Vitamin D Supplements Do Not Reduce Falls, Fractures or Improve Bone Density

Much has been written about the benefits of supplementing Vitamin D in patients. The World Health Organization sets its normal blood level at 20 while in North America it is listed at over 30. Under normal circumstances when your skin is exposed to sunlight your kidneys produce adequate amounts of Vitamin D.

Over the last few years low vitamin D levels have been associated with acute illness and flare-ups of chronic illness. The Vitamin D level is now the most ordered test in the Medicare system and at extraordinary expense. Supplementing Vitamin D has become a major industry unto itself.

The October 4th edition of the Lancet Diabetes and Endocrinology contained an article written by New Zealand researchers that looked at 81 randomized research trials containing almost 54 thousand participants. “In the pooled analyses, researchers found that Vitamin D Supplementation did not reduce total fracture, hip fracture, or falls – even in trials in which participants took doses greater than 800 IU per day.” Vitamin D supplementation did not improve bone mineral density at any site studied (lumbar spine, hip, femoral neck, forearm or total body).

They concluded that there is little justification for the use of Vitamin D Supplements to maintain or improve musculoskeletal health, and clinical guidelines should reflect these findings.

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Controversial Study on Body Weight and Development of Dementia

DementiaAs the Baby Boomers age and develop more chronic diseases there is a predicted epidemic of cognitive dysfunction and dementia expected to occur. At the same time the Baby Boomer retirement explosion is occurring the nations of the world are experiencing a significant increase in obesity and its health related problems. In the April 10th issue of The Lancet Diabetes & Endocrinology researchers in Great Britain published a paper suggesting that being overweight might be more protective against the development of dementia than being at a normal weight or underweight. In fact they felt that underweight individuals having a Body Mass Index of < 20 had a far higher risk of developing dementia than normal weight individuals or obese individuals (BMI > 30). The data was collected and analyzed from the United Kingdom Clinical Practice Research Datalink by Nawab Qizilbash, MSc, DPhil, from the London School of Hygiene and Tropical Medicine. The study looked at records of people aged 40 or older between 1992 and 2007.

The author concluded that “If increased weight in midlife is protective against dementia, the reasons for this inverse relationship are unclear at present.” Previous smaller studies on the issue suggested just the opposite that being overweight in midlife was a risk factor for developing dementia. Deborah Gustafson,, PhD, from SUNY Downstate Medical Center in New York cautioned that these results are certainly not the “final word” on the topic.

As a clinician we always advise patients to live a life and eat a diet based on moderation. The study did not make it clear if the protective effect of being overweight extended to the massively obese or not. What is clear is that being at an extreme seems deleterious, while being at normal body weight or mildly overweight may be protective.

Three More Strikes Against Smoking

There is no doubt that cigarette smoking is a practice that contributes to poor health and earlier death. Despite this, the practice is still popular among the young. Over the last three weeks several new research articles have been published that support the concept that smoking is severely detrimental to your health.

An Australian study published in Stroke: Journal of the American Stroke Association pointed out that individuals who had a stroke at the time they were active smokers had a far worse outcome and long term outcome than non- smokers. It additionally showed that smokers had the stroke at a younger age than nonsmokers. The group was followed for another 10 years and had a higher incidence of strokes, heart attacks and deaths than the nonsmoking group. The study emphasized the devastation and cost of “healthy years of life lost” as a consequence of continuing to smoke.

In an online publication in the Lancet, researchers working in the “Great Britain Million Women Study” noted that women who quit smoking lived longer than women who continued – irrespective of the age they decided to stop smoking. They additionally lowered their chances of dying from lung cancer.

A study out of the Mayo Clinic in Rochester, Minnesota looked at the effect of indoor smoking bans on heart attack rates in a community. This study looked at the effect of secondhand smoke on individuals. The Mayo Clinic has an exhaustive and large data base of individuals in the Midwest who have come to their clinic for health care for generations. They believe that in their study population, the number and extent of cardiovascular risk factors has remained fairly constant but, since the institution of strict bans on indoor smoking, the number of heart attacks has dropped dramatically.

Spray on Skin Cells Heal Wounds Fast

Non healing ulcers and wounds in the elderly are a common and severe problem. These skin breakdowns are painful, often get infected and often require wound care teams to treat the problem.  Robert Kirsner, MD, PhD of the University of Miami Miller School of Medicine Division of Dermatology reported in the online edition of the prestigious Lancet magazine that he is using a spray bottle containing a mix of skin cells called keratinocytes and fibroblasts to enhance the rate of healing.

Dr. Kirsner is looking at healing venous stasis ulcers of the legs. It is common to find venous insufficiency of the legs in senior citizens (poor return of blood from the legs through the veins and back towards the heart).  Venous ulceration and skin breakdown occur in 1 – 2.5% of these adults 65 years and older.  Treatment routinely consists of clearing and controlling infection with antibiotics, primary dressings and compression bandages and stockings. This is successful in 30% – 75% of the situations.  The remaining cases require skin grafting and surgical procedures to heal.

To treat this common and persistent problem, Dr Kirsner and associates have been working with a product known as HP802-247 which is a cryopreserved sampling of fibroblasts and keratinocytes derived from neonatal foreskin tissue that is discarded after circumcision of newborn infants. Thawed cells are suspended in a spray for application to a wound.   The researchers created three strengths of the spray and tested all against standard treatment.  All patients in the study, whether receiving the experimental spray or a placebo, received standard and traditional wound care.  Kirsner’s results show that by using the lowest dose of the spray he was able to achieve complete healing in almost a third more patients as compared with the placebo group.  Differences in the healing rate became apparent within the first week of the treatment.

The product, HP802-247, has shown enough improvement in healing rate and total healing to warrant advancing it to Phase III studies which have begun in the United States and Europe.  While the initial studies have looked only at wounds caused by venous insufficiency, it will be interesting to see if similar studies are initiated on additional slow healing wounds common in seniors as well as in burn unit situations.

Statins Reduce Risks, Even in the Lowest Risk Groups

Current guidelines for the use of statins in the USA (Lipitor, Zocor, Crestor, Atoravastatin, Simvastatin, Pravastatin, etc.) call for only treating individuals who have a ten-year risk of major vascular event of at least 20%.

European researchers including Borislava Mihaylova, MSc DPhil, and colleagues on the Cholesterol Treatment and Trialists Collaborators team writing in the Lancet question whether the guidelines should be changed to treat individuals with even lower risks. Their large Meta analysis suggests that statins provide substantial benefits for primary prevention – especially in patients with a 5-10% ten year risk of a major vascular event. They looked at data from 27 trials including over 175,000 participants. When they took into account cost and side effects of statins, such as muscle pain and inflammation, rhabdomyolysis, diabetes and hemorrhagic stroke, they concluded that the benefits still far outweighed the risks. They think that the clear-cut affect on lower risk individuals coupled with the fact that almost 50% of vascular events occur in patients without previous cardiovascular disease necessitates the broadening of USA guidelines for treatment of patients. The researchers go on to hypothesize that as more generic statins enter the market, cost concerns will become far less of a factor in the decision to treat or not treat.

They noted that for each 1 mmol/L reduction in LDL cholesterol, there was a 21% reduction in the relative risk of major vascular events, and all cause death, irrespective of age, baseline LDL or previous cardiovascular disease.

This research makes it clear that there is great value in assessing the statistical cardiovascular risk of each individual and being more aggressive in the use of statins than current national guidelines call for.  Incorporating risk tools such as the Framingham Risk assessment plus looking at newer techniques such as the measurement of carotid artery intimal thickness may be appropriate in the decision to choose a statin or not.

Aspirin – Cardiovascular and Cancer Benefits

In this week’s on line edition of MedPage, a publication of the University Of Pennsylvania Perelman School Of Medicine, they summarize a series of articles published in the prestigious medical journal Lancet, which conclude that taking aspirin daily reduces your risk of cancer.

Aspirin received its notoriety after a Veterans’ Administration study years ago noted that if you took a daily aspirin and were a male over 45 years old you had fewer heart attacks and strokes. That classic study has led to the recommendation over the years that everyone over the age of 45 years old take aspirin daily to prevent cardiovascular events. No one can quite agree on the dosage of a full aspirin (325 mg), a baby aspirin (81 mg), or two baby aspirin?

As more and more people began taking aspirin for cardiovascular benefits researchers noted more frequent episodes of major internal bleeding either in the gastrointestinal tract or in the brain and head. At the same time, it was whispered among professionals that taking aspirin daily reduced adenomatous growths in the colon (pre-malignant polyps) and reduced colon cancer.   In the past few weeks several studies have tried to stratify whether aspirin use daily should be restricted to men as opposed to women, or to individuals with documented heart and vascular disease for secondary prevention of the next heart attack or stroke rather than primary prevention.  They cited the large number of bleeding episodes in individuals trying to protect themselves from their first heart attack or stroke compared to the events prevented and lives saved.

Today’s MedPage review of three Lancet articles claims that daily aspirin use reduces the risk of adenomatous cancer by 38% and cancer mortality by 15%. It reduces the development of metastatic disease by up to 15%.  These studies looked at more than 51 trials, including well over 100,000 participants, leading Dr Peter Rotwell of Oxford University in the United Kingdom to say that the papers “add to the case for the long term use of aspirin for cancer prevention in middle age.”

As a primary care physician I will continue to take my daily 81 mg enteric coated buffered aspirin (2) with food and take my chances with GI bleeding and cerebral hemorrhage.  If my patients do not have any strong contraindications to aspirin ingestion I will continue to make the suggestion that if they are over 45 years old they consider doing the same.

Lancet Study Emphasizes Long Term Benefit and Safety of Statin Use

Richard Bulbulia, MD, of the Heart Protection Study Group reported in the Lancet that statin medications are safe and effective over long periods of time.  They looked at 20,536 patients at high risk for vascular events. They studied patients who were between 40 and 80 years old. These patients were randomized to one group receiving Simvastatin (Zocor) daily at the 40 mg dose or placebo for 5.3 years. They were then followed for another six years during which both groups received the statin.

Researchers found that during the initial 5.3 years of the study there was a 23% decrease in major vascular events and an 18% reduction in vascular mortality in the Simvastatin treated group.

They also looked at complications of therapy over the eleven year period and concluded, “Reassuringly, there was no evidence that any adverse effect on particular causes of non–vascular mortality or major morbidity, including site-specific cancer, was emerging during this prolonged follow-up period.”  In an editorial in the same edition, Payal Kohli, MD and Christopher Cannon, MD of the Brigham and Women’s Hospital in Boston said the results “provide contemporary and confirmatory evidence that extended use of statins is safe with respect to possible risk of cancer and non-vascular mortality.”

It is noted that the dosages used are higher than what the FDA currently recommends for Simvastatin due to the risk of muscle injury at higher doses. Despite that, the Lancet editorialists concluded that “concerns should be put to rest and doctors should feel reassured about the long-term safety of this life saving treatment for patients at increased cardiovascular risk.”