Posts Tagged cardiovascular disease

Hormone Replacement Therapy for Menopausal Symptoms: Setting the Record Straight

Whether you call them hot flashes or “power surges,” the symptoms of menopause can be very distressing. They were routinely treated with hormone replacement therapy (HRT) until the Women’s Health Initiative study in 2002 persuaded many patients and doctors to abandon that treatment. The results of that study were misunderstood by some and questioned by others, and there continues to be confusion about what the evidence shows and how menopausal symptoms should be treated. We have learned much more about this subject since 2002. HRT is still the most effective treatment and can be used safely under the new treatment guidelines.

The history of hormone replacement therapy

In the second half of the 20th century, there was much enthusiasm about estrogen. Mimicking the estrogen levels of a young woman was seen as a way to remain young and healthy. Doctors recognized that there were risks, but they seemed minor. There were studies showing that HRT protected women from the increased risk of heart disease after menopause. Few if any doctors prescribed it solely to prevent heart disease, but cardiovascular protection and osteoporosis prevention were seen as added benefits that served to tip the balance towards a decision to prescribe it for menopausal symptoms.

Then the Women’s Health Initiative study (WHI) dropped a bomb. It found that HRT didn’t protect women from cardiovascular disease after all. It showed that HRT did more harm than good. The number of prescriptions dropped by as much as 80%. Many women turned to alternative treatments that had not been studied anywhere near as extensively as HRT. (more…)

Posted in: Obstetrics & gynecology, Pharmaceuticals

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An aspirin a day to prevent heart attacks, strokes, and cancer?

Low dose aspirin is now recommended to prevent heart disease and cancer.

Low dose aspirin is now recommended to prevent heart disease and cancer.

Despite the remarkable advances in medicine over the past 20 years, cardiovascular disease and cancer will still kill half of us. Beyond the deaths, millions survive heart attacks, strokes and cancer, but many are left with disability and a reduced quality of life. While lifestyle changes can improve our odds of avoiding these diseases, they do not eliminate our risk. Finding ways to medically prevent these diseases before they occur, a term called “primary prevention”, is a holy grail in medicine. Primary prevention can be a tough sell, personally and medically. It means taking medicine (which may cause side effects) when you’re well, with the hope of preventing a disease before it occurs.

The US Preventative Services Task Force (USPSTF) released draft guidelines on the primary prevention of cardiovascular disease and colorectal cancer last week. The USPSTF is now recommending daily aspirin in some age groups who have at least a 10% risk of cardiovascular disease in the next 10 years. This isn’t the first guideline that’s recommended aspirin for primary prevention of cardiovascular disease, but it is the first major guideline to endorse aspirin to prevent colorectal cancer. Given these recommendations will apply to millions of people, they have attracted considerable controversy. Is this strategy going to reduce deaths and disability? Or are we about to start “medicalizing” healthy people inappropriately? (more…)

Posted in: Public Health, Science and Medicine

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Update on Cholesterol and Statins

The statin hypothesis is that statins reduce cardiac risk more than can be explained by the reduction in LDL cholesterol. That hypothesis has been overturned by a new study.

The statin hypothesis is that statins reduce cardiac risk more than can be explained by the reduction in LDL cholesterol. That hypothesis has been overturned by a new study.


The consensus of mainstream medicine is that a high blood level of LDL cholesterol is a major risk factor for cardiovascular disease and that lowering high levels can help with prevention and treatment. Statins have been proven effective for lowering cholesterol levels and for decreasing cardiovascular and all-cause mortality. I recently wrote about the new guidelines for statin therapy.

Currently half of American men between the ages of 65 and 74 are taking statins, and 71 percent of adults with heart disease and 54 percent of adults with high cholesterol take a cholesterol-lowering drug.

There is still a fringe group of a few maverick “cholesterol skeptics” who think lowering cholesterol is useless or counterproductive, but the evidence shows they are wrong.


Posted in: Clinical Trials

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Of the Trial to Assess Chelation Therapy, Bayes, the NIH, and Human Studies Ethics

An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means.
~ Henry K. Beecher


A couple of weeks ago, Dr. Josephine Briggs, the Director of the National Center for Complementary and Alternative Medicine (NCCAM), posted a short essay on the NCCAM Research Blog touting the results of the Trial to Assess Chelation Therapy (TACT) (italics added):

The authors found that those receiving the active treatment clearly fared better than those receiving placebo. The accompanying editorial in the AHJ reminds readers about the value of equipoise and the need to “test our beliefs against evidence.”

Most physicians did not expect benefit from chelation treatment for cardiovascular disease. I readily admit, initially, I also did not expect we would find evidence that these treatments reduce heart attack, strokes, or death. So, the evidence of benefit coming from analyses of the TACT trial has been a surprise to many of us. The subgroup analyses are suggesting sizable benefit for diabetic patients—and also, importantly, no benefit for the non-diabetic patient. Clearly subgroup analyses, even if prespecified, do not give us the final answer. But it is also clear that more research is needed to test these important findings.

And TACT findings are indeed a reminder of the importance of retaining equipoise [sic], seeking further research aimed at replicating the findings, and neither accepting nor rejecting findings based on personal biases. The scientific process is designed to weed out our preconceived notions and replace them with evidence.

Dr. Briggs concluded:

So, TACT is a reminder—an open mind is at the center of the scientific method.

Dr. Briggs’s title was “Bayes’ Rule and Being Ready To Change Our Minds”, a reference to a recent editorial that had accompanied one of the TACT papers. That editorial, by Dr. Sanjay Kaul, a physician and statistician from UCLA, begins with this quotation:

Preconceived notions are the locks on the door to wisdom.
~ Merry Browne

Here is the relevant passage from Dr. Kaul’s editorial (italics added):

Sixth, it has been argued that the trial was unethical because there was no compelling clinical or preclinical evidence that chelation therapy has significant efficacy against atherosclerotic cardiovascular disease, and given that chelation therapy can cause harm, the risk was not minimal. A Bayesian analysis would not look kindly on the results because of the low prior probability of treatment effect (the so-called implausibility argument).6 This is an uncharitable (and unwarranted) interpretation of the data because previous systematic reviews concluded, “insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes among people with atherosclerotic cardiovascular disease.” It is axiomatic that absence of evidence of efficacy is not the same as evidence of the absence of efficacy.

From a Bayesian perspective, the strength of evidence is often summarized using a Bayes factor, which is a measure of how well 2 competing hypotheses (the null and the alternate) predict the data. The Bayes factor and the corresponding strength of evidence for the primary end point result in TACT overall, and diabetic cohorts are shown in Table 1. The p-value of 0.035 for TACT overall cohort translates into a Bayes factor of 0.108, which means the evidence supports the null hypothesis ≈1/9th as strongly as it does the alternative. This reduces the null probability from 50% pretrial (justified by suspension of one’s belief in treatment effect) to 10% post-trial. Although this does not represent strong evidence against the null, it does reduce the level of skepticism surrounding chelation therapy. In the diabetic cohort, the nominal p-value of 0.0002 translates into a Bayes factor of 0.002 (1/500), which reduces the extremely skeptical prior null probability of 95% to 4% post- trial, indicating very strong evidence against the null.

In concluding, Dr. Kaul states:

Finally, TACT highlights the double standard when it comes to accepting inconvenient results not aligned with our preconceived notions on so-called dubious quack cures such as chelation…

Closed minds?

Dr. Kaul’s reference “6” above is to a lengthy article that we published in 2008 titled “Why the NIH Trial to Assess Chelation Therapy Should Be Abandoned”. So, it seems, both Drs. Briggs and Kaul were chastising us for our biased, preconceived beliefs about so-called dubious quack cures. Our minds were, apparently, not open. Let’s examine this contention. (more…)

Posted in: Clinical Trials, Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation

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More evidence that routine multivitamin use should be avoided

If scientific evidence guides our health decisions, we will look back at the vitamin craze of the last few decades with disbelief. Indiscriminate use is, in most cases, probably useless and potentially harmful. We are collectively throwing away billions of dollars into supplements, chasing the idea of benefits that have never materialized. Multivitamins are marketed with a veneer of science but that image is a mirage – rigorous testing doesn’t support the health claims. But I don’t think the routine use of vitamins will disappear anytime soon. It’s a skillfully-marketed panacea that about half of us buy into.

Not all vitamin and mineral supplementation is useless. They can be used appropriately, when our decisions are informed by scientific evidence: Folic acid prevents neural tube defects in the developing fetus. Vitamin B12 can reverse anemia. Vitamin D is recommended for breastfeeding babies to prevent deficiency. Vitamin K injections in newborns prevent potentially catastrophic bleeding events. But the most common reason for taking vitamins isn’t a clear need, but rather our desire to “improve overall health”. It’s deemed “primary prevention” – the belief that we’re just filling in the gaps in our diet. Others may believe that if vitamins are good, then more vitamins must be better. And there is no debate that we need dietary vitamins to live. The case for indiscriminate supplementation, however, has never been established. We’ve been led to believe, through very effective marketing, that taking vitamins is beneficial to our overall health – even if our health status is reasonably good. So if supplements truly provide real benefits, then we should be able to verify this claim by studying health effects in populations of people that consume vitamins for years at a time. Those studies have been done. Different endpoints, different study populations, and different combinations of vitamins. The evidence is clear. Routine multivitamin supplementation doesn’t offer any meaningful health benefits. The parrot is dead. (more…)

Posted in: Herbs & Supplements, Science and Medicine

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New Cholesterol Guidelines

On November 15, the American College of Cardiology and the American Heart Association released an updated guideline for the use of statins to prevent and treat atherosclerotic cardiovascular disease (ASCVD). The full report is available online. It has already generated a lot of controversy. The news media have characterized it as a “huge departure” from previous practice and have trumpeted that it will lead doctors to prescribe statins to millions more people. As usual, the truth is much more nuanced. There are some problems with the guidelines, but on the whole they represent an improved, more rational approach to prescribing statins.

Statins have always been a source of controversy: people seem to either love them or hate them, and discussions about them generate a lot of emotion. The International Network of Cholesterol Skeptics denies that cholesterol has anything to do with cardiovascular disease. An article on HuffPo calls statins “an unsafe, unnecessary product that will now be recommended to healthy people to make them sicker.” Mercola says they can actually make heart disease worse and cause premature aging, and no one should take them unless they have the genetic defect of familial hypercholesterolemia. A website collects patient self-reports of adverse effects; but like the vaccine reports on VAERS, these are only anecdotal reports of correlation, not evidence for causation.

At one time the evidence only supported using statins for secondary prevention and for men. We now have better evidence showing that they are effective for both primary and secondary prevention in patients of both sexes and all ages, and that they are more effective for those with higher risk factors. (more…)

Posted in: Pharmaceuticals

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Do vitamins prevent cancer and heart disease?

It is a triumph of marketing over evidence that millions take supplements every day. There is no question we need vitamins in our diet to live. But do we need vitamin supplements? It’s not so clear. There is evidence that our diets, even in developed countries, can be deficient in some micronutrients. But there’s also a lack of evidence to demonstrate that routine supplementation is beneficial. And there’s no convincing evidence that supplementing vitamins in the absence of deficiency is beneficial. Studies of supplements suggest that most vitamins are useless at best and harmful at worst. Yet the sales of vitamins seem completely immune to negative publicity. One negative clinical trial can kill a drug, but vitamins retain an aura of wellness, even as the evidence accumulates that they may not offer any meaningful health benefits. So why do so many buy supplements? As I’ve said before, vitamins are magic. Or more accurately, we believe this to be the case.

There can be many reasons for taking vitamins but one of the most popular I hear is “insurance” which is effectively primary prevention – taking a supplement in the absence of a confirmed deficiency or medical need with the belief we’re better off for taking it. A survey backs this up – 48% reported “to improve overall health” as the primary reason for taking vitamins. Yes, there is some vitamin and supplement use that is appropriate and science-based: Vitamin D deficiencies can occur, particularly in northern climates. Folic acid supplements during pregnancy can reduce the risk of neural tube defects. Vitamin B12 supplementation is often justified in the elderly. But what about in the absence of any clear medical need? (more…)

Posted in: Herbs & Supplements, Nutrition, Science and Medicine

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What Can We Learn from the Kitavans?

A Swedish researcher, Staffan Lindeberg, has been studying the inhabitants of Kitava, one of the Trobriand Islands of Papua New Guinea. He claims that sudden cardiac death, stroke, and exertion-related chest pain never occur in Kitava; and he attributes this to their eating a Paleolithic diet.

2,250 people live on Kitava. They are traditional farmers. Their dietary staples are tubers (yam, sweet potato and taro), fruit, fish, and coconut. They don’t use dairy products, alcohol, coffee, or tea. Their intake of oils, margarine, cereals, and sugar is negligible. Western foods constitute less than 1% of their diet. Their activity level is only slightly higher than in Western populations. 80% of them smoke daily and an unspecified number of them chew betel. The macronutrient composition of the Kitavan diet was estimated as 21% of total calories from fat, 17% from saturated fat, 10% from protein, and 69% from carbohydrates.

Lindeberg’s Kitava study examined a sample of 220 Kitavans aged 14-87 and compared them to healthy Swedish populations. They found substantially lower diastolic blood pressure, body mass index, and triceps skinfold thickness in the Kitavans. Systolic blood pressure was lower in Kitava than in Sweden for men over 20 and women over 60. Total cholesterol, LDL cholesterol, and apolipoprotein B were lower in men over 40 and in women over 60. Triglycerides were higher in Kitavans aged 20-39 than in Swedes of the same age. HDL was not significantly different. (more…)

Posted in: Nutrition

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The deceptive rebranding of aspects of science-based medicine as “alternative” by naturopaths continues apace

That naturopathy is a veritable cornucopia of quackery mixed with the odd sensible, science-based suggestion here and there is not in doubt, at least not to supporters of science-based medicine (SBM). However, what naturopaths are very good at doing is representing their pseudoscience as somehow being scientific and thus on par with conventional SBM. So how do they accomplish this? Certainly, it’s not through the validation of any of the cornucopia of pseudoscience and quackery that naturopaths apply to their patients as though picking “one from column A and one from column B” from a proverbial Chinese menu of woo. Naturopaths’ favored modalities include homeopathy (which remains to this day an integral part of naturopathy that all naturopaths are taught), acupuncture and traditional Chinese medicine (TCM), “detoxification” practices (a key precept of a lot of naturopathy) such as juicing, enemas, and chelation therapy, and the various other quack modalities that make up the practice of naturopathy. Treatments like these (especially homeopathy, whose precepts would require a massive rewriting of the laws of physics and chemistry for it to work) have not been and almost certainly cannot ever be scientifically validated with an evidence base of the quality and quantity supporting SBM.

So, instead naturopaths play a very clever game. In all fairness, naturopaths are not the only practitioners of so-called “complementary and alternative medicine” (CAM) or “integrative medicine” who play this game, but from my observations they appear to be the most talented at it. Their skill at obfuscating the line between SBM and naturopathy is evidenced by the success they have had in state legislatures in expanding their scope of practice, most recently in Colorado, where, if there is not a groundswell of support urging the Governor to veto SB-215 (or, as Jann Bellamy aptly called it, the quack full employment act), consumer protections against quackery in Colorado will be laid waste. At the same time, there is a naturopath licensing act (HB-1111) sitting on the Governor’s desk as well that would license naturopaths and give them the path to mandatory reimbursement from insurance companies. Instructions to write to the Governor opposing both bills can be found here and here; they would be disastrous for efforts to keep full vaccination in Colorado. A direct link to write the Governor can be found here.

Posted in: Clinical Trials, Homeopathy, Naturopathy, Nutrition, Science and the Media

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AAFP CME Program Succumbs to “Integrative Medicine”

For many years I have been using Continuing Medical Education (CME) programs offered by the American Academy of Family Physicians (AAFP). The FP Essentials program consists of a monthly monograph with a post-test that can be submitted electronically for 5 hours of CME credit. Over a 9-year cycle, a complete family medicine curriculum is covered to prepare participants for the re-certification board exams. Some examples of typical subjects are skin cancer, hand and wrist injuries, valvular heart disease, and care of the newborn. I rely on these programs to learn, review, and keep up-to-date in my specialty. Imagine my dismay when I opened the latest package to find a monograph on Integrative Medicine.

First it was called various names like folk medicine, quackery, and unproven/untested treatments, then all of those (the less rational right along with the more rational) were lumped together under the umbrella term “Alternative Medicine,” then it became “Complementary and Alternative Medicine” (CAM), and now it has been re-branded as “Integrative Medicine.” The term is designed to make unscientific treatments seem more acceptable to science-based doctors. “Integrative Medicine” is a marketing term, not a meaningful scientific category. It is a euphemism for combining Complementary and Alternative Medicine (CAM) with mainstream medical practice, unproven with proven, magic with science.  It has been critiqued many times on this blog. We have stressed that there is only one medicine, and that when a treatment is proven to work by good evidence, it is just “medicine.” When the evidence for a CAM treatment is not good, it essentially amounts to experimental treatments and/or comfort measures. Worse, sometimes CAM even persists in using treatments that have been proven not to work or that are totally implausible, like therapeutic touch or homeopathy. (more…)

Posted in: Acupuncture, Cancer, Energy Medicine, Medical Academia

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