New Diet Drugs Not Being Used

Diet DrugsA joint survey was conducted by the online medical news service MedPage Today, Everyday Health and The Daily Meal to evaluate physicians’ methods of treating obesity. They surveyed almost 1000 providers and found that the newer drugs such as Qsymia (phentermine/topiramate) are only being used by about 6% and Belviq (lorcaserin) in only 3.3%. Several of the survey respondents cited the high cost of the medications as barriers to use. One provider noted that “middle class (patients) and below cannot afford “these medications so he prescribes generic phentermine 37.5 mg one half tablet each morning with generic topiramate 25 mg twice a day with similar effectiveness.

Fat absorption blockers such as orlistat in it’s over the counter form “Alli” or its prescription form xenical were popular with over 20 % of respondents using those products. Generic phentermine was used alone by 16%. Other medications frequently mentioned included metformin the diabetic drug, and victoza another diabetic drug not yet approved for weight loss therapy.

The majority of the respondents prescribe diet and exercise to begin with. Weight Watchers is their favorite commercial diet with over 75% of those surveyed noting that it works steadily and safely. The South Beach Diet was the clear runner up. When the Atkins Diet was mentioned there was concern and controversy.

In our local clinical practice we are asked frequently about medication to lose weight. The survey did not look at the average age of the patients the respondents treated and their associated medical issues. Locally we have many elderly individuals using multiple medications for heart disease, elevated lipids, diabetes, heart rhythm control and other complex problems. It is much more difficult to find any oral medications for weight loss that do not adversely react with their prescribed medicines or that are not contraindicated due to their underlying medical problems.

Supplement Toxicity on the Rise

VitaminsIn a report in MedPage Today, the medical newsletter of the University of Pennsylvania School of Medicine, researchers attending the meeting of the American Association of the Study of Liver Diseases reported a striking increase in the number of severe liver injuries reported in supplements between the years 2004 and 2012. They reported the number of cases increased from 7 – 20% and blamed the vast proportion of those cases on dietary and herbal supplements.  Particularly disturbing was the number of injuries in young people involved in bodybuilding.

Mary Rinella, MD of Northwestern Memorial Hospital in Chicago moderated a discussion group on the topic and mentioned what a large problem it is; “It’s made worse by the popular belief that such supplements are harmless, which leads patients to omit mentioning them when they are in a clinic or doctor’s office.”  She went on to say that, “We don’t know what’s in the products or even what’s in the bottle.” Rinella said.  “Dietary and herbal supplements are not considered drugs and so escape oversight by the FDA.”

Warren Kupin, MD, FACP of the University of Miami Miller School of Medicine division of nephrology delivered a similar message on the epidemic of kidney disease in young adults being caused by the contents of common herbs and supplements sold on our shelves with pleasant healthful sounding names. He raised the red flag on products produced in India and Asia or products containing materials from those areas which contain high levels of heavy metals such as mercury, cadmium, arsenic and others. The target market is young women of child bearing age and they expose their partners and children to these products.  He took a commonly sold supplement, opened the bottle and said that the aroma escaping contained so many heavy metals that if this was produced in a US factory OSHA would require the workers to be wearing respirators in that type of toxic environment.

Consumers need to read labels and ask questions of their doctors before they add an herb or supplement to their daily regimen.  Women of child bearing age need to be especially vigilant and discuss these supplements with their obstetricians and pediatricians before considering ingesting them. The National Institute of Health maintains a very objective website on alternative and complimentary medications at nccam.nih.gov/health/whatiscam that is a great resource and location of factual material.   

I always suggest that when you visit your doctor you bring all your medications, vitamins, minerals, herbs and supplements in a plastic bag with you so that the doctor can read the labels with you.  Accepting the advice you receive on the Internet or from the sales personnel at a vitamin and mineral store is not the most accurate way to learn the truth.  The public is injuring and maiming themselves by consuming too much of the wrong things and there is little or no government oversight and regulation of these products. Protect yourself and ask your doctor for assistance!

 

Testosterone Therapy in Low T Syndrome in Veteran’s tied To Higher Cardiovascular Risk.

Cardiovascular RiskMedPage Today is reporting a Veteran’s Affair study which indicates that men with and without coronary artery disease who received testosterone supplements had a higher risk of death, heart attack and stroke.  The current study looked at 8709 veterans who underwent coronary angiography between 2005 and 2011 and had a testosterone level less than 300 ng/dL.  These findings surprised researchers who had looked at a previous VA study that suggested that testosterone therapy reduced cardiovascular risk.

Steven Nissen, MD of the Cleveland Clinic, a world respected cardiologist felt the study was a “red flag” that “demands attention from not just physicians but also from regulators.”  He is concerned about the “increasingly commonly prescribed (testosterone replacement therapy) “practice which is largely “fueled by direct to consumer advertising that’s urging men to get tested for low testosterone and then to seek replacement.” Nissen pointed out that in both men and women a drop in hormone levels is a normal part of aging and it is not necessarily a disease. “Making it into a disease may end up causing more harm than good.”

Anne R. Coppola, MD of the University of Pennsylvania in an editorial noted that “what is missing from the literature are data from randomized trials that include a sufficient numbers of men for an adequate amount of time to assess the long term benefits and risks of testosterone therapy.”   She cited a small study called the Testosterone Trial in Older Men which had to be stopped early because of a higher rate of cardiovascular events “in the group taking testosterone.

In our market you cannot turn on a sports talk radio show or ride down an Interstate highway without seeing ads for “Low- T Syndrome.”  It is a highly profitable cash business being fueled by testimonials and word of mouth rather than well planned medical studies. Legitimate research is ongoing at Harvard Medical School but it is difficult for others to obtain funding when the producers of the product can make so much money based on here say and nothing else. The number of prescriptions for testosterone products has increased since 2000 from 5.3 million to 1.6 billion.  The American College of Endocrinology has clear and strict guidelines on when supplementation in young men is appropriate. There is a large anti-aging medical community who feel that even if you are older and have normal levels you will feel better and benefit from supplementation. This research questions that feeling and begs for regulators to step in and stop an unproven possibly dangerous practice until we have more data.

 

Low Dose Aspirin Cuts Colon Cancer Risk in Women

AspirinNancy Cook, SCD of Brigham and Women’s Hospital in Boston and colleagues reported in the July 16, 2013 issue of the Annals of Internal Medicine that data from the Women’s Health Initiative including 39,876 women 45 years or older, who were randomly assigned to take 100 mg of aspirin every other day for ten years, experienced a 20% reduction in the risk of colorectal cancer. The study did not show that there was an all-cause reduction in mortality .

The very conservative US Preventive Services Task Force currently recommends aspirin in Women 55 – 79 only if potential benefits are greater than harms. The aspirin group did have more bleeding from peptic ulcers and gastrointestinal bleeding. The article was accompanied by an editorial comment by Peter Rothwell, MD, PhD of the University of Oxford. He felt that the risk of bleeding and the fact that there was no all-cause mortality reduction, or risk in all cause cancer reduction, should result in a tempering of suggestions for widespread use of aspirin in healthy middle-aged women. MedPage Today, the online Journal of the University Of Pennsylvania School Of Medicine, ran a comment from Dr. Randal Burt, MD, a gastroenterologist at the Huntsman Cancer Institute who felt that this was one more piece of evidence that aspirin can reduce colorectal cancer.

It is clear that there are multiple studies showing that aspirin can reduce the risk of colorectal cancer. There are studies showing it reduces the risk of a stroke in women as well.

Like all decisions to take or prescribe a medication, the risks and benefits must be examined first. It is clear to me that in a woman with a strong family history of colorectal cancer, and little or no history of gastrointestinal or systemic bleeding, an aspirin with close monitoring should seriously be considered.

A Large Review Proves Statins Are Safe

StatinsThe online version of Circulation: Cardiovascular Quality and Outcome published a review of the safety of statin drugs. The study looked at 135 randomized research trials including 246,955 participants. Medications examined included atorvastatin (Lipitor), fluvastatin (Lescol), simvastatin (Zocor), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor) and trials of pitavastatin.

They found there were no differences in the rates of discontinuation of the statins because of adverse events compared with discontinuation of placebo. The same applied to elevation of the muscle enzyme creatine kinase, muscle aches or myalgias and/or the development of cancer. As the doses of these medicines increased they found the participants reported more adverse effects.

Christie Ballantyne, MD of the Baylor College of Medicine reviewed the study for MedPage, the online journal of the University Of Pennsylvania School Of Medicine, and felt the study certainly confirmed the tolerability of the statins as a class of drugs to lower cholesterol and reduce cardiovascular events. He reaffirmed the very small increased risk of statin use and developing Type II Diabetes and the need to monitor liver function blood tests while taking the drugs. He concluded these risks were well worth taking in view of the benefits to your health statins provided.

Fish Consumption and Reduction of Risk of Developing Breast Cancer

Fish v2MedPage, the online medical journal of the University of Pennsylvania School Of Medicine reviewed an article published in the British Medical Journal concerning a relationship between consumption of marine fish oil from fish and a reduction in the risk of developing breast cancer. The study was published by Duo Li, MD, a professor of nutrition at Zhejiang University in Hangzhou, China. They reviewed data from 21 “prospective cohort studies involving nearly 900,000 people”. According to their data, eating just one or two portions a week of salmon, sardines, mackerel or other fish rich in marine n-3 polyunsaturated fatty acids is associated with a 1 % reduced risk of breast cancer in later life. Their data came from questionnaires that asked about patients’ intake of fatty acids and from blood levels measured in several studies. When they looked at similar fatty acids which come from plants not fish, such as alpha linoleic acid, they could not see a similar protective effect.

The study was critiqued by Alice H Lichtenstein, DSc, director for the cardiovascular nutrition lab at Tufts University. She had numerous questions and concerns about the methodology and conclusions but did support the need for future prospective studies to examine this question. While I have neither the credentials nor experience of Dr. Lichtenstein in evaluating this type of data I believe strongly in the KISS (keep it simple stupid) principle. Fleshy fish provides fish oils which are felt to be beneficial to our health. The same cannot be said for fish oils which you receive in pills and preparations.

My advice is to eat fish two or three times per week. Prepare it simply in a Mediterranean diet style and obtain the benefits that research seems to consistently show for this eating pattern.

Exercise May Protect Against Memory Loss of Aging

Senior Citizens, exercise v2Dorothy Edwards, PhD of the University of Wisconsin in Madison and colleagues presented a study at the Alzheimer’s Association International Conference this week that implies that physical exercise and activity slows down or prevents age related memory loss in patients considered high risk for developing Alzheimer’s disease or Minimal Cognitive Impairment. The data was presented in the University of Pennsylvania’s School of Medicine on line journal MedPage.

The study showed that the brain hippocampus was more resistant to the memory loss effects of aging in a population that had first degree relatives with dementia and who exercised aggressively. Past research has shown that physical exercise stimulates “neurogenesis “in the hippocampus.

Maria Carrillo, PhD, vice president of medical and scientific relations at the Alzheimer’s Association said, “We already know that exercise is important in terms of all sorts of health measures. Now it appears that over time, it also had benefits in preserving memory and other aspects of cognition, even in high risk people.”

The study of 317 patients is one more supporting piece of evidence that should be encouraging us all to get out and walk, cycle, swim, run and participate in whatever physical activities we find enjoyable to do. The health benefits are too important to ignore.

Prolotherapy for Osteoarthritis of the Knee

Knee X-rayThe National Institute of Health Division of Alternative and Complimentary Medicine has said that if a treatment works, and its results can be reproduced, then it is not alternative therapy.  Such a wise mantra is at the heart of a study published in the May/June issue of the Annals of Family Medicine and recently reviewed in MedPage.

David Rabago, MD, of the University of Wisconsin in Madison and his associates looked at whether prolotherapy is beneficial for those patients suffering from arthritis of the knee. Prolotherapy involves the injection of sugar water or dextrose into joints for the relief of pain. It has been used in different joints for over 75 years but most of the research studies available on its use suffer from poor scientific design and reproducibility.

This study involved 90 adults with knee arthritis in one or both knees for at least five years.  The mean age of the enrollees was 57 years with 2/3 of the enrollees being women and ¾ overweight or obese.  The enrollees were separated into groups. One group received dextrose injections, another received saline or salt water, and a non-injection exercise group. The injections were given at weeks 1, 5, 9, 13 and 17. 

Prolotherapy required them to make multiple punctures around the knee at various tendon and ligament sites. 22.5 mL of either concentrated dextrose or saline placebo were injected into the knees followed by an intra-articular injection of 6mL of additional fluid.   A third arm of the study included patients given no injections but instructed in a home exercise physical therapy program. 

In the dextrose group, 17 patients received injections in only one knee and 13 had treatment in both knees. In the placebo saline group, 15 had a single knee treated while 13 had both knees treated.   During the study, 14 patients in each group used oral non-steroidal inflammatory drugs to relieve pain and discomfort.  All patients receiving injections reported mild to moderate pain after the procedure and up to 2/3 used oral oxycodone before or after the procedure.

The patients used the Western Ontario McMaster University Osteoarthritis Index to score their pain, function and stiffness. There was a significant difference in the improvement of those receiving the dextrose injections as compared to those receiving saline injections. Ninety-one percent of those receiving the dextrose injections said they would recommend the treatment to others.

This was a preliminary study which showed the effectiveness of an alternative therapy in treating a common and chronic condition. It is clear that these findings necessitate a larger study which can look at the correct dosage to inject and to explore how the sugar injections actually work. It appears to be a relatively inexpensive way to relieve chronic pain and is worthy of further study!

pH Testing For GERD May Save Money

HeartburnHeartburn and dyspepsia are common conditions exacerbated by being overweight, eating too much, eating certain types of foods (red sauces, berries, alcohol, fatty foods, caffeinated beverages, chocolate) reclining after eating, wearing constrictive clothing at the belt line and a host of other items. The heartburn is supposed to be due to the reflux of acidic digestive juices from the stomach into the gullet or esophagus. There is no true physical barrier between the stomach and the lower esophagus like a trap door but there are a group of muscles known as the lower esophageal sphincter. These muscles are supposed to recognize that the stomach contains food and acidic digestive juices and contract and prevent the stomach contents from kicking back up the esophagus and producing heartburn symptoms.

The treatments of choice are; avoiding those foods that produce the heartburn, wearing less constrictive clothing and, medications. The gold standard of medications is the PPI’s or proton pump inhibitors. These would be medicines like Prilosec, Nexium, and Prevacid. The product inserts suggests we take these medications for eight weeks and no longer. Most patients continue to take the medications long after the recommended eight weeks.

In an interview in MedPage, the online journal of the University Of Pennsylvania School Of Medicine, David Kleiman, MD of Weill Cornell Medical College in New York City proposes that at eight weeks patients be given a pH test or what used to be called the “Bernstein Test”.

With the pH test, a thin plastic tube is inserted through the nose and placed so the tip is at the lower portion of the esophagus adjacent to the stomach. You then sample and test the fluid for acidity by measuring its pH. The test costs under $700 and is fairly accurate and safe.

According to Dr. Kleiman, he examined patients with GERD who continued to take PPI’s beyond eight weeks and almost 1/3 of them did not have any signs of acidic material refluxing into the esophagus. When looking at the lower dose PPI’s sold over the counter, versus the prescription items, the average weekly cost of PPI’s varies from $29 to $107. This translates to a cost of between $2000 and $7,300 a year on medicines not needed.

While the idea of inserting a tube to measure acidity as a way to distinguish who should continue PPI’s has its merits, the practical question is “How available is the test and who is doing it?”.

It is always a good idea to discontinue medications you do not need – especially expensive ones. The availability of the testing in local communities may preclude this approach.

Fitness in Mid-life Leads to Less Illness in Later Life

Woman with DumbbellsAt doctor/patient visits, physicians stress the importance of developing and following a healthy lifestyle. That healthy lifestyle includes eating correctly and in moderation, controlling your weight, going for periodic benchmarking checkups and getting regular and consistent exercise. An untold number of research studies have supported these recommendations.  Medpage, the online medical journal of the University Of Pennsylvania School Of Medicine printed two reviews of studies which confirm the findings.

Ambrish Pandey, MD, of the prestigious University of Texas Southwestern Medical Center in Dallas, Texas with his colleagues presented data that links fitness in your fifties with a reduced risk of cardiovascular heart failure in later life.  They looked at 9,050 men and women with an average age of 48 and followed them for a period of eight years. They evaluated their fitness at entry into the study and eight years later. They followed patients for 60,635 patient years.  

Their findings were quite simple. Those people who exercised regularly and improved their fitness over time had less heart disease and heart failure. They proved that your risk of cardiovascular disease in your sixties and seventies was modifiable based on your fitness level and effort to improve it and sustain it.

Susan Lakoski, MD, of the University of Vermont in Burlington looked at fitness in men in their fifties and concluded that “physical fitness reduces the risk of lung and colorectal cancer”.  She pointed out that if fit men developed cancer they tended to have a higher survival rate than unfit men. Interestingly, her study suggested that weight was NOT the issue.  Overweight men who were fit did well, while unfit lean men did not do as well.

It is refreshing to have data to back up the recommendations we make to our patients – find some form of exercise they enjoy and keep doing it, frequently and repeatedly if you wish to have fewer health issues to deal with as you age.