Tag Archives: human health

Majority of Clinical Trials Don’t Provide Meaningful Evidence

The largest comprehensive analysis of ClinicalTrials.gov finds that clinical trials are falling short of producing high-quality evidence needed to guide medical decision-making.

The analysis, published today in the Journal of the American Medical Association, found the majority of clinical trials is small, and there are significant differences among methodical approaches, including randomizing, blinding and the use of data monitoring committees.

This is a critical issue as medical studies continue to leave quite a bit to be desired. Even more importantly the failure to systemically study and share evidence of effectiveness once treatments are authorized leaves a great deal to be desired. On top of leaving quite a bit to be desired, the consequences are serious. If we make mistakes for example in how we date fossils it matters but it is unlikely to cause people their lives or health. Failure to adequately manage and analyze health care experiments may very well cost people their health or lives.

“Our analysis raises questions about the best methods for generating evidence, as well as the capacity of the clinical trials enterprise to supply sufficient amounts of high quality evidence to ensure confidence in guideline recommendations,” said Robert Califf, MD, first author of the paper, vice chancellor for clinical research at Duke University Medical Center, and director of the Duke Translational Medicine Institute.

The analysis was conducted by the Clinical Trials Transformation Initiative (CTTI), a public-private partnership founded by the Food and Drug Administration (FDA) and Duke. It extends the usability of the data in ClinicalTrials.gov for research by placing the data through September 27, 2010 into a database structured to facilitate aggregate analysis.

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Flavonoids Reduce Instances of Parkinson’s Disease in Men

Men who eat flavonoid-rich foods such as berries, tea, apples and red wine significantly reduce their risk of developing Parkinson’s disease, according to new research by Harvard University and the University of East Anglia.

The findings add to the growing body of evidence that regular consumption of some flavonoids can have a marked effect on human health. Recent studies have shown that these compounds can offer protection against a wide range of diseases including heart disease, hypertension, some cancers and dementia.

This latest study is the first study in humans to show that flavonoids can protect neurons against diseases of the brain such as Parkinson’s.

Around 130,000 men and women took part in the research. More than 800 had developed Parkinson’s disease within 20 years of follow-up. After a detailed analysis of their diets and adjusting for age and lifestyle, male participants who ate the most flavonoids were shown to be 40 per cent less likely to develop the disease than those who ate the least. No similar link was found for total flavonoid intake in women.

“These exciting findings provide further confirmation that regular consumption of flavonoids can have potential health benefits,” said Prof Aedin Cassidy of the Department of Nutrition, Norwich Medical School at UEA.

“This is the first study in humans to look at the associations between the range of flavonoids in the diet and the risk of developing Parkinson’s disease and our findings suggest that a sub-class of flavonoids called anthocyanins may have neuroprotective effects.”

Prof Gao said: “Interestingly, anthocyanins and berry fruits, which are rich in anthocyanins, seem to be associated with a lower risk of Parkinson’s disease in pooled analyses. Participants who consumed one or more portions of berry fruits each week were around 25 per cent less likely to develop Parkinson’s disease, relative to those who did not eat berry fruits. Given the other potential health effects of berry fruits, such as lowering risk of hypertension as reported in our previous studies, it is good to regularly add these fruits to your diet.”

Flavonoids are a group of naturally occurring, bioactive compounds found in many plant-based foods and drinks. In this study the main protective effect was from higher intake of anthocyanins, which are present in berries and other fruits and vegetables including aubergines, blackcurrants and blackberries. Those who consumed the most anthocyanins had a 24% reduction in risk of developing Parkinson’s disease.

The findings must now be confirmed by other large epidemiological studies and clinical trials.

Parkinson’s disease is a progresssive neurological condition affecting one in 500 people. There are few effective drug therapies available.

The result is far from conclusive and even if the result were confirmed the 24% reduction is hardly huge. But since berries are yummy there seem little reason to not tilt toward more berries in your diet.

Dangerous Drug-Resistant Strains of TB are a Growing Threat

Drug-resistant strains of TB are out of control

The fight against new, antibiotic-resistant strains of tuberculosis has already been lost in some parts of the world, according to a senior World Health Organisation expert.
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Dr Paul Nunn, head of the WHO’s global TB response team, is leading the efforts against multi-drug resistant TB (MDR-TB). Nunn said that, while TB is preventable and curable, a combination of bad management and misdiagnosis was leaving pharmaceutical companies struggling to keep up. Meanwhile, the disease kills millions every year.

“It occurs basically when the health system screws up,” said Nunn. “Treating TB requires a carefully followed regime of medication over six months. In places where health services are fragmented or underfunded, or patients poor and health professionals ill-trained, that treatment can fall short, which can in turn lead to patients developing drug-resistant strains. It’s been estimated that an undiagnosed TB-infected person can infect 10 others a year.

We tend to do a poor job of dealing with systemic effects of poorly functioning systems. Direct present threats get out attention. And we are decent at directing brain power and resources to find solutions. We are not very good at dealing with failures that put us in much worse shape in the long term. For small threats we can wait until it becomes a present threat and then deal with it. There are costs to doing this (economic and personal) but it can be done.

Some problems though become enormously complicated to deal with once they become obvious. Global climate change, for example. And often, even once they are obvious, we won’t act until the costs (economic and in human lives) are very large. It is possible that once we decide to get serious about dealing with some of these issues that the costs (economic and in human lives) will be catastrophic.

The failure to use anti-biotics medicine properly is a very serious threat to become one of these catastrophic societal failures. While tuberculosis failures may be larger in poorer countries, rich countries are failing probably much more critically in the misuse of anti-biotics (I would guess, without having much evidence at my fingertips to back up my opinion. I believe the evidence exists I am just not an expert). These failures have huge costs for all of humanity but we are risking many premature deaths because we systemically fail to deal with issues until the consequences are immediate.

Is Dirt Healthier Than Broccoli?

That dirt I ate as a kid is maybe why I have been relatively healthy. Ok, probably that hasn’t been the most important factor. But it may be that some dirt and germs (kids licking their dirty hands and the ice cream melts on it, etc.) is actually more important for their long term health than finishing off the broccoli (of course, a healthy diet requires eating a bunch of vegetables, more than most kids eat).

The hygiene hypothesis has become a popular explanation for the boom in asthma, allergies and other health problems. Boiled down to one sentence the hypothesis is that exposure to germs early in life creates a healthy immune system and too little exposure results in a hypersensitive immune system (that is not as effective and leads to things like allergies).

A recent closed science paper, Microbial Exposure During Early Life Has Persistent Effects on Natural Killer T Cell Function, found mice exposed to more germs early on where healthier:

Exposure to microbes during early childhood is associated with protection from immune-mediated diseases such as inflammatory bowel disease (IBD) and asthma. Here, we show that, in germ-free (GF) mice, invariant natural killer T (iNKT) cells accumulate in the colonic lamina propria and lung, resulting in increased morbidity in models of IBD and allergic asthma compared to specific pathogen-free (SPF) mice. This was associated with increased intestinal and pulmonary expression of the chemokine ligand CXCL16, which was associated with increased mucosal iNKT cells. Colonization of neonatal—but not adult—GF mice with a conventional microbiota protected the animals from mucosal iNKT accumulation and related pathology. These results indicate that age-sensitive contact with commensal microbes is critical for establishing mucosal iNKT cell tolerance to later environmental exposures.

The microscopic battles waged in our bodies every day and over our lifetimes are amazing.

Science Continues to Explore Causes of Weight Gain

Science is amazing when it explains very cool ideas. It is also very interesting (if a bit frustrating) when the scientific inquiry process is ongoing and open to debate. Weight gain is one such area that is of great concern and large amount of study but some issues are still unclear. I have discussed this before. I think that calories in compared to calories consumed is a good first approximation. I believe it makes sense that the efficiency of our bodies at capturing the calories and turning them into weight gain could be affected by things other than the total calories in. It might be the type of calories or it might be other factors (bacteria or chemical present)…

What’s Really Making Us Fat?

Researchers in a relatively new field are looking at the role of industrial chemicals and non-caloric aspects of foods — called obesogens — in weight gain. Scientists conducting this research believe that these substances that are now prevalent in our food supply may be altering the way our bodies store fat and regulate our metabolism. But not everyone agrees. Many scientists, nutritionists, and doctors are still firm believers in the energy balance model. A debate has ensued, leaving a rather unclear picture as to what’s really at work behind our nation’s spike in obesity.
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A widely reported study that came out in January in The American Journal of Clinical Nutrition (AJCN) would seem to dispute this finding: it confirms the belief in the energy balance model, and has been cited as proof by many researchers working in the field. I asked an author of the study, Dr. George Bray, professor of medicine at Louisiana State University, about the myriad of additives and industrial ingredients in our food that were not accounted for in this study. “It doesn’t make any difference,” he said in a telephone interview. “Calories count. If you can show me that it doesn’t work, I’d love to see it. Or anybody else who says it doesn’t — there ain’t no data the other way around.”

It seems to me that it certainly makes sense to reduce calories if you need to lose weight. And it sure seems the strongest evidence is for calories being the most important factor.

I also believe exercise is good, for overall health. It also seems more and more evidence is being found about how difficult it is to lose weight which reinforces the importance of preventing the weight gain in the first place.

Cool Animation of a Virus Invading a Person’s Body

Flu Attack! How A Virus Invades Your Body

First, some new viruses get caught in mucus and other fluids inside your body and are destroyed. Other viruses get expelled in coughs and sneezes. Second, lots of those new viruses are lemons. They don’t work that well. Some don’t have the right “keys” to invade healthy cells so they can’t spread the infection. And third, as the animation shows, your immune system is busy attacking the viruses whenever and wherever possible.

That is why most of the time, after a struggle (when you get a fever and need to lie down), your immune system rebounds, and, in time, so do you.

A health body with a strong immune system is able to fight off viruses, and other health issues more easily. Also when you body has run across a specific virus before it is ready to fight it. It has cataloged that virus and is on the look out for it and is prepared to produce specialized cells to attack it. The flu vaccinations you get are priming your body to be ready to attack if that virus is found. Those antibodies take about 2 weeks to build up in sufficient numbers to offer protection against the flu. Viruses are constantly mutating which helps them evade your detectors. This stuff is so amazing. And your body is just doing this stuff every day while you watch youtube or play basketball or…

NASA Biocapsules Deliver Medical Interventions Based Upon What They Detect in the Body

Very cool innovation from NASA. The biocapsule monitors the environment (the body it is in) and responds with medical help. Basically it is acting very much like your body, which does exactly that: monitors and then responds based on what is found.

The Miraculous NASA Breakthrough That Could Save Millions of Lives

The Biocapsules aren’t one-shot deals. Each capsule could be capable of delivering many metred doses over a period of years. There is no “shelf-life” to the Biocapsules. They are extremely resilient, and there is currently no known enzyme that can break down their nanostructures. And because the nanostructures are inert, they are extremely well-tolerated by the body. The capsules’ porous natures allow medication to pass through their walls, but the nanostructures are strong enough to keep the cells in one place. Once all of the cells are expended, the Biocapsule stays in the body, stable and unnoticed, until it is eventually removed by a doctor back on Earth.
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Dr. Loftus [NASA] thinks we could realistically see wildspread usage on Earth within 10 to 15 years.
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The cells don’t get released from the capsule. The cells inside the capsule secrete therapeutic molecules (proteins, peptides), and these agents exit the capsule by diffusion across the capsule wall.

NASA plans to use the biocapsules in space, but they also have very promising uses on earth. They can monitor a diabetes patient and if insulin is needed, deliver it. No need for the person to remember, or give themselves a shot of insulin. The biocapsule act just like out bodies do, responding to needs without us consciously having to think about it. They can also be used to provide high dose chemotherapy directly to the tumor site (thus decreasing the side effects and increasing the dosage delivered to the target location. Biocapsules could also respond to severe allergic reaction and deliver epinephrine (which many people know have to carry with them to try and survive an attack).

It would be great if this were to have widespread use 15 years from now. Sadly, these innovations tend to take far longer to get into productive use than we would hope. But not always, so here is hoping this innovation from NASA gets into ourselves soon.

Ritalin Doesn’t Show Long Term Effectiveness for ADHD

From the New York Times opinion piece, Ritalin Gone Wrong, by L. Alan Sroufe is a professor emeritus of psychology at the University of Minnesota’s Institute of Child Development:

Attention-deficit drugs increase concentration in the short term, which is why they work so well for college students cramming for exams. But when given to children over long periods of time, they neither improve school achievement nor reduce behavior problems. The drugs can also have serious side effects, including stunting growth.
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To date, no study has found any long-term benefit of attention-deficit medication on academic performance, peer relationships or behavior problems, the very things we would most want to improve. Until recently, most studies of these drugs had not been properly randomized, and some of them had other methodological flaws.

But in 2009, findings were published from a well-controlled study that had been going on for more than a decade, and the results were very clear… At first this study suggested that medication, or medication plus therapy, produced the best results. However, after three years, these effects had faded, and by eight years there was no evidence that medication produced any academic or behavioral benefits.

As I have written before I am skeptical of the amount of drug use our health care system encourages: Lifestyle Drugs and Risk.

Microbiologist Develops Mouthwash That Targets Only Harmful Cavity Causing Bacteria

A new mouthwash developed by a microbiologist at the UCLA School of Dentistry is highly successful in targeting the harmful Streptococcus mutans bacteria that is the principal cause tooth decay and cavities.

In a recent clinical study, 12 subjects who rinsed just one time with the experimental mouthwash experienced a nearly complete elimination of the S. mutans bacteria over the entire four-day testing period.

Dental caries, commonly known as tooth decay or cavities, is one of the most common and costly infectious diseases in the United States, affecting more than 50 percent of children and the vast majority of adults aged 18 and older. Americans spend more than $70 billion each year on dental services, with the majority of that amount going toward the treatment of dental caries.

This new mouthwash is the product of nearly a decade of research conducted by Wenyuan Shi, chair of the oral biology section at the UCLA School of Dentistry. Shi developed a new antimicrobial technology called STAMP (specifically targeted anti-microbial peptides) with support from Colgate-Palmolive and from C3-Jian Inc., a company he founded around patent rights he developed at UCLA; the patents were exclusively licensed by UCLA to C3-Jian.

The human body is home to millions of different bacteria, some of which cause diseases such as dental caries but many of which are vital for optimum health. Most common broad-spectrum antibiotics, like conventional mouthwash, indiscriminately kill both benign and harmful pathogenic organisms and only do so for a 12-hour time period.

The overuse of broad-spectrum antibiotics can seriously disrupt the body’s normal ecological balance, rendering humans more susceptible to bacterial, yeast and parasitic infections.

Shi’s Sm STAMP C16G2 investigational drug, tested in the clinical study, acts as a sort of “smart bomb,” eliminating only the harmful bacteria and remaining effective for an extended period.

“With this new antimicrobial technology, we have the prospect of actually wiping out tooth decay in our lifetime,” said Shi, who noted that this work may lay the foundation for developing additional target-specific “smart bomb” antimicrobials to combat other diseases.

The Beneficial Phytochemicals in Vegetables Help Us Lead Healthy Lives

If I don’t pay attention, I won’t eat enough vegetables. Even when I do pay attention I still don’t eat enough (but get closer). Paying attention to what you eat is important for your health.

Some tips from the video.

Eat a wide variety of vegetables, to get the benefits each offers.
Cruciferous vegetables have cancer preventing benefits and enhancing the immune system. Vegetables in this category include broccoli and cauliflower.
Berries also have chemicals that aid in the prevention of cancer.