Plasmodium sporozoite

Image courtesy of Ute

Frevert and Margaret Shear

A synthetic version of the protein PD-L2 can treat malaria in mice and protect them from re-infection, according to researchers.

The team’s experiments indicated that PD-L2 determines the severity of malaria infection and is essential for CD4+ T-cell immunity against malaria.

When the researchers administered soluble multimeric PD-L2 to mice, the animals were cured of severe malaria and protected from re-infection months later.

Michelle Wykes, DPhil, of QIMR Berghofer Medical Research Institute in Herston, Queensland, Australia, and her colleagues reported these results in Immunity.

The researchers noted that Plasmodium parasites exploit the interaction between PD-1 and PD-L1 to prevent T cells from fighting malaria, but the role of PD-L2 has not been clear.

With this study, the team found that PD-L2 regulates the PD-1—PD-L1 interaction and might therefore be used to treat malaria.

“We found that, when humans and mice are infected with severe malaria, levels of PD-L2 decrease, and so the T cells aren’t being told to keep fighting the parasites,” Dr Wykes explained.

“We don’t know how malaria manages to block the production of PD-L2. But once we knew how important this protein was for fighting the disease, we developed a synthetic version of it in the laboratory.”

The researchers gave 3 doses of this synthetic PD-L2 to mice that had been infected with a lethal dose of malaria.

“All of these mice were cured of the malaria,” Dr Wykes said. “About 5 months later, we re-infected the same mice with malaria parasites, but, this time, we didn’t give them any more of the synthetic protein. All of the mice were completely protected and didn’t become infected.”

Dr Wykes said these findings could form the basis for new ways to treat malaria in the future.

“[I]f this approach is successful, it should treat all species of malaria parasite,” she noted. “This would be a completely new way of treating malaria—by stimulating a person’s own immune system to destroy the parasites.”

Plasmodium sporozoite

Image courtesy of Ute

Frevert and Margaret Shear

A synthetic version of the protein PD-L2 can treat malaria in mice and protect them from re-infection, according to researchers.

The team’s experiments indicated that PD-L2 determines the severity of malaria infection and is essential for CD4+ T-cell immunity against malaria.

When the researchers administered soluble multimeric PD-L2 to mice, the animals were cured of severe malaria and protected from re-infection months later.

Michelle Wykes, DPhil, of QIMR Berghofer Medical Research Institute in Herston, Queensland, Australia, and her colleagues reported these results in Immunity.

The researchers noted that Plasmodium parasites exploit the interaction between PD-1 and PD-L1 to prevent T cells from fighting malaria, but the role of PD-L2 has not been clear.

With this study, the team found that PD-L2 regulates the PD-1—PD-L1 interaction and might therefore be used to treat malaria.

“We found that, when humans and mice are infected with severe malaria, levels of PD-L2 decrease, and so the T cells aren’t being told to keep fighting the parasites,” Dr Wykes explained.

“We don’t know how malaria manages to block the production of PD-L2. But once we knew how important this protein was for fighting the disease, we developed a synthetic version of it in the laboratory.”

The researchers gave 3 doses of this synthetic PD-L2 to mice that had been infected with a lethal dose of malaria.

“All of these mice were cured of the malaria,” Dr Wykes said. “About 5 months later, we re-infected the same mice with malaria parasites, but, this time, we didn’t give them any more of the synthetic protein. All of the mice were completely protected and didn’t become infected.”

Dr Wykes said these findings could form the basis for new ways to treat malaria in the future.

“[I]f this approach is successful, it should treat all species of malaria parasite,” she noted. “This would be a completely new way of treating malaria—by stimulating a person’s own immune system to destroy the parasites.”

Plasmodium sporozoite

Image courtesy of Ute

Frevert and Margaret Shear

A synthetic version of the protein PD-L2 can treat malaria in mice and protect them from re-infection, according to researchers.

The team’s experiments indicated that PD-L2 determines the severity of malaria infection and is essential for CD4+ T-cell immunity against malaria.

When the researchers administered soluble multimeric PD-L2 to mice, the animals were cured of severe malaria and protected from re-infection months later.

Michelle Wykes, DPhil, of QIMR Berghofer Medical Research Institute in Herston, Queensland, Australia, and her colleagues reported these results in Immunity.

The researchers noted that Plasmodium parasites exploit the interaction between PD-1 and PD-L1 to prevent T cells from fighting malaria, but the role of PD-L2 has not been clear.

With this study, the team found that PD-L2 regulates the PD-1—PD-L1 interaction and might therefore be used to treat malaria.

“We found that, when humans and mice are infected with severe malaria, levels of PD-L2 decrease, and so the T cells aren’t being told to keep fighting the parasites,” Dr Wykes explained.

“We don’t know how malaria manages to block the production of PD-L2. But once we knew how important this protein was for fighting the disease, we developed a synthetic version of it in the laboratory.”

The researchers gave 3 doses of this synthetic PD-L2 to mice that had been infected with a lethal dose of malaria.

“All of these mice were cured of the malaria,” Dr Wykes said. “About 5 months later, we re-infected the same mice with malaria parasites, but, this time, we didn’t give them any more of the synthetic protein. All of the mice were completely protected and didn’t become infected.”

Dr Wykes said these findings could form the basis for new ways to treat malaria in the future.

“[I]f this approach is successful, it should treat all species of malaria parasite,” she noted. “This would be a completely new way of treating malaria—by stimulating a person’s own immune system to destroy the parasites.”

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new study suggests cancer survivors and the general population have comparable sex lives, although cancer survivors don’t realize it.

According to a survey of more than 6500 people, cancer survivors over the age of 49 have just as much sex and similar levels of sexual function as individuals of the same age who never had cancer.

However, the cancer survivors were more likely to report being dissatisfied with their sex lives.

“We hope our findings will put cancer survivors’ concerns to rest—showing that they are just as sexually active and function just as well as others their age,” said Sarah Jackson, PhD, of University College London in the UK.

“The next stage of our research will look at why cancer patients feel less satisfied with their sex lives.”

Dr Jackson and her colleagues reported their current findings in Cancer.

The researchers set out to explore differences in sexual activity and function, as well as concerns about sex, between cancer survivors and cancer-free controls in a population-based study.

The team surveyed 3708 women (341 cancer survivors and 3367 controls) and 2982 men (220 cancer survivors and 2762 controls) aged 50 and older. Male and female cancer survivors were significantly older than controls (P<0.001 for both) and reported more comorbidities (P=0.003 for both).

Frequency

There were no significant differences in levels of sexual activity between cancer survivors and controls of either sex.

Among women, 58.2% of cancer survivors and 55.5% of controls reported having any sexual activity in the last year. Among men, the rates were 76.0% and 78.5%, respectively.

Overall, about half of the people surveyed reported having “frequent” sexual intercourse, which was defined as 2 to 3 times a month or more.

This included 49.1% of female cancer survivors, 50.1% of female controls, 49% of male cancer survivors, and 48% of male controls.

Function

The incidence of sexual problems was similar in cancer survivors and controls—both male and female.

For example, around a third of the women said they had problems becoming aroused (31.4% of cancer survivors and 31.8% of controls), and about 40% of the men had erectile dysfunction (40.3% of cancer survivors and 39.3% of controls).

Satisfaction

Despite similar levels of sexual activity and function, cancer survivors were more likely than controls to report feeling dissatisfied with their sex lives.

Among the women, 18.2% of cancer survivors and 11.8% of controls reported dissatisfaction (P=0.034). Among the men, the rates were 30.9% and 19.8%, respectively (P=0.023).

In addition, female cancer survivors were more likely to be concerned about their libido than female controls—10.2% and 7.1%, respectively (P=0.006). But there was no significant difference for the men.

Time from cancer diagnosis

The researchers also found the amount of time from cancer diagnosis was a factor affecting sexual function and concern among women but not men.

Females diagnosed with cancer less than 5 years from the time they were surveyed were more likely than female controls to report difficulty becoming aroused (55.4% and 31.8%, respectively, P=0.016) and achieving orgasm (60.6% and 28.3%, respectively, P<0.001).

The recently diagnosed females were also more likely than controls to be concerned about sexual desire (14.8% and 7.1%, respectively, P=0.007) and orgasmic experience (17.6% and 7.1%, respectively, P=0.042).

“Although some cancer treatments are known to impact on sexual function, this study suggests that the majority of cancer patients have similar sexual function and activity as the general population,” said Martin Ledwick, of Cancer Research UK, which sponsored this study.

“However, cancer patients in the study were more likely to be dissatisfied with their sex lives . . . . This highlights the need for health professionals to make sure they talk about sex with all patients—not just the ones whose sexual function is likely to be affected by their cancer or its treatment.”

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new study suggests cancer survivors and the general population have comparable sex lives, although cancer survivors don’t realize it.

According to a survey of more than 6500 people, cancer survivors over the age of 49 have just as much sex and similar levels of sexual function as individuals of the same age who never had cancer.

However, the cancer survivors were more likely to report being dissatisfied with their sex lives.

“We hope our findings will put cancer survivors’ concerns to rest—showing that they are just as sexually active and function just as well as others their age,” said Sarah Jackson, PhD, of University College London in the UK.

“The next stage of our research will look at why cancer patients feel less satisfied with their sex lives.”

Dr Jackson and her colleagues reported their current findings in Cancer.

The researchers set out to explore differences in sexual activity and function, as well as concerns about sex, between cancer survivors and cancer-free controls in a population-based study.

The team surveyed 3708 women (341 cancer survivors and 3367 controls) and 2982 men (220 cancer survivors and 2762 controls) aged 50 and older. Male and female cancer survivors were significantly older than controls (P<0.001 for both) and reported more comorbidities (P=0.003 for both).

Frequency

There were no significant differences in levels of sexual activity between cancer survivors and controls of either sex.

Among women, 58.2% of cancer survivors and 55.5% of controls reported having any sexual activity in the last year. Among men, the rates were 76.0% and 78.5%, respectively.

Overall, about half of the people surveyed reported having “frequent” sexual intercourse, which was defined as 2 to 3 times a month or more.

This included 49.1% of female cancer survivors, 50.1% of female controls, 49% of male cancer survivors, and 48% of male controls.

Function

The incidence of sexual problems was similar in cancer survivors and controls—both male and female.

For example, around a third of the women said they had problems becoming aroused (31.4% of cancer survivors and 31.8% of controls), and about 40% of the men had erectile dysfunction (40.3% of cancer survivors and 39.3% of controls).

Satisfaction

Despite similar levels of sexual activity and function, cancer survivors were more likely than controls to report feeling dissatisfied with their sex lives.

Among the women, 18.2% of cancer survivors and 11.8% of controls reported dissatisfaction (P=0.034). Among the men, the rates were 30.9% and 19.8%, respectively (P=0.023).

In addition, female cancer survivors were more likely to be concerned about their libido than female controls—10.2% and 7.1%, respectively (P=0.006). But there was no significant difference for the men.

Time from cancer diagnosis

The researchers also found the amount of time from cancer diagnosis was a factor affecting sexual function and concern among women but not men.

Females diagnosed with cancer less than 5 years from the time they were surveyed were more likely than female controls to report difficulty becoming aroused (55.4% and 31.8%, respectively, P=0.016) and achieving orgasm (60.6% and 28.3%, respectively, P<0.001).

The recently diagnosed females were also more likely than controls to be concerned about sexual desire (14.8% and 7.1%, respectively, P=0.007) and orgasmic experience (17.6% and 7.1%, respectively, P=0.042).

“Although some cancer treatments are known to impact on sexual function, this study suggests that the majority of cancer patients have similar sexual function and activity as the general population,” said Martin Ledwick, of Cancer Research UK, which sponsored this study.

“However, cancer patients in the study were more likely to be dissatisfied with their sex lives . . . . This highlights the need for health professionals to make sure they talk about sex with all patients—not just the ones whose sexual function is likely to be affected by their cancer or its treatment.”

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new study suggests cancer survivors and the general population have comparable sex lives, although cancer survivors don’t realize it.

According to a survey of more than 6500 people, cancer survivors over the age of 49 have just as much sex and similar levels of sexual function as individuals of the same age who never had cancer.

However, the cancer survivors were more likely to report being dissatisfied with their sex lives.

“We hope our findings will put cancer survivors’ concerns to rest—showing that they are just as sexually active and function just as well as others their age,” said Sarah Jackson, PhD, of University College London in the UK.

“The next stage of our research will look at why cancer patients feel less satisfied with their sex lives.”

Dr Jackson and her colleagues reported their current findings in Cancer.

The researchers set out to explore differences in sexual activity and function, as well as concerns about sex, between cancer survivors and cancer-free controls in a population-based study.

The team surveyed 3708 women (341 cancer survivors and 3367 controls) and 2982 men (220 cancer survivors and 2762 controls) aged 50 and older. Male and female cancer survivors were significantly older than controls (P<0.001 for both) and reported more comorbidities (P=0.003 for both).

Frequency

There were no significant differences in levels of sexual activity between cancer survivors and controls of either sex.

Among women, 58.2% of cancer survivors and 55.5% of controls reported having any sexual activity in the last year. Among men, the rates were 76.0% and 78.5%, respectively.

Overall, about half of the people surveyed reported having “frequent” sexual intercourse, which was defined as 2 to 3 times a month or more.

This included 49.1% of female cancer survivors, 50.1% of female controls, 49% of male cancer survivors, and 48% of male controls.

Function

The incidence of sexual problems was similar in cancer survivors and controls—both male and female.

For example, around a third of the women said they had problems becoming aroused (31.4% of cancer survivors and 31.8% of controls), and about 40% of the men had erectile dysfunction (40.3% of cancer survivors and 39.3% of controls).

Satisfaction

Despite similar levels of sexual activity and function, cancer survivors were more likely than controls to report feeling dissatisfied with their sex lives.

Among the women, 18.2% of cancer survivors and 11.8% of controls reported dissatisfaction (P=0.034). Among the men, the rates were 30.9% and 19.8%, respectively (P=0.023).

In addition, female cancer survivors were more likely to be concerned about their libido than female controls—10.2% and 7.1%, respectively (P=0.006). But there was no significant difference for the men.

Time from cancer diagnosis

The researchers also found the amount of time from cancer diagnosis was a factor affecting sexual function and concern among women but not men.

Females diagnosed with cancer less than 5 years from the time they were surveyed were more likely than female controls to report difficulty becoming aroused (55.4% and 31.8%, respectively, P=0.016) and achieving orgasm (60.6% and 28.3%, respectively, P<0.001).

The recently diagnosed females were also more likely than controls to be concerned about sexual desire (14.8% and 7.1%, respectively, P=0.007) and orgasmic experience (17.6% and 7.1%, respectively, P=0.042).

“Although some cancer treatments are known to impact on sexual function, this study suggests that the majority of cancer patients have similar sexual function and activity as the general population,” said Martin Ledwick, of Cancer Research UK, which sponsored this study.

“However, cancer patients in the study were more likely to be dissatisfied with their sex lives . . . . This highlights the need for health professionals to make sure they talk about sex with all patients—not just the ones whose sexual function is likely to be affected by their cancer or its treatment.”

Red blood cells

Anemia may increase the risk of death in older adults who have had a stroke, according to research published in the Journal of the American Heart Association.

An initial analysis of more than 8000 patients showed that anemia was associated with a higher risk of death for up to 1 year following ischemic or hemorrhagic stroke.

A second analysis of nearly 30,000 patients suggested the risk of dying from ischemic stroke is about 2 times higher in patients with anemia than those without it, and the risk of death from hemorrhagic stroke is about 1.5 times higher in anemic patients.

“So there’s the potential for a much poorer outcome if somebody comes in with stroke and they’re also anemic,” said study author Phyo Myint, MD, of the University of Aberdeen in Scotland.

Dr Myint and his colleagues first examined data from the UK Regional Stroke Register. This included 8013 patients with an average age of 78 who were admitted to the hospital with acute stroke between 2003 and 2015.

The team assessed the impact of anemia and hemoglobin levels at admission on death at different time points—inpatient, 7 days, 14 days, 1 month, 3 months, 6 months, and 1 year after stroke.

Anemia was associated with higher odds of death at most of the time points examined. And elevated hemoglobin was associated with a higher risk of death, mainly within the first month.

In addition to analyzing data from the UK Regional Stroke Registry, the researchers systematically reviewed relevant literature published to date. They compiled data from 20 previous studies, increasing the study population to 29,943 stroke patients.

In analyzing these patients, the researchers found that anemia on admission was associated with an increased risk of mortality in both ischemic stroke and hemorrhagic stroke. The odds ratios were 1.97 and 1.46, respectively.

The researchers believe this study emphasizes the impact of anemia on stroke outcomes and the need for increased awareness and interventions for stroke patients with anemia.

“One example of an intervention might be treating the underlying causes of anemia, such as iron deficiency, which is common in this age group,” said study author Raphae Barlas, a medical student at the University of Aberdeen.

“As the study has convincingly demonstrated, anemia does worsen the outcome of stroke, so it is very important that we identify at-risk patients and optimize the management.”

Red blood cells

Anemia may increase the risk of death in older adults who have had a stroke, according to research published in the Journal of the American Heart Association.

An initial analysis of more than 8000 patients showed that anemia was associated with a higher risk of death for up to 1 year following ischemic or hemorrhagic stroke.

A second analysis of nearly 30,000 patients suggested the risk of dying from ischemic stroke is about 2 times higher in patients with anemia than those without it, and the risk of death from hemorrhagic stroke is about 1.5 times higher in anemic patients.

“So there’s the potential for a much poorer outcome if somebody comes in with stroke and they’re also anemic,” said study author Phyo Myint, MD, of the University of Aberdeen in Scotland.

Dr Myint and his colleagues first examined data from the UK Regional Stroke Register. This included 8013 patients with an average age of 78 who were admitted to the hospital with acute stroke between 2003 and 2015.

The team assessed the impact of anemia and hemoglobin levels at admission on death at different time points—inpatient, 7 days, 14 days, 1 month, 3 months, 6 months, and 1 year after stroke.

Anemia was associated with higher odds of death at most of the time points examined. And elevated hemoglobin was associated with a higher risk of death, mainly within the first month.

In addition to analyzing data from the UK Regional Stroke Registry, the researchers systematically reviewed relevant literature published to date. They compiled data from 20 previous studies, increasing the study population to 29,943 stroke patients.

In analyzing these patients, the researchers found that anemia on admission was associated with an increased risk of mortality in both ischemic stroke and hemorrhagic stroke. The odds ratios were 1.97 and 1.46, respectively.

The researchers believe this study emphasizes the impact of anemia on stroke outcomes and the need for increased awareness and interventions for stroke patients with anemia.

“One example of an intervention might be treating the underlying causes of anemia, such as iron deficiency, which is common in this age group,” said study author Raphae Barlas, a medical student at the University of Aberdeen.

“As the study has convincingly demonstrated, anemia does worsen the outcome of stroke, so it is very important that we identify at-risk patients and optimize the management.”

Red blood cells

Anemia may increase the risk of death in older adults who have had a stroke, according to research published in the Journal of the American Heart Association.

An initial analysis of more than 8000 patients showed that anemia was associated with a higher risk of death for up to 1 year following ischemic or hemorrhagic stroke.

A second analysis of nearly 30,000 patients suggested the risk of dying from ischemic stroke is about 2 times higher in patients with anemia than those without it, and the risk of death from hemorrhagic stroke is about 1.5 times higher in anemic patients.

“So there’s the potential for a much poorer outcome if somebody comes in with stroke and they’re also anemic,” said study author Phyo Myint, MD, of the University of Aberdeen in Scotland.

Dr Myint and his colleagues first examined data from the UK Regional Stroke Register. This included 8013 patients with an average age of 78 who were admitted to the hospital with acute stroke between 2003 and 2015.

The team assessed the impact of anemia and hemoglobin levels at admission on death at different time points—inpatient, 7 days, 14 days, 1 month, 3 months, 6 months, and 1 year after stroke.

Anemia was associated with higher odds of death at most of the time points examined. And elevated hemoglobin was associated with a higher risk of death, mainly within the first month.

In addition to analyzing data from the UK Regional Stroke Registry, the researchers systematically reviewed relevant literature published to date. They compiled data from 20 previous studies, increasing the study population to 29,943 stroke patients.

In analyzing these patients, the researchers found that anemia on admission was associated with an increased risk of mortality in both ischemic stroke and hemorrhagic stroke. The odds ratios were 1.97 and 1.46, respectively.

The researchers believe this study emphasizes the impact of anemia on stroke outcomes and the need for increased awareness and interventions for stroke patients with anemia.

“One example of an intervention might be treating the underlying causes of anemia, such as iron deficiency, which is common in this age group,” said study author Raphae Barlas, a medical student at the University of Aberdeen.

“As the study has convincingly demonstrated, anemia does worsen the outcome of stroke, so it is very important that we identify at-risk patients and optimize the management.”

Woman listening to music

Photo by Lars Frantzen

Results of a systematic review suggest music can help alleviate symptoms of anxiety, pain, and fatigue in cancer patients.

The review included more than 50 studies investigating the impact of music therapy—a personalized music experience offered by trained music therapists—and music medicine—listening to pre-recorded music provided by a doctor or nurse—on psychological and physical outcomes in people with cancer.

“We found that music therapy interventions specifically help improve patients’ quality of life,” said study author Joke Bradt, PhD, of Drexel University in Philadelphia, Pennsylvania.

“These are important findings, as these outcomes play an important role in patients’ overall well-being.”

Dr Bradt and her colleagues reported their findings in Cochrane Database of Systematic Reviews.

The researchers examined 52 trials including 3731 cancer patients. The music interventions were classified as music therapy in 23 of the trials and as music medicine in 29 trials.

Analyses suggested that both types of music interventions positively impacted patients. The interventions had a moderate-to-strong effect on anxiety, a strong effect on pain reduction, and a small-to-moderate effect on fatigue.

Small reductions in heart and respiratory rates, as well as lowered blood pressure, were linked to the interventions as well.

In addition, the researchers observed a moderate increase in patients’ quality of life with music therapy but not music medicine.

The team could not determine the effect of music interventions on depression due to the low quality of evidence. And there was no evidence that the interventions improve mood, distress, or physical functioning, but there were few trials investigating these outcomes.

Similarly, the researchers said they could not draw any conclusions about the effect of music interventions on immunologic functioning, coping, resilience, or communication because there were not enough trials evaluating these outcomes.

Still, the researchers hope music interventions will become more widely used, in light of the potential benefits to cancer patients.

“We hope that the findings of this review will encourage healthcare providers in medical settings to seriously consider the use of music therapy in the psychosocial care of people with cancer,” Dr Bradt said.

Woman listening to music

Photo by Lars Frantzen

Results of a systematic review suggest music can help alleviate symptoms of anxiety, pain, and fatigue in cancer patients.

The review included more than 50 studies investigating the impact of music therapy—a personalized music experience offered by trained music therapists—and music medicine—listening to pre-recorded music provided by a doctor or nurse—on psychological and physical outcomes in people with cancer.

“We found that music therapy interventions specifically help improve patients’ quality of life,” said study author Joke Bradt, PhD, of Drexel University in Philadelphia, Pennsylvania.

“These are important findings, as these outcomes play an important role in patients’ overall well-being.”

Dr Bradt and her colleagues reported their findings in Cochrane Database of Systematic Reviews.

The researchers examined 52 trials including 3731 cancer patients. The music interventions were classified as music therapy in 23 of the trials and as music medicine in 29 trials.

Analyses suggested that both types of music interventions positively impacted patients. The interventions had a moderate-to-strong effect on anxiety, a strong effect on pain reduction, and a small-to-moderate effect on fatigue.

Small reductions in heart and respiratory rates, as well as lowered blood pressure, were linked to the interventions as well.

In addition, the researchers observed a moderate increase in patients’ quality of life with music therapy but not music medicine.

The team could not determine the effect of music interventions on depression due to the low quality of evidence. And there was no evidence that the interventions improve mood, distress, or physical functioning, but there were few trials investigating these outcomes.

Similarly, the researchers said they could not draw any conclusions about the effect of music interventions on immunologic functioning, coping, resilience, or communication because there were not enough trials evaluating these outcomes.

Still, the researchers hope music interventions will become more widely used, in light of the potential benefits to cancer patients.

“We hope that the findings of this review will encourage healthcare providers in medical settings to seriously consider the use of music therapy in the psychosocial care of people with cancer,” Dr Bradt said.

Woman listening to music

Photo by Lars Frantzen

Results of a systematic review suggest music can help alleviate symptoms of anxiety, pain, and fatigue in cancer patients.

The review included more than 50 studies investigating the impact of music therapy—a personalized music experience offered by trained music therapists—and music medicine—listening to pre-recorded music provided by a doctor or nurse—on psychological and physical outcomes in people with cancer.

“We found that music therapy interventions specifically help improve patients’ quality of life,” said study author Joke Bradt, PhD, of Drexel University in Philadelphia, Pennsylvania.

“These are important findings, as these outcomes play an important role in patients’ overall well-being.”

Dr Bradt and her colleagues reported their findings in Cochrane Database of Systematic Reviews.

The researchers examined 52 trials including 3731 cancer patients. The music interventions were classified as music therapy in 23 of the trials and as music medicine in 29 trials.

Analyses suggested that both types of music interventions positively impacted patients. The interventions had a moderate-to-strong effect on anxiety, a strong effect on pain reduction, and a small-to-moderate effect on fatigue.

Small reductions in heart and respiratory rates, as well as lowered blood pressure, were linked to the interventions as well.

In addition, the researchers observed a moderate increase in patients’ quality of life with music therapy but not music medicine.

The team could not determine the effect of music interventions on depression due to the low quality of evidence. And there was no evidence that the interventions improve mood, distress, or physical functioning, but there were few trials investigating these outcomes.

Similarly, the researchers said they could not draw any conclusions about the effect of music interventions on immunologic functioning, coping, resilience, or communication because there were not enough trials evaluating these outcomes.

Still, the researchers hope music interventions will become more widely used, in light of the potential benefits to cancer patients.

“We hope that the findings of this review will encourage healthcare providers in medical settings to seriously consider the use of music therapy in the psychosocial care of people with cancer,” Dr Bradt said.

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.

In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.

©tupungato/Thinkstock.com

The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.

The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).

There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.

Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.

“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.

This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.

As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.

In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.

©tupungato/Thinkstock.com

The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.

The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).

There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.

Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.

“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.

This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.

As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.

In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.

©tupungato/Thinkstock.com

The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.

The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).

There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.

Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.

“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.

This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.

Obeticholic acid reduced alkaline phosphatase level, total bilirubin level, and other biomarkers of cholestasis, hepatocellular injury, inflammation, and apoptosis in patients with primary biliary cholangitis participating in a phase III clinical trial, which was reported online August 17 in the New England Journal of Medicine.

A study to assess the drug’s effects on clinical outcomes is currently enrolling patients (NCT02308111), said Frederik Nevens, MD, PhD, of University Hospitals Leuven (Belgium) and his associates.

©Ricardo Gaudêncio/News Farma

They assessed treatment with obeticholic acid, a selective farnesoid X receptor agonist, in a manufacturer-sponsored double-blind randomized trial involving 217 patients treated at 59 sites in 13 countries. Participants were assigned to receive a once-daily oral placebo (73 patients), obeticholic acid at an initial dose of 5 mg with escalation to 10 mg if possible (71 patients), or a daily 10-mg dose of obeticholic acid (73 patients). All were also given standard ursodiol (13-15 mg per kg) at the same time, with the expectation that many would have to discontinue that drug due to adverse events. The study participants were treated for 1 year, when the double-blind phase of the study was completed and all were offered entry into a 5-year open-label phase.

The primary composite endpoint was 1) an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% below baseline level, and 2) a total bilirubin level at or below the upper limit of the normal range. After 1 year of treatment, 46% of the 5-mg group and 47% of the 10-mg group achieved this endpoint, compared with only 10% of the placebo group. The response to treatment was rapid, with patients in the active-treatment groups showing significantly lower alkaline phosphatase and bilirubin levels than the placebo group within 2 weeks of starting therapy.

In addition, the percentage of patients who showed at least a 15% reduction in alkaline phosphatase level was significantly higher with 5-10 mg active treatment (77%) and with 10 mg active treatment (77%) than with placebo (29%). And total bilirubin level progressively decreased in both active treatment groups but progressively increased in the placebo group, Dr. Nevens and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1509840). Obeticholic acid also reduced levels of IgM and interleukin-12, as well as levels of gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and conjugated bilirubin. It did not induce significant symptom relief as measured by a disease-specific quality of life questionnaire, and it didn’t reduce liver fibrosis as measured by noninvasive techniques.

In the open-label extension phase of the study, treatment efficacy was similar.

The most common adverse event was pruritus, which is also characteristic of the disease itself. The incidence was higher in both active-treatment groups (56% with 5-10-mg therapy and 68% with 10-mg therapy) than in the placebo group (38%). One patient (1%) in the 5-10-mg group and seven patients (10%) in the 10-mg group discontinued treatment because of pruritus, compared with no patients in the placebo group.

The treatment’s beneficial effects persisted for 2 years, but that is a relatively short follow-up for a chronic disease that will require lifelong therapy. Future research must address longer-term benefits as well as adverse events, the investigators said.

Obeticholic acid reduced alkaline phosphatase level, total bilirubin level, and other biomarkers of cholestasis, hepatocellular injury, inflammation, and apoptosis in patients with primary biliary cholangitis participating in a phase III clinical trial, which was reported online August 17 in the New England Journal of Medicine.

A study to assess the drug’s effects on clinical outcomes is currently enrolling patients (NCT02308111), said Frederik Nevens, MD, PhD, of University Hospitals Leuven (Belgium) and his associates.

©Ricardo Gaudêncio/News Farma

They assessed treatment with obeticholic acid, a selective farnesoid X receptor agonist, in a manufacturer-sponsored double-blind randomized trial involving 217 patients treated at 59 sites in 13 countries. Participants were assigned to receive a once-daily oral placebo (73 patients), obeticholic acid at an initial dose of 5 mg with escalation to 10 mg if possible (71 patients), or a daily 10-mg dose of obeticholic acid (73 patients). All were also given standard ursodiol (13-15 mg per kg) at the same time, with the expectation that many would have to discontinue that drug due to adverse events. The study participants were treated for 1 year, when the double-blind phase of the study was completed and all were offered entry into a 5-year open-label phase.

The primary composite endpoint was 1) an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% below baseline level, and 2) a total bilirubin level at or below the upper limit of the normal range. After 1 year of treatment, 46% of the 5-mg group and 47% of the 10-mg group achieved this endpoint, compared with only 10% of the placebo group. The response to treatment was rapid, with patients in the active-treatment groups showing significantly lower alkaline phosphatase and bilirubin levels than the placebo group within 2 weeks of starting therapy.

In addition, the percentage of patients who showed at least a 15% reduction in alkaline phosphatase level was significantly higher with 5-10 mg active treatment (77%) and with 10 mg active treatment (77%) than with placebo (29%). And total bilirubin level progressively decreased in both active treatment groups but progressively increased in the placebo group, Dr. Nevens and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1509840). Obeticholic acid also reduced levels of IgM and interleukin-12, as well as levels of gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and conjugated bilirubin. It did not induce significant symptom relief as measured by a disease-specific quality of life questionnaire, and it didn’t reduce liver fibrosis as measured by noninvasive techniques.

In the open-label extension phase of the study, treatment efficacy was similar.

The most common adverse event was pruritus, which is also characteristic of the disease itself. The incidence was higher in both active-treatment groups (56% with 5-10-mg therapy and 68% with 10-mg therapy) than in the placebo group (38%). One patient (1%) in the 5-10-mg group and seven patients (10%) in the 10-mg group discontinued treatment because of pruritus, compared with no patients in the placebo group.

The treatment’s beneficial effects persisted for 2 years, but that is a relatively short follow-up for a chronic disease that will require lifelong therapy. Future research must address longer-term benefits as well as adverse events, the investigators said.

Obeticholic acid reduced alkaline phosphatase level, total bilirubin level, and other biomarkers of cholestasis, hepatocellular injury, inflammation, and apoptosis in patients with primary biliary cholangitis participating in a phase III clinical trial, which was reported online August 17 in the New England Journal of Medicine.

A study to assess the drug’s effects on clinical outcomes is currently enrolling patients (NCT02308111), said Frederik Nevens, MD, PhD, of University Hospitals Leuven (Belgium) and his associates.

©Ricardo Gaudêncio/News Farma

They assessed treatment with obeticholic acid, a selective farnesoid X receptor agonist, in a manufacturer-sponsored double-blind randomized trial involving 217 patients treated at 59 sites in 13 countries. Participants were assigned to receive a once-daily oral placebo (73 patients), obeticholic acid at an initial dose of 5 mg with escalation to 10 mg if possible (71 patients), or a daily 10-mg dose of obeticholic acid (73 patients). All were also given standard ursodiol (13-15 mg per kg) at the same time, with the expectation that many would have to discontinue that drug due to adverse events. The study participants were treated for 1 year, when the double-blind phase of the study was completed and all were offered entry into a 5-year open-label phase.

The primary composite endpoint was 1) an alkaline phosphatase level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% below baseline level, and 2) a total bilirubin level at or below the upper limit of the normal range. After 1 year of treatment, 46% of the 5-mg group and 47% of the 10-mg group achieved this endpoint, compared with only 10% of the placebo group. The response to treatment was rapid, with patients in the active-treatment groups showing significantly lower alkaline phosphatase and bilirubin levels than the placebo group within 2 weeks of starting therapy.

In addition, the percentage of patients who showed at least a 15% reduction in alkaline phosphatase level was significantly higher with 5-10 mg active treatment (77%) and with 10 mg active treatment (77%) than with placebo (29%). And total bilirubin level progressively decreased in both active treatment groups but progressively increased in the placebo group, Dr. Nevens and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1509840). Obeticholic acid also reduced levels of IgM and interleukin-12, as well as levels of gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and conjugated bilirubin. It did not induce significant symptom relief as measured by a disease-specific quality of life questionnaire, and it didn’t reduce liver fibrosis as measured by noninvasive techniques.

In the open-label extension phase of the study, treatment efficacy was similar.

The most common adverse event was pruritus, which is also characteristic of the disease itself. The incidence was higher in both active-treatment groups (56% with 5-10-mg therapy and 68% with 10-mg therapy) than in the placebo group (38%). One patient (1%) in the 5-10-mg group and seven patients (10%) in the 10-mg group discontinued treatment because of pruritus, compared with no patients in the placebo group.

The treatment’s beneficial effects persisted for 2 years, but that is a relatively short follow-up for a chronic disease that will require lifelong therapy. Future research must address longer-term benefits as well as adverse events, the investigators said.

Airway fistula is a rare but life-threatening complication of esophageal surgery, but an innovative technique using two custom-made, Y-shaped metallic stents can preserve airway patency, researchers at Zhengzhou University in China reported in the August issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2016;152:557-63).

The study involved 10 patients who received Y-shaped stents to treat gastrotracheal or gastrobronchial fistulas (GTFs and GBFs, respectively) after esophageal surgery from 2010 through 2014. “Our patients tolerated the stents well and had good palliation of their symptoms,” wrote Teng-Fei Li, MD, and colleagues.

Courtesy JTCVS/American Association for Thoracic Surgery

Six patients died within 8 months for unrelated reasons – either tumors (four patients), or hemoptysis or pulmonary infection (one each). In one patient, the carinal fistula enlarged 4 months after stenting, but the researchers successfully placed an additional small Y-shaped stent. At the publication of the paper, this patient and three others had survived, Dr. Li and colleagues said.

After esophagectomy, fistulas can form between the tracheobronchial tree and stomach for a variety of reasons. A metallic stent would seem the logical choice after fistula formation, but it can be problematic, Dr. Li and colleagues pointed out. “Most often the clinician faces a situation in which the esophageal stent should have a larger diameter on the gastric side, making stenting the alimentary side of the fistula insufficient,” they said. The risk of stent migration is high, and the bifurcated structure of the trachea and main bronchi can cause leakage and stent displacement.

The researchers noted that Y-shaped self-expanding stents have been used for sealing airway fistulas, but they don’t always fully seal large GTFs and GBFs. Their primary objective in studying the combined-type Y-shaped covered metallic stent was to determine the safety and feasibility of the technique; the secondary aim was to evaluate long-term patency and complication rates.

They designed a Y-shaped stent delivery system (Micro-Tech) and used a combined bundle-and-push to insert the main body of the stent. In all, they inserted 20 Y-shaped stents in the 10 patients, although two stents did not fully expand and were dilated with a balloon. The researchers reported resolution of coughing during eating, toleration of liquid or semiliquid diet, and no complications after insertion.

Dr. Li and colleagues also developed strategies to avoid complications of Y-shaped stents, which have been known to retain secretions because they hinder cilia function. “To avoid this, we provided sputum suction and administered continuous high-concentration oxygen during the procedure,” they noted. Also, speed and agility in placement are important. “The operation should be performed as rapidly and gently as possible to avoid irritation to the airway,” Dr. Li and colleagues wrote. The postoperative course involved IV expectorants and antiasthma agents and aerosol inhalation of terbutaline. Surveillance bronchoscopes and debridement of granulation tissue helped avoid stent obstruction.

Nonetheless, the researches acknowledged limitations of the retrospective study, namely its small sample size and lack of a control group.

Dr. Li and colleagues had no financial relationships to disclose.

Airway fistula is a rare but life-threatening complication of esophageal surgery, but an innovative technique using two custom-made, Y-shaped metallic stents can preserve airway patency, researchers at Zhengzhou University in China reported in the August issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2016;152:557-63).

The study involved 10 patients who received Y-shaped stents to treat gastrotracheal or gastrobronchial fistulas (GTFs and GBFs, respectively) after esophageal surgery from 2010 through 2014. “Our patients tolerated the stents well and had good palliation of their symptoms,” wrote Teng-Fei Li, MD, and colleagues.

Courtesy JTCVS/American Association for Thoracic Surgery

Six patients died within 8 months for unrelated reasons – either tumors (four patients), or hemoptysis or pulmonary infection (one each). In one patient, the carinal fistula enlarged 4 months after stenting, but the researchers successfully placed an additional small Y-shaped stent. At the publication of the paper, this patient and three others had survived, Dr. Li and colleagues said.

After esophagectomy, fistulas can form between the tracheobronchial tree and stomach for a variety of reasons. A metallic stent would seem the logical choice after fistula formation, but it can be problematic, Dr. Li and colleagues pointed out. “Most often the clinician faces a situation in which the esophageal stent should have a larger diameter on the gastric side, making stenting the alimentary side of the fistula insufficient,” they said. The risk of stent migration is high, and the bifurcated structure of the trachea and main bronchi can cause leakage and stent displacement.

The researchers noted that Y-shaped self-expanding stents have been used for sealing airway fistulas, but they don’t always fully seal large GTFs and GBFs. Their primary objective in studying the combined-type Y-shaped covered metallic stent was to determine the safety and feasibility of the technique; the secondary aim was to evaluate long-term patency and complication rates.

They designed a Y-shaped stent delivery system (Micro-Tech) and used a combined bundle-and-push to insert the main body of the stent. In all, they inserted 20 Y-shaped stents in the 10 patients, although two stents did not fully expand and were dilated with a balloon. The researchers reported resolution of coughing during eating, toleration of liquid or semiliquid diet, and no complications after insertion.

Dr. Li and colleagues also developed strategies to avoid complications of Y-shaped stents, which have been known to retain secretions because they hinder cilia function. “To avoid this, we provided sputum suction and administered continuous high-concentration oxygen during the procedure,” they noted. Also, speed and agility in placement are important. “The operation should be performed as rapidly and gently as possible to avoid irritation to the airway,” Dr. Li and colleagues wrote. The postoperative course involved IV expectorants and antiasthma agents and aerosol inhalation of terbutaline. Surveillance bronchoscopes and debridement of granulation tissue helped avoid stent obstruction.

Nonetheless, the researches acknowledged limitations of the retrospective study, namely its small sample size and lack of a control group.

Dr. Li and colleagues had no financial relationships to disclose.

Airway fistula is a rare but life-threatening complication of esophageal surgery, but an innovative technique using two custom-made, Y-shaped metallic stents can preserve airway patency, researchers at Zhengzhou University in China reported in the August issue of the Journal of Thoracic and Cardiovascular Surgery (J Thorac Cardiovasc Surg. 2016;152:557-63).

The study involved 10 patients who received Y-shaped stents to treat gastrotracheal or gastrobronchial fistulas (GTFs and GBFs, respectively) after esophageal surgery from 2010 through 2014. “Our patients tolerated the stents well and had good palliation of their symptoms,” wrote Teng-Fei Li, MD, and colleagues.

Courtesy JTCVS/American Association for Thoracic Surgery

Six patients died within 8 months for unrelated reasons – either tumors (four patients), or hemoptysis or pulmonary infection (one each). In one patient, the carinal fistula enlarged 4 months after stenting, but the researchers successfully placed an additional small Y-shaped stent. At the publication of the paper, this patient and three others had survived, Dr. Li and colleagues said.

After esophagectomy, fistulas can form between the tracheobronchial tree and stomach for a variety of reasons. A metallic stent would seem the logical choice after fistula formation, but it can be problematic, Dr. Li and colleagues pointed out. “Most often the clinician faces a situation in which the esophageal stent should have a larger diameter on the gastric side, making stenting the alimentary side of the fistula insufficient,” they said. The risk of stent migration is high, and the bifurcated structure of the trachea and main bronchi can cause leakage and stent displacement.

The researchers noted that Y-shaped self-expanding stents have been used for sealing airway fistulas, but they don’t always fully seal large GTFs and GBFs. Their primary objective in studying the combined-type Y-shaped covered metallic stent was to determine the safety and feasibility of the technique; the secondary aim was to evaluate long-term patency and complication rates.

They designed a Y-shaped stent delivery system (Micro-Tech) and used a combined bundle-and-push to insert the main body of the stent. In all, they inserted 20 Y-shaped stents in the 10 patients, although two stents did not fully expand and were dilated with a balloon. The researchers reported resolution of coughing during eating, toleration of liquid or semiliquid diet, and no complications after insertion.

Dr. Li and colleagues also developed strategies to avoid complications of Y-shaped stents, which have been known to retain secretions because they hinder cilia function. “To avoid this, we provided sputum suction and administered continuous high-concentration oxygen during the procedure,” they noted. Also, speed and agility in placement are important. “The operation should be performed as rapidly and gently as possible to avoid irritation to the airway,” Dr. Li and colleagues wrote. The postoperative course involved IV expectorants and antiasthma agents and aerosol inhalation of terbutaline. Surveillance bronchoscopes and debridement of granulation tissue helped avoid stent obstruction.

Nonetheless, the researches acknowledged limitations of the retrospective study, namely its small sample size and lack of a control group.

Dr. Li and colleagues had no financial relationships to disclose.

Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ (DCIS), according to a multidisciplinary consensus panel.

Despite the widespread use of surgical excision in breast-conserving therapy among patients with DCIS, there is no consensus on the optimal negative margin to prevent recurrence and re-excision. Therefore, the Society of Surgical Oncology, the American Society for Radiation Oncology, and the American Society of Clinical Oncology convened a panel to answer the following question: What margin width minimizes the risk of ipsilateral breast tumor recurrence in patients with DCIS receiving breast-conserving surgery?

The guideline panel reviewed 20 studies including 7,883 DCIS patients. A median of 100% of patients received whole-breast radiation therapy and a median of 21% received endocrine therapy. Patients were followed for a median of 6.5 years and the median incidence of recurrence was 8.3%.

“There is no debate that a positive margin ... implies a potentially incomplete resection and is associated with a higher rate of [recurrence],” according to Monica Morrow, MD, of Memorial Sloan-Kettering Cancer Center, and her fellow panelists. Further, the addition of whole-breast irradiation did not negate this increased risk, the panelists noted (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3573).

According to the meta-analysis, patients with 2-mm negative margins plus whole-breast irradiation were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.

“Margins of at least 2 mm are associated with a reduced risk of [recurrence] relative to narrower negative margin widths in patients receiving [whole-breast radiotherapy]. The routine practice of obtaining negative margin widths wider than 2 mm is not supported by the evidence,” they wrote.

The panel also noted that treatment with excision alone is associated with higher rates of recurrence compared with treatment involving with both excision and whole-breast radiation therapy. However, if patients are treated with excision alone, the optimal margin, which is unknown for this subset of patients, should be at least 2 millimeters, according to the guideline.

Due to variability in specimen sampling and in margin evaluation and assessment, “clinical judgment must be used in determining whether patients with smaller negative margin widths (0 or 1 mm) require re-excision,” the panelists noted. “The findings should not be extrapolated to DCIS patients treated with [accelerated partial breast irradiation] or those with invasive carcinoma for whom a separate guideline has been developed,” Dr. Morrow and her associates wrote.

The guideline development process was funded by the Susan G. Komen Foundation. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ (DCIS), according to a multidisciplinary consensus panel.

Despite the widespread use of surgical excision in breast-conserving therapy among patients with DCIS, there is no consensus on the optimal negative margin to prevent recurrence and re-excision. Therefore, the Society of Surgical Oncology, the American Society for Radiation Oncology, and the American Society of Clinical Oncology convened a panel to answer the following question: What margin width minimizes the risk of ipsilateral breast tumor recurrence in patients with DCIS receiving breast-conserving surgery?

The guideline panel reviewed 20 studies including 7,883 DCIS patients. A median of 100% of patients received whole-breast radiation therapy and a median of 21% received endocrine therapy. Patients were followed for a median of 6.5 years and the median incidence of recurrence was 8.3%.

“There is no debate that a positive margin ... implies a potentially incomplete resection and is associated with a higher rate of [recurrence],” according to Monica Morrow, MD, of Memorial Sloan-Kettering Cancer Center, and her fellow panelists. Further, the addition of whole-breast irradiation did not negate this increased risk, the panelists noted (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3573).

According to the meta-analysis, patients with 2-mm negative margins plus whole-breast irradiation were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.

“Margins of at least 2 mm are associated with a reduced risk of [recurrence] relative to narrower negative margin widths in patients receiving [whole-breast radiotherapy]. The routine practice of obtaining negative margin widths wider than 2 mm is not supported by the evidence,” they wrote.

The panel also noted that treatment with excision alone is associated with higher rates of recurrence compared with treatment involving with both excision and whole-breast radiation therapy. However, if patients are treated with excision alone, the optimal margin, which is unknown for this subset of patients, should be at least 2 millimeters, according to the guideline.

Due to variability in specimen sampling and in margin evaluation and assessment, “clinical judgment must be used in determining whether patients with smaller negative margin widths (0 or 1 mm) require re-excision,” the panelists noted. “The findings should not be extrapolated to DCIS patients treated with [accelerated partial breast irradiation] or those with invasive carcinoma for whom a separate guideline has been developed,” Dr. Morrow and her associates wrote.

The guideline development process was funded by the Susan G. Komen Foundation. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig

Surgical excision with 2-mm clear margins combined with whole-breast irradiation may be the optimal standard to reduce recurrence in patients with ductal carcinoma in situ (DCIS), according to a multidisciplinary consensus panel.

Despite the widespread use of surgical excision in breast-conserving therapy among patients with DCIS, there is no consensus on the optimal negative margin to prevent recurrence and re-excision. Therefore, the Society of Surgical Oncology, the American Society for Radiation Oncology, and the American Society of Clinical Oncology convened a panel to answer the following question: What margin width minimizes the risk of ipsilateral breast tumor recurrence in patients with DCIS receiving breast-conserving surgery?

The guideline panel reviewed 20 studies including 7,883 DCIS patients. A median of 100% of patients received whole-breast radiation therapy and a median of 21% received endocrine therapy. Patients were followed for a median of 6.5 years and the median incidence of recurrence was 8.3%.

“There is no debate that a positive margin ... implies a potentially incomplete resection and is associated with a higher rate of [recurrence],” according to Monica Morrow, MD, of Memorial Sloan-Kettering Cancer Center, and her fellow panelists. Further, the addition of whole-breast irradiation did not negate this increased risk, the panelists noted (J Clin Oncol. 2016 Aug. doi: 10.1200/JCO.2016.68.3573).

According to the meta-analysis, patients with 2-mm negative margins plus whole-breast irradiation were significantly less likely to experience ipsilateral breast tumor recurrence compared with patients who had excisions with positive margins.

“Margins of at least 2 mm are associated with a reduced risk of [recurrence] relative to narrower negative margin widths in patients receiving [whole-breast radiotherapy]. The routine practice of obtaining negative margin widths wider than 2 mm is not supported by the evidence,” they wrote.

The panel also noted that treatment with excision alone is associated with higher rates of recurrence compared with treatment involving with both excision and whole-breast radiation therapy. However, if patients are treated with excision alone, the optimal margin, which is unknown for this subset of patients, should be at least 2 millimeters, according to the guideline.

Due to variability in specimen sampling and in margin evaluation and assessment, “clinical judgment must be used in determining whether patients with smaller negative margin widths (0 or 1 mm) require re-excision,” the panelists noted. “The findings should not be extrapolated to DCIS patients treated with [accelerated partial breast irradiation] or those with invasive carcinoma for whom a separate guideline has been developed,” Dr. Morrow and her associates wrote.

The guideline development process was funded by the Susan G. Komen Foundation. The authors had no relevant disclosures to report.

[email protected]

On Twitter @jessnicolecraig