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Not all plant-based diets equal for CRC risk reduction
although the strength of the association may vary by race and ethnicity and tumor site, new research shows.
The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.
The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.
The study was published online in BMC Medicine.
The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).
All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.
Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.
They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.
During a mean follow-up of about 19 years, 4,976 participants developed CRC.
The plant-based diet indices were significantly inversely associated with the risk for CRC in men.
Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.
None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.
In general, women consume more plant foods and less animal foods than men do, they point out.
In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.
These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.
In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.
“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.
“We should investigate that more in the future,” Ms. Kim added.
By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.
Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.
Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.
The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
although the strength of the association may vary by race and ethnicity and tumor site, new research shows.
The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.
The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.
The study was published online in BMC Medicine.
The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).
All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.
Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.
They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.
During a mean follow-up of about 19 years, 4,976 participants developed CRC.
The plant-based diet indices were significantly inversely associated with the risk for CRC in men.
Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.
None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.
In general, women consume more plant foods and less animal foods than men do, they point out.
In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.
These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.
In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.
“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.
“We should investigate that more in the future,” Ms. Kim added.
By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.
Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.
Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.
The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
although the strength of the association may vary by race and ethnicity and tumor site, new research shows.
The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.
The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.
The study was published online in BMC Medicine.
The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).
All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.
Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.
They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.
During a mean follow-up of about 19 years, 4,976 participants developed CRC.
The plant-based diet indices were significantly inversely associated with the risk for CRC in men.
Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.
None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.
In general, women consume more plant foods and less animal foods than men do, they point out.
In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.
These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.
In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.
“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.
“We should investigate that more in the future,” Ms. Kim added.
By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.
Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.
Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.
The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM BMC MEDICINE
FDA OKs first fecal microbiota therapy for recurrent C. difficile
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients,” Phillip I. Tarr, MD, chair of the American Gastroenterological Association’s Center for Gut Microbiome Research and Education Scientific Advisory Board, said in a written statement issued by the AGA. “This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators. AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that, because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” said Dr. Malter said, who reported no relevant financial relationships.
The AGA will continue to follow the long-term effectiveness and safety of patients receiving Rebyota, fecal microbiota transplant, and other microbiota-based therapies through its FMT National Registry, according to the AGA statement.
Full prescribing information for Rebyota is available online.
For more information about CDI and FMT, visit patient.gastro.org.
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients,” Phillip I. Tarr, MD, chair of the American Gastroenterological Association’s Center for Gut Microbiome Research and Education Scientific Advisory Board, said in a written statement issued by the AGA. “This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators. AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that, because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” said Dr. Malter said, who reported no relevant financial relationships.
The AGA will continue to follow the long-term effectiveness and safety of patients receiving Rebyota, fecal microbiota transplant, and other microbiota-based therapies through its FMT National Registry, according to the AGA statement.
Full prescribing information for Rebyota is available online.
For more information about CDI and FMT, visit patient.gastro.org.
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients,” Phillip I. Tarr, MD, chair of the American Gastroenterological Association’s Center for Gut Microbiome Research and Education Scientific Advisory Board, said in a written statement issued by the AGA. “This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators. AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that, because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” said Dr. Malter said, who reported no relevant financial relationships.
The AGA will continue to follow the long-term effectiveness and safety of patients receiving Rebyota, fecal microbiota transplant, and other microbiota-based therapies through its FMT National Registry, according to the AGA statement.
Full prescribing information for Rebyota is available online.
For more information about CDI and FMT, visit patient.gastro.org.
Florida doc dies by suicide after allegedly drugging and raping patients
according to a police statement.
A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.
Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.
Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.
Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.
The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.
At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.
“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”
Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.
Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”
A version of this article first appeared on Medscape.com.
according to a police statement.
A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.
Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.
Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.
Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.
The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.
At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.
“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”
Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.
Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”
A version of this article first appeared on Medscape.com.
according to a police statement.
A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.
Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.
Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.
Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.
The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.
At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.
“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”
Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.
Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”
A version of this article first appeared on Medscape.com.
Visualization can improve sports performance
Over the past 30 years, Dr. Richard W. Cohen has used visualization techniques to help world class tennis players and recreational tennis players become the best they could be.
Visualization should be used in two ways to help players improve. First, to improve technique, after every practice session I have the player think about one shot they did not do well technically, and I have them, in vivo, shadow the shot on the court correctly before they leave the court. That night I tell the player to put themselves in a quiet, relaxed place and, in vitro, visualize themselves hitting the shot the correct way.
Almost always, the next day the players tell me they are hitting that one shot better and are motivated to again think about the one shot that was not technically correct and repeat the in vivo technique with similar great results.
The second way I use visualization for tennis players is to decrease their anxiety before matches. It is important to have some preparatory anxiety to perform optimally but having excessive anxiety will decrease performance. To alleviate excessive anxiety before matches, I have players watch their opponents hit the day before the match for at least 5 minutes to see their strengths and weaknesses. Then, the night before the match, I have them visualize how they will play a big point utilizing their strength into their opponent’s weakness. This rehearsal using imagery the night before a big match will decrease a player’s excessive anxiety and allow them to achieve their best effort in the match.
An example of this is if their opponent has a weak backhand that they can only slice. They visualize hitting wide to their forehand to get into their weak backhand and see themselves going forward and putting away a volley. Visualization used in these two ways helps improve stroke mechanics and match results in players of all levels. These visualization techniques can also be extended to other sports and to help improve life habits.
For example, Dr. Susan A. Cohen has seen that many patients have a decline in their dental health because of fear of going to the dentist to receive the treatment they need. Visualization techniques decrease the patient’s anxiety by rehearsing the possible traumatic events of the dental visit – e.g., the injection of anesthesia before the dental procedure. Visualization of calmness with systematic desensitization has helped decrease anxiety in patients.
In 20 years of clinical experience as a dentist, Dr. Cohen has seen how these techniques have increased compliance in her dental patients. She has also noted that visualizing the results of having a healthy mouth with improved appearance and function leads to an overall willingness to visit the dentist regularly and enjoy the dental experience. These examples demonstrate how visualization can enhance sports performance, quality of life, and overall health.
Dr. Richard W. Cohen is a psychiatrist who has been in private practice for over 40 years and is on the editorial advisory board for Clinical Psychiatry News. He has won 18 USTA national tennis championships. Dr. Susan A. Cohen has practiced dentistry for over 20 years. The Cohens, who are married, are based in Philadelphia.
Over the past 30 years, Dr. Richard W. Cohen has used visualization techniques to help world class tennis players and recreational tennis players become the best they could be.
Visualization should be used in two ways to help players improve. First, to improve technique, after every practice session I have the player think about one shot they did not do well technically, and I have them, in vivo, shadow the shot on the court correctly before they leave the court. That night I tell the player to put themselves in a quiet, relaxed place and, in vitro, visualize themselves hitting the shot the correct way.
Almost always, the next day the players tell me they are hitting that one shot better and are motivated to again think about the one shot that was not technically correct and repeat the in vivo technique with similar great results.
The second way I use visualization for tennis players is to decrease their anxiety before matches. It is important to have some preparatory anxiety to perform optimally but having excessive anxiety will decrease performance. To alleviate excessive anxiety before matches, I have players watch their opponents hit the day before the match for at least 5 minutes to see their strengths and weaknesses. Then, the night before the match, I have them visualize how they will play a big point utilizing their strength into their opponent’s weakness. This rehearsal using imagery the night before a big match will decrease a player’s excessive anxiety and allow them to achieve their best effort in the match.
An example of this is if their opponent has a weak backhand that they can only slice. They visualize hitting wide to their forehand to get into their weak backhand and see themselves going forward and putting away a volley. Visualization used in these two ways helps improve stroke mechanics and match results in players of all levels. These visualization techniques can also be extended to other sports and to help improve life habits.
For example, Dr. Susan A. Cohen has seen that many patients have a decline in their dental health because of fear of going to the dentist to receive the treatment they need. Visualization techniques decrease the patient’s anxiety by rehearsing the possible traumatic events of the dental visit – e.g., the injection of anesthesia before the dental procedure. Visualization of calmness with systematic desensitization has helped decrease anxiety in patients.
In 20 years of clinical experience as a dentist, Dr. Cohen has seen how these techniques have increased compliance in her dental patients. She has also noted that visualizing the results of having a healthy mouth with improved appearance and function leads to an overall willingness to visit the dentist regularly and enjoy the dental experience. These examples demonstrate how visualization can enhance sports performance, quality of life, and overall health.
Dr. Richard W. Cohen is a psychiatrist who has been in private practice for over 40 years and is on the editorial advisory board for Clinical Psychiatry News. He has won 18 USTA national tennis championships. Dr. Susan A. Cohen has practiced dentistry for over 20 years. The Cohens, who are married, are based in Philadelphia.
Over the past 30 years, Dr. Richard W. Cohen has used visualization techniques to help world class tennis players and recreational tennis players become the best they could be.
Visualization should be used in two ways to help players improve. First, to improve technique, after every practice session I have the player think about one shot they did not do well technically, and I have them, in vivo, shadow the shot on the court correctly before they leave the court. That night I tell the player to put themselves in a quiet, relaxed place and, in vitro, visualize themselves hitting the shot the correct way.
Almost always, the next day the players tell me they are hitting that one shot better and are motivated to again think about the one shot that was not technically correct and repeat the in vivo technique with similar great results.
The second way I use visualization for tennis players is to decrease their anxiety before matches. It is important to have some preparatory anxiety to perform optimally but having excessive anxiety will decrease performance. To alleviate excessive anxiety before matches, I have players watch their opponents hit the day before the match for at least 5 minutes to see their strengths and weaknesses. Then, the night before the match, I have them visualize how they will play a big point utilizing their strength into their opponent’s weakness. This rehearsal using imagery the night before a big match will decrease a player’s excessive anxiety and allow them to achieve their best effort in the match.
An example of this is if their opponent has a weak backhand that they can only slice. They visualize hitting wide to their forehand to get into their weak backhand and see themselves going forward and putting away a volley. Visualization used in these two ways helps improve stroke mechanics and match results in players of all levels. These visualization techniques can also be extended to other sports and to help improve life habits.
For example, Dr. Susan A. Cohen has seen that many patients have a decline in their dental health because of fear of going to the dentist to receive the treatment they need. Visualization techniques decrease the patient’s anxiety by rehearsing the possible traumatic events of the dental visit – e.g., the injection of anesthesia before the dental procedure. Visualization of calmness with systematic desensitization has helped decrease anxiety in patients.
In 20 years of clinical experience as a dentist, Dr. Cohen has seen how these techniques have increased compliance in her dental patients. She has also noted that visualizing the results of having a healthy mouth with improved appearance and function leads to an overall willingness to visit the dentist regularly and enjoy the dental experience. These examples demonstrate how visualization can enhance sports performance, quality of life, and overall health.
Dr. Richard W. Cohen is a psychiatrist who has been in private practice for over 40 years and is on the editorial advisory board for Clinical Psychiatry News. He has won 18 USTA national tennis championships. Dr. Susan A. Cohen has practiced dentistry for over 20 years. The Cohens, who are married, are based in Philadelphia.
What are the risk factors for Mohs surgery–related anxiety?
confirmed by a health care provider (HCP), results from a single-center survey demonstrated.
“Higher patient-reported anxiety in hospital settings is significantly linked to lower patient satisfaction with the quality of care and higher patient-reported postoperative pain,” corresponding author Ally-Khan Somani, MD, PhD, and colleagues wrote in the study, which was published online in Dermatologic Surgery. “Identifying factors associated with perioperative patient anxiety could improve outcomes and patient satisfaction.”
Dr. Somani, director of dermatologic surgery and cutaneous oncology in the department of dermatology at the University of Indiana, Indianapolis, and coauthors surveyed 145 patients who underwent Mohs micrographic surgery (MMS) at the university from February 2018 to March 2020. They collected patient self-reported demographics, medical history, and administered a 10-point visual analog scale assessment of anxiety at multiple stages. They also sought HCP-perceived assessments of anxiety and used a stepwise regression mode to explore factors that potentially contributed to anxiety outcomes. The mean age of the 145 patients was 63 years, 60% were female, and 77% had no self-reported anxiety confirmed by a prior HCP’s diagnosis.
Two-thirds of patients (66%) received a pre-MMS consultation with the surgeon, 59% had a history of skin cancer removal surgery, and 86% had 1-2 layers removed during the current MMS.
Prior to MMS, the researchers found that significant risk factors for increased anxiety included younger age, female sex, and self-reported history of anxiety confirmed by an HCP (P < .05), while intraoperatively, HCP-perceived patient anxiety increased with younger patient age and more layers removed. Following MMS, patient anxiety increased significantly with more layers removed and higher self-reported preoperative anxiety levels. “Although existing research is divided regarding the efficacy of pre-MMS consultation for anxiety reduction, these findings suggest that patient-reported and HCP-perceived anxiety were not significantly affected by in-person pre-MMS consultation with the surgeon,” Dr. Somani and colleagues wrote. “Thus, routinely recommending consultations may not be the best approach for improving anxiety outcomes.”
They acknowledged certain limitations of their analysis, including its single-center design, enrollment of demographically similar patients, and the fact that no objective measurements of anxiety such as heart rate or blood pressure were taken.
“One of the main benefits of Mohs surgery is that we are able to operate under local anesthesia, but this also means that our patients are acutely aware of everything going on around them,” said Patricia M. Richey, MD, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and was asked to comment on the study.
“I think it is so important that this study is primarily focusing on the patient experience,” she said. “While this study did not find that a pre-op consult impacted patient anxiety levels, I do think we can infer that it is critical to connect with your patients on some level prior to surgery, as it helps you tailor your process to make the day more tolerable for them [such as] playing music, determining the need for an oral anxiolytic, etc.”
Neither the researchers nor Dr. Richey reported having financial disclosures.
confirmed by a health care provider (HCP), results from a single-center survey demonstrated.
“Higher patient-reported anxiety in hospital settings is significantly linked to lower patient satisfaction with the quality of care and higher patient-reported postoperative pain,” corresponding author Ally-Khan Somani, MD, PhD, and colleagues wrote in the study, which was published online in Dermatologic Surgery. “Identifying factors associated with perioperative patient anxiety could improve outcomes and patient satisfaction.”
Dr. Somani, director of dermatologic surgery and cutaneous oncology in the department of dermatology at the University of Indiana, Indianapolis, and coauthors surveyed 145 patients who underwent Mohs micrographic surgery (MMS) at the university from February 2018 to March 2020. They collected patient self-reported demographics, medical history, and administered a 10-point visual analog scale assessment of anxiety at multiple stages. They also sought HCP-perceived assessments of anxiety and used a stepwise regression mode to explore factors that potentially contributed to anxiety outcomes. The mean age of the 145 patients was 63 years, 60% were female, and 77% had no self-reported anxiety confirmed by a prior HCP’s diagnosis.
Two-thirds of patients (66%) received a pre-MMS consultation with the surgeon, 59% had a history of skin cancer removal surgery, and 86% had 1-2 layers removed during the current MMS.
Prior to MMS, the researchers found that significant risk factors for increased anxiety included younger age, female sex, and self-reported history of anxiety confirmed by an HCP (P < .05), while intraoperatively, HCP-perceived patient anxiety increased with younger patient age and more layers removed. Following MMS, patient anxiety increased significantly with more layers removed and higher self-reported preoperative anxiety levels. “Although existing research is divided regarding the efficacy of pre-MMS consultation for anxiety reduction, these findings suggest that patient-reported and HCP-perceived anxiety were not significantly affected by in-person pre-MMS consultation with the surgeon,” Dr. Somani and colleagues wrote. “Thus, routinely recommending consultations may not be the best approach for improving anxiety outcomes.”
They acknowledged certain limitations of their analysis, including its single-center design, enrollment of demographically similar patients, and the fact that no objective measurements of anxiety such as heart rate or blood pressure were taken.
“One of the main benefits of Mohs surgery is that we are able to operate under local anesthesia, but this also means that our patients are acutely aware of everything going on around them,” said Patricia M. Richey, MD, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and was asked to comment on the study.
“I think it is so important that this study is primarily focusing on the patient experience,” she said. “While this study did not find that a pre-op consult impacted patient anxiety levels, I do think we can infer that it is critical to connect with your patients on some level prior to surgery, as it helps you tailor your process to make the day more tolerable for them [such as] playing music, determining the need for an oral anxiolytic, etc.”
Neither the researchers nor Dr. Richey reported having financial disclosures.
confirmed by a health care provider (HCP), results from a single-center survey demonstrated.
“Higher patient-reported anxiety in hospital settings is significantly linked to lower patient satisfaction with the quality of care and higher patient-reported postoperative pain,” corresponding author Ally-Khan Somani, MD, PhD, and colleagues wrote in the study, which was published online in Dermatologic Surgery. “Identifying factors associated with perioperative patient anxiety could improve outcomes and patient satisfaction.”
Dr. Somani, director of dermatologic surgery and cutaneous oncology in the department of dermatology at the University of Indiana, Indianapolis, and coauthors surveyed 145 patients who underwent Mohs micrographic surgery (MMS) at the university from February 2018 to March 2020. They collected patient self-reported demographics, medical history, and administered a 10-point visual analog scale assessment of anxiety at multiple stages. They also sought HCP-perceived assessments of anxiety and used a stepwise regression mode to explore factors that potentially contributed to anxiety outcomes. The mean age of the 145 patients was 63 years, 60% were female, and 77% had no self-reported anxiety confirmed by a prior HCP’s diagnosis.
Two-thirds of patients (66%) received a pre-MMS consultation with the surgeon, 59% had a history of skin cancer removal surgery, and 86% had 1-2 layers removed during the current MMS.
Prior to MMS, the researchers found that significant risk factors for increased anxiety included younger age, female sex, and self-reported history of anxiety confirmed by an HCP (P < .05), while intraoperatively, HCP-perceived patient anxiety increased with younger patient age and more layers removed. Following MMS, patient anxiety increased significantly with more layers removed and higher self-reported preoperative anxiety levels. “Although existing research is divided regarding the efficacy of pre-MMS consultation for anxiety reduction, these findings suggest that patient-reported and HCP-perceived anxiety were not significantly affected by in-person pre-MMS consultation with the surgeon,” Dr. Somani and colleagues wrote. “Thus, routinely recommending consultations may not be the best approach for improving anxiety outcomes.”
They acknowledged certain limitations of their analysis, including its single-center design, enrollment of demographically similar patients, and the fact that no objective measurements of anxiety such as heart rate or blood pressure were taken.
“One of the main benefits of Mohs surgery is that we are able to operate under local anesthesia, but this also means that our patients are acutely aware of everything going on around them,” said Patricia M. Richey, MD, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and was asked to comment on the study.
“I think it is so important that this study is primarily focusing on the patient experience,” she said. “While this study did not find that a pre-op consult impacted patient anxiety levels, I do think we can infer that it is critical to connect with your patients on some level prior to surgery, as it helps you tailor your process to make the day more tolerable for them [such as] playing music, determining the need for an oral anxiolytic, etc.”
Neither the researchers nor Dr. Richey reported having financial disclosures.
FROM DERMATOLOGIC SURGERY
Overdose deaths up 81% in pregnant, postpartum women
Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.
Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.
The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.
The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
Sharp increase at start of COVID pandemic
The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.
“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.
Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.
The trend mirrors a pattern in people of reproductive age overall, the authors write.
Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
Fentanyl deaths increase
The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).
Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.
Numbers of late postpartum overdose deaths were notable in the paper.
In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).
Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.
She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”
Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.
The authors and Dr. Schiff declare no relevant financial relationships.
Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.
Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.
The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.
The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
Sharp increase at start of COVID pandemic
The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.
“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.
Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.
The trend mirrors a pattern in people of reproductive age overall, the authors write.
Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
Fentanyl deaths increase
The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).
Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.
Numbers of late postpartum overdose deaths were notable in the paper.
In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).
Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.
She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”
Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.
The authors and Dr. Schiff declare no relevant financial relationships.
Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.
Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.
The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.
The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
Sharp increase at start of COVID pandemic
The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.
“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.
Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.
The trend mirrors a pattern in people of reproductive age overall, the authors write.
Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
Fentanyl deaths increase
The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).
Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.
Numbers of late postpartum overdose deaths were notable in the paper.
In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).
Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.
She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”
Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.
The authors and Dr. Schiff declare no relevant financial relationships.
FROM JAMA
Dapagliflozin reduces hospitalizations in patients with CKD
These findings add to a growing body of evidence supporting a range of positive benefits from dapagliflozin, including reduced risks of mortality, cardiovascular events, and kidney events, lead author Meir Schechter, MD, PhD, of the Hebrew University of Jerusalem and colleagues wrote in Annals of Internal Medicine.“Although cardiovascular and kidney outcomes with SGLT2 inhibitors have been studied extensively, there is a paucity of data evaluating the effects of SGLT2 inhibitors on hospitalizations for any cause.”
The findings are based on a post hoc analysis of the DAPA-CKD trial, which involved 4,304 patients with CKD in 21 countries. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once a day or matching placebo. The present analysis quantified first hospitalizations for any cause, all hospitalizations, cause-specific hospitalizations, and several related outcomes.
After a median follow-up of 2.4 years, 28% of the population had been hospitalized a total of 2,072 times.
Compared with placebo, dapagliflozin significantly reduced risk of first hospitalization by 16% (hazard ratio, 0.84; 95% confidence interval, 0.75-0.94) and rate of all hospitalizations by 21% (rate ratio, 0.79; 95% CI, 0.70-0.89). These findings remained significant regardless of type 2 diabetes status, with significant benefits seen across reasons for admission, including renal/urinary disorders, cardiac disorders, neoplasms, and metabolism/nutrition disorders. In addition, dapagliflozin was associated with shorter mean time in hospital (2.3 vs. 2.8 days; P = .027) and longer time alive and out of hospital (354.9 vs. 351.7; P = .023).
“These findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR [estimated glomerular filtration rate] slope, and albuminuria and should be considered when evaluating the totality of evidence favoring provision of dapagliflozin to patients with CKD,” the investigators concluded.
Positive data, positive experiences
Shree Mulay, MD, a nephrologist in private practice in western Tennessee, said this study is “one of several other articles that already exist” demonstrating the broad benefits of SGLT2 inhibitors.
“The evidence is pretty substantial,” Dr. Mulay said in an interview. “I think SGLT2 inhibitors are the new statin of this era. ... I won’t be surprised if in the next year or 2 or 3 they truly become the standard of care.”
Dr. Mulay also speaks from experience working in both the chronic and acute setting, where he’s observed “some magical stuff happening” in patients started on SGLT2 inhibitors, especially those in heart failure who are fluid overloaded.
“It’s phenomenal stuff,” Dr. Mulay said. “You can really stabilize patients’ hemodynamics.”
In the private health care setting, he described widespread enthusiasm among nephrologists, although others still appear skeptical.
“It’s really our cardiology colleagues that I feel are underprescribing it,” Dr. Mulay said. “So, I’m kind of taking it on myself, when I see a heart failure patient, to go ahead and put them on this.”
It’s unclear why some cardiologists seem apprehensive, Dr. Mulay continued, although he suggested that unclear guidelines and a lack of first-hand experience may be to blame.
Nephrologists and cardiologists sometimes agree
In the academic arena, Leslie Gewin, MD, associate professor at Washington University in St. Louis and the John Cochran VA Hospital, also in St. Louis, has seen similar support for SGLT2 inhibitors among both nephrologists and cardiologists.
“We had a joint nephrology-cardiology medicine grand rounds at Wash U in St. Louis maybe 2 weeks ago,” Dr. Gewin said in an interview. “The cardiologists and nephrologists tag-teamed to present data about SGLT2 inhibitors, and we kind of joked that this was the one thing we both could get behind and support.”
Still, she has seen some reluctance among non-nephrology clinicians lacking SGLT2 experience, specifically when managing patients who have poor kidney function.
“There can be some hesitancy among physicians if the GFR is low,” Dr. Gewin said. “That’s where I’ve had to sort of push the envelope with non-nephrologists, saying: ‘Look, we feel pretty comfortable starting down to a GFR of about 20.’ ”
Early rises in creatinine may also spook providers, she noted.
“Sometimes, when we start SGLT2 inhibitors, the creatinine increases slightly, and the [primary care provider] gets concerned,” Dr. Gewin said. “We say: ‘No, this is expected. Don’t worry, hold the course, this is a good drug.’ ”
Like Dr. Mulay, Dr. Gewin said the present study offers further encouragement for the efficacy of this drug class. She also said sufficient data have been published to allay earlier concerns about potential safety signals, such as bone fractures and amputations.
“SGLT2 inhibitors seem to be a lot safer than what we initially had thought,” Dr. Gewin said. “That’s very encouraging.”
The study was funded by AstraZeneca. The investigators disclosed additional relationships with Bayer, Janssen, Gilead, and others. Dr. Gewin and Dr. Mulay disclosed no relevant conflicts of interest.
These findings add to a growing body of evidence supporting a range of positive benefits from dapagliflozin, including reduced risks of mortality, cardiovascular events, and kidney events, lead author Meir Schechter, MD, PhD, of the Hebrew University of Jerusalem and colleagues wrote in Annals of Internal Medicine.“Although cardiovascular and kidney outcomes with SGLT2 inhibitors have been studied extensively, there is a paucity of data evaluating the effects of SGLT2 inhibitors on hospitalizations for any cause.”
The findings are based on a post hoc analysis of the DAPA-CKD trial, which involved 4,304 patients with CKD in 21 countries. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once a day or matching placebo. The present analysis quantified first hospitalizations for any cause, all hospitalizations, cause-specific hospitalizations, and several related outcomes.
After a median follow-up of 2.4 years, 28% of the population had been hospitalized a total of 2,072 times.
Compared with placebo, dapagliflozin significantly reduced risk of first hospitalization by 16% (hazard ratio, 0.84; 95% confidence interval, 0.75-0.94) and rate of all hospitalizations by 21% (rate ratio, 0.79; 95% CI, 0.70-0.89). These findings remained significant regardless of type 2 diabetes status, with significant benefits seen across reasons for admission, including renal/urinary disorders, cardiac disorders, neoplasms, and metabolism/nutrition disorders. In addition, dapagliflozin was associated with shorter mean time in hospital (2.3 vs. 2.8 days; P = .027) and longer time alive and out of hospital (354.9 vs. 351.7; P = .023).
“These findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR [estimated glomerular filtration rate] slope, and albuminuria and should be considered when evaluating the totality of evidence favoring provision of dapagliflozin to patients with CKD,” the investigators concluded.
Positive data, positive experiences
Shree Mulay, MD, a nephrologist in private practice in western Tennessee, said this study is “one of several other articles that already exist” demonstrating the broad benefits of SGLT2 inhibitors.
“The evidence is pretty substantial,” Dr. Mulay said in an interview. “I think SGLT2 inhibitors are the new statin of this era. ... I won’t be surprised if in the next year or 2 or 3 they truly become the standard of care.”
Dr. Mulay also speaks from experience working in both the chronic and acute setting, where he’s observed “some magical stuff happening” in patients started on SGLT2 inhibitors, especially those in heart failure who are fluid overloaded.
“It’s phenomenal stuff,” Dr. Mulay said. “You can really stabilize patients’ hemodynamics.”
In the private health care setting, he described widespread enthusiasm among nephrologists, although others still appear skeptical.
“It’s really our cardiology colleagues that I feel are underprescribing it,” Dr. Mulay said. “So, I’m kind of taking it on myself, when I see a heart failure patient, to go ahead and put them on this.”
It’s unclear why some cardiologists seem apprehensive, Dr. Mulay continued, although he suggested that unclear guidelines and a lack of first-hand experience may be to blame.
Nephrologists and cardiologists sometimes agree
In the academic arena, Leslie Gewin, MD, associate professor at Washington University in St. Louis and the John Cochran VA Hospital, also in St. Louis, has seen similar support for SGLT2 inhibitors among both nephrologists and cardiologists.
“We had a joint nephrology-cardiology medicine grand rounds at Wash U in St. Louis maybe 2 weeks ago,” Dr. Gewin said in an interview. “The cardiologists and nephrologists tag-teamed to present data about SGLT2 inhibitors, and we kind of joked that this was the one thing we both could get behind and support.”
Still, she has seen some reluctance among non-nephrology clinicians lacking SGLT2 experience, specifically when managing patients who have poor kidney function.
“There can be some hesitancy among physicians if the GFR is low,” Dr. Gewin said. “That’s where I’ve had to sort of push the envelope with non-nephrologists, saying: ‘Look, we feel pretty comfortable starting down to a GFR of about 20.’ ”
Early rises in creatinine may also spook providers, she noted.
“Sometimes, when we start SGLT2 inhibitors, the creatinine increases slightly, and the [primary care provider] gets concerned,” Dr. Gewin said. “We say: ‘No, this is expected. Don’t worry, hold the course, this is a good drug.’ ”
Like Dr. Mulay, Dr. Gewin said the present study offers further encouragement for the efficacy of this drug class. She also said sufficient data have been published to allay earlier concerns about potential safety signals, such as bone fractures and amputations.
“SGLT2 inhibitors seem to be a lot safer than what we initially had thought,” Dr. Gewin said. “That’s very encouraging.”
The study was funded by AstraZeneca. The investigators disclosed additional relationships with Bayer, Janssen, Gilead, and others. Dr. Gewin and Dr. Mulay disclosed no relevant conflicts of interest.
These findings add to a growing body of evidence supporting a range of positive benefits from dapagliflozin, including reduced risks of mortality, cardiovascular events, and kidney events, lead author Meir Schechter, MD, PhD, of the Hebrew University of Jerusalem and colleagues wrote in Annals of Internal Medicine.“Although cardiovascular and kidney outcomes with SGLT2 inhibitors have been studied extensively, there is a paucity of data evaluating the effects of SGLT2 inhibitors on hospitalizations for any cause.”
The findings are based on a post hoc analysis of the DAPA-CKD trial, which involved 4,304 patients with CKD in 21 countries. Patients were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once a day or matching placebo. The present analysis quantified first hospitalizations for any cause, all hospitalizations, cause-specific hospitalizations, and several related outcomes.
After a median follow-up of 2.4 years, 28% of the population had been hospitalized a total of 2,072 times.
Compared with placebo, dapagliflozin significantly reduced risk of first hospitalization by 16% (hazard ratio, 0.84; 95% confidence interval, 0.75-0.94) and rate of all hospitalizations by 21% (rate ratio, 0.79; 95% CI, 0.70-0.89). These findings remained significant regardless of type 2 diabetes status, with significant benefits seen across reasons for admission, including renal/urinary disorders, cardiac disorders, neoplasms, and metabolism/nutrition disorders. In addition, dapagliflozin was associated with shorter mean time in hospital (2.3 vs. 2.8 days; P = .027) and longer time alive and out of hospital (354.9 vs. 351.7; P = .023).
“These findings highlight additional benefits of dapagliflozin beyond those seen for cardiovascular and kidney events, all-cause and cause-specific mortality, eGFR [estimated glomerular filtration rate] slope, and albuminuria and should be considered when evaluating the totality of evidence favoring provision of dapagliflozin to patients with CKD,” the investigators concluded.
Positive data, positive experiences
Shree Mulay, MD, a nephrologist in private practice in western Tennessee, said this study is “one of several other articles that already exist” demonstrating the broad benefits of SGLT2 inhibitors.
“The evidence is pretty substantial,” Dr. Mulay said in an interview. “I think SGLT2 inhibitors are the new statin of this era. ... I won’t be surprised if in the next year or 2 or 3 they truly become the standard of care.”
Dr. Mulay also speaks from experience working in both the chronic and acute setting, where he’s observed “some magical stuff happening” in patients started on SGLT2 inhibitors, especially those in heart failure who are fluid overloaded.
“It’s phenomenal stuff,” Dr. Mulay said. “You can really stabilize patients’ hemodynamics.”
In the private health care setting, he described widespread enthusiasm among nephrologists, although others still appear skeptical.
“It’s really our cardiology colleagues that I feel are underprescribing it,” Dr. Mulay said. “So, I’m kind of taking it on myself, when I see a heart failure patient, to go ahead and put them on this.”
It’s unclear why some cardiologists seem apprehensive, Dr. Mulay continued, although he suggested that unclear guidelines and a lack of first-hand experience may be to blame.
Nephrologists and cardiologists sometimes agree
In the academic arena, Leslie Gewin, MD, associate professor at Washington University in St. Louis and the John Cochran VA Hospital, also in St. Louis, has seen similar support for SGLT2 inhibitors among both nephrologists and cardiologists.
“We had a joint nephrology-cardiology medicine grand rounds at Wash U in St. Louis maybe 2 weeks ago,” Dr. Gewin said in an interview. “The cardiologists and nephrologists tag-teamed to present data about SGLT2 inhibitors, and we kind of joked that this was the one thing we both could get behind and support.”
Still, she has seen some reluctance among non-nephrology clinicians lacking SGLT2 experience, specifically when managing patients who have poor kidney function.
“There can be some hesitancy among physicians if the GFR is low,” Dr. Gewin said. “That’s where I’ve had to sort of push the envelope with non-nephrologists, saying: ‘Look, we feel pretty comfortable starting down to a GFR of about 20.’ ”
Early rises in creatinine may also spook providers, she noted.
“Sometimes, when we start SGLT2 inhibitors, the creatinine increases slightly, and the [primary care provider] gets concerned,” Dr. Gewin said. “We say: ‘No, this is expected. Don’t worry, hold the course, this is a good drug.’ ”
Like Dr. Mulay, Dr. Gewin said the present study offers further encouragement for the efficacy of this drug class. She also said sufficient data have been published to allay earlier concerns about potential safety signals, such as bone fractures and amputations.
“SGLT2 inhibitors seem to be a lot safer than what we initially had thought,” Dr. Gewin said. “That’s very encouraging.”
The study was funded by AstraZeneca. The investigators disclosed additional relationships with Bayer, Janssen, Gilead, and others. Dr. Gewin and Dr. Mulay disclosed no relevant conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
New guidelines say pediatricians should screen for anxiety: Now what?
Recently the U.S. Preventive Services Task Force issued a formal recommendation that adolescents and children as young as 8 should be screened for anxiety.1 The advice was based on a review of the research that concluded that anxiety disorders were common in youth (prevalence around 8%), screening was not overly burdensome or dangerous, and treatments were available and effective.
While pediatricians fully appreciate how common clinically significant anxiety is and its impact on the lives of youth, the reception for the recommendations have been mixed. Some are concerned that it could lead to the overprescribing of medications. Arguably, the biggest pushback, however, relates to the question of what to do when a child screens positive in a time when finding an available child and adolescent psychiatrist or other type of pediatric mental health professional can feel next to impossible. The hope of this article is to fill in some of those gaps.
Screening for anxiety disorders
The recommendations suggest using a rating scale as part of the screen but doesn’t dictate which one. A common instrument that has been employed is the Screen for Child Anxiety and Related Disorders, which is a freely available 41-item instrument that has versions for youth self-report and parent-report. A shorter 7-item rating scale, the General Anxiety Disorder–7, and the even shorter GAD-2 (the first two questions of the GAD-7), are also popular but focus, as the name applies, on general anxiety disorder and not related conditions such as social or separation anxiety that can have some different symptoms. These instruments can be given to patients and families in the waiting room or administered with the help of a nurse, physician, or embedded mental health professional. The recommendations do not include specific guidance on how often the screening should be done but repeated screenings are likely important at some interval.
Confirming the diagnosis
Of course, a screening isn’t a formal diagnosis. The American Academy of Pediatrics has expressed the view that the initial diagnosis and treatment for anxiety disorders is well within a pediatrician’s scope of practice, which means further steps are likely required beyond a referral. Fortunately, going from a positive screen to an initial diagnosis does not have to overly laborious and can focus on reviewing the DSM-5 criteria for key anxiety disorders while also ensuring that there isn’t a nonpsychiatric cause driving the symptoms, such as the often cited but rarely seen pheochromocytoma. More common rule-outs include medication-induced anxiety or substance use, excessive caffeine intake, and cardiac arrhythmias. Assessing for current and past trauma or specific causes of the anxiety such as bullying are also important.
It is important to note that it is the rule rather than the exception that youth with clinical levels of anxiety will frequently endorse a number of criteria that span multiple diagnoses including generalized anxiety disorder, social anxiety disorder, and separation anxiety disorder.2 Spending a lot of effort to narrow things down to a single anxiety diagnosis often is unnecessary, as both pharmacologic and nonpharmacologic treatments don’t change all that much between individual diagnoses.
Explaining the diagnosis
In general, I’m a strong proponent of trying to explain any behavioral diagnoses that you make to kids in a way that is accurate but nonstigmatizing. When it comes to anxiety, one parallel I often draw is to our immune system, which most youth understand at least in basic terms. Both our immune system and our anxiety networks are natural and important; as a species, we wouldn’t have lasted long without them. Both are built to assess and respond to threats. Problems can arise, however, if the response is too strong relative to the threat or the response is activated when it doesn’t need to be. Treatment is directed not at ridding ourselves of anxiety but at helping regulate it so it works for us and not against us. Spending a few minutes going through a discussion like this can be very helpful, and perhaps more so than some dry summary of DSM-5 criteria.
Starting treatment
It is important to note that best practice recommendations when it comes to the treatment of anxiety disorder in youth do not suggest medications as the only type of treatment and often urge clinicians to try nonpharmacological interventions first.3 A specific type of psychotherapy called cognitive-behavioral therapy has the strongest scientific support as an effective treatment for anxiety but other modalities, including parenting guidance, can be helpful as well. Consequently, a referral to a good psychotherapist is paramount. For many kids, the key to overcoming anxiety is exposure: which means confronting anxiety slowly, with support, and with specific skills.
If there is a traumatic source of the anxiety, addressing that as much as possible is obviously critical and could involve working with the family or school. For some kids, this may involve frightening things they are seeing online or through other media. Finally, some health promotion activities such as exercise or mindfulness can also be quite useful.
Despite the fact that SSRIs are referred to as antidepressants, there is increasing appreciation that these medications are useful for anxiety, perhaps even more so than for mood. While only one medication, duloxetine, has Food and Drug Administration approval to treat anxiety in children as young as 7, there is good evidence to support the use of many of the most common SSRIs in treating clinical anxiety. Buspirone, beta-blockers, and antihistamine medications like hydroxyzine also can have their place in treatment, while benzodiazepines and antipsychotic medications are generally best avoided for anxious youth, especially in the primary care setting. A short but helpful medication guide with regard to pediatric anxiety has been published by the American Academy of Child and Adolescent Psychiatry.4
Conclusions
Clinical levels of anxiety in children and adolescents are both common and quite treatable, which has prompted new recommendations that primary care clinicians screen for them starting at age 8. While this recommendation may at first seem like yet one more task to fit in, following the guidance can be accomplished with the help of short screening tools and a managed multimodal approach to treatment.
Dr. Rettew is a child and adolescent psychiatrist with Lane County Behavioral Health in Eugene, Ore., and Oregon Health & Science University, Portland. You can follow him on Twitter and Facebook @PediPsych.
References
1. U.S. Preventive Services Task Force. JAMA. 2022;328(14):1438-44.
2. Strawn JR. Curr Psychiatry. 2012;11(9):16-21.
3. Walter HJ et al. J Am Acad Child Adolesc Psychiatry. 2020;59(10):1107-24.
4. Anxiety Disorders: Parents’ Medication Guide Workgroup. “Anxiety disorders: Parents’ medication guide.” Washington D.C.: American Academy of Child & Adolescent Psychiatry, 2020.
Recently the U.S. Preventive Services Task Force issued a formal recommendation that adolescents and children as young as 8 should be screened for anxiety.1 The advice was based on a review of the research that concluded that anxiety disorders were common in youth (prevalence around 8%), screening was not overly burdensome or dangerous, and treatments were available and effective.
While pediatricians fully appreciate how common clinically significant anxiety is and its impact on the lives of youth, the reception for the recommendations have been mixed. Some are concerned that it could lead to the overprescribing of medications. Arguably, the biggest pushback, however, relates to the question of what to do when a child screens positive in a time when finding an available child and adolescent psychiatrist or other type of pediatric mental health professional can feel next to impossible. The hope of this article is to fill in some of those gaps.
Screening for anxiety disorders
The recommendations suggest using a rating scale as part of the screen but doesn’t dictate which one. A common instrument that has been employed is the Screen for Child Anxiety and Related Disorders, which is a freely available 41-item instrument that has versions for youth self-report and parent-report. A shorter 7-item rating scale, the General Anxiety Disorder–7, and the even shorter GAD-2 (the first two questions of the GAD-7), are also popular but focus, as the name applies, on general anxiety disorder and not related conditions such as social or separation anxiety that can have some different symptoms. These instruments can be given to patients and families in the waiting room or administered with the help of a nurse, physician, or embedded mental health professional. The recommendations do not include specific guidance on how often the screening should be done but repeated screenings are likely important at some interval.
Confirming the diagnosis
Of course, a screening isn’t a formal diagnosis. The American Academy of Pediatrics has expressed the view that the initial diagnosis and treatment for anxiety disorders is well within a pediatrician’s scope of practice, which means further steps are likely required beyond a referral. Fortunately, going from a positive screen to an initial diagnosis does not have to overly laborious and can focus on reviewing the DSM-5 criteria for key anxiety disorders while also ensuring that there isn’t a nonpsychiatric cause driving the symptoms, such as the often cited but rarely seen pheochromocytoma. More common rule-outs include medication-induced anxiety or substance use, excessive caffeine intake, and cardiac arrhythmias. Assessing for current and past trauma or specific causes of the anxiety such as bullying are also important.
It is important to note that it is the rule rather than the exception that youth with clinical levels of anxiety will frequently endorse a number of criteria that span multiple diagnoses including generalized anxiety disorder, social anxiety disorder, and separation anxiety disorder.2 Spending a lot of effort to narrow things down to a single anxiety diagnosis often is unnecessary, as both pharmacologic and nonpharmacologic treatments don’t change all that much between individual diagnoses.
Explaining the diagnosis
In general, I’m a strong proponent of trying to explain any behavioral diagnoses that you make to kids in a way that is accurate but nonstigmatizing. When it comes to anxiety, one parallel I often draw is to our immune system, which most youth understand at least in basic terms. Both our immune system and our anxiety networks are natural and important; as a species, we wouldn’t have lasted long without them. Both are built to assess and respond to threats. Problems can arise, however, if the response is too strong relative to the threat or the response is activated when it doesn’t need to be. Treatment is directed not at ridding ourselves of anxiety but at helping regulate it so it works for us and not against us. Spending a few minutes going through a discussion like this can be very helpful, and perhaps more so than some dry summary of DSM-5 criteria.
Starting treatment
It is important to note that best practice recommendations when it comes to the treatment of anxiety disorder in youth do not suggest medications as the only type of treatment and often urge clinicians to try nonpharmacological interventions first.3 A specific type of psychotherapy called cognitive-behavioral therapy has the strongest scientific support as an effective treatment for anxiety but other modalities, including parenting guidance, can be helpful as well. Consequently, a referral to a good psychotherapist is paramount. For many kids, the key to overcoming anxiety is exposure: which means confronting anxiety slowly, with support, and with specific skills.
If there is a traumatic source of the anxiety, addressing that as much as possible is obviously critical and could involve working with the family or school. For some kids, this may involve frightening things they are seeing online or through other media. Finally, some health promotion activities such as exercise or mindfulness can also be quite useful.
Despite the fact that SSRIs are referred to as antidepressants, there is increasing appreciation that these medications are useful for anxiety, perhaps even more so than for mood. While only one medication, duloxetine, has Food and Drug Administration approval to treat anxiety in children as young as 7, there is good evidence to support the use of many of the most common SSRIs in treating clinical anxiety. Buspirone, beta-blockers, and antihistamine medications like hydroxyzine also can have their place in treatment, while benzodiazepines and antipsychotic medications are generally best avoided for anxious youth, especially in the primary care setting. A short but helpful medication guide with regard to pediatric anxiety has been published by the American Academy of Child and Adolescent Psychiatry.4
Conclusions
Clinical levels of anxiety in children and adolescents are both common and quite treatable, which has prompted new recommendations that primary care clinicians screen for them starting at age 8. While this recommendation may at first seem like yet one more task to fit in, following the guidance can be accomplished with the help of short screening tools and a managed multimodal approach to treatment.
Dr. Rettew is a child and adolescent psychiatrist with Lane County Behavioral Health in Eugene, Ore., and Oregon Health & Science University, Portland. You can follow him on Twitter and Facebook @PediPsych.
References
1. U.S. Preventive Services Task Force. JAMA. 2022;328(14):1438-44.
2. Strawn JR. Curr Psychiatry. 2012;11(9):16-21.
3. Walter HJ et al. J Am Acad Child Adolesc Psychiatry. 2020;59(10):1107-24.
4. Anxiety Disorders: Parents’ Medication Guide Workgroup. “Anxiety disorders: Parents’ medication guide.” Washington D.C.: American Academy of Child & Adolescent Psychiatry, 2020.
Recently the U.S. Preventive Services Task Force issued a formal recommendation that adolescents and children as young as 8 should be screened for anxiety.1 The advice was based on a review of the research that concluded that anxiety disorders were common in youth (prevalence around 8%), screening was not overly burdensome or dangerous, and treatments were available and effective.
While pediatricians fully appreciate how common clinically significant anxiety is and its impact on the lives of youth, the reception for the recommendations have been mixed. Some are concerned that it could lead to the overprescribing of medications. Arguably, the biggest pushback, however, relates to the question of what to do when a child screens positive in a time when finding an available child and adolescent psychiatrist or other type of pediatric mental health professional can feel next to impossible. The hope of this article is to fill in some of those gaps.
Screening for anxiety disorders
The recommendations suggest using a rating scale as part of the screen but doesn’t dictate which one. A common instrument that has been employed is the Screen for Child Anxiety and Related Disorders, which is a freely available 41-item instrument that has versions for youth self-report and parent-report. A shorter 7-item rating scale, the General Anxiety Disorder–7, and the even shorter GAD-2 (the first two questions of the GAD-7), are also popular but focus, as the name applies, on general anxiety disorder and not related conditions such as social or separation anxiety that can have some different symptoms. These instruments can be given to patients and families in the waiting room or administered with the help of a nurse, physician, or embedded mental health professional. The recommendations do not include specific guidance on how often the screening should be done but repeated screenings are likely important at some interval.
Confirming the diagnosis
Of course, a screening isn’t a formal diagnosis. The American Academy of Pediatrics has expressed the view that the initial diagnosis and treatment for anxiety disorders is well within a pediatrician’s scope of practice, which means further steps are likely required beyond a referral. Fortunately, going from a positive screen to an initial diagnosis does not have to overly laborious and can focus on reviewing the DSM-5 criteria for key anxiety disorders while also ensuring that there isn’t a nonpsychiatric cause driving the symptoms, such as the often cited but rarely seen pheochromocytoma. More common rule-outs include medication-induced anxiety or substance use, excessive caffeine intake, and cardiac arrhythmias. Assessing for current and past trauma or specific causes of the anxiety such as bullying are also important.
It is important to note that it is the rule rather than the exception that youth with clinical levels of anxiety will frequently endorse a number of criteria that span multiple diagnoses including generalized anxiety disorder, social anxiety disorder, and separation anxiety disorder.2 Spending a lot of effort to narrow things down to a single anxiety diagnosis often is unnecessary, as both pharmacologic and nonpharmacologic treatments don’t change all that much between individual diagnoses.
Explaining the diagnosis
In general, I’m a strong proponent of trying to explain any behavioral diagnoses that you make to kids in a way that is accurate but nonstigmatizing. When it comes to anxiety, one parallel I often draw is to our immune system, which most youth understand at least in basic terms. Both our immune system and our anxiety networks are natural and important; as a species, we wouldn’t have lasted long without them. Both are built to assess and respond to threats. Problems can arise, however, if the response is too strong relative to the threat or the response is activated when it doesn’t need to be. Treatment is directed not at ridding ourselves of anxiety but at helping regulate it so it works for us and not against us. Spending a few minutes going through a discussion like this can be very helpful, and perhaps more so than some dry summary of DSM-5 criteria.
Starting treatment
It is important to note that best practice recommendations when it comes to the treatment of anxiety disorder in youth do not suggest medications as the only type of treatment and often urge clinicians to try nonpharmacological interventions first.3 A specific type of psychotherapy called cognitive-behavioral therapy has the strongest scientific support as an effective treatment for anxiety but other modalities, including parenting guidance, can be helpful as well. Consequently, a referral to a good psychotherapist is paramount. For many kids, the key to overcoming anxiety is exposure: which means confronting anxiety slowly, with support, and with specific skills.
If there is a traumatic source of the anxiety, addressing that as much as possible is obviously critical and could involve working with the family or school. For some kids, this may involve frightening things they are seeing online or through other media. Finally, some health promotion activities such as exercise or mindfulness can also be quite useful.
Despite the fact that SSRIs are referred to as antidepressants, there is increasing appreciation that these medications are useful for anxiety, perhaps even more so than for mood. While only one medication, duloxetine, has Food and Drug Administration approval to treat anxiety in children as young as 7, there is good evidence to support the use of many of the most common SSRIs in treating clinical anxiety. Buspirone, beta-blockers, and antihistamine medications like hydroxyzine also can have their place in treatment, while benzodiazepines and antipsychotic medications are generally best avoided for anxious youth, especially in the primary care setting. A short but helpful medication guide with regard to pediatric anxiety has been published by the American Academy of Child and Adolescent Psychiatry.4
Conclusions
Clinical levels of anxiety in children and adolescents are both common and quite treatable, which has prompted new recommendations that primary care clinicians screen for them starting at age 8. While this recommendation may at first seem like yet one more task to fit in, following the guidance can be accomplished with the help of short screening tools and a managed multimodal approach to treatment.
Dr. Rettew is a child and adolescent psychiatrist with Lane County Behavioral Health in Eugene, Ore., and Oregon Health & Science University, Portland. You can follow him on Twitter and Facebook @PediPsych.
References
1. U.S. Preventive Services Task Force. JAMA. 2022;328(14):1438-44.
2. Strawn JR. Curr Psychiatry. 2012;11(9):16-21.
3. Walter HJ et al. J Am Acad Child Adolesc Psychiatry. 2020;59(10):1107-24.
4. Anxiety Disorders: Parents’ Medication Guide Workgroup. “Anxiety disorders: Parents’ medication guide.” Washington D.C.: American Academy of Child & Adolescent Psychiatry, 2020.
Strong two-way link between epilepsy and depression
, with implications for diagnosis and patient care. The findings “strongly support previous observations of a bidirectional association between these two brain disorders,” said Eva Bølling-Ladegaard, MD, a PhD student, department of clinical medicine (Neurology), Aarhus (Denmark) University.
“We add to the existing evidence in temporal range, showing that the increased risks of depression following epilepsy, and vice versa, are sustained over a much more extended time period than previously shown; that is, 20 years on both sides of receiving a diagnosis of the index disorder,” Ms. Bølling-Ladegaard said.
The study was published online in Neurology.
Epilepsy then depression
The researchers examined the magnitude and long-term temporal association between epilepsy and depression. They compared the risk of the two brain disorders following another chronic disorder (asthma) in a nationwide, register-based, matched cohort study.
In a population of more than 8.7 million people, they identified 139,014 persons with epilepsy (54% males; median age at diagnosis, 43 years), 219,990 with depression (37% males; median age at diagnosis, 43 years), and 358,821 with asthma (49% males; median age at diagnosis, 29 years).
The rate of developing depression was increased nearly twofold among people with epilepsy compared with the matched population who did not have epilepsy (adjusted hazard ratio, 1.88; 95% confidence interval, 1.82-1.95).
The rate of depression was highest during the first months and years after epilepsy diagnosis. It declined over time, yet remained significantly elevated throughout the 20+ years of observation.
The cumulative incidence of depression at 5 and 35 years’ follow-up in the epilepsy cohort was 1.37% and 6.05%, respectively, compared with 0.59% and 3.92% in the reference population.
The highest rate of depression after epilepsy was among individuals aged 40-59 years, and the lowest was among those aged 0-19 years at first epilepsy diagnosis.
Depression then epilepsy
The rate of developing epilepsy was increased more than twofold among patients with incident depression compared with the matched population who were without depression (aHR, 2.35; 95% CI, 2.25-2.44).
As in the opposite analysis, the rate of epilepsy was highest during the first months and years after depression diagnosis and declined over time.
The cumulative incidence of epilepsy at 5 and 35 years after depression diagnosis was 1.10% and 4.19%, respectively, compared with 0.32% and 2.06% in the reference population.
The rate of epilepsy was highest among those aged 0-19 years at time of first depression diagnosis and was lowest among those aged 80+ at first depression diagnosis.
For comparison, after asthma diagnosis, rates of depression and epilepsy were increased 1.63-fold (95% CI, 1.59-1.67) and 1.48-fold (95% CI, 1.44-1.53), respectively, compared with matched individuals without asthma.
Using admission with seizures as a proxy for treatment failure, the researchers observed an increased risk of treatment failure among people with epilepsy who were diagnosed with depression.
“Our results support previous findings indicating worse seizure outcomes in people with epilepsy and coexisting depression,” said Ms. Bølling-Ladegaard.
“Increased clinical awareness of the association between epilepsy and depression is therefore needed in order to increase the proportion of patients that receive appropriate treatment and improve outcomes for these patient groups,” she said.
Clinical implications
Reached for comment, Zulfi Haneef, MBBS, MD, associate professor of neurology, Baylor College of Medicine, Houston, noted that the link between epilepsy and depression is “well-known.”
“However, typically one thinks of epilepsy as leading to depression, not vice versa. Here they show the risk of epilepsy following depression to be high (highest of the risks given), which is thought provoking. However, association does not imply causation,” Dr. Haneef said.
“Prima facie, there is no biological rationale for depression to lead to epilepsy,” he said. He noted that some antidepressants can reduce the seizure threshold.
The findings do have implications for care, he said.
“For neurologists, this is another study that exhorts them to screen for depression and treat adequately in all patients with epilepsy,” Dr. Haneef said.
“For psychiatrists, this study may give guidance to watch more carefully for seizures in patients with depression, especially when using antidepressant medications that induce seizures.
“For the general public with either epilepsy or depression, it would help them be aware about this bidirectional association,” Dr. Haneef said.
The study was funded by the Lundbeck Foundation, the Danish Epilepsy Association, and the Novo Nordisk Foundation. Ms. Bølling-Ladegaard and Dr. Haneef have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, with implications for diagnosis and patient care. The findings “strongly support previous observations of a bidirectional association between these two brain disorders,” said Eva Bølling-Ladegaard, MD, a PhD student, department of clinical medicine (Neurology), Aarhus (Denmark) University.
“We add to the existing evidence in temporal range, showing that the increased risks of depression following epilepsy, and vice versa, are sustained over a much more extended time period than previously shown; that is, 20 years on both sides of receiving a diagnosis of the index disorder,” Ms. Bølling-Ladegaard said.
The study was published online in Neurology.
Epilepsy then depression
The researchers examined the magnitude and long-term temporal association between epilepsy and depression. They compared the risk of the two brain disorders following another chronic disorder (asthma) in a nationwide, register-based, matched cohort study.
In a population of more than 8.7 million people, they identified 139,014 persons with epilepsy (54% males; median age at diagnosis, 43 years), 219,990 with depression (37% males; median age at diagnosis, 43 years), and 358,821 with asthma (49% males; median age at diagnosis, 29 years).
The rate of developing depression was increased nearly twofold among people with epilepsy compared with the matched population who did not have epilepsy (adjusted hazard ratio, 1.88; 95% confidence interval, 1.82-1.95).
The rate of depression was highest during the first months and years after epilepsy diagnosis. It declined over time, yet remained significantly elevated throughout the 20+ years of observation.
The cumulative incidence of depression at 5 and 35 years’ follow-up in the epilepsy cohort was 1.37% and 6.05%, respectively, compared with 0.59% and 3.92% in the reference population.
The highest rate of depression after epilepsy was among individuals aged 40-59 years, and the lowest was among those aged 0-19 years at first epilepsy diagnosis.
Depression then epilepsy
The rate of developing epilepsy was increased more than twofold among patients with incident depression compared with the matched population who were without depression (aHR, 2.35; 95% CI, 2.25-2.44).
As in the opposite analysis, the rate of epilepsy was highest during the first months and years after depression diagnosis and declined over time.
The cumulative incidence of epilepsy at 5 and 35 years after depression diagnosis was 1.10% and 4.19%, respectively, compared with 0.32% and 2.06% in the reference population.
The rate of epilepsy was highest among those aged 0-19 years at time of first depression diagnosis and was lowest among those aged 80+ at first depression diagnosis.
For comparison, after asthma diagnosis, rates of depression and epilepsy were increased 1.63-fold (95% CI, 1.59-1.67) and 1.48-fold (95% CI, 1.44-1.53), respectively, compared with matched individuals without asthma.
Using admission with seizures as a proxy for treatment failure, the researchers observed an increased risk of treatment failure among people with epilepsy who were diagnosed with depression.
“Our results support previous findings indicating worse seizure outcomes in people with epilepsy and coexisting depression,” said Ms. Bølling-Ladegaard.
“Increased clinical awareness of the association between epilepsy and depression is therefore needed in order to increase the proportion of patients that receive appropriate treatment and improve outcomes for these patient groups,” she said.
Clinical implications
Reached for comment, Zulfi Haneef, MBBS, MD, associate professor of neurology, Baylor College of Medicine, Houston, noted that the link between epilepsy and depression is “well-known.”
“However, typically one thinks of epilepsy as leading to depression, not vice versa. Here they show the risk of epilepsy following depression to be high (highest of the risks given), which is thought provoking. However, association does not imply causation,” Dr. Haneef said.
“Prima facie, there is no biological rationale for depression to lead to epilepsy,” he said. He noted that some antidepressants can reduce the seizure threshold.
The findings do have implications for care, he said.
“For neurologists, this is another study that exhorts them to screen for depression and treat adequately in all patients with epilepsy,” Dr. Haneef said.
“For psychiatrists, this study may give guidance to watch more carefully for seizures in patients with depression, especially when using antidepressant medications that induce seizures.
“For the general public with either epilepsy or depression, it would help them be aware about this bidirectional association,” Dr. Haneef said.
The study was funded by the Lundbeck Foundation, the Danish Epilepsy Association, and the Novo Nordisk Foundation. Ms. Bølling-Ladegaard and Dr. Haneef have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, with implications for diagnosis and patient care. The findings “strongly support previous observations of a bidirectional association between these two brain disorders,” said Eva Bølling-Ladegaard, MD, a PhD student, department of clinical medicine (Neurology), Aarhus (Denmark) University.
“We add to the existing evidence in temporal range, showing that the increased risks of depression following epilepsy, and vice versa, are sustained over a much more extended time period than previously shown; that is, 20 years on both sides of receiving a diagnosis of the index disorder,” Ms. Bølling-Ladegaard said.
The study was published online in Neurology.
Epilepsy then depression
The researchers examined the magnitude and long-term temporal association between epilepsy and depression. They compared the risk of the two brain disorders following another chronic disorder (asthma) in a nationwide, register-based, matched cohort study.
In a population of more than 8.7 million people, they identified 139,014 persons with epilepsy (54% males; median age at diagnosis, 43 years), 219,990 with depression (37% males; median age at diagnosis, 43 years), and 358,821 with asthma (49% males; median age at diagnosis, 29 years).
The rate of developing depression was increased nearly twofold among people with epilepsy compared with the matched population who did not have epilepsy (adjusted hazard ratio, 1.88; 95% confidence interval, 1.82-1.95).
The rate of depression was highest during the first months and years after epilepsy diagnosis. It declined over time, yet remained significantly elevated throughout the 20+ years of observation.
The cumulative incidence of depression at 5 and 35 years’ follow-up in the epilepsy cohort was 1.37% and 6.05%, respectively, compared with 0.59% and 3.92% in the reference population.
The highest rate of depression after epilepsy was among individuals aged 40-59 years, and the lowest was among those aged 0-19 years at first epilepsy diagnosis.
Depression then epilepsy
The rate of developing epilepsy was increased more than twofold among patients with incident depression compared with the matched population who were without depression (aHR, 2.35; 95% CI, 2.25-2.44).
As in the opposite analysis, the rate of epilepsy was highest during the first months and years after depression diagnosis and declined over time.
The cumulative incidence of epilepsy at 5 and 35 years after depression diagnosis was 1.10% and 4.19%, respectively, compared with 0.32% and 2.06% in the reference population.
The rate of epilepsy was highest among those aged 0-19 years at time of first depression diagnosis and was lowest among those aged 80+ at first depression diagnosis.
For comparison, after asthma diagnosis, rates of depression and epilepsy were increased 1.63-fold (95% CI, 1.59-1.67) and 1.48-fold (95% CI, 1.44-1.53), respectively, compared with matched individuals without asthma.
Using admission with seizures as a proxy for treatment failure, the researchers observed an increased risk of treatment failure among people with epilepsy who were diagnosed with depression.
“Our results support previous findings indicating worse seizure outcomes in people with epilepsy and coexisting depression,” said Ms. Bølling-Ladegaard.
“Increased clinical awareness of the association between epilepsy and depression is therefore needed in order to increase the proportion of patients that receive appropriate treatment and improve outcomes for these patient groups,” she said.
Clinical implications
Reached for comment, Zulfi Haneef, MBBS, MD, associate professor of neurology, Baylor College of Medicine, Houston, noted that the link between epilepsy and depression is “well-known.”
“However, typically one thinks of epilepsy as leading to depression, not vice versa. Here they show the risk of epilepsy following depression to be high (highest of the risks given), which is thought provoking. However, association does not imply causation,” Dr. Haneef said.
“Prima facie, there is no biological rationale for depression to lead to epilepsy,” he said. He noted that some antidepressants can reduce the seizure threshold.
The findings do have implications for care, he said.
“For neurologists, this is another study that exhorts them to screen for depression and treat adequately in all patients with epilepsy,” Dr. Haneef said.
“For psychiatrists, this study may give guidance to watch more carefully for seizures in patients with depression, especially when using antidepressant medications that induce seizures.
“For the general public with either epilepsy or depression, it would help them be aware about this bidirectional association,” Dr. Haneef said.
The study was funded by the Lundbeck Foundation, the Danish Epilepsy Association, and the Novo Nordisk Foundation. Ms. Bølling-Ladegaard and Dr. Haneef have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
Infant BCG vaccine protects only those under age 5 years
Bacillus Calmette-Guérin (BCG) vaccines are given to more than 100 million children every year, but there is considerable debate regarding the effectiveness of BCG vaccination in preventing tuberculosis and death, particularly among older children and adults.
The most extensive study ever conducted on the efficacy of the BCG vaccine for protection against tuberculosis, stratified by age and history of previous tuberculosis, was published in September 2022 in The Lancet Global Health. The study, which comprises a systematic review and meta-analysis, analyzed individual-level data from 26 case-contact cohort studies published over the past 20 years. The studies included data from 70,000 participants. The primary outcome was a composite of prevalent (diagnosed at or within 90 days of baseline) and incident (diagnosed more than 90 days after baseline) tuberculosis in contacts exposed to tuberculosis. Secondary outcomes were pulmonary tuberculosis, extrapulmonary tuberculosis, and mortality.
Participants were characterized as having been exposed to tuberculosis if they were reported to have been a close contact (either living in the same household or having substantial interaction outside the household) of a person with microbiologically or radiologically diagnosed pulmonary tuberculosis. Previous tuberculosis was defined as a positive interferon-gamma (IFN-gamma) release assay or tuberculin skin test, also known as PPD or Mantoux test.
Most studies included in the analysis were conducted in the past 10 years in countries with a high tuberculosis burden. Those countries included India, South Africa, China, Vietnam, Indonesia, Uganda, the Gambia, and Brazil.
Primary outcomes
The study’s main findings included the following:
- The overall effectiveness of BCG vaccination against all forms of tuberculosis was 18% (adjusted odds ratio, 0.82; 95% CI, 0.74-0.91).
- Stratified by age, BCG vaccination only significantly protected against all tuberculosis in children younger than 5 years (aOR, 0.63; 95% CI, 0.49-0.81).
- There was no protective effect among those whose previous tests for tuberculosis were negative unless they were younger than 5 years (aOR, 0.54; 95% CI, 0.32-0.90).
- Among contacts who had a positive tuberculin skin test or IFN-gamma release assay, BCG vaccination significantly protected against tuberculosis among all participants (aOR, 0.81; 95% CI, 0.69-0.96), participants younger than 5 years (aOR, 0.68; 95% CI, 0.47-0.97), and participants aged 5-9 years (aOR, 0.62; 95% CI, 0.38-0.99).
- BCG vaccination was protective against pulmonary tuberculosis (19% effectiveness), but this effect was only seen in children younger than 3 years (42% effectiveness) when stratified by age.
- Protection against all tuberculosis and pulmonary tuberculosis was greater among female participants than male participants.
“This is a definitive BCG protection study because it involves a significant number of individuals evaluated using this meta-analysis. Protection is clearly lost with age. From as early as age 5, no protective effect can be observed. Protection, including against pulmonary tuberculosis, can be observed up to 3 years of age,” stated study author Julio Croda, MD, PhD, chair of the Brazilian Society of Tropical Medicine.
Dr. Croda emphasized that the findings from their study indicate that BCG vaccine protects against pulmonary tuberculosis and that those results differ from results of some previous studies.
“Every physician believes the BCG vaccine protects against serious forms of tuberculosis up to age 5. That fact is not surprising at all,” Dr. Croda remarked. “However, the fact that it protects against pulmonary tuberculosis, especially in children younger than 3, was surprising. In medical practice, we did not believe in this protection.”
Currently, 1.2% of new tuberculosis cases in Brazil occur among those younger than 5. Nevertheless, these cases represent 40.1% of new diagnoses recorded among those younger than 15, highlighting the importance of protection for this age group. An increase in extrapulmonary tuberculosis cases was recently observed in patients younger than 5.
Isabella Ballalai, MD, PhD, is deputy chair of the Brazilian Society of Immunizations. Although she did not participate in this study, she commented on its findings. “All publications are welcome; they help us think,” she explained. She emphasized that the BCG vaccine is not optimal. “There are studies indicating 80% efficacy and others indicating 0%. So, what we can look at is decades of effectiveness in practice.”
Dr. Ballalai explained that the BCG vaccine could keep severe forms of tuberculosis, meningitis, and miliary tuberculosis at bay. She shared her experience of caring for several patients with tuberculous meningitis shortly after she had graduated. “Today, thanks to the BCG vaccine, we don’t see it anymore.” However, she pointed out that the vaccine›s efficacy and effectiveness against pulmonary tuberculosis are low and that pulmonary tuberculosis remains the most significant problem among adults.
Dr. Ballalai also emphasized a few shortcomings of the study. “One is the definition of ‘vaccinated’ and ‘unvaccinated,’ which was based on the presence or absence of a mark on the arm. Today, we know that the absence of a mark does not indicate that the child has not been vaccinated, nor that the vaccine has not been effective. Therefore, several vaccinated participants may have been included amongst the unvaccinated participants.”
The authors emphasized that the definition of “vaccinated” and “unvaccinated” was based on a scar and on vaccination records, and they recognized that participants who did not have a scar on their arm could have been misclassified. Regardless, it is still considered a sensitive indicator. “Few vaccinated children from various settings do not show a scar years after vaccine administration,” they stated in their article.
Adults unprotected
Dr. Ballalai also shared her concerns regarding the lack of protection for older individuals. “We know those older than 60 are at greater risk for complications of tuberculosis. Individuals in this age group naturally have a lower immunity, and they usually have comorbidities. From this study, I can only conclude what was already expected: that adults who received a BCG vaccine as infants are not clear of pulmonary tuberculosis.”
Dr. Croda agreed that it was already evident that the BCG vaccine administered at birth did not provide protection for adults. “In the past, even with 80%-90% vaccine coverage, there were numerous tuberculosis cases in adults in Brazil.”
Are boosters needed?
The authors concluded that immunoprotection needs to be boosted in older populations, as vaccination at birth is ineffective for adolescents and adults. They have also discussed whether children older than 10 years and adults could benefit from a booster shot.
Dr. Croda emphasized that there is no indication for this, because there are no data regarding protection with a booster dose during adulthood. However, he cited a study conducted in South Africa in which the BCG vaccine was compared with another vaccine, and another study, which is being conducted in India, is assessing whether a BCG booster offers protection against pulmonary tuberculosis. “There are few studies. Perhaps the revaccination of more vulnerable groups could be of interest, but additional studies are needed first.”
Dr. Croda intends to assess revaccination in those deprived of liberty, in which the incidence of tuberculosis is very high. From 2015 to 2021, many new cases were recorded in this population in Brazil. The number rose from 5,860 to 6,773 during that period.
“However, BCG revaccination carries a significant risk of patients presenting with serious adverse events,” Dr. Ballalai pointed out. He noted that several years ago, to extend protection, Brazil adopted a booster program for persons aged 10 years or older, but the program was discontinued owing to the numerous adverse events reported and the absence of evidence of benefit from increased protection against tuberculosis.
“The adult groups at greater risk for severe tuberculosis manifestations normally presented with an underlying disease, particularly in immunocompromised patient groups. The [administration of the] BCG [vaccine] is contraindicated for those who are immunocompromised. And, for the older population, we do not have data on [vaccine] safety,” she emphasized.
Nonspecific immune protection
One of the study’s secondary outcomes regarded mortality. Four studies in the meta-analysis followed up tuberculosis contacts for death. In these studies, which evaluated 20,000 participants, BCG vaccination was shown to be significantly protective against death for participants younger than 15 years.
However, the authors urged caution in interpreting these data. They emphasized that they were unable to identify specific mechanisms by which BCG vaccination might have reduced mortality, and there are possible study biases that could have led to an overestimation of mortality benefit. Moreover, given the observational nature of the included studies, vaccinated children might have had higher socioeconomic status and greater access to health care, and they may have been more likely to have received other vaccinations, compared with children who did not receive BCG vaccines.
Nevertheless, previous experimental and observational studies have found that BCG vaccination might provide nonspecific or off-target immune protection against an array of other pathogens.
“In small studies conducted in Africa, those younger than 5 were protected not only against tuberculosis but also against other respiratory diseases,” Dr. Croda affirmed. “However, these are small studies, and for now, there is no recommendation for using BCG vaccination to prevent other respiratory infections.”
A long-awaited, critical study on the impact of the BCG vaccine on COVID-19, in which Brazilian researchers participated, will be published in the New England Journal of Medicine.
New vaccines needed
The BCG vaccine is one of the oldest vaccines, but there are still several crucial unanswered questions about its use.
Previously published studies that examined the protective effect of BCG vaccination only considered low-burden settings and the historical literature before 1950. These studies need updating, but doing so has not been a simple task. To answer their questions, individual-level participant data for a prespecified list of variables, including the characteristics of the exposed participant (contact), the index case, and the environment, were requested from authors of all eligible studies.
Much of the data used in the published research were found through discussions with authors and experts in the field, as well as through data deposited in data storage repositories, conference abstracts, dissertations, and even direct requests to the authors. “The Pan-American Health Organization helped with this data collection and contacting some authors,” said Dr. Croda.
With the new data, the authors confirmed that infant BCG vaccination, although important to young children who are at high risk for tuberculosis, does not prevent adult-type cavitary tuberculosis and is therefore insufficient to impede the tuberculosis epidemic. “Novel vaccines are urgently needed,” they concluded.
“We need to develop novel, more effective vaccines, which, when administered during infancy, would ensure lifelong protection,” Dr. Croda added.
Dr. Croda and Dr. Ballalai reported no relevant financial relationships.
This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.
Bacillus Calmette-Guérin (BCG) vaccines are given to more than 100 million children every year, but there is considerable debate regarding the effectiveness of BCG vaccination in preventing tuberculosis and death, particularly among older children and adults.
The most extensive study ever conducted on the efficacy of the BCG vaccine for protection against tuberculosis, stratified by age and history of previous tuberculosis, was published in September 2022 in The Lancet Global Health. The study, which comprises a systematic review and meta-analysis, analyzed individual-level data from 26 case-contact cohort studies published over the past 20 years. The studies included data from 70,000 participants. The primary outcome was a composite of prevalent (diagnosed at or within 90 days of baseline) and incident (diagnosed more than 90 days after baseline) tuberculosis in contacts exposed to tuberculosis. Secondary outcomes were pulmonary tuberculosis, extrapulmonary tuberculosis, and mortality.
Participants were characterized as having been exposed to tuberculosis if they were reported to have been a close contact (either living in the same household or having substantial interaction outside the household) of a person with microbiologically or radiologically diagnosed pulmonary tuberculosis. Previous tuberculosis was defined as a positive interferon-gamma (IFN-gamma) release assay or tuberculin skin test, also known as PPD or Mantoux test.
Most studies included in the analysis were conducted in the past 10 years in countries with a high tuberculosis burden. Those countries included India, South Africa, China, Vietnam, Indonesia, Uganda, the Gambia, and Brazil.
Primary outcomes
The study’s main findings included the following:
- The overall effectiveness of BCG vaccination against all forms of tuberculosis was 18% (adjusted odds ratio, 0.82; 95% CI, 0.74-0.91).
- Stratified by age, BCG vaccination only significantly protected against all tuberculosis in children younger than 5 years (aOR, 0.63; 95% CI, 0.49-0.81).
- There was no protective effect among those whose previous tests for tuberculosis were negative unless they were younger than 5 years (aOR, 0.54; 95% CI, 0.32-0.90).
- Among contacts who had a positive tuberculin skin test or IFN-gamma release assay, BCG vaccination significantly protected against tuberculosis among all participants (aOR, 0.81; 95% CI, 0.69-0.96), participants younger than 5 years (aOR, 0.68; 95% CI, 0.47-0.97), and participants aged 5-9 years (aOR, 0.62; 95% CI, 0.38-0.99).
- BCG vaccination was protective against pulmonary tuberculosis (19% effectiveness), but this effect was only seen in children younger than 3 years (42% effectiveness) when stratified by age.
- Protection against all tuberculosis and pulmonary tuberculosis was greater among female participants than male participants.
“This is a definitive BCG protection study because it involves a significant number of individuals evaluated using this meta-analysis. Protection is clearly lost with age. From as early as age 5, no protective effect can be observed. Protection, including against pulmonary tuberculosis, can be observed up to 3 years of age,” stated study author Julio Croda, MD, PhD, chair of the Brazilian Society of Tropical Medicine.
Dr. Croda emphasized that the findings from their study indicate that BCG vaccine protects against pulmonary tuberculosis and that those results differ from results of some previous studies.
“Every physician believes the BCG vaccine protects against serious forms of tuberculosis up to age 5. That fact is not surprising at all,” Dr. Croda remarked. “However, the fact that it protects against pulmonary tuberculosis, especially in children younger than 3, was surprising. In medical practice, we did not believe in this protection.”
Currently, 1.2% of new tuberculosis cases in Brazil occur among those younger than 5. Nevertheless, these cases represent 40.1% of new diagnoses recorded among those younger than 15, highlighting the importance of protection for this age group. An increase in extrapulmonary tuberculosis cases was recently observed in patients younger than 5.
Isabella Ballalai, MD, PhD, is deputy chair of the Brazilian Society of Immunizations. Although she did not participate in this study, she commented on its findings. “All publications are welcome; they help us think,” she explained. She emphasized that the BCG vaccine is not optimal. “There are studies indicating 80% efficacy and others indicating 0%. So, what we can look at is decades of effectiveness in practice.”
Dr. Ballalai explained that the BCG vaccine could keep severe forms of tuberculosis, meningitis, and miliary tuberculosis at bay. She shared her experience of caring for several patients with tuberculous meningitis shortly after she had graduated. “Today, thanks to the BCG vaccine, we don’t see it anymore.” However, she pointed out that the vaccine›s efficacy and effectiveness against pulmonary tuberculosis are low and that pulmonary tuberculosis remains the most significant problem among adults.
Dr. Ballalai also emphasized a few shortcomings of the study. “One is the definition of ‘vaccinated’ and ‘unvaccinated,’ which was based on the presence or absence of a mark on the arm. Today, we know that the absence of a mark does not indicate that the child has not been vaccinated, nor that the vaccine has not been effective. Therefore, several vaccinated participants may have been included amongst the unvaccinated participants.”
The authors emphasized that the definition of “vaccinated” and “unvaccinated” was based on a scar and on vaccination records, and they recognized that participants who did not have a scar on their arm could have been misclassified. Regardless, it is still considered a sensitive indicator. “Few vaccinated children from various settings do not show a scar years after vaccine administration,” they stated in their article.
Adults unprotected
Dr. Ballalai also shared her concerns regarding the lack of protection for older individuals. “We know those older than 60 are at greater risk for complications of tuberculosis. Individuals in this age group naturally have a lower immunity, and they usually have comorbidities. From this study, I can only conclude what was already expected: that adults who received a BCG vaccine as infants are not clear of pulmonary tuberculosis.”
Dr. Croda agreed that it was already evident that the BCG vaccine administered at birth did not provide protection for adults. “In the past, even with 80%-90% vaccine coverage, there were numerous tuberculosis cases in adults in Brazil.”
Are boosters needed?
The authors concluded that immunoprotection needs to be boosted in older populations, as vaccination at birth is ineffective for adolescents and adults. They have also discussed whether children older than 10 years and adults could benefit from a booster shot.
Dr. Croda emphasized that there is no indication for this, because there are no data regarding protection with a booster dose during adulthood. However, he cited a study conducted in South Africa in which the BCG vaccine was compared with another vaccine, and another study, which is being conducted in India, is assessing whether a BCG booster offers protection against pulmonary tuberculosis. “There are few studies. Perhaps the revaccination of more vulnerable groups could be of interest, but additional studies are needed first.”
Dr. Croda intends to assess revaccination in those deprived of liberty, in which the incidence of tuberculosis is very high. From 2015 to 2021, many new cases were recorded in this population in Brazil. The number rose from 5,860 to 6,773 during that period.
“However, BCG revaccination carries a significant risk of patients presenting with serious adverse events,” Dr. Ballalai pointed out. He noted that several years ago, to extend protection, Brazil adopted a booster program for persons aged 10 years or older, but the program was discontinued owing to the numerous adverse events reported and the absence of evidence of benefit from increased protection against tuberculosis.
“The adult groups at greater risk for severe tuberculosis manifestations normally presented with an underlying disease, particularly in immunocompromised patient groups. The [administration of the] BCG [vaccine] is contraindicated for those who are immunocompromised. And, for the older population, we do not have data on [vaccine] safety,” she emphasized.
Nonspecific immune protection
One of the study’s secondary outcomes regarded mortality. Four studies in the meta-analysis followed up tuberculosis contacts for death. In these studies, which evaluated 20,000 participants, BCG vaccination was shown to be significantly protective against death for participants younger than 15 years.
However, the authors urged caution in interpreting these data. They emphasized that they were unable to identify specific mechanisms by which BCG vaccination might have reduced mortality, and there are possible study biases that could have led to an overestimation of mortality benefit. Moreover, given the observational nature of the included studies, vaccinated children might have had higher socioeconomic status and greater access to health care, and they may have been more likely to have received other vaccinations, compared with children who did not receive BCG vaccines.
Nevertheless, previous experimental and observational studies have found that BCG vaccination might provide nonspecific or off-target immune protection against an array of other pathogens.
“In small studies conducted in Africa, those younger than 5 were protected not only against tuberculosis but also against other respiratory diseases,” Dr. Croda affirmed. “However, these are small studies, and for now, there is no recommendation for using BCG vaccination to prevent other respiratory infections.”
A long-awaited, critical study on the impact of the BCG vaccine on COVID-19, in which Brazilian researchers participated, will be published in the New England Journal of Medicine.
New vaccines needed
The BCG vaccine is one of the oldest vaccines, but there are still several crucial unanswered questions about its use.
Previously published studies that examined the protective effect of BCG vaccination only considered low-burden settings and the historical literature before 1950. These studies need updating, but doing so has not been a simple task. To answer their questions, individual-level participant data for a prespecified list of variables, including the characteristics of the exposed participant (contact), the index case, and the environment, were requested from authors of all eligible studies.
Much of the data used in the published research were found through discussions with authors and experts in the field, as well as through data deposited in data storage repositories, conference abstracts, dissertations, and even direct requests to the authors. “The Pan-American Health Organization helped with this data collection and contacting some authors,” said Dr. Croda.
With the new data, the authors confirmed that infant BCG vaccination, although important to young children who are at high risk for tuberculosis, does not prevent adult-type cavitary tuberculosis and is therefore insufficient to impede the tuberculosis epidemic. “Novel vaccines are urgently needed,” they concluded.
“We need to develop novel, more effective vaccines, which, when administered during infancy, would ensure lifelong protection,” Dr. Croda added.
Dr. Croda and Dr. Ballalai reported no relevant financial relationships.
This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.
Bacillus Calmette-Guérin (BCG) vaccines are given to more than 100 million children every year, but there is considerable debate regarding the effectiveness of BCG vaccination in preventing tuberculosis and death, particularly among older children and adults.
The most extensive study ever conducted on the efficacy of the BCG vaccine for protection against tuberculosis, stratified by age and history of previous tuberculosis, was published in September 2022 in The Lancet Global Health. The study, which comprises a systematic review and meta-analysis, analyzed individual-level data from 26 case-contact cohort studies published over the past 20 years. The studies included data from 70,000 participants. The primary outcome was a composite of prevalent (diagnosed at or within 90 days of baseline) and incident (diagnosed more than 90 days after baseline) tuberculosis in contacts exposed to tuberculosis. Secondary outcomes were pulmonary tuberculosis, extrapulmonary tuberculosis, and mortality.
Participants were characterized as having been exposed to tuberculosis if they were reported to have been a close contact (either living in the same household or having substantial interaction outside the household) of a person with microbiologically or radiologically diagnosed pulmonary tuberculosis. Previous tuberculosis was defined as a positive interferon-gamma (IFN-gamma) release assay or tuberculin skin test, also known as PPD or Mantoux test.
Most studies included in the analysis were conducted in the past 10 years in countries with a high tuberculosis burden. Those countries included India, South Africa, China, Vietnam, Indonesia, Uganda, the Gambia, and Brazil.
Primary outcomes
The study’s main findings included the following:
- The overall effectiveness of BCG vaccination against all forms of tuberculosis was 18% (adjusted odds ratio, 0.82; 95% CI, 0.74-0.91).
- Stratified by age, BCG vaccination only significantly protected against all tuberculosis in children younger than 5 years (aOR, 0.63; 95% CI, 0.49-0.81).
- There was no protective effect among those whose previous tests for tuberculosis were negative unless they were younger than 5 years (aOR, 0.54; 95% CI, 0.32-0.90).
- Among contacts who had a positive tuberculin skin test or IFN-gamma release assay, BCG vaccination significantly protected against tuberculosis among all participants (aOR, 0.81; 95% CI, 0.69-0.96), participants younger than 5 years (aOR, 0.68; 95% CI, 0.47-0.97), and participants aged 5-9 years (aOR, 0.62; 95% CI, 0.38-0.99).
- BCG vaccination was protective against pulmonary tuberculosis (19% effectiveness), but this effect was only seen in children younger than 3 years (42% effectiveness) when stratified by age.
- Protection against all tuberculosis and pulmonary tuberculosis was greater among female participants than male participants.
“This is a definitive BCG protection study because it involves a significant number of individuals evaluated using this meta-analysis. Protection is clearly lost with age. From as early as age 5, no protective effect can be observed. Protection, including against pulmonary tuberculosis, can be observed up to 3 years of age,” stated study author Julio Croda, MD, PhD, chair of the Brazilian Society of Tropical Medicine.
Dr. Croda emphasized that the findings from their study indicate that BCG vaccine protects against pulmonary tuberculosis and that those results differ from results of some previous studies.
“Every physician believes the BCG vaccine protects against serious forms of tuberculosis up to age 5. That fact is not surprising at all,” Dr. Croda remarked. “However, the fact that it protects against pulmonary tuberculosis, especially in children younger than 3, was surprising. In medical practice, we did not believe in this protection.”
Currently, 1.2% of new tuberculosis cases in Brazil occur among those younger than 5. Nevertheless, these cases represent 40.1% of new diagnoses recorded among those younger than 15, highlighting the importance of protection for this age group. An increase in extrapulmonary tuberculosis cases was recently observed in patients younger than 5.
Isabella Ballalai, MD, PhD, is deputy chair of the Brazilian Society of Immunizations. Although she did not participate in this study, she commented on its findings. “All publications are welcome; they help us think,” she explained. She emphasized that the BCG vaccine is not optimal. “There are studies indicating 80% efficacy and others indicating 0%. So, what we can look at is decades of effectiveness in practice.”
Dr. Ballalai explained that the BCG vaccine could keep severe forms of tuberculosis, meningitis, and miliary tuberculosis at bay. She shared her experience of caring for several patients with tuberculous meningitis shortly after she had graduated. “Today, thanks to the BCG vaccine, we don’t see it anymore.” However, she pointed out that the vaccine›s efficacy and effectiveness against pulmonary tuberculosis are low and that pulmonary tuberculosis remains the most significant problem among adults.
Dr. Ballalai also emphasized a few shortcomings of the study. “One is the definition of ‘vaccinated’ and ‘unvaccinated,’ which was based on the presence or absence of a mark on the arm. Today, we know that the absence of a mark does not indicate that the child has not been vaccinated, nor that the vaccine has not been effective. Therefore, several vaccinated participants may have been included amongst the unvaccinated participants.”
The authors emphasized that the definition of “vaccinated” and “unvaccinated” was based on a scar and on vaccination records, and they recognized that participants who did not have a scar on their arm could have been misclassified. Regardless, it is still considered a sensitive indicator. “Few vaccinated children from various settings do not show a scar years after vaccine administration,” they stated in their article.
Adults unprotected
Dr. Ballalai also shared her concerns regarding the lack of protection for older individuals. “We know those older than 60 are at greater risk for complications of tuberculosis. Individuals in this age group naturally have a lower immunity, and they usually have comorbidities. From this study, I can only conclude what was already expected: that adults who received a BCG vaccine as infants are not clear of pulmonary tuberculosis.”
Dr. Croda agreed that it was already evident that the BCG vaccine administered at birth did not provide protection for adults. “In the past, even with 80%-90% vaccine coverage, there were numerous tuberculosis cases in adults in Brazil.”
Are boosters needed?
The authors concluded that immunoprotection needs to be boosted in older populations, as vaccination at birth is ineffective for adolescents and adults. They have also discussed whether children older than 10 years and adults could benefit from a booster shot.
Dr. Croda emphasized that there is no indication for this, because there are no data regarding protection with a booster dose during adulthood. However, he cited a study conducted in South Africa in which the BCG vaccine was compared with another vaccine, and another study, which is being conducted in India, is assessing whether a BCG booster offers protection against pulmonary tuberculosis. “There are few studies. Perhaps the revaccination of more vulnerable groups could be of interest, but additional studies are needed first.”
Dr. Croda intends to assess revaccination in those deprived of liberty, in which the incidence of tuberculosis is very high. From 2015 to 2021, many new cases were recorded in this population in Brazil. The number rose from 5,860 to 6,773 during that period.
“However, BCG revaccination carries a significant risk of patients presenting with serious adverse events,” Dr. Ballalai pointed out. He noted that several years ago, to extend protection, Brazil adopted a booster program for persons aged 10 years or older, but the program was discontinued owing to the numerous adverse events reported and the absence of evidence of benefit from increased protection against tuberculosis.
“The adult groups at greater risk for severe tuberculosis manifestations normally presented with an underlying disease, particularly in immunocompromised patient groups. The [administration of the] BCG [vaccine] is contraindicated for those who are immunocompromised. And, for the older population, we do not have data on [vaccine] safety,” she emphasized.
Nonspecific immune protection
One of the study’s secondary outcomes regarded mortality. Four studies in the meta-analysis followed up tuberculosis contacts for death. In these studies, which evaluated 20,000 participants, BCG vaccination was shown to be significantly protective against death for participants younger than 15 years.
However, the authors urged caution in interpreting these data. They emphasized that they were unable to identify specific mechanisms by which BCG vaccination might have reduced mortality, and there are possible study biases that could have led to an overestimation of mortality benefit. Moreover, given the observational nature of the included studies, vaccinated children might have had higher socioeconomic status and greater access to health care, and they may have been more likely to have received other vaccinations, compared with children who did not receive BCG vaccines.
Nevertheless, previous experimental and observational studies have found that BCG vaccination might provide nonspecific or off-target immune protection against an array of other pathogens.
“In small studies conducted in Africa, those younger than 5 were protected not only against tuberculosis but also against other respiratory diseases,” Dr. Croda affirmed. “However, these are small studies, and for now, there is no recommendation for using BCG vaccination to prevent other respiratory infections.”
A long-awaited, critical study on the impact of the BCG vaccine on COVID-19, in which Brazilian researchers participated, will be published in the New England Journal of Medicine.
New vaccines needed
The BCG vaccine is one of the oldest vaccines, but there are still several crucial unanswered questions about its use.
Previously published studies that examined the protective effect of BCG vaccination only considered low-burden settings and the historical literature before 1950. These studies need updating, but doing so has not been a simple task. To answer their questions, individual-level participant data for a prespecified list of variables, including the characteristics of the exposed participant (contact), the index case, and the environment, were requested from authors of all eligible studies.
Much of the data used in the published research were found through discussions with authors and experts in the field, as well as through data deposited in data storage repositories, conference abstracts, dissertations, and even direct requests to the authors. “The Pan-American Health Organization helped with this data collection and contacting some authors,” said Dr. Croda.
With the new data, the authors confirmed that infant BCG vaccination, although important to young children who are at high risk for tuberculosis, does not prevent adult-type cavitary tuberculosis and is therefore insufficient to impede the tuberculosis epidemic. “Novel vaccines are urgently needed,” they concluded.
“We need to develop novel, more effective vaccines, which, when administered during infancy, would ensure lifelong protection,” Dr. Croda added.
Dr. Croda and Dr. Ballalai reported no relevant financial relationships.
This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.
FROM THE LANCET GLOBAL HEALTH