The FDA Approves Wegovy for Heart Disease

As a primary care concierge service committed to providing our patients with the latest and most effective healthcare solutions, we are thrilled to discuss a groundbreaking development in the realm of cardiovascular health. The U.S. Food and Drug Administration (FDA) has recently approved Wegovy, a medication initially designed for weight loss, as a preventative treatment for heart disease in specific patient populations. This approval marks a significant milestone in the battle against cardiovascular diseases and opens new doors for patient care in our practice.

Wegovy, an injectable semaglutide, has already made a name for itself in the weight loss domain. Its efficacy for certain patients in reducing weight is well recognized. However, its latest approval stems from its capability to diminish the risk of cardiovascular death, heart attacks, and strokes in adults who have cardiovascular disease and are either overweight or obese. As articulated by John Sharretts, M.D., the director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA, this patient demographic faces an elevated risk of severe cardiovascular events. The introduction of Wegovy as a treatment option that can mitigate this risk is indeed a monumental stride in enhancing public health.

The approval of Wegovy for cardiovascular disease prevention is grounded in robust scientific evidence. A substantial, randomized, double-blind trial involving 17,600 participants evaluated the efficacy of Wegovy in conjunction with standard care, including blood pressure and cholesterol management and lifestyle counseling. The results were compelling; the group using Wegovy exhibited a significant reduction in life-threatening cardiovascular incidents.

At our concierge medical practice, we understand the significance of this development, especially for patients struggling with heart disease alongside being overweight or obese. Brooke Boyarsky Pratt, the CEO of Knownwell, highlighted this approval as an “exciting day” for such patients and their healthcare providers, emphasizing the critical role of GLP-1 receptor agonists in managing chronic conditions beyond diabetes and obesity.

The endorsement of Wegovy also addresses the prevailing bias and stigma associated with medications for weight management, underscoring their potential to address severe health risks. Dr. Darren McGuire from UT Southwestern lauded the FDA’s decision as pivotal, noting that semaglutide is now the first U.S.-approved medication promising more than just cardiovascular safety for individuals living with obesity.

Looking forward, we anticipate more innovations in this therapeutic area, as Dr. McGuire predicts an influx of similar medications. For our patients, this development signifies an expanded arsenal against cardiovascular diseases, offering new hope and treatment possibilities.

As always, we are here to guide our patients through these new treatment options, evaluating the benefits and potential side effects to tailor the best possible care plans. If you or a loved one could benefit from Wegovy or have concerns about cardiovascular risks, we encourage you to reach out to us. Together, we can navigate these new advancements and continue our mission of providing exceptional, personalized healthcare.

For those interested in further discussions or consultations regarding Wegovy or other cardiovascular prevention strategies, please feel free to contact our office. Your health and well-being remain our utmost priority, and we are committed to keeping you informed and cared for with the latest medical advancements.

Weight Loss Drugs: What You Need to Know About New Findings on Severe Stomach Problems

Many patients turn to medication as a potential solution in the quest for weight loss solutions. Among the popular choices are drugs like Wegovy, Ozempic, and Rybelsus. While their effectiveness in weight loss and diabetes management is well-known, a recent study from the University of British Columbia has shed light on potential severe gastrointestinal side effects.

Here’s what you should know.

1. A Brief Overview of GLP-1 Agonist Weightloss Drugs:

These drugs mimic the action of a gut hormone activated after eating, enhancing insulin release, suppressing sugar production in the liver, and reducing appetite. They have been widely prescribed for diabetes management, but their use for weight loss in non-diabetic patients has grown significantly.

2. Previous Concerns with Digestive Issues:

Past research indicated some risk of digestive problems for diabetes patients using these medications. However, this new study provides the first large-scale insight into these effects on non-diabetic patients using them solely for weight loss.

3. The New Findings:

  • 9.09 times increased risk of pancreatitis.
  • 4.22 times increased risk of bowel obstruction.
  • 3.67 times higher risk of gastroparesis.

While an increase in biliary disease was observed, it wasn’t statistically significant.

4. The Implications:

The sheer number of individuals using these drugs worldwide means that, even if these side effects are rare, hundreds of thousands might still experience these conditions. Understanding the risks becomes vital, especially for those who might be using the medications for general weight loss rather than for diabetes or obesity.

5. The Call to Action:

Researchers hope that pharmaceutical companies and regulatory bodies, such as the U.S. Food and Drug Administration, will include the risk of gastroparesis on warning labels.

Conclusion:

Drugs can be a powerful tool in the journey towards better health and weight loss. However, as with all medical interventions, being informed is crucial. The potential side effects, while rare, can be severe. Patients must weigh the benefits against the risks and make an informed decision.

“Knowing the potential side effects is critical. It empowers patients to seek medical attention promptly and prevent further complications,” says Sodhi, emphasizing the importance of this new research. As always, consulting with your healthcare provider is recommended before starting or stopping any medication.

Surviving Spring Allergies Without Gaining Weight

With the fresh air of the ocean and year-round warmth, you might be surprised to find that Florida is one of the top hot spots in the country for spring allergies. You might also be surprised to learn that some of the over-the-counter (OTC) allergy medications you automatically reach for to stop the resulting sneezing and sniffling can cause you to gain weight.

So our concierge primary care doctors in Jupiter want to tell you the differences between the various types of antihistamines and suggest other ways of battling spring allergies.

‘Pollen Storm’

As NBC News reported last month, a growing number of adults in their 30s, 40s, and 50s who’ve never had allergies before are experiencing them now.

“What I see is people coming in for the first time, especially over the last five, seven years or so,” Dr. Clifford Bassett, an allergist at NYU Langone Health in New York City, told NBC.

“They will always say, ‘I don’t understand how this is happening to me,’ ” he added.

The culprit appears to be climate change, the network reported. As CO2 levels rise, plants and trees produce more pollen, coupled with earlier spring blooms from trees. This is driving a longer season, with more severe reactions from sufferers.

“The pollen season right now is about three weeks longer than it was 30 years ago, and there’s about 20 percent more pollen in the air,” Dr. Neelu Tummala, an ear, nose, and throat specialist and co-director of the Climate Health Institute at George Washington University, told the network.

Dr. Stanley Fineman, an allergist at Atlanta Allergy and Asthma and a spokesperson for the American College of Allergy, Asthma & Immunology, calls the phenomenon a “pollen storm.”

“The pollen counts, particularly this season, have been much, much higher than we’ve seen in the past,” he told NBC.

COVID, Cold, or Allergies?

And since the dawn of the SARS-CoV-2 pandemic, now people are wondering whether their stuffy or runny nose, loss of taste or smell, and itchy, watery eyes are symptoms of COVID-19.

For instance, the loss of the senses of taste and smell can also happen with allergies and colds when the nasal passages become blocked.

In the past, doctors would say that if you’ve never had allergies before, your symptoms are likely something else, such as a cold or other type of virus. But because more people are now experiencing allergies, that’s not necessarily a reliable indicator.

Experts generally agree, however, that fever, chills, and body aches typically indicate viruses, while the telltale symptom of allergies is itching.

“The biggest symptom I would suggest is the itchiness of the eyes, nose, and throat,” Bassett said. “You don’t get itchiness if you have a cold or if you’re having a sinus infection.”

Nevertheless, it’s best to get tested if you’re experiencing new symptoms.

“We’ve definitely had patients come to our clinic who thought they were having allergies, but they had COVID instead,” Dr. Michelle Pham, an allergist, and immunologist at USCF Health in San Francisco, told NBC.

The Risk of Weight Gain

Depending on the severity of your symptoms, there are several ways to treat allergies.  One of these is oral antihistamines.

But a 2010 Yale University Study that found those who regularly took antihistamines weighed more than those who didn’t gave some allergy sufferers pause. The researchers cautioned that it wasn’t clear whether those who were already overweight were more prone to allergies, and thus more likely to take antihistamines.

According to the non-profit Obesity Medicine Association, however, “Histamine decreases our hunger by in part affecting the appetite control center in our brains, and it makes sense [that] an anti-histamine would have the opposite effect. These drugs can interfere with the ‘I’m full’ signal coming from the rest of our bodies and lead to overeating.”

In fact, some antihistamines—particularly cyproheptadine—are prescribed for children and pets to increase appetite.

But not all antihistamines have this effect. The Cleveland Clinic explains that so-called first-generation antihistamines were approved in the 1930s, but had more serious side effects, including drowsiness, dry mouth, and rapid heart rate. The second-generation antihistamines, approved in the 1980s, carry far fewer side effects. They also don’t relieve nasal congestion the way many first-generation antihistamines do.

What To Do Instead

If you want to try to do without antihistamines, first, avoid exposing yourself as much as possible to pollen.

  • Avoid outdoor activity in the early morning when pollen counts are highest.
  • Keep windows closed, in the home and car.
  • Wear a mask, hat, and sunglasses if you need to be outdoors.
  • Use a vacuum equipped with a HEPA filter.

Next, rinse frequently with a saline nasal spray or a neti pot to clean out pollen in your sinuses.

Finally, try switching to second-generation antihistamines. These include:

  • azelastine (Astelin)
  • loratadine (Claritin, Alavert)
  • cetirizine (Zyrtec)
  • desloratadine (Clarinex)
  • fexofenadine (Allegra)

If OTC medications aren’t working, be sure to let us know. There are prescription approaches that may help.

Keep in mind that, even if your allergies have been manageable in the past, with the stepped-up pollen levels accompanying global warming, you may need more intensive therapy.

“Before, you could get away with just using an intranasal steroid,” Tummala told NBC, “and now you have to do a neti pot rinse and then the steroid,” she said.

What to Know About the Newest Migraine Drug

Our primary care concierge doctors in Jupiter have a great deal of sympathy for our patients who suffer from migraines. It can be a debilitating condition and is often difficult to treat. So we welcome any new drug that can help relieve the pain. 

The latest such treatment is a new nasal spray that the U.S. Food and Drug Administration (FDA) approved earlier this month. In a clinical trial, the drug was found to provide relief from migraine pain in as little as 15 minutes.

According to health experts, nearly 40 million Americans suffer from migraines.

“They often interfere with daily functioning, keeping patients away from their work and unable to enjoy time with their loved ones,” neurologist Leah Croll at the Lewis Katz School of Medicine at Temple University, told ABC News.

“The faster we can bring relief to people suffering from a migraine attack, the sooner we can give them back that lost time,” she said.

What is a Migraine?

A migraine is not technically a headache, but a neurological disorder that includes a constellation of symptoms, with a painful, long-lasting headache at the center. Its main symptom is a severe throbbing pain or pulsing sensation in the head, which feels like a very bad headache, usually on one side of the head, but in a third of migraine attacks, both sides are affected.

It is often—but not always—preceded by what is known as an “aura,” strange tricks of vision that can encompass anything from a blind spot in the vision to flashing or shimmering lights to wavy or zigzagging lines.

Migraines are also usually, but not always, associated with such symptoms as nausea, vomiting, and extreme sensitivity to lights and noises, and can also include a pins-and-needles sensation in the arms and legs or a weakness or numbness on one side of the face or body.

One or two days before the onset of a migraine, patients often experience subtle body signals (called “prodrome”) that can alert them to an upcoming migraine. These changes can include neck stiffness, constipation, increased thirst and urination, food cravings, frequent yawning, and mood swings from depression to euphoria.

It is also possible to have many migraine symptoms, especially the aura, without a headache. The primary signs of a migraine, however, are the extreme incapacitation associated with the headache pain involved.

The Nasal Spray Advantage

According to the National Institute of Neurological Disorders and Stroke, migraines are caused by the activation of nerve fibers in the wall of brain blood vessels. 

Calcitonin gene-related peptide (CGRP) is a chemical messenger in the brain that controls pain and inflammation. The newly approved drug, Zavzpret, works by blocking CGRP’s pain signals, according to its maker Pfizer.

Pfizer says Zavzpret (generic name “zavegepant”) is the “first and only” CGRP nasal spray for treating migraines with or without an aura. A March study published in the journal Lancet found the drug began working to treat symptoms in as little as 15 minutes, offer normal functioning in 30 minutes, and provided some relief for up to 48 hours for 24 percent of migraine sufferers.

The rapid relief Zavzpret provides offers an advantage over existing oral treatments, Dr. Emad Estemalik, a headache specialist at the Cleveland Clinic, told NBC News.

“A lot of patients, when they have migraines, they’re throwing up, for instance, so they may not be able to hold oral medication,” he said. “That’s where an intranasal comes as an advantage.”

Kate Mullin, a board-certified neurologist at the New England Institute for Neurology and Headache who helped conduct the trial for Pfizer, explained to ABC News that at least 60 percent of migraine sufferers also experience nausea, making it difficult to swallow pills.

“You can’t absorb oral medications when you’ve got what’s called gastroparesis of migraine,” she said.

“Your gut pretty much falls asleep and is not in a place to absorb mediations effectively for many migraine sufferers,” she added. “A nasal spray helps bypass the gut altogether to optimize absorption.”

Some Reservations

As with all drugs, of course, there are side effects to Zavzpret.

The FDA listed the following side effects reported by participants during the clinical trial:

  • taste disorders (18 percent)
  • nausea (four percent)
  • nasal discomfort (three percent)
  • vomiting (two percent)

Still, those who treat migraines welcomed the addition of the new drug to the migraine arsenal. 

Elizabeth Kraus, Phar.D., Neurology Clinical Pharmacy Specialist at Corewell Health, told Prevention that while she’s not overly impressed with the 24 percent success rate, Zavzpret may be better for those whose migraines tend to progress rapidly, those who don’t do well with oral medications, and individuals who struggle with severe nausea.

Amit Sachdev, M.D. M.S. medical director in the Department of Neurology at Michigan State University told Prevention that he, too, wasn’t happy with the 24 percent success rate.

“I would like to see a more broad effect, but the current trial results wouldn’t keep me from thinking of this medication [for patients],” he said.

Kraus concurred.

“If I can give someone something that will act fast and have a more lasting effect . . . That’s what I care about,” Kraus said.

The new drug is expected to be released in July of this year.

Zero-Calorie Sweetener Linked to Heart Attacks, Strokes

You may have heard the expression, “There ain’t no such thing as a free lunch.” It means that few things are actually free; there’s often a hidden cost to “freebies.”

Our concierge primary care doctors in Jupiter were reminded of that saying when we heard the results of a new study on the sugar substitute erythritol, popular in keto diets, which suggested it can cause an increase in strokes and heart attacks.

The Study

Researchers from the Cleveland Clinic evaluated more than 4,000 Americans and Europeans who were being evaluated for heart disease. The results, published last month in the journal Nature Medicine, showed that those with the highest blood concentration of the artificial sweetener erythritol were at an increased risk of heart attack or stroke in the following three years.

The researchers examined the subjects’ blood platelets—the type of blood cell that sticks together to form blood clots—and found those with the highest level of erythritol showed increased platelet activity, thereby encouraging the greater formation of clots. Clots in the bloodstream have the potential to cause heart attacks or strokes when they block the normal flow of blood.

The researchers also injected mice with erythritol and found that clots formed more quickly after an injury than those who had been injected with saline.

Finally, they took blood samples from subjects who had consumed an erythritol-sweetened drink and found levels of the sweetener remained high for two days.

“Every way we looked at it, it kept showing the same signal,” Stanley Hazen, a cardiologist at the Cleveland Clinic, who also directs the Cleveland Clinic’s Center for Microbiome and Human Health, told The New York Times.

“People are trying to do something healthy for themselves but inadvertently may be doing harm,” he told the paper.

About Erythritol

Erythritol is a sugar alcohol like xylitol and sorbitol and is found naturally in many fruits, vegetables, and fermented foods. It is also manufactured artificially for use in food products.

It has become more popular than earlier types of artificial sweeteners because it has no lingering aftertaste, doesn’t spike blood sugar, and doesn’t cause the laxative effect common with other such additives.

USA Today reports that it is added to many processed foods and beverages and is commonly found in products aimed at those on the keto diet because it does not affect blood glucose. It is also an ingredient in the sweetener Truvia.

“Erythritol looks like sugar, it tastes like sugar, and you can bake with it,” Hazen told CNN.

“It’s become the sweetheart of the food industry, an extremely popular additive to keto and other low-carb products and foods marketed to people with diabetes,” he added.

The U.S. Food and Drug Administration (FDA) lists erythritol as generally recognized as safe or GRAS. Therefore, it is not required to be listed on a product’s ingredient list, according to Hazen. The label might simply say, “artificially sweetened with natural products,” or “zero sugar.”

Other Research

Robert Rankin, executive director of the Calorie Control Council, an association representing the low- and reduced-calorie food and beverage industry, told USA Today that the people in the study were at higher risk for cardiovascular disease (CVD), so the results shouldn’t be applied to the general population.

“The results of this study are contrary to decades of scientific research showing reduced-calorie sweeteners like erythritol are safe,” he said.

But other studies have raised the question about the safety of erythritol.

For example, Karsten Hiller, a biochemist, and specialist in human metabolism at the Braunschweig Institute of Technology in Germany published a paper in 2017 showing that Cornell University freshmen whose blood contained high levels of erythritol gained more weight than students with low levels, the USA Today reported. Which kind of defeats the purpose of using an artificial sweetener.

“Science needs to take a deeper dive into erythritol and in a hurry, because this substance is widely available right now,” Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health, a hospital in Denver, told CNN. Freeman was not involved in Hazen’s research.

Hazen agreed.

“I normally don’t get up on a pedestal and sound the alarm,” he told CNN.

“But this is something that I think we need to be looking at carefully,” he added.

Eating Healthier

Artificial sweeteners in general have been called into question by numerous studies. For example, a 2020 study by a group of Yale researchers found that those who used the artificial sweetener sucralose (found in the brand names Splenda, Zerocal, and others) can result in high blood sugar levels in the blood. The Washington Post reports that sucralose is found in thousands of consumer-packaged goods such as baked goods, yogurt, canned soups, condiments, and syrups.

Another study at the Weizmann Institute of Science last year looked at what happened to subjects who consumed aspartame, saccharine, stevia, or sucralose in amounts well below the FDA’s daily allowances. The researchers found that these sweeteners caused changes in both the function and composition of the participants’ gut microbiomes, the communities of bacteria, viruses, and fungi that live in the intestines, The Post reported.

There’s no question that artificial sweeteners are hard to avoid these days. And we keep trying to have our sugar without paying the price.

But for the sake of your long-term health, we recommend sticking as closely as possible to fresh, natural, unprocessed foods and beverages.

Could You Have Hidden Thyroid Problems?

Has your sex drive decreased recently? Have you been constipated lately? Do you have brain fog or unusual fatigue? Are you unusually sensitive to heat or cold?

You could have a thyroid problem and not even know it. The World Health Organization (WHO) estimates that 750 million people in the world have some form of thyroid disease, and as many as 60 percent of those are undiagnosed.

Because January is Thyroid Awareness Month, our concierge primary care doctors in Jupiter want to take this opportunity to share some facts you may not know about this critical gland in your body.

About Thyroid Disease

Many people go through their lives feeling “blah” or “not right” or putting up with symptoms they think is just a part of life, when in fact a malfunctioning thyroid is the real issue.

This gland, shaped like a butterfly, is located at the front of the neck, just below the Adam’s apple. It produces a hormone (thyroid stimulating hormone, or TSH) that influences nearly all the metabolic processes in the body. So when something goes wrong, this little gland can produce big problems.

The U.S. Department of Health and Human Services (HHS) reports that women are more likely than men to have thyroid disease. One in eight women will develop thyroid problems during their lifetime. Anyone over age 60, especially women, is at higher risk of developing thyroid disease, along with anyone who has diabetes.

In women, thyroid disease can cause several issues specific to their sex, including problems with the menstrual period, problems with getting pregnant, and problems during pregnancy.

In general, the two main types of thyroid disorders result from either underproduction or overproduction of TSH, and the symptoms of each are generally opposites of each other, although thyroid dysfunction can have hundreds of possible symptoms.

These two main disorders, hyperthyroidism, and hypothyroidism can result from many different causes, and can also be inherited.

Symptoms of Each Type

Hyperthyroidism results from the overproduction of thyroid hormones, thereby speeding up every process in the body. The heart beats faster, food is digested more rapidly, the kidneys process urine more quickly, etc.

Some of the symptoms of hyperthyroidism can include:

-increased perspiration
-insomnia
-increased appetite
-weight loss
-nervousness/anxiety
-irritability
-hand tremors
-muscle weakness, especially in the upper arms or thighs
-hair loss/fine brittle hair
-heart palpitations/irregular heartbeat/racing heart
-sensitivity to heat
-carpal tunnel syndrome
-more frequent bowel movements
-light or less frequent menstrual cycles

Hypothyroidism is the more common type of thyroid disease, in which the thyroid doesn’t release enough thyroid hormone. As you might expect, with this type of thyroid problem every process in the body slows down.

Some of the symptoms of hypothyroidism can include:

-fatigue
-sensitivity to cold, especially cold hands and feet
-constipation and gas
-pain, stiffness, or swelling in joints
-brain fog/memory problems
-weight gain
-irregular or heavy menstrual periods
-hoarseness
-dry skin
-poor appetite
-lowered libido
-puffy/swollen face
-fluid retention/bloating
-thinning hair or hair loss
-muscle weakness
-depression

There can also be other symptoms, and they vary from person to person. Often they are dismissed as stressed, feeling “run down,” or simply aging. So you can see why so many people have undiagnosed thyroid dysfunction.

Simple Treatments

Another type of thyroid issue that frequently has no symptoms is thyroid cancer. According to the American Society of Clinical Oncology (ASCO), thyroid cancer is the most common form of cancer in women between the ages of 20 and 34, and the only symptoms may be difficulty swallowing, or sometimes throat pain accompanied by a persistent cough.

Approximately one percent of Americans are diagnosed with thyroid cancer in their lifetimes, representing about two percent of all cancer cases in the U.S. The good news is that this cancer is highly treatable, even in advanced stages.

And treatment for an over- or underactive thyroid is simple, safe, and effective. This includes anti-thyroid drugs, radioactive iodine, and beta-blockers to help control symptoms.

If you are experiencing any of these symptoms, it’s important that you let us know so you can get treatment. Untreated thyroid disease can damage many organs of the body, including the heart and kidneys.

Keeping it Healthy

Here are some steps you can take to keep your thyroid healthy.

  1. Be sure the salt you use is iodized. Many of the specialty salts do not contain iodine. The thyroid requires iodine to function properly, but the recent popularity of such specialty salts as sea salt and Himalayan salt has reduced the amount of iodine in some diets. Too little iodine can result in hypothyroidism.
  2. Avoid uncooked cruciferous vegetables, including broccoli, cauliflower, cabbage, Brussels sprouts kale, watercress, and kohlrabi. These particular vegetables contain substances called goitrogens that interfere with the efficient synthesis of thyroid hormones. Cooking inactivates these substances, making them safer to eat.
  3. Opt for more seafood in your diet, especially crab, shrimp, lobster, clams, and mussels. All of these are rich sources of iodine.
  4. Avoid processed foods. Although high in sodium, processed and packaged foods do not contain iodized salt.

These guidelines can help maintain the health of your thyroid. But do not try to self-treat a suspected thyroid problem, especially with iodine supplements, which can make symptoms worse.

vit d

Vitamin D: Is It the ‘Cure-All’ Vitamin?

Studies surrounding vitamin D can be conflicting, often leading to confusion on the part of our patients. So our concierge primary care doctors in Jupiter thought we’d take a look at some of the newest findings about this essential vitamin.

Dueling Conclusions

As an example of how different researchers can draw opposite conclusions even from the same study, one doctor recently wrote in The Washington Post that a study she led “found no statistically significant reduction in cardiovascular disease or cancer” in a nationwide randomized trial of 26,000 adults over five years.

Furthermore, she wrote, “My colleagues and I have conducted further studies from VITAL [the study’s title] showing that vitamin D supplements do not decrease the risk of cognitive decline, depression, macular degeneration, atrial fibrillation or several other health conditions. The most recent report showed no reduction in the rate of bone fractures—once the vitamin’s most commonly touted benefit.”

She concluded that the vast majority of Americans are already getting all the vitamin D they need from brief sun exposure and a normal diet.

“Is it necessary for you to spend money on the supplement? For most healthy adults, the answer is no,” JoAnn Manson wrote in The Post.

However, this same researcher told the Harvard Gazette in January of this year that the VITAL study showed subjects who took vitamin D, or vitamin D and omega-3 fatty acids, had a significantly lower rate of autoimmune diseases such as rheumatoid arthritis and psoriasis than those who took a placebo.

“Given the benefits of vitamin D and omega-3s for reducing inflammation, we were particularly in whether they could protect against autoimmune diseases,” she said.

More Confusion

So maybe the vitamin has some value after all, at least for some.

Yet in 2018, another study published in the National Institutes of Health’s (NIH) National Library of Medicine looked at the prevalence of vitamin D deficiency in the U.S. population. In the introduction, the study’s authors wrote that, “Since foods containing natural vitamin D are rare, the primary source of the compound remains . . . exposure to ultraviolet rays in sunlight.”

It went on to assert that “subclinical vitamin D deficiency . . . plays a role in downstream clinical consequences, including cardiovascular disease, cancer, diabetes, osteoporosis, and fractures.”

Why the frequent discrepancy among various studies? One 2020 clinical study published in the journal BMJ sought to answer that question. 

“Our analysis of pooled raw data from each of the 10,933 trial participants allowed us to address the question of why vitamin D ‘worked’ in some trials, but not in others,” Adrian Martineau, a professor at Queen Mary University of London (QMUL) and a lead researcher on the study, wrote in a release.

Those who have the lowest levels of vitamin D in their blood seem to show the largest benefit, he said, along with those who took it daily or weekly, as opposed to intermittently.

The Last Word?

A fact sheet on vitamin D produced by the NIH’s Office of Dietary Supplements (ODS) updated last month summarized numerous studies, including the VITAL study.

For each of the most common health claims connected to vitamin D it reached the following conclusions:

Bone health – All adults should consume recommended amounts of vitamin D and calcium from foods and supplements.

Cancer – Taken together, studies to date do not indicate that vitamin D with or without calcium supplementation reduces the incidence of cancer, but adequate or higher levels might reduce cancer mortality rates.

Cardiovascular disease (CVD) – Overall, clinical trials show that vitamin D supplementation does not reduce CVD risk, even for people with low levels as measured in their blood.

Depression – Overall, clinical trials did not find that vitamin D supplements helped prevent or treat depressive symptoms or mild depression, especially in middle-aged to older adults who were not taking antidepressants.

Type 2 diabetes – Clinical trials provide little support for the benefits of vitamin D supplementation for glucose homeostasis.

Weight loss – Overall, the available research suggests that consuming higher amounts of vitamin D or taking vitamin D supplements does not promote weight loss.

And although the COVID-19 pandemic sparked hope that vitamin D could help prevent or reduce the severity of the illness, two new clinical studies released this month found that it didn’t help with the coronavirus or any other type of respiratory virus.

Vitamin D Overdose?

According to the NIH, the recommended daily allowances for vitamin D are:

  • 0-12 months: 10 mcg (400 IU)
  • 1-70 years: 15 mcg (600 IU)
  • >70 years: 20 mcg (800 IU)

And while many people who supplement with vitamin D take much higher doses than that, too much can be dangerous. Vitamin D is a fat-soluble vitamin, which means it tends to be stored in the body’s fat and can lead to accidental overdoses. 

The upper limit of safety appears to be 100 mcg (4,000 IU) daily.

Those who take more than that could experience side effects from supplementing with vitamin D, including nausea and vomiting, constipation, weakness, and kidney damage, among others.

Overall, most studies seem to show that supplementing with vitamin D doesn’t have much effect on various conditions. On the other hand, moderate doses from a reputable manufacturer are generally considered safe. So if you think you could benefit from vitamin D supplements, the decision is up to you.

is kratom safe

Use Caution with Kratom

Our concierge primary care doctors in Jupiter know that many of our patients are interested in over-the-counter (OTC) alternative treatments for their ailments.

One of the more popular of these is kratom, an herb that has been used for centuries in Asian countries as a way to reduce fatigue and ease various aches and pains. In this country, it is sold in drinks or as supplements and is said to treat such common conditions as anxiety, depression, and opioid withdrawal.

One report estimated that as many as 16 million Americans also use kratom for pain relief in such chronic diseases as lupus, multiple sclerosis, fibromyalgia, rheumatoid arthritis, and other similar conditions.

Testimonials from users include such claims as, “Kratom gave me my life back after being addicted to pain pills;” “It has helped me enormously with chronic back pain;” and, “It got me off a 20-plus-year addiction to narcotics and opioids.”

On the other side are statements like these from a former user who told The Washington Post that “kratom was fun—it was like having morphine and cocaine at the same time”—until he got addicted. Withdrawal, he reported, was like “getting ripped apart by fishhooks.”

Agencies fighting it

Various agencies including the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO), and even the U.S. Drug Enforcement Agency (DEA) have spent the last several years trying to ban it. Six states have already done so, with several others considering it. It is still legal in Florida, but may be banned or controlled in some localities here.

In April, the FDA released a statement warning consumers not to use the herb, Mitragyna speciosa, commonly known as kratom:

“FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence.”

FDA

Opponents have been buoyed in their arguments by several studies linking kratom to serious side effects.

One such study in 2019 reported that the number of phone calls to U.S. poison control centers regarding adverse effects from kratom have soared, from 13 calls in 2011 to 682 in 2017. Reported effects of kratom overdose included rapid heartbeat, agitation, high blood pressure, seizures, coma, kidney failure, and 11 deaths during the study period. Two of those deaths were attributed to kratom alone, while the other nine occurred in people who combined kratom with other drugs.

Another study on kratom use disorder (KUD) by the National Institute on Drug Abuse (NIDA), published in the Journal of Addiction Medicine in March, found that over half of 129 past and current kratom users showed no signs of addiction. But 29.5 percent met the diagnostic criteria for KUD, which includes increased use, tolerance, withdrawal, unsuccessful attempts to quit, and cravings.

Counter-arguments

Proponents attribute these adverse reports to a profit motive on the part of drug companies, overly restrictive U.S. drug policies, and poor research. They say it has been used successfully for thousands of years in Southeast Asia without a problem.

Advocates also maintain that, in these times of widespread and deadly opioid addiction, kratom is an acceptable alternative and that its dangers have been wildly overblown.

In a recent editorial published in the Scientific American, Maia Szalavitz, an author and journalist who focuses on science, public policy, and addiction treatment, writes that kratom “does appear to be far safer than all illegal and most prescription opioids.” She referred to a Centers for Disease Control and Prevention (CDC) study in 2016 and 2017 of some 27,000 kratom-related overdoses. Of those, kratom was implicated in less than one percent of overdose deaths.

“Moreover, in nearly all overdose deaths associated with kratom, it was accompanied by stronger drugs that kill more often, so it is not clear that it actually played a major role or even any at all,” she wrote.

“For example, around two-thirds of the 152 deaths the CDC studied also involved illicit fentanyl and its analogues, which are thousands of times more potent. In only seven cases was kratom the only only substance identified—and even here, researchers cannot rule out the possibility of undetected drugs,” she added.

Caution warranted

Nevertheless, most medical experts warn that kratom use can have adverse consequences. According to the Cleveland Clinic, “kratom’s potential for serious side effects outweigh its potential benefits.”

It lists the following most common side effects of kratom:

  • aggression
  • altered mental status
  • anxiety and irritability
  • constipation
  • delusion and hallucination
  • drowsiness and sedation
  • dry mouth
  • frequent urination
  • itching
  • nausea and vomiting
  • tongue numbness

More serious side effects can include:

  • cardiac issues, such as heart attack, abnormal heart rhythms, and high blood pressure
  • encephalopathy (brain disease)
  • hypothyroidism (underactive thyroid)
  • insomnia
  • liver damage and liver failure
  • loss of appetite
  • psychosis
  • respiratory depression (difficulty breathing)
  • seizure
  • tremor
  • weight loss

In addition, people going through kratom withdrawal may experience:

  • muscle spasms
  • pain
  • rhabdomyolysis (a condition leading to kidney damage when muscles disintegrate and release a protein into the blood)
  • rigidity
  • seizures
  • tremors

Think twice about kratom

While proponents hope more research will eventually vindicate kratom as a useful supplement, the medical community generally holds that its side effects more than outweigh any potential benefits. It can be especially dangerous when combined with other legal and illegal drugs.

While it’s up to you, we would suggest that our patients not take the risk of using this substance. If you’re thinking of using kratom for any reason, please discuss it with us first. We may be able to help you find other safer treatment options.

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