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Exercising for upwards of 30 minutes most days may help relieve pain in patients who’ve been diagnosed with cancer, according to a study of exercise and pain outcomes from more than 60,000 people, including 10,000 with a history of cancer. 

Study participants who’d been diagnosed with cancer and surpassed 150 minutes of moderate activity a week were 16% less likely to report pain than those who did not exercise or who exercised less. Exercise was particularly helpful for those with moderate to severe pain. In general, the more people exercised, the less pain they felt — and that was true for those with and without a history of cancer.

“This adds to a large evidence base regarding other benefits of exercise after cancer,” said lead study author Christopher Swain, PhD, a researcher at the University of Melbourne, Australia, who studies how physical activity can protect against cancer. “It would be great for physicians to encourage physical activity” for anyone who’s ever been diagnosed with cancer. 

The findings also add to mounting evidence — including observational and experimental studies — that physical activity may help ease people’s pain. One large cross-sectional study of Norwegian adults found that the prevalence of chronic pain was 10%-38% lower among people who exercised. Randomized trials suggest exercise could be an effective pain management tool for a range of conditions, including neck and low-back pain, osteoarthritis, myofascial pain, and fibromyalgia. 

Still, the analgesic effects of exercise are less established for cancer-related pain, the authors wrote in the recent study published in Cancer — even though cancer pain remains a common and critical issue. 

Cancer-related pain is unique, stemming from multiple potential causes, said Shakil Ahmed, MB, an anesthesiologist at Weill Cornell Medicine who specializes in treating cancer pain. (Dr. Ahmed was not involved in the study.) Patients “might be having pain from the tumor itself,” — such as a tumor pressing on nerves — “or as a result of treatment, including surgery, radiation, chemotherapy, or complications from long-term medications,” Dr. Ahmed said. Indeed, some 40% of patients have chronic pain post cancer diagnosis, and it›s often undertreated and underdiagnosed.
 

How Does Exercise Reduce Pain?

Researchers aren’t exactly sure how exercise modulates pain, but they have some theories.

A 2021 meta-analysis found that exercise training can raise a person›s pain threshold, particularly at the pain site, suggesting adaptations in central inhibition, a process in the central nervous system that suppresses the perception of pain. This echoes a 2017 review that suggests exercise may help relieve pain by activating central inhibitory pathways. 

“There’s definitely evidence that there is improvement in the pain-reduction chemicals and augmentation of the pain inhibitory process in the central nervous system,” said Dr. Ahmed. That is, exercise may induce chemical changes that alter how much pain the brain’s sensory neurons can detect. 

Regular exercise can also reduce inflammation and improve blood flow, noted William McCarthy, PhD, a public health researcher with UCLA Health — both effects that may help to reduce pain.

Psychological factors may be another part of it. “There’s a lot of psychological stress as a result of a cancer diagnosis, which can lower the pain threshold,” said Dr. Ahmed. Exercise may help boost mood and reduce stress, increasing pain tolerance.

“People who are physically active also tend to be more socially active,” Dr. McCarthy added. “Engaging in social networks that provide social support can often palliate a sense of constant battling with fatigue, pain, and other negative effects of cancer.” Social activity, in turn, may promote physical activity: Studies show that when sedentary people socialize with active people, they become more active themselves — often by joining in walks or sports.

 

Help Patients Reap the Pain-Relieving Benefits of Exercise 

For beginners, the key to establishing a long-term exercise routine is to start low and slow, said Dr. Ahmed. That is, start with low-intensity activities like walking (walking was the most common activity reported in the study) or using light weights. Then, build slowly from there. 

Keep in mind that some pain or stiffness is normal at first, as one’s muscles and joints get used to the new activity. But be sure to investigate any new pain, Dr. Ahmed said. “Especially for patients who have had cancer, you want to see if the patient has any recurrence of disease,” Dr. Ahmed said. “That has to be kept in mind when you recommend any kind of exercise. “ 

It’s worth acknowledging that pain can be a significant barrier to exercise. If appropriate, you may consider referring out to exercise or physical therapy professionals in your network. Emphasizing the benefits of exercise — like the pain relief — may help motivate patients as well. 

For Dr. Swain, encouraging exercise is less about prescribing specific quantities and more about helping patients find activities “that give them enjoyment, that they feel comfortable doing, and that they can sustain over time.”

“The field needs to consider the different ways of supporting physical activity after a cancer diagnosis and treatment,” Dr. Swain said. “We have a lot of great research that shows the benefit of physical activity but not as strong an understanding of how to encourage and support it.”

A version of this article appeared on Medscape.com.

Exercising for upwards of 30 minutes most days may help relieve pain in patients who’ve been diagnosed with cancer, according to a study of exercise and pain outcomes from more than 60,000 people, including 10,000 with a history of cancer. 

Study participants who’d been diagnosed with cancer and surpassed 150 minutes of moderate activity a week were 16% less likely to report pain than those who did not exercise or who exercised less. Exercise was particularly helpful for those with moderate to severe pain. In general, the more people exercised, the less pain they felt — and that was true for those with and without a history of cancer.

“This adds to a large evidence base regarding other benefits of exercise after cancer,” said lead study author Christopher Swain, PhD, a researcher at the University of Melbourne, Australia, who studies how physical activity can protect against cancer. “It would be great for physicians to encourage physical activity” for anyone who’s ever been diagnosed with cancer. 

The findings also add to mounting evidence — including observational and experimental studies — that physical activity may help ease people’s pain. One large cross-sectional study of Norwegian adults found that the prevalence of chronic pain was 10%-38% lower among people who exercised. Randomized trials suggest exercise could be an effective pain management tool for a range of conditions, including neck and low-back pain, osteoarthritis, myofascial pain, and fibromyalgia. 

Still, the analgesic effects of exercise are less established for cancer-related pain, the authors wrote in the recent study published in Cancer — even though cancer pain remains a common and critical issue. 

Cancer-related pain is unique, stemming from multiple potential causes, said Shakil Ahmed, MB, an anesthesiologist at Weill Cornell Medicine who specializes in treating cancer pain. (Dr. Ahmed was not involved in the study.) Patients “might be having pain from the tumor itself,” — such as a tumor pressing on nerves — “or as a result of treatment, including surgery, radiation, chemotherapy, or complications from long-term medications,” Dr. Ahmed said. Indeed, some 40% of patients have chronic pain post cancer diagnosis, and it›s often undertreated and underdiagnosed.
 

How Does Exercise Reduce Pain?

Researchers aren’t exactly sure how exercise modulates pain, but they have some theories.

A 2021 meta-analysis found that exercise training can raise a person›s pain threshold, particularly at the pain site, suggesting adaptations in central inhibition, a process in the central nervous system that suppresses the perception of pain. This echoes a 2017 review that suggests exercise may help relieve pain by activating central inhibitory pathways. 

“There’s definitely evidence that there is improvement in the pain-reduction chemicals and augmentation of the pain inhibitory process in the central nervous system,” said Dr. Ahmed. That is, exercise may induce chemical changes that alter how much pain the brain’s sensory neurons can detect. 

Regular exercise can also reduce inflammation and improve blood flow, noted William McCarthy, PhD, a public health researcher with UCLA Health — both effects that may help to reduce pain.

Psychological factors may be another part of it. “There’s a lot of psychological stress as a result of a cancer diagnosis, which can lower the pain threshold,” said Dr. Ahmed. Exercise may help boost mood and reduce stress, increasing pain tolerance.

“People who are physically active also tend to be more socially active,” Dr. McCarthy added. “Engaging in social networks that provide social support can often palliate a sense of constant battling with fatigue, pain, and other negative effects of cancer.” Social activity, in turn, may promote physical activity: Studies show that when sedentary people socialize with active people, they become more active themselves — often by joining in walks or sports.

 

Help Patients Reap the Pain-Relieving Benefits of Exercise 

For beginners, the key to establishing a long-term exercise routine is to start low and slow, said Dr. Ahmed. That is, start with low-intensity activities like walking (walking was the most common activity reported in the study) or using light weights. Then, build slowly from there. 

Keep in mind that some pain or stiffness is normal at first, as one’s muscles and joints get used to the new activity. But be sure to investigate any new pain, Dr. Ahmed said. “Especially for patients who have had cancer, you want to see if the patient has any recurrence of disease,” Dr. Ahmed said. “That has to be kept in mind when you recommend any kind of exercise. “ 

It’s worth acknowledging that pain can be a significant barrier to exercise. If appropriate, you may consider referring out to exercise or physical therapy professionals in your network. Emphasizing the benefits of exercise — like the pain relief — may help motivate patients as well. 

For Dr. Swain, encouraging exercise is less about prescribing specific quantities and more about helping patients find activities “that give them enjoyment, that they feel comfortable doing, and that they can sustain over time.”

“The field needs to consider the different ways of supporting physical activity after a cancer diagnosis and treatment,” Dr. Swain said. “We have a lot of great research that shows the benefit of physical activity but not as strong an understanding of how to encourage and support it.”

A version of this article appeared on Medscape.com.

Exercising for upwards of 30 minutes most days may help relieve pain in patients who’ve been diagnosed with cancer, according to a study of exercise and pain outcomes from more than 60,000 people, including 10,000 with a history of cancer. 

Study participants who’d been diagnosed with cancer and surpassed 150 minutes of moderate activity a week were 16% less likely to report pain than those who did not exercise or who exercised less. Exercise was particularly helpful for those with moderate to severe pain. In general, the more people exercised, the less pain they felt — and that was true for those with and without a history of cancer.

“This adds to a large evidence base regarding other benefits of exercise after cancer,” said lead study author Christopher Swain, PhD, a researcher at the University of Melbourne, Australia, who studies how physical activity can protect against cancer. “It would be great for physicians to encourage physical activity” for anyone who’s ever been diagnosed with cancer. 

The findings also add to mounting evidence — including observational and experimental studies — that physical activity may help ease people’s pain. One large cross-sectional study of Norwegian adults found that the prevalence of chronic pain was 10%-38% lower among people who exercised. Randomized trials suggest exercise could be an effective pain management tool for a range of conditions, including neck and low-back pain, osteoarthritis, myofascial pain, and fibromyalgia. 

Still, the analgesic effects of exercise are less established for cancer-related pain, the authors wrote in the recent study published in Cancer — even though cancer pain remains a common and critical issue. 

Cancer-related pain is unique, stemming from multiple potential causes, said Shakil Ahmed, MB, an anesthesiologist at Weill Cornell Medicine who specializes in treating cancer pain. (Dr. Ahmed was not involved in the study.) Patients “might be having pain from the tumor itself,” — such as a tumor pressing on nerves — “or as a result of treatment, including surgery, radiation, chemotherapy, or complications from long-term medications,” Dr. Ahmed said. Indeed, some 40% of patients have chronic pain post cancer diagnosis, and it›s often undertreated and underdiagnosed.
 

How Does Exercise Reduce Pain?

Researchers aren’t exactly sure how exercise modulates pain, but they have some theories.

A 2021 meta-analysis found that exercise training can raise a person›s pain threshold, particularly at the pain site, suggesting adaptations in central inhibition, a process in the central nervous system that suppresses the perception of pain. This echoes a 2017 review that suggests exercise may help relieve pain by activating central inhibitory pathways. 

“There’s definitely evidence that there is improvement in the pain-reduction chemicals and augmentation of the pain inhibitory process in the central nervous system,” said Dr. Ahmed. That is, exercise may induce chemical changes that alter how much pain the brain’s sensory neurons can detect. 

Regular exercise can also reduce inflammation and improve blood flow, noted William McCarthy, PhD, a public health researcher with UCLA Health — both effects that may help to reduce pain.

Psychological factors may be another part of it. “There’s a lot of psychological stress as a result of a cancer diagnosis, which can lower the pain threshold,” said Dr. Ahmed. Exercise may help boost mood and reduce stress, increasing pain tolerance.

“People who are physically active also tend to be more socially active,” Dr. McCarthy added. “Engaging in social networks that provide social support can often palliate a sense of constant battling with fatigue, pain, and other negative effects of cancer.” Social activity, in turn, may promote physical activity: Studies show that when sedentary people socialize with active people, they become more active themselves — often by joining in walks or sports.

 

Help Patients Reap the Pain-Relieving Benefits of Exercise 

For beginners, the key to establishing a long-term exercise routine is to start low and slow, said Dr. Ahmed. That is, start with low-intensity activities like walking (walking was the most common activity reported in the study) or using light weights. Then, build slowly from there. 

Keep in mind that some pain or stiffness is normal at first, as one’s muscles and joints get used to the new activity. But be sure to investigate any new pain, Dr. Ahmed said. “Especially for patients who have had cancer, you want to see if the patient has any recurrence of disease,” Dr. Ahmed said. “That has to be kept in mind when you recommend any kind of exercise. “ 

It’s worth acknowledging that pain can be a significant barrier to exercise. If appropriate, you may consider referring out to exercise or physical therapy professionals in your network. Emphasizing the benefits of exercise — like the pain relief — may help motivate patients as well. 

For Dr. Swain, encouraging exercise is less about prescribing specific quantities and more about helping patients find activities “that give them enjoyment, that they feel comfortable doing, and that they can sustain over time.”

“The field needs to consider the different ways of supporting physical activity after a cancer diagnosis and treatment,” Dr. Swain said. “We have a lot of great research that shows the benefit of physical activity but not as strong an understanding of how to encourage and support it.”

A version of this article appeared on Medscape.com.

TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

• A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
• Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

• Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
• By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
• Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
• After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
• However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
• Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

• A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
• Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

• Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
• By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
• Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
• After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
• However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
• Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

• A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
• Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

• Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
• By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
• Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
• After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
• However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
• Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Two breakdown products from excess niacin, called 2PY and 4PY, were strongly associated with myocardial infarction, stroke, and other adverse cardiac events, suggesting that niacin supplementation may require a more “nuanced, titrated approach,” researchers said.

METHODOLOGY:

• Investigators performed an untargeted metabolomics analysis of fasting plasma from stable cardiac patients in a prospective discovery cohort of 1162 individuals (36% women).
• Additional analyses were performed in a US validation cohort, including measurement of soluble vascular adhesion molecule-1 (sVCAM-1), and on archival fasting samples from patients in a European validation cohort undergoing diagnostic coronary angiography.
• Genetic analyses of samples from the UK Biobank were used to test the association with sVCAM-1 levels of a genetic variant, rs10496731, which was significantly associated with both N1-methyl-2-pyridone-5-carboxamide (2 PY) and N1-methyl-4-pyridone-3-carboxamide (4PY) levels.

TAKEAWAY:

• Niacin metabolism was associated with incident major adverse cardiovascular events (MACE).
• Plasma levels of the terminal metabolites of excess niacin, 2PY and 4PY, were associated with increased 3-year MACE risk in two validation cohorts (US: 2331 total, 33% women; European: 832 total, 30% women), with adjusted hazard ratios for 2PY of 1.64 and 2.02, respectively, and for 4PY, 1.89 and 1.99.
• The genetic variant rs10496731 was significantly associated with levels of sVCAM-1.
• Treatment with physiological levels of 4PY, but not 2PY, induced expression of VCAM-1 and leukocyte adherence to vascular endothelium in mice, suggesting an inflammation-dependent mechanism underlying the clinical association of 4PY, in particular, with MACE.
• In functional testing, a physiological level of 4PY, but not 2PY, provoked messenger RNA and protein expression of VCAM-1 on human endothelial cells.

IN PRACTICE:

“Total niacin consumption in the US averaged 48 mg/d from 2017 to 2020 — more than triple the Recommended Daily Allowance — and 2PY and 4PY were also increased by nicotinamideriboside and nicotinamide mononucleotide, both of which are commonly sold supplements with claimed antiaging benefits,” the authors noted.

“The present studies suggest that niacin pool supplementation may optimally require a more nuanced, titrated approach to achieve intended health benefits,” while not fostering excess 4PY generation.

SOURCE:

Stanley Hazen, MD, PhD, of Cleveland Clinic, Cleveland, Ohio, was the principal author of the study, published online in Nature Medicine.

LIMITATIONS:

Measurement of 2PY and 4PY in the validation cohorts was performed only once, whereas serial measures might have provided enhanced prognostic value for incident cardiovascular disease (CVD) risks. Cohorts were recruited at quaternary referral centers and showed a high prevalence of CVD and cardiometabolic disease risk factors. Although the meta-analysis of the community-based genomic (Biobank) studies showed a link between 4PY and VCAM-1 expression in multiple ethnic groups, the clinical studies linking 4PY to CVD events were based on high-risk European ancestry populations in the US and European cohorts.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health (NIH; both the National Heart, Lung, and Blood Institute and the Office of Dietary Supplements: A), Pilot Project Programs of the USC Center for Genetic Epidemiology and Southern California Environmental Health Sciences Center, and the Deutsche Forschungsgemeinschaft. One co-author was supported, in part, by NIH training grants; another was a participant in the BIH-Charité Advanced Clinician Scientist Program funded by Charité – Universitätsmedizin Berlin and the Berlin Institute of Health. The LipidCardio study [validation cohort] was partially supported by Sanofi-Aventis Deutschland GmbH. The UK Biobank Resource provided access to their data. Dr. Hazen and a co-author reported being coinventors on pending and issued patents held by the Cleveland Clinic relating to cardiovascular diagnostics and therapeutics, and Dr. Hazen and two co-authors received funds from industry.

A version of the article appeared on Medscape.com.

TOPLINE:

Two breakdown products from excess niacin, called 2PY and 4PY, were strongly associated with myocardial infarction, stroke, and other adverse cardiac events, suggesting that niacin supplementation may require a more “nuanced, titrated approach,” researchers said.

METHODOLOGY:

• Investigators performed an untargeted metabolomics analysis of fasting plasma from stable cardiac patients in a prospective discovery cohort of 1162 individuals (36% women).
• Additional analyses were performed in a US validation cohort, including measurement of soluble vascular adhesion molecule-1 (sVCAM-1), and on archival fasting samples from patients in a European validation cohort undergoing diagnostic coronary angiography.
• Genetic analyses of samples from the UK Biobank were used to test the association with sVCAM-1 levels of a genetic variant, rs10496731, which was significantly associated with both N1-methyl-2-pyridone-5-carboxamide (2 PY) and N1-methyl-4-pyridone-3-carboxamide (4PY) levels.

TAKEAWAY:

• Niacin metabolism was associated with incident major adverse cardiovascular events (MACE).
• Plasma levels of the terminal metabolites of excess niacin, 2PY and 4PY, were associated with increased 3-year MACE risk in two validation cohorts (US: 2331 total, 33% women; European: 832 total, 30% women), with adjusted hazard ratios for 2PY of 1.64 and 2.02, respectively, and for 4PY, 1.89 and 1.99.
• The genetic variant rs10496731 was significantly associated with levels of sVCAM-1.
• Treatment with physiological levels of 4PY, but not 2PY, induced expression of VCAM-1 and leukocyte adherence to vascular endothelium in mice, suggesting an inflammation-dependent mechanism underlying the clinical association of 4PY, in particular, with MACE.
• In functional testing, a physiological level of 4PY, but not 2PY, provoked messenger RNA and protein expression of VCAM-1 on human endothelial cells.

IN PRACTICE:

“Total niacin consumption in the US averaged 48 mg/d from 2017 to 2020 — more than triple the Recommended Daily Allowance — and 2PY and 4PY were also increased by nicotinamideriboside and nicotinamide mononucleotide, both of which are commonly sold supplements with claimed antiaging benefits,” the authors noted.

“The present studies suggest that niacin pool supplementation may optimally require a more nuanced, titrated approach to achieve intended health benefits,” while not fostering excess 4PY generation.

SOURCE:

Stanley Hazen, MD, PhD, of Cleveland Clinic, Cleveland, Ohio, was the principal author of the study, published online in Nature Medicine.

LIMITATIONS:

Measurement of 2PY and 4PY in the validation cohorts was performed only once, whereas serial measures might have provided enhanced prognostic value for incident cardiovascular disease (CVD) risks. Cohorts were recruited at quaternary referral centers and showed a high prevalence of CVD and cardiometabolic disease risk factors. Although the meta-analysis of the community-based genomic (Biobank) studies showed a link between 4PY and VCAM-1 expression in multiple ethnic groups, the clinical studies linking 4PY to CVD events were based on high-risk European ancestry populations in the US and European cohorts.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health (NIH; both the National Heart, Lung, and Blood Institute and the Office of Dietary Supplements: A), Pilot Project Programs of the USC Center for Genetic Epidemiology and Southern California Environmental Health Sciences Center, and the Deutsche Forschungsgemeinschaft. One co-author was supported, in part, by NIH training grants; another was a participant in the BIH-Charité Advanced Clinician Scientist Program funded by Charité – Universitätsmedizin Berlin and the Berlin Institute of Health. The LipidCardio study [validation cohort] was partially supported by Sanofi-Aventis Deutschland GmbH. The UK Biobank Resource provided access to their data. Dr. Hazen and a co-author reported being coinventors on pending and issued patents held by the Cleveland Clinic relating to cardiovascular diagnostics and therapeutics, and Dr. Hazen and two co-authors received funds from industry.

A version of the article appeared on Medscape.com.

TOPLINE:

Two breakdown products from excess niacin, called 2PY and 4PY, were strongly associated with myocardial infarction, stroke, and other adverse cardiac events, suggesting that niacin supplementation may require a more “nuanced, titrated approach,” researchers said.

METHODOLOGY:

• Investigators performed an untargeted metabolomics analysis of fasting plasma from stable cardiac patients in a prospective discovery cohort of 1162 individuals (36% women).
• Additional analyses were performed in a US validation cohort, including measurement of soluble vascular adhesion molecule-1 (sVCAM-1), and on archival fasting samples from patients in a European validation cohort undergoing diagnostic coronary angiography.
• Genetic analyses of samples from the UK Biobank were used to test the association with sVCAM-1 levels of a genetic variant, rs10496731, which was significantly associated with both N1-methyl-2-pyridone-5-carboxamide (2 PY) and N1-methyl-4-pyridone-3-carboxamide (4PY) levels.

TAKEAWAY:

• Niacin metabolism was associated with incident major adverse cardiovascular events (MACE).
• Plasma levels of the terminal metabolites of excess niacin, 2PY and 4PY, were associated with increased 3-year MACE risk in two validation cohorts (US: 2331 total, 33% women; European: 832 total, 30% women), with adjusted hazard ratios for 2PY of 1.64 and 2.02, respectively, and for 4PY, 1.89 and 1.99.
• The genetic variant rs10496731 was significantly associated with levels of sVCAM-1.
• Treatment with physiological levels of 4PY, but not 2PY, induced expression of VCAM-1 and leukocyte adherence to vascular endothelium in mice, suggesting an inflammation-dependent mechanism underlying the clinical association of 4PY, in particular, with MACE.
• In functional testing, a physiological level of 4PY, but not 2PY, provoked messenger RNA and protein expression of VCAM-1 on human endothelial cells.

IN PRACTICE:

“Total niacin consumption in the US averaged 48 mg/d from 2017 to 2020 — more than triple the Recommended Daily Allowance — and 2PY and 4PY were also increased by nicotinamideriboside and nicotinamide mononucleotide, both of which are commonly sold supplements with claimed antiaging benefits,” the authors noted.

“The present studies suggest that niacin pool supplementation may optimally require a more nuanced, titrated approach to achieve intended health benefits,” while not fostering excess 4PY generation.

SOURCE:

Stanley Hazen, MD, PhD, of Cleveland Clinic, Cleveland, Ohio, was the principal author of the study, published online in Nature Medicine.

LIMITATIONS:

Measurement of 2PY and 4PY in the validation cohorts was performed only once, whereas serial measures might have provided enhanced prognostic value for incident cardiovascular disease (CVD) risks. Cohorts were recruited at quaternary referral centers and showed a high prevalence of CVD and cardiometabolic disease risk factors. Although the meta-analysis of the community-based genomic (Biobank) studies showed a link between 4PY and VCAM-1 expression in multiple ethnic groups, the clinical studies linking 4PY to CVD events were based on high-risk European ancestry populations in the US and European cohorts.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health (NIH; both the National Heart, Lung, and Blood Institute and the Office of Dietary Supplements: A), Pilot Project Programs of the USC Center for Genetic Epidemiology and Southern California Environmental Health Sciences Center, and the Deutsche Forschungsgemeinschaft. One co-author was supported, in part, by NIH training grants; another was a participant in the BIH-Charité Advanced Clinician Scientist Program funded by Charité – Universitätsmedizin Berlin and the Berlin Institute of Health. The LipidCardio study [validation cohort] was partially supported by Sanofi-Aventis Deutschland GmbH. The UK Biobank Resource provided access to their data. Dr. Hazen and a co-author reported being coinventors on pending and issued patents held by the Cleveland Clinic relating to cardiovascular diagnostics and therapeutics, and Dr. Hazen and two co-authors received funds from industry.

A version of the article appeared on Medscape.com.

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

• According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
• This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
• In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
• The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
• The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

• Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
• Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
• The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
• On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

• According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
• This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
• In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
• The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
• The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

• Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
• Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
• The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
• On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

• According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
• This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
• In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
• The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
• The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

• Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
• Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
• The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
• On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

• The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
• Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
• Referring patients for diabetes self-management education and support
• Navigating available therapeutic options and explaining complex regimens to patients
• Minimizing therapeutic and clinical inertia
• Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
• Discussing strategies to minimize hypoglycemia when relevant
• Using telehealth when appropriate
• Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

• The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
• Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
• Referring patients for diabetes self-management education and support
• Navigating available therapeutic options and explaining complex regimens to patients
• Minimizing therapeutic and clinical inertia
• Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
• Discussing strategies to minimize hypoglycemia when relevant
• Using telehealth when appropriate
• Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

• The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
• Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
• Referring patients for diabetes self-management education and support
• Navigating available therapeutic options and explaining complex regimens to patients
• Minimizing therapeutic and clinical inertia
• Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
• Discussing strategies to minimize hypoglycemia when relevant
• Using telehealth when appropriate
• Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Upon reviewing repeated prostate cancer screenings, researchers observed the absence of suspicious MRI findings in over 86% of men who had prostate-specific antigen (PSA) levels of 3 ng/mL or higher during their second screening.

METHODOLOGY:

• New initiatives are focusing on organizing prostate cancer screening using MRI to reduce overdiagnosis, as current evidence does not support the effectiveness of a single PSA test, with guidelines now recommending repeated testing every 1-4 years.
• In the STHLM3-MRI trial, men, aged 50-74 years, living in Stockholm County, Sweden, were invited to participate in prostate cancer screening and randomly assigned to traditional screening with systematic  or an MRI-based strategy.
• Blood samples were analyzed for PSA levels and Stockholm3 risk score; men with elevated risk underwent targeted MRI and biopsy procedures.
• In this follow-up analysis, 2,078 men with PSA levels of 1.5 ng/mL or higher and a Stockholm3 risk score less than 0.11 were re-invited for screening 2-3 years after their initial screening.
• The primary outcome was clinically significant prostate cancer (Gleason score of 3 + 4 or greater). A Gleason score of 6 was detected in 0.7% of patients, and a score of 4 + 3 or greater was detected in 19 (1.3%) men.

TAKEAWAY:

• Of 1,500 men (median age of 67 years) who underwent a blood test, the median PSA level was 2.8 ng/mL and 26.0% changed risk classification groups (PSA levels < 3 vs 3 ng/mL).
• Out of 667 men with PSA levels of 3 ng/mL or higher, 617 (92.5%) had an MRI. Of the 617, 51 (7.6%) had equivocal lesions (a Prostate Imaging-Reporting and Data System score of 3) and 33 (4.9%) had suspicious lesions.
• Of the 1,500 rescreened men, clinically significant prostate cancer was detected in 48 men (3.2%); this corresponds to 59.2% of the biopsied men.
• Out of 383 men who had previously received a negative MRI result, only 10 (2.6%) exhibited a lesion with a Prostate Imaging-Reporting and Data System score of 4 or higher.

IN PRACTICE:

In an accompanying editorial, Ola Bratt, MD, PhD, noted that the “most important finding was the very high proportion of nonsuspicious repeat MRI scans,” but also emphasizes the necessity of observing a decrease in overall prostate cancer incidence before asserting that the current cancer diagnostics effectively reduce overdiagnosis.

SOURCE:

This study, led by Tobias Nordström, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published on February 7, 2024, in JAMA Network Open.

LIMITATIONS:

Long-term outcomes like prostate cancer mortality were not evaluated. Information on cancer detection in men with a negative MRI result at rescreening was not available. Authors noted that a subset of individuals may still be at risk despite lower PSA levels.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare, Karolinska Institute, Prostatacancerförbundet, Region Stockholm, and Åke Wibergs Stiftelse. The authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Upon reviewing repeated prostate cancer screenings, researchers observed the absence of suspicious MRI findings in over 86% of men who had prostate-specific antigen (PSA) levels of 3 ng/mL or higher during their second screening.

METHODOLOGY:

• New initiatives are focusing on organizing prostate cancer screening using MRI to reduce overdiagnosis, as current evidence does not support the effectiveness of a single PSA test, with guidelines now recommending repeated testing every 1-4 years.
• In the STHLM3-MRI trial, men, aged 50-74 years, living in Stockholm County, Sweden, were invited to participate in prostate cancer screening and randomly assigned to traditional screening with systematic  or an MRI-based strategy.
• Blood samples were analyzed for PSA levels and Stockholm3 risk score; men with elevated risk underwent targeted MRI and biopsy procedures.
• In this follow-up analysis, 2,078 men with PSA levels of 1.5 ng/mL or higher and a Stockholm3 risk score less than 0.11 were re-invited for screening 2-3 years after their initial screening.
• The primary outcome was clinically significant prostate cancer (Gleason score of 3 + 4 or greater). A Gleason score of 6 was detected in 0.7% of patients, and a score of 4 + 3 or greater was detected in 19 (1.3%) men.

TAKEAWAY:

• Of 1,500 men (median age of 67 years) who underwent a blood test, the median PSA level was 2.8 ng/mL and 26.0% changed risk classification groups (PSA levels < 3 vs 3 ng/mL).
• Out of 667 men with PSA levels of 3 ng/mL or higher, 617 (92.5%) had an MRI. Of the 617, 51 (7.6%) had equivocal lesions (a Prostate Imaging-Reporting and Data System score of 3) and 33 (4.9%) had suspicious lesions.
• Of the 1,500 rescreened men, clinically significant prostate cancer was detected in 48 men (3.2%); this corresponds to 59.2% of the biopsied men.
• Out of 383 men who had previously received a negative MRI result, only 10 (2.6%) exhibited a lesion with a Prostate Imaging-Reporting and Data System score of 4 or higher.

IN PRACTICE:

In an accompanying editorial, Ola Bratt, MD, PhD, noted that the “most important finding was the very high proportion of nonsuspicious repeat MRI scans,” but also emphasizes the necessity of observing a decrease in overall prostate cancer incidence before asserting that the current cancer diagnostics effectively reduce overdiagnosis.

SOURCE:

This study, led by Tobias Nordström, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published on February 7, 2024, in JAMA Network Open.

LIMITATIONS:

Long-term outcomes like prostate cancer mortality were not evaluated. Information on cancer detection in men with a negative MRI result at rescreening was not available. Authors noted that a subset of individuals may still be at risk despite lower PSA levels.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare, Karolinska Institute, Prostatacancerförbundet, Region Stockholm, and Åke Wibergs Stiftelse. The authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Upon reviewing repeated prostate cancer screenings, researchers observed the absence of suspicious MRI findings in over 86% of men who had prostate-specific antigen (PSA) levels of 3 ng/mL or higher during their second screening.

METHODOLOGY:

• New initiatives are focusing on organizing prostate cancer screening using MRI to reduce overdiagnosis, as current evidence does not support the effectiveness of a single PSA test, with guidelines now recommending repeated testing every 1-4 years.
• In the STHLM3-MRI trial, men, aged 50-74 years, living in Stockholm County, Sweden, were invited to participate in prostate cancer screening and randomly assigned to traditional screening with systematic  or an MRI-based strategy.
• Blood samples were analyzed for PSA levels and Stockholm3 risk score; men with elevated risk underwent targeted MRI and biopsy procedures.
• In this follow-up analysis, 2,078 men with PSA levels of 1.5 ng/mL or higher and a Stockholm3 risk score less than 0.11 were re-invited for screening 2-3 years after their initial screening.
• The primary outcome was clinically significant prostate cancer (Gleason score of 3 + 4 or greater). A Gleason score of 6 was detected in 0.7% of patients, and a score of 4 + 3 or greater was detected in 19 (1.3%) men.

TAKEAWAY:

• Of 1,500 men (median age of 67 years) who underwent a blood test, the median PSA level was 2.8 ng/mL and 26.0% changed risk classification groups (PSA levels < 3 vs 3 ng/mL).
• Out of 667 men with PSA levels of 3 ng/mL or higher, 617 (92.5%) had an MRI. Of the 617, 51 (7.6%) had equivocal lesions (a Prostate Imaging-Reporting and Data System score of 3) and 33 (4.9%) had suspicious lesions.
• Of the 1,500 rescreened men, clinically significant prostate cancer was detected in 48 men (3.2%); this corresponds to 59.2% of the biopsied men.
• Out of 383 men who had previously received a negative MRI result, only 10 (2.6%) exhibited a lesion with a Prostate Imaging-Reporting and Data System score of 4 or higher.

IN PRACTICE:

In an accompanying editorial, Ola Bratt, MD, PhD, noted that the “most important finding was the very high proportion of nonsuspicious repeat MRI scans,” but also emphasizes the necessity of observing a decrease in overall prostate cancer incidence before asserting that the current cancer diagnostics effectively reduce overdiagnosis.

SOURCE:

This study, led by Tobias Nordström, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published on February 7, 2024, in JAMA Network Open.

LIMITATIONS:

Long-term outcomes like prostate cancer mortality were not evaluated. Information on cancer detection in men with a negative MRI result at rescreening was not available. Authors noted that a subset of individuals may still be at risk despite lower PSA levels.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare, Karolinska Institute, Prostatacancerförbundet, Region Stockholm, and Åke Wibergs Stiftelse. The authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

A version of this article first appeared on Medscape.com.

PHOENIX — Black women who develop high blood pressure before age 35 have a threefold increased risk of having a midlife stroke, new observational data suggest. The Black Women’s Health Study, which has followed 59,000 participants in the United States since 1990s, also showed that those who develop hypertension before age 45 have twice the risk of suffering a stroke.

“The really concerning thing about this data is the high proportion of young Black women who had high blood pressure and are suffering strokes relatively early in life,” said the study’s lead author, Hugo J. Aparicio, MD, associate professor of neurology at Boston University Chobanian & Avedisian School of Medicine, Boston. “This can lead to a burden of disability in relatively young women who may be at the prime of their life, pursuing careers, and looking after family.”

Dr. Aparicio presented the data at the International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.

He explained that while there has been good progress in reducing stroke rates in older people over the past decades, there is a concerning observation from multiple datasets showing that stroke rates in midlife have been plateauing or even increasing in recent years.

“For Black women specifically, there is a concern, as we know this group has higher rates of raised blood pressure and stroke overall,” said Dr. Aparicio. “We were interested in looking at whether the onset of hypertension at an earlier age in this group is one of the reasons for the increased stroke risk in midlife.”
 

A Large Study Cohort

The researchers analyzed data from the Black Women’s Health Study; the baseline year for this analysis, which included 46,754 stroke-free participants younger than age 65 (mean age, 42 years), was the 1999 questionnaire.

Both history of hypertension — defined as physician-diagnosed hypertension with the use of an antihypertensive medication — and stroke occurrence were determined by self-report. It has been shown in previous studies that these self-reported data on incidence of hypertension in this dataset are highly reliable, Dr. Aparicio noted.

At baseline, 10.5% of participants aged 45-64 years had hypertension. Stroke occurred in 3.2% of individuals over a mean follow-up of 17 years.

Black women with hypertension before age 45 had a higher risk for midlife stroke (hazard ratio [HR], 2.23; 95% confidence interval [CI], 1.79-2.78), after adjustment for age, neighborhood socioeconomic status, residence in the Stroke Belt, smoking, body mass index, and diabetes than women with no history of hypertension.

The risk was also increased with hypertension at midlife ages 45-64 years (HR, 1.69; 95% CI, 1.47-1.95) and was highest among those with hypertension at ages 24-34 years (HR, 3.15; 95% CI, 1.92-5.16).

“Our results show that among young Black women, those with hypertension have a much higher stroke risk than those without hypertension, even if they are taking antihypertensive medication,” Dr. Aparicio said. “This underscores how potent hypertension is as a risk factor for stroke.”

He concluded that both individuals and doctors need to realize that hypertension and stroke are not problems of the elderly exclusively.

“These are conditions that need to be addressed very early in life. This is even more important for Black women, as they are a high-risk group. They need to pay attention to blood pressure numbers early in life — ideally from adolescence — to catch levels before they become too elevated,” Dr. Aparicio said.

“We also need to address lifestyle changes including diet, physical activity, sleep habits, and address other cardiovascular risk factors such as cholesterol and body mass index, so we can prevent strokes from occurring,” he added. “At the policy level, we need to advocate, provide and fund primary prevention measures, and enable earlier screening and better treatment.”
 

The Role of Psychosocial Stressors

Commenting on the study, the American Heart Association immediate past president, Michelle A. Albert, MD, professor of medicine at the University of California, San Francisco, emphasized the importance of regular primary care appointments to screen for high blood pressure and other cardiovascular risk factors.

She pointed out that one of the contributing factors that may increase the risk for Black women is their disproportionate experience of psychosocial stressors and chronic cumulative stress.

This could include stress related to financial issues, racism and other forms of bias, the neighborhood environment, and having to take care of multiple generations of family with limited resources.

“These are some of the things that are less talked about as going into the heightened risk for many cardiovascular risk factors, including hypertension, very early in life for Black women that we need to bring to the forefront of conversations,” Dr. Albert said.

“These stressors not only impact hypertension onset but also they impact one’s ability to be able to seek help, and once the help is sought, to be able to sustain the therapies recommended and the interventions recommended,” she added.

The authors reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

PHOENIX — Black women who develop high blood pressure before age 35 have a threefold increased risk of having a midlife stroke, new observational data suggest. The Black Women’s Health Study, which has followed 59,000 participants in the United States since 1990s, also showed that those who develop hypertension before age 45 have twice the risk of suffering a stroke.

“The really concerning thing about this data is the high proportion of young Black women who had high blood pressure and are suffering strokes relatively early in life,” said the study’s lead author, Hugo J. Aparicio, MD, associate professor of neurology at Boston University Chobanian & Avedisian School of Medicine, Boston. “This can lead to a burden of disability in relatively young women who may be at the prime of their life, pursuing careers, and looking after family.”

Dr. Aparicio presented the data at the International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.

He explained that while there has been good progress in reducing stroke rates in older people over the past decades, there is a concerning observation from multiple datasets showing that stroke rates in midlife have been plateauing or even increasing in recent years.

“For Black women specifically, there is a concern, as we know this group has higher rates of raised blood pressure and stroke overall,” said Dr. Aparicio. “We were interested in looking at whether the onset of hypertension at an earlier age in this group is one of the reasons for the increased stroke risk in midlife.”
 

A Large Study Cohort

The researchers analyzed data from the Black Women’s Health Study; the baseline year for this analysis, which included 46,754 stroke-free participants younger than age 65 (mean age, 42 years), was the 1999 questionnaire.

Both history of hypertension — defined as physician-diagnosed hypertension with the use of an antihypertensive medication — and stroke occurrence were determined by self-report. It has been shown in previous studies that these self-reported data on incidence of hypertension in this dataset are highly reliable, Dr. Aparicio noted.

At baseline, 10.5% of participants aged 45-64 years had hypertension. Stroke occurred in 3.2% of individuals over a mean follow-up of 17 years.

Black women with hypertension before age 45 had a higher risk for midlife stroke (hazard ratio [HR], 2.23; 95% confidence interval [CI], 1.79-2.78), after adjustment for age, neighborhood socioeconomic status, residence in the Stroke Belt, smoking, body mass index, and diabetes than women with no history of hypertension.

The risk was also increased with hypertension at midlife ages 45-64 years (HR, 1.69; 95% CI, 1.47-1.95) and was highest among those with hypertension at ages 24-34 years (HR, 3.15; 95% CI, 1.92-5.16).

“Our results show that among young Black women, those with hypertension have a much higher stroke risk than those without hypertension, even if they are taking antihypertensive medication,” Dr. Aparicio said. “This underscores how potent hypertension is as a risk factor for stroke.”

He concluded that both individuals and doctors need to realize that hypertension and stroke are not problems of the elderly exclusively.

“These are conditions that need to be addressed very early in life. This is even more important for Black women, as they are a high-risk group. They need to pay attention to blood pressure numbers early in life — ideally from adolescence — to catch levels before they become too elevated,” Dr. Aparicio said.

“We also need to address lifestyle changes including diet, physical activity, sleep habits, and address other cardiovascular risk factors such as cholesterol and body mass index, so we can prevent strokes from occurring,” he added. “At the policy level, we need to advocate, provide and fund primary prevention measures, and enable earlier screening and better treatment.”
 

The Role of Psychosocial Stressors

Commenting on the study, the American Heart Association immediate past president, Michelle A. Albert, MD, professor of medicine at the University of California, San Francisco, emphasized the importance of regular primary care appointments to screen for high blood pressure and other cardiovascular risk factors.

She pointed out that one of the contributing factors that may increase the risk for Black women is their disproportionate experience of psychosocial stressors and chronic cumulative stress.

This could include stress related to financial issues, racism and other forms of bias, the neighborhood environment, and having to take care of multiple generations of family with limited resources.

“These are some of the things that are less talked about as going into the heightened risk for many cardiovascular risk factors, including hypertension, very early in life for Black women that we need to bring to the forefront of conversations,” Dr. Albert said.

“These stressors not only impact hypertension onset but also they impact one’s ability to be able to seek help, and once the help is sought, to be able to sustain the therapies recommended and the interventions recommended,” she added.

The authors reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

PHOENIX — Black women who develop high blood pressure before age 35 have a threefold increased risk of having a midlife stroke, new observational data suggest. The Black Women’s Health Study, which has followed 59,000 participants in the United States since 1990s, also showed that those who develop hypertension before age 45 have twice the risk of suffering a stroke.

“The really concerning thing about this data is the high proportion of young Black women who had high blood pressure and are suffering strokes relatively early in life,” said the study’s lead author, Hugo J. Aparicio, MD, associate professor of neurology at Boston University Chobanian & Avedisian School of Medicine, Boston. “This can lead to a burden of disability in relatively young women who may be at the prime of their life, pursuing careers, and looking after family.”

Dr. Aparicio presented the data at the International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.

He explained that while there has been good progress in reducing stroke rates in older people over the past decades, there is a concerning observation from multiple datasets showing that stroke rates in midlife have been plateauing or even increasing in recent years.

“For Black women specifically, there is a concern, as we know this group has higher rates of raised blood pressure and stroke overall,” said Dr. Aparicio. “We were interested in looking at whether the onset of hypertension at an earlier age in this group is one of the reasons for the increased stroke risk in midlife.”
 

A Large Study Cohort

The researchers analyzed data from the Black Women’s Health Study; the baseline year for this analysis, which included 46,754 stroke-free participants younger than age 65 (mean age, 42 years), was the 1999 questionnaire.

Both history of hypertension — defined as physician-diagnosed hypertension with the use of an antihypertensive medication — and stroke occurrence were determined by self-report. It has been shown in previous studies that these self-reported data on incidence of hypertension in this dataset are highly reliable, Dr. Aparicio noted.

At baseline, 10.5% of participants aged 45-64 years had hypertension. Stroke occurred in 3.2% of individuals over a mean follow-up of 17 years.

Black women with hypertension before age 45 had a higher risk for midlife stroke (hazard ratio [HR], 2.23; 95% confidence interval [CI], 1.79-2.78), after adjustment for age, neighborhood socioeconomic status, residence in the Stroke Belt, smoking, body mass index, and diabetes than women with no history of hypertension.

The risk was also increased with hypertension at midlife ages 45-64 years (HR, 1.69; 95% CI, 1.47-1.95) and was highest among those with hypertension at ages 24-34 years (HR, 3.15; 95% CI, 1.92-5.16).

“Our results show that among young Black women, those with hypertension have a much higher stroke risk than those without hypertension, even if they are taking antihypertensive medication,” Dr. Aparicio said. “This underscores how potent hypertension is as a risk factor for stroke.”

He concluded that both individuals and doctors need to realize that hypertension and stroke are not problems of the elderly exclusively.

“These are conditions that need to be addressed very early in life. This is even more important for Black women, as they are a high-risk group. They need to pay attention to blood pressure numbers early in life — ideally from adolescence — to catch levels before they become too elevated,” Dr. Aparicio said.

“We also need to address lifestyle changes including diet, physical activity, sleep habits, and address other cardiovascular risk factors such as cholesterol and body mass index, so we can prevent strokes from occurring,” he added. “At the policy level, we need to advocate, provide and fund primary prevention measures, and enable earlier screening and better treatment.”
 

The Role of Psychosocial Stressors

Commenting on the study, the American Heart Association immediate past president, Michelle A. Albert, MD, professor of medicine at the University of California, San Francisco, emphasized the importance of regular primary care appointments to screen for high blood pressure and other cardiovascular risk factors.

She pointed out that one of the contributing factors that may increase the risk for Black women is their disproportionate experience of psychosocial stressors and chronic cumulative stress.

This could include stress related to financial issues, racism and other forms of bias, the neighborhood environment, and having to take care of multiple generations of family with limited resources.

“These are some of the things that are less talked about as going into the heightened risk for many cardiovascular risk factors, including hypertension, very early in life for Black women that we need to bring to the forefront of conversations,” Dr. Albert said.

“These stressors not only impact hypertension onset but also they impact one’s ability to be able to seek help, and once the help is sought, to be able to sustain the therapies recommended and the interventions recommended,” she added.

The authors reported no relevant disclosures.
 

A version of this article appeared on Medscape.com.

In 2013, a prostate-specific antigen (PSA) blood test revealed that Richard LaFrate’s levels had jumped. 

Previously in a normal range, his PSA was now above 6 ng/mL, indicating an elevated likelihood for prostate cancer. The jazz guitarist from Leesburg, Florida, then 70 years old, underwent a biopsy, which found two Gleason 6 lesions. 

Mr. LaFrate had low-risk prostate cancer.

Guidelines now recommend active surveillance for patients like Mr. LaFrate, who have low-risk disease. This strategy would mean monitoring the cancer until LaFrate required treatment, with the upside being he might never need therapy.

Mr. LaFrate’s urologist, however, was pushing whole gland surgery — an invasive and unnecessary procedure given his diagnosis and age. 

Mr. LaFrate decided to look for another doctor. He filled out a form online that pointed him to a new urologist who offered him one option: An investigational procedure known as high-intensity focused ultrasound.

At the time, high-intensity focused ultrasound — a form of focal therapy — was being studied in the United States to treat men with low or intermediate-risk prostate cancer, but it was still relatively early days.

Mr. LaFrate’s urologist asked him to pay $25,000 out of pocket to undergo the focal procedure at a clinic in the Bahamas. He refused and, ultimately, landed on active surveillance as the best strategy to manage for his low-risk disease.

That urologist was “a shyster in my opinion,” Mr. LaFrate said. 

Over the past 10 years, the popularity of focal therapy has grown among men with intermediate-risk prostate cancer — Gleason 3+4 (grade group 2) tumors — as an alternative to invasive surgery and active surveillance. Prestigious medical centers, such as Cleveland Clinic, Mayo Clinic, Memorial Sloan Kettering, UCLA, and the University of Chicago, routinely offer focal therapy. 

But use of the techniques remains controversial and costly.

As the Cleveland Clinic’s website acknowledges, although “the use of focal therapy for localized prostate cancer appears to be a promising development in a number of ways, it is still considered investigational and not yet part of standard therapy.” Major caveats to focal therapy include unknown long-term effectiveness, the possibility of leaving behind untreated cancer, and higher overall costs. 

No major national guidelines endorse the use of focal therapy, unless offered in a research or clinical trial setting. Insurance companies, such as Aetna, Blue Cross Blue Shield, and United, also consider focal therapy for prostate cancer investigational and don’t cover it.

Without a stamp of approval from guideline bodies and insurance companies, patients, like Mr. LaFrate, remain vulnerable to the high out-of-pocket costs for these focal techniques. 

“Almost every place charges $15,000-$30,000 in cash,” said Daniel Spratt, MD, radiation oncology chair at University Hospitals Seidman Cancer Center and Case Western Reserve University in Cleveland. 

Dr. Spratt has seen hundreds of patients after focal therapy, some from prominent centers, who have emptied their bank accounts to undergo treatment with the promise of great results and ultimately felt misled when the cancer has recurred.

“It pains me that there are doctors willing to ignore the Hippocratic oath of ‘Do No Harm’ simply to jump on this fad to bring in revenue,” Dr. Spratt said. 
 

Evidence-Based or Oversold?

Focal therapy gained a foothold in the United Kingdom well before the United States.

Hashim Ahmed, FRCS, urology chair at Imperial College London, has used focal therapy for 15 years, treated over 1000 patients, and taught dozens of surgeons how to use the leading focal therapies — focal cryoablation, in which surgeons use a needle-thin probe to target, freeze, and kill prostate tumors, as well as high-intensity focused ultrasound, which uses sound wave energy to superheat and kill tumors.

“Certainly, in the United Kingdom, focal therapy has been prime time in a number of centers for a number of years,” Dr. Ahmed said. 

In the United States, focal therapy has become an attractive option for men with prostate cancer who want to avoid radiation or radical prostatectomy but don’t feel comfortable simply monitoring their disease with active surveillance. Experts from specialized focal therapy centers touting the promise of this “innovative technique” predict its routine use in the next few years.

But the excitement surrounding the use of focal therapy in prostate cancer has outpaced broader acceptance.

In 2015, the FDA approved high-intensity focused ultrasound to treat prostatic disease, but not prostate cancer specifically. Although the approval language “means that companies cannot advertise that their devices can be used for prostate cancer,” physicians can still determine how to use the technology, which includes treating prostate cancer, Dr. Ahmed said. 

The evidence is starting to catch up to the demand. The latest research suggests that the partial-gland techniques may stand up well to radical prostatectomy.

A 2022 prospective database study comparing radical prostatectomies to focal therapy — mostly high-intensity focused ultrasound — in more than 800 men found similar rates of failure-free survival in the two groups at the 8-year follow-up. A 2019 registry study found that failure-free survival at 3 years was just over 90% in high and intermediate-risk patients receiving focal cryotherapy, with the rate rising to about 93% for the intermediate-risk group. And a 2018 prospective study of 625 patients with intermediate or high-risk prostate cancer who underwent high-intensity focused ultrasound had 5-year metastasis-free survival of 98% and overall survival rates of 100%.

One of the biggest draws of focal therapy vs more aggressive treatments is the “massive differences in side-effect profiles,” said Dr. Ahmed.

In a 2021 meta-analysis, researchers found that 6 months after high-intensity focused ultrasound, 98% of patients remained continent and 80% retained erectile function, while erectile dysfunction can occur in 30% to as many as 85% of patients following prostatectomy or radiotherapy and urinary incontinence can occur in as many as 40% of patients.

Despite these potential advantages of focal therapy, the long-term efficacy of the techniques remains uncertain.

A recent study from a team at MSK, for instance, reported that 40% of men with intermediate (grade 2) or high-risk (grade 3) disease had residual cancer following MRI-guided focused ultrasound. A 2020 prospective registry study found that almost 20% of patients undergoing high-intensity focal ultrasound required a second round following a recurrence. 

Dr. Spratt worries that patients who recur after focal therapy may go on to receive a second round — often offered at half price — and will still ultimately need surgery or radiation therapy later. By that point, however, patients may have spent as much as $45,000 — ie, $30,000 on the initial and another $15,000 on the follow-up procedure.

When patients see Dr. Spratt after a recurrence, he informs them that their side effects will be worse if he gives them radiation or surgery now vs if he had given them curative therapy upfront. “But this is what we’re left with,” he tells them.

Another big concern in the field is “the quality of data for focal therapy is overwhelmingly poor,” said Jonathan Shoag, MD, a urologic oncologist at University Hospitals and an associate professor of urology at Case Western Reserve University School of Medicine in Cleveland. “Essentially, the bulk of the data is from single-institution retrospective series without defined follow-up protocols or endpoints.”

The American Urological Association (AUA) has even cautioned experts and patients about the lack of high-quality data comparing focal therapy techniques to radiation therapy, surgery, and active surveillance. According to the AUA, focal options should only be considered in intermediate-risk prostate cancer in a clinical trial setting.

“The lack of randomized clinical trials poses a major stumbling block for the field,” said Dr. Ahmed.

Although randomized trials would be ideal, the results would take many years to mature, and growing patient demand for these less invasive focal procedures has made randomized trials difficult to complete, explained Arvin George, MD, associate professor at Johns Hopkins School of Medicine in Baltimore. Several randomized trials attempted in Norway and the United Kingdom, for instance, fell apart when patients refused to be randomized between focal and radical therapy, Dr. George said.

Focal therapy is now in the same position that active surveillance was a few years ago, according to Dr. George.

“We are hearing the same concerns about focal therapy now as we did about active surveillance,” he said. The initial evidence supporting active surveillance largely came from real-world experience and retrospective studies. The randomized data came later, and skeptics of active surveillance “were proven wrong,” he added.

But Dr. Shoag has a different take on the trajectory of focal therapy research and care in the United States. 

“I think there’s this emerging kind of tragedy happening in our field now, where you have even academic institutions offering focal therapy to patients off-trial with essentially no data to suggest it is oncologically effective,” Dr. Shoag said.

William Catalona, MD, Northwestern University Feinberg School of Medicine, Chicago, agreed, noting that too many low-risk patients are undergoing focal treatment who should be on active surveillance. “Many men are attracted to focal because they just are uncomfortable having a cancer in their body that’s not treated,” Dr. Catalona said. But “giving these patients focal therapy is really overtreatment.”

Patients with higher-risk disease who want to avoid aggressive treatment are also being lured into focal without guidelines or clear evidence to back up that option, Dr. Catalona explained.

Although it’s not clear how many men in the United States are receiving focal therapy who shouldn’t, even proponents of focal therapy, like George, have expressed concern.

Dr. George agreed that focal therapy marketing geared towards patients is drawing in some men who are not good candidates for these techniques, and feels there’s not enough objective material from medical societies or academic centers giving patients a realistic picture of focal therapy. 

“There is concern that patients may be receiving biased information,” Dr. George said, adding that it’s ultimately up to the physician to reconcile the best available evidence, understand the outcomes, and discuss these options with the patient to guide them to what’s best.

At the end of the day, Dr. Spratt said, physicians giving focal therapy off a clinical trial need to pause and ask themselves “why are they giving a treatment that remains investigational by payers, not recommended by any major guideline, and that lacks any randomized evidence?” 

Mr. LaFrate does not regret his decision to forgo focal therapy in 2013. He has been on active surveillance for about a decade now.

Following an MRI in 2022, Mr. LaFrate’s radiology report found that “clinically significant cancer is very unlikely to be present.”

Still, his PSA has risen two points in the past year to 14. His current urologist feels that the PSA is going up because there’s cancer present and is suggesting focal therapy for Mr. LaFrate.

Mr. LaFrate, who has prostate enlargement issues, remains skeptical of focal therapy and is still resisting the sales pitch.

“My doctor is not aggressively pushing it. He’s just giving me that as one of my options,” he said. “I just have a hunch I don’t need it at this point.”

A version of this article appeared on Medscape.com.

In 2013, a prostate-specific antigen (PSA) blood test revealed that Richard LaFrate’s levels had jumped. 

Previously in a normal range, his PSA was now above 6 ng/mL, indicating an elevated likelihood for prostate cancer. The jazz guitarist from Leesburg, Florida, then 70 years old, underwent a biopsy, which found two Gleason 6 lesions. 

Mr. LaFrate had low-risk prostate cancer.

Guidelines now recommend active surveillance for patients like Mr. LaFrate, who have low-risk disease. This strategy would mean monitoring the cancer until LaFrate required treatment, with the upside being he might never need therapy.

Mr. LaFrate’s urologist, however, was pushing whole gland surgery — an invasive and unnecessary procedure given his diagnosis and age. 

Mr. LaFrate decided to look for another doctor. He filled out a form online that pointed him to a new urologist who offered him one option: An investigational procedure known as high-intensity focused ultrasound.

At the time, high-intensity focused ultrasound — a form of focal therapy — was being studied in the United States to treat men with low or intermediate-risk prostate cancer, but it was still relatively early days.

Mr. LaFrate’s urologist asked him to pay $25,000 out of pocket to undergo the focal procedure at a clinic in the Bahamas. He refused and, ultimately, landed on active surveillance as the best strategy to manage for his low-risk disease.

That urologist was “a shyster in my opinion,” Mr. LaFrate said. 

Over the past 10 years, the popularity of focal therapy has grown among men with intermediate-risk prostate cancer — Gleason 3+4 (grade group 2) tumors — as an alternative to invasive surgery and active surveillance. Prestigious medical centers, such as Cleveland Clinic, Mayo Clinic, Memorial Sloan Kettering, UCLA, and the University of Chicago, routinely offer focal therapy. 

But use of the techniques remains controversial and costly.

As the Cleveland Clinic’s website acknowledges, although “the use of focal therapy for localized prostate cancer appears to be a promising development in a number of ways, it is still considered investigational and not yet part of standard therapy.” Major caveats to focal therapy include unknown long-term effectiveness, the possibility of leaving behind untreated cancer, and higher overall costs. 

No major national guidelines endorse the use of focal therapy, unless offered in a research or clinical trial setting. Insurance companies, such as Aetna, Blue Cross Blue Shield, and United, also consider focal therapy for prostate cancer investigational and don’t cover it.

Without a stamp of approval from guideline bodies and insurance companies, patients, like Mr. LaFrate, remain vulnerable to the high out-of-pocket costs for these focal techniques. 

“Almost every place charges $15,000-$30,000 in cash,” said Daniel Spratt, MD, radiation oncology chair at University Hospitals Seidman Cancer Center and Case Western Reserve University in Cleveland. 

Dr. Spratt has seen hundreds of patients after focal therapy, some from prominent centers, who have emptied their bank accounts to undergo treatment with the promise of great results and ultimately felt misled when the cancer has recurred.

“It pains me that there are doctors willing to ignore the Hippocratic oath of ‘Do No Harm’ simply to jump on this fad to bring in revenue,” Dr. Spratt said. 
 

Evidence-Based or Oversold?

Focal therapy gained a foothold in the United Kingdom well before the United States.

Hashim Ahmed, FRCS, urology chair at Imperial College London, has used focal therapy for 15 years, treated over 1000 patients, and taught dozens of surgeons how to use the leading focal therapies — focal cryoablation, in which surgeons use a needle-thin probe to target, freeze, and kill prostate tumors, as well as high-intensity focused ultrasound, which uses sound wave energy to superheat and kill tumors.

“Certainly, in the United Kingdom, focal therapy has been prime time in a number of centers for a number of years,” Dr. Ahmed said. 

In the United States, focal therapy has become an attractive option for men with prostate cancer who want to avoid radiation or radical prostatectomy but don’t feel comfortable simply monitoring their disease with active surveillance. Experts from specialized focal therapy centers touting the promise of this “innovative technique” predict its routine use in the next few years.

But the excitement surrounding the use of focal therapy in prostate cancer has outpaced broader acceptance.

In 2015, the FDA approved high-intensity focused ultrasound to treat prostatic disease, but not prostate cancer specifically. Although the approval language “means that companies cannot advertise that their devices can be used for prostate cancer,” physicians can still determine how to use the technology, which includes treating prostate cancer, Dr. Ahmed said. 

The evidence is starting to catch up to the demand. The latest research suggests that the partial-gland techniques may stand up well to radical prostatectomy.

A 2022 prospective database study comparing radical prostatectomies to focal therapy — mostly high-intensity focused ultrasound — in more than 800 men found similar rates of failure-free survival in the two groups at the 8-year follow-up. A 2019 registry study found that failure-free survival at 3 years was just over 90% in high and intermediate-risk patients receiving focal cryotherapy, with the rate rising to about 93% for the intermediate-risk group. And a 2018 prospective study of 625 patients with intermediate or high-risk prostate cancer who underwent high-intensity focused ultrasound had 5-year metastasis-free survival of 98% and overall survival rates of 100%.

One of the biggest draws of focal therapy vs more aggressive treatments is the “massive differences in side-effect profiles,” said Dr. Ahmed.

In a 2021 meta-analysis, researchers found that 6 months after high-intensity focused ultrasound, 98% of patients remained continent and 80% retained erectile function, while erectile dysfunction can occur in 30% to as many as 85% of patients following prostatectomy or radiotherapy and urinary incontinence can occur in as many as 40% of patients.

Despite these potential advantages of focal therapy, the long-term efficacy of the techniques remains uncertain.

A recent study from a team at MSK, for instance, reported that 40% of men with intermediate (grade 2) or high-risk (grade 3) disease had residual cancer following MRI-guided focused ultrasound. A 2020 prospective registry study found that almost 20% of patients undergoing high-intensity focal ultrasound required a second round following a recurrence. 

Dr. Spratt worries that patients who recur after focal therapy may go on to receive a second round — often offered at half price — and will still ultimately need surgery or radiation therapy later. By that point, however, patients may have spent as much as $45,000 — ie, $30,000 on the initial and another $15,000 on the follow-up procedure.

When patients see Dr. Spratt after a recurrence, he informs them that their side effects will be worse if he gives them radiation or surgery now vs if he had given them curative therapy upfront. “But this is what we’re left with,” he tells them.

Another big concern in the field is “the quality of data for focal therapy is overwhelmingly poor,” said Jonathan Shoag, MD, a urologic oncologist at University Hospitals and an associate professor of urology at Case Western Reserve University School of Medicine in Cleveland. “Essentially, the bulk of the data is from single-institution retrospective series without defined follow-up protocols or endpoints.”

The American Urological Association (AUA) has even cautioned experts and patients about the lack of high-quality data comparing focal therapy techniques to radiation therapy, surgery, and active surveillance. According to the AUA, focal options should only be considered in intermediate-risk prostate cancer in a clinical trial setting.

“The lack of randomized clinical trials poses a major stumbling block for the field,” said Dr. Ahmed.

Although randomized trials would be ideal, the results would take many years to mature, and growing patient demand for these less invasive focal procedures has made randomized trials difficult to complete, explained Arvin George, MD, associate professor at Johns Hopkins School of Medicine in Baltimore. Several randomized trials attempted in Norway and the United Kingdom, for instance, fell apart when patients refused to be randomized between focal and radical therapy, Dr. George said.

Focal therapy is now in the same position that active surveillance was a few years ago, according to Dr. George.

“We are hearing the same concerns about focal therapy now as we did about active surveillance,” he said. The initial evidence supporting active surveillance largely came from real-world experience and retrospective studies. The randomized data came later, and skeptics of active surveillance “were proven wrong,” he added.

But Dr. Shoag has a different take on the trajectory of focal therapy research and care in the United States. 

“I think there’s this emerging kind of tragedy happening in our field now, where you have even academic institutions offering focal therapy to patients off-trial with essentially no data to suggest it is oncologically effective,” Dr. Shoag said.

William Catalona, MD, Northwestern University Feinberg School of Medicine, Chicago, agreed, noting that too many low-risk patients are undergoing focal treatment who should be on active surveillance. “Many men are attracted to focal because they just are uncomfortable having a cancer in their body that’s not treated,” Dr. Catalona said. But “giving these patients focal therapy is really overtreatment.”

Patients with higher-risk disease who want to avoid aggressive treatment are also being lured into focal without guidelines or clear evidence to back up that option, Dr. Catalona explained.

Although it’s not clear how many men in the United States are receiving focal therapy who shouldn’t, even proponents of focal therapy, like George, have expressed concern.

Dr. George agreed that focal therapy marketing geared towards patients is drawing in some men who are not good candidates for these techniques, and feels there’s not enough objective material from medical societies or academic centers giving patients a realistic picture of focal therapy. 

“There is concern that patients may be receiving biased information,” Dr. George said, adding that it’s ultimately up to the physician to reconcile the best available evidence, understand the outcomes, and discuss these options with the patient to guide them to what’s best.

At the end of the day, Dr. Spratt said, physicians giving focal therapy off a clinical trial need to pause and ask themselves “why are they giving a treatment that remains investigational by payers, not recommended by any major guideline, and that lacks any randomized evidence?” 

Mr. LaFrate does not regret his decision to forgo focal therapy in 2013. He has been on active surveillance for about a decade now.

Following an MRI in 2022, Mr. LaFrate’s radiology report found that “clinically significant cancer is very unlikely to be present.”

Still, his PSA has risen two points in the past year to 14. His current urologist feels that the PSA is going up because there’s cancer present and is suggesting focal therapy for Mr. LaFrate.

Mr. LaFrate, who has prostate enlargement issues, remains skeptical of focal therapy and is still resisting the sales pitch.

“My doctor is not aggressively pushing it. He’s just giving me that as one of my options,” he said. “I just have a hunch I don’t need it at this point.”

A version of this article appeared on Medscape.com.

In 2013, a prostate-specific antigen (PSA) blood test revealed that Richard LaFrate’s levels had jumped. 

Previously in a normal range, his PSA was now above 6 ng/mL, indicating an elevated likelihood for prostate cancer. The jazz guitarist from Leesburg, Florida, then 70 years old, underwent a biopsy, which found two Gleason 6 lesions. 

Mr. LaFrate had low-risk prostate cancer.

Guidelines now recommend active surveillance for patients like Mr. LaFrate, who have low-risk disease. This strategy would mean monitoring the cancer until LaFrate required treatment, with the upside being he might never need therapy.

Mr. LaFrate’s urologist, however, was pushing whole gland surgery — an invasive and unnecessary procedure given his diagnosis and age. 

Mr. LaFrate decided to look for another doctor. He filled out a form online that pointed him to a new urologist who offered him one option: An investigational procedure known as high-intensity focused ultrasound.

At the time, high-intensity focused ultrasound — a form of focal therapy — was being studied in the United States to treat men with low or intermediate-risk prostate cancer, but it was still relatively early days.

Mr. LaFrate’s urologist asked him to pay $25,000 out of pocket to undergo the focal procedure at a clinic in the Bahamas. He refused and, ultimately, landed on active surveillance as the best strategy to manage for his low-risk disease.

That urologist was “a shyster in my opinion,” Mr. LaFrate said. 

Over the past 10 years, the popularity of focal therapy has grown among men with intermediate-risk prostate cancer — Gleason 3+4 (grade group 2) tumors — as an alternative to invasive surgery and active surveillance. Prestigious medical centers, such as Cleveland Clinic, Mayo Clinic, Memorial Sloan Kettering, UCLA, and the University of Chicago, routinely offer focal therapy. 

But use of the techniques remains controversial and costly.

As the Cleveland Clinic’s website acknowledges, although “the use of focal therapy for localized prostate cancer appears to be a promising development in a number of ways, it is still considered investigational and not yet part of standard therapy.” Major caveats to focal therapy include unknown long-term effectiveness, the possibility of leaving behind untreated cancer, and higher overall costs. 

No major national guidelines endorse the use of focal therapy, unless offered in a research or clinical trial setting. Insurance companies, such as Aetna, Blue Cross Blue Shield, and United, also consider focal therapy for prostate cancer investigational and don’t cover it.

Without a stamp of approval from guideline bodies and insurance companies, patients, like Mr. LaFrate, remain vulnerable to the high out-of-pocket costs for these focal techniques. 

“Almost every place charges $15,000-$30,000 in cash,” said Daniel Spratt, MD, radiation oncology chair at University Hospitals Seidman Cancer Center and Case Western Reserve University in Cleveland. 

Dr. Spratt has seen hundreds of patients after focal therapy, some from prominent centers, who have emptied their bank accounts to undergo treatment with the promise of great results and ultimately felt misled when the cancer has recurred.

“It pains me that there are doctors willing to ignore the Hippocratic oath of ‘Do No Harm’ simply to jump on this fad to bring in revenue,” Dr. Spratt said. 
 

Evidence-Based or Oversold?

Focal therapy gained a foothold in the United Kingdom well before the United States.

Hashim Ahmed, FRCS, urology chair at Imperial College London, has used focal therapy for 15 years, treated over 1000 patients, and taught dozens of surgeons how to use the leading focal therapies — focal cryoablation, in which surgeons use a needle-thin probe to target, freeze, and kill prostate tumors, as well as high-intensity focused ultrasound, which uses sound wave energy to superheat and kill tumors.

“Certainly, in the United Kingdom, focal therapy has been prime time in a number of centers for a number of years,” Dr. Ahmed said. 

In the United States, focal therapy has become an attractive option for men with prostate cancer who want to avoid radiation or radical prostatectomy but don’t feel comfortable simply monitoring their disease with active surveillance. Experts from specialized focal therapy centers touting the promise of this “innovative technique” predict its routine use in the next few years.

But the excitement surrounding the use of focal therapy in prostate cancer has outpaced broader acceptance.

In 2015, the FDA approved high-intensity focused ultrasound to treat prostatic disease, but not prostate cancer specifically. Although the approval language “means that companies cannot advertise that their devices can be used for prostate cancer,” physicians can still determine how to use the technology, which includes treating prostate cancer, Dr. Ahmed said. 

The evidence is starting to catch up to the demand. The latest research suggests that the partial-gland techniques may stand up well to radical prostatectomy.

A 2022 prospective database study comparing radical prostatectomies to focal therapy — mostly high-intensity focused ultrasound — in more than 800 men found similar rates of failure-free survival in the two groups at the 8-year follow-up. A 2019 registry study found that failure-free survival at 3 years was just over 90% in high and intermediate-risk patients receiving focal cryotherapy, with the rate rising to about 93% for the intermediate-risk group. And a 2018 prospective study of 625 patients with intermediate or high-risk prostate cancer who underwent high-intensity focused ultrasound had 5-year metastasis-free survival of 98% and overall survival rates of 100%.

One of the biggest draws of focal therapy vs more aggressive treatments is the “massive differences in side-effect profiles,” said Dr. Ahmed.

In a 2021 meta-analysis, researchers found that 6 months after high-intensity focused ultrasound, 98% of patients remained continent and 80% retained erectile function, while erectile dysfunction can occur in 30% to as many as 85% of patients following prostatectomy or radiotherapy and urinary incontinence can occur in as many as 40% of patients.

Despite these potential advantages of focal therapy, the long-term efficacy of the techniques remains uncertain.

A recent study from a team at MSK, for instance, reported that 40% of men with intermediate (grade 2) or high-risk (grade 3) disease had residual cancer following MRI-guided focused ultrasound. A 2020 prospective registry study found that almost 20% of patients undergoing high-intensity focal ultrasound required a second round following a recurrence. 

Dr. Spratt worries that patients who recur after focal therapy may go on to receive a second round — often offered at half price — and will still ultimately need surgery or radiation therapy later. By that point, however, patients may have spent as much as $45,000 — ie, $30,000 on the initial and another $15,000 on the follow-up procedure.

When patients see Dr. Spratt after a recurrence, he informs them that their side effects will be worse if he gives them radiation or surgery now vs if he had given them curative therapy upfront. “But this is what we’re left with,” he tells them.

Another big concern in the field is “the quality of data for focal therapy is overwhelmingly poor,” said Jonathan Shoag, MD, a urologic oncologist at University Hospitals and an associate professor of urology at Case Western Reserve University School of Medicine in Cleveland. “Essentially, the bulk of the data is from single-institution retrospective series without defined follow-up protocols or endpoints.”

The American Urological Association (AUA) has even cautioned experts and patients about the lack of high-quality data comparing focal therapy techniques to radiation therapy, surgery, and active surveillance. According to the AUA, focal options should only be considered in intermediate-risk prostate cancer in a clinical trial setting.

“The lack of randomized clinical trials poses a major stumbling block for the field,” said Dr. Ahmed.

Although randomized trials would be ideal, the results would take many years to mature, and growing patient demand for these less invasive focal procedures has made randomized trials difficult to complete, explained Arvin George, MD, associate professor at Johns Hopkins School of Medicine in Baltimore. Several randomized trials attempted in Norway and the United Kingdom, for instance, fell apart when patients refused to be randomized between focal and radical therapy, Dr. George said.

Focal therapy is now in the same position that active surveillance was a few years ago, according to Dr. George.

“We are hearing the same concerns about focal therapy now as we did about active surveillance,” he said. The initial evidence supporting active surveillance largely came from real-world experience and retrospective studies. The randomized data came later, and skeptics of active surveillance “were proven wrong,” he added.

But Dr. Shoag has a different take on the trajectory of focal therapy research and care in the United States. 

“I think there’s this emerging kind of tragedy happening in our field now, where you have even academic institutions offering focal therapy to patients off-trial with essentially no data to suggest it is oncologically effective,” Dr. Shoag said.

William Catalona, MD, Northwestern University Feinberg School of Medicine, Chicago, agreed, noting that too many low-risk patients are undergoing focal treatment who should be on active surveillance. “Many men are attracted to focal because they just are uncomfortable having a cancer in their body that’s not treated,” Dr. Catalona said. But “giving these patients focal therapy is really overtreatment.”

Patients with higher-risk disease who want to avoid aggressive treatment are also being lured into focal without guidelines or clear evidence to back up that option, Dr. Catalona explained.

Although it’s not clear how many men in the United States are receiving focal therapy who shouldn’t, even proponents of focal therapy, like George, have expressed concern.

Dr. George agreed that focal therapy marketing geared towards patients is drawing in some men who are not good candidates for these techniques, and feels there’s not enough objective material from medical societies or academic centers giving patients a realistic picture of focal therapy. 

“There is concern that patients may be receiving biased information,” Dr. George said, adding that it’s ultimately up to the physician to reconcile the best available evidence, understand the outcomes, and discuss these options with the patient to guide them to what’s best.

At the end of the day, Dr. Spratt said, physicians giving focal therapy off a clinical trial need to pause and ask themselves “why are they giving a treatment that remains investigational by payers, not recommended by any major guideline, and that lacks any randomized evidence?” 

Mr. LaFrate does not regret his decision to forgo focal therapy in 2013. He has been on active surveillance for about a decade now.

Following an MRI in 2022, Mr. LaFrate’s radiology report found that “clinically significant cancer is very unlikely to be present.”

Still, his PSA has risen two points in the past year to 14. His current urologist feels that the PSA is going up because there’s cancer present and is suggesting focal therapy for Mr. LaFrate.

Mr. LaFrate, who has prostate enlargement issues, remains skeptical of focal therapy and is still resisting the sales pitch.

“My doctor is not aggressively pushing it. He’s just giving me that as one of my options,” he said. “I just have a hunch I don’t need it at this point.”

A version of this article appeared on Medscape.com.