Wednesday, July 10, 2019

Do I really need those vitamins?

Americans love their vitamins and “nutritional supplements.” Surveys have shown that over half of us take at least one and 10% use at least 4 dietary supplements daily. Among those 60 or older, use is even higher; 70% take at least one and 29% take four or more supplements. The market is huge, in the billions of dollars, and “brand extension” is common. You can buy multivitamins, multivitamins for women and multivitamins for seniors. Vitamin D capsules crowd the shelves with sizes from 1000 units to 4000 units and more. Ever since chemist Linus Pauling pronounced it a miracle, millions of us use Vitamin C to prevent or cure a cold.
Besides making money for the manufacturers, pharmacies and GNC, do vitamins and supplements do any good? Clearly it is important to replace any deficiencies. If you have pernicious anemia, ( ) you need Vitamin B12, either by injection or in very large doses by mouth. If you do not drink milk and avoid the sun, you may well need to take Vitamin D. If you are a woman with very heavy periods, a daily iron supplement may be needed. Certain vitamins have been shown helpful in slowing the advance of macular degeneration.
What about the vast majority of supplement users? Most people who take these products take a multivitamin, but rarely is that the only product used. Other commonly used supplements are omega-3 or fish oil, calcium, Vitamin D, Vitamin C and botanical products. Ironically, but not surprisingly, supplement users are much more likely than non-users to say that they try to eat a balanced diet, see their doctor regularly, get a good night’s sleep, exercise regularly and maintain a healthy weight. Many studies over the years have looked at the benefits of taking various forms, particularly at their effect on cardiovascular disease, still the number one killer in western countries.
A recent study published in the Annals of Internal Medicine looked at 277 trials involving 24 supplements or combinations of supplements and almost 1 million subjects. These studies found that reduced salt intake lowered the death rate in all and cardiovascular death in subjects with hypertension. Omega-3 long-chain polyunsaturated fatty acid (LC-PUFA) reduced the risk of coronary disease and heart attacks by a modest amount (7-8%). Use of folic acid was associated with a 20% decreased rate of stroke. Somewhat alarmingly, use of calcium plus Vitamin D was associated with a 17% increased risk of stroke. All the other supplements, including Vitamins B6 and A, multivitamins, “antioxidants” and iron had no measurable benefit. Some 25% of us over 50 take a supplement touted as good for "brain health," but the AARP Global Council on Brain Health has come down strongly against this practice, calling it a "massive waste of money."
Bottom line? Don’t waste your money. If you eat a balanced diet, the odds are you are getting all the nutrition you need. If you feel better taking a multivitamin, there is no evidence it does you any harm, but you are better off choosing the house brand and saving money. If you are shoveling down 8 or 10 “supplements” daily, you are probably wasting your time and money.

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Wednesday, July 3, 2019

Is dementia the price to pay to be dry?

First, a little background and terminology. Our brain cells talk to each other via “neurotransmitters.” One of these is a compound called acetylcholine. There are two relevant classes of medication that act on acetylcholine. One group are anticholinergic drugs, which block the effect of acetylcholine. These are used in many ways, and there are many subgroups. They are used to treat vertigo and nausea; they are used to prevent seizures; they include many of the older antidepressants, antipsychotics and antihistamines; they are antispasmodics for the intestine, and notably, they are used to treat urinary incontinence. The other class of drugs are cholinesterase inhibitors. The chemists among you will figure out that these block the breakdown of acetylcholine and so increase its effect. The best-known of this class are the drugs used to slow the progression of Alzheimer’s Disease.
It has been long-known that use of anticholinergics can cause confusion in elderly patients, and doctors have been taught to use these cautiously. What has not been known is if they have any long-term effect in patients who seem to tolerate their use. A study published online in JAMA Internal Medicine in June looked at this by studying a very large (30 million patients) British research database. They compared patients diagnosed with dementia with those who were not, matched by age and gender. They then looked at use of any of over 50 drugs with anticholinergic properties by type and by duration of use. They found that patients with dementia were much more likely to have been prescribed an anticholinergic drug over extended periods than were controls. The drugs that most clearly showed this effect were from the group that were expected to be used daily for a long time.
I would like to call your attention in particular to the group of drugs used to treat urinary incontinence. I do this because they are very widely advertised and widely-used by middle-aged and older women. They tend to be used for indefinite periods. They are also of marginal benefit at best. Many of the other drugs in this class are of less current concern because they are used only infrequently (anti-nausea, muscle relaxants) or because they have been largely replaced by newer drugs (tricyclic anti-depressants). Bladder problems are very common and while not life-threatening can be annoying and embarrassing. Oxybutinin (Detrol and other brands) is probably the most widely-used drug to treat overactive bladder. It universally causes a dry mouth, such that the increased thirst works against the desire to void less often.
While this was an “observational study,” and not a randomized trial, it has some inherent validity. We know that anticholinergics can cause confusion in some users. We know that acetylcholine is important in brain function. We know that drugs that increase acetylcholine have some benefit in dementia. My advice is to use these drugs only if other remedies have failed and only if the benefit is very strong. If your reaction is “well, it seems better than nothing,” I’d think twice. Maybe a pantie-liner would do as well and be safer.

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Monday, June 24, 2019

Better than roses?

On June 21, the FDA approved for marketing bremelatonide (trade name Vyleesi) to treat acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
While I expect push-back commenting on this topic as a male, I am also a physician, and I think this represents a flaw in our drug-approval process. HSDD is defined in the psychiatrists’ “bible” of DSM (The Diagnostic and Statistical Manual of Mental Disorders is the handbook used by health care professionals in the United States and much of the world as the authoritative guide to the diagnosis of mental disorders) as low sexual desire that causes marked distress and/or interpersonal difficulty and which is not due to a co-existing medical or psychiatric condition. It can be diagnosed in both men and women, though I am unaware of any products marketed or in development to increase male sexual desire. Vyleesi is not the first medication for improving women’s sexual desires. Addyi, a drug approved by the FDA in 2015, also improves women’s sexual desires by working kind of like an anti-depressant. However, earlier this year, the FDA issued new safety orders mandating that the drug’s labeling include a boxed warning — the agency's strongest warning — after reports of concerning side effects, including severely low blood pressure and fainting, especially when used with alcohol. Many women’s groups were and remain unhappy that Addyi was approved as quickly as happened.
Changes in sexual desire are natural and may come and go depending on personal events or partner-related issues. When the lack of interest in sexual activity lasts longer than six months and causes distress, however, the criteria for a sexual desire disorder may be met. There are many reasons other than a “medical disorder” such as HSDD to cause decreased interest in sex. These may include, in part, negative attitudes about sex, relationship difficulties (poor communication, abuse), stresses such as financial difficulties, job loss, bereavement, etc., history of emotional or physical abuse, alcohol use, worry about children wandering in or simply a partner’s poor hygiene.
Leaving this all aside, how wonderful is Vyleesi? Is it a “cure?” The drug was approved based on two trials that compared the active drug in different doses versus placebo. The drug must be injected under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity (so much for spontaneity!). Possibly showing the power of placebos, the trials found that 25% of women using active medication had an increase in their sexual desire scores, compared to 17% of those using placebo. 35% of women who used the drug had a decrease in their distress score versus 31% of those using placebo. While the manufacturer will tout the “47% greater improvement” experienced by women using the active drug (17% increased to 25%), I think a more realistic viewpoint is that the drug benefitted 8 out of 100 women who used it.
What about side effects? About 40% of the women in clinical trials experienced nausea, and in 13% the nausea was severe enough to require medication. It also caused a transient (up to 12 hours) increase in blood pressure, meaning it should not be used in women with high blood pressure or cardiovascular disease. The drug will go on sale in September, and a price has not yet been announced.
Worth it? You can decide for yourself, but I’d try roses first.

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Thursday, June 20, 2019

Be nosy - read about yourself

For centuries, doctors felt that their notes were their property, and none of the patients’ business. This attitude slowly shifted, and the Health Insurance Portability and Availability Act (HIPAA) of 1996 put into law the fact that patients must be allowed to review and get copies of their medical records. Despite this, access to records has remained a daunting task for many. A study done in 2017 of 83 hospitals, all “top ranked” by US News and World Report, found that the information patients were given by phone often differed from that on the forms they had to sign, and that a majority of hospitals charged well over the federally-suggested cost for an electronic copy. Many refused to supply records in the format patients requested, even though this is mandated by law.
Is it worth the bother? Increasing evidence says that you should read your own medical records. There are many benefits. A common failing of current Electronic Medical Records (EMRs) is that they are filled with cut-and-paste from prior notes and often propagate misinformation. An old note says you had an appendectomy as a child and this is carried forward indefinitely, even if you still possess your appendix. Ditto for medicines you stopped taking eons ago, and allergies you never had. If for no other reason, it is worth looking through your record for such mistakes and having them corrected.
Beyond correcting errors, there are many benefits to reading your own records. Some seven years ago, researchers looked at how both doctors and patients reacted to completely “open notes.” Patients at three primary care practices, in Massachusetts, Pennsylvania and Washington State, were given complete access to their doctors’ notes via a secure portal. Included were 105 PCPs and 13,564 of their patients. 11,155 patients opened at least one note, and almost half of these completed a survey on their reactions. Over 80% reported that open notes helped them feel more in control of their care and three quarters of those taking prescription medications said that they were more regular with taking these after reading about their condition. About a third said they shared the notes with others. On the down side, a third had privacy concerns, worrying that others might get into the records and about 5% found something in the notes that was worrisome or offensive. At the end of the experiment, 99% of the patients wanted open notes to continue. The doctors were initially hesitant, but only rarely did the practice result in longer visits or more time addressing issues outside of visits, and none opted to stop when the experiment ended.
One of the biggest problems in patient-physician interactions is that patients find it hard to process all the information they are given during a visit, and it has been repeatedly shown that much of what a doctor says is quickly forgotten. I have advised people to take notes during visits and/or to bring a friend or relative with them as a second pair of ears. Having the ability to read and reread notes of the visit is another good way to be sure you truly know what happened at the visit.
Be an “engaged” patient. Read those notes.

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Thursday, June 13, 2019

News you can use

Several studies reported this week in medical journals had useful findings that should be widely known.
Beware of bats! The CDC reported on human rabies in the United States. Between 1960 and 2018, a total of 125 human rabies cases were reported. 36 were attributed to dog bites, all of which were bites that happened when the victims were travelling abroad. Since universal vaccination for pets was adopted decades ago, rabies in domestic pets has almost vanished. 89 cases were acquired in the U.S, and 62 (70%) of these were contracted from bats, that are by far the leading carriers of rabies in this country. Racoons were a far distant second, and foxes are also possible carriers.
Moving away from rabid bats to the much less scary but much more common problem of cardiovascular disease are findings from a number of important studies.
You don’t need to come back fasting. Traditionally, your blood lipids were always checked after an overnight fast. If you showed up having eaten breakfast, you were asked to come back to have your blood drawn. This requirement has been under question, and a recent study showed that non-fasting lipids were just as reliable a predictor of coronary disease as a fasting sample.
“White coat” hypertension needs to be taken seriously. It has long been known that some people have elevated blood pressure in the doctor’s office but normal BP when checked at home. There has been conflicting advice about whether this was a problem needing treatment. A careful analysis of many studies was published in the Annals of Internal Medicine that showed that people with so-called “white coat” hypertension ARE at increased risk if they are not on BP medication. Those on treatment for HBP who were well-controlled everywhere except in the office did not seem to be at increased risk.
Do you really need the “energy?” So-called energy drinks, which contain large amounts of caffeine among other ingredients, have been linked to increased emergency department visits, and were felt to be the cause of 34 deaths in recent years. About 30% of teenagers and 45% of deployed military personnel consume at least one of these drinks daily. Investigators had young healthy volunteers drink one of two widely sold drinks and monitored their vital signs and ECGs before and after. They reported their findings in the Journal of the American Heart Association. The energy drinks significantly raised pulse and BP in the volunteers and also prolonged the QT interval on the ECG, a change that may make the subjects more likely to have serious rhythm disturbances.
More on how diet affects health. The British Medical Journal reported on findings from the long-running Nurses Health Study. They found that increases in red meat consumption were associated with a higher risk of death, particularly so with processed meat. It is not clear that changing to “white meat” is any better. A study on healthy adults looked at cholesterol on three different diets: beef, chicken and no meat. Plant proteins had by far the most benefit, while chicken and beef were equally bad. Finally, a nutritionist from Tufts, speaking at the annual meeting of the American Society of Nutrition this month, presented evidence that inadequate intake of fruits and vegetables contributed to over 2.5 million excess deaths world-wide. Eat your fruits and veggies, folks!

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Sunday, June 9, 2019

Don't be scammed by stem cells

Earlier in June, the US Food and Drug Administration (FDA) won a major legal victory by getting an injunction to prevent Florida-based US Stem Cell Clinic from offering its treatments. The company claimed to create stem cells from patients’ body fat and use these to treat a variety of serious illnesses, including Parkinson’s Disease, ALS and chronic lung disease. This company is just one of many that have sprung up like weeds offering unproven and generally ineffective treatments to desperate patients.
What are stem cells? Most of the cells in our body have only a single specific job they can do. Heart muscle cells contract and let the heart pump blood around. Bone cells provide the scaffolding that keeps us upright. Red blood cells carry oxygen around our body. None of these can do the job of the other. We do, however, have less-specialized cells that carry the potential to turn into different kinds of cells, and these act as a reserve to repair injury and replace dying cells in many tissues. True “stem cells,” derived from embryos, can become any type of cell, but there are many more partially-developed cells that can turn into some but not all kinds of cells. The best-known are so-called “mesenchymal stem cells,” more properly called mesenchymal stromal cells. These cells reside in the bone marrow, fat, liver and muscle, and can turn into bone, cartilage and fat cells. They are known to contribute to repair of damaged tissues. There is a huge amount of research looking at whether and how these cells can help alleviate human disease. As of last fall, 939 trials were registered with the NIH, the largest number (218) looking at their potential to help neurologic disease. Since mesenchymal stromal cells cannot become nerve cells, it is not certain why they have shown promise in some studies, though one guess is that they donate their mitochondria (the energy producers of the cell) to damaged nerve cells.
Mesenchymal stem cells used in trials have been obtained from bone marrow, fat and umbilical cords. Many of the trials have shown promise, but most have been done in mice, or in a very small number of people. Scientists studying this feel it is a long way before they can be considered as proven useful for humans. This, of course, never stopped a dedicated scam artist. In 2017, there were at least 700 “stem cell clinics” advertising to consumers. They were claiming to be able to cure arthritis, heart and lung disease, erectile dysfunction, Alzheimer’s disease, ALS and macular degeneration, among many other conditions. When asked, the purveyors of these treatments do not point to any trials but to “numerous success stories,” akin to a trip to Lourdes. The most common source of the “stem cells” used in these clinics is birth tissue, usually obtained by mothers who have no idea what their donation will be used for and who are not compensated for their donation. This makes it easier to convince the sufferers than if they had to have needles placed in their bodies to obtain fatty tissue samples or bone marrow cells. It must be noted that when researchers have been able to look at the products sold to the stem cell clinics, none have contained the number of live cells they claimed.
The ”practitioners” at these clinics often blur the distinction between true embryonic stem cells and the mesenchymal cells they use, claiming that their “stem cells” can turn into any tissue needed, which is clearly untrue. Up until recently, there has been little or no oversight of these “clinics” by the FDA, but hopefully that is changing. In the meantime, as your daddy used to say, “if it sounds too good to be true, it probably isn’t.” Save your money.

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Sunday, June 2, 2019

B12 deficiency - the great imitator

Two recent patient experiences prompted this post. In the April 29 edition of the Wall Street Journal, Dana Hawkins-Simons described several years of being seen by specialist after specialist for her complaints of tiredness, dizziness, ringing in the ears, palpitations, shortness of breath and “brain fog.” She finally researched her symptoms and demanded that she be checked for vitamin B12 deficiency, which turned out to be the cause of her symptoms. Last month, the British Medical Journal published the case of a 69-year old woman who was diagnosed with multiple sclerosis based on her rapidly worsening symptoms of hand and leg weakness and numbness, slurred speech, poor concentration and urinary symptoms. At the center where she went for a second opinion, B12 deficiency was suspected and proved to be the cause of her symptoms rather than MS. Fortunately, she had not yet begun on the previously recommended immune-suppressive MS treatment.
Vitamin B12 is critical to many body functions. It is needed to build blood cells, and B12 deficiency was the cause of pernicious anemia, so-called because 100% of sufferers died. Dr. George Minot's discovery of the effectiveness of liver therapy in 1926 saved these people, even though no one was sure why it worked. Another pioneer working at the Boston City Hospital, Dr. Bill Castle, identified Vitamin B12 and allowed B12 injections to take the place of crude liver extracts. The neurologic system also needs B12, and deficiency can lead to many neuropsychiatric symptoms, including numbness of the extremities, an unsteady gait, forgetfulness or even dementia, irritability or depression, vision loss and a shock-like sensation down the spine with neck flexion (that is also seen in MS!). The tongue may be swollen, smooth and tender.
How does one get deficient in B12? The classic cause, commonest in elderly people, particularly those of northern European ancestry, is pernicious anemia, in which the body is unable to absorb B12 due to lack of the protein needed to allow it to pass through the intestine into the body. It was thought that dietary lack was uncommon because B12 is found in so many foods, but these are all of animal origin, and it is easy for strict vegans to become deficient if they do not take supplements. There may be decreased absorption of B12 after gastric bypass surgery or in the setting of gastrointestinal diseases such as celiac or Crohn’s diseases. Some medications, particularly the diabetes treatment metformin or long-term use of acid-suppression, may cause decreased absorption.
If you have any of the symptoms listed above, particularly if you have some the listed risk factors, you should insist on being tested. The level of B12 can be measured in the blood, but there is a wide range of “normal” and many people who are deficient may be in the low normal range. One clue may be found looking at the size of your red blood cells. If you have a patient portal or a print-out of a recent CBC (complete blood count), look for a number described as the MCV. This is short for mean corpuscular volume and describes the size of the red blood cells. Deficiency of B12 (or folic acid) typically leads to larger than normal red cells even before you become anemic. If your B12 level is below 200, you are deficient. If It is 200-300, you may be, even though the lab will list anything above 200 as normal. If your symptoms may suggest deficiency and your blood level is “low normal,” ask for further testing. This is not difficult. Another blood test, for methylmalonic acid (MMA) is almost always elevated with B12 deficiency. Be persistent. Ask to be tested – the testing is neither risky nor terribly expensive – and the consequences of missing B12 deficiency can be severe.

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