• A pair of immunotherapy drugs have shown impressive results in treating a subset of colorectal cancer known as mismatch repair-deficient (dMMR) colorectal cancer.
• DMMR colorectal cancer is characterized by genetic mutations which make it easier for the immune system to identify.
• The drugs resulted in a “major pathological response,” reducing tumor size to less than 10% in the vast majority of patients. 

Colorectal cancer is notoriously resistant to immunotherapy options. But, for a subset of patients, a novel treatment shows promise,

Mismatch repair-deficient (dMMR) colorectal cancer is present in between 10-15% of all colorectal cancer patients and is characterized by a high number of mutations in genes responsible for repairing mistakes that can occur during DNA replication. While it can show up in other forms of cancer, including breast and prostate, it is most commonly found in colorectal cancer.

Treatment options for DMMR colorectal cancer can be tricky. On one hand, it tends to be more resistant to chemotherapy, but researchers have now been making inroads with immunotherapy.

Major response in 98% of patients

Surgery is the primary treatment for colorectal cancer, but in research published this week in the New England Journal of Medicine scientists found that a pair of immunotherapy drugs administered before surgery significantly diminished tumor size without serious safety concerns. 

Researchers set out to study the safety profile of the drugs by observing whether patients who took them would still be able to undergo surgery within an allotted time frame or if they would have to delay their surgery. About 98% of patients underwent timely surgery, meaning they had less than a two-week delay when taking the combination of drugs.

Researchers observed immune-related side effects in 73 patients, with severe (grade 3 or 4) events occurring in 5 patients. None of the patients discontinued treatment due to these adverse events.

The effects of the drugs on the tumors themselves were also surprising. The study found 95% of patients experienced a major pathological response, shrinking the tumor to less than 10% of its size. Meanwhile, Two-thirds of patients had a complete pathological response, meaning there was no residual evidence of the tumor after treatment.

More than two years after surgery, no patients experienced a recurrence of the cancer. The patients are being followed for longer to evaluate the durability of their response.

“I don’t think anybody expected these results or the extent of these results,” Kristen Ciombor, MD, an Associate Professor of Medicine at Vanderbilt University Medical Center who wasn’t affiliated with the study told Healthline.

“Two-thirds of patients didn’t have any tumor left, which is really incredible. It’s something that we don’t see at that rate and extent with pretty much any other therapy,” she said.

Advances in immunotherapy

The study, conducted by researchers in the Netherlands, involved 115 patients with non-metastatic, locally advanced, previously untreated dMMR colon cancer. That’s a technical way of saying colorectal cancer which has developed beyond the earliest stages (patients in the study had either stage II or II cancer) but has still not spread (metastasized) to other organs in the body.

Doctors administered the patients two different immunotherapy drugs prior to surgery. The drugs, nivolumab and ipilimumab, belong to the same class of immunotherapy treatment, known as immune checkpoint inhibitors, but utilize unique biological mechanisms from one another.

“The greatest advance we’ve had in decades of cancer research has been in the field of immunotherapy. Developing immune treatments to help the immune system attack cancer is something that we’ve dreamed about since the 1950s,” George Fisher, MD, PhD, a Professor of Medical Oncology at Stanford Medicine, told Healthline.

The results of this latest trial demonstrate how far the field has come. 

The concept of immunotherapy is simple to describe, but extremely complex to implement. When the body mounts an immune response it must identify friendly cells and foreign invaders. In order to do this, T cells, which are your body’s defenders in the immune response, perform a sort of “handshake,” known as an immune checkpoint, with healthy cells that marks them as safe. Without this, the T cells will attack.

Some forms of cancer can abuse this mechanism to hide from the immune system. Those cancers can then continue to grow without fear of an immune response.

Immune checkpoint inhibitors work by preventing cancer cells from faking this “handshake” and allowing the immune system to identify and kill them.

An additional complication is that colorectal cancer in particular tends to remain well hidden from immune system detection. But dMMR versions are different; the genetic mutations characteristic of dMMR make it easier for the immune system to pick out, and also more susceptible to immunotherapies.

“If you have more mutations, then you make more abnormal proteins. And if the immune system is capable of recognizing abnormal proteins, then those cells that have the most mutations are the ones most likely to have proteins that might be recognized as foreign,” said Fisher.

“The genetic mutations in these tumors makes it what we call ‘immunologically hot.’ So the immunotherapy can work better against the tumor itself,” said Ciombor.

Implications of the study

Experts interviewed by Healthline said that there is still much more work to do before we can know if the immunotherapy treatments in the study will be safe and effective among a larger group of patients, but the results are exciting nonetheless.

“There’s no doubt that this study is very impressive and the fact that we can see such tremendous changes in such a short interval of time with treatment with both drugs really suggests that there is likely to be a subset of patients who will not need to go to surgery,” said Fisher.

Should trials continue to show safety and efficacy, certain groups of patients could have new options available to them. For example, older patients or those with certain comorbidities that make them an unsuitable candidate for surgery might be able to opt for immunotherapy.

Patients with low-grade cancer could also potentially elect not to have surgery, although the long-term outcomes of immunotherapy without surgery have not yet been established. 

As with any treatment, there will be a question of risk versus benefit. An immunotherapy treatment prior to surgery might preclude the necessity for chemotherapy but at the risk of a severe complication called immunotherapy toxicity.

“It at least raises the possibility that there may be other options to treat this type of cancer,” said Ciombor.

“If you can avoid chemotherapy, that would be a win. Ultimately if you can avoid surgery too, then that’s really amazing. But we can’t draw that conclusion from this study yet. It’s going a little too far to say,” she said.

The bottom line

In a study involving over 100 patients, a dual-drug immunotherapy treatment shows impressive results in treating a specific form of colorectal cancer.

Mismatch repair-deficient (dMMR) colorectal cancer is found in 10-15% of all colorectal cancer cases and is characterized by a high number of genetic mutations.

These genetic mutations allow it to be more easily recognized by the immune system and make immunotherapy more likely to be effective.

• Poppi brand soda is being sued for claims of consumer fraud and false and misleading advertising. 
• A class action lawsuit alleges that the drinks’ prebiotic fiber content is insufficient to provide meaningful gut health benefits.
• Experts say the amount of prebiotic fiber included in each can is likely insufficient, but Poppi is still a healthier choice than most other sodas
• You can get more prebiotics into your diet by eating certain plant and fermented foods. 

Prebiotic soda brand Poppi, beloved by celebrities, is being sued on claims of consumer fraud and “false and misleading claims.”

The class action lawsuit alleges that the brand’s claims that the drink is good for health are untrue. 

They say the drink, billed as a “better for you” soda, does not provide meaningful prebiotic effects. 

Poppi’s marketing has centered on the soda’s inclusion of prebiotic fibers, which are beneficial for gut health. 

However, the lawsuit claims, “Poppi soda only contains two grams of prebiotic fiber, an amount too low to cause meaningful gut health benefits for the consumer from just one can.”

Are Poppi’s claims about gut health benefits exaggerated?

Rebecca Russell, a functional medicine registered dietitian specializing in gut health, says this looks like another case of brands overpromising on the health benefits of their products. 

“All too often I see products that claim to be a ‘magical’ fix for a specific problem, when in reality our bodies are complex, and no one thing will be the fix,” she points out. 

Russell believes the prebiotic fiber in Poppi sodas is far too low to meaningfully improve gut health. 

“It is thought that closer to 3-10 grams of prebiotic fibers a day is considered effective in altering the gut microbiome,” she says, pointing to a study published in 2019. 

Another thing to note is that a variety of prebiotic fibers is key to gut health.

“Products like Poppi are just one type of prebiotic fiber, so it lacks that diversity that our guts need,” Russell explains. 

Like Russell, board certified registered dietitian Tiffany Ma says two grams of prebiotic fiber per can is likely insufficient to create meaningful changes in gut microbiota or overall gut health when consumed as a stand-alone source.

“Prebiotics are non-digestible food components that selectively stimulate the growth and activity of beneficial gut bacteria,” she explains. “They can improve gut health by enhancing digestion, boosting the immune system, and increasing the production of short-chain fatty acids (SCFAs) like butyrate, which have anti-inflammatory properties and support the integrity of the gut lining.” 

Does she believe a drink like Poppi could have a negative impact on the gut? 

Ma says the gut is unique and complex and differs so much from individual to individual that it’s difficult to tell.

However, she does point out that the inclusion of “added prebiotics” (insulin) in Poppi can actually cause gastrointestinal distress, such as bloating and cramping.

“Since Poppi is a liquid very little digestion is taking place, and that can heighten these negative effects,” she explains. 

Russell shares similar concerns. She says Poppi is unlikely to have a positive effect on your gut microbiome, largely because no single food or drink item can serve as a comprehensive solution for gut health. 

“This beverage may actually lead to unwanted gut symptoms such as gas, bloating, and loose stools as too much inulin, which is the prebiotic fiber included here, can potentially cause symptoms,” she explains. 

Sugar and “natural flavors” in sodas may negatively affect your gut

Another area of concern is sugar content. At 4 grams of sugar per 12 fluid oz can, Poppi is significantly lower in sugar than most sodas. 

Still, Russell says it would be better to get prebiotic fiber from other food sources that do not have added sugars. 

She says that excess sugar can harm gut bacteria, disrupting their delicate balance. 

“One ingredient that can be called into question is ‘natural flavors’ since this term is broad and encompasses a wide range of substances that may not be health-promoting,” Russell notes. “Despite being derived from natural sources, these flavorings undergo significant processing and may end up being chemically similar to artificial flavorings.” 

In spite of that, unless you’re drinking a lot of Poppi every day, it’s unlikely to have any serious negative health effects. 

“Unless one consumes a 12-pack of Poppi per day, there truly wouldn’t be any major health concerns to make note of,” says Ma. 

She believes Poppi can still prove to be a healthier alternative to full-calorie sodas for heavy soda drinkers or those who are looking to manage their weight.

Healthier alternatives to Poppi soda

If you are looking for a healthier alternative to Poppi, there are plenty to choose from. Eating more whole foods is the best way to get more prebiotic fiber in your diet. 

“For meaningful prebiotic effects, consider foods naturally high in prebiotics, such as garlic, onions, leeks, asparagus, bananas, and whole grains like oats and barley,” advises Ma. 

She says eating a diverse range of plant foods is key.

“Aiming for at least 30 different plant foods per week (which includes fruits, vegetables, nuts, seeds, legumes, and whole grains) has been shown in the literature to result in a more diverse gut microbiome,” she explains. 

Fermented foods are beneficial, too.

“Foods like yogurt, sauerkraut, kimchi, kefir, and miso contain probiotics that can help balance the gut microbiome,” Ma notes. 

Russell agrees. She says “eating the rainbow” by filling your plate up with colorful whole foods is a great way to get a variety of prebiotics into your diet. 

Limiting your sugar intake is also a good idea to optimize your gut health. 

“Excess added sugars can promote the growth of harmful bacteria in the gut and lead to a decrease in beneficial bacteria, so aim for less than 10% of total calories to come from added sugars,” Ma advises. 

Takeaway 

Poppi sodas likely don’t have enough prebiotic fiber to provide any meaningful benefit to your gut health.

However, that doesn’t mean they can’t be enjoyed in moderation.

They appear to be a healthier alternative to most other sodas, which typically have a much higher sugar content.

• Ongoing research presented at the Endocrine Society’s annual meeting shows promise for a new male contraceptive option.
• The product, a gel, has shown effectiveness beyond what researchers initially expected. 
• Experts are hopeful that this treatment, should it come to fruition in the long term, will provide another avenue for men to hold a larger role in reproductive health.

New research, presented at the Endocrine Society’s annual meeting on June 2, shows promise as a new contraceptive option for men.

The study, which is ongoing and included 222 participants and their partners, was an international effort that started in 2018.

The study has not yet been published in a peer-reviewed journal.

How the product works

The product, a gel, combines Nestorone (segesterone acetate) which suppresses sperm production by creating what researchers have called “a feedback loop” in the brain, and testosterone, which is required in order to maintain a person’s typical function. The men applied the gel once daily to each shoulder blade.

Study author Diana Blithe, PhD, the chief of the contraceptive development program within the National Institute of Child Health and Human Development, says that this research, which was delayed due to the COVID-19 pandemic, is a source for optimism, not just for the participants, but for their partners. 

“What I think is not clearly recognized, especially when I read comments from some of these articles that are being [put in the] press is how much it means to the women who are in this trial with their partners, because they get to spend a year off birth control that they weren’t real happy with to begin with. And it’s quite a burden lifted from them to be able to have this, you know, sort of rest period.”

The study followed participants as they applied the gel daily, with 86% of participants seeing their sperm count suppressed below the threshold identified (lower than one million sperm per milliliter) after 15 weeks, 64% after 9 weeks, and 21% after just 5 weeks, much faster than Blithe and her team anticipated.

Andrew Y. Sun, MD, Director of Men’s Health at Urology Partners of North Texas and an associate professor of medicine at Texas Christian University’s Anne Burnett Marion School of Medicine, says that this research has to be viewed in the context of America’s recent reduction in reproductive rights and a corresponding uptick in vasectomies.

“The topic of male contraception comes out [in conversation with patients] a lot. Especially, I think, with recent legal changes, especially in certain states here in America, this has become an even bigger issue as people are trying to basically find easier and more accessible ways to achieve contraception. Historically, unfortunately, that always fell on the women.”

The use of testosterone therapy, which has seen an uptick in the US in recent years for all manner of reasons, does come with the side effect of reducing sperm production, but that process is measured on the scale of months rather than weeks.

How this could help

Beyond its as-directed effectiveness, one of the biggest barriers to any contraceptive is regular use. Blithe says that the response from the study’s participants was broadly positive and that this bodes well for future uptake. 

“My favorite comment about acceptability is when the men finished the study and asked if they can re-enroll, they really liked it, they would stay on it if they could. And that’s a real endorsement for the product, because they’ve been at it for 20 months and they still want to keep going.”

Blithe sees this gel as complimenting other products on the market that were originally created with the hope that they could act as a male contraceptive, specifically SpermCheck and SpermCheck Vasectomy, and allow patients to get a better understanding of their sperm production at home.

Once the study has been finished, which is expected to complete enrollment by the end of the year, and once the final analysis has been done, Blithe and her team will turn their attention to identifying—alongside the FDA—an acceptable pathway for a phase three clinical trial. Once a phase three clinical trial is complete, the FDA can make a determination about granting the new therapy access to the market.

• More than 61% of American adults are projected to have some type of cardiovascular disease by 2050, American Heart Association research shows.
• This will be driven by an aging and more diverse population, as well as an increase in risk factors such as obesity and high blood pressure.
• Some risk factors for cardiovascular disease, though, will decline, including smoking and lack of regular physical activity.

More than 61% of American adults are expected to have some type of cardiovascular disease by 2050, according to new research from the American Heart Association (AHA). The healthcare and related costs resulting from this are projected to be $1.8 trillion.

This trend will be driven by an older, more diverse population and a large increase in risk factors such as high blood pressure and obesity.

Cardiovascular disease includes heart disease, heart attack, stroke, heart failure, abnormal heart rhythm such as atrial fibrillation or AFib, and heart valve problems. High blood pressure is also a type of cardiovascular disease, as well as a major risk factor for heart disease and stroke.

In spite of advances in treatments for these conditions, heart disease has been the leading cause of death in the United States for decades, resulting in 695,000 deaths in 2021. Stroke is the fifth leading cause of death.

In research published June 4, the AHA predicts that in 2050, 15% of American adults will have cardiovascular disease — including stroke, but excluding high blood pressure — up from 11.3% in 2020.

The percentage of people affected by stroke will nearly double during that time, from 3.9% to 6.4% of adults, AHA research shows. In addition, 61% of adults will have high blood pressure in 2050, an increase from 51.2% in 2020.

Changing population a key driver

An aging population is one of the key factors behind these trends — as people age, their chance of developing cardiovascular disease increases.

By 2050, 22% of Americans will be over the age of 65, an increase from 17% in 2020, according to the U.S. Census Bureau.

The United States is also becoming more diverse, and communities of color tend to be impacted more by cardiovascular disease.

By 2060, people who identify as Hispanic will make up 27.5% of the population, versus 17.8% in 2016, and people who identify as Black will be 15% of the population, up from 13.3% in 2016. The share who identify as Asian will increase from 5.7% to 9.1% during that time.

In 2050, Hispanic adults are projected to have the largest increase in cardiovascular disease, in terms of total numbers of people, the AHA research shows.

In addition, Black adults are projected to have the highest rates of high blood pressure, diabetes and obesity. They also are expected to have the highest rates of inadequate sleep and poor diet. These all contribute to the development of cardiovascular disease.

“Many Americans live with food insecurity, often in food ‘deserts’ without access to nutritious fruits and vegetables, subsisting on calorie-dense, nutrient-poor, unhealthy processed and fast food,” said Nate E. Lebowitz, MD, a cardiologist at Hackensack University Medical Center, who was not involved in the AHA research.

“According to the AHA research, the underserved populations subject to these food deserts are expected to suffer a magnified impact,” he told Healthline.

Increasing risk factors for heart disease

In addition to the expected increase in the rate of high blood pressure, other risk factors for cardiovascular disease are likely to rise over the next two decades.

Obesity is projected to increase from 43.1% of adults in 2020 to 60.6% in 2050, and diabetes will increase from 16.3% to 26.8%. Adults under 65 will see the highest growth for obesity, with the AHA research predicting that more than 70 million young adults will have a poor diet in 2050.

The research also looked at projections for children, finding concerning trends for certain risk factors. For example, obesity among 2- to 19-year-olds is projected to rise from 20.6% in 2020 to 33% in 2050.

In addition, poor diet and inadequate physical activity among children is expected to remain at nearly 60% each, the research found.

Americans, however, will see progress on certain risk factors. The percentage of adults with inadequate physical activity levels will drop from 33.5% in 2020 to 24.2% in 2050. Cigarette smoking rates are projected to drop by nearly half during that time, from 15.8% to 8.4%.

In addition, rates of high cholesterol will drop from 45.8% to 24.0%, in part due to an increase in the number of people taking cholesterol-lowering drugs called statins.

A 2023 study found that 92 million adults 40 years or older, or 35% of that age group, took a statin in 2018-2019, an increase from 12% in 2008-2009.

“I wish I could say that [the projected decline in high cholesterol] is due to improving diet and dropping obesity rates, but in reality it’s thanks to new, highly advanced medications we are starting to employ that dramatically lower cholesterol,” said Lebowitz.

“We know that [lowering cholesterol] drops the rates of coronary artery disease, so the report could have been much worse,” he said.

Turning things around

While the AHA projections paint a stark picture of cardiovascular disease two-and-a-half decades from now, study author Dhruv S. Kazi, MD, director of the cardiac critical care unit at Beth Israel Deaconess Medical Center in Boston, said in a release that these trends can be slowed, but “this will require strategic investments in cardiovascular prevention and treatment.”

Right now, though, preventing cardiovascular disease may not get as much attention as treatment.

“The U.S. spends a massive amount on high tech expensive interventions for acute cardiovascular illness, but doesn’t spend anywhere near as much on the far less expensive measures that could prevent the need for those interventions,” said Lebowitz.

For example, “after a heart attack or an acute coronary hospitalization with a stent or bypass surgery, half of patients don’t even get their cholesterol checked and there is a 42% readmission rate by 6 months,” he said.

In contrast, Cuba spends a fraction of what the United States does on healthcare, yet the two countries have similar average life expectancies.

In Cuba, doctors are “responsible for making sure the basics are covered for a certain number of people in their neighborhood,” said Lebowitz. “The majority of their responsibility focuses on blood pressure, body weight, cholesterol, nutrition, smoking cessation, etc. — the very basics that we don’t put enough effort into [in the United States].”

Also, “there is less processed food [in Cuba],” he said. “This reduces the development of chronic diseases, and as a result there is less need for high-tech expensive interventions for which [Americans] spend all that money.”

Lebowitz thinks more resources should be put into ensuring everyone has access to fresh, nutritious food, such as supporting community gardens.

“Simply switching calories by 20% from ultra-processed and fast foods to fruits and vegetables, lean meats and eggs (unprocessed food) can have a proven, magnified impact in disease prevention,” he said. “We need to make doing so cheaper and a priority, especially in the underserved food deserts.”

Takeaway

New research by the American Heart Association projected future rates of cardiovascular disease and risk factors. The study found that in 2050, more than 61% of American adults will have some type of cardiovascular disease, including high blood pressure.

This trend is driven by an aging population and a more diverse population. Communities of color tend to be impacted more by cardiovascular disease.

Rates of cigarette smoking, inadequate physical activity and high cholesterol are projected to drop by 2050. But experts say more work is needed to slow these trends, including ensuring that all Americans have access to healthy foods.

• The Body Roundness Index is a novel body composition measurement that is touted as being a more accurate alternative to Body Mass Index.
• In a large retrospective study of 33,000 US adults, researchers found a “U-shaped” curve, indicating those with a BRI below and above the normal range had an increased risk of death from any cause.
• The study also found that over a 20-year period, BRI showed an upward trend, another indicator of the USA’s obesity epidemic.

Is “body roundness” a good indicator of your weight and health risks? New research says, yes.

Scientists are turning to a novel way to calculate obesity using a system known as the Body Roundness Index, which is touted as a more accurate measurement than Body Mass Index (BMI).

In a new study published in JAMA Network Open, researchers found that a higher BRI was associated with an increased risk of death from any cause in a large retrospective study involving nearly 33,000 US adults.

The research is yet another confirmation of the US’s growing obesity epidemic, but also an indicator of a potential new tool in the fight against obesity. The authors conclude that the BRI is a tool that is almost as easy to perform as BMI, but offers a more accurate assessment of body composition and health risks.

“Our findings provide compelling evidence for the application of BRI as a noninvasive and easy to obtain screening tool for estimation of mortality risk and identification of high-risk individuals, a novel concept that could be incorporated into public health practice pending consistent validation in other independent studies,” the authors wrote.

Body roundness and mortality risk

The study included health data from a large cohort of nearly 33,000 American adults. Researchers pulled the data from the NHANES health database, a self-reported survey that assesses the health and nutrition of Americans.

Researchers looked at a 20-year period of NHANES data between 1999-2018. The average age of cohort members was 46 years old. Half of the group was women. The group was predominantly white (68.26%), but also included Black individuals (10.92%), and Mexican Americans (8.53%).

Then, using BRI which is a slightly more complex body measurement than BMI, they assessed one major outcome: all-cause mortality. The major finding: a “U-shaped” curve of mortality risk associated with BRI score. A U-shaped curve, as its name suggests, shows high risk at either end of a given spectrum, and lower risk in the middle. 

In this case, individuals with a BRI below and above the normal range were at greater risk of death from any cause. Meanwhile those in the middle, in the normal range, had the lowest risk. Individuals with a BRI less than 3.4 had a 25% increased mortality risk compared to the normal range, while those with a BRI of 6.9 had 49% increased risk.

Beverly Tchang, MD, an endocrinologist, Spokesperson for the Obesity Society and Assistant Professor of clinical medicine at Weill Cornell Medicine, told Healthline, “It is worthwhile that they are investigating other metrics of adiposity given the known limitations of the body mass index (BMI). 

“This is a more direct measure of central adiposity, which strongly correlates with metabolic diseases like type 2 diabetes,” she added. 

Researchers also documented a steady increase in average BRI over the 20 year period from 4.8 to 5.62. The trend was more obvious within certain groups, including women, the elderly, and those who identified as Mexican American.

What is the Body Roundness Index?

The Body Roundness Index is similar to the Body Mass Index, but relies on more anthropometric variables.

The BRI which was first proposed in 2013, uses height, weight, waist circumference, and sometimes hip circumference for its calculation. Throw in a dash of theory from 17th century German astronomer Johannes Kepler, and you’ve got the BRI.

Diana M. Thomas, PhD, a Professor of Mathematics at the United States Military Academy at West Point authored the initial paper detailing the concept of BRI explained the concept to Healthline:

“It has to do with geometry. So if you look at Body Mass Index, you can come up with a geometrical explanation.”

Using the necessary variables, you create an image of a circle, but the circle could be more egg-shaped, cylindrical, or maybe totally round. It uses the concept of “eccentricity,” which Johannes Kepler used to quantify planetary orbits. Eccentricity describes how round (like a circle) or narrow (like an ellipse) something is. It represents a number between zero, for a perfect circle, and one. 

“With BMI you’re actually using just two measurements. You’re using weight and height. In the Body Roundness Index, we’re using a few more measurements on the human body to capture that shape,” said Thomas.

That BRI number can then be used to make a more accurate calculation of body composition. The closer to zero, the rounder your body, and the greater the risk of all-cause mortality. 

How BMI compares

BMI is a simple measurement of body size based on your height and weight that has been used for decades as a general health assessment. Your BMI is a crude measurement of whether or not you fall into a healthy weight range. However, the measurement is far from perfect: it doesn’t distinguish between muscle and fat, for example; so an individual with obesity could very likely have the same BMI as, say, a bodybuilder.

Even with its flaws, BMI is still an important indicator of future health problems. The higher your BMI above normal (anything above 25), and the greater your risk for things like type 2 diabetes, high blood pressure, and cardiovascular disease.

BMI vs BRI

There are plenty of critics of BMI, but there’s no sign that it is going anywhere.

BMI is easy to assess in a doctor’s office or at home. Meanwhile, measuring body fat is more difficult, costly, and time-consuming. It’s not something that can readily be performed during a checkup.

However, BRI could offer a new method of assessing body composition and health risk in a manner that is still simple to perform but offers a more accurate assessment. Forget all that talk about Kepler’s orbiting eccentricities, you don’t need to actually know physics or geometry to perform a BRI test. You just need a few measurements. In fact, you can even plug them into an online calculator if you’re curious about your own BRI.

BRI is still a novel technique that needs further validation, which the study authors note in their paper, so it’s far from commonplace today. 

Tchang also notes that the name itself could be a barrier to its future use: “I don’t think BRI is going to catch on simply because “roundness” is a potentially offensive term,” she said.

The bottom line

Researchers used 20 years of American health data to look at mortality risk using the Body Roundness Index.

The BRI is a novel body composition test first proposed in 2013, that some experts believe offers a more accurate alternative to BMI that is similarly easy to perform.

The study found confirmatory evidence of America’s obesity epidemic in gradually increasing BRI over the twenty-year period. The authors also found a “U-shaped” curve indicating greater all-cause mortality risk for individuals with a BRI above and below the normal range.

• Sticking to the Mediterranean diet was associated with a decreased risk of mortality, according to a new study.
• The Mediterranean diet helps lower cardiometabolic risk factors, such as insulin resistance, BMI and blood pressure.
• The diet includes high amounts of vegetables, fruits, whole grains, and heart-healthy fats.

A new study showed higher adherence to the Mediterranean diet was linked with a reduced risk of all-cause mortality.

The findings were published in JAMA Network Open on May 31.

Researchers looked at health information from 25,315 women, which included blood samples, biomarker measurements, and dietary data between 1993 and 1996. These women were followed up for 25 years.

Results showed a 23% decrease in all-cause mortality risk, which may be partially explained by cardiometabolic risk factors. These include biomarkers of inflammation, insulin resistance, metabolism, and body mass index (BMI).

Health benefits of the Mediterranean diet

“When it comes to cardiovascular disease there are various risk factors which are modifiable – meaning we have control over them,” said Nicole Roach, a registered dietitian at Northwell Lenox Hill Hospital. “Diet is a major modifiable risk favor.”

To address cardiovascular disease, often times the Mediterranean diet will be recommended. There are several benefits to following a Mediterranean diet. 

• Lowering “bad cholesterol.” The Mediterranean diet avoids food rich in saturated fat, this can help lower our LDL Cholesterol, often known as “Bad Cholesterol.”
• A Mediterranean diet can also help raise our “Good Cholesterol,” otherwise known as HDL.
• This diet may promote weight loss by encouraging healthier, more nutritious food choices. However, it can also help maintain a healthy weight if you are not looking to lose weight.
• This diet may help lower blood pressure by avoiding processed foods, which often contain high sodium levels due to added salt.
• Following a Mediterranean diet can also help increase fiber intake as this diet is rich in whole fruits and vegetables. Fiber supports bowel movements and gut health, helps maintain blood sugars within targeted goals, and helps promote satiety, which can aid in weight loss or maintenance.
• Choosing foods known to have anti-inflammatory properties may help decrease overall inflammation within the body. Decreased inflammation is beneficial to the heart and reduces the risk for various types of cancer.
• May be helpful for mood, cognitive function, and healthy brain aging.

“All of the above benefits of a Mediterranean diet can result in improved heart health as well as improved over all health,” Roach stated. 

This study suggested that the diet helped reduce: inflammation, triglyceride-rich lipoproteins, insulin resistance, and body mass index. These factors likely contributed to why people with higher adherence to this diet had lower mortality risk.

Mediterranean diet and decreased risk of all-cause mortality

The blood metabolites measured explained some of the effects of the Mediterranean diet on mortality.

“This included having lower molecules that are involved in inflammation and lipids that cause deposits in arteries that can lead to heart disease,” Dr. Marie-Pierre St-Onge, associate professor of nutritional medicine at Columbia University Vagelos College of Physicians and Surgeons, stated. “Lower blood pressure and better glucose control also contribute to the reduced risk of mortality.”

John Higgins, MD, a sports cardiologist at UTHealth Houston, agreed.

“Improved cardiovascular risk factors (blood pressure, cholesterol, blood glucose) as well as improved vascular function, improved coagulation profile, and less chance of an angry plaque (lower inflammatory markers) would result in lower rates of cardiovascular events (heart attack, stroke, peripheral arterial disease),” Higgins said.

In the current study, researchers found that improvements in measures of blood pressure, HDL and LDL cholesterol, and blood glucose control, such as hemoglobin A1C, were not as strongly associated with reduced mortality risk from adherence to the Mediterranean diet as some other biomarkers. However, they did acknowledge that previous studies have reported such associations.

More specifically, the researchers found biomarkers of metabolism and inflammation, triglyceride-rich lipoproteins, insulin resistance, and body mass index may contribute the most to the reduced mortality risk associated with the Mediterranean diet.

“The Mediterranean diet is rich in many nutrients and dietary components like polyphenols, that have anti-inflammatory properties,” said St-Onge. “It is high in fiber and low in sugar, which contribute to better glucose control, and is low in saturated [fat] while being higher in monounsaturated fat, which are known to produce [a] better lipid profile with lower LDL cholesterol and triglycerides and higher HDL cholesterol.”

The foundations of the Mediterranean diet include fatty fish, nuts, extra virgin olive oil, legumes, vegetables and fruit.  

Julia Zumpano a registered dietitian with the Cleveland Clinic Center for Human Nutrition, said foods high in omega 3 fatty acids such as certain fish, walnuts, flax seeds and chia seeds when combined with foods that reduce inflammation, such as legumes, fruits and vegetables, “have been shown to reduce blood sugars, reduce insulin, improve gut health and regularity.”

Zumpano recommends eating grains that are whole grains, in addition to minimally processed foods.  Zumpano recommends avoiding commercial baked goods, sugar-sweetened beverages or processed meats, which have been shown to increase inflammation, blood sugars, triglycerides, weight and risk of chronic diseases.

Takeaway

A new study found that sticking to the Mediterranean diet was linked with a decreased risk of all-cause mortality in women.

The Mediterranean diet may help reduce cardiometabolic risk factors, such as insulin resistance, BMI, and inflammation.

There are other factors that need to be taken into consideration which are family history, exercise habits and lifestyle.

• An expert panel of the Food and Drug Administration reviewed two studies on MDMA-assisted therapy for the treatment of PTSD.
• The studies showed that the therapy improved symptoms of PTSD over 18 weeks and lasted for several months after treatment.
• Issues with the study design and safety led many committee members to vote against recommending the approval of this treatment right now.

A expert panel of the Food and Drug Administration (FDA) voted against recommending MDMA-assisted therapy as a treatment for PTSD.

Findings from two clinical trials presented at a public meeting on June 4 showed that MDMA-assisted therapy improved symptoms of PTSD over 18 weeks of treatment. These improvements appear to last for several months after the treatment period, researchers found.

However, the FDA meeting raised a number of ethical and safety issues about the two clinical trials that drug manufacturer Lykos Therapeutics used to make their case to the FDA’s Psychopharmacologic Drugs Advisory Committee.

When considering whether MDMA is effective in patients with post-traumatic stress disorder, the committee voted 2-to-9 against.

For the question of whether the benefits of MDMA, with FDA’s proposed risk evaluation and mitigation strategy (REMS), outweighs its risks for the treatment of PTSD, the committee voted 1-to-10 against.

Prior to the meeting, the FDA extended the public comment period, allowing more time for critics and supporters to weigh in on MDMA as a treatment for PTSD. Several veterans groups submitted public comments urging the FDA to approve MDMA-assisted therapy.

About 7% of veterans will experience PTSD at some point during their lifetime, compared to about 6% in the general population, according to the U.S. Department of Veterans Affairs. However, for some groups of veterans the rate is as high as 29%.

In the end, concerns about the trials outweighed the benefits of MDMA-assisted therapy seen in the trials.

“I think that some of the data was promising, but given that 40% [of participants] had previously used MDMA” may have impacted the efficacy and durability of the treatment, said Elizabeth Joniak-Grant, PhD, a sociologist and qualitative research consultant at the University of North Carolina, Chapel Hill, said in the meeting.

In addition, “I am concerned with the lack of diversity and what that would mean for the general population,” she added.

This research is “on the right track,” Walter S. Dunn, MD, PhD, assistant clinical professor at University of California Los Angeles, said during the meeting. “A tweak here and there can address some of the safety concerns we brought up.”

“We are in dire need of new treatments for PTSD … and this has the potential to make a difference,” he added.

MDMA used previously for therapy

MDMA is a synthetic oral drug that acts as a stimulant and a hallucinogen. It was first synthesized in 1912 and was used as a treatment by some psychiatrists and therapists until the mid 1980s.

Around that time, MDMA became a popular street drug, known as “ecstasy” or “molly.” This led to the Drug Enforcement Agency (DEA) classifying it as a Schedule I drug. This restricted use of the drug as a treatment for psychiatric diseases.

However, in 2017 the FDA granted MDMA breakthrough therapy designation for its use with psychotherapy for PTSD. This allowed additional clinical trials to be carried out.

“MDMA is not a new drug, and while it can be misunderstood due to its illicit counterpart, it actually has a well-documented history in the psychiatric field,” Amy Laverdiere, program lead at Lykos, said during the meeting.

She explained that MDMA is thought to work by “[catalyzing] the effectiveness of psychotherapy by facilitating memory recollection and extending the patient’s window of tolerance for revisiting distressing thoughts or experiences.”

Studies also show that MDMA improves self-awareness and enhances the therapeutic relationship between a patient and their therapist, Laverdiere said.

PTSD affects millions

In 2020, an estimated 13 million Americans had PTSD, not all of them veterans.

“Although PTSD is associated with exposure to deployment and combat, consequent to a number of potential experiences, civilian trauma is actually more common,” Jerry Rosenbaum, MD, director of the Center for Neuroscience of Psychedelics at Massachusetts General Hospital Research Institute, and professor of psychiatry at Harvard Medical School, said during the meeting.

“Individuals exposed to sexual violence, for example, or an unexpected death in the family or a life-threatening traumatic event may also develop PTSD,” he said.

Current treatment options for PTSD include psychotherapy and serotonin reuptake inhibitors (SSRIs). 

Rosenbaum said while psychotherapy can lead to clinically meaningful reductions in PTSD symptoms, many patients stop therapy due to increased distress. In addition, there is limited access to this type of treatment.

Clinical studies show that SSRIs improve symptoms of PTSD more than placebo, although fewer than 60% of people with PTSD benefit from these drugs, and less than 30% of patients have full remission of their symptoms, according to the FDA’s briefing document.

In addition, “several pharmacologic agents are used off-label and concurrently, despite lacking evidence of efficacy and not being approved for the PTSD indication,” said Rosenbaum, “which speaks to the demand from prescribers for novel-indicated therapeutics to provide our patients new tools to alleviate symptoms.”

Clinical trials of MDMA-assisted therapy

In the meeting, Lykos presented data from its two phase 3 clinical trials, named MAPP1 and MAPP2. In these trials, people with PTSD underwent three treatment cycles of MDMA-assisted therapy over 9 to 15 weeks. Treatments were scheduled 3 to 5 weeks apart.

On average, people undergoing MDMA-assisted therapy saw a greater improvement in PTSD symptoms over 18 weeks, compared to the placebo group. 

People taking MDMA also experienced functional improvements such as being able to pursue personal goals and maintain strong relationships.

The data also show that 67% of participants taking MDMA no longer met the diagnostic criteria for PTSD after 18 weeks, compared to 33% of the placebo group. Also 33% of participants treated with MDMA were in disease remission after three sessions, versus 5% in the placebo group.

“In this combination treatment, the acute effectiveness of MDMA facilitates the psychotherapy — strengthening the therapeutic alliance, facilitating the patient’s development of insights and tools, and continuing to cultivate long after the acute effects are worn off,” Kelley O’Donnell, MD, PhD, research assistant professor of psychiatry at NYU Grossman School of Medicine and director of clinical training at the NYU Langone Center for Psychedelic Medicine, said during the meeting.

In the trials, certain adverse events occurred more often in the MDMA group than the placebo group, including muscle tightness, decreased appetite, nausea, excessive sweating, and feeling hot or cold. People treated with MDMA also had a short-term increase in blood pressure and heart rate.

Researchers did not see an increase in suicidal thoughts in people taking MDMA, although Lykos’ documents for the meeting indicated that this is an “expected key risk in patients treated with [MDMA-assisted therapy].”

Committee raises concerns about studies

Tiffany R. Farchione, MD, director of the division of psychiatry in the office of neuroscience at the FDA, said the adverse events seen in the trials were consistent with the known effects of MDMA. 

However, adverse events related to the potential misuse of the drug — such as euphoria or elated mood — were not adequately collected or reported, she said during the meeting.

“It is the lack of data collection on the subjective effects of MDMA that may have the greatest impact on our regulatory decision-making,” she said.

Further, the effects of MDMA can last for several hours, which can leave patients impaired and vulnerable during that time.

As a result, “if this product were to be approved, we believe the REMS [FDA’s risk evaluation and mitigation strategy] will be necessary to ensure safe use, and to mitigate the risk of serious harm that can result from patient impairment,” said Farchione.

The FDA’s REMS proposal included requirements that patients be informed about the risk of impairment that can result from MDMA use, as well as ensuring that two or more healthcare providers are at the clinic to monitor patients for at least 8 hours after treatment.

Another key concern cited in the FDA review released last week was the potential for “functional unblinding” of participants. The studies were designed as double-blind trials, which means participants are not supposed to know whether they received the MDMA capsule or a non-active placebo. 

However, the effects of MDMA are so distinct that many trial participants in the MAPP2 study correctly guessed whether they received MDMA or placebo, the FDA review showed.

This unblinding could affect their treatment. It is also a common problem with clinical trials of psychedelics such as MDMA, LSD and psilocybin, and psychoactives such as cannabis.

“We rely on data from adequate and well-controlled trials to provide the basis for a substantial evidence of effectiveness,” David Millis, MD, clinical reviewer in the division of psychiatry at the FDA, said during the meeting. 

“Among other characteristics, to be considered adequate and well-controlled, a study must incorporate a design that permits valid comparison with a control condition, and measures must be taken to minimize bias,” he said.

He added that the FDA had suggested that Lykos use active comparators — such as niacin or low-dose MDMA — instead of placebo in the trials. The company and the FDA, though, did not reach an agreement on how to handle the blinding for the studies, he said.

The FDA’s review pointed out other limitations of the trials. For example, around 25% of participants dropped out between the parent study and the follow-up visit. Further, some participants also had other treatments for PTSD. These could affect the study results.

Takeaway

An expert panel of the Food and Drug Administration reviewed finding from two phase 3 clinical trials looking at the use of MDMA-assisted therapy for the treatment of PTSD.

The studies showed that symptoms of PTSD improved in people who took MDMA with psychotherapy, compared to those who took an inactive placebo. People who took MDMA in combination with psychotherapy also had improvements in their daily functioning.

Committee members raised concerns about the design of the trial, safety concerns of MDMA-assisted therapy, and ethical concerns with the trial. As a result, a majority of members voted against recommending approval of this as a treatment for PTSD.

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