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For Richer, for Poorer: Low-Carb Diets Work for All Incomes
For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.
Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.
She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.
“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.”
Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.
Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.
“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.
Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened.
“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”
I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.
Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.
Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.
Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis.
A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides.
Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.
Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds.
Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado.
“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.
Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com.
Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.
Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked.
A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.
Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.
Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.”
Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice.
A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.
It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.
Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.
When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said.
Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients.
This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged.
OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.)
Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine.
Tools and Tips for Clinicians:
- Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
- Illustrated low-carb guides by dietdoctor.com
- Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
- Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
- Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and
Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.
A version of this article appeared on Medscape.com.
For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.
Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.
She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.
“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.”
Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.
Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.
“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.
Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened.
“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”
I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.
Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.
Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.
Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis.
A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides.
Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.
Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds.
Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado.
“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.
Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com.
Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.
Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked.
A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.
Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.
Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.”
Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice.
A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.
It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.
Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.
When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said.
Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients.
This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged.
OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.)
Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine.
Tools and Tips for Clinicians:
- Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
- Illustrated low-carb guides by dietdoctor.com
- Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
- Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
- Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and
Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.
A version of this article appeared on Medscape.com.
For 3 years, Ajala Efem’s type 2 diabetes was so poorly controlled that her blood sugar often soared northward of 500 mg/dL despite insulin shots three to five times a day. She would experience dizziness, vomiting, severe headaches, and the neuropathy in her feet made walking painful. She was also — literally — frothing at the mouth. The 47-year-old single mother of two adult children with mental disabilities feared that she would die.
Ms. Efem lives in the South Bronx, which is among the poorest areas of New York City, where the combined rate of prediabetes and diabetes is close to 30%, the highest rate of any borough in the city.
She had to wait 8 months for an appointment with an endocrinologist, but that visit proved to be life-changing. She lost 28 pounds and got off 15 medications in a single month. She did not join a gym or count calories; she simply changed the food she ate and adopted a low-carb diet.
“I went from being sick to feeling so great,” she told her endocrinologist recently: “My feet aren’t hurting; I’m not in pain; I’m eating as much as I want, and I really enjoy my food so much.”
Ms. Efem’s life-changing visit was with Mariela Glandt, MD, at the offices of Essen Health Care. One month earlier, Dr. Glandt’s company, OwnaHealth, was contracted by Essen to conduct a 100-person pilot program for endocrinology patients. Essen is the largest Medicaid provider in New York City, and “they were desperate for an endocrinologist,” said Dr. Glandt, who trained at Columbia University in New York. So she came — all the way from Madrid, Spain. She commutes monthly, staying for a week each visit.
Dr. Glandt keeps up this punishing schedule because, as she explains, “it’s such a high for me to see these incredible transformations.” Her mostly Black and Hispanic patients are poor and lack resources, yet they lose significant amounts of weight, and their health issues resolve.
“Food is medicine” is an idea very much in vogue. The concept was central to the landmark White House Conference on Hunger, Nutrition, and Health in 2022 and is now the focus of a number of a wide range of government programs. Recently, the Senate held a hearing aimed at further expanding food as medicine programs.
Still, only a single randomized controlled clinical trial has been conducted on this nutritional approach, with unexpectedly disappointing results. In the mid-Atlantic region, 456 food-insecure adults with type 2 diabetes were randomly assigned to usual care or the provision of weekly groceries for their entire families for about 1 year. Provisions for a Mediterranean-style diet included whole grains, fruits and vegetables, lean protein, low-fat dairy products, cereal, brown rice, and bread. In addition, participants received dietary consultations. Yet, those who got free food and coaching did not see improvements in their average blood sugar (the study’s primary outcome), and their low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol levels appeared to have worsened.
“To be honest, I was surprised,” the study’s lead author, Joseph Doyle, PhD, professor at the Sloan School of Management at MIT in Cambridge, Massachusetts, told me. “I was hoping we would show improved outcomes, but the way to make progress is to do well-randomized trials to find out what works.”
I was not surprised by these results because a recent rigorous systematic review and meta-analysis in The BMJ did not show a Mediterranean-style diet to be the most effective for glycemic control. And Ms. Efem was not in fact following a Mediterranean-style diet.
Ms. Efem’s low-carb success story is anecdotal, but Dr. Glandt has an established track record from her 9 years’ experience as the medical director of the eponymous diabetes center she founded in Tel Aviv. A recent audit of 344 patients from the center found that after 6 months of following a very low–carbohydrate diet, 96.3% of those with diabetes saw their A1c fall from a median 7.6% to 6.3%. Weight loss was significant, with a median drop of 6.5 kg (14 pounds) for patients with diabetes and 5.7 kg for those with prediabetes. The diet comprises 5%-10% of calories from carbs, but Dr. Glandt does not use numeric targets with her patients.
Blood pressure, triglycerides, and liver enzymes also improved. And though LDL cholesterol went up by 8%, this result may have been offset by an accompanying 13% rise in HDL cholesterol. Of the 78 patients initially on insulin, 62 were able to stop this medication entirely.
Although these results aren’t from a clinical trial, they’re still highly meaningful because the current dietary standard of care for type 2 diabetes can only slow the progression of the disease, not cause remission. Indeed, the idea that type 2 diabetes could be put into remission was not seriously considered by the American Diabetes Association (ADA) until 2009. By 2019, an ADA report concluded that “[r]educing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia.” In other words, the best way to improve the key factor in diabetes is to reduce total carbohydrates. Yet, the ADA still advocates filling one quarter of one’s plate with carbohydrate-based foods, an amount that will prevent remission. Given that the ADA’s vision statement is “a life free of diabetes,” it seems negligent not to tell people with a deadly condition that they can reverse this diagnosis.
A 2023 meta-analysis of 42 controlled clinical trials on 4809 patients showed that a very low–carbohydrate ketogenic diet (keto) was “superior” to alternatives for glycemic control. A more recent review of 11 clinical trials found that this diet was equal but not superior to other nutritional approaches in terms of blood sugar control, but this review also concluded that keto led to greater increases in HDL cholesterol and lower triglycerides.
Dr. Glandt’s patients in the Bronx might not seem like obvious low-carb candidates. The diet is considered expensive and difficult to sustain. My interviews with a half dozen patients revealed some of these difficulties, but even for a woman living in a homeless shelter, the obstacles are not insurmountable.
Jerrilyn, who preferred that I use only her first name, lives in a shelter in Queens. While we strolled through a nearby park, she told me about her desire to lose weight and recover from polycystic ovary syndrome, which terrified her because it had caused dramatic hair loss. When she landed in Dr. Glandt’s office at age 28, she weighed 180 pounds.
Less than 5 months later, Jerrilyn had lost 25 pounds, and her period had returned with some regularity. She said she used “food stamps,” known as the Supplemental Nutrition Assistance Program (SNAP), to buy most of her food at local delis because the meals served at the shelter were too heavy in starches. She starts her day with eggs, turkey bacon, and avocado.
“It was hard to give up carbohydrates because in my culture [Latina], we have nothing but carbs: rice, potatoes, yuca,” Jerrilyn shared. She noticed that carbs make her hungrier, but after 3 days of going low-carb, her cravings diminished. “It was like getting over an addiction,” she said.
Jerrilyn told me she’d seen many doctors but none as involved as Dr. Glandt. “It feels awesome to know that I have a lot of really useful information coming from her all the time.” The OwnaHealth app tracks weight, blood pressure, blood sugar, ketones, meals, mood, and cravings. Patients wear continuous glucose monitors and enter other information manually. Ketone bodies are used to measure dietary adherence and are obtained through finger pricks and test strips provided by OwnaHealth. Dr. Glandt gives patients her own food plan, along with free visual guides to low-carbohydrate foods by dietdoctor.com.
Dr. Glandt also sends her patients for regular blood work. She says she does not frequently see a rise in LDL cholesterol, which can sometimes occur on a low-carbohydrate diet. This effect is most common among people who are lean and fit. She says she doesn’t discontinue statins unless cholesterol levels improve significantly.
Samuel Gonzalez, age 56, weighed 275 pounds when he walked into Dr. Glandt’s office this past November. His A1c was 9.2%, but none of his previous doctors had diagnosed him with diabetes. “I was like a walking bag of sugar!” he joked.
A low-carbohydrate diet seemed absurd to a Puerto Rican like himself: “Having coffee without sugar? That’s like sacrilegious in my culture!” exclaimed Mr. Gonzalez. Still, he managed, with SNAP, to cook eggs and bacon for breakfast and some kind of protein for dinner. He keeps lunch light, “like tuna fish,” and finds checking in with the OwnaHealth app to be very helpful. “Every day, I’m on it,” he said. In the past 7 months, he’s lost 50 pounds, normalized his cholesterol and blood pressure levels, and lowered his A1c to 5.5%.
Mr. Gonzalez gets disability payments due to a back injury, and Ms. Efem receives government payments because her husband died serving in the military. Ms. Efem says her new diet challenges her budget, but Mr. Gonzalez says he manages easily.
Mélissa Cruz, a 28-year-old studying to be a nail technician while also doing back office work at a physical therapy practice, says she’s stretched thin. “I end up sad because I can’t put energy into looking up recipes and cooking for me and my boyfriend,” she told me. She’ll often cook rice and plantains for him and meat for herself, but “it’s frustrating when I’m low on funds and can’t figure out what to eat.”
Low-carbohydrate diets have a reputation for being expensive because people often start eating pricier foods, like meat and cheese, to replace cheaper starchy foods such as pasta and rice.
A 2019 cost analysis published in Nutrition & Dietetics compared a low-carbohydrate dietary pattern with the New Zealand government’s recommended guidelines (which are almost identical to those in the United States) and found that it cost only an extra $1.27 in US dollars per person per day. One explanation is that protein and fat are more satiating than carbohydrates, so people who mostly consume these macronutrients often cut back on snacks like packaged chips, crackers, and even fruits. Also, those on a ketogenic diet usually cut down on medications, so the additional $1.27 daily is likely offset by reduced spending at the pharmacy.
It’s not just Bronx residents with low socioeconomic status (SES) who adapt well to low-carbohydrate diets. Among Alabama state employees with diabetes enrolled in a low-carbohydrate dietary program provided by a company called Virta, the low SES population had the best outcomes. Virta also published survey data in 2023 showing that participants in a program with the Veteran’s Administration did not find additional costs to be an obstacle to dietary adherence. In fact, some participants saw cost reductions due to decreased spending on processed snacks and fast foods.
Ms. Cruz told me she struggles financially, yet she’s still lost nearly 30 pounds in 5 months, and her A1c went from 7.1% down to 5.9%, putting her diabetes into remission. Equally motivating for her are the improvements she’s seen in other hormonal issues. Since childhood, she’s had acanthosis, a condition that causes the skin to darken in velvety patches, and more recently, she developed severe hirsutism to the point of growing sideburns. “I had tried going vegan and fasting, but these just weren’t sustainable for me, and I was so overwhelmed with counting calories all the time.” Now, on a low-carbohydrate diet, which doesn’t require calorie counting, she’s finally seeing both these conditions improve significantly.
When I last checked in with Ms. Cruz, she said she had “kind of ghosted” Dr. Glandt due to her work and school constraints, but she hadn’t abandoned the diet. She appreciated, too, that Dr. Glandt had not given up on her and kept calling and messaging. “She’s not at all like a typical doctor who would just tell me to lose weight and shake their head at me,” Ms. Cruz said.
Because Dr. Glandt’s approach is time-intensive and high-touch, it might seem impractical to scale up, but Dr. Glandt’s app uses artificial intelligence to help with communications thus allowing her, with help from part-time health coaches, to care for patients.
This early success in one of the United States’ poorest and sickest neighborhoods should give us hope that type 2 diabetes need not to be a progressive irreversible disease, even among the disadvantaged.
OwnaHealth’s track record, along with that of Virta and other similar low-carbohydrate medical practices also give hope to the food-is-medicine idea. Diabetes can go into remission, and people can be healed, provided that health practitioners prescribe the right foods. And in truth, it’s not a diet. It’s a way of eating that must be maintained. The sustainability of low-carbohydrate diets has been a point of contention, but the Virta trial, with 38% of patients sustaining remission at 2 years, showed that it’s possible. (OwnaHealth, for its part, offers long-term maintenance plans to help patients stay very low-carb permanently.)
Given the tremendous costs and health burden of diabetes, this approach should no doubt be the first line of treatment for doctors and the ADA. The past two decades of clinical trial research have demonstrated that remission of type 2 diabetes is possible through diet alone. It turns out that for metabolic diseases, only certain foods are truly medicine.
Tools and Tips for Clinicians:
- Free two-page keto starter’s guide by OwnaHealth; Dr. Glandt uses this guide with her patients.
- Illustrated low-carb guides by dietdoctor.com
- Free low-carbohydrate starter guide by the Michigan Collaborative for Type 2 Diabetes
- Low-Carb for Any Budget, a free digital booklet by Mark Cucuzzella, MD, and Kristie Sullivan, PhD
- Recipe and meal ideas from Ruled.me, Keto-Mojo.com, and
Dr. Teicholz is the founder of Nutrition Coalition, an independent nonprofit dedicated to ensuring that US dietary guidelines align with current science. She disclosed receiving book royalties from The Big Fat Surprise, and received honorarium not exceeding $2000 for speeches from various sources.
A version of this article appeared on Medscape.com.
Intervention Helps Transition From Postpartum Care to PCP Engagement
, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.
Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.
Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
Intervention vs Control Group
The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.
For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”
Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.
Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).
Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”
“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”
The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.
Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”
“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
Still, Only 40% Used Primary Care
She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.
Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.
Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.
, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.
Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.
Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
Intervention vs Control Group
The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.
For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”
Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.
Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).
Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”
“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”
The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.
Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”
“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
Still, Only 40% Used Primary Care
She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.
Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.
Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.
, according to study results published in JAMA Network Open. The intervention bundle includes default scheduling of postpartum primary care appointments and tailored reminders and messaging.
Researchers, led by Mark A. Clapp, MD, MPH, with Massachusetts General Hospital in Boston, highlighted a care transition gap common after a woman gives birth. More than 30% of pregnant people have at least one chronic condition and nearly 20% develop gestational diabetes or pregnancy-related hypertension, which increases the risk of future chronic disease, the authors write. They are closely monitored for these conditions during pregnancy, but many face barriers in transitioning to engagement with primary care.
Scheduling appointments, difficulty in finding information, and insurance or billing issues can impede access to care. In this study, the primary outcome measure was whether women completed a primary care visit for routine or chronic condition care within 4 months of delivery.
Intervention vs Control Group
The intervention included an introduction message talking about the importance of a primary care visit and notification that a staff member would be scheduling an appointment on the patients’ behalf within a 4-month window of the estimated due date (EDD). Patients could opt out or ask for specific scheduling. If a patient had already seen their primary care physician (PCP) for an annual visit within the year, they were scheduled for an annual visit when they were next eligible, even if outside the 4-month study follow-up.
For those who did not opt out and had appointments scheduled for them, reminders were sent about 1 month after the EDD and 1 week before the scheduled appointment through the EHR patient portal. Salient labeling of the message was used to describe the visit. For those for whom an appointment could not be scheduled, similar reminders were sent on the importance of primary care follow-up, urging patients to contact their primary care office directly to schedule. Reminders included evidence-based, best-practice wording including that “the appointment had been reserved for them.”
Patients in the control group received one message within 2 weeks of the EDD with a generic recommendation for primary care follow-up after delivery.
Researchers found that 40% of the intervention group (95% confidence interval (CI), 33.1%-47.4%) and 22% of the control group (95% CI, 6.4%-28.8%), completed a primary care visit within 4 months. “[T]he intervention increased PCP visit completion by 18.7 percentage points (95% CI, 9.1-28.2 percentage points),” they write. Those who received the intervention also had fewer postpartum readmissions (1.7% vs 5.8%) and were more likely to have had these services from a PCP: blood pressure screening (42.8% vs 28.3%); weight assessment (42.8% vs 27.7%); and depression screening (32.8% vs 16.8%).
Meghan Bellerose, MPH, with the Department of Health Services, Policy, and Practice at Brown University School of Public Health in Providence, Rhode Island, described in an accompanying editorial the “postpartum cliff.”
“Health system engagement plummets soon after childbirth in the US,” she writes. “Under current care practices, obstetric clinicians deliver a single postpartum visit within 12 weeks of delivery, after which patients are responsible for navigating the transition to primary care on their own.”
The intervention Dr. Clapp and colleagues propose could help increase the benefit of state and federal policies aimed at increasing care continuity after delivery, she writes. She pointed to the American Rescue Plan Act of 2021, in which states were given the option to provide 12 months of continuous Medicaid coverage to low-income postpartum women, up from the previous 2 months of coverage. By early May of 2024, 46 states had chosen the longer coverage.
Without a better bridge between postpartum and primary care, she notes, “we will not see the full value of extended Medicaid coverage.”
“The findings of Clapp et al. suggest that a relatively low-resource, scalable intervention including default scheduling of postpartum-to-primary care appointments and salient messaging could increase the use of primary care in the postpartum year to extend the effects of this policy.”
Still, Only 40% Used Primary Care
She noted, however, that despite the finding that the intervention in this study nearly doubled the percentage of primary care visits in 4 months, primary care use still was only 40%. Study staff were not able to schedule an appointment for 24% of the intervention group within a year, even though participants identified a PCP at enrollment. Reasons for that included the patient already having used their yearly primary care visit; patients needing to restart care with their primary care clinician or choose a new clinician; and study staff being unable to reach primary care offices for scheduling.
Clearly, “there is more work to be done to remove administrative barriers to care after delivery,” she writes.
Dr. Clapp reports holding equity from the Delfina Care Scientific Advisory Board outside the submitted work. Coauthor Dr. Ganguli reports grants from the National Institute on Aging, Commonwealth Fund, and Arnold Ventures, and personal fees from FPrime outside the submitted work. Dr. Cohen reports grants from the National Academy of Medicine and the National Academy on Aging during the conduct of the study. The study was funded by the National Institute on Aging via the Massachusetts Institute of Technology Roybal Center for Translational Research to Improve Health Care for the Aging and the National Bureau of Economic Research Roybal Center for Behavior Change in Health. Editorialist Meghan Bellerose reported no relevant financial disclosures.
FROM JAMA NETWORK OPEN
New ACOG Guidance Advises Clinicians on Cannabis Use for Gynecologic Pain
An increasing proportion of people are using cannabis products for pain, including that associated with gynecologic conditions, according to new guidance from the American College of Obstetricians and Gynecologists. The organization published its first guidance in July on the use of cannabis products for gynecologic pain.
“Many of our patients are using these products and many of our members are getting questions from their patients asking whether they should be using them,” Kimberly Gecsi, MD, a professor of ob.gyn. at Medical College of Wisconsin and Froedtert Health in Milwaukee, Wisconsin, and one of the document’s coauthors, said in an interview.* “We want ACOG members to walk away with some understanding that their patients are using these products, what the different products are, and the current state of the science so they can guide their patients about the potential advantages as well as the potential risks.”
Use of cannabis in the past month in the United States rose 38.2% between 2015 and 2019, according to the National Survey on Drug Use and Health. Other research using data from that survey found that US use of cannabis for medicinal purposes more than doubled, from 1.2% to 2.5% between 2013-2014 and 2019-2020, and use in states where it was legalized increased fourfold. Though little data exist on its use for gynecologic pain, at least one peer-reviewed online survey found that 61% of those who had never used it and 90% of those who had ever used it were willing to consider its use for gynecologic pain.
In assessing the current evidence, the researchers excluded studies looking at use of cannabis to manage symptoms related to cancer, obstetrics, or gynecologic malignancy. Of the remaining evidence, however, “there just isn’t enough data on gynecologic pain to really have tipped the scale toward a recommendation,” Dr. Gecsi said.
The consensus recommendations therefore state that current data are not sufficient to recommend or discourage use of cannabis products to treat pain linked to gynecologic conditions. Yet the potential for benefit suggests that “if they are already using these products, there’s no need to discourage them, especially if the patients feel they are getting some benefit from them,” Dr. Gecsi said.
The guidance also highlights the importance of clinicians being aware that their patients may be using these products and being prepared to discuss with them the limited data available as well as the theoretical benefits and potential negative effects for adult patients. In adolescent patients, however, the increased risk of negative cognitive effects and psychotic conditions currently appears to outweigh the theoretical benefits. Use of cannabis products in teens should therefore not be recommended until more data is available on the short-term and long-term effects of its use on adolescent brain development, the authors wrote.
Josephine Urbina, MD, MAS, an assistant professor of ob.gyn. and reproductive sciences at the University of California, San Francisco, said that the guidance confirms what most ob.gyns. suspected regarding the lack of data to support or refute the use of cannabis.
“Patients usually see cannabis as a last resort to control their pain,” Dr. Urbina added. “It seems that this decision to start using cannabis isn’t one that’s taken lightly, and they’re usually at their wits’ end. Some patients use cannabis as an adjunct so that they don’t have to rely on stronger pain medications like opioids, which we all know have a proven track record for being addicting.”
The ACOG guidance notes limited survey data suggesting that cannabis may help reduce patients’ use of opioids for pain relief, though there’s not enough data to confirm this potential benefit. The authors also highlight the limited data suggesting that PEA-transpolydatin may be effective for relieving pain related to primary dysmenorrhea, endometriosis, and chronic pelvic pain, but, again, there’s not yet enough data to formally recommend its use.
Current treatments for pain from gynecologic conditions depend on the cause of the pain, Dr. Gecsi said. One of the more common causes of pain, for example, is endometriosis, which can be treated with medications, including hormonal ones, or with surgery.
Other first-line treatments for pain, can include nonsteroidal anti-inflammatory drug and, for more complex cases, gonadotropin-releasing hormone agonists, antidepressants, and anticonvulsants. “Nonpharmacological treatments like physical therapy, acupuncture, cognitive-behavioral therapy and lifestyle changes, including diet and exercise, can also be beneficial,” Dr. Urbina added.
The new guidance also attempts to clarify the confusing legal landscape associated with cannabis use. In addition to the patchwork of state laws, federal distinctions in cannabis legality have been shifting in recent years. The 2018 Farm Bill defined any product with 0.3% or less tetrahydrocannabinol (THC) as hemp, which is now legal and commercially available in all states. That change introduced a wide range of topical and edible cannabidiol products to the market, even in states where marijuana is otherwise still illegal.
Products with a THC concentration greater than 0.3%, however, remain classified as a Schedule I drug, though the Justice Department proposed a rule in May to change that classification to Schedule III, which includes drugs such as ketamine, anabolic steroids, testosterone, and Tylenol with codeine. The guidance also includes a box of definitions for different types of cannabis products and differences in bioavailability, time to onset of effects, and duration of effects for different routes of exposure.
Kiran Kavipurapu, DO, JD, MPH, an assistant clinical professor and ob.gyn. residency program director at the University of California, Los Angeles, said the increasing availability and legalization of cannabis has meant that more patients are coming to their doctors’ offices having already tried it for medicinal purposes.
“Cannabis use discussions are often initiated by patients who are either inquiring about its benefits or because they have already tried it and want a physician to weigh in,” Dr. Kavipurapu said in an interview. “Over the past 5 years or so, this has become an increasingly common topic along with discussion of herbal or naturopathic remedies to supplement treatment of gynecologic conditions.”
Yet stigma about its use can lead patients to feel hesitant about bringing it up, Dr. Kavipurapu added. “I think it is necessary for clinicians to create a safe environment for patients to discuss their use of any and all therapies or supplements so their physician can assess for potential drug interactions or other harmful effects,” he said.
Dr. Gecsi agreed that this need to reassure patients was an important aspect of ACOG’s new guidance. Clinicians “should make sure that they strive to always foster a relationship with their patients where their patients can feel safe sharing their use and other things going on in their lives without feeling like they’re going to get in trouble,. Our job is not to put our patients at risk for any kind of legal or criminal problems.”
Meanwhile, the legal restrictions on cannabis remain a substantial barrier to the additional research that’s needed to make more informed recommendations about its use to patients, Dr. Gecsi said. But the inadequate amount of research goes beyond the challenges of studying cannabis in particular, Dr. Urbina noted.
“The paucity of research in women’s health, particularly in the realm of sexual and reproductive health care, underscores the urgent need to prioritize this topic in order to ensure comprehensive and equitable healthcare for women,” Dr. Urbina said. Underrepresentation of women’s health issues in clinical studies has led to knowledge gaps and “suboptimal treatment options for conditions unique to or more prevalent among women,” and it’s another reason for the lack of robust data on cannabis use for gynecologic-related pain.
“Prioritizing research in women’s health is essential to developing effective interventions, understanding gender-specific responses to treatments, and addressing the complex interplay of biological, social, and psychological factors affecting women’s well-being,” Dr. Urbina said. “Furthermore, advancing reproductive health research supports women’s reproductive autonomy, empowering them with the knowledge and resources to make informed decisions about their bodies and lives. By investing in robust, inclusive research, we can close existing gaps, improve health outcomes, and promote gender equity in healthcare — something that has been long overdue in this country.”
The guidance did not use external funding. Dr. Gecsi, Dr. Urbina, and Dr. Kavipurapu had no disclosures.
*This story was corrected on July 25, 2024.
An increasing proportion of people are using cannabis products for pain, including that associated with gynecologic conditions, according to new guidance from the American College of Obstetricians and Gynecologists. The organization published its first guidance in July on the use of cannabis products for gynecologic pain.
“Many of our patients are using these products and many of our members are getting questions from their patients asking whether they should be using them,” Kimberly Gecsi, MD, a professor of ob.gyn. at Medical College of Wisconsin and Froedtert Health in Milwaukee, Wisconsin, and one of the document’s coauthors, said in an interview.* “We want ACOG members to walk away with some understanding that their patients are using these products, what the different products are, and the current state of the science so they can guide their patients about the potential advantages as well as the potential risks.”
Use of cannabis in the past month in the United States rose 38.2% between 2015 and 2019, according to the National Survey on Drug Use and Health. Other research using data from that survey found that US use of cannabis for medicinal purposes more than doubled, from 1.2% to 2.5% between 2013-2014 and 2019-2020, and use in states where it was legalized increased fourfold. Though little data exist on its use for gynecologic pain, at least one peer-reviewed online survey found that 61% of those who had never used it and 90% of those who had ever used it were willing to consider its use for gynecologic pain.
In assessing the current evidence, the researchers excluded studies looking at use of cannabis to manage symptoms related to cancer, obstetrics, or gynecologic malignancy. Of the remaining evidence, however, “there just isn’t enough data on gynecologic pain to really have tipped the scale toward a recommendation,” Dr. Gecsi said.
The consensus recommendations therefore state that current data are not sufficient to recommend or discourage use of cannabis products to treat pain linked to gynecologic conditions. Yet the potential for benefit suggests that “if they are already using these products, there’s no need to discourage them, especially if the patients feel they are getting some benefit from them,” Dr. Gecsi said.
The guidance also highlights the importance of clinicians being aware that their patients may be using these products and being prepared to discuss with them the limited data available as well as the theoretical benefits and potential negative effects for adult patients. In adolescent patients, however, the increased risk of negative cognitive effects and psychotic conditions currently appears to outweigh the theoretical benefits. Use of cannabis products in teens should therefore not be recommended until more data is available on the short-term and long-term effects of its use on adolescent brain development, the authors wrote.
Josephine Urbina, MD, MAS, an assistant professor of ob.gyn. and reproductive sciences at the University of California, San Francisco, said that the guidance confirms what most ob.gyns. suspected regarding the lack of data to support or refute the use of cannabis.
“Patients usually see cannabis as a last resort to control their pain,” Dr. Urbina added. “It seems that this decision to start using cannabis isn’t one that’s taken lightly, and they’re usually at their wits’ end. Some patients use cannabis as an adjunct so that they don’t have to rely on stronger pain medications like opioids, which we all know have a proven track record for being addicting.”
The ACOG guidance notes limited survey data suggesting that cannabis may help reduce patients’ use of opioids for pain relief, though there’s not enough data to confirm this potential benefit. The authors also highlight the limited data suggesting that PEA-transpolydatin may be effective for relieving pain related to primary dysmenorrhea, endometriosis, and chronic pelvic pain, but, again, there’s not yet enough data to formally recommend its use.
Current treatments for pain from gynecologic conditions depend on the cause of the pain, Dr. Gecsi said. One of the more common causes of pain, for example, is endometriosis, which can be treated with medications, including hormonal ones, or with surgery.
Other first-line treatments for pain, can include nonsteroidal anti-inflammatory drug and, for more complex cases, gonadotropin-releasing hormone agonists, antidepressants, and anticonvulsants. “Nonpharmacological treatments like physical therapy, acupuncture, cognitive-behavioral therapy and lifestyle changes, including diet and exercise, can also be beneficial,” Dr. Urbina added.
The new guidance also attempts to clarify the confusing legal landscape associated with cannabis use. In addition to the patchwork of state laws, federal distinctions in cannabis legality have been shifting in recent years. The 2018 Farm Bill defined any product with 0.3% or less tetrahydrocannabinol (THC) as hemp, which is now legal and commercially available in all states. That change introduced a wide range of topical and edible cannabidiol products to the market, even in states where marijuana is otherwise still illegal.
Products with a THC concentration greater than 0.3%, however, remain classified as a Schedule I drug, though the Justice Department proposed a rule in May to change that classification to Schedule III, which includes drugs such as ketamine, anabolic steroids, testosterone, and Tylenol with codeine. The guidance also includes a box of definitions for different types of cannabis products and differences in bioavailability, time to onset of effects, and duration of effects for different routes of exposure.
Kiran Kavipurapu, DO, JD, MPH, an assistant clinical professor and ob.gyn. residency program director at the University of California, Los Angeles, said the increasing availability and legalization of cannabis has meant that more patients are coming to their doctors’ offices having already tried it for medicinal purposes.
“Cannabis use discussions are often initiated by patients who are either inquiring about its benefits or because they have already tried it and want a physician to weigh in,” Dr. Kavipurapu said in an interview. “Over the past 5 years or so, this has become an increasingly common topic along with discussion of herbal or naturopathic remedies to supplement treatment of gynecologic conditions.”
Yet stigma about its use can lead patients to feel hesitant about bringing it up, Dr. Kavipurapu added. “I think it is necessary for clinicians to create a safe environment for patients to discuss their use of any and all therapies or supplements so their physician can assess for potential drug interactions or other harmful effects,” he said.
Dr. Gecsi agreed that this need to reassure patients was an important aspect of ACOG’s new guidance. Clinicians “should make sure that they strive to always foster a relationship with their patients where their patients can feel safe sharing their use and other things going on in their lives without feeling like they’re going to get in trouble,. Our job is not to put our patients at risk for any kind of legal or criminal problems.”
Meanwhile, the legal restrictions on cannabis remain a substantial barrier to the additional research that’s needed to make more informed recommendations about its use to patients, Dr. Gecsi said. But the inadequate amount of research goes beyond the challenges of studying cannabis in particular, Dr. Urbina noted.
“The paucity of research in women’s health, particularly in the realm of sexual and reproductive health care, underscores the urgent need to prioritize this topic in order to ensure comprehensive and equitable healthcare for women,” Dr. Urbina said. Underrepresentation of women’s health issues in clinical studies has led to knowledge gaps and “suboptimal treatment options for conditions unique to or more prevalent among women,” and it’s another reason for the lack of robust data on cannabis use for gynecologic-related pain.
“Prioritizing research in women’s health is essential to developing effective interventions, understanding gender-specific responses to treatments, and addressing the complex interplay of biological, social, and psychological factors affecting women’s well-being,” Dr. Urbina said. “Furthermore, advancing reproductive health research supports women’s reproductive autonomy, empowering them with the knowledge and resources to make informed decisions about their bodies and lives. By investing in robust, inclusive research, we can close existing gaps, improve health outcomes, and promote gender equity in healthcare — something that has been long overdue in this country.”
The guidance did not use external funding. Dr. Gecsi, Dr. Urbina, and Dr. Kavipurapu had no disclosures.
*This story was corrected on July 25, 2024.
An increasing proportion of people are using cannabis products for pain, including that associated with gynecologic conditions, according to new guidance from the American College of Obstetricians and Gynecologists. The organization published its first guidance in July on the use of cannabis products for gynecologic pain.
“Many of our patients are using these products and many of our members are getting questions from their patients asking whether they should be using them,” Kimberly Gecsi, MD, a professor of ob.gyn. at Medical College of Wisconsin and Froedtert Health in Milwaukee, Wisconsin, and one of the document’s coauthors, said in an interview.* “We want ACOG members to walk away with some understanding that their patients are using these products, what the different products are, and the current state of the science so they can guide their patients about the potential advantages as well as the potential risks.”
Use of cannabis in the past month in the United States rose 38.2% between 2015 and 2019, according to the National Survey on Drug Use and Health. Other research using data from that survey found that US use of cannabis for medicinal purposes more than doubled, from 1.2% to 2.5% between 2013-2014 and 2019-2020, and use in states where it was legalized increased fourfold. Though little data exist on its use for gynecologic pain, at least one peer-reviewed online survey found that 61% of those who had never used it and 90% of those who had ever used it were willing to consider its use for gynecologic pain.
In assessing the current evidence, the researchers excluded studies looking at use of cannabis to manage symptoms related to cancer, obstetrics, or gynecologic malignancy. Of the remaining evidence, however, “there just isn’t enough data on gynecologic pain to really have tipped the scale toward a recommendation,” Dr. Gecsi said.
The consensus recommendations therefore state that current data are not sufficient to recommend or discourage use of cannabis products to treat pain linked to gynecologic conditions. Yet the potential for benefit suggests that “if they are already using these products, there’s no need to discourage them, especially if the patients feel they are getting some benefit from them,” Dr. Gecsi said.
The guidance also highlights the importance of clinicians being aware that their patients may be using these products and being prepared to discuss with them the limited data available as well as the theoretical benefits and potential negative effects for adult patients. In adolescent patients, however, the increased risk of negative cognitive effects and psychotic conditions currently appears to outweigh the theoretical benefits. Use of cannabis products in teens should therefore not be recommended until more data is available on the short-term and long-term effects of its use on adolescent brain development, the authors wrote.
Josephine Urbina, MD, MAS, an assistant professor of ob.gyn. and reproductive sciences at the University of California, San Francisco, said that the guidance confirms what most ob.gyns. suspected regarding the lack of data to support or refute the use of cannabis.
“Patients usually see cannabis as a last resort to control their pain,” Dr. Urbina added. “It seems that this decision to start using cannabis isn’t one that’s taken lightly, and they’re usually at their wits’ end. Some patients use cannabis as an adjunct so that they don’t have to rely on stronger pain medications like opioids, which we all know have a proven track record for being addicting.”
The ACOG guidance notes limited survey data suggesting that cannabis may help reduce patients’ use of opioids for pain relief, though there’s not enough data to confirm this potential benefit. The authors also highlight the limited data suggesting that PEA-transpolydatin may be effective for relieving pain related to primary dysmenorrhea, endometriosis, and chronic pelvic pain, but, again, there’s not yet enough data to formally recommend its use.
Current treatments for pain from gynecologic conditions depend on the cause of the pain, Dr. Gecsi said. One of the more common causes of pain, for example, is endometriosis, which can be treated with medications, including hormonal ones, or with surgery.
Other first-line treatments for pain, can include nonsteroidal anti-inflammatory drug and, for more complex cases, gonadotropin-releasing hormone agonists, antidepressants, and anticonvulsants. “Nonpharmacological treatments like physical therapy, acupuncture, cognitive-behavioral therapy and lifestyle changes, including diet and exercise, can also be beneficial,” Dr. Urbina added.
The new guidance also attempts to clarify the confusing legal landscape associated with cannabis use. In addition to the patchwork of state laws, federal distinctions in cannabis legality have been shifting in recent years. The 2018 Farm Bill defined any product with 0.3% or less tetrahydrocannabinol (THC) as hemp, which is now legal and commercially available in all states. That change introduced a wide range of topical and edible cannabidiol products to the market, even in states where marijuana is otherwise still illegal.
Products with a THC concentration greater than 0.3%, however, remain classified as a Schedule I drug, though the Justice Department proposed a rule in May to change that classification to Schedule III, which includes drugs such as ketamine, anabolic steroids, testosterone, and Tylenol with codeine. The guidance also includes a box of definitions for different types of cannabis products and differences in bioavailability, time to onset of effects, and duration of effects for different routes of exposure.
Kiran Kavipurapu, DO, JD, MPH, an assistant clinical professor and ob.gyn. residency program director at the University of California, Los Angeles, said the increasing availability and legalization of cannabis has meant that more patients are coming to their doctors’ offices having already tried it for medicinal purposes.
“Cannabis use discussions are often initiated by patients who are either inquiring about its benefits or because they have already tried it and want a physician to weigh in,” Dr. Kavipurapu said in an interview. “Over the past 5 years or so, this has become an increasingly common topic along with discussion of herbal or naturopathic remedies to supplement treatment of gynecologic conditions.”
Yet stigma about its use can lead patients to feel hesitant about bringing it up, Dr. Kavipurapu added. “I think it is necessary for clinicians to create a safe environment for patients to discuss their use of any and all therapies or supplements so their physician can assess for potential drug interactions or other harmful effects,” he said.
Dr. Gecsi agreed that this need to reassure patients was an important aspect of ACOG’s new guidance. Clinicians “should make sure that they strive to always foster a relationship with their patients where their patients can feel safe sharing their use and other things going on in their lives without feeling like they’re going to get in trouble,. Our job is not to put our patients at risk for any kind of legal or criminal problems.”
Meanwhile, the legal restrictions on cannabis remain a substantial barrier to the additional research that’s needed to make more informed recommendations about its use to patients, Dr. Gecsi said. But the inadequate amount of research goes beyond the challenges of studying cannabis in particular, Dr. Urbina noted.
“The paucity of research in women’s health, particularly in the realm of sexual and reproductive health care, underscores the urgent need to prioritize this topic in order to ensure comprehensive and equitable healthcare for women,” Dr. Urbina said. Underrepresentation of women’s health issues in clinical studies has led to knowledge gaps and “suboptimal treatment options for conditions unique to or more prevalent among women,” and it’s another reason for the lack of robust data on cannabis use for gynecologic-related pain.
“Prioritizing research in women’s health is essential to developing effective interventions, understanding gender-specific responses to treatments, and addressing the complex interplay of biological, social, and psychological factors affecting women’s well-being,” Dr. Urbina said. “Furthermore, advancing reproductive health research supports women’s reproductive autonomy, empowering them with the knowledge and resources to make informed decisions about their bodies and lives. By investing in robust, inclusive research, we can close existing gaps, improve health outcomes, and promote gender equity in healthcare — something that has been long overdue in this country.”
The guidance did not use external funding. Dr. Gecsi, Dr. Urbina, and Dr. Kavipurapu had no disclosures.
*This story was corrected on July 25, 2024.
Postpartum Screening Critical for Urinary Symptoms and Related Mental Health
Bothersome urinary symptoms and incontinence at 12 months post partum are common and treatable, so screening for those symptoms as well as associated depression and anxiety is essential, write authors of a new study.
Sonia Bhandari Randhawa, MD, with the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center in Dallas, led the study published in Urogynecology, which identified factors associated with persistent stress urinary incontinence (SUI), marked by leakage from sudden movements such as coughing or jumping; urgency UI (UUI), leakage after a sudden and intense need to urinate, even if the bladder isn’t full; and other overall bothersome urinary symptoms 1 year after delivery.
Associations by Subtype
Dr. Randhawa analyzed data provided by 419 patients (77% Hispanic White and 22% non-Hispanic Black). After multivariable analysis, SUI (n = 136, 32.5%) was significantly associated with greater body mass index (BMI) at the time of delivery and greater depression screening scores. Factors not associated included fetal birth weight, mode of delivery, degree of laceration, and breastfeeding status.
UUI (n = 69, 16.5%) was significantly associated with more births and higher anxiety screening scores. Women with overall urinary symptom bother also had significantly more births and higher anxiety screening scores.
“These findings support the [American College of Obstetricians and Gynecologists] recommendations for routine mental health and urinary incontinence screening in the postpartum period,” said Gena Dunivan, MD, director of the Division of Urogynecology and Pelvic Reconstructive Surgery at University of Alabama–Birmingham, who was not part of the study. “Routine screening for these issues will hopefully reduce the stigma, allowing more patients to receive the help they deserve.”
1 in 3 Postpartum Patients Affected by Urinary Incontinence
About one third of postpartum patients are affected by urinary incontinence, which is linked with poorer quality of life and mental health outcomes, the authors note.
Estimates of incontinence frequency post partum vary depending on the population studied, differences in subgroups, and definition of urinary incontinence. A strength of the study was its sizable population, made up almost entirely of Hispanic White and non-Hispanic Black women receiving care at a large safety-net hospital.
“This study has important clinical implications for postpartum patients,” the authors write. “Given an array of proven treatment options for both UUI and SUI, maternal health surveillance needs to include routine inquiry about UI to overcome patients’ reluctance for seeking care. Next, as elevated BMI was identified as a risk factor for persistent postpartum SUI, maintaining a healthy weight should be routinely encouraged during antenatal and postpartum clinic visits.”
Lauren Giugale, MD, director of UPMC’s Magee-Womens Hospital Postpartum Pelvic Floor Healing Clinic in Pittsburgh, Pennsylvania, says an important aspect of the study is that it measured urinary symptoms 1 year after delivery and shows that these symptoms persist. “A lot of studies look more short term,” she noted.
She also pointed to the study’s population of Black and Hispanic women, populations which “have been pretty hard to capture in urogynecology research. It’s important for us to understand these urinary symptoms are affecting those women as well as White women.”
Association With Anxiety
The association between postpartum depression scores and SUI is important, she says, but Dr. Randhawa’s team also “uniquely looked at anxiety scores in postpartum women. They showed an association between anxiety scores and UUI, so there’s certainly a potential impact of postpartum urinary symptoms on maternal mental health and maternal well-being.” The relationship between anxiety and depression and postpartum urinary symptoms is not well understood and warrants further research, she says.
In her role, Dr. Giugale says, she always asks about urinary symptoms, particularly in postpartum women. But she notes that some ob.gyn.s without urogynecology training may not prioritize those questions amid all the other information they need to cover.
She says she tells her residents to ask patients pointedly, “Are you having any urine leakage? Patients may not think it’s a problem that can be addressed. We do patients a disservice when we don’t ask the important questions that might potentially impact patients’ lives.”
The authors and Dr. Giugale and Dr. Dunivan report no relevant financial relationships.
Bothersome urinary symptoms and incontinence at 12 months post partum are common and treatable, so screening for those symptoms as well as associated depression and anxiety is essential, write authors of a new study.
Sonia Bhandari Randhawa, MD, with the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center in Dallas, led the study published in Urogynecology, which identified factors associated with persistent stress urinary incontinence (SUI), marked by leakage from sudden movements such as coughing or jumping; urgency UI (UUI), leakage after a sudden and intense need to urinate, even if the bladder isn’t full; and other overall bothersome urinary symptoms 1 year after delivery.
Associations by Subtype
Dr. Randhawa analyzed data provided by 419 patients (77% Hispanic White and 22% non-Hispanic Black). After multivariable analysis, SUI (n = 136, 32.5%) was significantly associated with greater body mass index (BMI) at the time of delivery and greater depression screening scores. Factors not associated included fetal birth weight, mode of delivery, degree of laceration, and breastfeeding status.
UUI (n = 69, 16.5%) was significantly associated with more births and higher anxiety screening scores. Women with overall urinary symptom bother also had significantly more births and higher anxiety screening scores.
“These findings support the [American College of Obstetricians and Gynecologists] recommendations for routine mental health and urinary incontinence screening in the postpartum period,” said Gena Dunivan, MD, director of the Division of Urogynecology and Pelvic Reconstructive Surgery at University of Alabama–Birmingham, who was not part of the study. “Routine screening for these issues will hopefully reduce the stigma, allowing more patients to receive the help they deserve.”
1 in 3 Postpartum Patients Affected by Urinary Incontinence
About one third of postpartum patients are affected by urinary incontinence, which is linked with poorer quality of life and mental health outcomes, the authors note.
Estimates of incontinence frequency post partum vary depending on the population studied, differences in subgroups, and definition of urinary incontinence. A strength of the study was its sizable population, made up almost entirely of Hispanic White and non-Hispanic Black women receiving care at a large safety-net hospital.
“This study has important clinical implications for postpartum patients,” the authors write. “Given an array of proven treatment options for both UUI and SUI, maternal health surveillance needs to include routine inquiry about UI to overcome patients’ reluctance for seeking care. Next, as elevated BMI was identified as a risk factor for persistent postpartum SUI, maintaining a healthy weight should be routinely encouraged during antenatal and postpartum clinic visits.”
Lauren Giugale, MD, director of UPMC’s Magee-Womens Hospital Postpartum Pelvic Floor Healing Clinic in Pittsburgh, Pennsylvania, says an important aspect of the study is that it measured urinary symptoms 1 year after delivery and shows that these symptoms persist. “A lot of studies look more short term,” she noted.
She also pointed to the study’s population of Black and Hispanic women, populations which “have been pretty hard to capture in urogynecology research. It’s important for us to understand these urinary symptoms are affecting those women as well as White women.”
Association With Anxiety
The association between postpartum depression scores and SUI is important, she says, but Dr. Randhawa’s team also “uniquely looked at anxiety scores in postpartum women. They showed an association between anxiety scores and UUI, so there’s certainly a potential impact of postpartum urinary symptoms on maternal mental health and maternal well-being.” The relationship between anxiety and depression and postpartum urinary symptoms is not well understood and warrants further research, she says.
In her role, Dr. Giugale says, she always asks about urinary symptoms, particularly in postpartum women. But she notes that some ob.gyn.s without urogynecology training may not prioritize those questions amid all the other information they need to cover.
She says she tells her residents to ask patients pointedly, “Are you having any urine leakage? Patients may not think it’s a problem that can be addressed. We do patients a disservice when we don’t ask the important questions that might potentially impact patients’ lives.”
The authors and Dr. Giugale and Dr. Dunivan report no relevant financial relationships.
Bothersome urinary symptoms and incontinence at 12 months post partum are common and treatable, so screening for those symptoms as well as associated depression and anxiety is essential, write authors of a new study.
Sonia Bhandari Randhawa, MD, with the Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center in Dallas, led the study published in Urogynecology, which identified factors associated with persistent stress urinary incontinence (SUI), marked by leakage from sudden movements such as coughing or jumping; urgency UI (UUI), leakage after a sudden and intense need to urinate, even if the bladder isn’t full; and other overall bothersome urinary symptoms 1 year after delivery.
Associations by Subtype
Dr. Randhawa analyzed data provided by 419 patients (77% Hispanic White and 22% non-Hispanic Black). After multivariable analysis, SUI (n = 136, 32.5%) was significantly associated with greater body mass index (BMI) at the time of delivery and greater depression screening scores. Factors not associated included fetal birth weight, mode of delivery, degree of laceration, and breastfeeding status.
UUI (n = 69, 16.5%) was significantly associated with more births and higher anxiety screening scores. Women with overall urinary symptom bother also had significantly more births and higher anxiety screening scores.
“These findings support the [American College of Obstetricians and Gynecologists] recommendations for routine mental health and urinary incontinence screening in the postpartum period,” said Gena Dunivan, MD, director of the Division of Urogynecology and Pelvic Reconstructive Surgery at University of Alabama–Birmingham, who was not part of the study. “Routine screening for these issues will hopefully reduce the stigma, allowing more patients to receive the help they deserve.”
1 in 3 Postpartum Patients Affected by Urinary Incontinence
About one third of postpartum patients are affected by urinary incontinence, which is linked with poorer quality of life and mental health outcomes, the authors note.
Estimates of incontinence frequency post partum vary depending on the population studied, differences in subgroups, and definition of urinary incontinence. A strength of the study was its sizable population, made up almost entirely of Hispanic White and non-Hispanic Black women receiving care at a large safety-net hospital.
“This study has important clinical implications for postpartum patients,” the authors write. “Given an array of proven treatment options for both UUI and SUI, maternal health surveillance needs to include routine inquiry about UI to overcome patients’ reluctance for seeking care. Next, as elevated BMI was identified as a risk factor for persistent postpartum SUI, maintaining a healthy weight should be routinely encouraged during antenatal and postpartum clinic visits.”
Lauren Giugale, MD, director of UPMC’s Magee-Womens Hospital Postpartum Pelvic Floor Healing Clinic in Pittsburgh, Pennsylvania, says an important aspect of the study is that it measured urinary symptoms 1 year after delivery and shows that these symptoms persist. “A lot of studies look more short term,” she noted.
She also pointed to the study’s population of Black and Hispanic women, populations which “have been pretty hard to capture in urogynecology research. It’s important for us to understand these urinary symptoms are affecting those women as well as White women.”
Association With Anxiety
The association between postpartum depression scores and SUI is important, she says, but Dr. Randhawa’s team also “uniquely looked at anxiety scores in postpartum women. They showed an association between anxiety scores and UUI, so there’s certainly a potential impact of postpartum urinary symptoms on maternal mental health and maternal well-being.” The relationship between anxiety and depression and postpartum urinary symptoms is not well understood and warrants further research, she says.
In her role, Dr. Giugale says, she always asks about urinary symptoms, particularly in postpartum women. But she notes that some ob.gyn.s without urogynecology training may not prioritize those questions amid all the other information they need to cover.
She says she tells her residents to ask patients pointedly, “Are you having any urine leakage? Patients may not think it’s a problem that can be addressed. We do patients a disservice when we don’t ask the important questions that might potentially impact patients’ lives.”
The authors and Dr. Giugale and Dr. Dunivan report no relevant financial relationships.
UROGYNECOLOGY
Polycystic Ovarian Syndrome: New Science Offers Old Remedy
An ancient Chinese remedy for malaria could offer new hope to the 10% of reproductive-age women living with polycystic ovarian syndrome (PCOS), a poorly understood endocrine disorder that can cause hormonal imbalances, irregular periods, and cysts in the ovaries.
“PCOS is among the most common disorders of reproductive-age women,” said endocrinologist Andrea Dunaif, MD, a professor at the Icahn School of Medicine at Mount Sinai, New York City, who studies diabetes and women’s health. “It is a major risk factor for obesity, type 2 diabetes, and heart disease.” It’s also a leading cause of infertility.
Yet despite how common it is, PCOS has no Food and Drug Administration–approved treatments, though a few early-stage clinical trials are underway. Many women end up taking off-label medications such as oral contraceptives, insulin-sensitizing agents, and antiandrogens to help manage symptoms. Surgery can also be used to treat fertility problems associated with PCOS, though it may not work for everyone.
In a new study, a derivative of artemisinin — a molecule that comes from Artemisia plants, which have been used as far back as 1596 to treat malaria in China — helped relieve PCOS symptoms in rats and a small group of women.
Previously, the study’s lead researcher Qi-qun Tang, MD, PhD, had found that this derivative, called artemether, can increase thermogenesis, boosting metabolism. Dr. Tang and his team at Fudan University, Shanghai, China, wanted to see if it would help with PCOS, which is associated with metabolic problems such as insulin resistance.
What the Researchers Did
To simulate PCOS in rats, the team treated the rodents with insulin and human chorionic gonadotropin. Then, they tested artemether on the rats and found that it lowered androgen production in the ovaries.
“A common feature [of PCOS] is that the ovaries, and often the adrenal glands, make increased male hormones, nowhere near what a man makes but slightly above what a normal woman makes,” said Dr. Dunaif, who was not involved in the study.
Artemether “inhibits one of the steroidogenic enzymes, CYP11A1, which is important in the production of male hormones,” Dr. Tang said. It does this by increasing the enzyme’s interaction with a protein called LONP1, triggering the enzyme’s breakdown. Increased levels of LONP1 also appeared to suppress androgen production in the ovaries.
In a pilot clinical study of 19 women with PCOS, taking dihydroartemisinin — an approved drug used to treat malaria that contains active artemisinin derivatives — for 12 weeks substantially reduced serum testosterone and anti-Müllerian hormone levels (which are higher in women with PCOS). Using ultrasound, the researchers found that the antral follicle count (also higher than normal with PCOS) had been reduced. All participants had regular menstrual cycles during treatment. And no one reported significant side effects.
“Regular menstrual cycles suggest that there is ovulation, which can result in conception,” Dr. Dunaif said. Still, testing would be needed to confirm that cycles are ovulatory.
Lowering androgen levels “could improve a substantial portion of the symptoms of PCOS,” said Dr. Dunaif. But the research didn’t see an improvement in insulin sensitivity among the women, suggesting that targeting androgens may not help the metabolic symptoms.
What’s Next?
A larger, placebo-controlled trial would still be needed to assess the drug’s efficacy, said Dr. Dunaif, pointing out that the human study did not have a placebo arm.
And unanswered questions remain. Are there any adrenal effects of the compound? “The enzymes that produce androgens are shared between the ovary and the adrenal [gland],” Dr. Dunaif said, but she pointed out that the study doesn’t address whether there is an adrenal benefit. It’s something to look at in future research.
Still, because artemisinin is an established drug, it may come to market faster than a new molecule would, she said. However, a pharmaceutical company would need to be willing to take on the drug. (Dr. Tang said several companies have already expressed interest.)
And while you can buy artemisinin on the Internet, Dr. Dunaif warned not to start taking it if you have PCOS. “I don’t think we’re at that point,” Dr. Dunaif said.
A version of this article first appeared on Medscape.com.
An ancient Chinese remedy for malaria could offer new hope to the 10% of reproductive-age women living with polycystic ovarian syndrome (PCOS), a poorly understood endocrine disorder that can cause hormonal imbalances, irregular periods, and cysts in the ovaries.
“PCOS is among the most common disorders of reproductive-age women,” said endocrinologist Andrea Dunaif, MD, a professor at the Icahn School of Medicine at Mount Sinai, New York City, who studies diabetes and women’s health. “It is a major risk factor for obesity, type 2 diabetes, and heart disease.” It’s also a leading cause of infertility.
Yet despite how common it is, PCOS has no Food and Drug Administration–approved treatments, though a few early-stage clinical trials are underway. Many women end up taking off-label medications such as oral contraceptives, insulin-sensitizing agents, and antiandrogens to help manage symptoms. Surgery can also be used to treat fertility problems associated with PCOS, though it may not work for everyone.
In a new study, a derivative of artemisinin — a molecule that comes from Artemisia plants, which have been used as far back as 1596 to treat malaria in China — helped relieve PCOS symptoms in rats and a small group of women.
Previously, the study’s lead researcher Qi-qun Tang, MD, PhD, had found that this derivative, called artemether, can increase thermogenesis, boosting metabolism. Dr. Tang and his team at Fudan University, Shanghai, China, wanted to see if it would help with PCOS, which is associated with metabolic problems such as insulin resistance.
What the Researchers Did
To simulate PCOS in rats, the team treated the rodents with insulin and human chorionic gonadotropin. Then, they tested artemether on the rats and found that it lowered androgen production in the ovaries.
“A common feature [of PCOS] is that the ovaries, and often the adrenal glands, make increased male hormones, nowhere near what a man makes but slightly above what a normal woman makes,” said Dr. Dunaif, who was not involved in the study.
Artemether “inhibits one of the steroidogenic enzymes, CYP11A1, which is important in the production of male hormones,” Dr. Tang said. It does this by increasing the enzyme’s interaction with a protein called LONP1, triggering the enzyme’s breakdown. Increased levels of LONP1 also appeared to suppress androgen production in the ovaries.
In a pilot clinical study of 19 women with PCOS, taking dihydroartemisinin — an approved drug used to treat malaria that contains active artemisinin derivatives — for 12 weeks substantially reduced serum testosterone and anti-Müllerian hormone levels (which are higher in women with PCOS). Using ultrasound, the researchers found that the antral follicle count (also higher than normal with PCOS) had been reduced. All participants had regular menstrual cycles during treatment. And no one reported significant side effects.
“Regular menstrual cycles suggest that there is ovulation, which can result in conception,” Dr. Dunaif said. Still, testing would be needed to confirm that cycles are ovulatory.
Lowering androgen levels “could improve a substantial portion of the symptoms of PCOS,” said Dr. Dunaif. But the research didn’t see an improvement in insulin sensitivity among the women, suggesting that targeting androgens may not help the metabolic symptoms.
What’s Next?
A larger, placebo-controlled trial would still be needed to assess the drug’s efficacy, said Dr. Dunaif, pointing out that the human study did not have a placebo arm.
And unanswered questions remain. Are there any adrenal effects of the compound? “The enzymes that produce androgens are shared between the ovary and the adrenal [gland],” Dr. Dunaif said, but she pointed out that the study doesn’t address whether there is an adrenal benefit. It’s something to look at in future research.
Still, because artemisinin is an established drug, it may come to market faster than a new molecule would, she said. However, a pharmaceutical company would need to be willing to take on the drug. (Dr. Tang said several companies have already expressed interest.)
And while you can buy artemisinin on the Internet, Dr. Dunaif warned not to start taking it if you have PCOS. “I don’t think we’re at that point,” Dr. Dunaif said.
A version of this article first appeared on Medscape.com.
An ancient Chinese remedy for malaria could offer new hope to the 10% of reproductive-age women living with polycystic ovarian syndrome (PCOS), a poorly understood endocrine disorder that can cause hormonal imbalances, irregular periods, and cysts in the ovaries.
“PCOS is among the most common disorders of reproductive-age women,” said endocrinologist Andrea Dunaif, MD, a professor at the Icahn School of Medicine at Mount Sinai, New York City, who studies diabetes and women’s health. “It is a major risk factor for obesity, type 2 diabetes, and heart disease.” It’s also a leading cause of infertility.
Yet despite how common it is, PCOS has no Food and Drug Administration–approved treatments, though a few early-stage clinical trials are underway. Many women end up taking off-label medications such as oral contraceptives, insulin-sensitizing agents, and antiandrogens to help manage symptoms. Surgery can also be used to treat fertility problems associated with PCOS, though it may not work for everyone.
In a new study, a derivative of artemisinin — a molecule that comes from Artemisia plants, which have been used as far back as 1596 to treat malaria in China — helped relieve PCOS symptoms in rats and a small group of women.
Previously, the study’s lead researcher Qi-qun Tang, MD, PhD, had found that this derivative, called artemether, can increase thermogenesis, boosting metabolism. Dr. Tang and his team at Fudan University, Shanghai, China, wanted to see if it would help with PCOS, which is associated with metabolic problems such as insulin resistance.
What the Researchers Did
To simulate PCOS in rats, the team treated the rodents with insulin and human chorionic gonadotropin. Then, they tested artemether on the rats and found that it lowered androgen production in the ovaries.
“A common feature [of PCOS] is that the ovaries, and often the adrenal glands, make increased male hormones, nowhere near what a man makes but slightly above what a normal woman makes,” said Dr. Dunaif, who was not involved in the study.
Artemether “inhibits one of the steroidogenic enzymes, CYP11A1, which is important in the production of male hormones,” Dr. Tang said. It does this by increasing the enzyme’s interaction with a protein called LONP1, triggering the enzyme’s breakdown. Increased levels of LONP1 also appeared to suppress androgen production in the ovaries.
In a pilot clinical study of 19 women with PCOS, taking dihydroartemisinin — an approved drug used to treat malaria that contains active artemisinin derivatives — for 12 weeks substantially reduced serum testosterone and anti-Müllerian hormone levels (which are higher in women with PCOS). Using ultrasound, the researchers found that the antral follicle count (also higher than normal with PCOS) had been reduced. All participants had regular menstrual cycles during treatment. And no one reported significant side effects.
“Regular menstrual cycles suggest that there is ovulation, which can result in conception,” Dr. Dunaif said. Still, testing would be needed to confirm that cycles are ovulatory.
Lowering androgen levels “could improve a substantial portion of the symptoms of PCOS,” said Dr. Dunaif. But the research didn’t see an improvement in insulin sensitivity among the women, suggesting that targeting androgens may not help the metabolic symptoms.
What’s Next?
A larger, placebo-controlled trial would still be needed to assess the drug’s efficacy, said Dr. Dunaif, pointing out that the human study did not have a placebo arm.
And unanswered questions remain. Are there any adrenal effects of the compound? “The enzymes that produce androgens are shared between the ovary and the adrenal [gland],” Dr. Dunaif said, but she pointed out that the study doesn’t address whether there is an adrenal benefit. It’s something to look at in future research.
Still, because artemisinin is an established drug, it may come to market faster than a new molecule would, she said. However, a pharmaceutical company would need to be willing to take on the drug. (Dr. Tang said several companies have already expressed interest.)
And while you can buy artemisinin on the Internet, Dr. Dunaif warned not to start taking it if you have PCOS. “I don’t think we’re at that point,” Dr. Dunaif said.
A version of this article first appeared on Medscape.com.
FROM SCIENCE
FDA Expands Durvalumab Label to Endometrial Cancer
Originally approved in 2017, the programmed death ligand 1 inhibitor caries previously approved indications for non–small cell lung cancer, biliary tract cancer, and hepatocellular carcinoma.
Approval of the new indication was based on the phase 3 DUO-E trial, which included 95 women with newly diagnosed advanced or recurrent dMMR endometrial cancer. Patients were randomized to durvalumab 1120 mg or placebo with carboplatin plus paclitaxel every 3 weeks for a maximum of six cycles followed by durvalumab 1500 mg every 4 weeks until disease progression.
Median progression-free survival (PFS) was 7 months in the placebo arm but not reached in the durvalumab group. Overall survival outcomes were immature at the PFS analysis.
A quarter or more of durvalumab patients experienced peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, diarrhea, vomiting, and cough.
The recommended treatment regimen for dMMR endometrial cancer in women who weigh ≥ 30 kg is 1120 mg with carboplatin plus paclitaxel every 3 weeks for six cycles, followed by single-agent durvalumab 1500 mg every 4 weeks.
The price of 2.4 mL of durvalumab at a concentration of 50 mg/mL is $1027, according to drugs.com.
A version of this article appeared on Medscape.com.
Originally approved in 2017, the programmed death ligand 1 inhibitor caries previously approved indications for non–small cell lung cancer, biliary tract cancer, and hepatocellular carcinoma.
Approval of the new indication was based on the phase 3 DUO-E trial, which included 95 women with newly diagnosed advanced or recurrent dMMR endometrial cancer. Patients were randomized to durvalumab 1120 mg or placebo with carboplatin plus paclitaxel every 3 weeks for a maximum of six cycles followed by durvalumab 1500 mg every 4 weeks until disease progression.
Median progression-free survival (PFS) was 7 months in the placebo arm but not reached in the durvalumab group. Overall survival outcomes were immature at the PFS analysis.
A quarter or more of durvalumab patients experienced peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, diarrhea, vomiting, and cough.
The recommended treatment regimen for dMMR endometrial cancer in women who weigh ≥ 30 kg is 1120 mg with carboplatin plus paclitaxel every 3 weeks for six cycles, followed by single-agent durvalumab 1500 mg every 4 weeks.
The price of 2.4 mL of durvalumab at a concentration of 50 mg/mL is $1027, according to drugs.com.
A version of this article appeared on Medscape.com.
Originally approved in 2017, the programmed death ligand 1 inhibitor caries previously approved indications for non–small cell lung cancer, biliary tract cancer, and hepatocellular carcinoma.
Approval of the new indication was based on the phase 3 DUO-E trial, which included 95 women with newly diagnosed advanced or recurrent dMMR endometrial cancer. Patients were randomized to durvalumab 1120 mg or placebo with carboplatin plus paclitaxel every 3 weeks for a maximum of six cycles followed by durvalumab 1500 mg every 4 weeks until disease progression.
Median progression-free survival (PFS) was 7 months in the placebo arm but not reached in the durvalumab group. Overall survival outcomes were immature at the PFS analysis.
A quarter or more of durvalumab patients experienced peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, diarrhea, vomiting, and cough.
The recommended treatment regimen for dMMR endometrial cancer in women who weigh ≥ 30 kg is 1120 mg with carboplatin plus paclitaxel every 3 weeks for six cycles, followed by single-agent durvalumab 1500 mg every 4 weeks.
The price of 2.4 mL of durvalumab at a concentration of 50 mg/mL is $1027, according to drugs.com.
A version of this article appeared on Medscape.com.
Could British Columbia Eliminate Cervical Cancer by 2031?
To achieve this goal, the province will also need to reach historically underscreened, equity-seeking populations (ie, Black, indigenous, immigrant, LGBTQ, and disabled patients, and those with sexual trauma) through mailed self-screening HPV tests.
The adoption of both these strategies is essential, according to a modeling study that was published on June 3 in CMAJ, especially because the true impact of HPV vaccination has yet to be fully realized.
“In BC, we have a school-based program to increase vaccine coverage in boys and girls starting in grade 6,” study author Reka Pataky, PhD, a senior research health economist at the Canadian Centre for Applied Research in Cancer Control and BC Cancer in Vancouver, British Columbia, Canada, told this news organization. Dr. Pataky noted that this immunization program was launched in 2008 and that some of the initial cohorts haven›t yet reached the average age of diagnosis, which is between 30 and 59 years.
Three’s a Charm
The investigators undertook a modeling study to determine when and how BC might achieve the elimination of cervical cancer following a transition to HPV-based screening. Elimination was defined as an annual age-standardized incidence rate of < 4.0 per 100,000 women.
Modeling scenarios were developed using the Canadian Partnership Against Cancer’s priority targets, which include increasing HPV vaccination through school-based coverage from 70% to 90%, increasing the probability of ever receiving a screening test from 90% to 95%, increasing the rate of on-time screening from 70% to 90%, and improving follow-up to 95% for colposcopy (currently 88%) and HPV testing (currently 80%). Modeling simulated HPV transmission and the natural history of cervical cancer in the Canadian population and relied upon two reference scenarios: One using BC’s cytology-based screening at the time of analysis, and the other an HPV base-case scenario.
The researchers found that with the status quo (ie, cytology-based screening and no change to vaccination or screening participation rates), BC would not eliminate cervical cancer until 2045. Implementation of HPV-based screening at the current 70% participation rate would achieve elimination in 2034 and prevent 942 cases compared with cytology screening. Increasing the proportion of patients who were ever screened or increasing vaccination coverage would result in cervical cancer elimination by 2033. The time line would be shortened even further (to 2031) through a combination of three strategies (ie, improving recruitment, on-time screening, and follow-up compliance).
Low Incidence, Strained System
The incidence of cervical cancer in Canada is relatively low, accounting for 1.3% of all new female cancers and 1.1% of all female cancer deaths.
“The reason that we have such low rates is because we have organized screening programs,” explained Rachel Kupets, MD, associate professor of gynecologic oncology at the University of Toronto and Sunnybrook Hospital, Toronto. She was not involved in the study.
“We’re starting to see what happens when the system gets strained with lower participation rates. I am starting to see a lot more women with invasive cervical cancer. They’re younger, and their cancers are less curable and less treatable,” she said.
Difficulties with access, interest, and education have contributed to low cervical screening rates among equity-seeking populations, according to Dr. Pataky and Dr. Kupets.
“Self-screening is another tool that can incrementally benefit those folks who wouldn’t otherwise undergo screening or don’t want an invasive test,” said Dr. Kupets. It can also play an increasing role, while current access to primary care services in Canada is at an all-time low. Community outreach through centers, mobile coaches, and nursing stations might help ensure participation by at-risk populations. These measures also could boost follow-up for and education about positive results, said Dr. Kupets.
In a related editorial, Shannon Charlebois, MD, medical editor of CMAJ, and Sarah Kean, MD, assistant professor of gynecologic oncology at the University of Manitoba in Winnipeg, Manitoba, Canada, emphasized the need for mailed HPV self-screening kits to be paid for and integrated into provincial cervical cancer screening programs across Canada to support earlier cervical cancer detection and lower invasive cancer rates.
Dr. Pataky concurred. “There have been discussions about making the big transition from traditional cytology to implementing HPV self-screening,” she said. “We have really effective tools for preventing cervical cancer, and it’s important to not lose sight of that goal.”
The study was funded by the National Institutes of Health. Dr. Pataky and Dr. Kupets reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
To achieve this goal, the province will also need to reach historically underscreened, equity-seeking populations (ie, Black, indigenous, immigrant, LGBTQ, and disabled patients, and those with sexual trauma) through mailed self-screening HPV tests.
The adoption of both these strategies is essential, according to a modeling study that was published on June 3 in CMAJ, especially because the true impact of HPV vaccination has yet to be fully realized.
“In BC, we have a school-based program to increase vaccine coverage in boys and girls starting in grade 6,” study author Reka Pataky, PhD, a senior research health economist at the Canadian Centre for Applied Research in Cancer Control and BC Cancer in Vancouver, British Columbia, Canada, told this news organization. Dr. Pataky noted that this immunization program was launched in 2008 and that some of the initial cohorts haven›t yet reached the average age of diagnosis, which is between 30 and 59 years.
Three’s a Charm
The investigators undertook a modeling study to determine when and how BC might achieve the elimination of cervical cancer following a transition to HPV-based screening. Elimination was defined as an annual age-standardized incidence rate of < 4.0 per 100,000 women.
Modeling scenarios were developed using the Canadian Partnership Against Cancer’s priority targets, which include increasing HPV vaccination through school-based coverage from 70% to 90%, increasing the probability of ever receiving a screening test from 90% to 95%, increasing the rate of on-time screening from 70% to 90%, and improving follow-up to 95% for colposcopy (currently 88%) and HPV testing (currently 80%). Modeling simulated HPV transmission and the natural history of cervical cancer in the Canadian population and relied upon two reference scenarios: One using BC’s cytology-based screening at the time of analysis, and the other an HPV base-case scenario.
The researchers found that with the status quo (ie, cytology-based screening and no change to vaccination or screening participation rates), BC would not eliminate cervical cancer until 2045. Implementation of HPV-based screening at the current 70% participation rate would achieve elimination in 2034 and prevent 942 cases compared with cytology screening. Increasing the proportion of patients who were ever screened or increasing vaccination coverage would result in cervical cancer elimination by 2033. The time line would be shortened even further (to 2031) through a combination of three strategies (ie, improving recruitment, on-time screening, and follow-up compliance).
Low Incidence, Strained System
The incidence of cervical cancer in Canada is relatively low, accounting for 1.3% of all new female cancers and 1.1% of all female cancer deaths.
“The reason that we have such low rates is because we have organized screening programs,” explained Rachel Kupets, MD, associate professor of gynecologic oncology at the University of Toronto and Sunnybrook Hospital, Toronto. She was not involved in the study.
“We’re starting to see what happens when the system gets strained with lower participation rates. I am starting to see a lot more women with invasive cervical cancer. They’re younger, and their cancers are less curable and less treatable,” she said.
Difficulties with access, interest, and education have contributed to low cervical screening rates among equity-seeking populations, according to Dr. Pataky and Dr. Kupets.
“Self-screening is another tool that can incrementally benefit those folks who wouldn’t otherwise undergo screening or don’t want an invasive test,” said Dr. Kupets. It can also play an increasing role, while current access to primary care services in Canada is at an all-time low. Community outreach through centers, mobile coaches, and nursing stations might help ensure participation by at-risk populations. These measures also could boost follow-up for and education about positive results, said Dr. Kupets.
In a related editorial, Shannon Charlebois, MD, medical editor of CMAJ, and Sarah Kean, MD, assistant professor of gynecologic oncology at the University of Manitoba in Winnipeg, Manitoba, Canada, emphasized the need for mailed HPV self-screening kits to be paid for and integrated into provincial cervical cancer screening programs across Canada to support earlier cervical cancer detection and lower invasive cancer rates.
Dr. Pataky concurred. “There have been discussions about making the big transition from traditional cytology to implementing HPV self-screening,” she said. “We have really effective tools for preventing cervical cancer, and it’s important to not lose sight of that goal.”
The study was funded by the National Institutes of Health. Dr. Pataky and Dr. Kupets reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
To achieve this goal, the province will also need to reach historically underscreened, equity-seeking populations (ie, Black, indigenous, immigrant, LGBTQ, and disabled patients, and those with sexual trauma) through mailed self-screening HPV tests.
The adoption of both these strategies is essential, according to a modeling study that was published on June 3 in CMAJ, especially because the true impact of HPV vaccination has yet to be fully realized.
“In BC, we have a school-based program to increase vaccine coverage in boys and girls starting in grade 6,” study author Reka Pataky, PhD, a senior research health economist at the Canadian Centre for Applied Research in Cancer Control and BC Cancer in Vancouver, British Columbia, Canada, told this news organization. Dr. Pataky noted that this immunization program was launched in 2008 and that some of the initial cohorts haven›t yet reached the average age of diagnosis, which is between 30 and 59 years.
Three’s a Charm
The investigators undertook a modeling study to determine when and how BC might achieve the elimination of cervical cancer following a transition to HPV-based screening. Elimination was defined as an annual age-standardized incidence rate of < 4.0 per 100,000 women.
Modeling scenarios were developed using the Canadian Partnership Against Cancer’s priority targets, which include increasing HPV vaccination through school-based coverage from 70% to 90%, increasing the probability of ever receiving a screening test from 90% to 95%, increasing the rate of on-time screening from 70% to 90%, and improving follow-up to 95% for colposcopy (currently 88%) and HPV testing (currently 80%). Modeling simulated HPV transmission and the natural history of cervical cancer in the Canadian population and relied upon two reference scenarios: One using BC’s cytology-based screening at the time of analysis, and the other an HPV base-case scenario.
The researchers found that with the status quo (ie, cytology-based screening and no change to vaccination or screening participation rates), BC would not eliminate cervical cancer until 2045. Implementation of HPV-based screening at the current 70% participation rate would achieve elimination in 2034 and prevent 942 cases compared with cytology screening. Increasing the proportion of patients who were ever screened or increasing vaccination coverage would result in cervical cancer elimination by 2033. The time line would be shortened even further (to 2031) through a combination of three strategies (ie, improving recruitment, on-time screening, and follow-up compliance).
Low Incidence, Strained System
The incidence of cervical cancer in Canada is relatively low, accounting for 1.3% of all new female cancers and 1.1% of all female cancer deaths.
“The reason that we have such low rates is because we have organized screening programs,” explained Rachel Kupets, MD, associate professor of gynecologic oncology at the University of Toronto and Sunnybrook Hospital, Toronto. She was not involved in the study.
“We’re starting to see what happens when the system gets strained with lower participation rates. I am starting to see a lot more women with invasive cervical cancer. They’re younger, and their cancers are less curable and less treatable,” she said.
Difficulties with access, interest, and education have contributed to low cervical screening rates among equity-seeking populations, according to Dr. Pataky and Dr. Kupets.
“Self-screening is another tool that can incrementally benefit those folks who wouldn’t otherwise undergo screening or don’t want an invasive test,” said Dr. Kupets. It can also play an increasing role, while current access to primary care services in Canada is at an all-time low. Community outreach through centers, mobile coaches, and nursing stations might help ensure participation by at-risk populations. These measures also could boost follow-up for and education about positive results, said Dr. Kupets.
In a related editorial, Shannon Charlebois, MD, medical editor of CMAJ, and Sarah Kean, MD, assistant professor of gynecologic oncology at the University of Manitoba in Winnipeg, Manitoba, Canada, emphasized the need for mailed HPV self-screening kits to be paid for and integrated into provincial cervical cancer screening programs across Canada to support earlier cervical cancer detection and lower invasive cancer rates.
Dr. Pataky concurred. “There have been discussions about making the big transition from traditional cytology to implementing HPV self-screening,” she said. “We have really effective tools for preventing cervical cancer, and it’s important to not lose sight of that goal.”
The study was funded by the National Institutes of Health. Dr. Pataky and Dr. Kupets reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Ovarian Cancer Risk Doubled by Estrogen-Only HRT
Two decades after the landmark Women’s Health Initiative (WHI) changed the way clinicians thought about hormone therapy and cancer, new findings suggest this national health study is "the gift that keeps on giving."
Estrogen and progesterone together, meanwhile, did not increase ovarian cancer risk, and significantly reduced the risk of endometrial cancer. Rowan T. Chlebowski, MD, PhD, of The Lundquist Institute in Torrance, California, presented these results from the latest WHI findings, at the annual meeting of the American Society of Clinical Oncology in Chicago.
Dr. Chlebowski and his colleagues conducted an analysis from two randomized, placebo-controlled trials, which between 1993 and 1998 enrolled nearly 28,000 postmenopausal women aged 50-79 years without prior cancer from 40 centers across the United States. (The full WHI effort involved a total cohort of 161,000 patients, and included an observational study and two other non-drug trials.)
In one of the hormone therapy trials, 17,000 women with a uterus at baseline were randomized to combined equine estrogen plus medroxyprogesterone acetate, or placebo. In the other trial, about 11,000 women with prior hysterectomy were randomized to daily estrogen alone or placebo. Both trials were stopped early: the estrogen-only trial due to an increased stroke risk, and the combined therapy trial due to findings of increased breast cancer and cardiovascular risk.
Mean exposure to hormone therapy was 5.6 years for the combined therapy trial and 7.2 years for estrogen alone trial.
Ovarian Cancer Incidence Doubles with Estrogen
At 20 years’ follow up, with mortality information available for nearly the full cohort, Dr. Chlebowski and his colleagues could determine that ovarian cancer incidence doubled among women who had taken estrogen alone (hazard ratio = 2.04; 95% CI 1.14-3.65; P = .01), a difference that reached statistical significance at 12 years’ follow up. Ovarian cancer mortality was also significantly increased (HR = 2.79 95% CI 1.30-5.99, P = .006). Absolute numbers were small, however, with 35 cases of ovarian cancer compared with 17 in the placebo group.
Combined therapy recipients saw no increased risk for ovarian cancer and significantly lower endometrial cancer incidence (106 cases vs. 140 HR = 0.72; 95% CI, 0.56-0.92; P = .01).
Conjugated equine estrogen, Dr. Chlebowski said during his presentation at the meeting, “was introduced in US clinical practice in 1943 and used for over half a century, yet the question about hormone therapy’s influence on endometrial and ovarian cancer remains unsettled. Endometrial cancer and ovarian cancer are the fourth and fifth leading causes of cancer deaths in women ... and there’s some discordant findings from observational studies.”
Care of Ovarian Cancer Survivors Should Change
The new findings should prompt practice and guideline changes regarding the use of estrogen alone in ovarian cancer survivors, Dr. Chlebowski said.
In an interview, oncologist Eleonora Teplinsky, MD, of Valley-Mount Sinai Comprehensive Cancer Care in Paramus, New Jersey, said that apart from this subgroup of ovarian cancer survivors, the findings would not likely have much impact on how clinicians and patients approach hormone replacement therapy today.
“Twenty years ago the Women’s Health Initiative showed that hormone replacement therapy increases breast cancer risk, and everyone stopped taking HRT. And now people pushing back on it and saying wait a second – it was the estrogen plus progesterone that increased breast cancer, not estrogen alone. And now we’ve got these newer [estrogen] formulations.
“Yes, there’s a little bit of an increased risk [for ovarian cancer]. Patients should be aware. They should know the symptoms of ovarian cancer. But if they have indications and have been recommended HRT, this is not something that we would advise them against because of this very slightly increased risk,” Dr. Teplinsky said.
Oncologist Allison Kurian, MD of Stanford University in Stanford, California, who specializes in breast cancer, also noted that the duration of hormone treatment, treatment timing relative to age of menopause onset, and commonly used estrogen preparations had indeed changed since the time the WHI trials were conducted, making it harder to generalize the findings to current practice. Nonetheless, she argued, they still have real significance.
“WHI is an incredibly complex but also incredibly valuable resource,” said Dr. Kurian, who has conducted studies using WHI data. “The first big results came out in 2002, and we’re still learning from it. These are randomized trials, which offer the strongest form of scientific evidence that exists. So whenever we see results from this study, we have to take note of them,” she said.
Because the WHI trials had shown combined therapy, not estrogen alone, to be associated with breast cancer risk, clinicians have felt reassured over the years about using estrogen alone.
“You can’t give it to a person unless they have their uterus removed, because we know it will cause uterine cancer if the uterus is in place. But if the uterus is removed, the feeling was that you can give estrogen alone. I think the new piece that is going to get everyone’s attention is this signal for ovarian cancer.”
Something else the new findings show, Dr. Kurian said, is that WHI is “the gift that keeps on giving,” even after decades. “Some of the participants had a relatively short-term exposure to HRT. They took a medication for just a little while. But you didn’t see the effects until you followed people 12 years. So we’re now going to be a little more worried about ovarian cancer in this setting than we used to be. And that’s going to be something we’re all going to keep an eye on and think twice about in terms of talking to patients.”
These results help demonstrate what happens when a society invests in science on a national scale, Dr. Kurian said. “Here we have a really long-term, incredibly informative study that keeps generating knowledge to help women.”
When the WHI began, it “really was the first time that people decided it was important to systematically study women at midlife. It was a remarkable thing then that society got mobilized to do this, and we’re still seeing the benefits.”
Dr. Chlebowski disclosed receiving consulting or advisory fees from Pfizer. Dr. Teplinsky and Dr. Kurian disclosed no financial conflicts of interest.
Two decades after the landmark Women’s Health Initiative (WHI) changed the way clinicians thought about hormone therapy and cancer, new findings suggest this national health study is "the gift that keeps on giving."
Estrogen and progesterone together, meanwhile, did not increase ovarian cancer risk, and significantly reduced the risk of endometrial cancer. Rowan T. Chlebowski, MD, PhD, of The Lundquist Institute in Torrance, California, presented these results from the latest WHI findings, at the annual meeting of the American Society of Clinical Oncology in Chicago.
Dr. Chlebowski and his colleagues conducted an analysis from two randomized, placebo-controlled trials, which between 1993 and 1998 enrolled nearly 28,000 postmenopausal women aged 50-79 years without prior cancer from 40 centers across the United States. (The full WHI effort involved a total cohort of 161,000 patients, and included an observational study and two other non-drug trials.)
In one of the hormone therapy trials, 17,000 women with a uterus at baseline were randomized to combined equine estrogen plus medroxyprogesterone acetate, or placebo. In the other trial, about 11,000 women with prior hysterectomy were randomized to daily estrogen alone or placebo. Both trials were stopped early: the estrogen-only trial due to an increased stroke risk, and the combined therapy trial due to findings of increased breast cancer and cardiovascular risk.
Mean exposure to hormone therapy was 5.6 years for the combined therapy trial and 7.2 years for estrogen alone trial.
Ovarian Cancer Incidence Doubles with Estrogen
At 20 years’ follow up, with mortality information available for nearly the full cohort, Dr. Chlebowski and his colleagues could determine that ovarian cancer incidence doubled among women who had taken estrogen alone (hazard ratio = 2.04; 95% CI 1.14-3.65; P = .01), a difference that reached statistical significance at 12 years’ follow up. Ovarian cancer mortality was also significantly increased (HR = 2.79 95% CI 1.30-5.99, P = .006). Absolute numbers were small, however, with 35 cases of ovarian cancer compared with 17 in the placebo group.
Combined therapy recipients saw no increased risk for ovarian cancer and significantly lower endometrial cancer incidence (106 cases vs. 140 HR = 0.72; 95% CI, 0.56-0.92; P = .01).
Conjugated equine estrogen, Dr. Chlebowski said during his presentation at the meeting, “was introduced in US clinical practice in 1943 and used for over half a century, yet the question about hormone therapy’s influence on endometrial and ovarian cancer remains unsettled. Endometrial cancer and ovarian cancer are the fourth and fifth leading causes of cancer deaths in women ... and there’s some discordant findings from observational studies.”
Care of Ovarian Cancer Survivors Should Change
The new findings should prompt practice and guideline changes regarding the use of estrogen alone in ovarian cancer survivors, Dr. Chlebowski said.
In an interview, oncologist Eleonora Teplinsky, MD, of Valley-Mount Sinai Comprehensive Cancer Care in Paramus, New Jersey, said that apart from this subgroup of ovarian cancer survivors, the findings would not likely have much impact on how clinicians and patients approach hormone replacement therapy today.
“Twenty years ago the Women’s Health Initiative showed that hormone replacement therapy increases breast cancer risk, and everyone stopped taking HRT. And now people pushing back on it and saying wait a second – it was the estrogen plus progesterone that increased breast cancer, not estrogen alone. And now we’ve got these newer [estrogen] formulations.
“Yes, there’s a little bit of an increased risk [for ovarian cancer]. Patients should be aware. They should know the symptoms of ovarian cancer. But if they have indications and have been recommended HRT, this is not something that we would advise them against because of this very slightly increased risk,” Dr. Teplinsky said.
Oncologist Allison Kurian, MD of Stanford University in Stanford, California, who specializes in breast cancer, also noted that the duration of hormone treatment, treatment timing relative to age of menopause onset, and commonly used estrogen preparations had indeed changed since the time the WHI trials were conducted, making it harder to generalize the findings to current practice. Nonetheless, she argued, they still have real significance.
“WHI is an incredibly complex but also incredibly valuable resource,” said Dr. Kurian, who has conducted studies using WHI data. “The first big results came out in 2002, and we’re still learning from it. These are randomized trials, which offer the strongest form of scientific evidence that exists. So whenever we see results from this study, we have to take note of them,” she said.
Because the WHI trials had shown combined therapy, not estrogen alone, to be associated with breast cancer risk, clinicians have felt reassured over the years about using estrogen alone.
“You can’t give it to a person unless they have their uterus removed, because we know it will cause uterine cancer if the uterus is in place. But if the uterus is removed, the feeling was that you can give estrogen alone. I think the new piece that is going to get everyone’s attention is this signal for ovarian cancer.”
Something else the new findings show, Dr. Kurian said, is that WHI is “the gift that keeps on giving,” even after decades. “Some of the participants had a relatively short-term exposure to HRT. They took a medication for just a little while. But you didn’t see the effects until you followed people 12 years. So we’re now going to be a little more worried about ovarian cancer in this setting than we used to be. And that’s going to be something we’re all going to keep an eye on and think twice about in terms of talking to patients.”
These results help demonstrate what happens when a society invests in science on a national scale, Dr. Kurian said. “Here we have a really long-term, incredibly informative study that keeps generating knowledge to help women.”
When the WHI began, it “really was the first time that people decided it was important to systematically study women at midlife. It was a remarkable thing then that society got mobilized to do this, and we’re still seeing the benefits.”
Dr. Chlebowski disclosed receiving consulting or advisory fees from Pfizer. Dr. Teplinsky and Dr. Kurian disclosed no financial conflicts of interest.
Two decades after the landmark Women’s Health Initiative (WHI) changed the way clinicians thought about hormone therapy and cancer, new findings suggest this national health study is "the gift that keeps on giving."
Estrogen and progesterone together, meanwhile, did not increase ovarian cancer risk, and significantly reduced the risk of endometrial cancer. Rowan T. Chlebowski, MD, PhD, of The Lundquist Institute in Torrance, California, presented these results from the latest WHI findings, at the annual meeting of the American Society of Clinical Oncology in Chicago.
Dr. Chlebowski and his colleagues conducted an analysis from two randomized, placebo-controlled trials, which between 1993 and 1998 enrolled nearly 28,000 postmenopausal women aged 50-79 years without prior cancer from 40 centers across the United States. (The full WHI effort involved a total cohort of 161,000 patients, and included an observational study and two other non-drug trials.)
In one of the hormone therapy trials, 17,000 women with a uterus at baseline were randomized to combined equine estrogen plus medroxyprogesterone acetate, or placebo. In the other trial, about 11,000 women with prior hysterectomy were randomized to daily estrogen alone or placebo. Both trials were stopped early: the estrogen-only trial due to an increased stroke risk, and the combined therapy trial due to findings of increased breast cancer and cardiovascular risk.
Mean exposure to hormone therapy was 5.6 years for the combined therapy trial and 7.2 years for estrogen alone trial.
Ovarian Cancer Incidence Doubles with Estrogen
At 20 years’ follow up, with mortality information available for nearly the full cohort, Dr. Chlebowski and his colleagues could determine that ovarian cancer incidence doubled among women who had taken estrogen alone (hazard ratio = 2.04; 95% CI 1.14-3.65; P = .01), a difference that reached statistical significance at 12 years’ follow up. Ovarian cancer mortality was also significantly increased (HR = 2.79 95% CI 1.30-5.99, P = .006). Absolute numbers were small, however, with 35 cases of ovarian cancer compared with 17 in the placebo group.
Combined therapy recipients saw no increased risk for ovarian cancer and significantly lower endometrial cancer incidence (106 cases vs. 140 HR = 0.72; 95% CI, 0.56-0.92; P = .01).
Conjugated equine estrogen, Dr. Chlebowski said during his presentation at the meeting, “was introduced in US clinical practice in 1943 and used for over half a century, yet the question about hormone therapy’s influence on endometrial and ovarian cancer remains unsettled. Endometrial cancer and ovarian cancer are the fourth and fifth leading causes of cancer deaths in women ... and there’s some discordant findings from observational studies.”
Care of Ovarian Cancer Survivors Should Change
The new findings should prompt practice and guideline changes regarding the use of estrogen alone in ovarian cancer survivors, Dr. Chlebowski said.
In an interview, oncologist Eleonora Teplinsky, MD, of Valley-Mount Sinai Comprehensive Cancer Care in Paramus, New Jersey, said that apart from this subgroup of ovarian cancer survivors, the findings would not likely have much impact on how clinicians and patients approach hormone replacement therapy today.
“Twenty years ago the Women’s Health Initiative showed that hormone replacement therapy increases breast cancer risk, and everyone stopped taking HRT. And now people pushing back on it and saying wait a second – it was the estrogen plus progesterone that increased breast cancer, not estrogen alone. And now we’ve got these newer [estrogen] formulations.
“Yes, there’s a little bit of an increased risk [for ovarian cancer]. Patients should be aware. They should know the symptoms of ovarian cancer. But if they have indications and have been recommended HRT, this is not something that we would advise them against because of this very slightly increased risk,” Dr. Teplinsky said.
Oncologist Allison Kurian, MD of Stanford University in Stanford, California, who specializes in breast cancer, also noted that the duration of hormone treatment, treatment timing relative to age of menopause onset, and commonly used estrogen preparations had indeed changed since the time the WHI trials were conducted, making it harder to generalize the findings to current practice. Nonetheless, she argued, they still have real significance.
“WHI is an incredibly complex but also incredibly valuable resource,” said Dr. Kurian, who has conducted studies using WHI data. “The first big results came out in 2002, and we’re still learning from it. These are randomized trials, which offer the strongest form of scientific evidence that exists. So whenever we see results from this study, we have to take note of them,” she said.
Because the WHI trials had shown combined therapy, not estrogen alone, to be associated with breast cancer risk, clinicians have felt reassured over the years about using estrogen alone.
“You can’t give it to a person unless they have their uterus removed, because we know it will cause uterine cancer if the uterus is in place. But if the uterus is removed, the feeling was that you can give estrogen alone. I think the new piece that is going to get everyone’s attention is this signal for ovarian cancer.”
Something else the new findings show, Dr. Kurian said, is that WHI is “the gift that keeps on giving,” even after decades. “Some of the participants had a relatively short-term exposure to HRT. They took a medication for just a little while. But you didn’t see the effects until you followed people 12 years. So we’re now going to be a little more worried about ovarian cancer in this setting than we used to be. And that’s going to be something we’re all going to keep an eye on and think twice about in terms of talking to patients.”
These results help demonstrate what happens when a society invests in science on a national scale, Dr. Kurian said. “Here we have a really long-term, incredibly informative study that keeps generating knowledge to help women.”
When the WHI began, it “really was the first time that people decided it was important to systematically study women at midlife. It was a remarkable thing then that society got mobilized to do this, and we’re still seeing the benefits.”
Dr. Chlebowski disclosed receiving consulting or advisory fees from Pfizer. Dr. Teplinsky and Dr. Kurian disclosed no financial conflicts of interest.
FROM ASCO 2024
HPV Vaccine Offers Cancer Protection Beyond Cervical Cancer
The analysis, featured at a press briefing ahead of the presentation at the American Society of Clinical Oncology (ASCO) 2024 annual meeting, notably found that men who received the HPV vaccine had a 56% lower risk for head and neck cancers.
“We’ve known for a long time that having the HPV vaccine can prevent the development of HPV infection, yes, but importantly, cancer,” primarily cervical cancer, said briefing moderator and ASCO president Lynn Schuchter, MD, Abramson Cancer Center, University of Pennsylvania, Philadelphia. “This is a really important study that extends the information about the impact.”
Using the US TriNetX database, lead investigator Jefferson DeKloe, BS, a research fellow with Thomas Jefferson University, Philadelphia, and colleagues created a matched cohort of 760,540 HPV-vaccinated and unvaccinated men and 945,999 HPV-vaccinated and unvaccinated women.
HPV-vaccinated men had a 54% lower risk for all HPV-related cancers (odds ratio [OR], 0.46; P < .001) and a 56% lower risk for head and neck cancers (OR, 0.44; P < .001) than unvaccinated men. There were not enough cases of anal and penile cancers for analysis.
HPV-vaccinated women had a 27% lower risk for all HPV-related cancers (OR, 0.73; P < .05), a 54% lower risk for cervical cancer (OR, 0.46; P < .05), and a 33% lower risk for head and neck cancers (OR, 0.67; 95% CI, 0.42-1.08) than HPV-unvaccinated women, but this finding was not significant. There were not enough cases of anal cancers for analysis, and the odds of developing vulvar or vaginal cancer was not significantly different in HPV-vaccinated vs unvaccinated women.
Vaccinated women, however, were less likely than unvaccinated women to develop high-grade squamous intraepithelial lesions (OR, 0.44), cervical carcinoma in situ (OR, 0.42), or abnormal Pap findings (OR, 0.87), and were less likely to undergo cone biopsy and loop electrosurgical excision (OR, 0.45).
“This study really highlights the importance of getting the HPV vaccine,” Dr. Schuchter said at the briefing.
“HPV vaccination is cancer prevention,” Glenn Hanna, MD, with Dana-Farber Cancer Institute, Boston, said in an ASCO statement.
Still, HPV vaccination rates in the United States remain relatively low. According to the National Cancer Institute, in 2022, only about 58% of adolescents aged 13-15 years had received two or three doses of HPV vaccine as recommended.
“The goal,” Dr. Schuchter said at the briefing, “is that younger girls and young boys get vaccinated to prevent development of HPV infection, and that should decrease the risk of cancer, which is what we’ve seen.”
Mr. DeKloe agreed and highlighted the importance of improving vaccination rates. “Identifying effective interventions that increase HPV vaccination rates is critical in reducing undue cancer burden in the United States,” Mr. DeKloe said in a statement.
The study had no funding source. Mr. DeKloe had no relevant disclosures. Dr. Hanna has disclosed relationships with Bicara Therapeutics, Bristol Myers Squibb, Coherus BioSciences, and others. Dr. Schuchter had no relevant disclosures.
A version of this article appeared on Medscape.com .
The analysis, featured at a press briefing ahead of the presentation at the American Society of Clinical Oncology (ASCO) 2024 annual meeting, notably found that men who received the HPV vaccine had a 56% lower risk for head and neck cancers.
“We’ve known for a long time that having the HPV vaccine can prevent the development of HPV infection, yes, but importantly, cancer,” primarily cervical cancer, said briefing moderator and ASCO president Lynn Schuchter, MD, Abramson Cancer Center, University of Pennsylvania, Philadelphia. “This is a really important study that extends the information about the impact.”
Using the US TriNetX database, lead investigator Jefferson DeKloe, BS, a research fellow with Thomas Jefferson University, Philadelphia, and colleagues created a matched cohort of 760,540 HPV-vaccinated and unvaccinated men and 945,999 HPV-vaccinated and unvaccinated women.
HPV-vaccinated men had a 54% lower risk for all HPV-related cancers (odds ratio [OR], 0.46; P < .001) and a 56% lower risk for head and neck cancers (OR, 0.44; P < .001) than unvaccinated men. There were not enough cases of anal and penile cancers for analysis.
HPV-vaccinated women had a 27% lower risk for all HPV-related cancers (OR, 0.73; P < .05), a 54% lower risk for cervical cancer (OR, 0.46; P < .05), and a 33% lower risk for head and neck cancers (OR, 0.67; 95% CI, 0.42-1.08) than HPV-unvaccinated women, but this finding was not significant. There were not enough cases of anal cancers for analysis, and the odds of developing vulvar or vaginal cancer was not significantly different in HPV-vaccinated vs unvaccinated women.
Vaccinated women, however, were less likely than unvaccinated women to develop high-grade squamous intraepithelial lesions (OR, 0.44), cervical carcinoma in situ (OR, 0.42), or abnormal Pap findings (OR, 0.87), and were less likely to undergo cone biopsy and loop electrosurgical excision (OR, 0.45).
“This study really highlights the importance of getting the HPV vaccine,” Dr. Schuchter said at the briefing.
“HPV vaccination is cancer prevention,” Glenn Hanna, MD, with Dana-Farber Cancer Institute, Boston, said in an ASCO statement.
Still, HPV vaccination rates in the United States remain relatively low. According to the National Cancer Institute, in 2022, only about 58% of adolescents aged 13-15 years had received two or three doses of HPV vaccine as recommended.
“The goal,” Dr. Schuchter said at the briefing, “is that younger girls and young boys get vaccinated to prevent development of HPV infection, and that should decrease the risk of cancer, which is what we’ve seen.”
Mr. DeKloe agreed and highlighted the importance of improving vaccination rates. “Identifying effective interventions that increase HPV vaccination rates is critical in reducing undue cancer burden in the United States,” Mr. DeKloe said in a statement.
The study had no funding source. Mr. DeKloe had no relevant disclosures. Dr. Hanna has disclosed relationships with Bicara Therapeutics, Bristol Myers Squibb, Coherus BioSciences, and others. Dr. Schuchter had no relevant disclosures.
A version of this article appeared on Medscape.com .
The analysis, featured at a press briefing ahead of the presentation at the American Society of Clinical Oncology (ASCO) 2024 annual meeting, notably found that men who received the HPV vaccine had a 56% lower risk for head and neck cancers.
“We’ve known for a long time that having the HPV vaccine can prevent the development of HPV infection, yes, but importantly, cancer,” primarily cervical cancer, said briefing moderator and ASCO president Lynn Schuchter, MD, Abramson Cancer Center, University of Pennsylvania, Philadelphia. “This is a really important study that extends the information about the impact.”
Using the US TriNetX database, lead investigator Jefferson DeKloe, BS, a research fellow with Thomas Jefferson University, Philadelphia, and colleagues created a matched cohort of 760,540 HPV-vaccinated and unvaccinated men and 945,999 HPV-vaccinated and unvaccinated women.
HPV-vaccinated men had a 54% lower risk for all HPV-related cancers (odds ratio [OR], 0.46; P < .001) and a 56% lower risk for head and neck cancers (OR, 0.44; P < .001) than unvaccinated men. There were not enough cases of anal and penile cancers for analysis.
HPV-vaccinated women had a 27% lower risk for all HPV-related cancers (OR, 0.73; P < .05), a 54% lower risk for cervical cancer (OR, 0.46; P < .05), and a 33% lower risk for head and neck cancers (OR, 0.67; 95% CI, 0.42-1.08) than HPV-unvaccinated women, but this finding was not significant. There were not enough cases of anal cancers for analysis, and the odds of developing vulvar or vaginal cancer was not significantly different in HPV-vaccinated vs unvaccinated women.
Vaccinated women, however, were less likely than unvaccinated women to develop high-grade squamous intraepithelial lesions (OR, 0.44), cervical carcinoma in situ (OR, 0.42), or abnormal Pap findings (OR, 0.87), and were less likely to undergo cone biopsy and loop electrosurgical excision (OR, 0.45).
“This study really highlights the importance of getting the HPV vaccine,” Dr. Schuchter said at the briefing.
“HPV vaccination is cancer prevention,” Glenn Hanna, MD, with Dana-Farber Cancer Institute, Boston, said in an ASCO statement.
Still, HPV vaccination rates in the United States remain relatively low. According to the National Cancer Institute, in 2022, only about 58% of adolescents aged 13-15 years had received two or three doses of HPV vaccine as recommended.
“The goal,” Dr. Schuchter said at the briefing, “is that younger girls and young boys get vaccinated to prevent development of HPV infection, and that should decrease the risk of cancer, which is what we’ve seen.”
Mr. DeKloe agreed and highlighted the importance of improving vaccination rates. “Identifying effective interventions that increase HPV vaccination rates is critical in reducing undue cancer burden in the United States,” Mr. DeKloe said in a statement.
The study had no funding source. Mr. DeKloe had no relevant disclosures. Dr. Hanna has disclosed relationships with Bicara Therapeutics, Bristol Myers Squibb, Coherus BioSciences, and others. Dr. Schuchter had no relevant disclosures.
A version of this article appeared on Medscape.com .
FROM ASCO 2024
Is Vaginal Estrogen Safe in Breast Cancer Survivors?
TOPLINE:
Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.
METHODOLOGY:
- Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
- Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
- Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.
TAKEAWAY:
- Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both.
- Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
- No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
- In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).
IN PRACTICE:
“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.
Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.
SOURCE:
The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.
LIMITATIONS:
No limitations were discussed in the presentation.
DISCLOSURES:
Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.
A version of this article first appeared on Medscape.com.
TOPLINE:
Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.
METHODOLOGY:
- Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
- Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
- Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.
TAKEAWAY:
- Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both.
- Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
- No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
- In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).
IN PRACTICE:
“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.
Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.
SOURCE:
The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.
LIMITATIONS:
No limitations were discussed in the presentation.
DISCLOSURES:
Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.
A version of this article first appeared on Medscape.com.
TOPLINE:
Vaginal estrogen therapy does not increase the risk for recurrence in women with hormone receptor (HR)–negative breast cancer or in those with HR–positive tumors concurrently treated with tamoxifen but should be avoided in aromatase inhibitor users, a French study suggested.
METHODOLOGY:
- Survivors of breast cancer often experience genitourinary symptoms due to declining estrogen levels. Vaginal estrogen therapies, including estriol and promestriene (3-propyl ethyl, 17B-methyl estradiol), can prevent these symptoms, but the effect on breast cancer outcomes remains uncertain.
- Researchers used French insurance claims data to emulate a target trial assessing the effect of initiating vaginal estrogen therapy — any molecule, promestriene, or estriol — on disease-free survival in survivors of breast cancer.
- Patients included in the study had a median age of 54 years; 85% were HR-positive, and 15% were HR–negative. The researchers conducted subgroup analyses based on HR status and endocrine therapy regimen.
TAKEAWAY:
- Among 134,942 unique patients, 1739 started vaginal estrogen therapy — 56%, promestriene; 34%, estriol; and 10%, both.
- Initiation of vaginal estrogen therapy led to a modest decrease in disease-free survival in patients with HR–positive tumors (−2.1 percentage point at 5 years), particularly in those concurrently treated with an aromatase inhibitor (−3.0 percentage points).
- No decrease in disease-free survival was observed in patients with HR–negative tumors or in those treated with tamoxifen.
- In aromatase inhibitor users, starting estriol led to a “more severe and premature” decrease in disease-free survival (−4.2 percentage point after 3 years) compared with initiating promestriene (1.0 percentage point difference at 3 years).
IN PRACTICE:
“This study addresses a very important survivorship issue — sexual dysfunction in cancer patients — which is associated with anxiety and depression and should be considered a crucial component of survivorship care,” said study discussant Matteo Lambertini, MD, PhD, with University of Genova, Genova, Italy.
Our results suggest that using vaginal estrogen therapy “is safe in individuals with HR-negative tumors and in those concurrently treated with tamoxifen,” said study presenter Elise Dumas, PhD, with Institut Curie, Paris, France. For breast cancer survivors treated with aromatase inhibitors, vaginal estrogen therapy should be avoided as much as possible, but promestriene is preferred over estriol in this subgroup of patients.
SOURCE:
The research (Abstract 268MO) was presented at the European Society for Medical Oncology Breast Cancer 2024 Annual Congress on May 17, 2024.
LIMITATIONS:
No limitations were discussed in the presentation.
DISCLOSURES:
Funding was provided by Monoprix and the French National Cancer Institute. Dumas declared no conflicts of interest. Lambertini has financial relationships with various pharmaceutical companies including Roche, Novartis, AstraZeneca, Lilly, Exact Sciences, Pfizer, and others.
A version of this article first appeared on Medscape.com.