Heidi Splete

Capacitively coupled electrical field stimulation did not significantly shorten the healing time when it was used to treat tibial stress fractures, according to the results of a randomized trial.

Tibial stress fractures have become an increasingly common problem, especially among athletes and military recruits. Few effective management techniques exist to treat stress fractures, but electrical stimulation has been shown to enhance healing of regular fractures, Belinda R. Beck, Ph.D., of Griffith University in Queensland, Australia, and her colleagues wrote.

The investigators conducted a randomized trial that yielded complete results for 19 men and 24 women with acute posteromedial tibial stress fractures. The average ages of the 8 men who received treatment and 11 men who received the placebo were 28 years and 26 years, respectively. The average ages of the 14 women who received treatment and the 10 women who received the placebo were 28 years and 24 years, respectively. More than half of the subjects (10 men and 14 women) reported distance running as their primary sporting activity.

The patients were randomized to receive either actual or sham electrical field stimulation for 15 hours/day until the stress fracture was healed. Healing was defined as the time when a patient could hop on the injured leg to a height of 10 cm for 30 seconds without pain.

Treatment was delivered via a portable, battery-powered capacitively coupled electrical field (CCEF) device worn around the lower leg (Am. J. Sports. Med. 2007 [Epub doi: 10.1177/0363546507310076]). In addition, all patients were instructed to consume one 500-mg chewable calcium supplement each day and to avoid weight-bearing activities.

Overall, no difference in the average time to healing was found between the treatment and placebo groups (29 days vs. 26 days), although women in the treatment group took significantly longer to heal, compared with the men in the treatment group (31 days vs. 23 days). No sex differences in healing times were noted in the placebo group.

But those patients in either group who were the most compliant with their treatment protocols healed significantly faster than those who were less compliant.

More hours of daily device use were significantly associated with a shorter healing time within the test group. Specifically, patients who used the device for more than 12.25 hours/day healed significantly faster than those who used the device for less than 12.25 hours/day. No similar association was noted in the placebo group.

Engaging in more weight-bearing activity (which was noncompliant with instructions to rest and avoid excessive weight-bearing activity) was significantly associated with a longer healing time from baseline in the test group, compared with the placebo group.

Although there were no discernible effects of injury severity on healing within the treatment group, the patients with grades 3 and 4 tibial stress fractures in the treatment group healed 24.5 days faster than patients with grades 3 and 4 tibial stress fractures in the placebo group.

The researchers had no financial conflicts to disclose, but the Ortho-Pak devices used in the study were supplied by Biolectron Inc.

Capacitively coupled electrical field stimulation did not significantly shorten the healing time when it was used to treat tibial stress fractures, according to the results of a randomized trial.

Tibial stress fractures have become an increasingly common problem, especially among athletes and military recruits. Few effective management techniques exist to treat stress fractures, but electrical stimulation has been shown to enhance healing of regular fractures, Belinda R. Beck, Ph.D., of Griffith University in Queensland, Australia, and her colleagues wrote.

The investigators conducted a randomized trial that yielded complete results for 19 men and 24 women with acute posteromedial tibial stress fractures. The average ages of the 8 men who received treatment and 11 men who received the placebo were 28 years and 26 years, respectively. The average ages of the 14 women who received treatment and the 10 women who received the placebo were 28 years and 24 years, respectively. More than half of the subjects (10 men and 14 women) reported distance running as their primary sporting activity.

The patients were randomized to receive either actual or sham electrical field stimulation for 15 hours/day until the stress fracture was healed. Healing was defined as the time when a patient could hop on the injured leg to a height of 10 cm for 30 seconds without pain.

Treatment was delivered via a portable, battery-powered capacitively coupled electrical field (CCEF) device worn around the lower leg (Am. J. Sports. Med. 2007 [Epub doi: 10.1177/0363546507310076]). In addition, all patients were instructed to consume one 500-mg chewable calcium supplement each day and to avoid weight-bearing activities.

Overall, no difference in the average time to healing was found between the treatment and placebo groups (29 days vs. 26 days), although women in the treatment group took significantly longer to heal, compared with the men in the treatment group (31 days vs. 23 days). No sex differences in healing times were noted in the placebo group.

But those patients in either group who were the most compliant with their treatment protocols healed significantly faster than those who were less compliant.

More hours of daily device use were significantly associated with a shorter healing time within the test group. Specifically, patients who used the device for more than 12.25 hours/day healed significantly faster than those who used the device for less than 12.25 hours/day. No similar association was noted in the placebo group.

Engaging in more weight-bearing activity (which was noncompliant with instructions to rest and avoid excessive weight-bearing activity) was significantly associated with a longer healing time from baseline in the test group, compared with the placebo group.

Although there were no discernible effects of injury severity on healing within the treatment group, the patients with grades 3 and 4 tibial stress fractures in the treatment group healed 24.5 days faster than patients with grades 3 and 4 tibial stress fractures in the placebo group.

The researchers had no financial conflicts to disclose, but the Ortho-Pak devices used in the study were supplied by Biolectron Inc.

Capacitively coupled electrical field stimulation did not significantly shorten the healing time when it was used to treat tibial stress fractures, according to the results of a randomized trial.

Tibial stress fractures have become an increasingly common problem, especially among athletes and military recruits. Few effective management techniques exist to treat stress fractures, but electrical stimulation has been shown to enhance healing of regular fractures, Belinda R. Beck, Ph.D., of Griffith University in Queensland, Australia, and her colleagues wrote.

The investigators conducted a randomized trial that yielded complete results for 19 men and 24 women with acute posteromedial tibial stress fractures. The average ages of the 8 men who received treatment and 11 men who received the placebo were 28 years and 26 years, respectively. The average ages of the 14 women who received treatment and the 10 women who received the placebo were 28 years and 24 years, respectively. More than half of the subjects (10 men and 14 women) reported distance running as their primary sporting activity.

The patients were randomized to receive either actual or sham electrical field stimulation for 15 hours/day until the stress fracture was healed. Healing was defined as the time when a patient could hop on the injured leg to a height of 10 cm for 30 seconds without pain.

Treatment was delivered via a portable, battery-powered capacitively coupled electrical field (CCEF) device worn around the lower leg (Am. J. Sports. Med. 2007 [Epub doi: 10.1177/0363546507310076]). In addition, all patients were instructed to consume one 500-mg chewable calcium supplement each day and to avoid weight-bearing activities.

Overall, no difference in the average time to healing was found between the treatment and placebo groups (29 days vs. 26 days), although women in the treatment group took significantly longer to heal, compared with the men in the treatment group (31 days vs. 23 days). No sex differences in healing times were noted in the placebo group.

But those patients in either group who were the most compliant with their treatment protocols healed significantly faster than those who were less compliant.

More hours of daily device use were significantly associated with a shorter healing time within the test group. Specifically, patients who used the device for more than 12.25 hours/day healed significantly faster than those who used the device for less than 12.25 hours/day. No similar association was noted in the placebo group.

Engaging in more weight-bearing activity (which was noncompliant with instructions to rest and avoid excessive weight-bearing activity) was significantly associated with a longer healing time from baseline in the test group, compared with the placebo group.

Although there were no discernible effects of injury severity on healing within the treatment group, the patients with grades 3 and 4 tibial stress fractures in the treatment group healed 24.5 days faster than patients with grades 3 and 4 tibial stress fractures in the placebo group.

The researchers had no financial conflicts to disclose, but the Ortho-Pak devices used in the study were supplied by Biolectron Inc.

Use of helmets by skiers and snowboarders could reduce head injury risk–a leading cause of injury and death in this population–by as much as 60%, according to the findings of a meta-analysis.

To characterize traumatic brain injuries (TBI) and spinal cord injuries (SCI) in skiers and snowboarders and to assess prevention strategies, Alun Ackery, a medical student at the University of Toronto and colleagues reviewed 24 articles from 10 countries published between January 1990 and December 2004 that were associated with skiing, snowboarding, or both.

The findings show an increasing incidence of both TBI and SCI, in part because of the growing popularity of high-speed and acrobatic maneuvers on skis and snowboards (Inj. Prev. 2007;13[6]:368-75).

A study from the United States found that 88% of all skiing and snowboarding deaths resulted from head injuries, based on data from a trauma registry. And a Canadian study found that a majority of SCIs occurred among expert snowboarders during jumps ranging from 2 feet to 25 feet.

Young men sustain the most head and spine injuries from skiing and snowboarding, according to several studies in the meta-analysis. A study of data from two complete ski seasons in British Columbia, Canada, found that 70% of SCIs in skiers and 100% of SCIs in snowboarders occurred in men. The mean age of the injured male skiers was 35 years and the mean age of the injured snowboarders was 22 years.

In addition, data from a 10-year study conducted by researchers at the Innsbruck (Austria) University Hospital showed an increase in winter sports injuries between 1982 and 1992 that could be attributed to speed and collisions, and that nearly 40% of spinal injuries from winter sports occurred in young men aged 15-25 years.

Data from the Consumer Product Safety Commission showed an increased percentage of head injuries in skiers from 12% in 1993 to 15% in 1997, and the estimated number of head injuries in snowboarders jumped from 1,000 in 1993 to 5,200 in 1997. Head injuries accounted for 14% of all ski and snowboard injuries in children and teens aged 15 years and younger.

Additional data from the commission suggest that wearing a helmet could prevent 44% of head injuries while skiing or snowboarding and reduce head injuries in children and teens aged 15 years and younger by 53%. But many countries have no standards for helmet use in these sports.

The researchers recommended the use of helmets “by all skiing and snowboarding participants [and] the promotion and enforcement of standards for ski and snowboarding helmets in countries in which these activities are common.”

Although some concerns have been raised about increased risk of cervical spine injuries in children caused by helmet use, the accident data don't support this risk. And parents should be cautioned that helmets should be properly fitted to the child's current size, not bought larger to allow “room to grow,” the researchers noted.

Most countries do not require skiers or snowboarders to wear a helmet, even though doing so would reduce head injuries. CEZARY MACIOCHA/FOTOLIA

Use of helmets by skiers and snowboarders could reduce head injury risk–a leading cause of injury and death in this population–by as much as 60%, according to the findings of a meta-analysis.

To characterize traumatic brain injuries (TBI) and spinal cord injuries (SCI) in skiers and snowboarders and to assess prevention strategies, Alun Ackery, a medical student at the University of Toronto and colleagues reviewed 24 articles from 10 countries published between January 1990 and December 2004 that were associated with skiing, snowboarding, or both.

The findings show an increasing incidence of both TBI and SCI, in part because of the growing popularity of high-speed and acrobatic maneuvers on skis and snowboards (Inj. Prev. 2007;13[6]:368-75).

A study from the United States found that 88% of all skiing and snowboarding deaths resulted from head injuries, based on data from a trauma registry. And a Canadian study found that a majority of SCIs occurred among expert snowboarders during jumps ranging from 2 feet to 25 feet.

Young men sustain the most head and spine injuries from skiing and snowboarding, according to several studies in the meta-analysis. A study of data from two complete ski seasons in British Columbia, Canada, found that 70% of SCIs in skiers and 100% of SCIs in snowboarders occurred in men. The mean age of the injured male skiers was 35 years and the mean age of the injured snowboarders was 22 years.

In addition, data from a 10-year study conducted by researchers at the Innsbruck (Austria) University Hospital showed an increase in winter sports injuries between 1982 and 1992 that could be attributed to speed and collisions, and that nearly 40% of spinal injuries from winter sports occurred in young men aged 15-25 years.

Data from the Consumer Product Safety Commission showed an increased percentage of head injuries in skiers from 12% in 1993 to 15% in 1997, and the estimated number of head injuries in snowboarders jumped from 1,000 in 1993 to 5,200 in 1997. Head injuries accounted for 14% of all ski and snowboard injuries in children and teens aged 15 years and younger.

Additional data from the commission suggest that wearing a helmet could prevent 44% of head injuries while skiing or snowboarding and reduce head injuries in children and teens aged 15 years and younger by 53%. But many countries have no standards for helmet use in these sports.

The researchers recommended the use of helmets “by all skiing and snowboarding participants [and] the promotion and enforcement of standards for ski and snowboarding helmets in countries in which these activities are common.”

Although some concerns have been raised about increased risk of cervical spine injuries in children caused by helmet use, the accident data don't support this risk. And parents should be cautioned that helmets should be properly fitted to the child's current size, not bought larger to allow “room to grow,” the researchers noted.

Most countries do not require skiers or snowboarders to wear a helmet, even though doing so would reduce head injuries. CEZARY MACIOCHA/FOTOLIA

Use of helmets by skiers and snowboarders could reduce head injury risk–a leading cause of injury and death in this population–by as much as 60%, according to the findings of a meta-analysis.

To characterize traumatic brain injuries (TBI) and spinal cord injuries (SCI) in skiers and snowboarders and to assess prevention strategies, Alun Ackery, a medical student at the University of Toronto and colleagues reviewed 24 articles from 10 countries published between January 1990 and December 2004 that were associated with skiing, snowboarding, or both.

The findings show an increasing incidence of both TBI and SCI, in part because of the growing popularity of high-speed and acrobatic maneuvers on skis and snowboards (Inj. Prev. 2007;13[6]:368-75).

A study from the United States found that 88% of all skiing and snowboarding deaths resulted from head injuries, based on data from a trauma registry. And a Canadian study found that a majority of SCIs occurred among expert snowboarders during jumps ranging from 2 feet to 25 feet.

Young men sustain the most head and spine injuries from skiing and snowboarding, according to several studies in the meta-analysis. A study of data from two complete ski seasons in British Columbia, Canada, found that 70% of SCIs in skiers and 100% of SCIs in snowboarders occurred in men. The mean age of the injured male skiers was 35 years and the mean age of the injured snowboarders was 22 years.

In addition, data from a 10-year study conducted by researchers at the Innsbruck (Austria) University Hospital showed an increase in winter sports injuries between 1982 and 1992 that could be attributed to speed and collisions, and that nearly 40% of spinal injuries from winter sports occurred in young men aged 15-25 years.

Data from the Consumer Product Safety Commission showed an increased percentage of head injuries in skiers from 12% in 1993 to 15% in 1997, and the estimated number of head injuries in snowboarders jumped from 1,000 in 1993 to 5,200 in 1997. Head injuries accounted for 14% of all ski and snowboard injuries in children and teens aged 15 years and younger.

Additional data from the commission suggest that wearing a helmet could prevent 44% of head injuries while skiing or snowboarding and reduce head injuries in children and teens aged 15 years and younger by 53%. But many countries have no standards for helmet use in these sports.

The researchers recommended the use of helmets “by all skiing and snowboarding participants [and] the promotion and enforcement of standards for ski and snowboarding helmets in countries in which these activities are common.”

Although some concerns have been raised about increased risk of cervical spine injuries in children caused by helmet use, the accident data don't support this risk. And parents should be cautioned that helmets should be properly fitted to the child's current size, not bought larger to allow “room to grow,” the researchers noted.

Most countries do not require skiers or snowboarders to wear a helmet, even though doing so would reduce head injuries. CEZARY MACIOCHA/FOTOLIA

Vitamin D deficiency may increase the risk of cardiovascular disease in adults, especially in people who also have hypertension, based on data from the Framingham Offspring Study.

More studies are needed to show whether correcting vitamin D deficiency could prevent or reduce the risk of cardiovascular disease, but the clinical implication of the finding is that correcting the deficiency, which is prevalent worldwide, could have a significant effect on public health, according to the study's authors.

Previous clinical studies have shown associations between lower levels of vitamin D and an increased risk of problems including prevalent cardiovascular disease, coronary artery calcification, and plasma renin activity (an indicator of high blood pressure). These associations may occur in part because vitamin D receptors are found in a range of tissues including vascular smooth muscle tissue, the lining of the interior surface of blood vessels, and heart muscle tissue.

But more data are needed to show whether vitamin D deficiency is a result of cardiovascular disease or a contributing factor. To determine the relationship between vitamin D status and the incidence of cardiovascular events in a population with no history of cardiovascular disease, Dr. Thomas J. Wang of Harvard Medical School, Boston, and his colleagues followed 1,739 participants in the Framingham Offspring Study for at least 5 years. The average age of the participants was 59 years, 55% were women, and all were white. The study consists of the children of participants in the original Framingham Heart Study that began in 1948.

In this study, a 25-hydroxyvitamin D (25-OH D) level lower than 15 ng/mL was used to define vitamin D deficiency. This value was chosen for consistency with other cross-sectional studies of the Framingham data and with hospital-based samples, although 25-OH D levels greater than 30 ng/mL are considered preferable for promoting bone metabolism, the researchers noted.

At the start of the study, 28% of the participants had 25-OH D levels lower than 15 ng/mL, and 9% had levels lower than 10 ng/mL (Circulation 2008 Jan. 29 [Epub doi:10.1161/circulationaha.107.706127]).

A total of 120 participants had a cardiovascular event after an average of 5.4 years of follow-up (approximately 8,069 person-years). Overall, those with 25-OH D levels lower than 15 ng/mL were significantly more likely to have had a cardiovascular event than were those whose 25-OH D levels were 15 ng/mL or higher. After adjusting for age and sex, the 5-year incidence rate was more than twice as high in those with 25-OH D levels lower than 15 ng/mL than in those with higher levels (4.4 vs. 8.9).

In particular, the highest rates of cardiovascular event risk were observed in subjects with hypertension as well as vitamin D deficiency. The 5-year rate of cardiovascular disease was more than twice as high in the subjects with hypertension and vitamin D deficiency, compared with the hypertensive subjects who were not vitamin D deficient (5.8 vs. 14.2).

Furthermore, the higher cardiovascular risk appeared to increase as vitamin D decreased in the hypertensive patients. When vitamin D levels were divided into three categories, the hazard ratios were 1.00, 1.93, and 2.51 for those with 25-OH D levels of 15 ng/mL or higher, 10-15 ng/mL, and lower than 10 ng/mL, respectively. But no similar progressions across categories of 25-OH D deficiency were noted among nonhypertensive subjects.

The cardiovascular events included 65 fatal or nonfatal coronary heart disease events, 28 fatal or nonfatal cerebrovascular events, 19 cases of heart failure, and 8 instances of claudication.

The study was limited because not all variables that affect vitamin D were measured. But using an objective measure of vitamin D (25-OH D) rather than relying on subjects' self-reports of vitamin D intake makes the findings stronger.

Although the findings suggest that treating vitamin D deficiency could reduce the risk of heart disease, the findings are not enough to advise a treatment plan, and more clinical and experimental research is needed. The study was supported in part by grants from the American Heart Association, the U.S. Department of Agriculture, and the National Institutes of Health. Dr. Wang, the lead author, had no financial conflicts to disclose.

Vitamin D deficiency may increase the risk of cardiovascular disease in adults, especially in people who also have hypertension, based on data from the Framingham Offspring Study.

More studies are needed to show whether correcting vitamin D deficiency could prevent or reduce the risk of cardiovascular disease, but the clinical implication of the finding is that correcting the deficiency, which is prevalent worldwide, could have a significant effect on public health, according to the study's authors.

Previous clinical studies have shown associations between lower levels of vitamin D and an increased risk of problems including prevalent cardiovascular disease, coronary artery calcification, and plasma renin activity (an indicator of high blood pressure). These associations may occur in part because vitamin D receptors are found in a range of tissues including vascular smooth muscle tissue, the lining of the interior surface of blood vessels, and heart muscle tissue.

But more data are needed to show whether vitamin D deficiency is a result of cardiovascular disease or a contributing factor. To determine the relationship between vitamin D status and the incidence of cardiovascular events in a population with no history of cardiovascular disease, Dr. Thomas J. Wang of Harvard Medical School, Boston, and his colleagues followed 1,739 participants in the Framingham Offspring Study for at least 5 years. The average age of the participants was 59 years, 55% were women, and all were white. The study consists of the children of participants in the original Framingham Heart Study that began in 1948.

In this study, a 25-hydroxyvitamin D (25-OH D) level lower than 15 ng/mL was used to define vitamin D deficiency. This value was chosen for consistency with other cross-sectional studies of the Framingham data and with hospital-based samples, although 25-OH D levels greater than 30 ng/mL are considered preferable for promoting bone metabolism, the researchers noted.

At the start of the study, 28% of the participants had 25-OH D levels lower than 15 ng/mL, and 9% had levels lower than 10 ng/mL (Circulation 2008 Jan. 29 [Epub doi:10.1161/circulationaha.107.706127]).

A total of 120 participants had a cardiovascular event after an average of 5.4 years of follow-up (approximately 8,069 person-years). Overall, those with 25-OH D levels lower than 15 ng/mL were significantly more likely to have had a cardiovascular event than were those whose 25-OH D levels were 15 ng/mL or higher. After adjusting for age and sex, the 5-year incidence rate was more than twice as high in those with 25-OH D levels lower than 15 ng/mL than in those with higher levels (4.4 vs. 8.9).

In particular, the highest rates of cardiovascular event risk were observed in subjects with hypertension as well as vitamin D deficiency. The 5-year rate of cardiovascular disease was more than twice as high in the subjects with hypertension and vitamin D deficiency, compared with the hypertensive subjects who were not vitamin D deficient (5.8 vs. 14.2).

Furthermore, the higher cardiovascular risk appeared to increase as vitamin D decreased in the hypertensive patients. When vitamin D levels were divided into three categories, the hazard ratios were 1.00, 1.93, and 2.51 for those with 25-OH D levels of 15 ng/mL or higher, 10-15 ng/mL, and lower than 10 ng/mL, respectively. But no similar progressions across categories of 25-OH D deficiency were noted among nonhypertensive subjects.

The cardiovascular events included 65 fatal or nonfatal coronary heart disease events, 28 fatal or nonfatal cerebrovascular events, 19 cases of heart failure, and 8 instances of claudication.

The study was limited because not all variables that affect vitamin D were measured. But using an objective measure of vitamin D (25-OH D) rather than relying on subjects' self-reports of vitamin D intake makes the findings stronger.

Although the findings suggest that treating vitamin D deficiency could reduce the risk of heart disease, the findings are not enough to advise a treatment plan, and more clinical and experimental research is needed. The study was supported in part by grants from the American Heart Association, the U.S. Department of Agriculture, and the National Institutes of Health. Dr. Wang, the lead author, had no financial conflicts to disclose.

Vitamin D deficiency may increase the risk of cardiovascular disease in adults, especially in people who also have hypertension, based on data from the Framingham Offspring Study.

More studies are needed to show whether correcting vitamin D deficiency could prevent or reduce the risk of cardiovascular disease, but the clinical implication of the finding is that correcting the deficiency, which is prevalent worldwide, could have a significant effect on public health, according to the study's authors.

Previous clinical studies have shown associations between lower levels of vitamin D and an increased risk of problems including prevalent cardiovascular disease, coronary artery calcification, and plasma renin activity (an indicator of high blood pressure). These associations may occur in part because vitamin D receptors are found in a range of tissues including vascular smooth muscle tissue, the lining of the interior surface of blood vessels, and heart muscle tissue.

But more data are needed to show whether vitamin D deficiency is a result of cardiovascular disease or a contributing factor. To determine the relationship between vitamin D status and the incidence of cardiovascular events in a population with no history of cardiovascular disease, Dr. Thomas J. Wang of Harvard Medical School, Boston, and his colleagues followed 1,739 participants in the Framingham Offspring Study for at least 5 years. The average age of the participants was 59 years, 55% were women, and all were white. The study consists of the children of participants in the original Framingham Heart Study that began in 1948.

In this study, a 25-hydroxyvitamin D (25-OH D) level lower than 15 ng/mL was used to define vitamin D deficiency. This value was chosen for consistency with other cross-sectional studies of the Framingham data and with hospital-based samples, although 25-OH D levels greater than 30 ng/mL are considered preferable for promoting bone metabolism, the researchers noted.

At the start of the study, 28% of the participants had 25-OH D levels lower than 15 ng/mL, and 9% had levels lower than 10 ng/mL (Circulation 2008 Jan. 29 [Epub doi:10.1161/circulationaha.107.706127]).

A total of 120 participants had a cardiovascular event after an average of 5.4 years of follow-up (approximately 8,069 person-years). Overall, those with 25-OH D levels lower than 15 ng/mL were significantly more likely to have had a cardiovascular event than were those whose 25-OH D levels were 15 ng/mL or higher. After adjusting for age and sex, the 5-year incidence rate was more than twice as high in those with 25-OH D levels lower than 15 ng/mL than in those with higher levels (4.4 vs. 8.9).

In particular, the highest rates of cardiovascular event risk were observed in subjects with hypertension as well as vitamin D deficiency. The 5-year rate of cardiovascular disease was more than twice as high in the subjects with hypertension and vitamin D deficiency, compared with the hypertensive subjects who were not vitamin D deficient (5.8 vs. 14.2).

Furthermore, the higher cardiovascular risk appeared to increase as vitamin D decreased in the hypertensive patients. When vitamin D levels were divided into three categories, the hazard ratios were 1.00, 1.93, and 2.51 for those with 25-OH D levels of 15 ng/mL or higher, 10-15 ng/mL, and lower than 10 ng/mL, respectively. But no similar progressions across categories of 25-OH D deficiency were noted among nonhypertensive subjects.

The cardiovascular events included 65 fatal or nonfatal coronary heart disease events, 28 fatal or nonfatal cerebrovascular events, 19 cases of heart failure, and 8 instances of claudication.

The study was limited because not all variables that affect vitamin D were measured. But using an objective measure of vitamin D (25-OH D) rather than relying on subjects' self-reports of vitamin D intake makes the findings stronger.

Although the findings suggest that treating vitamin D deficiency could reduce the risk of heart disease, the findings are not enough to advise a treatment plan, and more clinical and experimental research is needed. The study was supported in part by grants from the American Heart Association, the U.S. Department of Agriculture, and the National Institutes of Health. Dr. Wang, the lead author, had no financial conflicts to disclose.

WASHINGTON — Postmenopausal women who took a low-dose estrogen/progestin hormone therapy reported significant improvements in vasomotor symptoms and quality of life after 6 months, according to findings from an open-label efficacy study.

The therapy caused a significant increase in mean triglycerides, from 129 mg/dL at baseline to 168 mg/dL after 6 months. But the women had no other significant changes in their lipid profiles or in their body weight, body mass index, or blood glucose during the study period, Dr. Fernando Ayala Aguilera of the Hospital Universitario, Monterrey (Mexico) and colleagues reported in a poster presentation at the annual meeting of the American Society for Reproductive Medicine.

In the study, sponsored by Wyeth Pharmaceuticals, 68 postmenopausal women aged 45–55 years who reported at least four hot flashes per day received a combination of 1 mg 17β-estradiol and 0.125 mg trimegestone orally each day for 6 months. The study criteria excluded women without an intact uterus, with known or suspected breast cancer, or with abnormal bleeding.

Overall, patient scores on the MENQOL (a questionnaire designed specifically to evaluate the quality-of-life symptoms in menopausal women) dropped from an average of 78 at baseline to an average of 5 after 6 months of treatment.

The average total cholesterol remained stable between baseline and 6 months (201.3 vs. 200.2 mg/dL). Blood glucose, body weight, and body mass index were essentially unchanged from baseline to the 6-month follow-up: Average blood glucose was 92 at both baseline and 6 months, average body weight was 67 kg at baseline vs. 66 kg at 6 months, and average BMI was 27 kg/m

High triglycerides may be a cause for concern, but the triglycerides in this study did not reach unhealthy levels (above 200 mg/dL).

Although the findings were limited by a small number of patients and a short follow-up period, the preliminary results from this ongoing study suggest that a 17β-estradiol/trimegestone combination may provide enough relief from menopausal symptoms to outweigh the potential risks of increased triglycerides in the absence of other adverse effects on lipid profiles.

WASHINGTON — Postmenopausal women who took a low-dose estrogen/progestin hormone therapy reported significant improvements in vasomotor symptoms and quality of life after 6 months, according to findings from an open-label efficacy study.

The therapy caused a significant increase in mean triglycerides, from 129 mg/dL at baseline to 168 mg/dL after 6 months. But the women had no other significant changes in their lipid profiles or in their body weight, body mass index, or blood glucose during the study period, Dr. Fernando Ayala Aguilera of the Hospital Universitario, Monterrey (Mexico) and colleagues reported in a poster presentation at the annual meeting of the American Society for Reproductive Medicine.

In the study, sponsored by Wyeth Pharmaceuticals, 68 postmenopausal women aged 45–55 years who reported at least four hot flashes per day received a combination of 1 mg 17β-estradiol and 0.125 mg trimegestone orally each day for 6 months. The study criteria excluded women without an intact uterus, with known or suspected breast cancer, or with abnormal bleeding.

Overall, patient scores on the MENQOL (a questionnaire designed specifically to evaluate the quality-of-life symptoms in menopausal women) dropped from an average of 78 at baseline to an average of 5 after 6 months of treatment.

The average total cholesterol remained stable between baseline and 6 months (201.3 vs. 200.2 mg/dL). Blood glucose, body weight, and body mass index were essentially unchanged from baseline to the 6-month follow-up: Average blood glucose was 92 at both baseline and 6 months, average body weight was 67 kg at baseline vs. 66 kg at 6 months, and average BMI was 27 kg/m

High triglycerides may be a cause for concern, but the triglycerides in this study did not reach unhealthy levels (above 200 mg/dL).

Although the findings were limited by a small number of patients and a short follow-up period, the preliminary results from this ongoing study suggest that a 17β-estradiol/trimegestone combination may provide enough relief from menopausal symptoms to outweigh the potential risks of increased triglycerides in the absence of other adverse effects on lipid profiles.

WASHINGTON — Postmenopausal women who took a low-dose estrogen/progestin hormone therapy reported significant improvements in vasomotor symptoms and quality of life after 6 months, according to findings from an open-label efficacy study.

The therapy caused a significant increase in mean triglycerides, from 129 mg/dL at baseline to 168 mg/dL after 6 months. But the women had no other significant changes in their lipid profiles or in their body weight, body mass index, or blood glucose during the study period, Dr. Fernando Ayala Aguilera of the Hospital Universitario, Monterrey (Mexico) and colleagues reported in a poster presentation at the annual meeting of the American Society for Reproductive Medicine.

In the study, sponsored by Wyeth Pharmaceuticals, 68 postmenopausal women aged 45–55 years who reported at least four hot flashes per day received a combination of 1 mg 17β-estradiol and 0.125 mg trimegestone orally each day for 6 months. The study criteria excluded women without an intact uterus, with known or suspected breast cancer, or with abnormal bleeding.

Overall, patient scores on the MENQOL (a questionnaire designed specifically to evaluate the quality-of-life symptoms in menopausal women) dropped from an average of 78 at baseline to an average of 5 after 6 months of treatment.

The average total cholesterol remained stable between baseline and 6 months (201.3 vs. 200.2 mg/dL). Blood glucose, body weight, and body mass index were essentially unchanged from baseline to the 6-month follow-up: Average blood glucose was 92 at both baseline and 6 months, average body weight was 67 kg at baseline vs. 66 kg at 6 months, and average BMI was 27 kg/m

High triglycerides may be a cause for concern, but the triglycerides in this study did not reach unhealthy levels (above 200 mg/dL).

Although the findings were limited by a small number of patients and a short follow-up period, the preliminary results from this ongoing study suggest that a 17β-estradiol/trimegestone combination may provide enough relief from menopausal symptoms to outweigh the potential risks of increased triglycerides in the absence of other adverse effects on lipid profiles.

Peripheral visual field loss significantly increased the risk of falling in older adults, according to data from 2,375 community-dwelling adults aged 65 to 84 years.

Poor vision has been implicated in falls in previous studies, and many interventions to prevent falls in the elderly have included vision assessments. But few studies have examined the specific types of vision loss that contribute most to the risk of falling, according to the Salisbury Eye Evaluation (SEE) study.

Ellen E. Freeman, Ph.D., of the Wilmer Eye Institute at Johns Hopkins University in Baltimore, Md., and her colleagues tested the vision of community-dwelling elderly SEE participants and then prospectively collected their reports of falls for up to 20 months. The average follow-up period was 17 months (Invest. Ophthalmol. Vis. Sci. 2007;48:4445–50).

At least 4 months of follow-up data were available for 2,312 participants, of whom 680 (29%) reported at least one fall during the follow-up period.

Total visual field loss was the only visual element that significantly increased the risk of falling. For every 10% loss in visual field, the participants were 8% more likely to fall after adjusting for demographic and health variables. When visual field loss was broken down into central and peripheral, only peripheral visual field loss remained significantly associated with fall risk (participants were 6% more likely to fall). Central visual field loss was associated with increased fall risk but did not reach statistical significance. The researchers were not able to determine whether the upper or lower peripheral visual field was more important.

Neither visual acuity nor contrast sensitivity was significantly associated with increased fall risk. Nonvision variables that were independently associated with fall risk when combined with total visual field loss included poor balance, depression, sedative use, a history of stroke, Parkinson's disease, or arthritis, and being white and female.

The circumstances of the first reported falls were available for 743 participants. Of these, 50% said they were performing a “mildly displacing” activity such as standing or walking, compared with 46% who said that they were reaching, bending, or stepping (a “moderately displacing” activity) when the falls occurred. And 4% reported that the falls occurred during a “markedly displacing” activity such as climbing or participating in sports. The proportion of individuals in the study who had at least one fall in the study was consistent with findings in other community-based studies, according to the researchers.

“Visual field reduction is most likely related to the risk of falls, at least in part, through its effects on postural stability and the ability to maneuver around objects,” they wrote. “Persons with such deficits may benefit from mobility training to navigate the environment more safely and reduce the risk of falling.”

The researchers had no financial conflicts to disclose.

Peripheral visual field loss significantly increased the risk of falling in older adults, according to data from 2,375 community-dwelling adults aged 65 to 84 years.

Poor vision has been implicated in falls in previous studies, and many interventions to prevent falls in the elderly have included vision assessments. But few studies have examined the specific types of vision loss that contribute most to the risk of falling, according to the Salisbury Eye Evaluation (SEE) study.

Ellen E. Freeman, Ph.D., of the Wilmer Eye Institute at Johns Hopkins University in Baltimore, Md., and her colleagues tested the vision of community-dwelling elderly SEE participants and then prospectively collected their reports of falls for up to 20 months. The average follow-up period was 17 months (Invest. Ophthalmol. Vis. Sci. 2007;48:4445–50).

At least 4 months of follow-up data were available for 2,312 participants, of whom 680 (29%) reported at least one fall during the follow-up period.

Total visual field loss was the only visual element that significantly increased the risk of falling. For every 10% loss in visual field, the participants were 8% more likely to fall after adjusting for demographic and health variables. When visual field loss was broken down into central and peripheral, only peripheral visual field loss remained significantly associated with fall risk (participants were 6% more likely to fall). Central visual field loss was associated with increased fall risk but did not reach statistical significance. The researchers were not able to determine whether the upper or lower peripheral visual field was more important.

Neither visual acuity nor contrast sensitivity was significantly associated with increased fall risk. Nonvision variables that were independently associated with fall risk when combined with total visual field loss included poor balance, depression, sedative use, a history of stroke, Parkinson's disease, or arthritis, and being white and female.

The circumstances of the first reported falls were available for 743 participants. Of these, 50% said they were performing a “mildly displacing” activity such as standing or walking, compared with 46% who said that they were reaching, bending, or stepping (a “moderately displacing” activity) when the falls occurred. And 4% reported that the falls occurred during a “markedly displacing” activity such as climbing or participating in sports. The proportion of individuals in the study who had at least one fall in the study was consistent with findings in other community-based studies, according to the researchers.

“Visual field reduction is most likely related to the risk of falls, at least in part, through its effects on postural stability and the ability to maneuver around objects,” they wrote. “Persons with such deficits may benefit from mobility training to navigate the environment more safely and reduce the risk of falling.”

The researchers had no financial conflicts to disclose.

Peripheral visual field loss significantly increased the risk of falling in older adults, according to data from 2,375 community-dwelling adults aged 65 to 84 years.

Poor vision has been implicated in falls in previous studies, and many interventions to prevent falls in the elderly have included vision assessments. But few studies have examined the specific types of vision loss that contribute most to the risk of falling, according to the Salisbury Eye Evaluation (SEE) study.

Ellen E. Freeman, Ph.D., of the Wilmer Eye Institute at Johns Hopkins University in Baltimore, Md., and her colleagues tested the vision of community-dwelling elderly SEE participants and then prospectively collected their reports of falls for up to 20 months. The average follow-up period was 17 months (Invest. Ophthalmol. Vis. Sci. 2007;48:4445–50).

At least 4 months of follow-up data were available for 2,312 participants, of whom 680 (29%) reported at least one fall during the follow-up period.

Total visual field loss was the only visual element that significantly increased the risk of falling. For every 10% loss in visual field, the participants were 8% more likely to fall after adjusting for demographic and health variables. When visual field loss was broken down into central and peripheral, only peripheral visual field loss remained significantly associated with fall risk (participants were 6% more likely to fall). Central visual field loss was associated with increased fall risk but did not reach statistical significance. The researchers were not able to determine whether the upper or lower peripheral visual field was more important.

Neither visual acuity nor contrast sensitivity was significantly associated with increased fall risk. Nonvision variables that were independently associated with fall risk when combined with total visual field loss included poor balance, depression, sedative use, a history of stroke, Parkinson's disease, or arthritis, and being white and female.

The circumstances of the first reported falls were available for 743 participants. Of these, 50% said they were performing a “mildly displacing” activity such as standing or walking, compared with 46% who said that they were reaching, bending, or stepping (a “moderately displacing” activity) when the falls occurred. And 4% reported that the falls occurred during a “markedly displacing” activity such as climbing or participating in sports. The proportion of individuals in the study who had at least one fall in the study was consistent with findings in other community-based studies, according to the researchers.

“Visual field reduction is most likely related to the risk of falls, at least in part, through its effects on postural stability and the ability to maneuver around objects,” they wrote. “Persons with such deficits may benefit from mobility training to navigate the environment more safely and reduce the risk of falling.”

The researchers had no financial conflicts to disclose.

WASHINGTON — Postmenopausal women who took a low-dose estrogen/progestin medication reported significant improvements in vasomotor symptoms and quality of life after 6 months, according to findings from an open-label efficacy study.

The therapy caused a significant increase in triglycerides, from an average of 129 mg/dL at baseline to an average of 168 mg/dL after 6 months. But the women had no other significant changes in their lipid profiles or in their body weight, body mass index, or blood glucose during the study period, Dr. Fernando Ayala Aguilera of the Hospital Universitario, Monterrey (Mexico), and colleagues reported in a poster presentation at the annual meeting of the American Society for Reproductive Medicine.

In the study, sponsored by Wyeth Pharmaceuticals, 68 postmenopausal women aged 45–55 years who reported at least four hot flashes a day received a combination of 1 mg 17β-estradiol and 0.125 mg trimegestone orally each day for 6 months. Women without an intact uterus, with known or suspected breast cancer, or with abnormal bleeding were excluded.

Patient scores on the MENQOL (a questionnaire designed to evaluate the quality of life symptoms in menopausal women) dropped from an average of 78 at baseline to an average of 5 after 6 months of treatment. Scores on the Blatt-Kupperman menopausal index dropped from an average of 40 at baseline to an average of 8 after 6 months. The average total cholesterol was stable between baseline and 6 months. Blood glucose, body weight, and body mass index were essentially also unchanged.

The preliminary results suggest the combination may provide enough relief from menopausal symptoms to outweigh the potential risks of increased triglycerides in the absence of other adverse effects on lipid profiles.

WASHINGTON — Postmenopausal women who took a low-dose estrogen/progestin medication reported significant improvements in vasomotor symptoms and quality of life after 6 months, according to findings from an open-label efficacy study.

The therapy caused a significant increase in triglycerides, from an average of 129 mg/dL at baseline to an average of 168 mg/dL after 6 months. But the women had no other significant changes in their lipid profiles or in their body weight, body mass index, or blood glucose during the study period, Dr. Fernando Ayala Aguilera of the Hospital Universitario, Monterrey (Mexico), and colleagues reported in a poster presentation at the annual meeting of the American Society for Reproductive Medicine.

In the study, sponsored by Wyeth Pharmaceuticals, 68 postmenopausal women aged 45–55 years who reported at least four hot flashes a day received a combination of 1 mg 17β-estradiol and 0.125 mg trimegestone orally each day for 6 months. Women without an intact uterus, with known or suspected breast cancer, or with abnormal bleeding were excluded.

Patient scores on the MENQOL (a questionnaire designed to evaluate the quality of life symptoms in menopausal women) dropped from an average of 78 at baseline to an average of 5 after 6 months of treatment. Scores on the Blatt-Kupperman menopausal index dropped from an average of 40 at baseline to an average of 8 after 6 months. The average total cholesterol was stable between baseline and 6 months. Blood glucose, body weight, and body mass index were essentially also unchanged.

The preliminary results suggest the combination may provide enough relief from menopausal symptoms to outweigh the potential risks of increased triglycerides in the absence of other adverse effects on lipid profiles.

WASHINGTON — Postmenopausal women who took a low-dose estrogen/progestin medication reported significant improvements in vasomotor symptoms and quality of life after 6 months, according to findings from an open-label efficacy study.

The therapy caused a significant increase in triglycerides, from an average of 129 mg/dL at baseline to an average of 168 mg/dL after 6 months. But the women had no other significant changes in their lipid profiles or in their body weight, body mass index, or blood glucose during the study period, Dr. Fernando Ayala Aguilera of the Hospital Universitario, Monterrey (Mexico), and colleagues reported in a poster presentation at the annual meeting of the American Society for Reproductive Medicine.

In the study, sponsored by Wyeth Pharmaceuticals, 68 postmenopausal women aged 45–55 years who reported at least four hot flashes a day received a combination of 1 mg 17β-estradiol and 0.125 mg trimegestone orally each day for 6 months. Women without an intact uterus, with known or suspected breast cancer, or with abnormal bleeding were excluded.

Patient scores on the MENQOL (a questionnaire designed to evaluate the quality of life symptoms in menopausal women) dropped from an average of 78 at baseline to an average of 5 after 6 months of treatment. Scores on the Blatt-Kupperman menopausal index dropped from an average of 40 at baseline to an average of 8 after 6 months. The average total cholesterol was stable between baseline and 6 months. Blood glucose, body weight, and body mass index were essentially also unchanged.

The preliminary results suggest the combination may provide enough relief from menopausal symptoms to outweigh the potential risks of increased triglycerides in the absence of other adverse effects on lipid profiles.

A strategy of high positive-end expiratory pressure combined with low tidal volume ventilation failed to improve mortality rates, although it improved oxygenation and reduced the need for rescue actions in patients with acute lung conditions, based on results from a randomized, controlled trial.

Although mechanical ventilation is essential to keep lung injury patients alive, the ventilation process can worsen their injuries, and previous studies have explored the effectiveness of various mechanical ventilation protocols. In patients with acute lung injury and acute respiratory distress syndrome (ARDS) who have increased lung weight due to edema, studies have shown that a higher positive-end expiratory pressure (PEEP) can help keep the lung from collapsing, but at the risk of further damage. Conversely, a PEEP that is too low can increase the risk for hypoxemia and the need for rescue procedures.

In the multicenter study, Dr. Maureen O. Meade of McMaster University in Hamilton, Ont., and her colleagues enrolled 985 adult patients with acute lung injury and ARDS at 30 intensive care units in Canada, Australia, and Saudi Arabia to receive two PEEP protocols to evaluate the impact on all-cause hospital mortality (JAMA 2008;299:637–45).

The experimental group was treated with a “lung open ventilation” strategy, which included recruitment maneuvers, a target tidal volume of 6 mL/kg of predicted body weight, and plateau airway pressure not to exceed 40 cm H₂O. The control group was treated with a target tidal volume of 6 mL/kg of predicted body weight and plateau airway pressure not exceeding 30 cm H₂O. Recruitment maneuvers were not used in the control group.

A total of 475 patients who received the experimental ventilation and 508 who received the control ventilation were included in the primary analysis. One patient in each group withdrew consent. The average age of experimental group patients was 55 years, and of control group patients was 57 years. There were no significant demographic differences between the groups.

All-cause hospital mortality was lower in the experimental group than in the control group (36% vs. 40%), but the difference was not significant. The researchers found no association between baseline injury severity and response to either treatment.

A total of 53 experimental patients and 47 controls developed barotrauma, and this difference was not significant.

But the experimental group's rates of refractory hypoxemia and death with refractory hypoxemia were half those of the control group: 5% vs. 10%, and 4% vs. 9%, respectively. The differences were statistically significant.

A total of 366 patients in the experimental group received at least one recruitment maneuver, and 81 of these (22%) developed a complication as a result. The most common complications were a mean arterial pressure lower than 60 mm Hg (4.5%), oxygen saturation less than 85% (4.2%), and brachycardia or tachycardia (1.8%).

The use of cointerventions was similar in both groups, and the most common interventions were sedative or narcotic infusion, vasopressors, and neuromuscular blockades. Overall use of rescue therapies was significantly lower in the experimental group than in controls (8% vs. 12%).

The study might have been limited by insufficient power to show a small mortality reduction, the researchers noted, and by the fact that the greatest benefits of the higher PEEP strategy might have been to an undefined subgroup.

They added, however, that the absence of significant harm or increased barotrauma in this study supports findings from previous research that justify a higher PEEP for the benefits of better oxygenation in patients with acute lung injury and ARDS. “The 'open-lung' strategy appeared to improve oxygenation, with fewer hypoxemia-related deaths and a lower use of rescue therapies by clinicians,” the investigators said. But the best choice of PEEP protocol remains controversial.

A higher level of PEEP will be useless if edema is not present in an injured lung, Dr. Luciano Gattinoni and Dr. Pietro Caironi of the University of Milan wrote in an accompanying editorial (JAMA 2008;299:691–3).

“Ideally, the direct assessment of lung recruitability by a dynamic lung imaging technique would allow the best physiological titration of PEEP,” they said. The lack of benefit from higher PEEP in this study and other clinical trials contrasts with findings from several experimental studies, they added, and suggests that future studies should take care to identify patients with greater lung injury and lung edema.

Until such a technique becomes widely available, results from the current study suggest that PEEP “at the highest level compatible with a plateau pressure of 28 to 30 cm H₂O and a tidal volume of 6 mL/kg of predicted body weight seems to be a reasonable alternative,” they noted.

None of the investigators disclosed any financial conflicts.

A strategy of high positive-end expiratory pressure combined with low tidal volume ventilation failed to improve mortality rates, although it improved oxygenation and reduced the need for rescue actions in patients with acute lung conditions, based on results from a randomized, controlled trial.

Although mechanical ventilation is essential to keep lung injury patients alive, the ventilation process can worsen their injuries, and previous studies have explored the effectiveness of various mechanical ventilation protocols. In patients with acute lung injury and acute respiratory distress syndrome (ARDS) who have increased lung weight due to edema, studies have shown that a higher positive-end expiratory pressure (PEEP) can help keep the lung from collapsing, but at the risk of further damage. Conversely, a PEEP that is too low can increase the risk for hypoxemia and the need for rescue procedures.

In the multicenter study, Dr. Maureen O. Meade of McMaster University in Hamilton, Ont., and her colleagues enrolled 985 adult patients with acute lung injury and ARDS at 30 intensive care units in Canada, Australia, and Saudi Arabia to receive two PEEP protocols to evaluate the impact on all-cause hospital mortality (JAMA 2008;299:637–45).

The experimental group was treated with a “lung open ventilation” strategy, which included recruitment maneuvers, a target tidal volume of 6 mL/kg of predicted body weight, and plateau airway pressure not to exceed 40 cm H₂O. The control group was treated with a target tidal volume of 6 mL/kg of predicted body weight and plateau airway pressure not exceeding 30 cm H₂O. Recruitment maneuvers were not used in the control group.

A total of 475 patients who received the experimental ventilation and 508 who received the control ventilation were included in the primary analysis. One patient in each group withdrew consent. The average age of experimental group patients was 55 years, and of control group patients was 57 years. There were no significant demographic differences between the groups.

All-cause hospital mortality was lower in the experimental group than in the control group (36% vs. 40%), but the difference was not significant. The researchers found no association between baseline injury severity and response to either treatment.

A total of 53 experimental patients and 47 controls developed barotrauma, and this difference was not significant.

But the experimental group's rates of refractory hypoxemia and death with refractory hypoxemia were half those of the control group: 5% vs. 10%, and 4% vs. 9%, respectively. The differences were statistically significant.

A total of 366 patients in the experimental group received at least one recruitment maneuver, and 81 of these (22%) developed a complication as a result. The most common complications were a mean arterial pressure lower than 60 mm Hg (4.5%), oxygen saturation less than 85% (4.2%), and brachycardia or tachycardia (1.8%).

The use of cointerventions was similar in both groups, and the most common interventions were sedative or narcotic infusion, vasopressors, and neuromuscular blockades. Overall use of rescue therapies was significantly lower in the experimental group than in controls (8% vs. 12%).

The study might have been limited by insufficient power to show a small mortality reduction, the researchers noted, and by the fact that the greatest benefits of the higher PEEP strategy might have been to an undefined subgroup.

They added, however, that the absence of significant harm or increased barotrauma in this study supports findings from previous research that justify a higher PEEP for the benefits of better oxygenation in patients with acute lung injury and ARDS. “The 'open-lung' strategy appeared to improve oxygenation, with fewer hypoxemia-related deaths and a lower use of rescue therapies by clinicians,” the investigators said. But the best choice of PEEP protocol remains controversial.

A higher level of PEEP will be useless if edema is not present in an injured lung, Dr. Luciano Gattinoni and Dr. Pietro Caironi of the University of Milan wrote in an accompanying editorial (JAMA 2008;299:691–3).

“Ideally, the direct assessment of lung recruitability by a dynamic lung imaging technique would allow the best physiological titration of PEEP,” they said. The lack of benefit from higher PEEP in this study and other clinical trials contrasts with findings from several experimental studies, they added, and suggests that future studies should take care to identify patients with greater lung injury and lung edema.

Until such a technique becomes widely available, results from the current study suggest that PEEP “at the highest level compatible with a plateau pressure of 28 to 30 cm H₂O and a tidal volume of 6 mL/kg of predicted body weight seems to be a reasonable alternative,” they noted.

None of the investigators disclosed any financial conflicts.

A strategy of high positive-end expiratory pressure combined with low tidal volume ventilation failed to improve mortality rates, although it improved oxygenation and reduced the need for rescue actions in patients with acute lung conditions, based on results from a randomized, controlled trial.

Although mechanical ventilation is essential to keep lung injury patients alive, the ventilation process can worsen their injuries, and previous studies have explored the effectiveness of various mechanical ventilation protocols. In patients with acute lung injury and acute respiratory distress syndrome (ARDS) who have increased lung weight due to edema, studies have shown that a higher positive-end expiratory pressure (PEEP) can help keep the lung from collapsing, but at the risk of further damage. Conversely, a PEEP that is too low can increase the risk for hypoxemia and the need for rescue procedures.

In the multicenter study, Dr. Maureen O. Meade of McMaster University in Hamilton, Ont., and her colleagues enrolled 985 adult patients with acute lung injury and ARDS at 30 intensive care units in Canada, Australia, and Saudi Arabia to receive two PEEP protocols to evaluate the impact on all-cause hospital mortality (JAMA 2008;299:637–45).

The experimental group was treated with a “lung open ventilation” strategy, which included recruitment maneuvers, a target tidal volume of 6 mL/kg of predicted body weight, and plateau airway pressure not to exceed 40 cm H₂O. The control group was treated with a target tidal volume of 6 mL/kg of predicted body weight and plateau airway pressure not exceeding 30 cm H₂O. Recruitment maneuvers were not used in the control group.

A total of 475 patients who received the experimental ventilation and 508 who received the control ventilation were included in the primary analysis. One patient in each group withdrew consent. The average age of experimental group patients was 55 years, and of control group patients was 57 years. There were no significant demographic differences between the groups.

All-cause hospital mortality was lower in the experimental group than in the control group (36% vs. 40%), but the difference was not significant. The researchers found no association between baseline injury severity and response to either treatment.

A total of 53 experimental patients and 47 controls developed barotrauma, and this difference was not significant.

But the experimental group's rates of refractory hypoxemia and death with refractory hypoxemia were half those of the control group: 5% vs. 10%, and 4% vs. 9%, respectively. The differences were statistically significant.

A total of 366 patients in the experimental group received at least one recruitment maneuver, and 81 of these (22%) developed a complication as a result. The most common complications were a mean arterial pressure lower than 60 mm Hg (4.5%), oxygen saturation less than 85% (4.2%), and brachycardia or tachycardia (1.8%).

The use of cointerventions was similar in both groups, and the most common interventions were sedative or narcotic infusion, vasopressors, and neuromuscular blockades. Overall use of rescue therapies was significantly lower in the experimental group than in controls (8% vs. 12%).

The study might have been limited by insufficient power to show a small mortality reduction, the researchers noted, and by the fact that the greatest benefits of the higher PEEP strategy might have been to an undefined subgroup.

They added, however, that the absence of significant harm or increased barotrauma in this study supports findings from previous research that justify a higher PEEP for the benefits of better oxygenation in patients with acute lung injury and ARDS. “The 'open-lung' strategy appeared to improve oxygenation, with fewer hypoxemia-related deaths and a lower use of rescue therapies by clinicians,” the investigators said. But the best choice of PEEP protocol remains controversial.

A higher level of PEEP will be useless if edema is not present in an injured lung, Dr. Luciano Gattinoni and Dr. Pietro Caironi of the University of Milan wrote in an accompanying editorial (JAMA 2008;299:691–3).

“Ideally, the direct assessment of lung recruitability by a dynamic lung imaging technique would allow the best physiological titration of PEEP,” they said. The lack of benefit from higher PEEP in this study and other clinical trials contrasts with findings from several experimental studies, they added, and suggests that future studies should take care to identify patients with greater lung injury and lung edema.

Until such a technique becomes widely available, results from the current study suggest that PEEP “at the highest level compatible with a plateau pressure of 28 to 30 cm H₂O and a tidal volume of 6 mL/kg of predicted body weight seems to be a reasonable alternative,” they noted.

None of the investigators disclosed any financial conflicts.

WASHINGTON — Extended-release tolterodine improved overactive bladder problems and quality of life in sexually active postmenopausal women, according to a review of patient-reported outcomes presented in a poster at the annual meeting of the American Society for Reproductive Medicine.

“Physicians should consider the potential impact of [overactive bladder] symptoms and their treatment on postmenopausal patients' sexual function and quality of life,” wrote Dr. Gloria Bachmann of the University of Medicine and Dentistry of New Jersey, New Brunswick, and her colleagues.

The study was sponsored by Pfizer Inc., the manufacturer of Detrol LA extended-release tolterodine tartrate capsules.

Data from previous studies have shown that the prevalence of overactive bladder (OAB) in women increases with age and that the urinary symptoms that are associated with the condition are also associated with reduced sexual activity and quality of life.

To determine the effectiveness of the antimuscarinic agent tolterodine for relieving urinary incontinence and OAB, the investigators reviewed data from 211 postmenopausal women with OAB whose mean age was 56 years.

Of those, 112 women received 4 mg of extended-release tolterodine to be taken within 4 hours of bedtime each day for 12 weeks, and 99 women received a placebo for the same period.

The women completed several validated instruments at baseline and again at 12 weeks.

Overall, those in the tolterodine group reported significantly less use of absorbent pads and lower urination frequency, compared with those in the placebo group. The tolterodine group also reported fewer episodes of urgent urinary incontinence, but the difference was not statistically significant from the placebo group.

In addition, results from the Patient Perception of Bladder Condition showed that more of the tolterodine patients reported improvement in their symptoms than did placebo patients (74% vs. 62%, respectively). And the number of women in the tolterodine group who reported severe OAB problems dropped from 12% at baseline to 1% after 12 weeks, compared with a drop from 12% to 3% in the placebo group.

The treatment group also reported improvements in sexual function and quality of life from baseline to 12 weeks, based on the Physical, Behavioral/Emotive, Partner-Related, and total sections of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ). By contrast, the placebo patients reported significant improvements from baseline to 12 weeks only for the Physical section of the PISQ.

The total improvement in the PISQ scores for the treatment and placebo groups were 4.5% and 1.6%, respectively.

In addition, in the tolterodine group, overall quality-of-life scores were significantly higher after 12 weeks, compared with baseline, whereas quality-of-life scores were not significantly different in the placebo group after 12 weeks, compared with baseline.

No significant adverse events were reported in either of the groups during the study period, but the results were limited by the lack of long-term follow-up data beyond 12 weeks.

Dr. Bachmann has served as a consultant to Pfizer, and her three coinvestigators are currently employed by the company.

WASHINGTON — Extended-release tolterodine improved overactive bladder problems and quality of life in sexually active postmenopausal women, according to a review of patient-reported outcomes presented in a poster at the annual meeting of the American Society for Reproductive Medicine.

“Physicians should consider the potential impact of [overactive bladder] symptoms and their treatment on postmenopausal patients' sexual function and quality of life,” wrote Dr. Gloria Bachmann of the University of Medicine and Dentistry of New Jersey, New Brunswick, and her colleagues.

The study was sponsored by Pfizer Inc., the manufacturer of Detrol LA extended-release tolterodine tartrate capsules.

Data from previous studies have shown that the prevalence of overactive bladder (OAB) in women increases with age and that the urinary symptoms that are associated with the condition are also associated with reduced sexual activity and quality of life.

To determine the effectiveness of the antimuscarinic agent tolterodine for relieving urinary incontinence and OAB, the investigators reviewed data from 211 postmenopausal women with OAB whose mean age was 56 years.

Of those, 112 women received 4 mg of extended-release tolterodine to be taken within 4 hours of bedtime each day for 12 weeks, and 99 women received a placebo for the same period.

The women completed several validated instruments at baseline and again at 12 weeks.

Overall, those in the tolterodine group reported significantly less use of absorbent pads and lower urination frequency, compared with those in the placebo group. The tolterodine group also reported fewer episodes of urgent urinary incontinence, but the difference was not statistically significant from the placebo group.

In addition, results from the Patient Perception of Bladder Condition showed that more of the tolterodine patients reported improvement in their symptoms than did placebo patients (74% vs. 62%, respectively). And the number of women in the tolterodine group who reported severe OAB problems dropped from 12% at baseline to 1% after 12 weeks, compared with a drop from 12% to 3% in the placebo group.

The treatment group also reported improvements in sexual function and quality of life from baseline to 12 weeks, based on the Physical, Behavioral/Emotive, Partner-Related, and total sections of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ). By contrast, the placebo patients reported significant improvements from baseline to 12 weeks only for the Physical section of the PISQ.

The total improvement in the PISQ scores for the treatment and placebo groups were 4.5% and 1.6%, respectively.

In addition, in the tolterodine group, overall quality-of-life scores were significantly higher after 12 weeks, compared with baseline, whereas quality-of-life scores were not significantly different in the placebo group after 12 weeks, compared with baseline.

No significant adverse events were reported in either of the groups during the study period, but the results were limited by the lack of long-term follow-up data beyond 12 weeks.

Dr. Bachmann has served as a consultant to Pfizer, and her three coinvestigators are currently employed by the company.

WASHINGTON — Extended-release tolterodine improved overactive bladder problems and quality of life in sexually active postmenopausal women, according to a review of patient-reported outcomes presented in a poster at the annual meeting of the American Society for Reproductive Medicine.

“Physicians should consider the potential impact of [overactive bladder] symptoms and their treatment on postmenopausal patients' sexual function and quality of life,” wrote Dr. Gloria Bachmann of the University of Medicine and Dentistry of New Jersey, New Brunswick, and her colleagues.

The study was sponsored by Pfizer Inc., the manufacturer of Detrol LA extended-release tolterodine tartrate capsules.

Data from previous studies have shown that the prevalence of overactive bladder (OAB) in women increases with age and that the urinary symptoms that are associated with the condition are also associated with reduced sexual activity and quality of life.

To determine the effectiveness of the antimuscarinic agent tolterodine for relieving urinary incontinence and OAB, the investigators reviewed data from 211 postmenopausal women with OAB whose mean age was 56 years.

Of those, 112 women received 4 mg of extended-release tolterodine to be taken within 4 hours of bedtime each day for 12 weeks, and 99 women received a placebo for the same period.

The women completed several validated instruments at baseline and again at 12 weeks.

Overall, those in the tolterodine group reported significantly less use of absorbent pads and lower urination frequency, compared with those in the placebo group. The tolterodine group also reported fewer episodes of urgent urinary incontinence, but the difference was not statistically significant from the placebo group.

In addition, results from the Patient Perception of Bladder Condition showed that more of the tolterodine patients reported improvement in their symptoms than did placebo patients (74% vs. 62%, respectively). And the number of women in the tolterodine group who reported severe OAB problems dropped from 12% at baseline to 1% after 12 weeks, compared with a drop from 12% to 3% in the placebo group.

The treatment group also reported improvements in sexual function and quality of life from baseline to 12 weeks, based on the Physical, Behavioral/Emotive, Partner-Related, and total sections of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ). By contrast, the placebo patients reported significant improvements from baseline to 12 weeks only for the Physical section of the PISQ.

The total improvement in the PISQ scores for the treatment and placebo groups were 4.5% and 1.6%, respectively.

In addition, in the tolterodine group, overall quality-of-life scores were significantly higher after 12 weeks, compared with baseline, whereas quality-of-life scores were not significantly different in the placebo group after 12 weeks, compared with baseline.

No significant adverse events were reported in either of the groups during the study period, but the results were limited by the lack of long-term follow-up data beyond 12 weeks.

Dr. Bachmann has served as a consultant to Pfizer, and her three coinvestigators are currently employed by the company.

WASHINGTON — Increased pregnancy rates and oocyte survival rates support the superiority of vitrification over the traditional slow-freeze cryopreservation technique, based on the results from several studies presented at the annual meeting of the American Society for Reproductive Medicine.

In vitrification, blastocysts briefly are immersed in a medium and then quickly frozen using liquid nitrogen. The debate over which method of cryopreservation yields the best clinical results continues, but emerging data from studies of vitrification appear to favor the fast-freezing method.

Early outcomes data from one study of 41 women showed that blastocyst vitrification yielded significantly more pregnancies than embryos that had been slow frozen.

In this study, Alicia L. Clifford and her colleagues at the Center for Reproductive Biology of Indiana in Indianapolis compared pregnancy rates from 30 patients who received embryos from slow-frozen eggs with 11 patients who received embryos from vitrified eggs.

Overall, 4 of 10 women in the vitrification group (40%) had positive fetal cardiac activity at 6 weeks, compared with 4 of 29 women (14%) in the slow-freeze group.

Fetal cardiac activity data were pending for one woman in each group at the time of the poster presentation.

The mean age was similar between the slow-freeze and vitrification groups (33 years vs. 31 years), and each group had an average of three embryos transferred.

In a second study of 84 oocytes from 42 women, oocyte survival rates were significantly higher when they were frozen using vitrification than slow frozen. Dr. Susan Sarajari and colleagues at the University of California, Los Angeles, and her colleagues thawed 44 oocytes that were slow frozen and 40 oocytes that were frozen using vitrification after 2 days in order to test their viability.

Overall, 17 of the 40 vitrified oocytes survived (42%), compared with 11 of the 44 slow-frozen oocytes (25%). The surviving oocytes from each group were selected for in vitro maturation (IVM), incubated, and then reassessed after 24 hours.

“The number and percent of oocytes that matured by IVM was also higher in the vitrification group,” the researchers noted, although the difference was not statistically significant (eight oocytes in the vitrification group vs. five in the slow-freeze group).

Cryopreservation of immature oocytes by any method has clinical application potential for women at risk of losing ovarian function for any reason and for women who simply wish to preserve their fertility, but larger outcome studies are needed to confirm the most effective techniques.

None of the authors of either study had any financial conflicts to disclose.

WASHINGTON — Increased pregnancy rates and oocyte survival rates support the superiority of vitrification over the traditional slow-freeze cryopreservation technique, based on the results from several studies presented at the annual meeting of the American Society for Reproductive Medicine.

In vitrification, blastocysts briefly are immersed in a medium and then quickly frozen using liquid nitrogen. The debate over which method of cryopreservation yields the best clinical results continues, but emerging data from studies of vitrification appear to favor the fast-freezing method.

Early outcomes data from one study of 41 women showed that blastocyst vitrification yielded significantly more pregnancies than embryos that had been slow frozen.

In this study, Alicia L. Clifford and her colleagues at the Center for Reproductive Biology of Indiana in Indianapolis compared pregnancy rates from 30 patients who received embryos from slow-frozen eggs with 11 patients who received embryos from vitrified eggs.

Overall, 4 of 10 women in the vitrification group (40%) had positive fetal cardiac activity at 6 weeks, compared with 4 of 29 women (14%) in the slow-freeze group.

Fetal cardiac activity data were pending for one woman in each group at the time of the poster presentation.

The mean age was similar between the slow-freeze and vitrification groups (33 years vs. 31 years), and each group had an average of three embryos transferred.

In a second study of 84 oocytes from 42 women, oocyte survival rates were significantly higher when they were frozen using vitrification than slow frozen. Dr. Susan Sarajari and colleagues at the University of California, Los Angeles, and her colleagues thawed 44 oocytes that were slow frozen and 40 oocytes that were frozen using vitrification after 2 days in order to test their viability.

Overall, 17 of the 40 vitrified oocytes survived (42%), compared with 11 of the 44 slow-frozen oocytes (25%). The surviving oocytes from each group were selected for in vitro maturation (IVM), incubated, and then reassessed after 24 hours.

“The number and percent of oocytes that matured by IVM was also higher in the vitrification group,” the researchers noted, although the difference was not statistically significant (eight oocytes in the vitrification group vs. five in the slow-freeze group).

Cryopreservation of immature oocytes by any method has clinical application potential for women at risk of losing ovarian function for any reason and for women who simply wish to preserve their fertility, but larger outcome studies are needed to confirm the most effective techniques.

None of the authors of either study had any financial conflicts to disclose.

WASHINGTON — Increased pregnancy rates and oocyte survival rates support the superiority of vitrification over the traditional slow-freeze cryopreservation technique, based on the results from several studies presented at the annual meeting of the American Society for Reproductive Medicine.

In vitrification, blastocysts briefly are immersed in a medium and then quickly frozen using liquid nitrogen. The debate over which method of cryopreservation yields the best clinical results continues, but emerging data from studies of vitrification appear to favor the fast-freezing method.

Early outcomes data from one study of 41 women showed that blastocyst vitrification yielded significantly more pregnancies than embryos that had been slow frozen.

In this study, Alicia L. Clifford and her colleagues at the Center for Reproductive Biology of Indiana in Indianapolis compared pregnancy rates from 30 patients who received embryos from slow-frozen eggs with 11 patients who received embryos from vitrified eggs.

Overall, 4 of 10 women in the vitrification group (40%) had positive fetal cardiac activity at 6 weeks, compared with 4 of 29 women (14%) in the slow-freeze group.

Fetal cardiac activity data were pending for one woman in each group at the time of the poster presentation.

The mean age was similar between the slow-freeze and vitrification groups (33 years vs. 31 years), and each group had an average of three embryos transferred.

In a second study of 84 oocytes from 42 women, oocyte survival rates were significantly higher when they were frozen using vitrification than slow frozen. Dr. Susan Sarajari and colleagues at the University of California, Los Angeles, and her colleagues thawed 44 oocytes that were slow frozen and 40 oocytes that were frozen using vitrification after 2 days in order to test their viability.

Overall, 17 of the 40 vitrified oocytes survived (42%), compared with 11 of the 44 slow-frozen oocytes (25%). The surviving oocytes from each group were selected for in vitro maturation (IVM), incubated, and then reassessed after 24 hours.

“The number and percent of oocytes that matured by IVM was also higher in the vitrification group,” the researchers noted, although the difference was not statistically significant (eight oocytes in the vitrification group vs. five in the slow-freeze group).

Cryopreservation of immature oocytes by any method has clinical application potential for women at risk of losing ovarian function for any reason and for women who simply wish to preserve their fertility, but larger outcome studies are needed to confirm the most effective techniques.

None of the authors of either study had any financial conflicts to disclose.

CHICAGO — Bone density was no different in children treated with oral glucocorticoids for hemangiomas of infancy than it was in healthy controls, according to a presentation at the annual meeting of the Society for Pediatric Dermatology.

Although oral glucocorticoids are considered the first choice for the treatment of infant hemangiomas, concerns persist about the risk that these children will develop osteoporosis because glucocorticoids may prevent the formation of new bone, wrote Dr. Amy J. Nopper, of the Children's Mercy Hospitals and Clinics in Kansas City, Mo.

To assess the possible impact of systemic glucocorticoids on bone density, she and her colleagues compared 35 infants (mean age 44 months) who received glucocorticoids for hemangiomas for an average of 8.5 months with 35 controls. The average treatment dose was 2.2 mg/kg per day of prednisolone. The average body mass index was approximately 16 kg/m

The researchers measured the children's bone density after they had been off treatment for at least 1 year and found that the average spinal bone mineral density was the same (0.6 g/m

The results support findings from other studies that show steroid use to treat hemangiomas in early childhood does not prevent children from catching up in growth and achieving normal adult height, Dr. Nopper noted.

CHICAGO — Bone density was no different in children treated with oral glucocorticoids for hemangiomas of infancy than it was in healthy controls, according to a presentation at the annual meeting of the Society for Pediatric Dermatology.

Although oral glucocorticoids are considered the first choice for the treatment of infant hemangiomas, concerns persist about the risk that these children will develop osteoporosis because glucocorticoids may prevent the formation of new bone, wrote Dr. Amy J. Nopper, of the Children's Mercy Hospitals and Clinics in Kansas City, Mo.

To assess the possible impact of systemic glucocorticoids on bone density, she and her colleagues compared 35 infants (mean age 44 months) who received glucocorticoids for hemangiomas for an average of 8.5 months with 35 controls. The average treatment dose was 2.2 mg/kg per day of prednisolone. The average body mass index was approximately 16 kg/m

The researchers measured the children's bone density after they had been off treatment for at least 1 year and found that the average spinal bone mineral density was the same (0.6 g/m

The results support findings from other studies that show steroid use to treat hemangiomas in early childhood does not prevent children from catching up in growth and achieving normal adult height, Dr. Nopper noted.

CHICAGO — Bone density was no different in children treated with oral glucocorticoids for hemangiomas of infancy than it was in healthy controls, according to a presentation at the annual meeting of the Society for Pediatric Dermatology.

Although oral glucocorticoids are considered the first choice for the treatment of infant hemangiomas, concerns persist about the risk that these children will develop osteoporosis because glucocorticoids may prevent the formation of new bone, wrote Dr. Amy J. Nopper, of the Children's Mercy Hospitals and Clinics in Kansas City, Mo.

To assess the possible impact of systemic glucocorticoids on bone density, she and her colleagues compared 35 infants (mean age 44 months) who received glucocorticoids for hemangiomas for an average of 8.5 months with 35 controls. The average treatment dose was 2.2 mg/kg per day of prednisolone. The average body mass index was approximately 16 kg/m

The researchers measured the children's bone density after they had been off treatment for at least 1 year and found that the average spinal bone mineral density was the same (0.6 g/m

The results support findings from other studies that show steroid use to treat hemangiomas in early childhood does not prevent children from catching up in growth and achieving normal adult height, Dr. Nopper noted.