When Serena-Lian Sakheim-Devine’s best friend from childhood died of cancer, she felt sad and lonely while away at college. Wanting something warm to snuggle, she got a guinea pig and named her Basil. Then she got two more and called them Nutmeg and Paprika. The three became her Spice Girls.

“They were of great comfort to me, but also to others at times of need,” said Ms. Sakheim-Devine, 26, who lived with them in a dormitory at Smith College, an all-women’s institution in Northampton, Mass.

Her therapist wrote a letter and sent it to the disability office at Smith, which permitted the guinea pigs as emotional support animals (ESAs). Eventually, though, she wanted a dog to help manage her PTSD, depression, anxiety, and panic attacks. So, she adopted a beagle from a shelter.

Once again, a therapist provided a letter, and Ms. Sakheim-Devine was allowed to keep the beagle, Finnian, then about 13 years old, in her dorm room on the condition that she give up the guinea pigs, which she did.

She and Finnian bonded almost instantly. When she woke up drenched in sweat, unable to move or speak, the dog sensed how tense she was. Finnian licked her hands, got her fingers moving, and helped ground her.

“I didn’t really teach her that. She just knew,” said Ms. Sakheim-Devine, now a safety engineer who lives in New Haven, Conn. “It was incredible how well connected we were, even from the get-go.”
 

The therapeutic benefits of four-legged friends

Although there is limited scientific literature on the therapeutic use of ESAs, there are well-established benefits of having pets that also apply in these situations. Animals can provide distraction from stress, alleviate loneliness, and instill a sense of responsibility, said Rachel A. Davis, MD, associate professor of psychiatry and neurosurgery at the University of Colorado at Denver, Aurora.

They add structure to a person’s day by needing to be fed at specific times, and they can help the human get exercise. “Patients have reported improved sense of meaning in life and purpose,” Dr. Davis said.

A mental health clinician can recommend an ESA to help mitigate symptoms of a disability related to a mental illness as described in the DSM. Examples include depression, anxiety, obsessive-compulsive disorder, panic attacks, and PTSD.

ESAs differ from psychiatric service animals, which are trained to perform specific tasks, such as applying deep pressure that calms the owner. By their mere existence, ESAs provide emotional benefits to a person with a mental health disability.

“Social support, even from an animal, can really help people feel less alone, better about themselves, and safer from unpleasantness or even a physical attack,” said David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University.
 

Writing a letter on your patient’s behalf

Writing a letter that serves as proof of a person’s need for an ESA is a request that mental health professionals sometimes receive from patients. The letter can grant access to housing without additional cost regardless of no-pet polices, and some employers may allow an ESA at work as a reasonable accommodation for a psychological disability. Until recently, an ESA could accompany its owner on a plane, but most airlines no longer permit this, partly because some passengers falsely claim their pets as ESAs.

Before crafting a letter for someone with an ESA, Dr. Spiegel asks for the patient’s permission to elaborate on the clinical condition that merits professional help and to explain how the animal relieves associated symptoms.

The Fair Housing Act, a federal law, requires a landlord to grant a reasonable accommodation involving an emotional support or other assistance animal. Such an accommodation honors a request to live on the property despite a no-pets policy. It also waives a pet deposit, fee, or other rules involving animals on the premises.

Landlords are usually supportive of a request to permit an ESA, said Jonathan Betlinski, MD, associate professor and director of the public psychiatry division at Oregon Health and Science University, Portland. None of his patients have experienced any difficulties once they obtained a letter from him.

However, “anytime somebody asks me about a letter for an ESA, that’s the time to have a conversation. It’s not automatic,” Dr. Betlinski said. The discussion involves learning about the type of animal a patient has and how it helps his or her emotional state.

Because of privacy concerns, Dr. Betlinski doesn’t disclose the specific diagnosis in the letter unless the patient signs a release of information. The laws pertaining to ESAs only require his letter to note that an individual has a qualifying diagnosis and that an ESA helps improve symptoms, but it’s not necessary to explain how.

“You can see where writing the letter is a fine balancing act,” he said. But he finds it helpful to mention any training the animal has completed, such as the Canine Good Citizen course sponsored by the American Kennel Club.

Most of the letters Luis Anez, PsyD, a clinical psychologist and associate professor of psychiatry at Yale University, New Haven, Conn., has written for this purpose were in support of ESAs in housing. But he also recalled providing a letter for a patient who was flying to Puerto Rico with an ESA. The letters are generally provided only to established patients with psychiatric diagnoses.

Without a letter, “we’ve seen people say: ‘I’d rather be homeless than part with my dog,’ ”said Dr. Anez, who is also director of Hispanic services at Connecticut Mental Health Center in New Haven, a partnership between Yale and the Connecticut Department of Mental Health and Addiction Services. Before getting an ESA, Dr. Anez recommends that individuals become aware of their landlord’s policies on possible restrictions relating to dog sizes and breeds.
 

Additional considerations

An ESA doesn’t necessarily have to be a dog. “It certainly could be a cat. It could be a parrot, too,” said Stephen Stern, MD, a psychiatrist in private practice in Mount Kisco, N.Y. But, “if they say that their emotional support animal is an earthworm, that would make you wonder,” he added half-jokingly.

Dr. Stern only writes an ESA letter for a patient with whom he has an ongoing professional relationship. For instance, if he’s treating someone for depression and that patient tells him how the animal helps relieve symptoms, then that is sufficient justification to write a letter.

“Because you know them, you’ve assessed that what they’re saying is plausible,” said Dr. Stern, who is also an adjunct professor of psychiatry at the University of Texas Health Science in San Antonio, where he conducted research on companion dogs for veterans with PTSD and continues to collaborate with colleagues via email and Zoom.

While veterans benefit from ESAs, some live in housing that doesn’t permit animals, said Beth Zimmerman, founder and executive director of Pets for Patriots, a nationally operating nonprofit organization in Long Beach, N.Y., that partners with shelters and animal welfare groups to adopt dogs and cats for companionship and emotional support. She said an ESA can be “a wonderful complement to other forms of therapy that a veteran may undertake.

“Most of the time when the veteran encounters a problem, it’s because the landlord is ill-informed of the law,” Dr. Zimmerman said. “We provide information to the veteran to share with the landlord or building management, and always recommend taking a very amicable approach. In our experience, with very few exceptions, once the landlord understands his or her responsibilities under the law, they will permit the veteran to have that emotional support animal in their dwelling.”

For Kristin Lowe, a chocolate Labrador-Weimaraner mix named Lola provided emotional support from her puppy days until her death at age 12 in May 2021. Ms. Lowe’s psychiatrist provided letters that allowed Lola to live in her apartment and to travel on commercial airline flights.

“She was so connected to me,” said Ms. Lowe, 34, who lives in Denver and works as an administrative office worker in physical therapy. “She was a part of me. She could read every emotion that I had.”

Now, Ms. Lowe relies on Henry, an Australian shepherd puppy, to help her cope with obsessive-compulsive disorder, major depressive disorder, and an eating disorder. She described him as “a very happy little guy and a constant tail wagger – and that lights up something in me.”

More information, which is provided by the U.S. Department of Housing and Urban Development, can be found here.

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

When Serena-Lian Sakheim-Devine’s best friend from childhood died of cancer, she felt sad and lonely while away at college. Wanting something warm to snuggle, she got a guinea pig and named her Basil. Then she got two more and called them Nutmeg and Paprika. The three became her Spice Girls.

“They were of great comfort to me, but also to others at times of need,” said Ms. Sakheim-Devine, 26, who lived with them in a dormitory at Smith College, an all-women’s institution in Northampton, Mass.

Her therapist wrote a letter and sent it to the disability office at Smith, which permitted the guinea pigs as emotional support animals (ESAs). Eventually, though, she wanted a dog to help manage her PTSD, depression, anxiety, and panic attacks. So, she adopted a beagle from a shelter.

Once again, a therapist provided a letter, and Ms. Sakheim-Devine was allowed to keep the beagle, Finnian, then about 13 years old, in her dorm room on the condition that she give up the guinea pigs, which she did.

She and Finnian bonded almost instantly. When she woke up drenched in sweat, unable to move or speak, the dog sensed how tense she was. Finnian licked her hands, got her fingers moving, and helped ground her.

“I didn’t really teach her that. She just knew,” said Ms. Sakheim-Devine, now a safety engineer who lives in New Haven, Conn. “It was incredible how well connected we were, even from the get-go.”
 

The therapeutic benefits of four-legged friends

Although there is limited scientific literature on the therapeutic use of ESAs, there are well-established benefits of having pets that also apply in these situations. Animals can provide distraction from stress, alleviate loneliness, and instill a sense of responsibility, said Rachel A. Davis, MD, associate professor of psychiatry and neurosurgery at the University of Colorado at Denver, Aurora.

They add structure to a person’s day by needing to be fed at specific times, and they can help the human get exercise. “Patients have reported improved sense of meaning in life and purpose,” Dr. Davis said.

A mental health clinician can recommend an ESA to help mitigate symptoms of a disability related to a mental illness as described in the DSM. Examples include depression, anxiety, obsessive-compulsive disorder, panic attacks, and PTSD.

ESAs differ from psychiatric service animals, which are trained to perform specific tasks, such as applying deep pressure that calms the owner. By their mere existence, ESAs provide emotional benefits to a person with a mental health disability.

“Social support, even from an animal, can really help people feel less alone, better about themselves, and safer from unpleasantness or even a physical attack,” said David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University.
 

Writing a letter on your patient’s behalf

Writing a letter that serves as proof of a person’s need for an ESA is a request that mental health professionals sometimes receive from patients. The letter can grant access to housing without additional cost regardless of no-pet polices, and some employers may allow an ESA at work as a reasonable accommodation for a psychological disability. Until recently, an ESA could accompany its owner on a plane, but most airlines no longer permit this, partly because some passengers falsely claim their pets as ESAs.

Before crafting a letter for someone with an ESA, Dr. Spiegel asks for the patient’s permission to elaborate on the clinical condition that merits professional help and to explain how the animal relieves associated symptoms.

The Fair Housing Act, a federal law, requires a landlord to grant a reasonable accommodation involving an emotional support or other assistance animal. Such an accommodation honors a request to live on the property despite a no-pets policy. It also waives a pet deposit, fee, or other rules involving animals on the premises.

Landlords are usually supportive of a request to permit an ESA, said Jonathan Betlinski, MD, associate professor and director of the public psychiatry division at Oregon Health and Science University, Portland. None of his patients have experienced any difficulties once they obtained a letter from him.

However, “anytime somebody asks me about a letter for an ESA, that’s the time to have a conversation. It’s not automatic,” Dr. Betlinski said. The discussion involves learning about the type of animal a patient has and how it helps his or her emotional state.

Because of privacy concerns, Dr. Betlinski doesn’t disclose the specific diagnosis in the letter unless the patient signs a release of information. The laws pertaining to ESAs only require his letter to note that an individual has a qualifying diagnosis and that an ESA helps improve symptoms, but it’s not necessary to explain how.

“You can see where writing the letter is a fine balancing act,” he said. But he finds it helpful to mention any training the animal has completed, such as the Canine Good Citizen course sponsored by the American Kennel Club.

Most of the letters Luis Anez, PsyD, a clinical psychologist and associate professor of psychiatry at Yale University, New Haven, Conn., has written for this purpose were in support of ESAs in housing. But he also recalled providing a letter for a patient who was flying to Puerto Rico with an ESA. The letters are generally provided only to established patients with psychiatric diagnoses.

Without a letter, “we’ve seen people say: ‘I’d rather be homeless than part with my dog,’ ”said Dr. Anez, who is also director of Hispanic services at Connecticut Mental Health Center in New Haven, a partnership between Yale and the Connecticut Department of Mental Health and Addiction Services. Before getting an ESA, Dr. Anez recommends that individuals become aware of their landlord’s policies on possible restrictions relating to dog sizes and breeds.
 

Additional considerations

An ESA doesn’t necessarily have to be a dog. “It certainly could be a cat. It could be a parrot, too,” said Stephen Stern, MD, a psychiatrist in private practice in Mount Kisco, N.Y. But, “if they say that their emotional support animal is an earthworm, that would make you wonder,” he added half-jokingly.

Dr. Stern only writes an ESA letter for a patient with whom he has an ongoing professional relationship. For instance, if he’s treating someone for depression and that patient tells him how the animal helps relieve symptoms, then that is sufficient justification to write a letter.

“Because you know them, you’ve assessed that what they’re saying is plausible,” said Dr. Stern, who is also an adjunct professor of psychiatry at the University of Texas Health Science in San Antonio, where he conducted research on companion dogs for veterans with PTSD and continues to collaborate with colleagues via email and Zoom.

While veterans benefit from ESAs, some live in housing that doesn’t permit animals, said Beth Zimmerman, founder and executive director of Pets for Patriots, a nationally operating nonprofit organization in Long Beach, N.Y., that partners with shelters and animal welfare groups to adopt dogs and cats for companionship and emotional support. She said an ESA can be “a wonderful complement to other forms of therapy that a veteran may undertake.

“Most of the time when the veteran encounters a problem, it’s because the landlord is ill-informed of the law,” Dr. Zimmerman said. “We provide information to the veteran to share with the landlord or building management, and always recommend taking a very amicable approach. In our experience, with very few exceptions, once the landlord understands his or her responsibilities under the law, they will permit the veteran to have that emotional support animal in their dwelling.”

For Kristin Lowe, a chocolate Labrador-Weimaraner mix named Lola provided emotional support from her puppy days until her death at age 12 in May 2021. Ms. Lowe’s psychiatrist provided letters that allowed Lola to live in her apartment and to travel on commercial airline flights.

“She was so connected to me,” said Ms. Lowe, 34, who lives in Denver and works as an administrative office worker in physical therapy. “She was a part of me. She could read every emotion that I had.”

Now, Ms. Lowe relies on Henry, an Australian shepherd puppy, to help her cope with obsessive-compulsive disorder, major depressive disorder, and an eating disorder. She described him as “a very happy little guy and a constant tail wagger – and that lights up something in me.”

More information, which is provided by the U.S. Department of Housing and Urban Development, can be found here.

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

When Serena-Lian Sakheim-Devine’s best friend from childhood died of cancer, she felt sad and lonely while away at college. Wanting something warm to snuggle, she got a guinea pig and named her Basil. Then she got two more and called them Nutmeg and Paprika. The three became her Spice Girls.

“They were of great comfort to me, but also to others at times of need,” said Ms. Sakheim-Devine, 26, who lived with them in a dormitory at Smith College, an all-women’s institution in Northampton, Mass.

Her therapist wrote a letter and sent it to the disability office at Smith, which permitted the guinea pigs as emotional support animals (ESAs). Eventually, though, she wanted a dog to help manage her PTSD, depression, anxiety, and panic attacks. So, she adopted a beagle from a shelter.

Once again, a therapist provided a letter, and Ms. Sakheim-Devine was allowed to keep the beagle, Finnian, then about 13 years old, in her dorm room on the condition that she give up the guinea pigs, which she did.

She and Finnian bonded almost instantly. When she woke up drenched in sweat, unable to move or speak, the dog sensed how tense she was. Finnian licked her hands, got her fingers moving, and helped ground her.

“I didn’t really teach her that. She just knew,” said Ms. Sakheim-Devine, now a safety engineer who lives in New Haven, Conn. “It was incredible how well connected we were, even from the get-go.”
 

The therapeutic benefits of four-legged friends

Although there is limited scientific literature on the therapeutic use of ESAs, there are well-established benefits of having pets that also apply in these situations. Animals can provide distraction from stress, alleviate loneliness, and instill a sense of responsibility, said Rachel A. Davis, MD, associate professor of psychiatry and neurosurgery at the University of Colorado at Denver, Aurora.

They add structure to a person’s day by needing to be fed at specific times, and they can help the human get exercise. “Patients have reported improved sense of meaning in life and purpose,” Dr. Davis said.

A mental health clinician can recommend an ESA to help mitigate symptoms of a disability related to a mental illness as described in the DSM. Examples include depression, anxiety, obsessive-compulsive disorder, panic attacks, and PTSD.

ESAs differ from psychiatric service animals, which are trained to perform specific tasks, such as applying deep pressure that calms the owner. By their mere existence, ESAs provide emotional benefits to a person with a mental health disability.

“Social support, even from an animal, can really help people feel less alone, better about themselves, and safer from unpleasantness or even a physical attack,” said David Spiegel, MD, professor and associate chair of psychiatry and behavioral sciences and director of the Center on Stress and Health at Stanford (Calif.) University.
 

Writing a letter on your patient’s behalf

Writing a letter that serves as proof of a person’s need for an ESA is a request that mental health professionals sometimes receive from patients. The letter can grant access to housing without additional cost regardless of no-pet polices, and some employers may allow an ESA at work as a reasonable accommodation for a psychological disability. Until recently, an ESA could accompany its owner on a plane, but most airlines no longer permit this, partly because some passengers falsely claim their pets as ESAs.

Before crafting a letter for someone with an ESA, Dr. Spiegel asks for the patient’s permission to elaborate on the clinical condition that merits professional help and to explain how the animal relieves associated symptoms.

The Fair Housing Act, a federal law, requires a landlord to grant a reasonable accommodation involving an emotional support or other assistance animal. Such an accommodation honors a request to live on the property despite a no-pets policy. It also waives a pet deposit, fee, or other rules involving animals on the premises.

Landlords are usually supportive of a request to permit an ESA, said Jonathan Betlinski, MD, associate professor and director of the public psychiatry division at Oregon Health and Science University, Portland. None of his patients have experienced any difficulties once they obtained a letter from him.

However, “anytime somebody asks me about a letter for an ESA, that’s the time to have a conversation. It’s not automatic,” Dr. Betlinski said. The discussion involves learning about the type of animal a patient has and how it helps his or her emotional state.

Because of privacy concerns, Dr. Betlinski doesn’t disclose the specific diagnosis in the letter unless the patient signs a release of information. The laws pertaining to ESAs only require his letter to note that an individual has a qualifying diagnosis and that an ESA helps improve symptoms, but it’s not necessary to explain how.

“You can see where writing the letter is a fine balancing act,” he said. But he finds it helpful to mention any training the animal has completed, such as the Canine Good Citizen course sponsored by the American Kennel Club.

Most of the letters Luis Anez, PsyD, a clinical psychologist and associate professor of psychiatry at Yale University, New Haven, Conn., has written for this purpose were in support of ESAs in housing. But he also recalled providing a letter for a patient who was flying to Puerto Rico with an ESA. The letters are generally provided only to established patients with psychiatric diagnoses.

Without a letter, “we’ve seen people say: ‘I’d rather be homeless than part with my dog,’ ”said Dr. Anez, who is also director of Hispanic services at Connecticut Mental Health Center in New Haven, a partnership between Yale and the Connecticut Department of Mental Health and Addiction Services. Before getting an ESA, Dr. Anez recommends that individuals become aware of their landlord’s policies on possible restrictions relating to dog sizes and breeds.
 

Additional considerations

An ESA doesn’t necessarily have to be a dog. “It certainly could be a cat. It could be a parrot, too,” said Stephen Stern, MD, a psychiatrist in private practice in Mount Kisco, N.Y. But, “if they say that their emotional support animal is an earthworm, that would make you wonder,” he added half-jokingly.

Dr. Stern only writes an ESA letter for a patient with whom he has an ongoing professional relationship. For instance, if he’s treating someone for depression and that patient tells him how the animal helps relieve symptoms, then that is sufficient justification to write a letter.

“Because you know them, you’ve assessed that what they’re saying is plausible,” said Dr. Stern, who is also an adjunct professor of psychiatry at the University of Texas Health Science in San Antonio, where he conducted research on companion dogs for veterans with PTSD and continues to collaborate with colleagues via email and Zoom.

While veterans benefit from ESAs, some live in housing that doesn’t permit animals, said Beth Zimmerman, founder and executive director of Pets for Patriots, a nationally operating nonprofit organization in Long Beach, N.Y., that partners with shelters and animal welfare groups to adopt dogs and cats for companionship and emotional support. She said an ESA can be “a wonderful complement to other forms of therapy that a veteran may undertake.

“Most of the time when the veteran encounters a problem, it’s because the landlord is ill-informed of the law,” Dr. Zimmerman said. “We provide information to the veteran to share with the landlord or building management, and always recommend taking a very amicable approach. In our experience, with very few exceptions, once the landlord understands his or her responsibilities under the law, they will permit the veteran to have that emotional support animal in their dwelling.”

For Kristin Lowe, a chocolate Labrador-Weimaraner mix named Lola provided emotional support from her puppy days until her death at age 12 in May 2021. Ms. Lowe’s psychiatrist provided letters that allowed Lola to live in her apartment and to travel on commercial airline flights.

“She was so connected to me,” said Ms. Lowe, 34, who lives in Denver and works as an administrative office worker in physical therapy. “She was a part of me. She could read every emotion that I had.”

Now, Ms. Lowe relies on Henry, an Australian shepherd puppy, to help her cope with obsessive-compulsive disorder, major depressive disorder, and an eating disorder. She described him as “a very happy little guy and a constant tail wagger – and that lights up something in me.”

More information, which is provided by the U.S. Department of Housing and Urban Development, can be found here.

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

Many older patients with advanced kidney disease who decide to forgo dialysis still survive for several years after making their decision and have a good quality of life until their final days, a new systematic review of cohort studies suggests.

“Our findings challenge the common misconception that the only alternative to dialysis for many patients with advanced chronic kidney disease is no care or death,” say Susan Wong, MD, of the Renal Dialysis Unit, Seattle, and colleagues in their review, published online March 14 in JAMA Network Open.

In an accompanying commentary, Christine Liu, MD, and Kurella Tamura, MD, MPH, note: “The decision to initiate dialysis or focus on active alleviation of symptoms, known as conservative care … is likely one of the consequential decisions [patients] will face.”

“[But] in reality, dialysis is viewed as the default treatment for kidney failure, and the option to forgo dialysis treatment is often not explicitly discussed,” they add.

“We believe it is time to broaden the scope of kidney replacement therapy registries to include persons who receive conservative treatment of kidney failure … and we need to address the conservative care information gap so that lack of awareness is no longer a barrier to informed decision-making,” Dr. Liu and Dr. Tamura, both from Stanford (Calif.) University, note.

The work by Dr. Wong and colleagues “dispels the notion that conservative care for kidney failure means a grim and near-immediate death. The study advances the idea that a conservative care approach can provide time and sustain quality of life to support patients’ life goals,” they emphasize.
 

Conservative care assessed in 41 studies

The review included 41 studies involving 5,102 patients with a mean age ranging from 60 to 87 years conducted in the United Kingdom, Europe, and Asia.

Median survival of cohorts ranged from 1 to 41 months as measured from a baseline mean estimated glomerular filtration rate (eGFR) ranging from 7 to 19 mL/min/1.73m².

Younger patients between 70 and 79 years of age had a median survival of 7 to 41 months, the authors note, while cohorts consisting of patients 80 years of age and older had a median survival of 1 to 37 months despite overlapping ranges of baseline mean eGFRs.

During an observation period of 8-24 months, mental well-being improved, and physical well-being and overall quality of life were largely stable until late in the course of illness.

“Ten studies … provided information on the use of health care resources during follow-up,” the researchers say. Patients generally experienced one to two hospital admissions, 6-16 in-hospital days, seven to eight clinic visits, and two emergency department visits per person-year. Use of acute care services was “therefore common,” they note.

Not all studies provided information about end-of-life care, but those that did reported rates of hospice enrollment that ranged from 20% to 76%; hospitalization rates during the final month of life from 57% to 76%; in-hospital death rates of 27%-68%, and in-home death rates ranging from 12% to 71%.

This indicates substantial disparity in access to supportive care near the end of life across cohorts, the authors observe.

Nevertheless, “Most patients survived several years after the decision to forgo dialysis was made,” they stress.

“These findings not only suggest that conservative kidney management may be a viable and positive therapeutic alternative to dialysis, they also highlight the strengths of its multidisciplinary approach to care and aggressive symptom management.”

“Collectively, our findings demonstrate the need to implement systematic and unified research methods for conservative kidney management and to develop models of care and the care infrastructure to advance practice and outcomes of conservative kidney management,” they conclude.

Dr. Wong has no financial ties to industry. Dr. Tamura has reported receiving personal fees from the American Federation for Aging Research.

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

Many older patients with advanced kidney disease who decide to forgo dialysis still survive for several years after making their decision and have a good quality of life until their final days, a new systematic review of cohort studies suggests.

“Our findings challenge the common misconception that the only alternative to dialysis for many patients with advanced chronic kidney disease is no care or death,” say Susan Wong, MD, of the Renal Dialysis Unit, Seattle, and colleagues in their review, published online March 14 in JAMA Network Open.

In an accompanying commentary, Christine Liu, MD, and Kurella Tamura, MD, MPH, note: “The decision to initiate dialysis or focus on active alleviation of symptoms, known as conservative care … is likely one of the consequential decisions [patients] will face.”

“[But] in reality, dialysis is viewed as the default treatment for kidney failure, and the option to forgo dialysis treatment is often not explicitly discussed,” they add.

“We believe it is time to broaden the scope of kidney replacement therapy registries to include persons who receive conservative treatment of kidney failure … and we need to address the conservative care information gap so that lack of awareness is no longer a barrier to informed decision-making,” Dr. Liu and Dr. Tamura, both from Stanford (Calif.) University, note.

The work by Dr. Wong and colleagues “dispels the notion that conservative care for kidney failure means a grim and near-immediate death. The study advances the idea that a conservative care approach can provide time and sustain quality of life to support patients’ life goals,” they emphasize.
 

Conservative care assessed in 41 studies

The review included 41 studies involving 5,102 patients with a mean age ranging from 60 to 87 years conducted in the United Kingdom, Europe, and Asia.

Median survival of cohorts ranged from 1 to 41 months as measured from a baseline mean estimated glomerular filtration rate (eGFR) ranging from 7 to 19 mL/min/1.73m².

Younger patients between 70 and 79 years of age had a median survival of 7 to 41 months, the authors note, while cohorts consisting of patients 80 years of age and older had a median survival of 1 to 37 months despite overlapping ranges of baseline mean eGFRs.

During an observation period of 8-24 months, mental well-being improved, and physical well-being and overall quality of life were largely stable until late in the course of illness.

“Ten studies … provided information on the use of health care resources during follow-up,” the researchers say. Patients generally experienced one to two hospital admissions, 6-16 in-hospital days, seven to eight clinic visits, and two emergency department visits per person-year. Use of acute care services was “therefore common,” they note.

Not all studies provided information about end-of-life care, but those that did reported rates of hospice enrollment that ranged from 20% to 76%; hospitalization rates during the final month of life from 57% to 76%; in-hospital death rates of 27%-68%, and in-home death rates ranging from 12% to 71%.

This indicates substantial disparity in access to supportive care near the end of life across cohorts, the authors observe.

Nevertheless, “Most patients survived several years after the decision to forgo dialysis was made,” they stress.

“These findings not only suggest that conservative kidney management may be a viable and positive therapeutic alternative to dialysis, they also highlight the strengths of its multidisciplinary approach to care and aggressive symptom management.”

“Collectively, our findings demonstrate the need to implement systematic and unified research methods for conservative kidney management and to develop models of care and the care infrastructure to advance practice and outcomes of conservative kidney management,” they conclude.

Dr. Wong has no financial ties to industry. Dr. Tamura has reported receiving personal fees from the American Federation for Aging Research.

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

Many older patients with advanced kidney disease who decide to forgo dialysis still survive for several years after making their decision and have a good quality of life until their final days, a new systematic review of cohort studies suggests.

“Our findings challenge the common misconception that the only alternative to dialysis for many patients with advanced chronic kidney disease is no care or death,” say Susan Wong, MD, of the Renal Dialysis Unit, Seattle, and colleagues in their review, published online March 14 in JAMA Network Open.

In an accompanying commentary, Christine Liu, MD, and Kurella Tamura, MD, MPH, note: “The decision to initiate dialysis or focus on active alleviation of symptoms, known as conservative care … is likely one of the consequential decisions [patients] will face.”

“[But] in reality, dialysis is viewed as the default treatment for kidney failure, and the option to forgo dialysis treatment is often not explicitly discussed,” they add.

“We believe it is time to broaden the scope of kidney replacement therapy registries to include persons who receive conservative treatment of kidney failure … and we need to address the conservative care information gap so that lack of awareness is no longer a barrier to informed decision-making,” Dr. Liu and Dr. Tamura, both from Stanford (Calif.) University, note.

The work by Dr. Wong and colleagues “dispels the notion that conservative care for kidney failure means a grim and near-immediate death. The study advances the idea that a conservative care approach can provide time and sustain quality of life to support patients’ life goals,” they emphasize.
 

Conservative care assessed in 41 studies

The review included 41 studies involving 5,102 patients with a mean age ranging from 60 to 87 years conducted in the United Kingdom, Europe, and Asia.

Median survival of cohorts ranged from 1 to 41 months as measured from a baseline mean estimated glomerular filtration rate (eGFR) ranging from 7 to 19 mL/min/1.73m².

Younger patients between 70 and 79 years of age had a median survival of 7 to 41 months, the authors note, while cohorts consisting of patients 80 years of age and older had a median survival of 1 to 37 months despite overlapping ranges of baseline mean eGFRs.

During an observation period of 8-24 months, mental well-being improved, and physical well-being and overall quality of life were largely stable until late in the course of illness.

“Ten studies … provided information on the use of health care resources during follow-up,” the researchers say. Patients generally experienced one to two hospital admissions, 6-16 in-hospital days, seven to eight clinic visits, and two emergency department visits per person-year. Use of acute care services was “therefore common,” they note.

Not all studies provided information about end-of-life care, but those that did reported rates of hospice enrollment that ranged from 20% to 76%; hospitalization rates during the final month of life from 57% to 76%; in-hospital death rates of 27%-68%, and in-home death rates ranging from 12% to 71%.

This indicates substantial disparity in access to supportive care near the end of life across cohorts, the authors observe.

Nevertheless, “Most patients survived several years after the decision to forgo dialysis was made,” they stress.

“These findings not only suggest that conservative kidney management may be a viable and positive therapeutic alternative to dialysis, they also highlight the strengths of its multidisciplinary approach to care and aggressive symptom management.”

“Collectively, our findings demonstrate the need to implement systematic and unified research methods for conservative kidney management and to develop models of care and the care infrastructure to advance practice and outcomes of conservative kidney management,” they conclude.

Dr. Wong has no financial ties to industry. Dr. Tamura has reported receiving personal fees from the American Federation for Aging Research.

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

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

It’s no secret that heavy drinking is linked to potential health problems, from liver damage to a higher risk of cancer. But most people probably wouldn’t think a nightcap every evening is much of a health threat.

Now, new evidence published in Nature Communications suggests even one drink a day is linked to detectable changes in the brain, though it’s not clear whether the alcohol is causing the differences.

Previous research has found that people with alcohol use disorder have structural changes in their brains, compared with healthy people’s brains, such as reduced gray-matter and white-matter volume.

But those findings were in people with a history of heavy drinking, defined by the National Institute on Alcohol Abuse and Alcoholism as more than four drinks a day for men and more than three drinks a day for women.

The national dietary guidelines from the U.S. Department of Health & Human Services advise drinking no more than two standard drinks for men and one drink for women each day. A standard drink in the United States is 12 ounces of beer, 5 ounces of wine, or 1½ ounce of liquor.

But could even this modest amount of alcohol make a difference to our brains?

Researchers examined functional MRI brain scans from 36,678 healthy adults, aged 40-69 years, in the United Kingdom and compared those findings with their weekly alcohol consumption, adjusting for differences in age, sex, height, social and economic status, and country of residence, among other things.

In line with past studies, the researchers found that, as a person drank more alcohol, their gray-matter and white-matter volume decreased, getting worse the more drinks they had in a week.

But the researchers also noted that they could tell the difference between brain images of people who never drank alcohol and those who had just one or two drinks a day.

Going from 1 unit of alcohol to 2 – which in the United Kingdom means a full pint of beer or standard glass of wine – was linked to changes similar to 2 years of aging in the brain.

Other than comparing the changes with aging, it’s not yet clear what the findings mean until the scientists do more research, including looking at the genes of the people who took part in the study.

The study also has several drawbacks. The people who were studied are all middle-aged Europeans, so findings might be different in younger people or those with different ancestries. People also self-reported how much alcohol they drank for the past year, which they might not remember correctly or which might be different from previous years, including past years of heavy drinking.

And since the researchers compared drinking habits with brain imaging at one point in time, it’s not possible to say whether alcohol is actually causing the brain differences they saw.

Still, the findings raise the question of whether national guidelines should be revisited, and whether it’s better to cut that evening drink to a half-glass of wine instead.

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

It’s no secret that heavy drinking is linked to potential health problems, from liver damage to a higher risk of cancer. But most people probably wouldn’t think a nightcap every evening is much of a health threat.

Now, new evidence published in Nature Communications suggests even one drink a day is linked to detectable changes in the brain, though it’s not clear whether the alcohol is causing the differences.

Previous research has found that people with alcohol use disorder have structural changes in their brains, compared with healthy people’s brains, such as reduced gray-matter and white-matter volume.

But those findings were in people with a history of heavy drinking, defined by the National Institute on Alcohol Abuse and Alcoholism as more than four drinks a day for men and more than three drinks a day for women.

The national dietary guidelines from the U.S. Department of Health & Human Services advise drinking no more than two standard drinks for men and one drink for women each day. A standard drink in the United States is 12 ounces of beer, 5 ounces of wine, or 1½ ounce of liquor.

But could even this modest amount of alcohol make a difference to our brains?

Researchers examined functional MRI brain scans from 36,678 healthy adults, aged 40-69 years, in the United Kingdom and compared those findings with their weekly alcohol consumption, adjusting for differences in age, sex, height, social and economic status, and country of residence, among other things.

In line with past studies, the researchers found that, as a person drank more alcohol, their gray-matter and white-matter volume decreased, getting worse the more drinks they had in a week.

But the researchers also noted that they could tell the difference between brain images of people who never drank alcohol and those who had just one or two drinks a day.

Going from 1 unit of alcohol to 2 – which in the United Kingdom means a full pint of beer or standard glass of wine – was linked to changes similar to 2 years of aging in the brain.

Other than comparing the changes with aging, it’s not yet clear what the findings mean until the scientists do more research, including looking at the genes of the people who took part in the study.

The study also has several drawbacks. The people who were studied are all middle-aged Europeans, so findings might be different in younger people or those with different ancestries. People also self-reported how much alcohol they drank for the past year, which they might not remember correctly or which might be different from previous years, including past years of heavy drinking.

And since the researchers compared drinking habits with brain imaging at one point in time, it’s not possible to say whether alcohol is actually causing the brain differences they saw.

Still, the findings raise the question of whether national guidelines should be revisited, and whether it’s better to cut that evening drink to a half-glass of wine instead.

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

It’s no secret that heavy drinking is linked to potential health problems, from liver damage to a higher risk of cancer. But most people probably wouldn’t think a nightcap every evening is much of a health threat.

Now, new evidence published in Nature Communications suggests even one drink a day is linked to detectable changes in the brain, though it’s not clear whether the alcohol is causing the differences.

Previous research has found that people with alcohol use disorder have structural changes in their brains, compared with healthy people’s brains, such as reduced gray-matter and white-matter volume.

But those findings were in people with a history of heavy drinking, defined by the National Institute on Alcohol Abuse and Alcoholism as more than four drinks a day for men and more than three drinks a day for women.

The national dietary guidelines from the U.S. Department of Health & Human Services advise drinking no more than two standard drinks for men and one drink for women each day. A standard drink in the United States is 12 ounces of beer, 5 ounces of wine, or 1½ ounce of liquor.

But could even this modest amount of alcohol make a difference to our brains?

Researchers examined functional MRI brain scans from 36,678 healthy adults, aged 40-69 years, in the United Kingdom and compared those findings with their weekly alcohol consumption, adjusting for differences in age, sex, height, social and economic status, and country of residence, among other things.

In line with past studies, the researchers found that, as a person drank more alcohol, their gray-matter and white-matter volume decreased, getting worse the more drinks they had in a week.

But the researchers also noted that they could tell the difference between brain images of people who never drank alcohol and those who had just one or two drinks a day.

Going from 1 unit of alcohol to 2 – which in the United Kingdom means a full pint of beer or standard glass of wine – was linked to changes similar to 2 years of aging in the brain.

Other than comparing the changes with aging, it’s not yet clear what the findings mean until the scientists do more research, including looking at the genes of the people who took part in the study.

The study also has several drawbacks. The people who were studied are all middle-aged Europeans, so findings might be different in younger people or those with different ancestries. People also self-reported how much alcohol they drank for the past year, which they might not remember correctly or which might be different from previous years, including past years of heavy drinking.

And since the researchers compared drinking habits with brain imaging at one point in time, it’s not possible to say whether alcohol is actually causing the brain differences they saw.

Still, the findings raise the question of whether national guidelines should be revisited, and whether it’s better to cut that evening drink to a half-glass of wine instead.

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

A federal jury convicted New Jersey rheumatologist Alice Chu, MD, on March 8, 2022, for defrauding Medicare and private insurance companies for services that she never provided to patients, according to the Department of Justice.

At the Clifton, N.J., practice that Dr. Chu owned and operated, court documents and evidence showed that during 2010-2019 she billed Medicare and private insurance companies for more than $8.8 million in false and fraudulent claims for biologic infusion medications that were never purchased by her practice and for allergy services that were never provided to patients.

jsmith/iStockphoto

The 64-year-old Dr. Chu is 1 of 48 people who were charged in 2019 as part of a larger enforcement action involving more than $160 million in fraudulent claims, including 15 doctors or medical professionals who practiced mainly in the northeastern United States. The Department of Justice said that Dr. Chu was motivated by financial incentives to order expensive and medically unnecessary lab tests paid for by Medicare.

The jury convicted her on one count of conspiracy to commit health care fraud and five counts of health care fraud. She is scheduled to be sentenced on July 14, 2022, and faces a maximum penalty of 10 years in prison for each count.

The investigation was led by the Federal Bureau of Investigation; the Department of Health & Human Services Office of the Inspector General; and the Department of Defense Office of Inspector General, Defense Criminal Investigative Service.

A federal jury convicted New Jersey rheumatologist Alice Chu, MD, on March 8, 2022, for defrauding Medicare and private insurance companies for services that she never provided to patients, according to the Department of Justice.

At the Clifton, N.J., practice that Dr. Chu owned and operated, court documents and evidence showed that during 2010-2019 she billed Medicare and private insurance companies for more than $8.8 million in false and fraudulent claims for biologic infusion medications that were never purchased by her practice and for allergy services that were never provided to patients.

jsmith/iStockphoto

The 64-year-old Dr. Chu is 1 of 48 people who were charged in 2019 as part of a larger enforcement action involving more than $160 million in fraudulent claims, including 15 doctors or medical professionals who practiced mainly in the northeastern United States. The Department of Justice said that Dr. Chu was motivated by financial incentives to order expensive and medically unnecessary lab tests paid for by Medicare.

The jury convicted her on one count of conspiracy to commit health care fraud and five counts of health care fraud. She is scheduled to be sentenced on July 14, 2022, and faces a maximum penalty of 10 years in prison for each count.

The investigation was led by the Federal Bureau of Investigation; the Department of Health & Human Services Office of the Inspector General; and the Department of Defense Office of Inspector General, Defense Criminal Investigative Service.

A federal jury convicted New Jersey rheumatologist Alice Chu, MD, on March 8, 2022, for defrauding Medicare and private insurance companies for services that she never provided to patients, according to the Department of Justice.

At the Clifton, N.J., practice that Dr. Chu owned and operated, court documents and evidence showed that during 2010-2019 she billed Medicare and private insurance companies for more than $8.8 million in false and fraudulent claims for biologic infusion medications that were never purchased by her practice and for allergy services that were never provided to patients.

jsmith/iStockphoto

The 64-year-old Dr. Chu is 1 of 48 people who were charged in 2019 as part of a larger enforcement action involving more than $160 million in fraudulent claims, including 15 doctors or medical professionals who practiced mainly in the northeastern United States. The Department of Justice said that Dr. Chu was motivated by financial incentives to order expensive and medically unnecessary lab tests paid for by Medicare.

The jury convicted her on one count of conspiracy to commit health care fraud and five counts of health care fraud. She is scheduled to be sentenced on July 14, 2022, and faces a maximum penalty of 10 years in prison for each count.

The investigation was led by the Federal Bureau of Investigation; the Department of Health & Human Services Office of the Inspector General; and the Department of Defense Office of Inspector General, Defense Criminal Investigative Service.

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval was given for a complex generic drug-device combination product – a metered-dose inhaler that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). It is intended to be used as two inhalations, two times a day (usually morning and night, about 12 hours apart), to treat both diseases by preventing symptoms, such as wheezing for those with asthma and for improved breathing for patients with COPD.

The inhaler is approved at two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), according to the March 15 FDA announcement. The device is not intended for the treatment of acute asthma.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection, the FDA reported.

The approval of this generic drug-device combination was granted to Mylan Pharmaceuticals.

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

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval was given for a complex generic drug-device combination product – a metered-dose inhaler that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). It is intended to be used as two inhalations, two times a day (usually morning and night, about 12 hours apart), to treat both diseases by preventing symptoms, such as wheezing for those with asthma and for improved breathing for patients with COPD.

The inhaler is approved at two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), according to the March 15 FDA announcement. The device is not intended for the treatment of acute asthma.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection, the FDA reported.

The approval of this generic drug-device combination was granted to Mylan Pharmaceuticals.

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

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients 6 years of age and older and for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval was given for a complex generic drug-device combination product – a metered-dose inhaler that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). It is intended to be used as two inhalations, two times a day (usually morning and night, about 12 hours apart), to treat both diseases by preventing symptoms, such as wheezing for those with asthma and for improved breathing for patients with COPD.

The inhaler is approved at two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation), according to the March 15 FDA announcement. The device is not intended for the treatment of acute asthma.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, PhD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol for those with asthma are nasopharyngitis pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis (thrush). For those with COPD, the most common side effects are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection, the FDA reported.

The approval of this generic drug-device combination was granted to Mylan Pharmaceuticals.

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

Scientists are trying different approaches to developing vaccines against norovirus, seeking to replicate the success seen in developing shots against rotavirus.

Speaking at the 12th World Congress of the World Society for Pediatric Infectious Diseases (WSPID), Miguel O’Ryan, MD, of the University of Chile, Santiago, presented an overview of candidate vaccines. Dr. O’Ryan has been involved for many years with research on rotavirus vaccines and has branched into work with the somewhat similar norovirus.

With advances in preventing rotavirus, norovirus has emerged in recent years as a leading cause of acute gastroenteritis (AGE) in most countries worldwide. It’s associated with almost 20% of all acute diarrheal cases globally and with an estimated 685 million episodes and 212,000 deaths annually, Dr. O’Ryan and coauthors reported in a review in the journal Viruses.

If successful, norovirus vaccines may be used someday to prevent outbreaks among military personnel, as this contagious virus has the potential to disrupt missions, Dr. O’Ryan and coauthors wrote. They also said people might consider getting norovirus vaccines ahead of trips to prevent traveler’s diarrhea. But most importantly, these kinds of vaccines could reduce diarrhea-associated hospitalizations and deaths of children. 

Takeda Pharmaceutical Company, for whom Dr. O’Ryan has done consulting, last year announced a collaboration with Frazier Healthcare Partners to launch HilleVax. Based in Boston, the company is intended to commercialize Takeda’s norovirus vaccine candidate.

The Takeda-HilleVax candidate vaccine injection has advanced as far as phase 2 studies, including a test done over two winter seasons in U.S. Navy recruits. Takeda and U.S. Navy scientists reported in 2020 in the journal Vaccine that the primary efficacy outcome for this test could not be evaluated due to an unexpectedly low number of cases of norovirus. Still, data taken from this study indicate that the vaccine induces a broad immune response, the scientists reported.

In his WSPID presentation, Dr. O’Ryan also mentioned an oral norovirus vaccine candidate that the company Vaxart is developing, referring to this as a “very interesting approach.” 
 

Betting on the gut

Based in South San Francisco, California, Vaxart is pursuing a theory that a vaccine designed to generate mucosal antibodies locally in the intestine, in addition to systemic antibodies in the blood, may better protect against norovirus infection than an injectable vaccine.

“A key ability to protect against norovirus needs to come from an intestinal immune response, and injected vaccines don’t give those very well,” Sean Tucker, PhD, the founder and chief scientific officer of Vaxart, told this news organization in an interview. “We think that’s one of the reasons why our oral approaches can have significant advantages.”

Challenges to developing a norovirus vaccine have included a lack of good animal models to use in research and a lack of an ability to grow the virus well in cell culture, Dr. Tucker said.

Vaxart experienced disruptions in its research during the early stages of the pandemic but has since picked up the pace of its efforts to develop its oral vaccine, Dr. Tucker said during the interview.

In a recent filing with the Securities and Exchange Commission, Vaxart said in early 2021 it resumed its norovirus vaccine program by initiating three clinical studies. These included a phase 1b placebo-controlled dose ranging study in healthy elderly adults aged 55-80. Data from these trials may be unveiled in the coming months.

Vaxart said that this year it has already initiated a phase 2 norovirus challenge study, which will evaluate safety, immunogenicity, and clinical efficacy of a vaccine candidate against placebo.

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

Scientists are trying different approaches to developing vaccines against norovirus, seeking to replicate the success seen in developing shots against rotavirus.

Speaking at the 12th World Congress of the World Society for Pediatric Infectious Diseases (WSPID), Miguel O’Ryan, MD, of the University of Chile, Santiago, presented an overview of candidate vaccines. Dr. O’Ryan has been involved for many years with research on rotavirus vaccines and has branched into work with the somewhat similar norovirus.

With advances in preventing rotavirus, norovirus has emerged in recent years as a leading cause of acute gastroenteritis (AGE) in most countries worldwide. It’s associated with almost 20% of all acute diarrheal cases globally and with an estimated 685 million episodes and 212,000 deaths annually, Dr. O’Ryan and coauthors reported in a review in the journal Viruses.

If successful, norovirus vaccines may be used someday to prevent outbreaks among military personnel, as this contagious virus has the potential to disrupt missions, Dr. O’Ryan and coauthors wrote. They also said people might consider getting norovirus vaccines ahead of trips to prevent traveler’s diarrhea. But most importantly, these kinds of vaccines could reduce diarrhea-associated hospitalizations and deaths of children. 

Takeda Pharmaceutical Company, for whom Dr. O’Ryan has done consulting, last year announced a collaboration with Frazier Healthcare Partners to launch HilleVax. Based in Boston, the company is intended to commercialize Takeda’s norovirus vaccine candidate.

The Takeda-HilleVax candidate vaccine injection has advanced as far as phase 2 studies, including a test done over two winter seasons in U.S. Navy recruits. Takeda and U.S. Navy scientists reported in 2020 in the journal Vaccine that the primary efficacy outcome for this test could not be evaluated due to an unexpectedly low number of cases of norovirus. Still, data taken from this study indicate that the vaccine induces a broad immune response, the scientists reported.

In his WSPID presentation, Dr. O’Ryan also mentioned an oral norovirus vaccine candidate that the company Vaxart is developing, referring to this as a “very interesting approach.” 
 

Betting on the gut

Based in South San Francisco, California, Vaxart is pursuing a theory that a vaccine designed to generate mucosal antibodies locally in the intestine, in addition to systemic antibodies in the blood, may better protect against norovirus infection than an injectable vaccine.

“A key ability to protect against norovirus needs to come from an intestinal immune response, and injected vaccines don’t give those very well,” Sean Tucker, PhD, the founder and chief scientific officer of Vaxart, told this news organization in an interview. “We think that’s one of the reasons why our oral approaches can have significant advantages.”

Challenges to developing a norovirus vaccine have included a lack of good animal models to use in research and a lack of an ability to grow the virus well in cell culture, Dr. Tucker said.

Vaxart experienced disruptions in its research during the early stages of the pandemic but has since picked up the pace of its efforts to develop its oral vaccine, Dr. Tucker said during the interview.

In a recent filing with the Securities and Exchange Commission, Vaxart said in early 2021 it resumed its norovirus vaccine program by initiating three clinical studies. These included a phase 1b placebo-controlled dose ranging study in healthy elderly adults aged 55-80. Data from these trials may be unveiled in the coming months.

Vaxart said that this year it has already initiated a phase 2 norovirus challenge study, which will evaluate safety, immunogenicity, and clinical efficacy of a vaccine candidate against placebo.

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

Scientists are trying different approaches to developing vaccines against norovirus, seeking to replicate the success seen in developing shots against rotavirus.

Speaking at the 12th World Congress of the World Society for Pediatric Infectious Diseases (WSPID), Miguel O’Ryan, MD, of the University of Chile, Santiago, presented an overview of candidate vaccines. Dr. O’Ryan has been involved for many years with research on rotavirus vaccines and has branched into work with the somewhat similar norovirus.

With advances in preventing rotavirus, norovirus has emerged in recent years as a leading cause of acute gastroenteritis (AGE) in most countries worldwide. It’s associated with almost 20% of all acute diarrheal cases globally and with an estimated 685 million episodes and 212,000 deaths annually, Dr. O’Ryan and coauthors reported in a review in the journal Viruses.

If successful, norovirus vaccines may be used someday to prevent outbreaks among military personnel, as this contagious virus has the potential to disrupt missions, Dr. O’Ryan and coauthors wrote. They also said people might consider getting norovirus vaccines ahead of trips to prevent traveler’s diarrhea. But most importantly, these kinds of vaccines could reduce diarrhea-associated hospitalizations and deaths of children. 

Takeda Pharmaceutical Company, for whom Dr. O’Ryan has done consulting, last year announced a collaboration with Frazier Healthcare Partners to launch HilleVax. Based in Boston, the company is intended to commercialize Takeda’s norovirus vaccine candidate.

The Takeda-HilleVax candidate vaccine injection has advanced as far as phase 2 studies, including a test done over two winter seasons in U.S. Navy recruits. Takeda and U.S. Navy scientists reported in 2020 in the journal Vaccine that the primary efficacy outcome for this test could not be evaluated due to an unexpectedly low number of cases of norovirus. Still, data taken from this study indicate that the vaccine induces a broad immune response, the scientists reported.

In his WSPID presentation, Dr. O’Ryan also mentioned an oral norovirus vaccine candidate that the company Vaxart is developing, referring to this as a “very interesting approach.” 
 

Betting on the gut

Based in South San Francisco, California, Vaxart is pursuing a theory that a vaccine designed to generate mucosal antibodies locally in the intestine, in addition to systemic antibodies in the blood, may better protect against norovirus infection than an injectable vaccine.

“A key ability to protect against norovirus needs to come from an intestinal immune response, and injected vaccines don’t give those very well,” Sean Tucker, PhD, the founder and chief scientific officer of Vaxart, told this news organization in an interview. “We think that’s one of the reasons why our oral approaches can have significant advantages.”

Challenges to developing a norovirus vaccine have included a lack of good animal models to use in research and a lack of an ability to grow the virus well in cell culture, Dr. Tucker said.

Vaxart experienced disruptions in its research during the early stages of the pandemic but has since picked up the pace of its efforts to develop its oral vaccine, Dr. Tucker said during the interview.

In a recent filing with the Securities and Exchange Commission, Vaxart said in early 2021 it resumed its norovirus vaccine program by initiating three clinical studies. These included a phase 1b placebo-controlled dose ranging study in healthy elderly adults aged 55-80. Data from these trials may be unveiled in the coming months.

Vaxart said that this year it has already initiated a phase 2 norovirus challenge study, which will evaluate safety, immunogenicity, and clinical efficacy of a vaccine candidate against placebo.

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

The World Health Organization is expected to recommend truncating treatment of children with mild tuberculosis by 2 months – from 6 months to 4 – after a randomized trial found similar outcomes with the shorter regimen.

An international team of investigators found the abbreviated course of antibiotics was no less effective or safe than conventional treatment and saved an average of $17.34 per child – money that could be used to mitigate the toll of TB, which is estimated to sicken 1.1 million children worldwide each year.

The findings come as deaths from TB are rising as a result of the COVID-19 pandemic, which has hindered efforts to find and treat patients. In 2020, according to the WHO, an estimated 1.5 million people died from TB, the first year-over-year increase in such deaths since 2005.

Nearly a quarter of children with TB die, primarily because they go undiagnosed, according to the researchers, who published the study in the New England Journal of Medicine. Shorter treatment “translates into very large cost savings that could be used to improve screening and diagnosis to address the current case detection gap,” first author Anna Turkova, MD, of University College London, told this news organization.

The standard TB regimen is based on trials in adults with severe respiratory disease. However, about two-thirds of children have nonsevere infections.

For the study, Dr. Turkova and colleagues assigned 1,204 children with TB in four countries – Uganda, Zambia, South Africa, and India – to either a 4- or 6-month regimen with first-line medications rifampin, isoniazid, pyrazinamide, and ethambutol. Participants were aged 2 months to 15 years and had symptomatic nonsevere lung or lymph node infections with a negative test on a sputum smear microscopy. Eleven percent also had HIV.

After 18 months, 16 participants in the group that received the shortened treatment and 18 in the standard treatment group had experienced an unfavorable outcome – defined as treatment failure, recurrence of TB, loss to follow-up, or death (adjusted difference, -0.4 percentage points; 95% confidence interval, -2.2 to 1.5).

Similar numbers – 47 in the 4-month group and 48 in the 6-month group – experienced severe or life-threatening adverse events, most commonly chest infections, such as pneumonia, and liver problems, during treatment or up to 30 days after the last dose.  
 

New guidelines coming soon

The WHO plans to issue new guidelines and a handbook for TB management in children and adolescents on March 24, World Tuberculosis Day, a spokesman for the agency told Medscape.

Anna Mandalakas, MD, PhD, director of the Global Tuberculosis Program at Baylor College of Medicine, department of pediatrics, Houston, said the shorter regimen should enable more children to successfully complete TB treatment.

“It can be challenging to convince young children to take medications on a regular basis for 6 months,” Dr. Mandalakas, a member of a WHO guidelines development group that reviewed the study, told this news organization. “Despite best intentions, parents often become fatigued and give up the medicine battle.”

Leo Martinez, PhD, an epidemiologist at Boston University School of Public Health who studies pediatric TB, noted that study’s cost-effectiveness analysis applies only to health care costs. Families often suffer financially through lost wages, transportation to health care facilities, and lost employment, fueling a cycle of poverty and disease in low-income countries, he said.

A WHO statement noted that long treatment regimens can add toxicity and risk of drug interactions for children with HIV.

Separate efforts have been underway to hasten TB treatment in different groups of patients. A study published in NEJM showed that 4 months of the potent antibiotic rifapentine, along with another antibiotic, moxifloxacin, was non-inferior to the standard 6-month regimen in patients aged 12 and older. According to the editorial accompanying that study, the research illustrated the potential for shorter treatment courses that would be cheaper and less cumbersome, although that particular combination poses hurdles such as adherence issues and potential bacterial resistance.

Experts agreed that improved diagnostic procedures are critical to significantly reducing TB pediatric deaths – an issue that Dr. Turkova said will be addressed in WHO’s forthcoming handbook.

Because no gold-standard test exists for TB, and symptoms often overlap with other infections, widespread screening of children in households where adults have been diagnosed with TB has been found to improve detection of the disease. “Training of health care workers, easy-to-implement diagnostic algorithms, and widely accessible training materials on chest radiography in childhood TB should also improve case finding and treatment initiation,” she said.

The trial was supported by U.K. government and charitable research funders. Dr. Turkova and Dr. Martinez reported no financial disclosures. Dr. Mandalakas reported honoraria from WHO to support the preparation of diagnostics and treatment chapters in the operational handbook, for providing lectures for Medscape, and for serving on a data safety monitoring board for Janssen Pharmaceuticals.

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

The World Health Organization is expected to recommend truncating treatment of children with mild tuberculosis by 2 months – from 6 months to 4 – after a randomized trial found similar outcomes with the shorter regimen.

An international team of investigators found the abbreviated course of antibiotics was no less effective or safe than conventional treatment and saved an average of $17.34 per child – money that could be used to mitigate the toll of TB, which is estimated to sicken 1.1 million children worldwide each year.

The findings come as deaths from TB are rising as a result of the COVID-19 pandemic, which has hindered efforts to find and treat patients. In 2020, according to the WHO, an estimated 1.5 million people died from TB, the first year-over-year increase in such deaths since 2005.

Nearly a quarter of children with TB die, primarily because they go undiagnosed, according to the researchers, who published the study in the New England Journal of Medicine. Shorter treatment “translates into very large cost savings that could be used to improve screening and diagnosis to address the current case detection gap,” first author Anna Turkova, MD, of University College London, told this news organization.

The standard TB regimen is based on trials in adults with severe respiratory disease. However, about two-thirds of children have nonsevere infections.

For the study, Dr. Turkova and colleagues assigned 1,204 children with TB in four countries – Uganda, Zambia, South Africa, and India – to either a 4- or 6-month regimen with first-line medications rifampin, isoniazid, pyrazinamide, and ethambutol. Participants were aged 2 months to 15 years and had symptomatic nonsevere lung or lymph node infections with a negative test on a sputum smear microscopy. Eleven percent also had HIV.

After 18 months, 16 participants in the group that received the shortened treatment and 18 in the standard treatment group had experienced an unfavorable outcome – defined as treatment failure, recurrence of TB, loss to follow-up, or death (adjusted difference, -0.4 percentage points; 95% confidence interval, -2.2 to 1.5).

Similar numbers – 47 in the 4-month group and 48 in the 6-month group – experienced severe or life-threatening adverse events, most commonly chest infections, such as pneumonia, and liver problems, during treatment or up to 30 days after the last dose.  
 

New guidelines coming soon

The WHO plans to issue new guidelines and a handbook for TB management in children and adolescents on March 24, World Tuberculosis Day, a spokesman for the agency told Medscape.

Anna Mandalakas, MD, PhD, director of the Global Tuberculosis Program at Baylor College of Medicine, department of pediatrics, Houston, said the shorter regimen should enable more children to successfully complete TB treatment.

“It can be challenging to convince young children to take medications on a regular basis for 6 months,” Dr. Mandalakas, a member of a WHO guidelines development group that reviewed the study, told this news organization. “Despite best intentions, parents often become fatigued and give up the medicine battle.”

Leo Martinez, PhD, an epidemiologist at Boston University School of Public Health who studies pediatric TB, noted that study’s cost-effectiveness analysis applies only to health care costs. Families often suffer financially through lost wages, transportation to health care facilities, and lost employment, fueling a cycle of poverty and disease in low-income countries, he said.

A WHO statement noted that long treatment regimens can add toxicity and risk of drug interactions for children with HIV.

Separate efforts have been underway to hasten TB treatment in different groups of patients. A study published in NEJM showed that 4 months of the potent antibiotic rifapentine, along with another antibiotic, moxifloxacin, was non-inferior to the standard 6-month regimen in patients aged 12 and older. According to the editorial accompanying that study, the research illustrated the potential for shorter treatment courses that would be cheaper and less cumbersome, although that particular combination poses hurdles such as adherence issues and potential bacterial resistance.

Experts agreed that improved diagnostic procedures are critical to significantly reducing TB pediatric deaths – an issue that Dr. Turkova said will be addressed in WHO’s forthcoming handbook.

Because no gold-standard test exists for TB, and symptoms often overlap with other infections, widespread screening of children in households where adults have been diagnosed with TB has been found to improve detection of the disease. “Training of health care workers, easy-to-implement diagnostic algorithms, and widely accessible training materials on chest radiography in childhood TB should also improve case finding and treatment initiation,” she said.

The trial was supported by U.K. government and charitable research funders. Dr. Turkova and Dr. Martinez reported no financial disclosures. Dr. Mandalakas reported honoraria from WHO to support the preparation of diagnostics and treatment chapters in the operational handbook, for providing lectures for Medscape, and for serving on a data safety monitoring board for Janssen Pharmaceuticals.

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

The World Health Organization is expected to recommend truncating treatment of children with mild tuberculosis by 2 months – from 6 months to 4 – after a randomized trial found similar outcomes with the shorter regimen.

An international team of investigators found the abbreviated course of antibiotics was no less effective or safe than conventional treatment and saved an average of $17.34 per child – money that could be used to mitigate the toll of TB, which is estimated to sicken 1.1 million children worldwide each year.

The findings come as deaths from TB are rising as a result of the COVID-19 pandemic, which has hindered efforts to find and treat patients. In 2020, according to the WHO, an estimated 1.5 million people died from TB, the first year-over-year increase in such deaths since 2005.

Nearly a quarter of children with TB die, primarily because they go undiagnosed, according to the researchers, who published the study in the New England Journal of Medicine. Shorter treatment “translates into very large cost savings that could be used to improve screening and diagnosis to address the current case detection gap,” first author Anna Turkova, MD, of University College London, told this news organization.

The standard TB regimen is based on trials in adults with severe respiratory disease. However, about two-thirds of children have nonsevere infections.

For the study, Dr. Turkova and colleagues assigned 1,204 children with TB in four countries – Uganda, Zambia, South Africa, and India – to either a 4- or 6-month regimen with first-line medications rifampin, isoniazid, pyrazinamide, and ethambutol. Participants were aged 2 months to 15 years and had symptomatic nonsevere lung or lymph node infections with a negative test on a sputum smear microscopy. Eleven percent also had HIV.

After 18 months, 16 participants in the group that received the shortened treatment and 18 in the standard treatment group had experienced an unfavorable outcome – defined as treatment failure, recurrence of TB, loss to follow-up, or death (adjusted difference, -0.4 percentage points; 95% confidence interval, -2.2 to 1.5).

Similar numbers – 47 in the 4-month group and 48 in the 6-month group – experienced severe or life-threatening adverse events, most commonly chest infections, such as pneumonia, and liver problems, during treatment or up to 30 days after the last dose.  
 

New guidelines coming soon

The WHO plans to issue new guidelines and a handbook for TB management in children and adolescents on March 24, World Tuberculosis Day, a spokesman for the agency told Medscape.

Anna Mandalakas, MD, PhD, director of the Global Tuberculosis Program at Baylor College of Medicine, department of pediatrics, Houston, said the shorter regimen should enable more children to successfully complete TB treatment.

“It can be challenging to convince young children to take medications on a regular basis for 6 months,” Dr. Mandalakas, a member of a WHO guidelines development group that reviewed the study, told this news organization. “Despite best intentions, parents often become fatigued and give up the medicine battle.”

Leo Martinez, PhD, an epidemiologist at Boston University School of Public Health who studies pediatric TB, noted that study’s cost-effectiveness analysis applies only to health care costs. Families often suffer financially through lost wages, transportation to health care facilities, and lost employment, fueling a cycle of poverty and disease in low-income countries, he said.

A WHO statement noted that long treatment regimens can add toxicity and risk of drug interactions for children with HIV.

Separate efforts have been underway to hasten TB treatment in different groups of patients. A study published in NEJM showed that 4 months of the potent antibiotic rifapentine, along with another antibiotic, moxifloxacin, was non-inferior to the standard 6-month regimen in patients aged 12 and older. According to the editorial accompanying that study, the research illustrated the potential for shorter treatment courses that would be cheaper and less cumbersome, although that particular combination poses hurdles such as adherence issues and potential bacterial resistance.

Experts agreed that improved diagnostic procedures are critical to significantly reducing TB pediatric deaths – an issue that Dr. Turkova said will be addressed in WHO’s forthcoming handbook.

Because no gold-standard test exists for TB, and symptoms often overlap with other infections, widespread screening of children in households where adults have been diagnosed with TB has been found to improve detection of the disease. “Training of health care workers, easy-to-implement diagnostic algorithms, and widely accessible training materials on chest radiography in childhood TB should also improve case finding and treatment initiation,” she said.

The trial was supported by U.K. government and charitable research funders. Dr. Turkova and Dr. Martinez reported no financial disclosures. Dr. Mandalakas reported honoraria from WHO to support the preparation of diagnostics and treatment chapters in the operational handbook, for providing lectures for Medscape, and for serving on a data safety monitoring board for Janssen Pharmaceuticals.

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

The Food and Drug Administration has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease, the manufacturer has announced.

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.

Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.

“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.

The FDA approved Adlarity through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

The company expects the donepezil transdermal patch to be available in early Fall 2022.

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

The Food and Drug Administration has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease, the manufacturer has announced.

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.

Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.

“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.

The FDA approved Adlarity through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

The company expects the donepezil transdermal patch to be available in early Fall 2022.

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

The Food and Drug Administration has approved donepezil transdermal system (Adlarity) for patients with mild, moderate, or severe Alzheimer’s disease, the manufacturer has announced.

Adlarity is the first and only once-weekly patch to continuously deliver consistent doses of the acetylcholinesterase inhibitor through the skin, bypassing the digestive system and resulting in low likelihood of gastrointestinal side effects associated with oral donepezil, the company said in a press release.

Each patch delivers either 5 mg or 10 mg of donepezil daily for 7 days. After that, it is removed and a new patch is applied.

“The availability of a once-weekly patch formulation of donepezil has the potential to substantially benefit patients, caregivers, and health care providers,” Pierre Tariot, MD, director of the Banner Alzheimer’s Institute, Phoenix, said in the release.

“It offers effective, well-tolerated, and stable dosing for 7 days for patients who cannot take daily oral donepezil reliably because of impaired memory. It can also offer benefits for those patients who have diminished ability to swallow or have GI side effects associated with ingestion of oral donepezil,” Dr. Tariot added.

The FDA approved Adlarity through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.

The company expects the donepezil transdermal patch to be available in early Fall 2022.

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

Why are teenage boys obsessed with bulking up?

While the effects of Instagram on girls’ body image has long been documented – an article in The Wall Street Journal that was published this fall reported that Facebook knew Instagram was toxic for teen girls – teenage boys are under just as much pressure.

For adolescent boys, the goal is often to get superhero-size buff – and this is leading to anxiety, stress, excessive selfies, and, often, obsessive staring in the mirror to assess their “pec” progress.

So-called “bigorexia” – or extreme gym time, excessive focus on protein diets, and intense muscle-building goals – has hit new and concerning levels, according to a recent New York Times report.

Whether it’s the pandemic or TikTok that’s to blame, teen boys are pushing hard to achieve six-pack abs, with one-third of them in the U.S. trying to bulk up, according to a study published in the Journal of Adolescent Health. What’s more, 22% reported they’re engaging in muscle-enhancing behavior, including excess exercise, taking supplements or steroids, or eating more to bulk up, according to a study published in the International Journal of Eating Disorders.

“The pandemic and social media have been a perfect storm for eating disorders and body image issues for all teens, but this has been under-recognized in boys,” says Jason Nagata, MD, a pediatrician who specializes in adolescent medicine at the University of California, San Francisco. “Both are directly connected to an increase in muscle dysmorphia.”

While “bigorexia” is a newer term coined by mental health professionals, the concept of muscular dysmorphia isn’t, says Jennifer Bahrman, PhD, a licensed psychologist with McGovern Medical School at UTHealth Houston. This may be why about a third of boys ages 11-18 reported that they aren’t enamored with their bodies, according to a small survey published in 2019 in the Californian Journal of Health Promotion.

“When we think of dysmorphia, we think of girls having it, since we see it more in females,” says Dr. Bahrman, who works extensively with adolescents and athletes. “The interesting thing about muscular dysmorphia is that it’s the only body dysmorphic disorder that’s almost exclusively present in males.”
 

Social media’s role

Unlike other things in boys’ lives, like movies, TV, or even the uber-buff GI Joe doll, social media has created opportunities for young men to put their bodies on display – and become an influencer or get followers because of it.

“An everyday teen can become a celebrity,” Dr. Nagata says. “Then, thanks to social media algorithms, if a teenage boy likes or interacts with a post that features a muscular guy or is all about fitness, they’ll start getting all sorts of related content. They’ll get bombarded with tons of ads for protein shakes, for example, as well as bodybuilding equipment, and that will further distort reality.”

Before-and-after photos are also known to be quite misleading.

“Some of the most popular Instagram posts among teens feature people who have experienced a massive body transformation,” Dr. Nagata says. “It’s usually someone who lost a lot of weight or someone who was scrawny and then got muscular. The most drastic changes tend to get the most likes and are perpetuated the most and shared the most often with friends.”

But as many are aware, photos posted to social media are selected to tell the best story – with the best filters, lighting, and angles possible, however exaggerated.

“A guy will post his worst picture out of a thousand for his before shot and then post the best photo out of a thousand,” Dr. Nagata says. “This, in itself, can really confuse a teenager, because the story of this person’s changed body looks so realistic.”

Worse, these images tend to be damaging to your teenager’s self-esteem.

“When you see images of people you’re aspiring to look like, it can be very upsetting,” Dr. Bahrman says. “After all, it’s easy to think, ‘I’m doing all of these pushups, and I don’t look like this.’ From there, it’s easy to begin internalizing that something is wrong with you.”
 

Red flags to watch out for

If you’ve noticed that your son is obsessed with his appearance, weight, food, or exercise, take note. Also, notice if he’s asking you to buy protein powder or is spending more time at the gym than with his friends.

“Pay attention if he is withdrawing from friends and family because of his concerns about his appearance,” Dr. Nagata says. “For example, we often hear that a teenager will no longer eat family meals or at a restaurant because the protein content isn’t high enough or the food is too fatty.”

If you’re concerned, always make sure to discuss this with your son’s pediatrician.

“Ultimately, you want to make sure you share your concerns before your teen son becomes even more body-image obsessed,” Dr. Nagata says.

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

Why are teenage boys obsessed with bulking up?

While the effects of Instagram on girls’ body image has long been documented – an article in The Wall Street Journal that was published this fall reported that Facebook knew Instagram was toxic for teen girls – teenage boys are under just as much pressure.

For adolescent boys, the goal is often to get superhero-size buff – and this is leading to anxiety, stress, excessive selfies, and, often, obsessive staring in the mirror to assess their “pec” progress.

So-called “bigorexia” – or extreme gym time, excessive focus on protein diets, and intense muscle-building goals – has hit new and concerning levels, according to a recent New York Times report.

Whether it’s the pandemic or TikTok that’s to blame, teen boys are pushing hard to achieve six-pack abs, with one-third of them in the U.S. trying to bulk up, according to a study published in the Journal of Adolescent Health. What’s more, 22% reported they’re engaging in muscle-enhancing behavior, including excess exercise, taking supplements or steroids, or eating more to bulk up, according to a study published in the International Journal of Eating Disorders.

“The pandemic and social media have been a perfect storm for eating disorders and body image issues for all teens, but this has been under-recognized in boys,” says Jason Nagata, MD, a pediatrician who specializes in adolescent medicine at the University of California, San Francisco. “Both are directly connected to an increase in muscle dysmorphia.”

While “bigorexia” is a newer term coined by mental health professionals, the concept of muscular dysmorphia isn’t, says Jennifer Bahrman, PhD, a licensed psychologist with McGovern Medical School at UTHealth Houston. This may be why about a third of boys ages 11-18 reported that they aren’t enamored with their bodies, according to a small survey published in 2019 in the Californian Journal of Health Promotion.

“When we think of dysmorphia, we think of girls having it, since we see it more in females,” says Dr. Bahrman, who works extensively with adolescents and athletes. “The interesting thing about muscular dysmorphia is that it’s the only body dysmorphic disorder that’s almost exclusively present in males.”
 

Social media’s role

Unlike other things in boys’ lives, like movies, TV, or even the uber-buff GI Joe doll, social media has created opportunities for young men to put their bodies on display – and become an influencer or get followers because of it.

“An everyday teen can become a celebrity,” Dr. Nagata says. “Then, thanks to social media algorithms, if a teenage boy likes or interacts with a post that features a muscular guy or is all about fitness, they’ll start getting all sorts of related content. They’ll get bombarded with tons of ads for protein shakes, for example, as well as bodybuilding equipment, and that will further distort reality.”

Before-and-after photos are also known to be quite misleading.

“Some of the most popular Instagram posts among teens feature people who have experienced a massive body transformation,” Dr. Nagata says. “It’s usually someone who lost a lot of weight or someone who was scrawny and then got muscular. The most drastic changes tend to get the most likes and are perpetuated the most and shared the most often with friends.”

But as many are aware, photos posted to social media are selected to tell the best story – with the best filters, lighting, and angles possible, however exaggerated.

“A guy will post his worst picture out of a thousand for his before shot and then post the best photo out of a thousand,” Dr. Nagata says. “This, in itself, can really confuse a teenager, because the story of this person’s changed body looks so realistic.”

Worse, these images tend to be damaging to your teenager’s self-esteem.

“When you see images of people you’re aspiring to look like, it can be very upsetting,” Dr. Bahrman says. “After all, it’s easy to think, ‘I’m doing all of these pushups, and I don’t look like this.’ From there, it’s easy to begin internalizing that something is wrong with you.”
 

Red flags to watch out for

If you’ve noticed that your son is obsessed with his appearance, weight, food, or exercise, take note. Also, notice if he’s asking you to buy protein powder or is spending more time at the gym than with his friends.

“Pay attention if he is withdrawing from friends and family because of his concerns about his appearance,” Dr. Nagata says. “For example, we often hear that a teenager will no longer eat family meals or at a restaurant because the protein content isn’t high enough or the food is too fatty.”

If you’re concerned, always make sure to discuss this with your son’s pediatrician.

“Ultimately, you want to make sure you share your concerns before your teen son becomes even more body-image obsessed,” Dr. Nagata says.

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

Why are teenage boys obsessed with bulking up?

While the effects of Instagram on girls’ body image has long been documented – an article in The Wall Street Journal that was published this fall reported that Facebook knew Instagram was toxic for teen girls – teenage boys are under just as much pressure.

For adolescent boys, the goal is often to get superhero-size buff – and this is leading to anxiety, stress, excessive selfies, and, often, obsessive staring in the mirror to assess their “pec” progress.

So-called “bigorexia” – or extreme gym time, excessive focus on protein diets, and intense muscle-building goals – has hit new and concerning levels, according to a recent New York Times report.

Whether it’s the pandemic or TikTok that’s to blame, teen boys are pushing hard to achieve six-pack abs, with one-third of them in the U.S. trying to bulk up, according to a study published in the Journal of Adolescent Health. What’s more, 22% reported they’re engaging in muscle-enhancing behavior, including excess exercise, taking supplements or steroids, or eating more to bulk up, according to a study published in the International Journal of Eating Disorders.

“The pandemic and social media have been a perfect storm for eating disorders and body image issues for all teens, but this has been under-recognized in boys,” says Jason Nagata, MD, a pediatrician who specializes in adolescent medicine at the University of California, San Francisco. “Both are directly connected to an increase in muscle dysmorphia.”

While “bigorexia” is a newer term coined by mental health professionals, the concept of muscular dysmorphia isn’t, says Jennifer Bahrman, PhD, a licensed psychologist with McGovern Medical School at UTHealth Houston. This may be why about a third of boys ages 11-18 reported that they aren’t enamored with their bodies, according to a small survey published in 2019 in the Californian Journal of Health Promotion.

“When we think of dysmorphia, we think of girls having it, since we see it more in females,” says Dr. Bahrman, who works extensively with adolescents and athletes. “The interesting thing about muscular dysmorphia is that it’s the only body dysmorphic disorder that’s almost exclusively present in males.”
 

Social media’s role

Unlike other things in boys’ lives, like movies, TV, or even the uber-buff GI Joe doll, social media has created opportunities for young men to put their bodies on display – and become an influencer or get followers because of it.

“An everyday teen can become a celebrity,” Dr. Nagata says. “Then, thanks to social media algorithms, if a teenage boy likes or interacts with a post that features a muscular guy or is all about fitness, they’ll start getting all sorts of related content. They’ll get bombarded with tons of ads for protein shakes, for example, as well as bodybuilding equipment, and that will further distort reality.”

Before-and-after photos are also known to be quite misleading.

“Some of the most popular Instagram posts among teens feature people who have experienced a massive body transformation,” Dr. Nagata says. “It’s usually someone who lost a lot of weight or someone who was scrawny and then got muscular. The most drastic changes tend to get the most likes and are perpetuated the most and shared the most often with friends.”

But as many are aware, photos posted to social media are selected to tell the best story – with the best filters, lighting, and angles possible, however exaggerated.

“A guy will post his worst picture out of a thousand for his before shot and then post the best photo out of a thousand,” Dr. Nagata says. “This, in itself, can really confuse a teenager, because the story of this person’s changed body looks so realistic.”

Worse, these images tend to be damaging to your teenager’s self-esteem.

“When you see images of people you’re aspiring to look like, it can be very upsetting,” Dr. Bahrman says. “After all, it’s easy to think, ‘I’m doing all of these pushups, and I don’t look like this.’ From there, it’s easy to begin internalizing that something is wrong with you.”
 

Red flags to watch out for

If you’ve noticed that your son is obsessed with his appearance, weight, food, or exercise, take note. Also, notice if he’s asking you to buy protein powder or is spending more time at the gym than with his friends.

“Pay attention if he is withdrawing from friends and family because of his concerns about his appearance,” Dr. Nagata says. “For example, we often hear that a teenager will no longer eat family meals or at a restaurant because the protein content isn’t high enough or the food is too fatty.”

If you’re concerned, always make sure to discuss this with your son’s pediatrician.

“Ultimately, you want to make sure you share your concerns before your teen son becomes even more body-image obsessed,” Dr. Nagata says.

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