User login
Bringing you the latest news, research and reviews, exclusive interviews, podcasts, quizzes, and more.
div[contains(@class, 'header__large-screen')]
div[contains(@class, 'read-next-article')]
div[contains(@class, 'nav-primary')]
nav[contains(@class, 'nav-primary')]
section[contains(@class, 'footer-nav-section-wrapper')]
footer[@id='footer']
div[contains(@class, 'main-prefix')]
section[contains(@class, 'nav-hidden')]
div[contains(@class, 'ce-card-content')]
nav[contains(@class, 'nav-ce-stack')]
The road to weight loss is paved with collusion and sabotage
Three big bumps on the weight-loss journey
The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.
Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.
Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.
Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.
Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”
The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.
“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.
Like we said before, weight loss is a journey. The right support can only improve the odds of success.
Robots vs. mosquitoes
If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.
Yet.
Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.
To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.
The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?
The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
This is knot what you were expecting
Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.
That’s not enough for you, is it? Fine, we were warned.
Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.
For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.
That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.
But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.
The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.
Three big bumps on the weight-loss journey
The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.
Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.
Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.
Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.
Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”
The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.
“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.
Like we said before, weight loss is a journey. The right support can only improve the odds of success.
Robots vs. mosquitoes
If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.
Yet.
Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.
To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.
The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?
The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
This is knot what you were expecting
Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.
That’s not enough for you, is it? Fine, we were warned.
Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.
For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.
That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.
But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.
The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.
Three big bumps on the weight-loss journey
The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.
Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.
Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.
Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.
Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”
The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.
“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.
Like we said before, weight loss is a journey. The right support can only improve the odds of success.
Robots vs. mosquitoes
If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.
Yet.
Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.
To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.
The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?
The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
This is knot what you were expecting
Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.
That’s not enough for you, is it? Fine, we were warned.
Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.
For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.
That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.
But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.
The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.
New bill would provide greater length of time to sue doctors
A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?
As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.
“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.
Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.
In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
Time of injury versus time of discovery
Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.
This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.
Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.
Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.
“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.
Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
Medical malpractice statutes of limitations by state
Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”
In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
Statutes of limitations by state
1 Year: California, Kentucky, Louisiana, Ohio, Tennessee
2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming
2.5 Years: New York
3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin
4 Years: Minnesota
To protect yourself
Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.
“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.
Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.
“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
Keep good records
If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.
“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
Keep an eye on malpractice insurance rates
It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.
He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.
“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”
Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.
“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.
In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
Key takeaways
Ultimately, to protect yourself and your practice, you can do the following:
- Know the statute of limitations and discovery rules for your state.
- Review your coverage with your insurer to better understand your liability.
- Keep accurate records for as long as your statute requires.
- Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.
“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”
A version of this article first appeared on Medscape.com.
A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?
As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.
“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.
Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.
In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
Time of injury versus time of discovery
Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.
This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.
Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.
Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.
“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.
Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
Medical malpractice statutes of limitations by state
Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”
In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
Statutes of limitations by state
1 Year: California, Kentucky, Louisiana, Ohio, Tennessee
2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming
2.5 Years: New York
3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin
4 Years: Minnesota
To protect yourself
Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.
“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.
Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.
“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
Keep good records
If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.
“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
Keep an eye on malpractice insurance rates
It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.
He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.
“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”
Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.
“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.
In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
Key takeaways
Ultimately, to protect yourself and your practice, you can do the following:
- Know the statute of limitations and discovery rules for your state.
- Review your coverage with your insurer to better understand your liability.
- Keep accurate records for as long as your statute requires.
- Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.
“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”
A version of this article first appeared on Medscape.com.
A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?
As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.
“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.
Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.
In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
Time of injury versus time of discovery
Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.
This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.
Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.
Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.
“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.
Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
Medical malpractice statutes of limitations by state
Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”
In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
Statutes of limitations by state
1 Year: California, Kentucky, Louisiana, Ohio, Tennessee
2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming
2.5 Years: New York
3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin
4 Years: Minnesota
To protect yourself
Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.
“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.
Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.
“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
Keep good records
If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.
“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
Keep an eye on malpractice insurance rates
It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.
He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.
“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”
Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.
“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.
In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
Key takeaways
Ultimately, to protect yourself and your practice, you can do the following:
- Know the statute of limitations and discovery rules for your state.
- Review your coverage with your insurer to better understand your liability.
- Keep accurate records for as long as your statute requires.
- Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.
“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”
A version of this article first appeared on Medscape.com.
Protecting your practice data
While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.
You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.
In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.
A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.
Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.
Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.
Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.
Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.
In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.
Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.
It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.
Backing up data
I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.
Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.
The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.
The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.
You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.
In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.
A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.
Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.
Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.
Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.
Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.
In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.
Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.
It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.
Backing up data
I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.
Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.
The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.
The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
While data protection is important in any industry, it is particularly critical in health care because in addition to the usual financial records, trade secrets, and other valuable data, confidential patient information is also at risk.
You may think that your computer vendor is responsible for safeguarding your data, but third parties can only do so much. And if your data is compromised, the ultimate responsibility is yours – not to mention the financial loss, and the damage to your practice’s reputation.
In addition to the security vulnerabilities inherent in any system, there are external vulnerabilities, such as weak passwords, viruses, and hacking (either externally or internally). And as hardware becomes more and more portable, there is the increasing risk of theft of platforms and storage media containing confidential data.
A close and ongoing relationship with your hardware and software vendors is essential to good data protection. Your office should have a permanent contact at each company, and you should talk to them regularly. Ask them what sort of firewalls, antivirus software, and other safeguards are in place to protect your system. Whenever they identify a bug or other vulnerability, you should know about it. They should tell you about each software update, what improvements it makes, and what defects it fixes. You should also know about any changes to your data encryption.
Encryption has become an essential component of data protection. It is especially important if you use portable devices such as laptops, pads, or smart phones to store and transport patient information. If you lose one of these devices, or a thumb drive or other storage media, HIPAA will probably not consider it a breach if the data it contains is encrypted.
Encryption isn’t perfect, of course. Log-in credentials can be stolen; and data that is stored in house is can be hacked with malware and phishing techniques, especially if the key to decryption is located on that server. And make sure that employees are not putting any medical data on their own private (unencrypted) devices.
Each employee should have his or her own password, and sharing should be strictly prohibited. Multifactor authentication is becoming increasingly popular for an extra level of security.
Your vendor should require you to change your passwords every few months. If it doesn’t, you need to establish a timetable to do it yourself. All passwords should be strong (no birthdays, pet names, etc.), and they shouldn’t be the same or similar to old passwords.
In some offices, I’ve been surprised to see that every employee has unrestricted access to all practice data. The vulnerabilities of such an arrangement are obvious. There is no reason why receptionists, for example, should have access to medical histories, and insurance people don’t need to know what medications a patient is on. Your vendor can help you design partitions that restrict each employee to only the information they need access to.
Ask if your vendor provides security training for employees. If not, look into hiring a security firm to do it. Regular security training can help employees to recognize data security attacks like phishing, and instills a heightened sense of security awareness and vigilance among staff. They will also gain a better understanding of the role they play in maintaining the overall security of your office.
It goes without saying that third parties, such as business vendors, payers, and managed care providers, should never have access to patient records or other personal health information.
Backing up data
I have written many times about the importance of regularly backing up your data. Industry statistics show that fully 10% of hard drives fail in any given year, and 43% of computer users lose one or more files every year in the form of clinical data, financial records, photos, email, documents, and other important information. Recovery of lost data, when it’s possible at all, can be very expensive.
Even if your EHR vendor backs up your data, you should consider making a separate backup of your own. Backup drives have been known to fail too; and if you decide to switch computer vendors, you don’t want to be at the mercy of the old company that might be reluctant to transfer your data without a hefty payment.
The first rule of backing up is to store your backup drives in a different location from your computers. Unfortunately, that’s a pain; and external drives can be lost or stolen, creating a HIPAA nightmare. So an increasingly popular alternative is automatic remote backup. Several companies offer that service, and the cost is very reasonable for individual computers. Backing up an entire office costs more, depending on how many computers and/or servers you have, but it’s still very reasonable and includes other services, such as operating system and network share support.
The procedure is simple: You create an account and tell the service which files you want copied. Your first backup can take a long time, often days, depending on how much data you are sending and how fast your Internet connection runs. After that the program runs in the background, copying only those files that have changed since the previous backup. Files are encrypted before leaving your computer, and they remain encrypted at the service’s data center, making them HIPAA compliant and, theoretically, only accessible by you.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
Insurers poised to crack down on off-label Ozempic prescriptions
The warning letters, first reported by The Washington Post, include threats such as the possibility of reporting “suspected inappropriate or fraudulent activity ... to the state licensure board, federal and/or state law enforcement.”
It’s the latest chapter in the story of the popular, highly effective, and very expensive drug intended for diabetes that results in quick weight loss. Off-label prescribing means a medicine has been prescribed for a reason other than the uses approved by the Food and Drug Administration. The practice is common and legal (the U.S. Agency for Healthcare Research and Quality says one in five prescriptions in the U.S. are off label).
But insurance companies are pushing back because many do not cover weight loss medications, while they do cover diabetes treatments. The insurance company letters suggest that prescribers are failing to document in a person’s medical record that the person actually has diabetes.
Ozempic, which is FDA approved for treatment of diabetes, is similar to the drug Wegovy, which is approved to be used for weight loss. Ozempic typically costs more than $900 per month. Both Wegovy and Ozempic contain semaglutide, which mimics a hormone that helps the brain regulate appetite and food intake. Clinical studies show that after taking semaglutide for more than 5 years, people lose on average 17% of their body weight. But once they stop taking it, most people regain much of the weight.
Demand for both Ozempic and Wegovy has been surging, leading to shortages and tactics to acquire the drugs outside of the United States, as well as warnings from public health officials about the dangers of knockoff versions of the drugs. The Centers for Disease Control and Prevention says 42% of people in the United States are obese.
“Obesity is a complex disease involving an excessive amount of body fat,” the Mayo Clinic explained. “Obesity isn’t just a cosmetic concern. It’s a medical problem that increases the risk of other diseases and health problems, such as heart disease, diabetes, high blood pressure, and certain cancers.”
A version of this article first appeared on WebMD.com.
The warning letters, first reported by The Washington Post, include threats such as the possibility of reporting “suspected inappropriate or fraudulent activity ... to the state licensure board, federal and/or state law enforcement.”
It’s the latest chapter in the story of the popular, highly effective, and very expensive drug intended for diabetes that results in quick weight loss. Off-label prescribing means a medicine has been prescribed for a reason other than the uses approved by the Food and Drug Administration. The practice is common and legal (the U.S. Agency for Healthcare Research and Quality says one in five prescriptions in the U.S. are off label).
But insurance companies are pushing back because many do not cover weight loss medications, while they do cover diabetes treatments. The insurance company letters suggest that prescribers are failing to document in a person’s medical record that the person actually has diabetes.
Ozempic, which is FDA approved for treatment of diabetes, is similar to the drug Wegovy, which is approved to be used for weight loss. Ozempic typically costs more than $900 per month. Both Wegovy and Ozempic contain semaglutide, which mimics a hormone that helps the brain regulate appetite and food intake. Clinical studies show that after taking semaglutide for more than 5 years, people lose on average 17% of their body weight. But once they stop taking it, most people regain much of the weight.
Demand for both Ozempic and Wegovy has been surging, leading to shortages and tactics to acquire the drugs outside of the United States, as well as warnings from public health officials about the dangers of knockoff versions of the drugs. The Centers for Disease Control and Prevention says 42% of people in the United States are obese.
“Obesity is a complex disease involving an excessive amount of body fat,” the Mayo Clinic explained. “Obesity isn’t just a cosmetic concern. It’s a medical problem that increases the risk of other diseases and health problems, such as heart disease, diabetes, high blood pressure, and certain cancers.”
A version of this article first appeared on WebMD.com.
The warning letters, first reported by The Washington Post, include threats such as the possibility of reporting “suspected inappropriate or fraudulent activity ... to the state licensure board, federal and/or state law enforcement.”
It’s the latest chapter in the story of the popular, highly effective, and very expensive drug intended for diabetes that results in quick weight loss. Off-label prescribing means a medicine has been prescribed for a reason other than the uses approved by the Food and Drug Administration. The practice is common and legal (the U.S. Agency for Healthcare Research and Quality says one in five prescriptions in the U.S. are off label).
But insurance companies are pushing back because many do not cover weight loss medications, while they do cover diabetes treatments. The insurance company letters suggest that prescribers are failing to document in a person’s medical record that the person actually has diabetes.
Ozempic, which is FDA approved for treatment of diabetes, is similar to the drug Wegovy, which is approved to be used for weight loss. Ozempic typically costs more than $900 per month. Both Wegovy and Ozempic contain semaglutide, which mimics a hormone that helps the brain regulate appetite and food intake. Clinical studies show that after taking semaglutide for more than 5 years, people lose on average 17% of their body weight. But once they stop taking it, most people regain much of the weight.
Demand for both Ozempic and Wegovy has been surging, leading to shortages and tactics to acquire the drugs outside of the United States, as well as warnings from public health officials about the dangers of knockoff versions of the drugs. The Centers for Disease Control and Prevention says 42% of people in the United States are obese.
“Obesity is a complex disease involving an excessive amount of body fat,” the Mayo Clinic explained. “Obesity isn’t just a cosmetic concern. It’s a medical problem that increases the risk of other diseases and health problems, such as heart disease, diabetes, high blood pressure, and certain cancers.”
A version of this article first appeared on WebMD.com.
Popular weight loss drugs can carry some unpleasant side effects
Johnna Mendenall had never been “the skinny friend,” she said, but the demands of motherhood – along with a sedentary desk job – made weight management even more difficult. Worried that family type 2 diabetes would catch up with her, she decided to start Wegovy shots for weight loss.
She was nervous about potential side effects. It took 5 days of staring at the Wegovy pen before she worked up the nerve for her first .25-milligram shot. And sure enough, the side effects came on strong.
“The nausea kicked in,” she said. “When I increased my dose to 1 milligram, I spent the entire night from 10 p.m. to 5 a.m. vomiting. I almost quit that day.”
While gastrointestinal (GI) symptoms seem to be the most common, a laundry list of others has been discussed in the news, on TikTok, and across online forums. Those include “Ozempic face,” or the gaunt look some get after taking the medication, along with hair loss, anxiety, depression, and debilitating fatigue.
Ms. Mendenall’s primary side effects have been vomiting, fatigue, and severe constipation, but she has also seen some positive changes: The “food noise,” or the urge to eat when she isn’t hungry, is gone. Since her first dose 12 weeks ago, she has gone from 236 pounds to 215.
Warning label
Wegovy’s active ingredient, semaglutide, mimics the role of a natural hormone called glucagonlike peptide–1 (GLP-1), which helps you feel well fed. Semaglutide is used at a lower dose under the brand name Ozempic, which is approved for type 2 diabetes and used off-label for weight loss.
Both Ozempic and Wegovy come with a warning label for potential side effects, the most common ones being nausea, diarrhea, stomach pain, and vomiting.
With the surging popularity of semaglutide, more people are getting prescriptions through telemedicine companies, forgoing more in-depth consultations, leading to more side effects, said Caroline Apovian, MD, professor of medicine at Harvard Medical School and codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital, Boston.
Specialists say starting with low doses and gradually increasing over time helps avoid side effects, but insurance companies often require a faster timeline to continue covering the medication, Dr. Apovian said.
“Insurance companies are practicing medicine for us by demanding the patient go up in dosage [too quickly],” she explained.
Ms. Mendenall’s insurance has paid for her Wegovy shots, but without that coverage, she said it would cost her $1,200 per month.
There are similar medications on the market, such as liraglutide, sold under the name Saxenda. But it is a daily, rather than a weekly, shot and also comes with side effects and has been shown to be less effective. In one clinical trial, the people being studied saw their average body weight over 68 weeks drop by 15.8% with semaglutide, and by 6.4% with liraglutide.
Tirzepatide, branded Mounjaro – a type 2 diabetes drug made by Eli Lilly that may soon gain Food and Drug Administration approval for weight loss – could have fewer side effects. In clinical trials, 44% of those taking semaglutide had nausea and 31% reported diarrhea, compared with 33% and 23% of those taking tirzepatide, although no trial has directly compared the two agents.
Loss of bowel control
For now, Wegovy and Saxenda are the only GLP-1 agonist shots authorized for weight loss, and their maker, Danish drug company Novo Nordisk, is facing its second shortage of Wegovy amid growing demand.
Personal stories online about semaglutide range from overwhelmingly positive – just what some need to win a lifelong battle with obesity – to harsh scenarios with potentially long-term health consequences, and everything in between.
One private community on Reddit is dedicated to a particularly unpleasant side effect: loss of bowel control while sleeping. Others have reported uncontrollable vomiting.
Kimberly Carew of Clearwater, Fla., started on .5 milligrams of Ozempic last year after her rheumatologist and endocrinologist suggested it to treat her type 2 diabetes. She was told it came with the bonus of weight loss, which she was hoping would help with her joint and back pain.
But after she increased the dose to 1 milligram, her GI symptoms, which started out mild, became unbearable. She couldn’t keep food down, and when she vomited, the food would often come up whole, she said.
“One night I ate ramen before bed. And the next morning, it came out just as it went down,” said Ms. Carew, 42, a registered mental health counseling intern. “I was getting severe heartburn and could not take a couple bites of food without getting nauseous.”
She also had “sulfur burps,” a side effect discussed by some Ozempic users, causing her to taste rotten egg sometimes.
She was diagnosed with gastroparesis. Some types of gastroparesis can be resolved by discontinuing GLP-1 medications, as referenced in two case reports in the Journal of Investigative Medicine.
Gut hormone
GI symptoms are most common with semaglutide because the hormone it imitates, GLP-1, is secreted by cells in the stomach, small intestines, and pancreas, said Anne Peters, MD, director of the USC Clinical Diabetes Programs.
“This is the deal: The side effects are real because it’s a gut hormone. It’s increasing the level of something your body already has,” she said.
But, like Dr. Apovian, Dr. Peters said those side effects can likely be avoided if shots are started at the lowest doses and gradually adjusted up.
While the average starting dose is .25 milligrams, Dr. Peters said she often starts her patients on about an eighth of that – just “a whiff of a dose.”
“It’ll take them months to get up to the starting dose, but what’s the rush?”
Dr. Peters said she also avoids giving diabetes patients the maximum dose, which is 2 milligrams per week for Ozempic (and 2.4 milligrams for Wegovy for weight loss).
When asked about the drugs’ side effects, Novo Nordisk responded that “GLP-1 receptor agonists are a well-established class of medicines, which have demonstrated long-term safety in clinical trials. The most common adverse reactions, as with all GLP-1 [agonists], are gastrointestinal related.”
Is it the drug or the weight loss?
Still, non-gastrointestinal side effects such as hair loss, mood changes, and sunken facial features are reported among semaglutide users across the Internet. While these cases are often anecdotal, they can be very heartfelt.
Celina Horvath Myers, also known as CelinaSpookyBoo, a Canadian YouTuber who took Ozempic for type 2 diabetes, said she began having intense panic attacks and depression after starting the medication.
“Who I have been these last couple weeks, has probably been the scariest time of my life,” she said on her YouTube channel.
While severe depression and anxiety are not established side effects of the medication, some people get anhedonia, said W. Scott Butsch, MD, MSc, director of obesity medicine in the Bariatric and Metabolic Institute at Cleveland Clinic. But that could be a natural consequence of lower appetite, he said, given that food gives most people pleasure in the moment.
Many other reported changes come from the weight loss itself, not the medication, said Dr. Butsch.
“These are drugs that change the body’s weight regulatory system,” he said. “When someone loses weight, you get the shrinking of the fat cells, as well as the atrophy of the muscles. This rapid weight loss may give the appearance of one’s face changing.”
For some people, like Ms. Mendenall, the side effects are worth it. For others, like Ms. Carew, they’re intolerable.
Ms. Carew said she stopped the medication after about 7 months, and gradually worked up to eating solid foods again.
“It’s the American way, we’ve all got to be thin and beautiful,” she said. “But I feel like it’s very unsafe because we just don’t know how seriously our bodies will react to these things in the long term. People see it as a quick fix, but it comes with risks.”
A version of this article first appeared on WebMD.com.
Johnna Mendenall had never been “the skinny friend,” she said, but the demands of motherhood – along with a sedentary desk job – made weight management even more difficult. Worried that family type 2 diabetes would catch up with her, she decided to start Wegovy shots for weight loss.
She was nervous about potential side effects. It took 5 days of staring at the Wegovy pen before she worked up the nerve for her first .25-milligram shot. And sure enough, the side effects came on strong.
“The nausea kicked in,” she said. “When I increased my dose to 1 milligram, I spent the entire night from 10 p.m. to 5 a.m. vomiting. I almost quit that day.”
While gastrointestinal (GI) symptoms seem to be the most common, a laundry list of others has been discussed in the news, on TikTok, and across online forums. Those include “Ozempic face,” or the gaunt look some get after taking the medication, along with hair loss, anxiety, depression, and debilitating fatigue.
Ms. Mendenall’s primary side effects have been vomiting, fatigue, and severe constipation, but she has also seen some positive changes: The “food noise,” or the urge to eat when she isn’t hungry, is gone. Since her first dose 12 weeks ago, she has gone from 236 pounds to 215.
Warning label
Wegovy’s active ingredient, semaglutide, mimics the role of a natural hormone called glucagonlike peptide–1 (GLP-1), which helps you feel well fed. Semaglutide is used at a lower dose under the brand name Ozempic, which is approved for type 2 diabetes and used off-label for weight loss.
Both Ozempic and Wegovy come with a warning label for potential side effects, the most common ones being nausea, diarrhea, stomach pain, and vomiting.
With the surging popularity of semaglutide, more people are getting prescriptions through telemedicine companies, forgoing more in-depth consultations, leading to more side effects, said Caroline Apovian, MD, professor of medicine at Harvard Medical School and codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital, Boston.
Specialists say starting with low doses and gradually increasing over time helps avoid side effects, but insurance companies often require a faster timeline to continue covering the medication, Dr. Apovian said.
“Insurance companies are practicing medicine for us by demanding the patient go up in dosage [too quickly],” she explained.
Ms. Mendenall’s insurance has paid for her Wegovy shots, but without that coverage, she said it would cost her $1,200 per month.
There are similar medications on the market, such as liraglutide, sold under the name Saxenda. But it is a daily, rather than a weekly, shot and also comes with side effects and has been shown to be less effective. In one clinical trial, the people being studied saw their average body weight over 68 weeks drop by 15.8% with semaglutide, and by 6.4% with liraglutide.
Tirzepatide, branded Mounjaro – a type 2 diabetes drug made by Eli Lilly that may soon gain Food and Drug Administration approval for weight loss – could have fewer side effects. In clinical trials, 44% of those taking semaglutide had nausea and 31% reported diarrhea, compared with 33% and 23% of those taking tirzepatide, although no trial has directly compared the two agents.
Loss of bowel control
For now, Wegovy and Saxenda are the only GLP-1 agonist shots authorized for weight loss, and their maker, Danish drug company Novo Nordisk, is facing its second shortage of Wegovy amid growing demand.
Personal stories online about semaglutide range from overwhelmingly positive – just what some need to win a lifelong battle with obesity – to harsh scenarios with potentially long-term health consequences, and everything in between.
One private community on Reddit is dedicated to a particularly unpleasant side effect: loss of bowel control while sleeping. Others have reported uncontrollable vomiting.
Kimberly Carew of Clearwater, Fla., started on .5 milligrams of Ozempic last year after her rheumatologist and endocrinologist suggested it to treat her type 2 diabetes. She was told it came with the bonus of weight loss, which she was hoping would help with her joint and back pain.
But after she increased the dose to 1 milligram, her GI symptoms, which started out mild, became unbearable. She couldn’t keep food down, and when she vomited, the food would often come up whole, she said.
“One night I ate ramen before bed. And the next morning, it came out just as it went down,” said Ms. Carew, 42, a registered mental health counseling intern. “I was getting severe heartburn and could not take a couple bites of food without getting nauseous.”
She also had “sulfur burps,” a side effect discussed by some Ozempic users, causing her to taste rotten egg sometimes.
She was diagnosed with gastroparesis. Some types of gastroparesis can be resolved by discontinuing GLP-1 medications, as referenced in two case reports in the Journal of Investigative Medicine.
Gut hormone
GI symptoms are most common with semaglutide because the hormone it imitates, GLP-1, is secreted by cells in the stomach, small intestines, and pancreas, said Anne Peters, MD, director of the USC Clinical Diabetes Programs.
“This is the deal: The side effects are real because it’s a gut hormone. It’s increasing the level of something your body already has,” she said.
But, like Dr. Apovian, Dr. Peters said those side effects can likely be avoided if shots are started at the lowest doses and gradually adjusted up.
While the average starting dose is .25 milligrams, Dr. Peters said she often starts her patients on about an eighth of that – just “a whiff of a dose.”
“It’ll take them months to get up to the starting dose, but what’s the rush?”
Dr. Peters said she also avoids giving diabetes patients the maximum dose, which is 2 milligrams per week for Ozempic (and 2.4 milligrams for Wegovy for weight loss).
When asked about the drugs’ side effects, Novo Nordisk responded that “GLP-1 receptor agonists are a well-established class of medicines, which have demonstrated long-term safety in clinical trials. The most common adverse reactions, as with all GLP-1 [agonists], are gastrointestinal related.”
Is it the drug or the weight loss?
Still, non-gastrointestinal side effects such as hair loss, mood changes, and sunken facial features are reported among semaglutide users across the Internet. While these cases are often anecdotal, they can be very heartfelt.
Celina Horvath Myers, also known as CelinaSpookyBoo, a Canadian YouTuber who took Ozempic for type 2 diabetes, said she began having intense panic attacks and depression after starting the medication.
“Who I have been these last couple weeks, has probably been the scariest time of my life,” she said on her YouTube channel.
While severe depression and anxiety are not established side effects of the medication, some people get anhedonia, said W. Scott Butsch, MD, MSc, director of obesity medicine in the Bariatric and Metabolic Institute at Cleveland Clinic. But that could be a natural consequence of lower appetite, he said, given that food gives most people pleasure in the moment.
Many other reported changes come from the weight loss itself, not the medication, said Dr. Butsch.
“These are drugs that change the body’s weight regulatory system,” he said. “When someone loses weight, you get the shrinking of the fat cells, as well as the atrophy of the muscles. This rapid weight loss may give the appearance of one’s face changing.”
For some people, like Ms. Mendenall, the side effects are worth it. For others, like Ms. Carew, they’re intolerable.
Ms. Carew said she stopped the medication after about 7 months, and gradually worked up to eating solid foods again.
“It’s the American way, we’ve all got to be thin and beautiful,” she said. “But I feel like it’s very unsafe because we just don’t know how seriously our bodies will react to these things in the long term. People see it as a quick fix, but it comes with risks.”
A version of this article first appeared on WebMD.com.
Johnna Mendenall had never been “the skinny friend,” she said, but the demands of motherhood – along with a sedentary desk job – made weight management even more difficult. Worried that family type 2 diabetes would catch up with her, she decided to start Wegovy shots for weight loss.
She was nervous about potential side effects. It took 5 days of staring at the Wegovy pen before she worked up the nerve for her first .25-milligram shot. And sure enough, the side effects came on strong.
“The nausea kicked in,” she said. “When I increased my dose to 1 milligram, I spent the entire night from 10 p.m. to 5 a.m. vomiting. I almost quit that day.”
While gastrointestinal (GI) symptoms seem to be the most common, a laundry list of others has been discussed in the news, on TikTok, and across online forums. Those include “Ozempic face,” or the gaunt look some get after taking the medication, along with hair loss, anxiety, depression, and debilitating fatigue.
Ms. Mendenall’s primary side effects have been vomiting, fatigue, and severe constipation, but she has also seen some positive changes: The “food noise,” or the urge to eat when she isn’t hungry, is gone. Since her first dose 12 weeks ago, she has gone from 236 pounds to 215.
Warning label
Wegovy’s active ingredient, semaglutide, mimics the role of a natural hormone called glucagonlike peptide–1 (GLP-1), which helps you feel well fed. Semaglutide is used at a lower dose under the brand name Ozempic, which is approved for type 2 diabetes and used off-label for weight loss.
Both Ozempic and Wegovy come with a warning label for potential side effects, the most common ones being nausea, diarrhea, stomach pain, and vomiting.
With the surging popularity of semaglutide, more people are getting prescriptions through telemedicine companies, forgoing more in-depth consultations, leading to more side effects, said Caroline Apovian, MD, professor of medicine at Harvard Medical School and codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital, Boston.
Specialists say starting with low doses and gradually increasing over time helps avoid side effects, but insurance companies often require a faster timeline to continue covering the medication, Dr. Apovian said.
“Insurance companies are practicing medicine for us by demanding the patient go up in dosage [too quickly],” she explained.
Ms. Mendenall’s insurance has paid for her Wegovy shots, but without that coverage, she said it would cost her $1,200 per month.
There are similar medications on the market, such as liraglutide, sold under the name Saxenda. But it is a daily, rather than a weekly, shot and also comes with side effects and has been shown to be less effective. In one clinical trial, the people being studied saw their average body weight over 68 weeks drop by 15.8% with semaglutide, and by 6.4% with liraglutide.
Tirzepatide, branded Mounjaro – a type 2 diabetes drug made by Eli Lilly that may soon gain Food and Drug Administration approval for weight loss – could have fewer side effects. In clinical trials, 44% of those taking semaglutide had nausea and 31% reported diarrhea, compared with 33% and 23% of those taking tirzepatide, although no trial has directly compared the two agents.
Loss of bowel control
For now, Wegovy and Saxenda are the only GLP-1 agonist shots authorized for weight loss, and their maker, Danish drug company Novo Nordisk, is facing its second shortage of Wegovy amid growing demand.
Personal stories online about semaglutide range from overwhelmingly positive – just what some need to win a lifelong battle with obesity – to harsh scenarios with potentially long-term health consequences, and everything in between.
One private community on Reddit is dedicated to a particularly unpleasant side effect: loss of bowel control while sleeping. Others have reported uncontrollable vomiting.
Kimberly Carew of Clearwater, Fla., started on .5 milligrams of Ozempic last year after her rheumatologist and endocrinologist suggested it to treat her type 2 diabetes. She was told it came with the bonus of weight loss, which she was hoping would help with her joint and back pain.
But after she increased the dose to 1 milligram, her GI symptoms, which started out mild, became unbearable. She couldn’t keep food down, and when she vomited, the food would often come up whole, she said.
“One night I ate ramen before bed. And the next morning, it came out just as it went down,” said Ms. Carew, 42, a registered mental health counseling intern. “I was getting severe heartburn and could not take a couple bites of food without getting nauseous.”
She also had “sulfur burps,” a side effect discussed by some Ozempic users, causing her to taste rotten egg sometimes.
She was diagnosed with gastroparesis. Some types of gastroparesis can be resolved by discontinuing GLP-1 medications, as referenced in two case reports in the Journal of Investigative Medicine.
Gut hormone
GI symptoms are most common with semaglutide because the hormone it imitates, GLP-1, is secreted by cells in the stomach, small intestines, and pancreas, said Anne Peters, MD, director of the USC Clinical Diabetes Programs.
“This is the deal: The side effects are real because it’s a gut hormone. It’s increasing the level of something your body already has,” she said.
But, like Dr. Apovian, Dr. Peters said those side effects can likely be avoided if shots are started at the lowest doses and gradually adjusted up.
While the average starting dose is .25 milligrams, Dr. Peters said she often starts her patients on about an eighth of that – just “a whiff of a dose.”
“It’ll take them months to get up to the starting dose, but what’s the rush?”
Dr. Peters said she also avoids giving diabetes patients the maximum dose, which is 2 milligrams per week for Ozempic (and 2.4 milligrams for Wegovy for weight loss).
When asked about the drugs’ side effects, Novo Nordisk responded that “GLP-1 receptor agonists are a well-established class of medicines, which have demonstrated long-term safety in clinical trials. The most common adverse reactions, as with all GLP-1 [agonists], are gastrointestinal related.”
Is it the drug or the weight loss?
Still, non-gastrointestinal side effects such as hair loss, mood changes, and sunken facial features are reported among semaglutide users across the Internet. While these cases are often anecdotal, they can be very heartfelt.
Celina Horvath Myers, also known as CelinaSpookyBoo, a Canadian YouTuber who took Ozempic for type 2 diabetes, said she began having intense panic attacks and depression after starting the medication.
“Who I have been these last couple weeks, has probably been the scariest time of my life,” she said on her YouTube channel.
While severe depression and anxiety are not established side effects of the medication, some people get anhedonia, said W. Scott Butsch, MD, MSc, director of obesity medicine in the Bariatric and Metabolic Institute at Cleveland Clinic. But that could be a natural consequence of lower appetite, he said, given that food gives most people pleasure in the moment.
Many other reported changes come from the weight loss itself, not the medication, said Dr. Butsch.
“These are drugs that change the body’s weight regulatory system,” he said. “When someone loses weight, you get the shrinking of the fat cells, as well as the atrophy of the muscles. This rapid weight loss may give the appearance of one’s face changing.”
For some people, like Ms. Mendenall, the side effects are worth it. For others, like Ms. Carew, they’re intolerable.
Ms. Carew said she stopped the medication after about 7 months, and gradually worked up to eating solid foods again.
“It’s the American way, we’ve all got to be thin and beautiful,” she said. “But I feel like it’s very unsafe because we just don’t know how seriously our bodies will react to these things in the long term. People see it as a quick fix, but it comes with risks.”
A version of this article first appeared on WebMD.com.
FDA approves first-ever OTC erectile dysfunction gel
The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe.
The Food and Drug Administration has approved the drug, called Eroxon, noting that it is a first-of-its-kind treatment. Eroxon is made by the British pharmaceutical company Futura Medical, which specializes in drugs that are given through the skin.
According to the product’s leaflet, Eroxon “stimulates blood flow in the penis through a unique physical cooling then warming effect, helping you get and keep an erection hard enough for sex.” The company said on the product’s website that 65% of people who used the drug were able to have sex.
A company spokesperson told CNN that the price of the product has not been set in the United States, but it costs the equivalent of about $31 in the United Kingdom. Futura Medical has not announced when it will be available in the United States.
Harvard Health reports that 30 million people in the United States have erectile dysfunction, which means a person cannot get an erection at all or one firm enough to have sex. The disorder is often linked to other physical or mental health problems, such as heart problems or clogged arteries.
Erectile dysfunction affects 1% of men in their 40s, 17% of men in their 60s, and nearly 50% of men who are age 75 or older, according to Harvard Health.
A version of this article originally appeared on WebMD.com.
The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe.
The Food and Drug Administration has approved the drug, called Eroxon, noting that it is a first-of-its-kind treatment. Eroxon is made by the British pharmaceutical company Futura Medical, which specializes in drugs that are given through the skin.
According to the product’s leaflet, Eroxon “stimulates blood flow in the penis through a unique physical cooling then warming effect, helping you get and keep an erection hard enough for sex.” The company said on the product’s website that 65% of people who used the drug were able to have sex.
A company spokesperson told CNN that the price of the product has not been set in the United States, but it costs the equivalent of about $31 in the United Kingdom. Futura Medical has not announced when it will be available in the United States.
Harvard Health reports that 30 million people in the United States have erectile dysfunction, which means a person cannot get an erection at all or one firm enough to have sex. The disorder is often linked to other physical or mental health problems, such as heart problems or clogged arteries.
Erectile dysfunction affects 1% of men in their 40s, 17% of men in their 60s, and nearly 50% of men who are age 75 or older, according to Harvard Health.
A version of this article originally appeared on WebMD.com.
The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe.
The Food and Drug Administration has approved the drug, called Eroxon, noting that it is a first-of-its-kind treatment. Eroxon is made by the British pharmaceutical company Futura Medical, which specializes in drugs that are given through the skin.
According to the product’s leaflet, Eroxon “stimulates blood flow in the penis through a unique physical cooling then warming effect, helping you get and keep an erection hard enough for sex.” The company said on the product’s website that 65% of people who used the drug were able to have sex.
A company spokesperson told CNN that the price of the product has not been set in the United States, but it costs the equivalent of about $31 in the United Kingdom. Futura Medical has not announced when it will be available in the United States.
Harvard Health reports that 30 million people in the United States have erectile dysfunction, which means a person cannot get an erection at all or one firm enough to have sex. The disorder is often linked to other physical or mental health problems, such as heart problems or clogged arteries.
Erectile dysfunction affects 1% of men in their 40s, 17% of men in their 60s, and nearly 50% of men who are age 75 or older, according to Harvard Health.
A version of this article originally appeared on WebMD.com.
Could semaglutide treat addiction as well as obesity?
As demand for semaglutide for weight loss grew following approval of Wegovy by the U.S. Food and Drug Administration in 2021, anecdotal reports of unexpected potential added benefits also began to surface.
Some patients taking these drugs for type 2 diabetes or weight loss also lost interest in addictive and compulsive behaviors such as drinking alcohol, smoking, shopping, nail biting, and skin picking, as reported in articles in the New York Times and The Atlantic, among others.
There is also some preliminary research to support these observations.
This news organization invited three experts to weigh in.
Recent and upcoming studies
The senior author of a recent randomized controlled trial of 127 patients with alcohol use disorder (AUD), Anders Fink-Jensen, MD, said: “I hope that GLP-1 analogs in the future can be used against AUD, but before that can happen, several GLP-1 trials [are needed to] prove an effect on alcohol intake.”
His study involved patients who received exenatide (Byetta, Bydureon, AstraZeneca), the first-generation GLP-1 agonist approved for type 2 diabetes, over 26 weeks, but treatment did not reduce the number of heavy drinking days (the primary outcome), compared with placebo.
However, in post hoc, exploratory analyses, heavy drinking days and total alcohol intake were significantly reduced in the subgroup of patients with AUD and obesity (body mass index > 30 kg/m2).
The participants were also shown pictures of alcohol or neutral subjects while they underwent functional magnetic resonance imaging. Those who had received exenatide, compared with placebo, had significantly less activation of brain reward centers when shown the pictures of alcohol.
“Something is happening in the brain and activation of the reward center is hampered by the GLP-1 compound,” Dr. Fink-Jensen, a clinical psychologist at the Psychiatric Centre Copenhagen, remarked in an email.
“If patients with AUD already fulfill the criteria for semaglutide (or other GLP-1 analogs) by having type 2 diabetes and/or a BMI over 30 kg/m2, they can of course use the compound right now,” he noted.
His team is also beginning a study in patients with AUD and a BMI ≥ 30 kg/m2 to investigate the effects on alcohol intake of semaglutide up to 2.4 mg weekly, the maximum dose currently approved for obesity in the United States.
“Based on the potency of exenatide and semaglutide,” Dr. Fink-Jensen said, “we expect that semaglutide will cause a stronger reduction in alcohol intake” than exenatide.
Animal studies have also shown that GLP-1 agonists suppress alcohol-induced reward, alcohol intake, motivation to consume alcohol, alcohol seeking, and relapse drinking of alcohol, Elisabet Jerlhag Holm, PhD, noted.
Interestingly, these agents also suppress the reward, intake, and motivation to consume other addictive drugs like cocaine, amphetamine, nicotine, and some opioids, Jerlhag Holm, professor, department of pharmacology, University of Gothenburg, Sweden, noted in an email.
In a recently published preclinical study, her group provides evidence to help explain anecdotal reports from patients with obesity treated with semaglutide who claim they also reduced their alcohol intake. In the study, semaglutide both reduced alcohol intake (and relapse-like drinking) and decreased body weight of rats of both sexes.
“Future research should explore the possibility of semaglutide decreasing alcohol intake in patients with AUD, particularly those who are overweight,” said Prof. Holm.
“AUD is a heterogenous disorder, and one medication is most likely not helpful for all AUD patients,” she added. “Therefore, an arsenal of different medications is beneficial when treating AUD.”
Janice J. Hwang, MD, MHS, echoed these thoughts: “Anecdotally, there are a lot of reports from patients (and in the news) that this class of medication [GLP-1 agonists] impacts cravings and could impact addictive behaviors.”
“I would say, overall, the jury is still out,” as to whether anecdotal reports of GLP-1 agonists curbing addictions will be borne out in randomized controlled trials.
“I think it is much too early to tell” whether these drugs might be approved for treating addictions without more solid clinical trial data, noted Dr. Hwang, who is an associate professor of medicine and chief, division of endocrinology and metabolism, at the University of North Carolina at Chapel Hill.
Meanwhile, another research group at the University of North Carolina at Chapel Hill, led by psychiatrist Christian Hendershot, PhD, is conducting a clinical trial in 48 participants with AUD who are also smokers.
They aim to determine if patients who receive semaglutide at escalating doses (0.25 mg to 1.0 mg per week via subcutaneous injection) over 9 weeks will consume less alcohol (the primary outcome) and smoke less (a secondary outcome) than those who receive a sham placebo injection. Results are expected in October 2023.
Dr. Fink-Jensen has received an unrestricted research grant from Novo Nordisk to investigate the effects of GLP-1 receptor stimulation on weight gain and metabolic disturbances in patients with schizophrenia treated with an antipsychotic.
A version of this article first appeared on Medscape.com.
As demand for semaglutide for weight loss grew following approval of Wegovy by the U.S. Food and Drug Administration in 2021, anecdotal reports of unexpected potential added benefits also began to surface.
Some patients taking these drugs for type 2 diabetes or weight loss also lost interest in addictive and compulsive behaviors such as drinking alcohol, smoking, shopping, nail biting, and skin picking, as reported in articles in the New York Times and The Atlantic, among others.
There is also some preliminary research to support these observations.
This news organization invited three experts to weigh in.
Recent and upcoming studies
The senior author of a recent randomized controlled trial of 127 patients with alcohol use disorder (AUD), Anders Fink-Jensen, MD, said: “I hope that GLP-1 analogs in the future can be used against AUD, but before that can happen, several GLP-1 trials [are needed to] prove an effect on alcohol intake.”
His study involved patients who received exenatide (Byetta, Bydureon, AstraZeneca), the first-generation GLP-1 agonist approved for type 2 diabetes, over 26 weeks, but treatment did not reduce the number of heavy drinking days (the primary outcome), compared with placebo.
However, in post hoc, exploratory analyses, heavy drinking days and total alcohol intake were significantly reduced in the subgroup of patients with AUD and obesity (body mass index > 30 kg/m2).
The participants were also shown pictures of alcohol or neutral subjects while they underwent functional magnetic resonance imaging. Those who had received exenatide, compared with placebo, had significantly less activation of brain reward centers when shown the pictures of alcohol.
“Something is happening in the brain and activation of the reward center is hampered by the GLP-1 compound,” Dr. Fink-Jensen, a clinical psychologist at the Psychiatric Centre Copenhagen, remarked in an email.
“If patients with AUD already fulfill the criteria for semaglutide (or other GLP-1 analogs) by having type 2 diabetes and/or a BMI over 30 kg/m2, they can of course use the compound right now,” he noted.
His team is also beginning a study in patients with AUD and a BMI ≥ 30 kg/m2 to investigate the effects on alcohol intake of semaglutide up to 2.4 mg weekly, the maximum dose currently approved for obesity in the United States.
“Based on the potency of exenatide and semaglutide,” Dr. Fink-Jensen said, “we expect that semaglutide will cause a stronger reduction in alcohol intake” than exenatide.
Animal studies have also shown that GLP-1 agonists suppress alcohol-induced reward, alcohol intake, motivation to consume alcohol, alcohol seeking, and relapse drinking of alcohol, Elisabet Jerlhag Holm, PhD, noted.
Interestingly, these agents also suppress the reward, intake, and motivation to consume other addictive drugs like cocaine, amphetamine, nicotine, and some opioids, Jerlhag Holm, professor, department of pharmacology, University of Gothenburg, Sweden, noted in an email.
In a recently published preclinical study, her group provides evidence to help explain anecdotal reports from patients with obesity treated with semaglutide who claim they also reduced their alcohol intake. In the study, semaglutide both reduced alcohol intake (and relapse-like drinking) and decreased body weight of rats of both sexes.
“Future research should explore the possibility of semaglutide decreasing alcohol intake in patients with AUD, particularly those who are overweight,” said Prof. Holm.
“AUD is a heterogenous disorder, and one medication is most likely not helpful for all AUD patients,” she added. “Therefore, an arsenal of different medications is beneficial when treating AUD.”
Janice J. Hwang, MD, MHS, echoed these thoughts: “Anecdotally, there are a lot of reports from patients (and in the news) that this class of medication [GLP-1 agonists] impacts cravings and could impact addictive behaviors.”
“I would say, overall, the jury is still out,” as to whether anecdotal reports of GLP-1 agonists curbing addictions will be borne out in randomized controlled trials.
“I think it is much too early to tell” whether these drugs might be approved for treating addictions without more solid clinical trial data, noted Dr. Hwang, who is an associate professor of medicine and chief, division of endocrinology and metabolism, at the University of North Carolina at Chapel Hill.
Meanwhile, another research group at the University of North Carolina at Chapel Hill, led by psychiatrist Christian Hendershot, PhD, is conducting a clinical trial in 48 participants with AUD who are also smokers.
They aim to determine if patients who receive semaglutide at escalating doses (0.25 mg to 1.0 mg per week via subcutaneous injection) over 9 weeks will consume less alcohol (the primary outcome) and smoke less (a secondary outcome) than those who receive a sham placebo injection. Results are expected in October 2023.
Dr. Fink-Jensen has received an unrestricted research grant from Novo Nordisk to investigate the effects of GLP-1 receptor stimulation on weight gain and metabolic disturbances in patients with schizophrenia treated with an antipsychotic.
A version of this article first appeared on Medscape.com.
As demand for semaglutide for weight loss grew following approval of Wegovy by the U.S. Food and Drug Administration in 2021, anecdotal reports of unexpected potential added benefits also began to surface.
Some patients taking these drugs for type 2 diabetes or weight loss also lost interest in addictive and compulsive behaviors such as drinking alcohol, smoking, shopping, nail biting, and skin picking, as reported in articles in the New York Times and The Atlantic, among others.
There is also some preliminary research to support these observations.
This news organization invited three experts to weigh in.
Recent and upcoming studies
The senior author of a recent randomized controlled trial of 127 patients with alcohol use disorder (AUD), Anders Fink-Jensen, MD, said: “I hope that GLP-1 analogs in the future can be used against AUD, but before that can happen, several GLP-1 trials [are needed to] prove an effect on alcohol intake.”
His study involved patients who received exenatide (Byetta, Bydureon, AstraZeneca), the first-generation GLP-1 agonist approved for type 2 diabetes, over 26 weeks, but treatment did not reduce the number of heavy drinking days (the primary outcome), compared with placebo.
However, in post hoc, exploratory analyses, heavy drinking days and total alcohol intake were significantly reduced in the subgroup of patients with AUD and obesity (body mass index > 30 kg/m2).
The participants were also shown pictures of alcohol or neutral subjects while they underwent functional magnetic resonance imaging. Those who had received exenatide, compared with placebo, had significantly less activation of brain reward centers when shown the pictures of alcohol.
“Something is happening in the brain and activation of the reward center is hampered by the GLP-1 compound,” Dr. Fink-Jensen, a clinical psychologist at the Psychiatric Centre Copenhagen, remarked in an email.
“If patients with AUD already fulfill the criteria for semaglutide (or other GLP-1 analogs) by having type 2 diabetes and/or a BMI over 30 kg/m2, they can of course use the compound right now,” he noted.
His team is also beginning a study in patients with AUD and a BMI ≥ 30 kg/m2 to investigate the effects on alcohol intake of semaglutide up to 2.4 mg weekly, the maximum dose currently approved for obesity in the United States.
“Based on the potency of exenatide and semaglutide,” Dr. Fink-Jensen said, “we expect that semaglutide will cause a stronger reduction in alcohol intake” than exenatide.
Animal studies have also shown that GLP-1 agonists suppress alcohol-induced reward, alcohol intake, motivation to consume alcohol, alcohol seeking, and relapse drinking of alcohol, Elisabet Jerlhag Holm, PhD, noted.
Interestingly, these agents also suppress the reward, intake, and motivation to consume other addictive drugs like cocaine, amphetamine, nicotine, and some opioids, Jerlhag Holm, professor, department of pharmacology, University of Gothenburg, Sweden, noted in an email.
In a recently published preclinical study, her group provides evidence to help explain anecdotal reports from patients with obesity treated with semaglutide who claim they also reduced their alcohol intake. In the study, semaglutide both reduced alcohol intake (and relapse-like drinking) and decreased body weight of rats of both sexes.
“Future research should explore the possibility of semaglutide decreasing alcohol intake in patients with AUD, particularly those who are overweight,” said Prof. Holm.
“AUD is a heterogenous disorder, and one medication is most likely not helpful for all AUD patients,” she added. “Therefore, an arsenal of different medications is beneficial when treating AUD.”
Janice J. Hwang, MD, MHS, echoed these thoughts: “Anecdotally, there are a lot of reports from patients (and in the news) that this class of medication [GLP-1 agonists] impacts cravings and could impact addictive behaviors.”
“I would say, overall, the jury is still out,” as to whether anecdotal reports of GLP-1 agonists curbing addictions will be borne out in randomized controlled trials.
“I think it is much too early to tell” whether these drugs might be approved for treating addictions without more solid clinical trial data, noted Dr. Hwang, who is an associate professor of medicine and chief, division of endocrinology and metabolism, at the University of North Carolina at Chapel Hill.
Meanwhile, another research group at the University of North Carolina at Chapel Hill, led by psychiatrist Christian Hendershot, PhD, is conducting a clinical trial in 48 participants with AUD who are also smokers.
They aim to determine if patients who receive semaglutide at escalating doses (0.25 mg to 1.0 mg per week via subcutaneous injection) over 9 weeks will consume less alcohol (the primary outcome) and smoke less (a secondary outcome) than those who receive a sham placebo injection. Results are expected in October 2023.
Dr. Fink-Jensen has received an unrestricted research grant from Novo Nordisk to investigate the effects of GLP-1 receptor stimulation on weight gain and metabolic disturbances in patients with schizophrenia treated with an antipsychotic.
A version of this article first appeared on Medscape.com.
Hormone therapies still ‘most effective’ in treating menopausal vasomotor symptoms
Despite new options in non–hormone-based treatments,
This recommendation emerged from an updated position statement from the North American Menopause Society in its first review of the scientific literature since 2015. The statement specifically targets nonhormonal management of symptoms such as hot flashes and night sweats, which occur in as many as 80% of menopausal women but are undertreated. The statement appears in the June issue of the Journal of The North American Menopause Society.
“Women with contraindications or objections to hormone treatment should be informed by professionals of evidence-based effective nonhormone treatment options,” stated a NAMS advisory panel led by Chrisandra L. Shufelt, MD, MS, professor and chair of the division of general internal medicine and associate director of the Women’s Health Research Center at the Mayo Clinic in Jacksonville, Fla. The statement is one of multiple NAMS updates performed at regular intervals, said Dr. Shufelt, also past president of NAMS, in an interview. “But the research has changed, and we wanted to make clinicians aware of new medications. One of our interesting findings was more evidence that off-label use of the nonhormonal overactive bladder drug oxybutynin can lower the rate of hot flashes.”
Dr. Shufelt noted that many of the current update’s findings align with previous research, and stressed that the therapeutic recommendations apply specifically to VMS. “Not all menopause-related symptoms are vasomotor, however,” she said. “While a lot of the lifestyle options such as cooling techniques and exercise are not recommended for controlling hot flashes, diet and exercise changes can be beneficial for other health reasons.”
Although it’s the most effective option for VMS, hormone therapy is not suitable for women with contraindications such as a previous blood clot, an estrogen-dependent cancer, a family history of such cancers, or a personal preference against hormone use, Dr. Shufelt added, so nonhormonal alternatives are important to prevent women from wasting time and money on ineffective remedies. “Women need to know what works and what doesn’t,” she said.
Recommended nonhormonal therapies
Based on a rigorous review of the scientific evidence to date, NAMS found the following therapies to be effective: cognitive-behavioral therapy; clinical hypnosis; SSRIs and serotonin-norepinephrine reuptake inhibitors – which yield mild to moderate improvements; gabapentin – which lessens the frequency and severity of hot flashes; fezolinetant (Veozah), a novel first-in-class neurokinin B antagonist that was Food and Drug Administration–approved in May for VSM; and oxybutynin, an antimuscarinic, anticholinergic drug, that reduces moderate to severe VMS, although long-term use in older adults may be linked to cognitive decline, weight loss, and stellate ganglion block.
Therapies that were ineffective, associated with adverse effects (AEs), or lacking adequate evidence of efficacy and thus not recommended for VMS included: paced respiration; supplemental and herbal remedies such as black cohosh, milk thistle, and evening primrose; cooling techniques; trigger avoidance; exercise and yoga; mindfulness-based intervention and relaxation; suvorexant, a dual orexin-receptor antagonist used for insomnia; soy foods, extracts, and the soy metabolite equol; cannabinoids; acupuncture; calibration of neural oscillations; chiropractics; clonidine, an alpha-2 adrenergic agonist that is associated with significant AEs with no recent evidence of benefit over placebo; dietary modification; and pregabalin – which is associated with significant AEs and has controlled-substance prescribing restrictions.
Ultimately, clinicians should individualize menopause care to each patient. For example, “if a patient says that avoiding caffeine in the morning stops her from having hot flashes in the afternoon, that’s fine,” Dr. Shufelt said.
HT still most effective
“This statement is excellent, comprehensive, and evidence-based,” commented Jill M. Rabin MD, vice chair of education and development, obstetrics and gynecology, at Northshore University Hospital/LIJ Medical Center in Manhasset, N.Y., and professor of obstetrics and gynecology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health in Hempstead, N.Y.
Dr. Rabin, coauthor of Mind Over Bladder was not involved in compiling the statement.
She agreed that hormone therapy is the most effective option for VMS and regularly prescribes it for suitable candidates in different forms depending on the type and severity of menopausal symptoms. As for nonhormonal options, Dr. Rabin added in an interview, some of those not recommended in the current NAMS statement could yet prove to be effective as more data accumulate. Suvorexant may be one to watch, for instance, but currently there are not enough data on its effectiveness.
“It’s really important to keep up on this nonhormonal research,” Dr. Rabin said. “As the population ages, more and more women will be in the peri- and postmenopausal periods and some have medical reasons for not taking hormone therapy.” It’s important to recommend nonhormonal therapies of proven benefit according to current high-level evidence, she said, “but also to keep your ear to the ground about those still under investigation.”
As for the lifestyle and alternative remedies of unproven benefit, Dr. Rabin added, there’s little harm in trying them. “As far as I know, no one’s ever died of relaxation and paced breathing.” In addition, a patient’s interaction with and sense of control over her own physiology provided by these techniques may be beneficial in themselves.
Dr. Shufelt reported grant support from the National Institutes of Health. Numerous authors reported consulting fees from and other financial ties to private-sector companies. Dr. Rabin had no relevant competing interests to disclose with regard to her comments.
Despite new options in non–hormone-based treatments,
This recommendation emerged from an updated position statement from the North American Menopause Society in its first review of the scientific literature since 2015. The statement specifically targets nonhormonal management of symptoms such as hot flashes and night sweats, which occur in as many as 80% of menopausal women but are undertreated. The statement appears in the June issue of the Journal of The North American Menopause Society.
“Women with contraindications or objections to hormone treatment should be informed by professionals of evidence-based effective nonhormone treatment options,” stated a NAMS advisory panel led by Chrisandra L. Shufelt, MD, MS, professor and chair of the division of general internal medicine and associate director of the Women’s Health Research Center at the Mayo Clinic in Jacksonville, Fla. The statement is one of multiple NAMS updates performed at regular intervals, said Dr. Shufelt, also past president of NAMS, in an interview. “But the research has changed, and we wanted to make clinicians aware of new medications. One of our interesting findings was more evidence that off-label use of the nonhormonal overactive bladder drug oxybutynin can lower the rate of hot flashes.”
Dr. Shufelt noted that many of the current update’s findings align with previous research, and stressed that the therapeutic recommendations apply specifically to VMS. “Not all menopause-related symptoms are vasomotor, however,” she said. “While a lot of the lifestyle options such as cooling techniques and exercise are not recommended for controlling hot flashes, diet and exercise changes can be beneficial for other health reasons.”
Although it’s the most effective option for VMS, hormone therapy is not suitable for women with contraindications such as a previous blood clot, an estrogen-dependent cancer, a family history of such cancers, or a personal preference against hormone use, Dr. Shufelt added, so nonhormonal alternatives are important to prevent women from wasting time and money on ineffective remedies. “Women need to know what works and what doesn’t,” she said.
Recommended nonhormonal therapies
Based on a rigorous review of the scientific evidence to date, NAMS found the following therapies to be effective: cognitive-behavioral therapy; clinical hypnosis; SSRIs and serotonin-norepinephrine reuptake inhibitors – which yield mild to moderate improvements; gabapentin – which lessens the frequency and severity of hot flashes; fezolinetant (Veozah), a novel first-in-class neurokinin B antagonist that was Food and Drug Administration–approved in May for VSM; and oxybutynin, an antimuscarinic, anticholinergic drug, that reduces moderate to severe VMS, although long-term use in older adults may be linked to cognitive decline, weight loss, and stellate ganglion block.
Therapies that were ineffective, associated with adverse effects (AEs), or lacking adequate evidence of efficacy and thus not recommended for VMS included: paced respiration; supplemental and herbal remedies such as black cohosh, milk thistle, and evening primrose; cooling techniques; trigger avoidance; exercise and yoga; mindfulness-based intervention and relaxation; suvorexant, a dual orexin-receptor antagonist used for insomnia; soy foods, extracts, and the soy metabolite equol; cannabinoids; acupuncture; calibration of neural oscillations; chiropractics; clonidine, an alpha-2 adrenergic agonist that is associated with significant AEs with no recent evidence of benefit over placebo; dietary modification; and pregabalin – which is associated with significant AEs and has controlled-substance prescribing restrictions.
Ultimately, clinicians should individualize menopause care to each patient. For example, “if a patient says that avoiding caffeine in the morning stops her from having hot flashes in the afternoon, that’s fine,” Dr. Shufelt said.
HT still most effective
“This statement is excellent, comprehensive, and evidence-based,” commented Jill M. Rabin MD, vice chair of education and development, obstetrics and gynecology, at Northshore University Hospital/LIJ Medical Center in Manhasset, N.Y., and professor of obstetrics and gynecology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health in Hempstead, N.Y.
Dr. Rabin, coauthor of Mind Over Bladder was not involved in compiling the statement.
She agreed that hormone therapy is the most effective option for VMS and regularly prescribes it for suitable candidates in different forms depending on the type and severity of menopausal symptoms. As for nonhormonal options, Dr. Rabin added in an interview, some of those not recommended in the current NAMS statement could yet prove to be effective as more data accumulate. Suvorexant may be one to watch, for instance, but currently there are not enough data on its effectiveness.
“It’s really important to keep up on this nonhormonal research,” Dr. Rabin said. “As the population ages, more and more women will be in the peri- and postmenopausal periods and some have medical reasons for not taking hormone therapy.” It’s important to recommend nonhormonal therapies of proven benefit according to current high-level evidence, she said, “but also to keep your ear to the ground about those still under investigation.”
As for the lifestyle and alternative remedies of unproven benefit, Dr. Rabin added, there’s little harm in trying them. “As far as I know, no one’s ever died of relaxation and paced breathing.” In addition, a patient’s interaction with and sense of control over her own physiology provided by these techniques may be beneficial in themselves.
Dr. Shufelt reported grant support from the National Institutes of Health. Numerous authors reported consulting fees from and other financial ties to private-sector companies. Dr. Rabin had no relevant competing interests to disclose with regard to her comments.
Despite new options in non–hormone-based treatments,
This recommendation emerged from an updated position statement from the North American Menopause Society in its first review of the scientific literature since 2015. The statement specifically targets nonhormonal management of symptoms such as hot flashes and night sweats, which occur in as many as 80% of menopausal women but are undertreated. The statement appears in the June issue of the Journal of The North American Menopause Society.
“Women with contraindications or objections to hormone treatment should be informed by professionals of evidence-based effective nonhormone treatment options,” stated a NAMS advisory panel led by Chrisandra L. Shufelt, MD, MS, professor and chair of the division of general internal medicine and associate director of the Women’s Health Research Center at the Mayo Clinic in Jacksonville, Fla. The statement is one of multiple NAMS updates performed at regular intervals, said Dr. Shufelt, also past president of NAMS, in an interview. “But the research has changed, and we wanted to make clinicians aware of new medications. One of our interesting findings was more evidence that off-label use of the nonhormonal overactive bladder drug oxybutynin can lower the rate of hot flashes.”
Dr. Shufelt noted that many of the current update’s findings align with previous research, and stressed that the therapeutic recommendations apply specifically to VMS. “Not all menopause-related symptoms are vasomotor, however,” she said. “While a lot of the lifestyle options such as cooling techniques and exercise are not recommended for controlling hot flashes, diet and exercise changes can be beneficial for other health reasons.”
Although it’s the most effective option for VMS, hormone therapy is not suitable for women with contraindications such as a previous blood clot, an estrogen-dependent cancer, a family history of such cancers, or a personal preference against hormone use, Dr. Shufelt added, so nonhormonal alternatives are important to prevent women from wasting time and money on ineffective remedies. “Women need to know what works and what doesn’t,” she said.
Recommended nonhormonal therapies
Based on a rigorous review of the scientific evidence to date, NAMS found the following therapies to be effective: cognitive-behavioral therapy; clinical hypnosis; SSRIs and serotonin-norepinephrine reuptake inhibitors – which yield mild to moderate improvements; gabapentin – which lessens the frequency and severity of hot flashes; fezolinetant (Veozah), a novel first-in-class neurokinin B antagonist that was Food and Drug Administration–approved in May for VSM; and oxybutynin, an antimuscarinic, anticholinergic drug, that reduces moderate to severe VMS, although long-term use in older adults may be linked to cognitive decline, weight loss, and stellate ganglion block.
Therapies that were ineffective, associated with adverse effects (AEs), or lacking adequate evidence of efficacy and thus not recommended for VMS included: paced respiration; supplemental and herbal remedies such as black cohosh, milk thistle, and evening primrose; cooling techniques; trigger avoidance; exercise and yoga; mindfulness-based intervention and relaxation; suvorexant, a dual orexin-receptor antagonist used for insomnia; soy foods, extracts, and the soy metabolite equol; cannabinoids; acupuncture; calibration of neural oscillations; chiropractics; clonidine, an alpha-2 adrenergic agonist that is associated with significant AEs with no recent evidence of benefit over placebo; dietary modification; and pregabalin – which is associated with significant AEs and has controlled-substance prescribing restrictions.
Ultimately, clinicians should individualize menopause care to each patient. For example, “if a patient says that avoiding caffeine in the morning stops her from having hot flashes in the afternoon, that’s fine,” Dr. Shufelt said.
HT still most effective
“This statement is excellent, comprehensive, and evidence-based,” commented Jill M. Rabin MD, vice chair of education and development, obstetrics and gynecology, at Northshore University Hospital/LIJ Medical Center in Manhasset, N.Y., and professor of obstetrics and gynecology at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health in Hempstead, N.Y.
Dr. Rabin, coauthor of Mind Over Bladder was not involved in compiling the statement.
She agreed that hormone therapy is the most effective option for VMS and regularly prescribes it for suitable candidates in different forms depending on the type and severity of menopausal symptoms. As for nonhormonal options, Dr. Rabin added in an interview, some of those not recommended in the current NAMS statement could yet prove to be effective as more data accumulate. Suvorexant may be one to watch, for instance, but currently there are not enough data on its effectiveness.
“It’s really important to keep up on this nonhormonal research,” Dr. Rabin said. “As the population ages, more and more women will be in the peri- and postmenopausal periods and some have medical reasons for not taking hormone therapy.” It’s important to recommend nonhormonal therapies of proven benefit according to current high-level evidence, she said, “but also to keep your ear to the ground about those still under investigation.”
As for the lifestyle and alternative remedies of unproven benefit, Dr. Rabin added, there’s little harm in trying them. “As far as I know, no one’s ever died of relaxation and paced breathing.” In addition, a patient’s interaction with and sense of control over her own physiology provided by these techniques may be beneficial in themselves.
Dr. Shufelt reported grant support from the National Institutes of Health. Numerous authors reported consulting fees from and other financial ties to private-sector companies. Dr. Rabin had no relevant competing interests to disclose with regard to her comments.
FROM THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY
WHO advises against nonsugar sweeteners for weight control
These sweeteners include aspartame, acesulfame K, advantame, saccharine, sucralose, stevia, and stevia derivatives.
The recommendation is based on the findings of a systematic review that collected data from 283 studies in adults, children, pregnant women, and mixed populations.
The findings suggest that use of NSSs does not confer any long-term benefit in reducing body fat in adults or children. They also suggest that long-term use of NSSs may have potential undesirable effects.
To clarify, short-term NSS use results in a small reduction in body weight and body mass index in adults without significant effects on other measures of adiposity or cardiometabolic health, including fasting glucose, insulin, blood lipids, and blood pressure.
Conversely, on a long-term basis, results from prospective cohort studies suggest that higher NSS intake is associated with increased risk for type 2 diabetes, cardiovascular diseases, and all-cause mortality in adults (very low– to low-certainty evidence).
Regarding the risk for cancer, results from case-control studies suggest an association between saccharine intake and bladder cancer (very low certainty evidence), but significant associations for other types of cancer were not observed in case-control studies or meta-analysis of prospective cohort studies.
Relatively fewer studies were found for children, and results were largely inconclusive.
Finally, results for pregnant women suggest that higher NSS intake is associated with increased risk for preterm birth (low-certainty evidence) and possibly adiposity in offspring (very low–certainty evidence).
Reducing sugar consumption
“Replacing free sugars with NSS does not help with weight control in the long-term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, MD, PhD, WHO director of the department of nutrition and food safety, said in a press release.
“NSSs are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” he added.
Applying the guideline
The recommendation applies to all people except individuals with preexisting diabetes and includes all synthetic and naturally occurring or modified nonnutritive sweeteners, said the WHO.
The recommendation does not apply to personal care and hygiene products containing NSSs, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols).
Because the link observed in the evidence between NSSs and disease outcomes might be confounded by the baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as “conditional” by the WHO.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” said the WHO press release.
This article was translated from the Medscape French Edition . A version of the article appeared on Medscape.com.
These sweeteners include aspartame, acesulfame K, advantame, saccharine, sucralose, stevia, and stevia derivatives.
The recommendation is based on the findings of a systematic review that collected data from 283 studies in adults, children, pregnant women, and mixed populations.
The findings suggest that use of NSSs does not confer any long-term benefit in reducing body fat in adults or children. They also suggest that long-term use of NSSs may have potential undesirable effects.
To clarify, short-term NSS use results in a small reduction in body weight and body mass index in adults without significant effects on other measures of adiposity or cardiometabolic health, including fasting glucose, insulin, blood lipids, and blood pressure.
Conversely, on a long-term basis, results from prospective cohort studies suggest that higher NSS intake is associated with increased risk for type 2 diabetes, cardiovascular diseases, and all-cause mortality in adults (very low– to low-certainty evidence).
Regarding the risk for cancer, results from case-control studies suggest an association between saccharine intake and bladder cancer (very low certainty evidence), but significant associations for other types of cancer were not observed in case-control studies or meta-analysis of prospective cohort studies.
Relatively fewer studies were found for children, and results were largely inconclusive.
Finally, results for pregnant women suggest that higher NSS intake is associated with increased risk for preterm birth (low-certainty evidence) and possibly adiposity in offspring (very low–certainty evidence).
Reducing sugar consumption
“Replacing free sugars with NSS does not help with weight control in the long-term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, MD, PhD, WHO director of the department of nutrition and food safety, said in a press release.
“NSSs are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” he added.
Applying the guideline
The recommendation applies to all people except individuals with preexisting diabetes and includes all synthetic and naturally occurring or modified nonnutritive sweeteners, said the WHO.
The recommendation does not apply to personal care and hygiene products containing NSSs, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols).
Because the link observed in the evidence between NSSs and disease outcomes might be confounded by the baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as “conditional” by the WHO.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” said the WHO press release.
This article was translated from the Medscape French Edition . A version of the article appeared on Medscape.com.
These sweeteners include aspartame, acesulfame K, advantame, saccharine, sucralose, stevia, and stevia derivatives.
The recommendation is based on the findings of a systematic review that collected data from 283 studies in adults, children, pregnant women, and mixed populations.
The findings suggest that use of NSSs does not confer any long-term benefit in reducing body fat in adults or children. They also suggest that long-term use of NSSs may have potential undesirable effects.
To clarify, short-term NSS use results in a small reduction in body weight and body mass index in adults without significant effects on other measures of adiposity or cardiometabolic health, including fasting glucose, insulin, blood lipids, and blood pressure.
Conversely, on a long-term basis, results from prospective cohort studies suggest that higher NSS intake is associated with increased risk for type 2 diabetes, cardiovascular diseases, and all-cause mortality in adults (very low– to low-certainty evidence).
Regarding the risk for cancer, results from case-control studies suggest an association between saccharine intake and bladder cancer (very low certainty evidence), but significant associations for other types of cancer were not observed in case-control studies or meta-analysis of prospective cohort studies.
Relatively fewer studies were found for children, and results were largely inconclusive.
Finally, results for pregnant women suggest that higher NSS intake is associated with increased risk for preterm birth (low-certainty evidence) and possibly adiposity in offspring (very low–certainty evidence).
Reducing sugar consumption
“Replacing free sugars with NSS does not help with weight control in the long-term. People need to consider other ways to reduce free sugars intake, such as consuming food with naturally occurring sugars, like fruit, or unsweetened food and beverages,” Francesco Branca, MD, PhD, WHO director of the department of nutrition and food safety, said in a press release.
“NSSs are not essential dietary factors and have no nutritional value. People should reduce the sweetness of the diet altogether, starting early in life, to improve their health,” he added.
Applying the guideline
The recommendation applies to all people except individuals with preexisting diabetes and includes all synthetic and naturally occurring or modified nonnutritive sweeteners, said the WHO.
The recommendation does not apply to personal care and hygiene products containing NSSs, such as toothpaste, skin cream, and medications, or to low-calorie sugars and sugar alcohols (polyols).
Because the link observed in the evidence between NSSs and disease outcomes might be confounded by the baseline characteristics of study participants and complicated patterns of NSS use, the recommendation has been assessed as “conditional” by the WHO.
“This signals that policy decisions based on this recommendation may require substantive discussion in specific country contexts, linked for example to the extent of consumption in different age groups,” said the WHO press release.
This article was translated from the Medscape French Edition . A version of the article appeared on Medscape.com.
Low-carb breakfast key to lower glucose variability in T2D?
These findings from a 3-month randomized study in 121 patients in Canada and Australia were published online recently in the American Journal of Clinical Nutrition.
The researchers aimed to determine whether a low-carbohydrate, high-fat breakfast (focused around eggs), compared with a standard, low-fat control breakfast (designed to have no/minimal eggs), would improve blood glucose control in individuals with type 2 diabetes.
“We’ve determined that if the first meal of the day is low-carb and higher in protein and fat we can limit hyperglycemic swings,” lead author Barbara Oliveira, PhD, School of Health and Exercise Sciences, University of British Columbia, Kelowna, said in a press release from the university.
“Having fewer carbs for breakfast not only aligns better with how people with [type 2 diabetes] handle glucose throughout the day,” she noted, “but it also has incredible potential for people with [type 2 diabetes] who struggle with their glucose levels in the morning.”
“By making a small adjustment to the carb content of a single meal rather than the entire diet,” Dr. Oliveira added, “we have the potential to increase adherence significantly while still obtaining significant benefits.”
The researchers conclude that “this trial provides evidence that advice to consume a low-carbohydrate breakfast could be a simple, feasible, and effective approach to manage postprandial hyperglycemia and lower glycemic variability in people living with type 2 diabetes.”
Could breakfast tweak improve glucose control?
People with type 2 diabetes have higher levels of insulin resistance and greater glucose intolerance in the morning, the researchers write.
And consuming a low-fat, high-carbohydrate meal in line with most dietary guidelines appears to incur the highest hyperglycemia spike and leads to higher glycemic variability.
They speculated that eating a low-carb breakfast, compared with a low-fat breakfast, might be an easy way to mitigate this.
They recruited participants from online ads in three provinces in Canada and four states in Australia, and they conducted the study from a site in British Columbia and one in Wollongong, Australia.
The participants were aged 20-79 years and diagnosed with type 2 diabetes. They also had a current hemoglobin A1c < 8.5% and no allergies to eggs, and they were able to follow remote, online guidance.
After screening, the participants had a phone or video conference call with a member of the research team who explained the study.
The researchers randomly assigned 75 participants in Canada and 46 participants in Australia 1:1 to the low-carbohydrate intervention or the control intervention.
The participants had a mean age of 64 and 53% were women. They had a mean weight of 93 kg (204 lb), body mass index of 32 kg/m2, and A1c of 7.0%.
Registered dietitians in Canada and Australia each designed 8-10 recipes/menus for low-carb breakfasts and an equal number of recipes/menus for control (low-fat) breakfasts that were specific for those countries.
Each recipe contains about 450 kcal, and they are available in Supplemental Appendix 1A and 1B, with the article.
Each low-carbohydrate breakfast contains about 25 g protein, 8 g carbohydrates, and 37 g fat. For example, one breakfast is a three-egg omelet with spinach.
Each control (low-fat) recipe contains about 20 g protein, 56 g carbohydrates, and 15 g fat. For example, one breakfast is a small blueberry muffin and a small plain Greek yogurt.
The participants were advised to select one of these breakfasts every day and follow it exactly (they were also required to upload a photograph of their breakfast every morning). They were not given any guidance or calorie restriction for the other meals of the day.
The participants also filled in 3-day food records and answered a questionnaire about exercise, hunger, and satiety, at the beginning, middle, and end of the intervention.
They provided self-reported height, weight, and waist circumference, and they were given requisitions for blood tests for A1c to be done at a local laboratory, at the beginning and end of the intervention.
The participants also wore a continuous glucose monitor (CGM) during the first and last 14 days of the intervention.
Intervention improved CGM measures
There was no significant difference in the primary outcome, change in A1c, at the end of 12 weeks, in the two groups. The mean A1c decreased by 0.3% in the intervention group vs 0.1% in the control group (P = .06).
Similarly, in secondary outcomes, weight and BMI each decreased about 1% and waist circumference decreased by about 2.5 cm in each group at 12 weeks (no significant difference). There were also no significant differences in hunger, satiety, or physical activity between the two groups.
However, the 24-hour CGM data showed that mean and maximum glucose, glycemic variability, and time above range were all significantly lower in participants in the low-carbohydrate breakfast intervention group vs. those in the control group (all P < .05).
Time in range was significantly higher among participants in the intervention group (P < .05).
In addition, the 2-hour postprandial CGM data showed that mean glucose and maximum glucose after breakfast were lower in participants in the low-carbohydrate breakfast group than in the control group.
This work was supported by investigator-initiated operating grants to senior author Jonathan P. Little, PhD, School of Health and Exercise Sciences, University of British Columbia, from the Egg Nutrition Center, United States, and Egg Farmers of Canada. The authors declare that they have no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
These findings from a 3-month randomized study in 121 patients in Canada and Australia were published online recently in the American Journal of Clinical Nutrition.
The researchers aimed to determine whether a low-carbohydrate, high-fat breakfast (focused around eggs), compared with a standard, low-fat control breakfast (designed to have no/minimal eggs), would improve blood glucose control in individuals with type 2 diabetes.
“We’ve determined that if the first meal of the day is low-carb and higher in protein and fat we can limit hyperglycemic swings,” lead author Barbara Oliveira, PhD, School of Health and Exercise Sciences, University of British Columbia, Kelowna, said in a press release from the university.
“Having fewer carbs for breakfast not only aligns better with how people with [type 2 diabetes] handle glucose throughout the day,” she noted, “but it also has incredible potential for people with [type 2 diabetes] who struggle with their glucose levels in the morning.”
“By making a small adjustment to the carb content of a single meal rather than the entire diet,” Dr. Oliveira added, “we have the potential to increase adherence significantly while still obtaining significant benefits.”
The researchers conclude that “this trial provides evidence that advice to consume a low-carbohydrate breakfast could be a simple, feasible, and effective approach to manage postprandial hyperglycemia and lower glycemic variability in people living with type 2 diabetes.”
Could breakfast tweak improve glucose control?
People with type 2 diabetes have higher levels of insulin resistance and greater glucose intolerance in the morning, the researchers write.
And consuming a low-fat, high-carbohydrate meal in line with most dietary guidelines appears to incur the highest hyperglycemia spike and leads to higher glycemic variability.
They speculated that eating a low-carb breakfast, compared with a low-fat breakfast, might be an easy way to mitigate this.
They recruited participants from online ads in three provinces in Canada and four states in Australia, and they conducted the study from a site in British Columbia and one in Wollongong, Australia.
The participants were aged 20-79 years and diagnosed with type 2 diabetes. They also had a current hemoglobin A1c < 8.5% and no allergies to eggs, and they were able to follow remote, online guidance.
After screening, the participants had a phone or video conference call with a member of the research team who explained the study.
The researchers randomly assigned 75 participants in Canada and 46 participants in Australia 1:1 to the low-carbohydrate intervention or the control intervention.
The participants had a mean age of 64 and 53% were women. They had a mean weight of 93 kg (204 lb), body mass index of 32 kg/m2, and A1c of 7.0%.
Registered dietitians in Canada and Australia each designed 8-10 recipes/menus for low-carb breakfasts and an equal number of recipes/menus for control (low-fat) breakfasts that were specific for those countries.
Each recipe contains about 450 kcal, and they are available in Supplemental Appendix 1A and 1B, with the article.
Each low-carbohydrate breakfast contains about 25 g protein, 8 g carbohydrates, and 37 g fat. For example, one breakfast is a three-egg omelet with spinach.
Each control (low-fat) recipe contains about 20 g protein, 56 g carbohydrates, and 15 g fat. For example, one breakfast is a small blueberry muffin and a small plain Greek yogurt.
The participants were advised to select one of these breakfasts every day and follow it exactly (they were also required to upload a photograph of their breakfast every morning). They were not given any guidance or calorie restriction for the other meals of the day.
The participants also filled in 3-day food records and answered a questionnaire about exercise, hunger, and satiety, at the beginning, middle, and end of the intervention.
They provided self-reported height, weight, and waist circumference, and they were given requisitions for blood tests for A1c to be done at a local laboratory, at the beginning and end of the intervention.
The participants also wore a continuous glucose monitor (CGM) during the first and last 14 days of the intervention.
Intervention improved CGM measures
There was no significant difference in the primary outcome, change in A1c, at the end of 12 weeks, in the two groups. The mean A1c decreased by 0.3% in the intervention group vs 0.1% in the control group (P = .06).
Similarly, in secondary outcomes, weight and BMI each decreased about 1% and waist circumference decreased by about 2.5 cm in each group at 12 weeks (no significant difference). There were also no significant differences in hunger, satiety, or physical activity between the two groups.
However, the 24-hour CGM data showed that mean and maximum glucose, glycemic variability, and time above range were all significantly lower in participants in the low-carbohydrate breakfast intervention group vs. those in the control group (all P < .05).
Time in range was significantly higher among participants in the intervention group (P < .05).
In addition, the 2-hour postprandial CGM data showed that mean glucose and maximum glucose after breakfast were lower in participants in the low-carbohydrate breakfast group than in the control group.
This work was supported by investigator-initiated operating grants to senior author Jonathan P. Little, PhD, School of Health and Exercise Sciences, University of British Columbia, from the Egg Nutrition Center, United States, and Egg Farmers of Canada. The authors declare that they have no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
These findings from a 3-month randomized study in 121 patients in Canada and Australia were published online recently in the American Journal of Clinical Nutrition.
The researchers aimed to determine whether a low-carbohydrate, high-fat breakfast (focused around eggs), compared with a standard, low-fat control breakfast (designed to have no/minimal eggs), would improve blood glucose control in individuals with type 2 diabetes.
“We’ve determined that if the first meal of the day is low-carb and higher in protein and fat we can limit hyperglycemic swings,” lead author Barbara Oliveira, PhD, School of Health and Exercise Sciences, University of British Columbia, Kelowna, said in a press release from the university.
“Having fewer carbs for breakfast not only aligns better with how people with [type 2 diabetes] handle glucose throughout the day,” she noted, “but it also has incredible potential for people with [type 2 diabetes] who struggle with their glucose levels in the morning.”
“By making a small adjustment to the carb content of a single meal rather than the entire diet,” Dr. Oliveira added, “we have the potential to increase adherence significantly while still obtaining significant benefits.”
The researchers conclude that “this trial provides evidence that advice to consume a low-carbohydrate breakfast could be a simple, feasible, and effective approach to manage postprandial hyperglycemia and lower glycemic variability in people living with type 2 diabetes.”
Could breakfast tweak improve glucose control?
People with type 2 diabetes have higher levels of insulin resistance and greater glucose intolerance in the morning, the researchers write.
And consuming a low-fat, high-carbohydrate meal in line with most dietary guidelines appears to incur the highest hyperglycemia spike and leads to higher glycemic variability.
They speculated that eating a low-carb breakfast, compared with a low-fat breakfast, might be an easy way to mitigate this.
They recruited participants from online ads in three provinces in Canada and four states in Australia, and they conducted the study from a site in British Columbia and one in Wollongong, Australia.
The participants were aged 20-79 years and diagnosed with type 2 diabetes. They also had a current hemoglobin A1c < 8.5% and no allergies to eggs, and they were able to follow remote, online guidance.
After screening, the participants had a phone or video conference call with a member of the research team who explained the study.
The researchers randomly assigned 75 participants in Canada and 46 participants in Australia 1:1 to the low-carbohydrate intervention or the control intervention.
The participants had a mean age of 64 and 53% were women. They had a mean weight of 93 kg (204 lb), body mass index of 32 kg/m2, and A1c of 7.0%.
Registered dietitians in Canada and Australia each designed 8-10 recipes/menus for low-carb breakfasts and an equal number of recipes/menus for control (low-fat) breakfasts that were specific for those countries.
Each recipe contains about 450 kcal, and they are available in Supplemental Appendix 1A and 1B, with the article.
Each low-carbohydrate breakfast contains about 25 g protein, 8 g carbohydrates, and 37 g fat. For example, one breakfast is a three-egg omelet with spinach.
Each control (low-fat) recipe contains about 20 g protein, 56 g carbohydrates, and 15 g fat. For example, one breakfast is a small blueberry muffin and a small plain Greek yogurt.
The participants were advised to select one of these breakfasts every day and follow it exactly (they were also required to upload a photograph of their breakfast every morning). They were not given any guidance or calorie restriction for the other meals of the day.
The participants also filled in 3-day food records and answered a questionnaire about exercise, hunger, and satiety, at the beginning, middle, and end of the intervention.
They provided self-reported height, weight, and waist circumference, and they were given requisitions for blood tests for A1c to be done at a local laboratory, at the beginning and end of the intervention.
The participants also wore a continuous glucose monitor (CGM) during the first and last 14 days of the intervention.
Intervention improved CGM measures
There was no significant difference in the primary outcome, change in A1c, at the end of 12 weeks, in the two groups. The mean A1c decreased by 0.3% in the intervention group vs 0.1% in the control group (P = .06).
Similarly, in secondary outcomes, weight and BMI each decreased about 1% and waist circumference decreased by about 2.5 cm in each group at 12 weeks (no significant difference). There were also no significant differences in hunger, satiety, or physical activity between the two groups.
However, the 24-hour CGM data showed that mean and maximum glucose, glycemic variability, and time above range were all significantly lower in participants in the low-carbohydrate breakfast intervention group vs. those in the control group (all P < .05).
Time in range was significantly higher among participants in the intervention group (P < .05).
In addition, the 2-hour postprandial CGM data showed that mean glucose and maximum glucose after breakfast were lower in participants in the low-carbohydrate breakfast group than in the control group.
This work was supported by investigator-initiated operating grants to senior author Jonathan P. Little, PhD, School of Health and Exercise Sciences, University of British Columbia, from the Egg Nutrition Center, United States, and Egg Farmers of Canada. The authors declare that they have no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF CLINICAL NUTRITION