for niacin-laropiprant versus 13.7% for placebo, RR 0.96, CI 0.90 – 1.03, p=0.29).  There was also no significant difference in an exploratory analysis of patients with low HDL and high triglyceride levels who might be expected to benefit the most from niacin therapy.

There were signs of harm associated with niacin-laropiprant. Serious adverse events occurred more often in the combination group (55.6% versus 52.7%, p < 0.001). Diabetes complications were especially concerning. Among patients who had diabetes at the start of the trial, serious complications related to diabetes occurred in 11.1% of patients in the treatment group versus 7.5% of patients in the control group, a 55% increase. Among patients who did not have diabetes at the start of the trial, there was a 32% increase in the diagnosis of diabetes in the treatment group (5.7% versus 4.3%).

Niacin therapy was also associated with significant increases in infections (8% versus 6.6%, p< .001) and bleeding (2.5% versus 1.9%, p < 0.001). These findings came as a surprise to the investigators. There were also significant increases in other, previously known adverse effects of niacin, including gastrointestinal, musculoskeletal, and skin-related adverse events.

The troubling findings of HPS2-THRIVE were not contradicted, and were at least partially confirmed, by a new analysis from the AIM-HIGH trial published in the correspondence section of NEJM. The trial randomized more than 3,400 patients with stable coronary artery disease to extended-release niacin (Niaspan, AbbVie) or placebo in addition to simvastatin and, if needed, ezetimibe. The trial was stopped early for lack of efficacy.

In their new analysis the AIM-HIGH investigators report a significant increase in serious infections (8.1% versus 5.8%, p=0.008) and a nonsignificant increase in serious bleeding events (3.4% versus 2.9%, p=0.36). But there was also a significant increase in all bleeding events in AIM-HIGH (10.1% versus 8.1%%, p=0.04).

The AIM-HIGH authors were reluctant to conclude that the new adverse effects seen in HPS2-THRIVE were also a genuine problem in AIM-HIGH. The findings, they wrote, “should be considered to be provisional and exploratory.” But the HPS2-THRIVE authors were more certain:

In light of the consistency of the results with those from previous trials of niacin alone, we believe that the findings from HPS2-THRIVE are likely to be generalizable to all high-dose niacin formulations. Although niacin might still be relevant for particular patient groups (e.g., patients at high risk for vascular events who have high levels of LDL cholesterol), any potential benefits should be considered in the context of the observed hazards.

Much of the initial discussion about HPS2-THRIVE revolved around the relative importance of the niacin and laropiprant components of the drug. In an accompanying editorial, Donald-Lloyd Jones writes that  ”the consistency of the overall findings with earlier trials of niacin alone suggest that niacin is the major problem.”

What now should we make of niacin and the HDL cholesterol causation hypothesis? On the basis of the weight of available evidence showing net clinical harm, niacin must be considered to have an unacceptable toxicity profile for the majority of patients, and it should not be used routinely.

The failure of the niacin trials, as well as other HDL-related trials, “lends further credence to the notion that HDL cholesterol is unlikely to be causal.”

Sanjay Kaul said that because the results of these trials have been known the lack of efficacy “is not surprising.” The safety findings, however, are “noteworthy.”

The increase in adverse events, including infections and bleeding, observed in HPS2-THRIVE likely represents an underestimate given that only about 50% of those screened were enrolled in the trial (one-third withdrawals on active drug). I do not agree with the AIM-HIGH investigators assertion that the significantly increased risk of infection and numerical excess in serious bleeding should be considered provisional and exploratory. AIM-HIGH, like most other lipid lowering trials, was powered for efficacy and not safety assessments. Lack of a significant difference in safety outcomes in inadequately powered studies should not be viewed as reassuring. Instead, safety should be assessed by examining the 95% CI and ruling out unacceptable harm. The difference in serious bleeding of 3.4% vs 2.9% results in a risk ratio of 1.19 (0.82, 1.73). In absence of any efficacy outcome benefit, I would argue that not being able to rule out a 73% increase in serious bleeding is unacceptable and points to an unfavorable benefit-risk balance. One has to also take into consideration that an absolute difference in the serious bleeding rate of 0.55% was observed in about 1/8th the number of patients enrolled in HPS2-THRIVE (difference in bleeding risk was 0.7%). Had AIM-HIGH enrolled as many patients as were enrolled in HPS2-THRIVE, this difference would have been statistically significant. If one were to count bleeding events of any severity in AIM-HIGH, the increase in risk would be statistically significant: 174 vs 137, risk ratio 1.25 (1.01, 1.55), p=0.04.

Bottom line, given the undesirable benefit-risk balance of extended release niacin, it is hard to make a case for it as frontline therapy in patients evaluated in these trials.

Another interesting observation is lack of efficacy in patients with mixed dyslipidemia (elevated TG and low HDL) in HPS2-THRIVE. In contrast, a beneficial effect was observed in AIM-HIGH. This could be related to different cutoffs for elevated TG or low HDL used in the 2 studies. Alternatively, the positive finding in AIM-HIGH might be spurious (false positive) given the overall null result!

New Evidence Fuels Issues About The Safety Of Niacin

Lastly! Tough Evidence We Can Slow Alzheimer"s By Exercising The Body And The Thoughts

English: PET scan of a human brain with Alzheimer’s ailment (Photo credit score: Wikipedia)

Alzheimer’s ailment is one of the most feared diagnoses between patients. It destroys people’s minds, their personalities, the extremely essence of who they are. And once the condition has been diagnosed, there is absolutely nothing contemporary medicine can do to end it.

But it can be slowed, and a new examine presented by researchers at the Karolinska Institut in Sweden gives some of the strongest evidence but as to how: through bodily exercising, by way of mental workouts and social interaction, by consuming a healthier diet rich in fruits and vegetables, and by monitoring the very same risk aspects that lead to cardiovascular disease.

The undesirable information: Alzheimer’s, in individuals who produce it, is nevertheless inexorable. The excellent news: even for individuals late in lifestyle who are presently at higher danger for developing the disease can advantage from altering their way of life. Patients in this research have been amongst 60 years and 77 many years old.

“This is a very important message,” says Miia Kivipelto, the lead investigator of the review who presented the outcomes at the yearly meeting of the Alzheimer’s Association. “It’s still feasible to do something for your brain when you are 70 years outdated.”

The Finnish Geriatric Intervention Review to Stop Cognitive Impairment and Disability (somehow abbreviated FINGER) was adhere to one,260 individuals in Finland who have been at large threat of dementia and had cognitive efficiency that was both regular for their age or worse for two many years. They had been randomly assigned into two groups. One, a handle group, obtained the greatest medical suggestions obtainable and typical cognitive testing. The other group acquired a battery of interventions.

Amongst the treatment options:

• Seven group sessions and 3 person sessions to help them boost their nutrition, focusing on including fruits, veggies, and fish, and steering clear of saturated fats


• Intensive physical exercise. Starting up at three months into the research, they did muscle-constructing exercising after or twice a week and cardiovascular coaching two to four occasions a week. The fat instruction continued throughout the study, and the cardio ramped up to five or 6 instances per week.


• They did cognitive instruction exercise routines. These had been completed in eleven group sessions above the course of the examine, along with lots of independent instruction.


• To track heart illness hazards like high blood strain and large cholesterol, they noticed a nurse every single 3 months, with three visits to a physician over 3 years.

The advantage of these interventions was measured with a battery of exams for memory, executive perform, and the velocity at which patients could consider. Correct now, the overall measure for the study is not very informative, Kivipelto says, due to the fact it combines so a lot of various tests into a single. But what’s clear is that soon after two many years of treatment, there was a statistically significant overall benefit.

This benefit remained when researchers looked individually at memory, executive function, and psychomotor pace. On executive function and psychomotor pace, Kivipelto says, the management group was actually steady, maybe since they too have been receiving additional healthcare care. But the individuals getting the treatment options in fact considerably enhanced.

“For the past few many years, bodily physical exercise (min three sessions/wk X thirty min/session) has been as great or greater than something that we can advise for people with or at chance for cognitive decline. Would that we had a pill as very good as that but we do not,” writesSamuel Gandy, Director, Mount Sinai Center for Cognitive Wellness and NFL Neurological Center, through e-mail right after reviewing the outcomes. He says he’s “prepared to believe” that extending beyond physical exercise could include extra rewards.

One massive question that will need to be answered by additional analyses: how did the diverse parts of treatment method influence patients’ psychological wellness? Will these therapies perform as nicely in Ohio as they did in Sweden? And what are the lengthy-phrase results of doing exercises the physique and brain? The study will proceed to comply with patients for seven years to consider to get some of individuals answers.

Lastly! Tough Evidence We Can Slow Alzheimer"s By Exercising The Body And The Thoughts

Gynaecologist: "no evidence" for abortion intercourse abuse claims

Women are currently being wrongly told that an abortion could enhance their danger of creating breast cancer, that the process could depart them infertile, or even make them far more likely to sexually abuse youngsters in the course of counselling sessions at independent advisory clinics.

Dr Kate Guthrie, spokesperson for the Royal University of Obstetricians and Gynaecologists stated there was no scientific evidence to propose an abortion put ladies at a better chance of breast cancer, or produced them more very likely to abuse a kid.

“Not only is there no proof for that, I think is a horrible factor to say to any female,” she stated.

Dr Guthrie extra that 1 of the counsellors recorded obviously was not up to date on present day techniques of abortion care and contrary to her claims instruments have been purposely blunt and there was no cutting.

She also made clear that the threat of getting left sterile by an abortion in Britain was “quite, really low”.

Gynaecologist: "no evidence" for abortion intercourse abuse claims

Soft-drink business resists sugar consumption evidence in documentary

The soft-drink market is standing by its position that Australian sugar consumption has declined in the wake of an investigation casting doubt on the claims.

ABC radio’s Background Briefing program on Sunday aired a documentary criticising the Australian Paradox, a Sydney University examine which argued that despite a rise in Australia’s obesity prices more than the past thirty many years, refined sugar consumption per person had undergone a “substantial and consistent decline”.

The review concluded the function of sugar in fuelling obesity charges was overblown.

The examine, co-written by renowned nutritionist Professor Jennie Brand-Miller, has been employed by the Australian soft-drink market to ward off public-well being initiatives aimed at curbing soft-drink consumption. A single this kind of measure was attempted in New York final 12 months when the sale of soft drinks in measures bigger than 16oz (473ml) was banned. The measure was later overturned by a state court.

The ABC’s investigation was based mostly on analysis by former Reserve Bank economist Rory Robertson, a longtime critic of the evidence backing the Australian Paradox research.

In the documentary Robertson pointed to one particular chart in Brand-Miller’s review displaying a rise in complete-sugar soft-drink revenue from 35 litres per person in 1994 to 45 litres per individual in 2006.

“In the paper they describe it as a 10% decline, which is nonsense – certainly it’s a thirty% boost,” Robertson advised the ABC.

But Australian Beverage Council chief executive Geoff Parker told Guardian Australia the controversial study was just “one of a number of distinct papers that we reference”.

“We really don’t seem to one specific source of information in figuring out our place, we seem at a selection of sources,” Parker said.

“There’s enough data out there for us to have the place that consumption of full-sugar sweets and drinks has been on the decline on the final 10 or 15 years,” he explained.

Sydney University has launched an inquiry into Robertson’s complaints, but a spokeswoman for the university stressed that, at this stage, “there have been no substantiated claims against the function of any academic at the university, nor indeed has there been any obtaining that the complaints warrant any additional investigation”.

Parker said he would await the results of the university’s inquiry into the paper just before he would think about taking it down from the Beverage Council’s web site.

Soft-drink business resists sugar consumption evidence in documentary

More Evidence That Sugar Is Harming Our Hearts

If the torrent of studies suggesting that sugar is bad for our health wasn’t quite enough, new research again suggests that added dietary sugar increases the risk of death from heart disease. Among the health concerns of eating or drinking too much sugar have been a higher risk of obesity, high blood pressure, dementia, type 2 diabetes, dyslipidemia (a bad assortment of blood fats), cirrhosis of the liver, and, of course, cardiovascular disease. And from the new study, which looked at sugar intake and the health of men and women over about 15 years, a clear trend emerged: The more added sugar a person consumed, the greater his or her risk of dying from heart disease.

Researchers from the CDC looked at data from 31,000 people who’d taken part in the National Health and Nutrition Examination Survey, comparing a multitude of different lifestyle and physical variables to health outcomes.

Heart Cake (Photo credit: FantasyClay)

The good news is that sugar consumption has decreased a bit over the years. The percentage of calories we get from added sugar decreased from 16.8% in 1999-2004 to 14.9% in the years 2005-2010.

The slightly discouraging news is that 70% of adults consumed 10% or more of their daily calories from added sugar – and about 10% of adults consumed more than 25% of their calories from added sugar. (To give some perspective, drinking a 20-ounce soda would be about the equivalent of taking 15% of your daily calories from added sugar, assuming a 2,000/day diet.)

The bad news is that added sugar appears to significantly increase our risk of death from heart disease. People who consumed about  15% of their daily calories from added sugar had a 18% higher risk of dying from heart disease, compared to people who only took in very little added sugar. For people whose added sugar intake made up over 21% of their daily calories, their risk of death doubled.

And the phenomenon appears to be completely independent of other factors – like weight, calories consumed, smoking, blood pressure, sex, cholesterol level, and physical activity – which indicates that there’s something specific about the relationship between sugar and the heart.

What could sugar be doing to increase the risk of heart disease? There are a lot of possibilities. One  is that sugar has been shown to increase blood pressure, independent of other health problems it can trigger. Another idea is that it increases unhealthy blood fats like triglycerides and “bad” LDL cholesterol levels, while decreasing “good” HDL cholesterol. Other studies have suggested that excess sugar can trigger inflammation in the body, by boosting levels of certain inflammatory biomarkers. Finally, some studies have suggested that sugar may enhance the genetic effects of obesity, boosting the heart risks that obesity genes were already threatening to begin with.

“Our findings indicate that most US adults consume more added sugar than is recommended for a healthy diet,” the authors write. “A higher percentage of calories from added sugar is associated with significantly increased risk of CVD mortality.”

The bottom line is that added sugar appears to confer risks far beyond weight gain. In her editorial, Laura Schmidt, a UCSF researcher, says that we’re beginning a paradigm shift in the current thinking on sugar. Unlike trans fats and salt, she points out, there’s no upper limit to how much food companies can add: Sugar is on the FDA’s “generally recognized as safe” list. This, she suggests, should change.

The WHO recommends having added sugar make up no more than 10% of our daily calories, while the Institute of Medicine (IOM), a U.S. organization, is more lenient, saying upper limit should be 25%. But the American Heart Association is much more conservative, recommending that added sugars should be limited to 100 calories per day for women and 150 per day for men.

And the new study supports that this lower estimate is probably pretty smart. Whether the government steps in with more “sin taxes,” or we continue to eat and drink less sugar on their own, is anybody’s guess. As Schmidt says, one thing’s for sure: “Too much sugar does not just make us fat; it can also make us sick.”

Follow me @alicewalton or find me on Facebook.

More Evidence That Sugar Is Harming Our Hearts

Evidence Of Vodka"s Grasp: Russian Males Nevertheless Dying Younger

A quarter of Russian guys die ahead of the age of 55, in accordance to a new research in The Lancet. If this sounds large, it is. In contrast, just seven% of guys in the United kingdom die before 55. The new big-scale examine tracked Russian guys in excess of time, finding that much of the high death charge was due to alcohol and alcohol-related triggers. And though the vodka-relevant mortality fee was always relatively higher in Russia, some exciting patterns emerged – namely, that the death fee waxed and waned in accordance to how government alcohol policies modified more than the years.

The new examine asked 151,000 residing guys about their alcohol use whilst they were still residing. The guys were followed for a decade, and researchers tracked how several died, and from what cause.

Russian Normal Vodka (Photo credit score: Eva Rinaldi Celebrity and Reside Music Photographer)

It turned out that the threat of death for 35-fifty five 12 months previous males consuming 3 or far more half-liter bottles per week was 35%. This jumped to a whopping 64% for men in between fifty five and 74. The authors say that their “study strongly reinforces other proof that vodka is a major result in of the higher danger of premature death in Russian grownups.”

For much more reasonable customers among ages 35 and 55, the story was much less grim. Guys who drank much less than a bottle per week had only a sixteen% likelihood of dying. These who drank 1 to two.9 bottles per week had a 20% danger of dying.

The triggers of death? Most were due to alcohol poisoning, accidents, violence, suicide, and to an additional group of illnesses, such as throat cancer, liver cancer, tuberculosis, pneumonia, pancreatitis, liver disease, acute ischemic heart ailment, and other unspecified healthcare situations.

The massive caveat is that just about all of the men were smokers the authors say that in Russia hefty drinking and heavy smoking are nearly inextricably linked, which makes the predicament even a lot more difficult to pull apart. But there is also hope, the authors say.

What’s intriguing is that alcohol-relevant deaths fluctuated with the times. After Mikhail Gorbachev’s 1985 alcohol restrictions, the authors level out, alcohol consumption – and deaths – fell by 25%. But soon after the fall of communism, both went way up. And soon after the alcohol policy reforms in 2006, consumption was lowered once again by about a third. Here’s an image that illustrates these large fluctuations more than time:

Permission of the authors

“Russian death prices have fluctuated wildly in excess of the past 30 many years as alcohol restrictions and social stability varied underneath Presidents Gorbachev, Yeltsin, and Putin, and the major factor driving these wild fluctuations in death was vodka,” mentioned examine author Sir Richard Peto. “This has been shown in retrospective research, and now we’ve confirmed it in a massive, reliable prospective study.”

And the review may possibly have even underestimated the effect, according to the authors, considering that consuming habits most likely shifted in excess of time.

As review author David Zaridze informed the BBC, much of the difficulty is due to the sort of drinking the guys engage in. “They binge drink. That is the principal difficulty. It’s the pattern of drinking not the per-capita sum they are drinking… They often say it is simply because of the cold climate but this is just an excuse. This is the nation’s way of life that requirements to alter.”

Luckily, the trends suggest that modify is achievable, and it can occur reasonably rapidly. “The significant decline in Russian mortality rates following the introduction of moderate alcohol controls in 2006 demonstrates the reversibility of the overall health crisis from hazardous drinking,” stated Zaridze. “People who drink spirits in hazardous ways significantly decrease their danger of premature death as soon as they quit.”

Stick to me @alicewalton or find me on Facebook.

Evidence Of Vodka"s Grasp: Russian Males Nevertheless Dying Younger