A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

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

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

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

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

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

The use of preimplantation genetic tests (PGT) in in vitro fertilization cycles, including tests for nonmedical sex selection, increased significantly in states without mandated insurance coverage, based on data from a study of 300,000 IVF cycles.

Previous studies have shown associations between IVF insurance coverage and various IVF practice patterns, but trends in genetic testing according to state-mandated insurance have not been explored, Bronwyn S. Bedrick, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.

“Preimplantation genetic testing was introduced into clinical practice to prevent transmission of genetic disease and to improve uptake of single embryo transfer, but in the real world there are many potential applications,” corresponding author Emily Jungheim, MD, of Northwestern University, Chicago, said in an interview. “We wanted to know how PGT is being applied given that its use is on the rise.”

In a study published in Obstetrics & Gynecology, the researchers analyzed genetic testing in deidentified autologous, nonbanking IVF cycles from 2014 to 2016 obtained through the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS). The data set included 301,465 IVF cycles and 224,235 unique patients over the 3-year study period. Of these, 78,578 cycles (26%) used PGT, and overall, the proportion of IVF cycles using PGT approximately doubled, from 17% in 2014 to 34% in 2016 – a significant increase over time (risk ratio, 1.37). As of 2021, 13 states had mandates that health insurance include IVF costs.

In states with insurance mandates versus nonmandated states, the proportion of any PGT was 28.8% vs. 19.6%, and the probability was 32% lower in states with mandates (RR. 0.68; P < .001).

Aneuploidy was the most common indication for PGT, and accounted for 60% of the cycles; however, the number of cycles using PGT for elective sex selection increased from 1,314 cycles in 2014 to 2,184 in 2016 (approximately 66% increase).

In a multivariate analysis, IVF cycles for elective sex selection was 56% lower in states with mandates, compared with those without (RR, 0.44; P < .001).

In addition, cycles involving nonmedical sex selection were significantly more likely to result in male offspring, the researchers said.

“The increase in the number of cycles using elective sex selection seen in this study may reflect the growing number of clinics offering [PGT] for nonmedical sex selection as well as increasing public awareness of preimplantation genetic testing,” the researchers wrote.

However, the socioeconomic characteristics of women may play a role in the use of PGT, as those living in states with no mandate must be able pay the cost of IVF procedures, as well as the cost of PGT if desired, they noted.

“Because fertility centers may offer patients the choice to select the sex of their embryo after preimplantation genetic testing, this may in effect permit elective sex selection,” the researchers said. The shift in the male-female sex ratio in these cases “is concerning given the implications for future social demographics as IVF and preimplantation genetic testing utilization increase, and the negative effect outcomes could have on medical insurance policy and allocation of resources for medically indicated IVF and preimplantation genetic testing.”

The study findings were limited by several factors including the lack of clinic identifiers and lack of data characteristics including, race, ethnicity, and previous live births, the researchers noted. Other limitations included a lack of data on the sex preferences of the couple, and whether the sex of the embryo was known, and whether male and female embryos were transferred. Also, no states have mandates to cover PGT, and the limited study period may not generalize to current practices.

However, the study strengths include the large size and comprehensive database, and have implications for future policies and expansion of insurance coverage for infertility treatment and for preventing transmission of genetic diseases, they said.
 

Be mindful of consequences of testing

In an interview, Dr. Jungheim said she was surprised by some of the findings. “I thought we would see that PGT-A utilization was lower in states without mandates given the already high cost of IVF for patients paying out of pocket. I was also surprised to see that more males were born after PGT-A; it suggests that overall, patients using PGT-A favor males.

“For clinicians, we need to be mindful of the long-term impact of our practices,” she emphasized. “Shifting the sex ratio in favor of one sex or the other is an unintended consequence of IVF with PGT-A that can have negative implications for future generations.”

In the study, the researchers proposed a revision to the American Society for Reproductive Medicine Ethics Committee opinion on sex selection to provide guidance in keeping with ASRM’s mission of “accessible, ethical, and quality reproductive care for every person.”

However, “even if the ASRM Ethics Committee Opinion was revised, it’s up to clinicians to decide what they are comfortable with,” said Dr. Jungheim. “When patients are paying out of pocket for expensive treatments that require emotional investment and time, it can be difficult to keep medical decision making strictly evidence based.” Improved insurance coverage and access to fertility care may help with some of these decisions, but more real-world evidence is needed. 
 

Let’s talk about sex (selection)

The study findings are both “novel and sobering,” and enhance the current body of evidence of associations between state insurance mandates and IVF outcomes, Jennifer Eaton, MD, of Brown University, Providence, R.I., wrote in an accompanying editorial.

“The association between mandate status and elective sex selection is particularly eye-opening,” said Dr. Eaton. The overall increased use of PGT for sex selection does not account for sex selection as part of testing for aneuploidy. In fact, “patients with euploid embryos of both sexes are frequently given the opportunity to select which embryo to transfer.”

The current study provides “compelling evidence that it is time to revisit the ethical dilemma of elective sex selection in the United States,” Dr. Eaton emphasized. The current ASRM guidance states that IVF clinics are not obligated to provide or refuse to provide nonmedically indicated methods of sex selection, but in light of the current study and other studies, a revision to the existing ASRM Ethics Committee opinion is needed.

The study received no outside funding. Neither the researchers nor Dr. Eaton had any financial conflicts to disclose.

The use of preimplantation genetic tests (PGT) in in vitro fertilization cycles, including tests for nonmedical sex selection, increased significantly in states without mandated insurance coverage, based on data from a study of 300,000 IVF cycles.

Previous studies have shown associations between IVF insurance coverage and various IVF practice patterns, but trends in genetic testing according to state-mandated insurance have not been explored, Bronwyn S. Bedrick, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.

“Preimplantation genetic testing was introduced into clinical practice to prevent transmission of genetic disease and to improve uptake of single embryo transfer, but in the real world there are many potential applications,” corresponding author Emily Jungheim, MD, of Northwestern University, Chicago, said in an interview. “We wanted to know how PGT is being applied given that its use is on the rise.”

In a study published in Obstetrics & Gynecology, the researchers analyzed genetic testing in deidentified autologous, nonbanking IVF cycles from 2014 to 2016 obtained through the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS). The data set included 301,465 IVF cycles and 224,235 unique patients over the 3-year study period. Of these, 78,578 cycles (26%) used PGT, and overall, the proportion of IVF cycles using PGT approximately doubled, from 17% in 2014 to 34% in 2016 – a significant increase over time (risk ratio, 1.37). As of 2021, 13 states had mandates that health insurance include IVF costs.

In states with insurance mandates versus nonmandated states, the proportion of any PGT was 28.8% vs. 19.6%, and the probability was 32% lower in states with mandates (RR. 0.68; P < .001).

Aneuploidy was the most common indication for PGT, and accounted for 60% of the cycles; however, the number of cycles using PGT for elective sex selection increased from 1,314 cycles in 2014 to 2,184 in 2016 (approximately 66% increase).

In a multivariate analysis, IVF cycles for elective sex selection was 56% lower in states with mandates, compared with those without (RR, 0.44; P < .001).

In addition, cycles involving nonmedical sex selection were significantly more likely to result in male offspring, the researchers said.

“The increase in the number of cycles using elective sex selection seen in this study may reflect the growing number of clinics offering [PGT] for nonmedical sex selection as well as increasing public awareness of preimplantation genetic testing,” the researchers wrote.

However, the socioeconomic characteristics of women may play a role in the use of PGT, as those living in states with no mandate must be able pay the cost of IVF procedures, as well as the cost of PGT if desired, they noted.

“Because fertility centers may offer patients the choice to select the sex of their embryo after preimplantation genetic testing, this may in effect permit elective sex selection,” the researchers said. The shift in the male-female sex ratio in these cases “is concerning given the implications for future social demographics as IVF and preimplantation genetic testing utilization increase, and the negative effect outcomes could have on medical insurance policy and allocation of resources for medically indicated IVF and preimplantation genetic testing.”

The study findings were limited by several factors including the lack of clinic identifiers and lack of data characteristics including, race, ethnicity, and previous live births, the researchers noted. Other limitations included a lack of data on the sex preferences of the couple, and whether the sex of the embryo was known, and whether male and female embryos were transferred. Also, no states have mandates to cover PGT, and the limited study period may not generalize to current practices.

However, the study strengths include the large size and comprehensive database, and have implications for future policies and expansion of insurance coverage for infertility treatment and for preventing transmission of genetic diseases, they said.
 

Be mindful of consequences of testing

In an interview, Dr. Jungheim said she was surprised by some of the findings. “I thought we would see that PGT-A utilization was lower in states without mandates given the already high cost of IVF for patients paying out of pocket. I was also surprised to see that more males were born after PGT-A; it suggests that overall, patients using PGT-A favor males.

“For clinicians, we need to be mindful of the long-term impact of our practices,” she emphasized. “Shifting the sex ratio in favor of one sex or the other is an unintended consequence of IVF with PGT-A that can have negative implications for future generations.”

In the study, the researchers proposed a revision to the American Society for Reproductive Medicine Ethics Committee opinion on sex selection to provide guidance in keeping with ASRM’s mission of “accessible, ethical, and quality reproductive care for every person.”

However, “even if the ASRM Ethics Committee Opinion was revised, it’s up to clinicians to decide what they are comfortable with,” said Dr. Jungheim. “When patients are paying out of pocket for expensive treatments that require emotional investment and time, it can be difficult to keep medical decision making strictly evidence based.” Improved insurance coverage and access to fertility care may help with some of these decisions, but more real-world evidence is needed. 
 

Let’s talk about sex (selection)

The study findings are both “novel and sobering,” and enhance the current body of evidence of associations between state insurance mandates and IVF outcomes, Jennifer Eaton, MD, of Brown University, Providence, R.I., wrote in an accompanying editorial.

“The association between mandate status and elective sex selection is particularly eye-opening,” said Dr. Eaton. The overall increased use of PGT for sex selection does not account for sex selection as part of testing for aneuploidy. In fact, “patients with euploid embryos of both sexes are frequently given the opportunity to select which embryo to transfer.”

The current study provides “compelling evidence that it is time to revisit the ethical dilemma of elective sex selection in the United States,” Dr. Eaton emphasized. The current ASRM guidance states that IVF clinics are not obligated to provide or refuse to provide nonmedically indicated methods of sex selection, but in light of the current study and other studies, a revision to the existing ASRM Ethics Committee opinion is needed.

The study received no outside funding. Neither the researchers nor Dr. Eaton had any financial conflicts to disclose.

The use of preimplantation genetic tests (PGT) in in vitro fertilization cycles, including tests for nonmedical sex selection, increased significantly in states without mandated insurance coverage, based on data from a study of 300,000 IVF cycles.

Previous studies have shown associations between IVF insurance coverage and various IVF practice patterns, but trends in genetic testing according to state-mandated insurance have not been explored, Bronwyn S. Bedrick, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.

“Preimplantation genetic testing was introduced into clinical practice to prevent transmission of genetic disease and to improve uptake of single embryo transfer, but in the real world there are many potential applications,” corresponding author Emily Jungheim, MD, of Northwestern University, Chicago, said in an interview. “We wanted to know how PGT is being applied given that its use is on the rise.”

In a study published in Obstetrics & Gynecology, the researchers analyzed genetic testing in deidentified autologous, nonbanking IVF cycles from 2014 to 2016 obtained through the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS). The data set included 301,465 IVF cycles and 224,235 unique patients over the 3-year study period. Of these, 78,578 cycles (26%) used PGT, and overall, the proportion of IVF cycles using PGT approximately doubled, from 17% in 2014 to 34% in 2016 – a significant increase over time (risk ratio, 1.37). As of 2021, 13 states had mandates that health insurance include IVF costs.

In states with insurance mandates versus nonmandated states, the proportion of any PGT was 28.8% vs. 19.6%, and the probability was 32% lower in states with mandates (RR. 0.68; P < .001).

Aneuploidy was the most common indication for PGT, and accounted for 60% of the cycles; however, the number of cycles using PGT for elective sex selection increased from 1,314 cycles in 2014 to 2,184 in 2016 (approximately 66% increase).

In a multivariate analysis, IVF cycles for elective sex selection was 56% lower in states with mandates, compared with those without (RR, 0.44; P < .001).

In addition, cycles involving nonmedical sex selection were significantly more likely to result in male offspring, the researchers said.

“The increase in the number of cycles using elective sex selection seen in this study may reflect the growing number of clinics offering [PGT] for nonmedical sex selection as well as increasing public awareness of preimplantation genetic testing,” the researchers wrote.

However, the socioeconomic characteristics of women may play a role in the use of PGT, as those living in states with no mandate must be able pay the cost of IVF procedures, as well as the cost of PGT if desired, they noted.

“Because fertility centers may offer patients the choice to select the sex of their embryo after preimplantation genetic testing, this may in effect permit elective sex selection,” the researchers said. The shift in the male-female sex ratio in these cases “is concerning given the implications for future social demographics as IVF and preimplantation genetic testing utilization increase, and the negative effect outcomes could have on medical insurance policy and allocation of resources for medically indicated IVF and preimplantation genetic testing.”

The study findings were limited by several factors including the lack of clinic identifiers and lack of data characteristics including, race, ethnicity, and previous live births, the researchers noted. Other limitations included a lack of data on the sex preferences of the couple, and whether the sex of the embryo was known, and whether male and female embryos were transferred. Also, no states have mandates to cover PGT, and the limited study period may not generalize to current practices.

However, the study strengths include the large size and comprehensive database, and have implications for future policies and expansion of insurance coverage for infertility treatment and for preventing transmission of genetic diseases, they said.
 

Be mindful of consequences of testing

In an interview, Dr. Jungheim said she was surprised by some of the findings. “I thought we would see that PGT-A utilization was lower in states without mandates given the already high cost of IVF for patients paying out of pocket. I was also surprised to see that more males were born after PGT-A; it suggests that overall, patients using PGT-A favor males.

“For clinicians, we need to be mindful of the long-term impact of our practices,” she emphasized. “Shifting the sex ratio in favor of one sex or the other is an unintended consequence of IVF with PGT-A that can have negative implications for future generations.”

In the study, the researchers proposed a revision to the American Society for Reproductive Medicine Ethics Committee opinion on sex selection to provide guidance in keeping with ASRM’s mission of “accessible, ethical, and quality reproductive care for every person.”

However, “even if the ASRM Ethics Committee Opinion was revised, it’s up to clinicians to decide what they are comfortable with,” said Dr. Jungheim. “When patients are paying out of pocket for expensive treatments that require emotional investment and time, it can be difficult to keep medical decision making strictly evidence based.” Improved insurance coverage and access to fertility care may help with some of these decisions, but more real-world evidence is needed. 
 

Let’s talk about sex (selection)

The study findings are both “novel and sobering,” and enhance the current body of evidence of associations between state insurance mandates and IVF outcomes, Jennifer Eaton, MD, of Brown University, Providence, R.I., wrote in an accompanying editorial.

“The association between mandate status and elective sex selection is particularly eye-opening,” said Dr. Eaton. The overall increased use of PGT for sex selection does not account for sex selection as part of testing for aneuploidy. In fact, “patients with euploid embryos of both sexes are frequently given the opportunity to select which embryo to transfer.”

The current study provides “compelling evidence that it is time to revisit the ethical dilemma of elective sex selection in the United States,” Dr. Eaton emphasized. The current ASRM guidance states that IVF clinics are not obligated to provide or refuse to provide nonmedically indicated methods of sex selection, but in light of the current study and other studies, a revision to the existing ASRM Ethics Committee opinion is needed.

The study received no outside funding. Neither the researchers nor Dr. Eaton had any financial conflicts to disclose.

Psychiatry may be emerging from the era of psychopharmacology and entering the era of the brain, but these reductionist, jingoistic labels do little justice to the need to acknowledge and incorporate the context of our lives into our theories and treatments. Yet psychiatrists who embrace context have much to celebrate in evolving neuroscience research.

One aptly named article – ’Families that fire together smile together’ – illustrates the fundamental connection between parent and child.¹ In the functional MRIs (fMRIs) taken of these parent-child dyads (n = 76), the dyads with similar resting state connectomes also have similar day-to-day emotional states, as reflected in their diary entries. Their empathic states were identified in the multivoxel patterns in the fusiform face area of the brain.² Another study of fMRIs and parent-child dyads (n = 93) found that the parental functional connectomes (fbc) predicted their children’s externalizing and internalizing problems. The maternal fbcs were correlated with the daughter-mother relationship, and to the daughter’s internalizing problems, suggesting a potential future focus on gendered relationships.³

The implications for psychotherapy are clear: These studies show that empathic connection between parent and child results in a better outcome for the child. Patient and psychotherapist can choose from a range of psychotherapeutic interventions that promote empathy, from providing behavioral tasks that support connection between parent and child to more in-depth family interventions. Family interventions that promote empathy include increasing the family’s understanding of the importance of empathic connection and providing a safe space to help establish empathic connection.

Studying prosocial behavior, Lukas Lengersdorff and colleagues found that fMRIs of male participants (n = 96) reflected stronger activity when they were acting on behalf of the other, rather than when acting for themselves.⁴ During this prosocial learning fMRI study, there was stronger engagement of the ventromedial prefrontal cortex (PFC) and higher connectivity between the ventromedial PFC and the right temporoparietal junction (rTPJ). Protecting others from harm appears to be associated with neural mechanisms that support self-relevant learning, but with the added recruitment of structures associated with the social brain. This study shows what we already know – that our brains are wired for social context. This research supports psychotherapeutic interventions aimed at creating interpersonal connection, not just at an intimate level, but also at the prosocial level, such as caring and helping others.

When social interactions are coded, the default mode network (DMN) shows increased activity. Participants (n = 11) in another study had heightened medial PFC–rTPJ connectivity, not only during rest that followed the experimental social encoding, but also during rest that followed a subsequent, nonsocial task.⁵ Engaging portions of the DMN during live social interactions when actively decoding the social environment, and later engaging these regions when relaxing after the social interaction, appears to facilitate social functioning. Our brains are wired to respond to context. This research underscores the positive impact of interventions such as group therapy and support groups, two underutilized modalities.

Neuroscience evaluation of our relationships provides depth to studies that fall under the medical paradigm of the gene/environment interaction. One of the most elegant in psychiatry is the Finnish study of a sample of offspring of mothers with schizophrenia who gave their children up for adoption.⁶ This sample of index offspring (n = 155) was compared blindly with matched controls (n = 186) of adopted/away offspring of parents without schizophrenia. The genetic effect manifested only as a psychiatric disorder in the presence of a disturbed family environment. We can now extrapolate certain possible mechanisms from the studies mentioned above: That the deficits lie in the activity or lack of activity in the DMN and associated areas, and in the generation of connectomes responsible for empathic connections.

Neuroscience expands our knowledge of our relational and social worlds, but can psychiatry make the case for inclusion of context in our conceptualization of psychiatric distress? From time to time, inroads are made, for example, the Global Assessment of Relational Functioning was incorporated into the DSM-IV-R and the Cultural Formulation Interview is in the DSM-5. However, without a sustained paradigm shift that places the gene/environment paradigm at the core of psychiatry, these efforts will rise and fall as the pioneers in these fields rise and fall.

A major barrier to moving the gene/environment paradigm more centrally in psychiatry is the prominence of individualism as an American ideal. As the neuroscience of context develops, we will be able to argue more robustly for a contextual approach to patient care.

A second barrier is the difficulty of teaching and learning about complexity. It is easy to learn how to use the DSM to make a diagnosis, to understand when and how to prescribe medications, but it is much more difficult to understand how to incorporate the complexity of life and the context within which we live, into our lexicon of psychiatric theories and treatments. As Tanya Luhrmann, PhD, points out in her study of the process of psychiatric training, residents are intimidated by the need to learn the many psychological theories and their practice; learning about medications is much simpler and takes much less time and effort.⁷

Nevertheless, context is embraced by several psychiatric subspecialties. Family psychiatrists recognize the power of relational dynamics in the family, and their role in shaping the individual. From understanding family communication patterns, to understanding how roles in the family get allocated, family psychiatry has well established tools for assessment and many evidence-based treatments that focus on changing relational dynamics. Social and community psychiatrists emphasize the role of race, poverty, and access, and support the assessment and treatment of the underprivileged. Cultural psychiatrists recognize that each culture has its own way of constructing identities and shaping our experiences, its own conceptualization of illness and specific idioms of distress. Cultural psychiatrists focus on sensitizing the general psychiatrist to these nuances. Child psychiatrists involve parents, and geriatric psychiatrists involve guardians. General psychiatrists understand context when, for example, understanding the role of trauma in the development of an individual, recognizing that its impact is contingent on the context within which the trauma occurs.

Neuroscience clarifies the neural pathways involved in the development of empathic and social behaviors. Our psychological theories and practice must reflect this advancement. We can teach the relevant neuroscience along with basic concepts such as child-parent relationships. We must assess an individual’s degree of fit within their family and community. Apart from asking relational questions, such as who in your world is important to you, we can use well recognized tools to help us bring context to the forefront. An easy tool is the three generational genogram, or an ecomap, which allows each individual to see where they sit in the context of their world.⁸ Cultural influences, societal, religious, and family influences can be drawn on the genogram, highlighting both formal and hidden family narratives. In addition, we can share how the brain works with our patients; the science of empathy and social behaviors shows us that our need for interpersonal connection is hardwired.

Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].

References

1. Lee TH et al. Families that fire together smile together: Resting state connectome similarity and daily emotional synchrony in parent-child dyads. Neuroimage. 2017 May 15;152:31-37. doi: 10.1016/j.neuroimage.2017.02.078.

2. Lee TH et al. Love flows downstream: Mothers’ and children’s neural representation similarity in perceiving distress of self and family. Soc Cogn Affect Neurosci. 2017 Dec 1;12(12):1916-27. doi: 10.1093/scan/nsx125.

3. Itahashi T et al. Functional connectomes linking child-parent relationships with psychological problems in adolescence. Neuroimage. 2020 Oct 1;219:117013. doi: 10.1016/j.neuroimage.2020.117013.

4. Lengersdorff LL et al. When implicit prosociality trumps selfishness: The neural valuation system underpins more optimal choices when learning to avoid harm to others than to oneself. J Neurosci. 2020 Sep 16;40(38):7286-99. doi: 10.1523/JNEUROSCI.0842-20.2020.

5. Meyer ML et al. Evidence that default network connectivity during rest consolidates social information. Cereb Cortex. 2019 May 1;29(5):1910-20. doi: 10.1093/cercor/bhy071.

6. Tienari P et al. The Finnish adoptive family study of schizophrenia. Implications for family research. Br J Psychiatry Suppl. 1994 Apr;(23):20-6.

7. Luhrmann, TM. Of two minds: The growing disorder in American psychiatry. New York, NY: Alfred A. Knopf, 2000.

8. Libbon R et al. Family skills for the resident toolbox: The 10-min. Genogram, Ecomap, and Prescribing Homework. Acad Psychiatry. 2019 Aug;43(4):435-439. doi: 10.1007/s40596-019-01054-6.

Psychiatry may be emerging from the era of psychopharmacology and entering the era of the brain, but these reductionist, jingoistic labels do little justice to the need to acknowledge and incorporate the context of our lives into our theories and treatments. Yet psychiatrists who embrace context have much to celebrate in evolving neuroscience research.

One aptly named article – ’Families that fire together smile together’ – illustrates the fundamental connection between parent and child.¹ In the functional MRIs (fMRIs) taken of these parent-child dyads (n = 76), the dyads with similar resting state connectomes also have similar day-to-day emotional states, as reflected in their diary entries. Their empathic states were identified in the multivoxel patterns in the fusiform face area of the brain.² Another study of fMRIs and parent-child dyads (n = 93) found that the parental functional connectomes (fbc) predicted their children’s externalizing and internalizing problems. The maternal fbcs were correlated with the daughter-mother relationship, and to the daughter’s internalizing problems, suggesting a potential future focus on gendered relationships.³

The implications for psychotherapy are clear: These studies show that empathic connection between parent and child results in a better outcome for the child. Patient and psychotherapist can choose from a range of psychotherapeutic interventions that promote empathy, from providing behavioral tasks that support connection between parent and child to more in-depth family interventions. Family interventions that promote empathy include increasing the family’s understanding of the importance of empathic connection and providing a safe space to help establish empathic connection.

Studying prosocial behavior, Lukas Lengersdorff and colleagues found that fMRIs of male participants (n = 96) reflected stronger activity when they were acting on behalf of the other, rather than when acting for themselves.⁴ During this prosocial learning fMRI study, there was stronger engagement of the ventromedial prefrontal cortex (PFC) and higher connectivity between the ventromedial PFC and the right temporoparietal junction (rTPJ). Protecting others from harm appears to be associated with neural mechanisms that support self-relevant learning, but with the added recruitment of structures associated with the social brain. This study shows what we already know – that our brains are wired for social context. This research supports psychotherapeutic interventions aimed at creating interpersonal connection, not just at an intimate level, but also at the prosocial level, such as caring and helping others.

When social interactions are coded, the default mode network (DMN) shows increased activity. Participants (n = 11) in another study had heightened medial PFC–rTPJ connectivity, not only during rest that followed the experimental social encoding, but also during rest that followed a subsequent, nonsocial task.⁵ Engaging portions of the DMN during live social interactions when actively decoding the social environment, and later engaging these regions when relaxing after the social interaction, appears to facilitate social functioning. Our brains are wired to respond to context. This research underscores the positive impact of interventions such as group therapy and support groups, two underutilized modalities.

Neuroscience evaluation of our relationships provides depth to studies that fall under the medical paradigm of the gene/environment interaction. One of the most elegant in psychiatry is the Finnish study of a sample of offspring of mothers with schizophrenia who gave their children up for adoption.⁶ This sample of index offspring (n = 155) was compared blindly with matched controls (n = 186) of adopted/away offspring of parents without schizophrenia. The genetic effect manifested only as a psychiatric disorder in the presence of a disturbed family environment. We can now extrapolate certain possible mechanisms from the studies mentioned above: That the deficits lie in the activity or lack of activity in the DMN and associated areas, and in the generation of connectomes responsible for empathic connections.

Neuroscience expands our knowledge of our relational and social worlds, but can psychiatry make the case for inclusion of context in our conceptualization of psychiatric distress? From time to time, inroads are made, for example, the Global Assessment of Relational Functioning was incorporated into the DSM-IV-R and the Cultural Formulation Interview is in the DSM-5. However, without a sustained paradigm shift that places the gene/environment paradigm at the core of psychiatry, these efforts will rise and fall as the pioneers in these fields rise and fall.

A major barrier to moving the gene/environment paradigm more centrally in psychiatry is the prominence of individualism as an American ideal. As the neuroscience of context develops, we will be able to argue more robustly for a contextual approach to patient care.

A second barrier is the difficulty of teaching and learning about complexity. It is easy to learn how to use the DSM to make a diagnosis, to understand when and how to prescribe medications, but it is much more difficult to understand how to incorporate the complexity of life and the context within which we live, into our lexicon of psychiatric theories and treatments. As Tanya Luhrmann, PhD, points out in her study of the process of psychiatric training, residents are intimidated by the need to learn the many psychological theories and their practice; learning about medications is much simpler and takes much less time and effort.⁷

Nevertheless, context is embraced by several psychiatric subspecialties. Family psychiatrists recognize the power of relational dynamics in the family, and their role in shaping the individual. From understanding family communication patterns, to understanding how roles in the family get allocated, family psychiatry has well established tools for assessment and many evidence-based treatments that focus on changing relational dynamics. Social and community psychiatrists emphasize the role of race, poverty, and access, and support the assessment and treatment of the underprivileged. Cultural psychiatrists recognize that each culture has its own way of constructing identities and shaping our experiences, its own conceptualization of illness and specific idioms of distress. Cultural psychiatrists focus on sensitizing the general psychiatrist to these nuances. Child psychiatrists involve parents, and geriatric psychiatrists involve guardians. General psychiatrists understand context when, for example, understanding the role of trauma in the development of an individual, recognizing that its impact is contingent on the context within which the trauma occurs.

Neuroscience clarifies the neural pathways involved in the development of empathic and social behaviors. Our psychological theories and practice must reflect this advancement. We can teach the relevant neuroscience along with basic concepts such as child-parent relationships. We must assess an individual’s degree of fit within their family and community. Apart from asking relational questions, such as who in your world is important to you, we can use well recognized tools to help us bring context to the forefront. An easy tool is the three generational genogram, or an ecomap, which allows each individual to see where they sit in the context of their world.⁸ Cultural influences, societal, religious, and family influences can be drawn on the genogram, highlighting both formal and hidden family narratives. In addition, we can share how the brain works with our patients; the science of empathy and social behaviors shows us that our need for interpersonal connection is hardwired.

Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].

References

1. Lee TH et al. Families that fire together smile together: Resting state connectome similarity and daily emotional synchrony in parent-child dyads. Neuroimage. 2017 May 15;152:31-37. doi: 10.1016/j.neuroimage.2017.02.078.

2. Lee TH et al. Love flows downstream: Mothers’ and children’s neural representation similarity in perceiving distress of self and family. Soc Cogn Affect Neurosci. 2017 Dec 1;12(12):1916-27. doi: 10.1093/scan/nsx125.

3. Itahashi T et al. Functional connectomes linking child-parent relationships with psychological problems in adolescence. Neuroimage. 2020 Oct 1;219:117013. doi: 10.1016/j.neuroimage.2020.117013.

4. Lengersdorff LL et al. When implicit prosociality trumps selfishness: The neural valuation system underpins more optimal choices when learning to avoid harm to others than to oneself. J Neurosci. 2020 Sep 16;40(38):7286-99. doi: 10.1523/JNEUROSCI.0842-20.2020.

5. Meyer ML et al. Evidence that default network connectivity during rest consolidates social information. Cereb Cortex. 2019 May 1;29(5):1910-20. doi: 10.1093/cercor/bhy071.

6. Tienari P et al. The Finnish adoptive family study of schizophrenia. Implications for family research. Br J Psychiatry Suppl. 1994 Apr;(23):20-6.

7. Luhrmann, TM. Of two minds: The growing disorder in American psychiatry. New York, NY: Alfred A. Knopf, 2000.

8. Libbon R et al. Family skills for the resident toolbox: The 10-min. Genogram, Ecomap, and Prescribing Homework. Acad Psychiatry. 2019 Aug;43(4):435-439. doi: 10.1007/s40596-019-01054-6.

Psychiatry may be emerging from the era of psychopharmacology and entering the era of the brain, but these reductionist, jingoistic labels do little justice to the need to acknowledge and incorporate the context of our lives into our theories and treatments. Yet psychiatrists who embrace context have much to celebrate in evolving neuroscience research.

One aptly named article – ’Families that fire together smile together’ – illustrates the fundamental connection between parent and child.¹ In the functional MRIs (fMRIs) taken of these parent-child dyads (n = 76), the dyads with similar resting state connectomes also have similar day-to-day emotional states, as reflected in their diary entries. Their empathic states were identified in the multivoxel patterns in the fusiform face area of the brain.² Another study of fMRIs and parent-child dyads (n = 93) found that the parental functional connectomes (fbc) predicted their children’s externalizing and internalizing problems. The maternal fbcs were correlated with the daughter-mother relationship, and to the daughter’s internalizing problems, suggesting a potential future focus on gendered relationships.³

The implications for psychotherapy are clear: These studies show that empathic connection between parent and child results in a better outcome for the child. Patient and psychotherapist can choose from a range of psychotherapeutic interventions that promote empathy, from providing behavioral tasks that support connection between parent and child to more in-depth family interventions. Family interventions that promote empathy include increasing the family’s understanding of the importance of empathic connection and providing a safe space to help establish empathic connection.

Studying prosocial behavior, Lukas Lengersdorff and colleagues found that fMRIs of male participants (n = 96) reflected stronger activity when they were acting on behalf of the other, rather than when acting for themselves.⁴ During this prosocial learning fMRI study, there was stronger engagement of the ventromedial prefrontal cortex (PFC) and higher connectivity between the ventromedial PFC and the right temporoparietal junction (rTPJ). Protecting others from harm appears to be associated with neural mechanisms that support self-relevant learning, but with the added recruitment of structures associated with the social brain. This study shows what we already know – that our brains are wired for social context. This research supports psychotherapeutic interventions aimed at creating interpersonal connection, not just at an intimate level, but also at the prosocial level, such as caring and helping others.

When social interactions are coded, the default mode network (DMN) shows increased activity. Participants (n = 11) in another study had heightened medial PFC–rTPJ connectivity, not only during rest that followed the experimental social encoding, but also during rest that followed a subsequent, nonsocial task.⁵ Engaging portions of the DMN during live social interactions when actively decoding the social environment, and later engaging these regions when relaxing after the social interaction, appears to facilitate social functioning. Our brains are wired to respond to context. This research underscores the positive impact of interventions such as group therapy and support groups, two underutilized modalities.

Neuroscience evaluation of our relationships provides depth to studies that fall under the medical paradigm of the gene/environment interaction. One of the most elegant in psychiatry is the Finnish study of a sample of offspring of mothers with schizophrenia who gave their children up for adoption.⁶ This sample of index offspring (n = 155) was compared blindly with matched controls (n = 186) of adopted/away offspring of parents without schizophrenia. The genetic effect manifested only as a psychiatric disorder in the presence of a disturbed family environment. We can now extrapolate certain possible mechanisms from the studies mentioned above: That the deficits lie in the activity or lack of activity in the DMN and associated areas, and in the generation of connectomes responsible for empathic connections.

Neuroscience expands our knowledge of our relational and social worlds, but can psychiatry make the case for inclusion of context in our conceptualization of psychiatric distress? From time to time, inroads are made, for example, the Global Assessment of Relational Functioning was incorporated into the DSM-IV-R and the Cultural Formulation Interview is in the DSM-5. However, without a sustained paradigm shift that places the gene/environment paradigm at the core of psychiatry, these efforts will rise and fall as the pioneers in these fields rise and fall.

A major barrier to moving the gene/environment paradigm more centrally in psychiatry is the prominence of individualism as an American ideal. As the neuroscience of context develops, we will be able to argue more robustly for a contextual approach to patient care.

A second barrier is the difficulty of teaching and learning about complexity. It is easy to learn how to use the DSM to make a diagnosis, to understand when and how to prescribe medications, but it is much more difficult to understand how to incorporate the complexity of life and the context within which we live, into our lexicon of psychiatric theories and treatments. As Tanya Luhrmann, PhD, points out in her study of the process of psychiatric training, residents are intimidated by the need to learn the many psychological theories and their practice; learning about medications is much simpler and takes much less time and effort.⁷

Nevertheless, context is embraced by several psychiatric subspecialties. Family psychiatrists recognize the power of relational dynamics in the family, and their role in shaping the individual. From understanding family communication patterns, to understanding how roles in the family get allocated, family psychiatry has well established tools for assessment and many evidence-based treatments that focus on changing relational dynamics. Social and community psychiatrists emphasize the role of race, poverty, and access, and support the assessment and treatment of the underprivileged. Cultural psychiatrists recognize that each culture has its own way of constructing identities and shaping our experiences, its own conceptualization of illness and specific idioms of distress. Cultural psychiatrists focus on sensitizing the general psychiatrist to these nuances. Child psychiatrists involve parents, and geriatric psychiatrists involve guardians. General psychiatrists understand context when, for example, understanding the role of trauma in the development of an individual, recognizing that its impact is contingent on the context within which the trauma occurs.

Neuroscience clarifies the neural pathways involved in the development of empathic and social behaviors. Our psychological theories and practice must reflect this advancement. We can teach the relevant neuroscience along with basic concepts such as child-parent relationships. We must assess an individual’s degree of fit within their family and community. Apart from asking relational questions, such as who in your world is important to you, we can use well recognized tools to help us bring context to the forefront. An easy tool is the three generational genogram, or an ecomap, which allows each individual to see where they sit in the context of their world.⁸ Cultural influences, societal, religious, and family influences can be drawn on the genogram, highlighting both formal and hidden family narratives. In addition, we can share how the brain works with our patients; the science of empathy and social behaviors shows us that our need for interpersonal connection is hardwired.

Dr. Heru is professor of psychiatry at the University of Colorado Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest to disclose. Contact Dr. Heru at [email protected].

References

1. Lee TH et al. Families that fire together smile together: Resting state connectome similarity and daily emotional synchrony in parent-child dyads. Neuroimage. 2017 May 15;152:31-37. doi: 10.1016/j.neuroimage.2017.02.078.

2. Lee TH et al. Love flows downstream: Mothers’ and children’s neural representation similarity in perceiving distress of self and family. Soc Cogn Affect Neurosci. 2017 Dec 1;12(12):1916-27. doi: 10.1093/scan/nsx125.

3. Itahashi T et al. Functional connectomes linking child-parent relationships with psychological problems in adolescence. Neuroimage. 2020 Oct 1;219:117013. doi: 10.1016/j.neuroimage.2020.117013.

4. Lengersdorff LL et al. When implicit prosociality trumps selfishness: The neural valuation system underpins more optimal choices when learning to avoid harm to others than to oneself. J Neurosci. 2020 Sep 16;40(38):7286-99. doi: 10.1523/JNEUROSCI.0842-20.2020.

5. Meyer ML et al. Evidence that default network connectivity during rest consolidates social information. Cereb Cortex. 2019 May 1;29(5):1910-20. doi: 10.1093/cercor/bhy071.

6. Tienari P et al. The Finnish adoptive family study of schizophrenia. Implications for family research. Br J Psychiatry Suppl. 1994 Apr;(23):20-6.

7. Luhrmann, TM. Of two minds: The growing disorder in American psychiatry. New York, NY: Alfred A. Knopf, 2000.

8. Libbon R et al. Family skills for the resident toolbox: The 10-min. Genogram, Ecomap, and Prescribing Homework. Acad Psychiatry. 2019 Aug;43(4):435-439. doi: 10.1007/s40596-019-01054-6.

Loss of vestibular function is a key contributor to a well-documented increased risk for falls in patients with Alzheimer’s disease (AD), new research confirms.

Falls are twice as common in patients with AD versu older individuals without the disorder and significantly increase the likelihood of institutionalization.

However, researchers recorded fewer falls in patients with a better functioning vestibular system, which detects head movements and plays a critical role in spatial orientation, posture, gait, and balance.

The results suggest that improving vestibular function with currently available therapies may prevent falls, something the researchers will investigate in a new clinical trial launching next month.

“One of the most dangerous and impactful symptoms in terms of function in patients with Alzheimer’s disease is their increased predisposition to falls,” study investigator Yuri Agrawal, MD, department of otolaryngology–head and neck surgery, Johns Hopkins University School of Medicine, Baltimore, said in an interview. “Alzheimer’s is the sixth leading cause of death in the U.S., and some people actually say that that high mortality rate is because of their predisposition to falls and the injuries that occur.”

The study was published online Feb. 14 in the Journal of Alzheimer’s Disease.
 

The ‘sixth hidden sense’

The vestibular system consists of three semicircular canals, which detect rotational head movement, and two otolith organs called the utricle and the saccule, which sense linear head movements and the orientation of the head with respect to gravity.

“We call the vestibular system the sixth hidden sense because it’s not a conscious perception like taste or smell,” Dr. Agrawal said. “It’s constantly providing input to our brain about where we are in space.”

Dr. Agrawal and colleagues previously reported that vestibular loss is twice as common in Alzheimer’s patients as in cognitively unimpaired age-matched controls. Now, they wanted to know if this sensory loss was associated with an increased risk for falls in this population.

The study included 48 patients age greater than or equal to 60 years with mild-to-moderate AD between 2018 and 2020. They also included an age-matched control group of healthy controls with no cognitive impairment.

Researchers assessed vestibular function at baseline by measuring semicircular canal and saccular function. One test required participants to wear goggles and complete a series of tests with their eyes open and closed while researchers recorded their eye movement with video-oculography. They also measured participants’ balance using the Berg Balance Scale.

Relative to matched controls, AD patients exhibited increased lateral instability when their eyes were open (P = .033) and closed (P = .042). Studies suggest that lateral stability declines more quickly with age and that instability with eyes closed is the single biggest predictor of incident falls in community-dwelling adults.

To determine if poor vestibular function increased fall risk in patients with AD, researchers followed the cohort for up to 2 years.

“We found that patients with vestibular loss at baseline were 50% more likely to fall, adjusting for other factors that could contribute to that,” Dr. Agrawal said.

Specifically, better semicircular canal function was significantly associated with lower likelihood of falls, even after adjusting for confounders (adjusted hazard ratio, 0.65; P = .009).
 

Can therapy help?

Commenting on the findings, James Burke, MD, PhD, professor of neurology at Duke University Medical Center, Durham, N.C., said that the finding that impaired vestibular function is associated with increased falls “significantly advances our understanding of the topic” and suggests that treating vestibular dysfunction could reduce falls in Alzheimer’s patients.

“Screening patients with Alzheimer’s disease for impaired vestibular function could lead to identification of individuals at high risk of falls and target those who would benefit from vestibular therapy,” he said.

Vestibular rehabilitation therapy is often used to treat a number of disorders related to vestibular function loss. There are also studies underway to measure the efficacy of a vestibular implant that works much like a cochlear implant.

While evaluation of vestibular function is currently not routinely included in AD care, studies such as these suggest it may be time to consider adding it to the standard of care, Jennifer Coto, PhD, assistant professor of otolaryngology at the University of Miami Miller School of Medicine, said in an interview.

“Best practice guidelines for management of Alzheimer’s patients should be revised to include routine vestibular evaluation and support from a multidisciplinary team that may address other crucial areas of functioning, particularly psychological functioning, sleep, and independence,” she said.

“Future research also needs to evaluate the effectiveness of vestibular therapy in patients with Alzheimer’s and the benefits of early identification and intervention for preventing recurrent falls.”

Dr. Agrawal is leading a 5-year, $3.5 million National Institute on Aging study that seeks to do just that. Enrollment in the study begins next month. Patients will complete an initial in-person screening, but the remainder of the study will be conducted virtually.

Therapies will be noninvasive, nonpharmaceutical, and performed in participants’ homes. If the therapy is successful at reducing falls, Dr. Agrawal said the virtual design would significantly broaden its potential patient reach.

The study was funded by the National Institute on Aging. Study authors’ disclosures are reported in the original article. Dr. Coto and Dr. Burke report no relevant financial relationships.

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

Loss of vestibular function is a key contributor to a well-documented increased risk for falls in patients with Alzheimer’s disease (AD), new research confirms.

Falls are twice as common in patients with AD versu older individuals without the disorder and significantly increase the likelihood of institutionalization.

However, researchers recorded fewer falls in patients with a better functioning vestibular system, which detects head movements and plays a critical role in spatial orientation, posture, gait, and balance.

The results suggest that improving vestibular function with currently available therapies may prevent falls, something the researchers will investigate in a new clinical trial launching next month.

“One of the most dangerous and impactful symptoms in terms of function in patients with Alzheimer’s disease is their increased predisposition to falls,” study investigator Yuri Agrawal, MD, department of otolaryngology–head and neck surgery, Johns Hopkins University School of Medicine, Baltimore, said in an interview. “Alzheimer’s is the sixth leading cause of death in the U.S., and some people actually say that that high mortality rate is because of their predisposition to falls and the injuries that occur.”

The study was published online Feb. 14 in the Journal of Alzheimer’s Disease.
 

The ‘sixth hidden sense’

The vestibular system consists of three semicircular canals, which detect rotational head movement, and two otolith organs called the utricle and the saccule, which sense linear head movements and the orientation of the head with respect to gravity.

“We call the vestibular system the sixth hidden sense because it’s not a conscious perception like taste or smell,” Dr. Agrawal said. “It’s constantly providing input to our brain about where we are in space.”

Dr. Agrawal and colleagues previously reported that vestibular loss is twice as common in Alzheimer’s patients as in cognitively unimpaired age-matched controls. Now, they wanted to know if this sensory loss was associated with an increased risk for falls in this population.

The study included 48 patients age greater than or equal to 60 years with mild-to-moderate AD between 2018 and 2020. They also included an age-matched control group of healthy controls with no cognitive impairment.

Researchers assessed vestibular function at baseline by measuring semicircular canal and saccular function. One test required participants to wear goggles and complete a series of tests with their eyes open and closed while researchers recorded their eye movement with video-oculography. They also measured participants’ balance using the Berg Balance Scale.

Relative to matched controls, AD patients exhibited increased lateral instability when their eyes were open (P = .033) and closed (P = .042). Studies suggest that lateral stability declines more quickly with age and that instability with eyes closed is the single biggest predictor of incident falls in community-dwelling adults.

To determine if poor vestibular function increased fall risk in patients with AD, researchers followed the cohort for up to 2 years.

“We found that patients with vestibular loss at baseline were 50% more likely to fall, adjusting for other factors that could contribute to that,” Dr. Agrawal said.

Specifically, better semicircular canal function was significantly associated with lower likelihood of falls, even after adjusting for confounders (adjusted hazard ratio, 0.65; P = .009).
 

Can therapy help?

Commenting on the findings, James Burke, MD, PhD, professor of neurology at Duke University Medical Center, Durham, N.C., said that the finding that impaired vestibular function is associated with increased falls “significantly advances our understanding of the topic” and suggests that treating vestibular dysfunction could reduce falls in Alzheimer’s patients.

“Screening patients with Alzheimer’s disease for impaired vestibular function could lead to identification of individuals at high risk of falls and target those who would benefit from vestibular therapy,” he said.

Vestibular rehabilitation therapy is often used to treat a number of disorders related to vestibular function loss. There are also studies underway to measure the efficacy of a vestibular implant that works much like a cochlear implant.

While evaluation of vestibular function is currently not routinely included in AD care, studies such as these suggest it may be time to consider adding it to the standard of care, Jennifer Coto, PhD, assistant professor of otolaryngology at the University of Miami Miller School of Medicine, said in an interview.

“Best practice guidelines for management of Alzheimer’s patients should be revised to include routine vestibular evaluation and support from a multidisciplinary team that may address other crucial areas of functioning, particularly psychological functioning, sleep, and independence,” she said.

“Future research also needs to evaluate the effectiveness of vestibular therapy in patients with Alzheimer’s and the benefits of early identification and intervention for preventing recurrent falls.”

Dr. Agrawal is leading a 5-year, $3.5 million National Institute on Aging study that seeks to do just that. Enrollment in the study begins next month. Patients will complete an initial in-person screening, but the remainder of the study will be conducted virtually.

Therapies will be noninvasive, nonpharmaceutical, and performed in participants’ homes. If the therapy is successful at reducing falls, Dr. Agrawal said the virtual design would significantly broaden its potential patient reach.

The study was funded by the National Institute on Aging. Study authors’ disclosures are reported in the original article. Dr. Coto and Dr. Burke report no relevant financial relationships.

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

Loss of vestibular function is a key contributor to a well-documented increased risk for falls in patients with Alzheimer’s disease (AD), new research confirms.

Falls are twice as common in patients with AD versu older individuals without the disorder and significantly increase the likelihood of institutionalization.

However, researchers recorded fewer falls in patients with a better functioning vestibular system, which detects head movements and plays a critical role in spatial orientation, posture, gait, and balance.

The results suggest that improving vestibular function with currently available therapies may prevent falls, something the researchers will investigate in a new clinical trial launching next month.

“One of the most dangerous and impactful symptoms in terms of function in patients with Alzheimer’s disease is their increased predisposition to falls,” study investigator Yuri Agrawal, MD, department of otolaryngology–head and neck surgery, Johns Hopkins University School of Medicine, Baltimore, said in an interview. “Alzheimer’s is the sixth leading cause of death in the U.S., and some people actually say that that high mortality rate is because of their predisposition to falls and the injuries that occur.”

The study was published online Feb. 14 in the Journal of Alzheimer’s Disease.
 

The ‘sixth hidden sense’

The vestibular system consists of three semicircular canals, which detect rotational head movement, and two otolith organs called the utricle and the saccule, which sense linear head movements and the orientation of the head with respect to gravity.

“We call the vestibular system the sixth hidden sense because it’s not a conscious perception like taste or smell,” Dr. Agrawal said. “It’s constantly providing input to our brain about where we are in space.”

Dr. Agrawal and colleagues previously reported that vestibular loss is twice as common in Alzheimer’s patients as in cognitively unimpaired age-matched controls. Now, they wanted to know if this sensory loss was associated with an increased risk for falls in this population.

The study included 48 patients age greater than or equal to 60 years with mild-to-moderate AD between 2018 and 2020. They also included an age-matched control group of healthy controls with no cognitive impairment.

Researchers assessed vestibular function at baseline by measuring semicircular canal and saccular function. One test required participants to wear goggles and complete a series of tests with their eyes open and closed while researchers recorded their eye movement with video-oculography. They also measured participants’ balance using the Berg Balance Scale.

Relative to matched controls, AD patients exhibited increased lateral instability when their eyes were open (P = .033) and closed (P = .042). Studies suggest that lateral stability declines more quickly with age and that instability with eyes closed is the single biggest predictor of incident falls in community-dwelling adults.

To determine if poor vestibular function increased fall risk in patients with AD, researchers followed the cohort for up to 2 years.

“We found that patients with vestibular loss at baseline were 50% more likely to fall, adjusting for other factors that could contribute to that,” Dr. Agrawal said.

Specifically, better semicircular canal function was significantly associated with lower likelihood of falls, even after adjusting for confounders (adjusted hazard ratio, 0.65; P = .009).
 

Can therapy help?

Commenting on the findings, James Burke, MD, PhD, professor of neurology at Duke University Medical Center, Durham, N.C., said that the finding that impaired vestibular function is associated with increased falls “significantly advances our understanding of the topic” and suggests that treating vestibular dysfunction could reduce falls in Alzheimer’s patients.

“Screening patients with Alzheimer’s disease for impaired vestibular function could lead to identification of individuals at high risk of falls and target those who would benefit from vestibular therapy,” he said.

Vestibular rehabilitation therapy is often used to treat a number of disorders related to vestibular function loss. There are also studies underway to measure the efficacy of a vestibular implant that works much like a cochlear implant.

While evaluation of vestibular function is currently not routinely included in AD care, studies such as these suggest it may be time to consider adding it to the standard of care, Jennifer Coto, PhD, assistant professor of otolaryngology at the University of Miami Miller School of Medicine, said in an interview.

“Best practice guidelines for management of Alzheimer’s patients should be revised to include routine vestibular evaluation and support from a multidisciplinary team that may address other crucial areas of functioning, particularly psychological functioning, sleep, and independence,” she said.

“Future research also needs to evaluate the effectiveness of vestibular therapy in patients with Alzheimer’s and the benefits of early identification and intervention for preventing recurrent falls.”

Dr. Agrawal is leading a 5-year, $3.5 million National Institute on Aging study that seeks to do just that. Enrollment in the study begins next month. Patients will complete an initial in-person screening, but the remainder of the study will be conducted virtually.

Therapies will be noninvasive, nonpharmaceutical, and performed in participants’ homes. If the therapy is successful at reducing falls, Dr. Agrawal said the virtual design would significantly broaden its potential patient reach.

The study was funded by the National Institute on Aging. Study authors’ disclosures are reported in the original article. Dr. Coto and Dr. Burke report no relevant financial relationships.

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.

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.