Low Dose Statin More Effective at Lowering Cholesterol Than Advertised OTC Supplements

At the Scientific Session of the American Heart Association, researchers presented the SPORT study (Supplement, Placebo or Rosuvastatin Clinical Trial). The study compared .5 mg of Rosuvastatin (Crestor) to multiple over the counter products advertised to lower cholesterol without the ill effects of a statin.

The products included:

  1. Placebo
  2. Fish Oil( Nature Made Fish Oil 240 mg)
  3. Cinnamon ( Nutriflair 2400 mg)
  4. Garlic ( Garlique 5000 mcg Allison)
  5. Turmeric ( BioSchwarrtz Brand 4500 mcg)
  6. Red Yeast Rice ( Amazon 2400 mg)
  7. Plant Sterols ( Nature Made Cholestoff Plus 1600 mcg plant sterols)

Nineteen-hundred adults aged 40-75 years, with no history of cardiovascular disease, were randomized to receive one of the products for 28 days. These individuals had pre-study LDL cholesterols between 70 – 189 and a 5-20% risk of developing atherosclerotic disease within 10 years.

The results showed that Rosuvastatin decreased LDL cholesterol by 37% with the supplements having no more effect than the placebo. Rosuvastatin also reduced total cholesterol by 24% and Triglycerides by 19%. LDL is the adverse cholesterol. It’s helpful to remember the phonic, L stands for “lousy”.

Plant Sterols lowered protective HDL cholesterol and garlic increased the LDL cholesterol when compared to placebo.

This study indicated OTC (over the counter) products just do not work to effectively lower cholesterol and protect against heart attack or stroke. Vitamins, minerals, herbs and supplements are treated as foods in the USA and are not inspected to ensure that what is on the label is in the bottle. Also, there is no assurance that there are no contaminants such as lead, arsenic or mercury in these OTC products.

Some will say that the length of the study was too short for the supplements to show their effectiveness. That may be a valid criticism, but it plays into the anti-science attitude being promoted which encourages sales and marketing of products over scientific testing and results.

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Tidbits with Tropical Storm/Hurricane Nicole Rolling In

November tropical weather systems, either storms or hurricanes, are a rarity for south Floridians including this grizzled veteran who has spent 45 years in this area.

My office has been in the same location since 2003 but this is at least the third ownership group (landlord) we have worked with. The building and grounds are well maintained. For reasons unclear to me, when NOAA issued a hurricane warning for Boca Raton yesterday at 2 p.m., the building management insisted we vacate the building by 4 p.m. so they could prepare for the storm. I have gone through multiple hurricanes as a tenant in this building, so I know just how long it takes to prepare the building for a storm. There are no shutters to install. There is no impact glass in the office building. The storm was not projected to arrive until sometime the next day.

Nonetheless we rescheduled our last patients, sent some home early and sent our wonderful staff home at 3:45 to comply. The storm still has not fully arrived and, thankfully when it does, it will not bring hurricane force winds or tornados to the area. I now have all this extra time on my hands to catch up on reading journal articles. None of the topics truly warranted a full blog so I thought I would give you a quick smorgasbord synopsis.

  1. A small study suggested that if you perform physical exercise 30-60 minutes prior to your flu shot or COVID-19 booster shot you get an enhanced immune system response.
  2. Drinking 2-5 cups a day of coffee probably reduces cardiac arrhythmia, cardiac events and cerebrovascular events. Ground coffee with caffeine seems more effective than decaf and instant coffee.
  3. The new guidelines for vaccinating adults against community acquired pneumonia are about as clear as mud. If you turned 65 and received Prevnar 13 followed a year later by Pneumovax 23 you are probably complete. If you only received Prevnar 13 please go to your pharmacy and get a PCV 20 vaccine to complete the series. There was much disagreement on giving boosters to seniors five years after completing the vaccine series. If this confuses you all well then welcome to the club.
  4. Screening for colorectal cancer with an office based flexible sigmoidoscopy saves lives. Screening with a traditional colonoscopy is even better at getting a look at the left and right colon. Any controversy created by a recent colorectal cancer study needs to be ignored. If you are 45 you need a screening colonoscopy. If your study is normal, then you will be retested in 7-10 years. In the future, tests such as Cologuard and fecal immune globulin may permit other safe means of evaluation and screening in low-risk patients.
  5. There are some new and safe treatments for acute migraine headaches and prevention of migraine headaches. These include injectable monoclonal antibodies and receptor site inhibitors. Avoiding triggers of these headaches. Tylenol, non-steroidal anti-inflammatory drugs and triptans remain the main options for treating migraines but new and better therapies are now available.
  6. Bebtelovimab, the monoclonal antibody infused to prevent COVID-19 from progressing to severe disease requiring hospitalization may not cover some of the newer Omicron variants. It is currently still recommended by the CDC in all 50 states and is the product administered at our local hospital. That may change in the next few weeks.

Hope you enjoyed this poo-poo platter of medical knowledge. Call me if you have any questions.

Recent Findings on Vitamin D and What It All Means

JoAnn Manson, MD is a professor of medicine and epidemiology at the Harvard Medical School and Brigham and Women’s Hospital where she directed the Vitamin D and Omega 3 trial known as VITAL. She was interviewed about the pros and cons of vitamin D supplementation and what is science and fact.

The VITAL study is one of the first large, randomized studies to study vitamin D and its effect on health. Dr. Manson points out that previous observational studies which cannot prove cause and effect directly led to the belief that vitamin D is a panacea and cure all for many chronic conditions such as cancer, cardiovascular disease, diabetes, bone fractures, cognitive decline, and depression. She said that the randomized studies do not support this conclusion, but she feels vitamin D remains essential to good health. It is so essential that she says we need exceedingly small doses to achieve the health outcomes we desire.

Most of it can be obtained in your diet (read labels) and by exposing yourself to sunshine a few minutes each day. Therefore, the National Academy of Medicine and US Preventive Services Task Force and many other professional organizations have advised against widespread screening for vitamin D deficiency and blanket supplementation.

Her VITAL study did not show a reduction in major health issues with supplementation of vitamin D except in two instances. Vitamin D Supplementation resulted in a 22% reduction in autoimmune diseases (Rheumatoid Arthritis and Psoriasis) and a 17% in advanced metastatic cancers at doses of 400- 800 IUs daily. In the VITAL study they used 2000 IU daily. They believe the vitamin D reduced the inflammatory process and damage.

Some scientists have hypothesized that vitamin D supplementation can reduce the severity of COVID-19 infections. That randomized study called VIVID (vitamin D for Covid Trials) is near completion using 3000 IU per day. The data should be available in the next few weeks.

When asked what Dr. Manson suggests for her own clinical patients, she admitted she suggests ingesting one thousand – 2000 IU per day hopefully getting most of it in her diet. That dosage has been shown to be safe during the VITAL trial. She went on to note vitamin D is found in fresh fatty fish and wild mushrooms. Most cereals, dairy products and some beverages are fortified with vitamin D.

Diet Had No Effect on Dementia Risk

Isabelle Glans, MD, of Lund University in Sweden and colleagues published an article in the online edition of Neurology looking at the relationship of one’s diet to the risk of developing dementia. The study included over 28,000 Swedish adults who were free of dementia upon entering the study and followed for twenty-years. Sixty one percent of the patients were women with a mean age of 58 years. The participants where part of an ongoing study called the Swedish Malmo Diet and Cancer Study.

One group of participants followed a traditional Mediterranean diet while the others followed what they thought was a healthy diet. Nearly 7% of the participants developed dementia over the next twenty years. There was no difference in the risk of developing dementia in either dietary program. Of interest is the fact that those who developed dementia were older, less educated and had more cardiovascular risk factors at the time they entered the study.

In an accompanying commentary, the study authors noted that diet alone is not a determinant of developing dementia but is probably one risk factor among many involved. They cited the need for regular exercise, control of vascular risk factors such as smoking, blood pressure control, lipid control and alcohol consumption.

Treating Sepsis & the Role of Vitamin C in Patient Outcomes

Vitamin C and its relationship to the immune system and infection have been the subject of studies for years. In the past I have written about the protective effects of Vitamin C exhibited in Scandinavian winter athletes and military troops who took a supplement daily. They developed fewer “colds” of a less severe nature than the control group who did not. Surprisingly, if Vitamin C was added once a participant showed symptoms of a cold or viral infection it did not have the same protective benefits.

The relationship between Vitamin C and severe infection came up again discussed in an abstract presented at the American Thoracic Society 2022 International Conference held this past May. Researchers looked at whether its addition to patients being treated for sepsis would be beneficial.

The researchers conducted a systemic review of PubMed, Embase and Central Cochran’s Registry and found 21 studies in which Vitamin C was introduced to patients with sepsis. They found that when Vitamin C was added to the treatment of sepsis, either orally or intravenously, there was a significant reduction in mortality and less need for interventions such as intubation and mechanical ventilation, use of vasopressors to support blood pressure. The theory is that Vitamin C may reduce pro-inflammatory bio markers in severe sepsis and normalize physiologic function which in other cases might have led to an exaggerated immune response and the destruction of multiple organ systems.

Vitamin C is plentiful in fruits and fairly inexpensive when purchasing as a supplement. Starting your day with an orange or a grapefruit just might be preventing infection down the road.

Misleading News on Colonoscopy for Colon Cancer Screening

I rarely take issue with research which is peer reviewed and published in prestigious medical journals but a study published in the New England Journal of Medicine regarding screening for colon cancer created more havoc and uncertainty about the worthiness of screening with a colonoscopy than is appropriate.

Michael Bretthaur, MD, PhD of the University of Oslo in Norway invited almost 85,000 adults aged 55-64 in Europe to participate in a screening colonoscopy or serve in a control group with no screening. Only 42% of those invited took the colonoscopy. Based on the large numbers in the study, the conclusion was that the procedure did little to reduce death from colon cancer over a 10-year period. This conclusion was noted by the international media and played up with the idea that maybe screening colonoscopy isn’t such a great tool? NBC and CBS nightly news covered it that way. CNN actually led with a misleading headline about it.

If you actually looked at just the data of those who had the procedure, it appears that colonoscopy reduced the incidence of colon cancer by 31 % and the risk of colon cancer related death by 50%. The message should have been “If you were screened with colonoscopy your chances of dying from colon cancer were reduced by at least 50%.”

There were problems with the study. The health care providers doing the colonoscopy were not as accomplished at finding polyps as the physicians who perform the study in the USA. The 10-year follow-up period of who developed colorectal cancer is considered too short a window for this particular disease which probably requires a 15-year observation window. The research team conducting the study will now be following the participants for another five years to correct this flaw. The numbers and conclusions are expected to change with the additional five years of data.

No sane person wants to prep for a colonoscopy and have the procedure. However. it is one of life’s necessary prevention evaluations. The media’s presentation of this study added great doubt to its efficacy. People will undoubtedly skip colonoscopy screening due to the way newspapers and TV news shows covered this study.

Colonoscopies save lives and by removing precancerous polyps with malignant potential save suffering too. I just had my colonoscopy. I hated every minute of the prep. The bowel cleansing preparation continued to upset my system for twelve hours post procedure. That said, it was worth every second of feeling uncomfortable to prevent a miserable disease.

Artificial Sweeteners & Cardiovascular Risk Increase

Mathilde Touvier, MD, and colleagues of the Sorbonne Paris Nord University published an observational study in the British Medical Journal online edition showing a link between consumption of artificial sweeteners and cardiovascular disease. Their study looked at total daily consumption of artificially sweetened drinks and consumption from foods as well as sweetener added from packets to food or beverages.

The study included over 103,000 French adults who were followed for an average of nine years.  The participants consumed on average the equivalent of 100 ml of diet soda or one individual packet of tabletop sweetener (42.46 mg/day). These individuals had a 9% increased risk of a heart attack, stroke, need for a cardiac catheterization and angioplasty or transient ischemic attack compared to those who did not use artificial sweeteners.

The researchers could not find a “safe daily dosage” below which the sweeteners did not increase risk. They did note that the higher the consumption of artificial sweetener the higher the risk of a cardiovascular event.  Aspartame intake was associated with an increased risk of cerebrovascular events while acesulfame potassium and sucralose increased the risk of a coronary event. It is felt that these sweeteners influence insulin sensitivity ultimately resulting in increased risk for a disease event.

A synopsis of the study was published in the online journal MDedge Internal Medicine.  This article included an opinion by researchers who published studies supported by the artificial sweeteners industry which dispute the methods and conclusions of Dr Touvier’s study.

Until the answers are resolved, it appears avoiding artificial sweeteners is as good an idea as avoiding too much sugar. I prefer limiting sugars at 16 calories per teaspoon compared to risking the potential ill effects of artificial sweeteners.

Will A Multivitamin a Day Keep Dementia Away?

Laura Baker, PhD, and associates of Wake Forest University reported in the journal Alzheimer’s & Dementia that taking a Centrum multivitamin daily seemed to improve cognitive function in senior citizens. The COSMOS-Mind study included 2262 participants with a mean age of 73 years. Sixty percent were women, almost 90% were Caucasian and none had a history of heart attack or stroke. The study looked at the effects of chocolate in the form of cocoa extract or a multivitamin on memory and cognitive function. The patients were followed for three years.

Daily multivitamin supplementation led to improvement in both memory and executive function. The effect was most pronounced in participants with cardiovascular disease. The researchers’ predictive formulas or “modeling” suggested that three years of multivitamin supplementation might slow cognitive aging by 60% or 1.8 years. In previous studies performed on older male physicians, this type of supplement did not reveal any cognitive benefits. In the Women’s Health Initiative this type of benefit did show some protection against certain malignant diseases, but no evaluation of cognitive function was performed.

The Alzheimer’s Association was encouraged by the findings but called for further randomized studies before they felt comfortable recommending a daily multivitamin. As a practicing physician, I see no downside to taking a Centrum multivitamin as long as patients read the label and make sure they are not taking any other fat-soluble vitamins (A, E, D, K) which can accumulate and, in large doses, cause toxicity.

I ask my patients to bring their vitamins and supplements to the office to read the labels or show me a photo of the labels if they feel uncomfortable performing this review themselves.

The Flu Shot Lowers Stroke Risk. It’s Time to Schedule Yours.

Fall is just around the corner and its time to start scheduling your flu shot. This season we have the high dose quadrivalent vaccine for people 65 years of age or older and the Quadrivalent for those younger than 65 years of age. The vaccine takes about two weeks to provide full immunity and will reduce your chance of catching the illness.  Most importantly, it will prevent serious illness requiring hospitalization and or death. Last year influenza caused almost 45,000 deaths in the USA.

The vaccine is being given in our office. My patients should call 561.368.0191 to schedule the flu shot. You can take this vaccine at the same time as the new Omicron specific booster and near that vaccine which is being given at local pharmacies including CVS and Walgreens.

The journal Neurology published a peer reviewed article that examined whether getting a flu shot provided any additional protection beyond preventing the flu  The study, led by Francisco Jose de Abajo, MD, MPH, PhD of the University of Alcala in Madrid Spain, showed that the flu vaccine reduced the risk of stroke by 12% in those who had risk factors for cerebrovascular or cardiovascular disease. The study noted the protection began within two weeks of receiving the vaccine for both patients with cerebrovascular risk factors regardless of age.

Another study published several weeks ago noted that the risk of dementia was diminished in those patients receiving the flu shot as well.

Flu season is here. Please call the office and schedule your vaccine.

Bisphosphonates, Prolia & Forteo in Osteoporosis Treatment

When I started practicing clinical medicine in South Florida there were few if any treatments for osteoporosis. We saw the devastating effects of this condition in lean post-menopausal women in their seventies and eighties – especially those who had multiple pregnancies and smoked. In men we were more likely to see it in male smokers taking corticosteroids for an inflammatory disease.

Spontaneous collapse of their vertebrae leading to nerve compressions, brutal unrelenting pain and at times neuromuscular injuries preventing walking were common. If we measured height, we saw a decrease in height over time before these catastrophic spinal injuries occurred. We also saw a plethora of spontaneous hip fractures which occurred causing a fall with trauma. In most cases, both presentations resulted in major and extensive surgery and rehabilitation before a patient resumed their life. The only medications we had at the time for women were estrogen and progesterone which carried their own list of potential adverse effects.

The introduction of oral bisphosphonates changed that. Medications like Fosamax, Actonel, Boniva slowed down the process and, with weight bearing exercise, smoking cessation, appropriate nutrition, and luck, reversed it. These medications in pill form were tough to take and still are. They are large, poorly absorbable and require you to take them on an empty stomach while upright. Most instructions call for drinking eight ounces of water with the pill followed by another eight ounces of water after the pill then staying upright for 30-60 minutes. These pills are extremely corrosive if they get caught in your esophagus because you didn’t swallow them with water. They can upset the gastric lining of your stomach as well.

Bone Densitometry tests allowed physicians to detect and then follow serially over years the thickness of your bones. I believe due to the size of the pills and the gastrointestinal problems they can cause convincing patients to try these medications has always been a difficult prospect. Fortunately, much of the responsibility falls on the gynecologists who look for osteoporosis and osteopenia as part of their evaluation of perimenopausal women routinely.

For those individuals unable to tolerate these oral medications, or unwilling to try, rheumatologists have injectables to help the bones. Prolia (denosumab) an injectable given every six months, and Forteo, (teriparatide) a daily injectable, were developed. They too can produce side effects including back and bone pain and a host of others. The good news is they work.

In a recent study of 50,862 women published in the journal Therapeutic Advances in Musculoskeletal Diseases researchers from the University of Verona, Italy led by Giovanni Adami, found that the oral medications can reduce the risk of fracture by 30% while monthly Prolia did so by 60% and daily Forteo by 90%. The significant difference was the fact that the oral agents required one year of use before the risk of a spontaneous fracture occurred while the injectables achieved success much sooner. While rheumatologists and gynecologists surmised this was occurring, this study provides solid evidence to back up their hunches.