John R. Bell

SAN ANTONIO — Dogs serving as visitation-therapy animals in health care facilities have tested positive for Clostridium difficile and can also harbor salmonella and methicillin-resistant Staphylococcus aureus, according to new research.

Sandra Lefebvre, D.V.M., and her colleagues of the Ontario Veterinary College at the University of Guelph discussed her group's findings on C. difficile in a poster presentation at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man.

They collected fecal samples from dogs used in a hospital visitation program in Ontario and used polymerase chain reaction techniques to identify microorganisms in the samples. They found C. difficile in 58 (57%) of the 102 dogs. Of the strains identified, 10% were indistinguishable from human strains.

One dog, a toy poodle, shed an epidemic strain of the bacteria. The investigators discovered that this healthy animal had previously visited a hospital with documented cases of C. difficile-associated disease. Dr. Lefebvre and her colleagues recently reported these findings in a published letter (Emerg. Infect. Dis. 2006;12:1036–7).

The group is currently conducting a prospective cohort canine study (to be published in October) that has revealed perhaps a more ominous discovery. “We're finding that dogs are picking up MRSA, too,” as well as salmonella, Dr. Lefebvre said in an interview. She noted that the dogs often lick the hand of a patient with the infection and then lick a noninfected patient, risking transmission of the disease. Such findings do not prove that dogs have spread such diseases to humans, her group wrote—but “they certainly support that possibility.”

Furthermore, visitation dogs then return to the home and neighborhood, where they can spread the disease to humans and other dogs, she said at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man. Three dogs so far have tested positive for MRSA after visiting hospitals, but one dog with no such exposure has also tested positive.

“These animals are going from patient to patient, getting up onto beds and licking people,” Dr. Lefebvre said. “They also lick and are handled by health care workers, who are notorious for having contaminated hands.”

She added that the MRSA found so far in the dogs is community acquired—an ominous fact, given that this type of bacterium (unlike the less robust hospital-acquired variant) attacks people other than the elderly and immunocompromised alone.

Additionally, one-third of the dogs have so far tested positive for salmonella, she noted, speculating that a diet containing raw meat or poultry (common among visitation dogs) is the prime suspect.

Dr. Lefebvre emphasized that, even in light of these findings, she personally supports dog-visitation programs and believes they “spread more good than harm. … But people are being really naive in their approaches, and they need to practice more intact vector control than they are right now.

“A few simple precautions, particularly practicing hand hygiene [before and] after handling the animals, can reduce the potential harms—to both pets and people,” she said.

She also targeted the dogs' habit of licking as a principal link in the disease-transmission chain. “I think it's a bad idea to … let dogs lick people and think there are no ramifications for that,” she said. Dr. Lefebvre also advised that people caring for visitation dogs not feed them raw meat or poultry.

SAN ANTONIO — Dogs serving as visitation-therapy animals in health care facilities have tested positive for Clostridium difficile and can also harbor salmonella and methicillin-resistant Staphylococcus aureus, according to new research.

Sandra Lefebvre, D.V.M., and her colleagues of the Ontario Veterinary College at the University of Guelph discussed her group's findings on C. difficile in a poster presentation at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man.

They collected fecal samples from dogs used in a hospital visitation program in Ontario and used polymerase chain reaction techniques to identify microorganisms in the samples. They found C. difficile in 58 (57%) of the 102 dogs. Of the strains identified, 10% were indistinguishable from human strains.

One dog, a toy poodle, shed an epidemic strain of the bacteria. The investigators discovered that this healthy animal had previously visited a hospital with documented cases of C. difficile-associated disease. Dr. Lefebvre and her colleagues recently reported these findings in a published letter (Emerg. Infect. Dis. 2006;12:1036–7).

The group is currently conducting a prospective cohort canine study (to be published in October) that has revealed perhaps a more ominous discovery. “We're finding that dogs are picking up MRSA, too,” as well as salmonella, Dr. Lefebvre said in an interview. She noted that the dogs often lick the hand of a patient with the infection and then lick a noninfected patient, risking transmission of the disease. Such findings do not prove that dogs have spread such diseases to humans, her group wrote—but “they certainly support that possibility.”

Furthermore, visitation dogs then return to the home and neighborhood, where they can spread the disease to humans and other dogs, she said at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man. Three dogs so far have tested positive for MRSA after visiting hospitals, but one dog with no such exposure has also tested positive.

“These animals are going from patient to patient, getting up onto beds and licking people,” Dr. Lefebvre said. “They also lick and are handled by health care workers, who are notorious for having contaminated hands.”

She added that the MRSA found so far in the dogs is community acquired—an ominous fact, given that this type of bacterium (unlike the less robust hospital-acquired variant) attacks people other than the elderly and immunocompromised alone.

Additionally, one-third of the dogs have so far tested positive for salmonella, she noted, speculating that a diet containing raw meat or poultry (common among visitation dogs) is the prime suspect.

Dr. Lefebvre emphasized that, even in light of these findings, she personally supports dog-visitation programs and believes they “spread more good than harm. … But people are being really naive in their approaches, and they need to practice more intact vector control than they are right now.

“A few simple precautions, particularly practicing hand hygiene [before and] after handling the animals, can reduce the potential harms—to both pets and people,” she said.

She also targeted the dogs' habit of licking as a principal link in the disease-transmission chain. “I think it's a bad idea to … let dogs lick people and think there are no ramifications for that,” she said. Dr. Lefebvre also advised that people caring for visitation dogs not feed them raw meat or poultry.

SAN ANTONIO — Dogs serving as visitation-therapy animals in health care facilities have tested positive for Clostridium difficile and can also harbor salmonella and methicillin-resistant Staphylococcus aureus, according to new research.

Sandra Lefebvre, D.V.M., and her colleagues of the Ontario Veterinary College at the University of Guelph discussed her group's findings on C. difficile in a poster presentation at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man.

They collected fecal samples from dogs used in a hospital visitation program in Ontario and used polymerase chain reaction techniques to identify microorganisms in the samples. They found C. difficile in 58 (57%) of the 102 dogs. Of the strains identified, 10% were indistinguishable from human strains.

One dog, a toy poodle, shed an epidemic strain of the bacteria. The investigators discovered that this healthy animal had previously visited a hospital with documented cases of C. difficile-associated disease. Dr. Lefebvre and her colleagues recently reported these findings in a published letter (Emerg. Infect. Dis. 2006;12:1036–7).

The group is currently conducting a prospective cohort canine study (to be published in October) that has revealed perhaps a more ominous discovery. “We're finding that dogs are picking up MRSA, too,” as well as salmonella, Dr. Lefebvre said in an interview. She noted that the dogs often lick the hand of a patient with the infection and then lick a noninfected patient, risking transmission of the disease. Such findings do not prove that dogs have spread such diseases to humans, her group wrote—but “they certainly support that possibility.”

Furthermore, visitation dogs then return to the home and neighborhood, where they can spread the disease to humans and other dogs, she said at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man. Three dogs so far have tested positive for MRSA after visiting hospitals, but one dog with no such exposure has also tested positive.

“These animals are going from patient to patient, getting up onto beds and licking people,” Dr. Lefebvre said. “They also lick and are handled by health care workers, who are notorious for having contaminated hands.”

She added that the MRSA found so far in the dogs is community acquired—an ominous fact, given that this type of bacterium (unlike the less robust hospital-acquired variant) attacks people other than the elderly and immunocompromised alone.

Additionally, one-third of the dogs have so far tested positive for salmonella, she noted, speculating that a diet containing raw meat or poultry (common among visitation dogs) is the prime suspect.

Dr. Lefebvre emphasized that, even in light of these findings, she personally supports dog-visitation programs and believes they “spread more good than harm. … But people are being really naive in their approaches, and they need to practice more intact vector control than they are right now.

“A few simple precautions, particularly practicing hand hygiene [before and] after handling the animals, can reduce the potential harms—to both pets and people,” she said.

She also targeted the dogs' habit of licking as a principal link in the disease-transmission chain. “I think it's a bad idea to … let dogs lick people and think there are no ramifications for that,” she said. Dr. Lefebvre also advised that people caring for visitation dogs not feed them raw meat or poultry.

BALTIMORE — In many situations, a physician may find that a treatment requested by an employing institution or a patient is contrary to the physician's religious or moral beliefs.

The best practice is to prevent these conflicts in the first place, Helen Norton, former Deputy Assistant Attorney General for Civil Rights, said at a conference on conscience-based refusals in health care sponsored by the University of Maryland School of Law.

Title VII of the Civil Rights Act of 1964 requires employers to “reasonably accommodate” any sincerely held belief, but the clause stating that the accommodation must not pose an undue hardship on an employer has led courts to consistently rule that almost any compromise offer extended by an employer will meet that standard. Ms. Norton, now of the law school, advised letting prospective employers know up front of any treatments or procedures you are unwilling to perform or participate in.

“In general, I think it's a very good idea to identify possible conflicts sooner rather than later,” she said in an interview. “Advance notice gives the institution a chance to plan ahead, identify reasonable accommodations, and make arrangements that address the concerns of all involved. Plus, institutions are likely to see such notice as a gesture of good faith—as are courts, if a matter ever ends up in litigation.”

Treatments that may result in conscience-based refusals include abortion, prescribing emergency contraceptives, care for the terminally ill, artificial insemination, and sterilization procedures.

What a physician is legally obligated to do varies by state. In most states, physicians are required to perform any emergency treatment, but emergency contraceptives are often placed in a different category, Ms. Norton said.

“Four states have passed conscience clause statutes that go beyond the usual focus on abortion, and sometimes sterilization, to allow pharmacists to refuse to dispense emergency contraception,” she said. “It's true that some state conscience clauses make clear that health care providers' refusals are not protected when they identify the conflict during certain emergency situations—like public health emergencies or in the middle of patient care when no other provider is available. But, as far as I know, the four don't-have-to-dispense-EC states do not define a patient's interest in emergency contraception as such an emergency.”

Ms. Norton noted that Title VII protects only employees, not independent contractors. “Most state conscience clause statutes, on the other hand, allow health care workers generally—regardless of their status as employee or independent contractors—to refuse to provide certain services,” she said.

As to whether there is any limit to how burdensome a compromise offer extended by an employer to an employee can be while still protecting the employer legally, “there is not a very clear answer,” she said.

As to the direction the law is likely to take, Ms. Norton expects the diversity of state statutes to continue. “In the short term, I think we'll continue to see a lot of action—and variation—on the state front. Some states clearly are focused primarily on protecting individual providers' claims of conscience and thus are enacting broader conscience clause statutes that, for example, protect a pharmacist's refusal to dispense EC. On the other hand, others are clearly focused primarily on patient access to health care services and thus are enacting laws that require institutional providers to expand access to that care.”

Ultimately, the different legislative approaches taken by states are setting up the kind of situation that has historically tempted Congress to weigh in, she said.

“The longer-term—and much harder—question is whether Congress will simply allow states to take different approaches or whether at some point it will step in to impose a consistent nationwide standard,” Ms. Norton said.

BALTIMORE — In many situations, a physician may find that a treatment requested by an employing institution or a patient is contrary to the physician's religious or moral beliefs.

The best practice is to prevent these conflicts in the first place, Helen Norton, former Deputy Assistant Attorney General for Civil Rights, said at a conference on conscience-based refusals in health care sponsored by the University of Maryland School of Law.

Title VII of the Civil Rights Act of 1964 requires employers to “reasonably accommodate” any sincerely held belief, but the clause stating that the accommodation must not pose an undue hardship on an employer has led courts to consistently rule that almost any compromise offer extended by an employer will meet that standard. Ms. Norton, now of the law school, advised letting prospective employers know up front of any treatments or procedures you are unwilling to perform or participate in.

“In general, I think it's a very good idea to identify possible conflicts sooner rather than later,” she said in an interview. “Advance notice gives the institution a chance to plan ahead, identify reasonable accommodations, and make arrangements that address the concerns of all involved. Plus, institutions are likely to see such notice as a gesture of good faith—as are courts, if a matter ever ends up in litigation.”

Treatments that may result in conscience-based refusals include abortion, prescribing emergency contraceptives, care for the terminally ill, artificial insemination, and sterilization procedures.

What a physician is legally obligated to do varies by state. In most states, physicians are required to perform any emergency treatment, but emergency contraceptives are often placed in a different category, Ms. Norton said.

“Four states have passed conscience clause statutes that go beyond the usual focus on abortion, and sometimes sterilization, to allow pharmacists to refuse to dispense emergency contraception,” she said. “It's true that some state conscience clauses make clear that health care providers' refusals are not protected when they identify the conflict during certain emergency situations—like public health emergencies or in the middle of patient care when no other provider is available. But, as far as I know, the four don't-have-to-dispense-EC states do not define a patient's interest in emergency contraception as such an emergency.”

Ms. Norton noted that Title VII protects only employees, not independent contractors. “Most state conscience clause statutes, on the other hand, allow health care workers generally—regardless of their status as employee or independent contractors—to refuse to provide certain services,” she said.

As to whether there is any limit to how burdensome a compromise offer extended by an employer to an employee can be while still protecting the employer legally, “there is not a very clear answer,” she said.

As to the direction the law is likely to take, Ms. Norton expects the diversity of state statutes to continue. “In the short term, I think we'll continue to see a lot of action—and variation—on the state front. Some states clearly are focused primarily on protecting individual providers' claims of conscience and thus are enacting broader conscience clause statutes that, for example, protect a pharmacist's refusal to dispense EC. On the other hand, others are clearly focused primarily on patient access to health care services and thus are enacting laws that require institutional providers to expand access to that care.”

Ultimately, the different legislative approaches taken by states are setting up the kind of situation that has historically tempted Congress to weigh in, she said.

“The longer-term—and much harder—question is whether Congress will simply allow states to take different approaches or whether at some point it will step in to impose a consistent nationwide standard,” Ms. Norton said.

BALTIMORE — In many situations, a physician may find that a treatment requested by an employing institution or a patient is contrary to the physician's religious or moral beliefs.

The best practice is to prevent these conflicts in the first place, Helen Norton, former Deputy Assistant Attorney General for Civil Rights, said at a conference on conscience-based refusals in health care sponsored by the University of Maryland School of Law.

Title VII of the Civil Rights Act of 1964 requires employers to “reasonably accommodate” any sincerely held belief, but the clause stating that the accommodation must not pose an undue hardship on an employer has led courts to consistently rule that almost any compromise offer extended by an employer will meet that standard. Ms. Norton, now of the law school, advised letting prospective employers know up front of any treatments or procedures you are unwilling to perform or participate in.

“In general, I think it's a very good idea to identify possible conflicts sooner rather than later,” she said in an interview. “Advance notice gives the institution a chance to plan ahead, identify reasonable accommodations, and make arrangements that address the concerns of all involved. Plus, institutions are likely to see such notice as a gesture of good faith—as are courts, if a matter ever ends up in litigation.”

Treatments that may result in conscience-based refusals include abortion, prescribing emergency contraceptives, care for the terminally ill, artificial insemination, and sterilization procedures.

What a physician is legally obligated to do varies by state. In most states, physicians are required to perform any emergency treatment, but emergency contraceptives are often placed in a different category, Ms. Norton said.

“Four states have passed conscience clause statutes that go beyond the usual focus on abortion, and sometimes sterilization, to allow pharmacists to refuse to dispense emergency contraception,” she said. “It's true that some state conscience clauses make clear that health care providers' refusals are not protected when they identify the conflict during certain emergency situations—like public health emergencies or in the middle of patient care when no other provider is available. But, as far as I know, the four don't-have-to-dispense-EC states do not define a patient's interest in emergency contraception as such an emergency.”

Ms. Norton noted that Title VII protects only employees, not independent contractors. “Most state conscience clause statutes, on the other hand, allow health care workers generally—regardless of their status as employee or independent contractors—to refuse to provide certain services,” she said.

As to whether there is any limit to how burdensome a compromise offer extended by an employer to an employee can be while still protecting the employer legally, “there is not a very clear answer,” she said.

As to the direction the law is likely to take, Ms. Norton expects the diversity of state statutes to continue. “In the short term, I think we'll continue to see a lot of action—and variation—on the state front. Some states clearly are focused primarily on protecting individual providers' claims of conscience and thus are enacting broader conscience clause statutes that, for example, protect a pharmacist's refusal to dispense EC. On the other hand, others are clearly focused primarily on patient access to health care services and thus are enacting laws that require institutional providers to expand access to that care.”

Ultimately, the different legislative approaches taken by states are setting up the kind of situation that has historically tempted Congress to weigh in, she said.

“The longer-term—and much harder—question is whether Congress will simply allow states to take different approaches or whether at some point it will step in to impose a consistent nationwide standard,” Ms. Norton said.

SAN ANTONIO — Physicians who see patients presenting with extreme localized pain beginning a few days after a tick bite have a new reason to consider the possibility of ehrlichiosis, based on findings reported at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man.

Researchers from the Centers for Disease Control and Prevention have discovered a possible new Ehrlichia species found to cause illness in humans, as well as goats. It has been determined that the vector for the disease is the domestic Lone Star tick.

Amanda Loftis, D.V.M., of the CDC's medical entomology laboratory in Atlanta, reported a human case that she said could be a “divergent strain” of the bacterium Ehrlichia ruminantium, which is on the U.S. Department of Agriculture's watch list of foreign pathogens, or a new Ehrlichia species.

Dr. Loftis said the new bacterium is genetically similar to Ehrlichia ruminantium, common in Africa and the Caribbean but so far unreported in the United States. The new agent causes only mild illness in humans and animals, unlike E. ruminantium, which causes heartwater disease.

Five days after removing a tick from his upper arm, the patient, an Atlanta man, experienced extreme neck pain that was unresponsive to NSAIDs. He presented to a physician 4 weeks after removing the tick. The physician suspected tick-borne illness, took a blood sample, and administered doxycycline; the patient reported significant improvement in neck pain after 48–60 hours, Dr. Loftis said.

Dr. Loftis and her colleagues first discovered the new agent when they tested local ticks on a laboratory goat that subsequently became mildly ill. Genetic tests for five genes showed that the agent infecting the goat was highly similar to E. ruminantium but not identical to any described strains.

Further, the CDC performed DNA tests on the patient's blood and found Ehrlichia DNA identical to sequences found in the goat and in wild Lone Star ticks. No other bacterial DNA were detected, Dr. Loftis reported at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man.

“Nothing like this has ever been reported from the United States,” Dr. Loftis said. “The scary thing is that the Hartsfield international airport, a USDA port of entry for import of animals, is very close to our collection site. Both are within the Atlanta metro area—so we have to ask the question, where did this come from?” she said.

There are 13 species of tick that can be vectors of Ehrlichia ruminantium, but only 3 of these species live in the United States, she noted.

SAN ANTONIO — Physicians who see patients presenting with extreme localized pain beginning a few days after a tick bite have a new reason to consider the possibility of ehrlichiosis, based on findings reported at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man.

Researchers from the Centers for Disease Control and Prevention have discovered a possible new Ehrlichia species found to cause illness in humans, as well as goats. It has been determined that the vector for the disease is the domestic Lone Star tick.

Amanda Loftis, D.V.M., of the CDC's medical entomology laboratory in Atlanta, reported a human case that she said could be a “divergent strain” of the bacterium Ehrlichia ruminantium, which is on the U.S. Department of Agriculture's watch list of foreign pathogens, or a new Ehrlichia species.

Dr. Loftis said the new bacterium is genetically similar to Ehrlichia ruminantium, common in Africa and the Caribbean but so far unreported in the United States. The new agent causes only mild illness in humans and animals, unlike E. ruminantium, which causes heartwater disease.

Five days after removing a tick from his upper arm, the patient, an Atlanta man, experienced extreme neck pain that was unresponsive to NSAIDs. He presented to a physician 4 weeks after removing the tick. The physician suspected tick-borne illness, took a blood sample, and administered doxycycline; the patient reported significant improvement in neck pain after 48–60 hours, Dr. Loftis said.

Dr. Loftis and her colleagues first discovered the new agent when they tested local ticks on a laboratory goat that subsequently became mildly ill. Genetic tests for five genes showed that the agent infecting the goat was highly similar to E. ruminantium but not identical to any described strains.

Further, the CDC performed DNA tests on the patient's blood and found Ehrlichia DNA identical to sequences found in the goat and in wild Lone Star ticks. No other bacterial DNA were detected, Dr. Loftis reported at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man.

“Nothing like this has ever been reported from the United States,” Dr. Loftis said. “The scary thing is that the Hartsfield international airport, a USDA port of entry for import of animals, is very close to our collection site. Both are within the Atlanta metro area—so we have to ask the question, where did this come from?” she said.

There are 13 species of tick that can be vectors of Ehrlichia ruminantium, but only 3 of these species live in the United States, she noted.

SAN ANTONIO — Physicians who see patients presenting with extreme localized pain beginning a few days after a tick bite have a new reason to consider the possibility of ehrlichiosis, based on findings reported at a meeting of the Southwest Conference on Diseases in Nature Transmissible to Man.

Researchers from the Centers for Disease Control and Prevention have discovered a possible new Ehrlichia species found to cause illness in humans, as well as goats. It has been determined that the vector for the disease is the domestic Lone Star tick.

Amanda Loftis, D.V.M., of the CDC's medical entomology laboratory in Atlanta, reported a human case that she said could be a “divergent strain” of the bacterium Ehrlichia ruminantium, which is on the U.S. Department of Agriculture's watch list of foreign pathogens, or a new Ehrlichia species.

Dr. Loftis said the new bacterium is genetically similar to Ehrlichia ruminantium, common in Africa and the Caribbean but so far unreported in the United States. The new agent causes only mild illness in humans and animals, unlike E. ruminantium, which causes heartwater disease.

Five days after removing a tick from his upper arm, the patient, an Atlanta man, experienced extreme neck pain that was unresponsive to NSAIDs. He presented to a physician 4 weeks after removing the tick. The physician suspected tick-borne illness, took a blood sample, and administered doxycycline; the patient reported significant improvement in neck pain after 48–60 hours, Dr. Loftis said.

Dr. Loftis and her colleagues first discovered the new agent when they tested local ticks on a laboratory goat that subsequently became mildly ill. Genetic tests for five genes showed that the agent infecting the goat was highly similar to E. ruminantium but not identical to any described strains.

Further, the CDC performed DNA tests on the patient's blood and found Ehrlichia DNA identical to sequences found in the goat and in wild Lone Star ticks. No other bacterial DNA were detected, Dr. Loftis reported at the meeting, held in conjunction with the International Conference on Diseases in Nature Communicable to Man.

“Nothing like this has ever been reported from the United States,” Dr. Loftis said. “The scary thing is that the Hartsfield international airport, a USDA port of entry for import of animals, is very close to our collection site. Both are within the Atlanta metro area—so we have to ask the question, where did this come from?” she said.

There are 13 species of tick that can be vectors of Ehrlichia ruminantium, but only 3 of these species live in the United States, she noted.

Patients with Parkinson's disease who received continuous electrical stimulation to the subthalamic nucleus experienced significantly greater improvements in various measures of quality of life and motor function after 6 months than did patients who received medication alone, according to a report by Dr. Günther Deuschl of Christian Albrechts University in Kiel, Germany, and his colleagues.

Conducted by the German Parkinson Study Group, this randomized controlled trial included 78 patient pairs (156 patients) recruited from centers in Germany and Austria. One patient in each pair continued to receive an individualized medication regimen alone, while the other received pulsed electrostimulation to the subthalamic nucleus via a surgically implanted device in addition to the medication regimen; stimulation was ongoing and adjusted for each patient (N. Engl. J. Med. 2006;355:896–908).

In 50 of the 78 pairs, the patient who had received neurostimulation showed greater improvements in Parkinson Disease Questionnaire 39 (PDQ-39) summary score than the patient treated with medication alone. The mean PDQ-39 summary score went from 42 at baseline in the neurostimulation group to 32 at 6 months—an improvement of 24%. In the medication-only group, the mean score was 40 at baseline and 40 after 6 months.

Motor function (level of symptom severity) in each patient was assessed via the Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III), after a 12-hour withdrawal of antiparkinsonian medications at baseline and at 6 months. In 55 pairs, the patient treated with neurostimulation had a better UPDRS-III score than the nonstimulated patient without medication, the investigators reported. The neurostimulation group's mean score was 48 without medication at baseline, improving to 28 at 6 months. For the nonstimulation group, the mean score barely changed, going from 47 at baseline to 46 at 6 months.

A dyskinesia assessment was collected via patient diaries, and different medications and dosages were converted to equivalents for comparison. Also administered were the Schwab and England scale for activities of daily living, the Montgomery and Asberg Depression Rating Scale, the Brief Psychiatric Rating Scale, and the Medical Outcomes Study 36-item Short-Form Health Survey. Most measures showed significant mean improvements for the neurostimulation group versus slight declines for the medication-only group. Notably, the neurostimulation patients saw a 39% improvement in activities of daily living, versus a 5% decline in the medication-only patients. Psychiatric measures did not differ significantly between the two treatment groups. The investigators reported 13 adverse events—10 in the neurostimulation group, including three deaths, one of which was suicide, and 3 in the medication-only group. A patient in the medication group died after driving during a psychotic episode.

The results demonstrate “superior efficacy” of neurostimulation, the investigators concluded, with “significant and clinically meaningful improvement in quality of life … [and] longer periods and better quality of mobility with less dyskinesia. These changes … led to improvement in measurements of activities of daily living, emotional well-being, stigma, and body discomfort.” However, these benefits should “be weighed against the risk of complications related to surgery,” they said.

ELSEVIER GLOBAL MEDICAL NEWS

Patients with Parkinson's disease who received continuous electrical stimulation to the subthalamic nucleus experienced significantly greater improvements in various measures of quality of life and motor function after 6 months than did patients who received medication alone, according to a report by Dr. Günther Deuschl of Christian Albrechts University in Kiel, Germany, and his colleagues.

Conducted by the German Parkinson Study Group, this randomized controlled trial included 78 patient pairs (156 patients) recruited from centers in Germany and Austria. One patient in each pair continued to receive an individualized medication regimen alone, while the other received pulsed electrostimulation to the subthalamic nucleus via a surgically implanted device in addition to the medication regimen; stimulation was ongoing and adjusted for each patient (N. Engl. J. Med. 2006;355:896–908).

In 50 of the 78 pairs, the patient who had received neurostimulation showed greater improvements in Parkinson Disease Questionnaire 39 (PDQ-39) summary score than the patient treated with medication alone. The mean PDQ-39 summary score went from 42 at baseline in the neurostimulation group to 32 at 6 months—an improvement of 24%. In the medication-only group, the mean score was 40 at baseline and 40 after 6 months.

Motor function (level of symptom severity) in each patient was assessed via the Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III), after a 12-hour withdrawal of antiparkinsonian medications at baseline and at 6 months. In 55 pairs, the patient treated with neurostimulation had a better UPDRS-III score than the nonstimulated patient without medication, the investigators reported. The neurostimulation group's mean score was 48 without medication at baseline, improving to 28 at 6 months. For the nonstimulation group, the mean score barely changed, going from 47 at baseline to 46 at 6 months.

A dyskinesia assessment was collected via patient diaries, and different medications and dosages were converted to equivalents for comparison. Also administered were the Schwab and England scale for activities of daily living, the Montgomery and Asberg Depression Rating Scale, the Brief Psychiatric Rating Scale, and the Medical Outcomes Study 36-item Short-Form Health Survey. Most measures showed significant mean improvements for the neurostimulation group versus slight declines for the medication-only group. Notably, the neurostimulation patients saw a 39% improvement in activities of daily living, versus a 5% decline in the medication-only patients. Psychiatric measures did not differ significantly between the two treatment groups. The investigators reported 13 adverse events—10 in the neurostimulation group, including three deaths, one of which was suicide, and 3 in the medication-only group. A patient in the medication group died after driving during a psychotic episode.

The results demonstrate “superior efficacy” of neurostimulation, the investigators concluded, with “significant and clinically meaningful improvement in quality of life … [and] longer periods and better quality of mobility with less dyskinesia. These changes … led to improvement in measurements of activities of daily living, emotional well-being, stigma, and body discomfort.” However, these benefits should “be weighed against the risk of complications related to surgery,” they said.

ELSEVIER GLOBAL MEDICAL NEWS

Patients with Parkinson's disease who received continuous electrical stimulation to the subthalamic nucleus experienced significantly greater improvements in various measures of quality of life and motor function after 6 months than did patients who received medication alone, according to a report by Dr. Günther Deuschl of Christian Albrechts University in Kiel, Germany, and his colleagues.

Conducted by the German Parkinson Study Group, this randomized controlled trial included 78 patient pairs (156 patients) recruited from centers in Germany and Austria. One patient in each pair continued to receive an individualized medication regimen alone, while the other received pulsed electrostimulation to the subthalamic nucleus via a surgically implanted device in addition to the medication regimen; stimulation was ongoing and adjusted for each patient (N. Engl. J. Med. 2006;355:896–908).

In 50 of the 78 pairs, the patient who had received neurostimulation showed greater improvements in Parkinson Disease Questionnaire 39 (PDQ-39) summary score than the patient treated with medication alone. The mean PDQ-39 summary score went from 42 at baseline in the neurostimulation group to 32 at 6 months—an improvement of 24%. In the medication-only group, the mean score was 40 at baseline and 40 after 6 months.

Motor function (level of symptom severity) in each patient was assessed via the Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III), after a 12-hour withdrawal of antiparkinsonian medications at baseline and at 6 months. In 55 pairs, the patient treated with neurostimulation had a better UPDRS-III score than the nonstimulated patient without medication, the investigators reported. The neurostimulation group's mean score was 48 without medication at baseline, improving to 28 at 6 months. For the nonstimulation group, the mean score barely changed, going from 47 at baseline to 46 at 6 months.

A dyskinesia assessment was collected via patient diaries, and different medications and dosages were converted to equivalents for comparison. Also administered were the Schwab and England scale for activities of daily living, the Montgomery and Asberg Depression Rating Scale, the Brief Psychiatric Rating Scale, and the Medical Outcomes Study 36-item Short-Form Health Survey. Most measures showed significant mean improvements for the neurostimulation group versus slight declines for the medication-only group. Notably, the neurostimulation patients saw a 39% improvement in activities of daily living, versus a 5% decline in the medication-only patients. Psychiatric measures did not differ significantly between the two treatment groups. The investigators reported 13 adverse events—10 in the neurostimulation group, including three deaths, one of which was suicide, and 3 in the medication-only group. A patient in the medication group died after driving during a psychotic episode.

The results demonstrate “superior efficacy” of neurostimulation, the investigators concluded, with “significant and clinically meaningful improvement in quality of life … [and] longer periods and better quality of mobility with less dyskinesia. These changes … led to improvement in measurements of activities of daily living, emotional well-being, stigma, and body discomfort.” However, these benefits should “be weighed against the risk of complications related to surgery,” they said.

ELSEVIER GLOBAL MEDICAL NEWS

A significant portion of neonates still do not receive effective pain relief when undergoing circumcision, according to the findings of a study by Dr. Daniel Yawman and his colleagues.

This is true despite the substantial increase over the last few years in the percentage of residency programs in which effective anesthesia for this procedure is taught. Moreover, the most commonly reported surgical technique taught in these programs is not the method associated in the literature with less pain, reported Dr. Yawman of the University of Rochester (N.Y.) and his colleagues (Ambul. Pediatr. 2006;6:210–4).

Following up on a 1998 study by other researchers, they found that the percentage of all family practice, ob.gyn., and pediatric residency programs in the United States that reported teaching effective (local or topical) anesthesia for the procedure rose from a previously reported 71% for the mid-1990s to 97% in 2003; however, only 84% of programs in 2003 reported actually practicing effective anesthesia in neonatal circumcision always or frequently. Overall, 82% of the programs reported teaching circumcision.

Data were collected via a survey mailed to all directors of family practice, ob.gyn., and pediatric residency programs in the United States. There was an 86% response rate involving 811 programs.

The investigators considered effective anesthesia to be either local methods (subcutaneous or dorsal penile nerve block) or topical anesthesia (a combination of lidocaine and prilocaine [EMLA] or other anesthetic cream). They also collected data on other forms of analgesia taught for and used during circumcision, such as pacifiers or parental comforting. The most commonly taught and most frequently used method was the dorsal penile nerve block; this method was taught in 81%, and used frequently in 35%, of the residency programs that teach neonatal circumcision. Overall, local anesthesia was taught in 91% of the residency programs, and topical anesthesia was taught in only 44% of the programs.

The researchers also collected data on the surgical technique used in each program. Despite the fact that the Mogen clamp “may provide a less painful procedure, compared with the Gomco clamp or the Plastibell method,” use of the Mogen clamp was taught in only 38% of the programs, vs. 95% for the Gomco clamp and 37% for the Plastibell technique.

Pediatric residency programs reported teaching circumcision much less often (49%) than did family practice residencies (95%) or ob.gyn. programs (86%).

The authors concluded that although education regarding pain relief in circumcision has improved, “a significant number of newborns may not receive appropriate analgesia, despite the fact that effective analgesic techniques are taught to residents.”

Dr. Yawman and his colleagues noted that since the 1998 study, the professional organizations for each of the included specialties (the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics) have issued recommendations for universal use of local or topical anesthetic.

A significant portion of neonates still do not receive effective pain relief when undergoing circumcision, according to the findings of a study by Dr. Daniel Yawman and his colleagues.

This is true despite the substantial increase over the last few years in the percentage of residency programs in which effective anesthesia for this procedure is taught. Moreover, the most commonly reported surgical technique taught in these programs is not the method associated in the literature with less pain, reported Dr. Yawman of the University of Rochester (N.Y.) and his colleagues (Ambul. Pediatr. 2006;6:210–4).

Following up on a 1998 study by other researchers, they found that the percentage of all family practice, ob.gyn., and pediatric residency programs in the United States that reported teaching effective (local or topical) anesthesia for the procedure rose from a previously reported 71% for the mid-1990s to 97% in 2003; however, only 84% of programs in 2003 reported actually practicing effective anesthesia in neonatal circumcision always or frequently. Overall, 82% of the programs reported teaching circumcision.

Data were collected via a survey mailed to all directors of family practice, ob.gyn., and pediatric residency programs in the United States. There was an 86% response rate involving 811 programs.

The investigators considered effective anesthesia to be either local methods (subcutaneous or dorsal penile nerve block) or topical anesthesia (a combination of lidocaine and prilocaine [EMLA] or other anesthetic cream). They also collected data on other forms of analgesia taught for and used during circumcision, such as pacifiers or parental comforting. The most commonly taught and most frequently used method was the dorsal penile nerve block; this method was taught in 81%, and used frequently in 35%, of the residency programs that teach neonatal circumcision. Overall, local anesthesia was taught in 91% of the residency programs, and topical anesthesia was taught in only 44% of the programs.

The researchers also collected data on the surgical technique used in each program. Despite the fact that the Mogen clamp “may provide a less painful procedure, compared with the Gomco clamp or the Plastibell method,” use of the Mogen clamp was taught in only 38% of the programs, vs. 95% for the Gomco clamp and 37% for the Plastibell technique.

Pediatric residency programs reported teaching circumcision much less often (49%) than did family practice residencies (95%) or ob.gyn. programs (86%).

The authors concluded that although education regarding pain relief in circumcision has improved, “a significant number of newborns may not receive appropriate analgesia, despite the fact that effective analgesic techniques are taught to residents.”

Dr. Yawman and his colleagues noted that since the 1998 study, the professional organizations for each of the included specialties (the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics) have issued recommendations for universal use of local or topical anesthetic.

A significant portion of neonates still do not receive effective pain relief when undergoing circumcision, according to the findings of a study by Dr. Daniel Yawman and his colleagues.

This is true despite the substantial increase over the last few years in the percentage of residency programs in which effective anesthesia for this procedure is taught. Moreover, the most commonly reported surgical technique taught in these programs is not the method associated in the literature with less pain, reported Dr. Yawman of the University of Rochester (N.Y.) and his colleagues (Ambul. Pediatr. 2006;6:210–4).

Following up on a 1998 study by other researchers, they found that the percentage of all family practice, ob.gyn., and pediatric residency programs in the United States that reported teaching effective (local or topical) anesthesia for the procedure rose from a previously reported 71% for the mid-1990s to 97% in 2003; however, only 84% of programs in 2003 reported actually practicing effective anesthesia in neonatal circumcision always or frequently. Overall, 82% of the programs reported teaching circumcision.

Data were collected via a survey mailed to all directors of family practice, ob.gyn., and pediatric residency programs in the United States. There was an 86% response rate involving 811 programs.

The investigators considered effective anesthesia to be either local methods (subcutaneous or dorsal penile nerve block) or topical anesthesia (a combination of lidocaine and prilocaine [EMLA] or other anesthetic cream). They also collected data on other forms of analgesia taught for and used during circumcision, such as pacifiers or parental comforting. The most commonly taught and most frequently used method was the dorsal penile nerve block; this method was taught in 81%, and used frequently in 35%, of the residency programs that teach neonatal circumcision. Overall, local anesthesia was taught in 91% of the residency programs, and topical anesthesia was taught in only 44% of the programs.

The researchers also collected data on the surgical technique used in each program. Despite the fact that the Mogen clamp “may provide a less painful procedure, compared with the Gomco clamp or the Plastibell method,” use of the Mogen clamp was taught in only 38% of the programs, vs. 95% for the Gomco clamp and 37% for the Plastibell technique.

Pediatric residency programs reported teaching circumcision much less often (49%) than did family practice residencies (95%) or ob.gyn. programs (86%).

The authors concluded that although education regarding pain relief in circumcision has improved, “a significant number of newborns may not receive appropriate analgesia, despite the fact that effective analgesic techniques are taught to residents.”

Dr. Yawman and his colleagues noted that since the 1998 study, the professional organizations for each of the included specialties (the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics) have issued recommendations for universal use of local or topical anesthetic.

Recombinant human thyrotropin before radioiodine therapy was associated with a 35% greater reduction in volume of nontoxic nodular goiters than that achieved with radioiodine alone, but with a fivefold increase in the rate of hypothyroidism, Danish researchers reported in the first large, double-blind, randomized, controlled trial of this therapy for nontoxic nodular goiter.

Dr. Viveque E. Nielsen of Odense (Denmark) University Hospital and colleagues assessed the effect of recombinant human thyrotropin (rhTSH) administered prior to treatment with radioiodine (iodine-131) in patients with nontoxic nodular goiter who were seen at the investigators' outpatient clinic (Arch. Intern. Med. 2006;166:1476–82).

Patients received 0.3 mg of either rhTSH or a placebo saline injection 24 hours before treatment with radioiodine doses customized to each patient, based in part on radioiodine uptake measured at baseline and 12 months. End points of thyroid size and function were assessed at 3, 6, 9, and 12 months, as were patient satisfaction before therapy and at 3 months and 1 year post treatment, via a visual analog scale.

In all, 57 patients were included in the final study results. In the placebo group, the median goiter volume had dropped from the baseline measure of 51 mL to 27 mL. The rhTSH group saw a decline from a median of 59 mL at baseline to a median of 20 mL at 12 months. Moreover, mean reduction at 12 months was 46% for the group receiving radioiodine alone and 62% for the group treated first with rhTSH—a difference of 16 percentage points, which constitutes a 35% advantage over the reduction achieved solely with radioiodine.

However, in terms of thyroid function, hypothyroidism developed in 62% of the rhTSH group versus 11% of the placebo group. And adverse events were more common in the rhTSH group—namely, hypothyroid symptoms, nausea, and headache.

Recombinant human thyrotropin before radioiodine therapy was associated with a 35% greater reduction in volume of nontoxic nodular goiters than that achieved with radioiodine alone, but with a fivefold increase in the rate of hypothyroidism, Danish researchers reported in the first large, double-blind, randomized, controlled trial of this therapy for nontoxic nodular goiter.

Dr. Viveque E. Nielsen of Odense (Denmark) University Hospital and colleagues assessed the effect of recombinant human thyrotropin (rhTSH) administered prior to treatment with radioiodine (iodine-131) in patients with nontoxic nodular goiter who were seen at the investigators' outpatient clinic (Arch. Intern. Med. 2006;166:1476–82).

Patients received 0.3 mg of either rhTSH or a placebo saline injection 24 hours before treatment with radioiodine doses customized to each patient, based in part on radioiodine uptake measured at baseline and 12 months. End points of thyroid size and function were assessed at 3, 6, 9, and 12 months, as were patient satisfaction before therapy and at 3 months and 1 year post treatment, via a visual analog scale.

In all, 57 patients were included in the final study results. In the placebo group, the median goiter volume had dropped from the baseline measure of 51 mL to 27 mL. The rhTSH group saw a decline from a median of 59 mL at baseline to a median of 20 mL at 12 months. Moreover, mean reduction at 12 months was 46% for the group receiving radioiodine alone and 62% for the group treated first with rhTSH—a difference of 16 percentage points, which constitutes a 35% advantage over the reduction achieved solely with radioiodine.

However, in terms of thyroid function, hypothyroidism developed in 62% of the rhTSH group versus 11% of the placebo group. And adverse events were more common in the rhTSH group—namely, hypothyroid symptoms, nausea, and headache.

Recombinant human thyrotropin before radioiodine therapy was associated with a 35% greater reduction in volume of nontoxic nodular goiters than that achieved with radioiodine alone, but with a fivefold increase in the rate of hypothyroidism, Danish researchers reported in the first large, double-blind, randomized, controlled trial of this therapy for nontoxic nodular goiter.

Dr. Viveque E. Nielsen of Odense (Denmark) University Hospital and colleagues assessed the effect of recombinant human thyrotropin (rhTSH) administered prior to treatment with radioiodine (iodine-131) in patients with nontoxic nodular goiter who were seen at the investigators' outpatient clinic (Arch. Intern. Med. 2006;166:1476–82).

Patients received 0.3 mg of either rhTSH or a placebo saline injection 24 hours before treatment with radioiodine doses customized to each patient, based in part on radioiodine uptake measured at baseline and 12 months. End points of thyroid size and function were assessed at 3, 6, 9, and 12 months, as were patient satisfaction before therapy and at 3 months and 1 year post treatment, via a visual analog scale.

In all, 57 patients were included in the final study results. In the placebo group, the median goiter volume had dropped from the baseline measure of 51 mL to 27 mL. The rhTSH group saw a decline from a median of 59 mL at baseline to a median of 20 mL at 12 months. Moreover, mean reduction at 12 months was 46% for the group receiving radioiodine alone and 62% for the group treated first with rhTSH—a difference of 16 percentage points, which constitutes a 35% advantage over the reduction achieved solely with radioiodine.

However, in terms of thyroid function, hypothyroidism developed in 62% of the rhTSH group versus 11% of the placebo group. And adverse events were more common in the rhTSH group—namely, hypothyroid symptoms, nausea, and headache.

The low-air-pressure, hypoxic environment experienced in air travel is not likely a cause of the increased risk for venous thromboembolism associated with long-distance flight, a team of British and Dutch researchers has reported.

The investigators, led by Dr. William D. Toff of the University of Leicester (England), performed a single-blind crossover study to compare the effects of a simulated long-haul flight—prolonged sitting in a hypobaric, hypoxic environment—with the effects of prolonged sitting in a normobaric, normoxic control environment.

Study participants in both groups showed significant changes in measures of several blood markers associated with thrombolysis, but these changes were not significantly different between the two exposure environments and were ascribed to circadian rhythm and the act of prolonged sitting, rather than to lowered atmospheric pressure (JAMA 2006;295:2251–61).

A total of 73 participants were screened for factor V Leiden and prothrombin G202190 mutations (the most common causes of thrombophilia) and stratified into three groups according to their risk of thromboembolism: a younger group (49 people; age 18–40 years; mean 23.5 years) not taking oral contraceptives, a smaller group of oral contraceptive users (12 people; age 18–40 years; mean 23.8 years), and an older group of men and women (12 people; age at least 50 years; mean age 57 years).

The researchers then randomly assigned all participants to one of two exposure groups, which differed only in the order of exposure. One group first sat for 8 hours in a bariatric chamber pressurized to create an environment of hypobaric hypoxia equal to roughly 8,000 feet (the lowest cabin pressure permitted by airline regulations) and 1 week later sat for another 8 hours in the chamber under normobaric normoxia; the second group underwent the same exposure but in the reverse order. Participants were allowed to stand up and move for 5 minutes each hour, could drink nonalcoholic beverages, and were given a light lunch and snacks.

The investigators recorded arterial oxygen saturation via pulse oximetry every hour and took blood samples before and after each 8-hour session to assess coagulation activation, fibrinolysis, platelet activation, and endothelial cell activation for each participant.

As expected, all three risk groups experienced lower arterial oxygen saturation during the low-pressure portion of the study. Notably, though, statistically significant changes were seen in markers of coagulation activation and fibrinolysis during not only the hypobaric exposure but also the normobaric (control) session—leading the investigators to conclude that such changes were associated with long-term sitting and natural circadian patterns, rather than air pressure. For example, the level of tissue plasminogen activator dropped a median of 1.23 ng/mL during normobaric normoxia and a median of 1.00 ng/mL during hypobaric hypoxia.

In addition, these changes were not significantly different between normal pressure and lower pressure for any of the three risk groups.

“In this large, controlled study with measurement of a wide range of markers … we found no procoagulant changes attributable to hypobaric hypoxia,” the investigators concluded. “Our findings do not support the hypothesis that hypobaric hypoxia of the degree that might be encountered during long-haul air travel is associated with prothrombotic alterations in the hemostatic system in healthy individuals at low risk of venous thromboembolism.”

The researchers did not comment on whether the changed blood marker levels, corresponding with increased risk for venous thromboembolism, are in themselves cause for concern. However, they called these changes “minor.”

“It is noteworthy that there was no significant change in endogenous thrombin potential, a global marker of coagulation activation,” they added. In some individuals, genetic risk factors might interact with hypoxia to increase the risk of thromboembolism, they conceded.

The study authors noted that reports of venous thromboembolism after long-haul air travel began more than 50 years ago.

In an accompanying editorial, Dr. Peter Bäärtsch of the University of Heidelberg (Germany) concurred with the study authors that mild hypoxia and prolonged sitting pose little risk to most people but added that “the small numbers of older participants and individuals taking contraceptives preclude drawing reliable conclusions about these groups” (JAMA 2006;295:2297–9).

The study was funded by the U.K. Department for Transport, the U.K. Department of Health, and the European Commission.

The low-air-pressure, hypoxic environment experienced in air travel is not likely a cause of the increased risk for venous thromboembolism associated with long-distance flight, a team of British and Dutch researchers has reported.

The investigators, led by Dr. William D. Toff of the University of Leicester (England), performed a single-blind crossover study to compare the effects of a simulated long-haul flight—prolonged sitting in a hypobaric, hypoxic environment—with the effects of prolonged sitting in a normobaric, normoxic control environment.

Study participants in both groups showed significant changes in measures of several blood markers associated with thrombolysis, but these changes were not significantly different between the two exposure environments and were ascribed to circadian rhythm and the act of prolonged sitting, rather than to lowered atmospheric pressure (JAMA 2006;295:2251–61).

A total of 73 participants were screened for factor V Leiden and prothrombin G202190 mutations (the most common causes of thrombophilia) and stratified into three groups according to their risk of thromboembolism: a younger group (49 people; age 18–40 years; mean 23.5 years) not taking oral contraceptives, a smaller group of oral contraceptive users (12 people; age 18–40 years; mean 23.8 years), and an older group of men and women (12 people; age at least 50 years; mean age 57 years).

The researchers then randomly assigned all participants to one of two exposure groups, which differed only in the order of exposure. One group first sat for 8 hours in a bariatric chamber pressurized to create an environment of hypobaric hypoxia equal to roughly 8,000 feet (the lowest cabin pressure permitted by airline regulations) and 1 week later sat for another 8 hours in the chamber under normobaric normoxia; the second group underwent the same exposure but in the reverse order. Participants were allowed to stand up and move for 5 minutes each hour, could drink nonalcoholic beverages, and were given a light lunch and snacks.

The investigators recorded arterial oxygen saturation via pulse oximetry every hour and took blood samples before and after each 8-hour session to assess coagulation activation, fibrinolysis, platelet activation, and endothelial cell activation for each participant.

As expected, all three risk groups experienced lower arterial oxygen saturation during the low-pressure portion of the study. Notably, though, statistically significant changes were seen in markers of coagulation activation and fibrinolysis during not only the hypobaric exposure but also the normobaric (control) session—leading the investigators to conclude that such changes were associated with long-term sitting and natural circadian patterns, rather than air pressure. For example, the level of tissue plasminogen activator dropped a median of 1.23 ng/mL during normobaric normoxia and a median of 1.00 ng/mL during hypobaric hypoxia.

In addition, these changes were not significantly different between normal pressure and lower pressure for any of the three risk groups.

“In this large, controlled study with measurement of a wide range of markers … we found no procoagulant changes attributable to hypobaric hypoxia,” the investigators concluded. “Our findings do not support the hypothesis that hypobaric hypoxia of the degree that might be encountered during long-haul air travel is associated with prothrombotic alterations in the hemostatic system in healthy individuals at low risk of venous thromboembolism.”

The researchers did not comment on whether the changed blood marker levels, corresponding with increased risk for venous thromboembolism, are in themselves cause for concern. However, they called these changes “minor.”

“It is noteworthy that there was no significant change in endogenous thrombin potential, a global marker of coagulation activation,” they added. In some individuals, genetic risk factors might interact with hypoxia to increase the risk of thromboembolism, they conceded.

The study authors noted that reports of venous thromboembolism after long-haul air travel began more than 50 years ago.

In an accompanying editorial, Dr. Peter Bäärtsch of the University of Heidelberg (Germany) concurred with the study authors that mild hypoxia and prolonged sitting pose little risk to most people but added that “the small numbers of older participants and individuals taking contraceptives preclude drawing reliable conclusions about these groups” (JAMA 2006;295:2297–9).

The study was funded by the U.K. Department for Transport, the U.K. Department of Health, and the European Commission.

The low-air-pressure, hypoxic environment experienced in air travel is not likely a cause of the increased risk for venous thromboembolism associated with long-distance flight, a team of British and Dutch researchers has reported.

The investigators, led by Dr. William D. Toff of the University of Leicester (England), performed a single-blind crossover study to compare the effects of a simulated long-haul flight—prolonged sitting in a hypobaric, hypoxic environment—with the effects of prolonged sitting in a normobaric, normoxic control environment.

Study participants in both groups showed significant changes in measures of several blood markers associated with thrombolysis, but these changes were not significantly different between the two exposure environments and were ascribed to circadian rhythm and the act of prolonged sitting, rather than to lowered atmospheric pressure (JAMA 2006;295:2251–61).

A total of 73 participants were screened for factor V Leiden and prothrombin G202190 mutations (the most common causes of thrombophilia) and stratified into three groups according to their risk of thromboembolism: a younger group (49 people; age 18–40 years; mean 23.5 years) not taking oral contraceptives, a smaller group of oral contraceptive users (12 people; age 18–40 years; mean 23.8 years), and an older group of men and women (12 people; age at least 50 years; mean age 57 years).

The researchers then randomly assigned all participants to one of two exposure groups, which differed only in the order of exposure. One group first sat for 8 hours in a bariatric chamber pressurized to create an environment of hypobaric hypoxia equal to roughly 8,000 feet (the lowest cabin pressure permitted by airline regulations) and 1 week later sat for another 8 hours in the chamber under normobaric normoxia; the second group underwent the same exposure but in the reverse order. Participants were allowed to stand up and move for 5 minutes each hour, could drink nonalcoholic beverages, and were given a light lunch and snacks.

The investigators recorded arterial oxygen saturation via pulse oximetry every hour and took blood samples before and after each 8-hour session to assess coagulation activation, fibrinolysis, platelet activation, and endothelial cell activation for each participant.

As expected, all three risk groups experienced lower arterial oxygen saturation during the low-pressure portion of the study. Notably, though, statistically significant changes were seen in markers of coagulation activation and fibrinolysis during not only the hypobaric exposure but also the normobaric (control) session—leading the investigators to conclude that such changes were associated with long-term sitting and natural circadian patterns, rather than air pressure. For example, the level of tissue plasminogen activator dropped a median of 1.23 ng/mL during normobaric normoxia and a median of 1.00 ng/mL during hypobaric hypoxia.

In addition, these changes were not significantly different between normal pressure and lower pressure for any of the three risk groups.

“In this large, controlled study with measurement of a wide range of markers … we found no procoagulant changes attributable to hypobaric hypoxia,” the investigators concluded. “Our findings do not support the hypothesis that hypobaric hypoxia of the degree that might be encountered during long-haul air travel is associated with prothrombotic alterations in the hemostatic system in healthy individuals at low risk of venous thromboembolism.”

The researchers did not comment on whether the changed blood marker levels, corresponding with increased risk for venous thromboembolism, are in themselves cause for concern. However, they called these changes “minor.”

“It is noteworthy that there was no significant change in endogenous thrombin potential, a global marker of coagulation activation,” they added. In some individuals, genetic risk factors might interact with hypoxia to increase the risk of thromboembolism, they conceded.

The study authors noted that reports of venous thromboembolism after long-haul air travel began more than 50 years ago.

In an accompanying editorial, Dr. Peter Bäärtsch of the University of Heidelberg (Germany) concurred with the study authors that mild hypoxia and prolonged sitting pose little risk to most people but added that “the small numbers of older participants and individuals taking contraceptives preclude drawing reliable conclusions about these groups” (JAMA 2006;295:2297–9).

The study was funded by the U.K. Department for Transport, the U.K. Department of Health, and the European Commission.

The Centers for Disease Control and Prevention has warned of an upswing in cases of eastern equine encephalitis in New England, including—for the first time in 41 years of reporting of the disease—cases occurring in New Hampshire.

In a report discussing cases occurring between August and September of last year, in addition to the seven New Hampshire cases, there were four from Massachusetts—five times the average of 0.08 for the previous 10 years (MMWR 2006;55:697–700).

The CDC advises health care providers that they need to be aware of the risk “even in areas that have not previously had much activity.”

Eastern equine encephalitis virus (EEEV) is spread by mosquitoes and can affect horses, as well as humans.

Mosquitoes carrying the EEEV most commonly inhabit swamps and marshes, the report said.

Notably, all infected patients spent time working or socializing near such wetland areas, and all lived within half a mile of a swamp or cranberry bog.

Dr. Julia McMillan, a member of the American Academy of Pediatrics' Committee on Infectious Disease and professor of pediatrics at Johns Hopkins University, Baltimore, agreed with the CDC's recommendations to use insect repellent and long-sleeved clothing to keep insects at bay.

Given that EEEV, like malaria and dengue, is caused by a virus, there is no specific treatment for this potentially fatal infection.

“I think that actually is one of the scariest things. It's the reason why protecting children and ourselves is so important, Dr. McMillan said.

When asked if the chemicals in insect repellent are safe for children, she said moderation is called for.

“There is no way to keep a child completely safe,” she said. “But that doesn't mean [parents] shouldn't try. It's just important to understand that everything is a balance.

“We want children to play outside, but we want them to do it safely. And there are all sorts of ways to do that. One is that we prevent bites from insects that convey infection—but we also don't douse them with so much repellent that it causes harm.”

The CDC on its Web page on West Nile virus cites the Environmental Protection Agency's advice: “Do not allow children to handle the [insect repellent]. When using on children, apply to your own hands first and then put it on the child.”

Likewise, the AAP warns not to apply DEET (N, N-diethyl-m-toluamide) to the hands of young children and to avoid areas around the eyes and mouth.

Dr. McMillan noted that a new version of the AAP Red Book is being delivered in the coming weeks and will be available online this month.

The new book will include an updated, more specific statement on DEET and will address other insect repellents, such as picaridin.

She said she believes it's too early to say there's a relationship between global warming and any upswing in insect-borne diseases.

Dengue: Tropical Climate Warning

Increases in the incidence of dengue hemorrhagic fever in tropical countries also have prompted the CDC to remind health care providers to consider this disease when diagnosing febrile patients who have recently returned from areas of risk—and to remind the public of protective measures.

There were 96 confirmed cases of dengue in U.S. residents last year, the CDC reported (MMWR 2006;55:700–2). Dengue, which is not endemic to North America, is not seen commonly by physicians here—but with increasing international travel, global warming, and slackening antimosquito efforts in some countries, physicians soon may see more suspected cases of dengue in their practice—particularly during the summer months.

Pediatricians and the people they advise need to remember that when they go to tropical areas that mosquitoes are a problem since these insects carry diseases not found in the United States. Malaria chemoprophylaxis doesn't protect against mosquitoes—just against the malaria that they carry, Dr. McMillan said.

The CDC on its Web site advises preventing dengue transmission by using insect repellent including DEET. The American Academy of Pediatrics warns that DEET should not be used on infants younger than 2 months nor on the hands of young children, and that when using on a child's face, the areas around their eyes and mouth should be avoided. Similarly, product labels for repellents containing oil of lemon eucalyptus note that this product should not be used on children younger than 3 years.

Unlike EEEV, Dr. McMillan noted, dengue is not now carried by mosquitoes in this country—and EEEV is very rare where it exists. “The CDC report [on EEEV] is significant because EEEV, unlike dengue, has high mortality rate associated with it.”

The Centers for Disease Control and Prevention has warned of an upswing in cases of eastern equine encephalitis in New England, including—for the first time in 41 years of reporting of the disease—cases occurring in New Hampshire.

In a report discussing cases occurring between August and September of last year, in addition to the seven New Hampshire cases, there were four from Massachusetts—five times the average of 0.08 for the previous 10 years (MMWR 2006;55:697–700).

The CDC advises health care providers that they need to be aware of the risk “even in areas that have not previously had much activity.”

Eastern equine encephalitis virus (EEEV) is spread by mosquitoes and can affect horses, as well as humans.

Mosquitoes carrying the EEEV most commonly inhabit swamps and marshes, the report said.

Notably, all infected patients spent time working or socializing near such wetland areas, and all lived within half a mile of a swamp or cranberry bog.

Dr. Julia McMillan, a member of the American Academy of Pediatrics' Committee on Infectious Disease and professor of pediatrics at Johns Hopkins University, Baltimore, agreed with the CDC's recommendations to use insect repellent and long-sleeved clothing to keep insects at bay.

Given that EEEV, like malaria and dengue, is caused by a virus, there is no specific treatment for this potentially fatal infection.

“I think that actually is one of the scariest things. It's the reason why protecting children and ourselves is so important, Dr. McMillan said.

When asked if the chemicals in insect repellent are safe for children, she said moderation is called for.

“There is no way to keep a child completely safe,” she said. “But that doesn't mean [parents] shouldn't try. It's just important to understand that everything is a balance.

“We want children to play outside, but we want them to do it safely. And there are all sorts of ways to do that. One is that we prevent bites from insects that convey infection—but we also don't douse them with so much repellent that it causes harm.”

The CDC on its Web page on West Nile virus cites the Environmental Protection Agency's advice: “Do not allow children to handle the [insect repellent]. When using on children, apply to your own hands first and then put it on the child.”

Likewise, the AAP warns not to apply DEET (N, N-diethyl-m-toluamide) to the hands of young children and to avoid areas around the eyes and mouth.

Dr. McMillan noted that a new version of the AAP Red Book is being delivered in the coming weeks and will be available online this month.

The new book will include an updated, more specific statement on DEET and will address other insect repellents, such as picaridin.

She said she believes it's too early to say there's a relationship between global warming and any upswing in insect-borne diseases.

Dengue: Tropical Climate Warning

Increases in the incidence of dengue hemorrhagic fever in tropical countries also have prompted the CDC to remind health care providers to consider this disease when diagnosing febrile patients who have recently returned from areas of risk—and to remind the public of protective measures.

There were 96 confirmed cases of dengue in U.S. residents last year, the CDC reported (MMWR 2006;55:700–2). Dengue, which is not endemic to North America, is not seen commonly by physicians here—but with increasing international travel, global warming, and slackening antimosquito efforts in some countries, physicians soon may see more suspected cases of dengue in their practice—particularly during the summer months.

Pediatricians and the people they advise need to remember that when they go to tropical areas that mosquitoes are a problem since these insects carry diseases not found in the United States. Malaria chemoprophylaxis doesn't protect against mosquitoes—just against the malaria that they carry, Dr. McMillan said.

The CDC on its Web site advises preventing dengue transmission by using insect repellent including DEET. The American Academy of Pediatrics warns that DEET should not be used on infants younger than 2 months nor on the hands of young children, and that when using on a child's face, the areas around their eyes and mouth should be avoided. Similarly, product labels for repellents containing oil of lemon eucalyptus note that this product should not be used on children younger than 3 years.

Unlike EEEV, Dr. McMillan noted, dengue is not now carried by mosquitoes in this country—and EEEV is very rare where it exists. “The CDC report [on EEEV] is significant because EEEV, unlike dengue, has high mortality rate associated with it.”

The Centers for Disease Control and Prevention has warned of an upswing in cases of eastern equine encephalitis in New England, including—for the first time in 41 years of reporting of the disease—cases occurring in New Hampshire.

In a report discussing cases occurring between August and September of last year, in addition to the seven New Hampshire cases, there were four from Massachusetts—five times the average of 0.08 for the previous 10 years (MMWR 2006;55:697–700).

The CDC advises health care providers that they need to be aware of the risk “even in areas that have not previously had much activity.”

Eastern equine encephalitis virus (EEEV) is spread by mosquitoes and can affect horses, as well as humans.

Mosquitoes carrying the EEEV most commonly inhabit swamps and marshes, the report said.

Notably, all infected patients spent time working or socializing near such wetland areas, and all lived within half a mile of a swamp or cranberry bog.

Dr. Julia McMillan, a member of the American Academy of Pediatrics' Committee on Infectious Disease and professor of pediatrics at Johns Hopkins University, Baltimore, agreed with the CDC's recommendations to use insect repellent and long-sleeved clothing to keep insects at bay.

Given that EEEV, like malaria and dengue, is caused by a virus, there is no specific treatment for this potentially fatal infection.

“I think that actually is one of the scariest things. It's the reason why protecting children and ourselves is so important, Dr. McMillan said.

When asked if the chemicals in insect repellent are safe for children, she said moderation is called for.

“There is no way to keep a child completely safe,” she said. “But that doesn't mean [parents] shouldn't try. It's just important to understand that everything is a balance.

“We want children to play outside, but we want them to do it safely. And there are all sorts of ways to do that. One is that we prevent bites from insects that convey infection—but we also don't douse them with so much repellent that it causes harm.”

The CDC on its Web page on West Nile virus cites the Environmental Protection Agency's advice: “Do not allow children to handle the [insect repellent]. When using on children, apply to your own hands first and then put it on the child.”

Likewise, the AAP warns not to apply DEET (N, N-diethyl-m-toluamide) to the hands of young children and to avoid areas around the eyes and mouth.

Dr. McMillan noted that a new version of the AAP Red Book is being delivered in the coming weeks and will be available online this month.

The new book will include an updated, more specific statement on DEET and will address other insect repellents, such as picaridin.

She said she believes it's too early to say there's a relationship between global warming and any upswing in insect-borne diseases.

Dengue: Tropical Climate Warning

Increases in the incidence of dengue hemorrhagic fever in tropical countries also have prompted the CDC to remind health care providers to consider this disease when diagnosing febrile patients who have recently returned from areas of risk—and to remind the public of protective measures.

There were 96 confirmed cases of dengue in U.S. residents last year, the CDC reported (MMWR 2006;55:700–2). Dengue, which is not endemic to North America, is not seen commonly by physicians here—but with increasing international travel, global warming, and slackening antimosquito efforts in some countries, physicians soon may see more suspected cases of dengue in their practice—particularly during the summer months.

Pediatricians and the people they advise need to remember that when they go to tropical areas that mosquitoes are a problem since these insects carry diseases not found in the United States. Malaria chemoprophylaxis doesn't protect against mosquitoes—just against the malaria that they carry, Dr. McMillan said.

The CDC on its Web site advises preventing dengue transmission by using insect repellent including DEET. The American Academy of Pediatrics warns that DEET should not be used on infants younger than 2 months nor on the hands of young children, and that when using on a child's face, the areas around their eyes and mouth should be avoided. Similarly, product labels for repellents containing oil of lemon eucalyptus note that this product should not be used on children younger than 3 years.

Unlike EEEV, Dr. McMillan noted, dengue is not now carried by mosquitoes in this country—and EEEV is very rare where it exists. “The CDC report [on EEEV] is significant because EEEV, unlike dengue, has high mortality rate associated with it.”

Cognitive-behavioral therapy led to greater improvements in a variety of sleep measures than did zopiclone in adults with insomnia, Norwegian researchers report.

Børge Sivertsen, Psy.D., of the University of Bergen, Norway, and his colleagues found in a randomized, double-blinded, placebo-controlled trial that among older patients randomly assigned to CBT, sleep efficiency, total wake time, and duration of slow-wave sleep were all significantly more improved by 6 weeks and 6 months than were patients taking zopiclone (JAMA 2006;295:2851–8).

A total of 45 patients enrolled from a Norwegian clinic received either CBT (18 patients), zopiclone (15 patients), or a placebo (12 patients). The mean age of the patients was 61 years.

Sleep measures were assessed at 6 weeks, which was the end of the treatment protocol. These measures were also assessed at 6 months, via polysomnography (PSG) and patient-reported sleep diaries filled out each morning for 2 weeks, at baseline, and at the two subsequent assessment points.

At 6 weeks, PSG data showed that subjects on CBT had a mean 52% improvement in total wake time, which rose to 56% at 6 months; those on zopiclone had a 4% and 10% improvement, respectively. Diary-reported data showed that the subjects believed the efficacy of both treatments to be even greater, with self-reported wake-time reductions in the CBT group of 34% and 51% at the two time points, and 16% and 27% for the zopiclone group.

Similarly, mean sleep efficiency, the ratio of total sleep time to time spent in bed multiplied by 100, improved by 9% and 11% at 6 weeks and 6 months, as assessed by PSG. The investigators found that efficiency actually decreased by 1% at both points among the zopiclone group. PSG-measured time spent in slow-wave sleep was improved by a mean of 34 minutes by 6 months in the CBT group, versus a loss of 23 minutes at 6 months in the zopiclone group.

Total sleep time as assessed via PSG actually decreased among both groups (and in the placebo group), even though the participants recorded improvements in their diaries. However, none of these data reached statistical significance.

“We found that CBT was more effective immediately and long-term, compared with both zopiclone and placebo in older adults with chronic primary insomnia,” the investigators concluded. This finding comes despite the clinical dominance of medications to treat insomnia in primary care, they noted.

The CBT arm underwent five treatment modules. Sleep hygiene education addressed exercise, diet and alcohol use, and environmental factors conducive to sleep. Sleep restriction imposed a schedule of when a patient could be in bed. The stimulus control module restricted bedroom activities to those compatible with sleep. The therapy addressed patient beliefs and fears about sleep, and the progressive relaxation techniques aimed to teach patients to control muscular tension via exercises.

Cognitive-behavioral therapy led to greater improvements in a variety of sleep measures than did zopiclone in adults with insomnia, Norwegian researchers report.

Børge Sivertsen, Psy.D., of the University of Bergen, Norway, and his colleagues found in a randomized, double-blinded, placebo-controlled trial that among older patients randomly assigned to CBT, sleep efficiency, total wake time, and duration of slow-wave sleep were all significantly more improved by 6 weeks and 6 months than were patients taking zopiclone (JAMA 2006;295:2851–8).

A total of 45 patients enrolled from a Norwegian clinic received either CBT (18 patients), zopiclone (15 patients), or a placebo (12 patients). The mean age of the patients was 61 years.

Sleep measures were assessed at 6 weeks, which was the end of the treatment protocol. These measures were also assessed at 6 months, via polysomnography (PSG) and patient-reported sleep diaries filled out each morning for 2 weeks, at baseline, and at the two subsequent assessment points.

At 6 weeks, PSG data showed that subjects on CBT had a mean 52% improvement in total wake time, which rose to 56% at 6 months; those on zopiclone had a 4% and 10% improvement, respectively. Diary-reported data showed that the subjects believed the efficacy of both treatments to be even greater, with self-reported wake-time reductions in the CBT group of 34% and 51% at the two time points, and 16% and 27% for the zopiclone group.

Similarly, mean sleep efficiency, the ratio of total sleep time to time spent in bed multiplied by 100, improved by 9% and 11% at 6 weeks and 6 months, as assessed by PSG. The investigators found that efficiency actually decreased by 1% at both points among the zopiclone group. PSG-measured time spent in slow-wave sleep was improved by a mean of 34 minutes by 6 months in the CBT group, versus a loss of 23 minutes at 6 months in the zopiclone group.

Total sleep time as assessed via PSG actually decreased among both groups (and in the placebo group), even though the participants recorded improvements in their diaries. However, none of these data reached statistical significance.

“We found that CBT was more effective immediately and long-term, compared with both zopiclone and placebo in older adults with chronic primary insomnia,” the investigators concluded. This finding comes despite the clinical dominance of medications to treat insomnia in primary care, they noted.

The CBT arm underwent five treatment modules. Sleep hygiene education addressed exercise, diet and alcohol use, and environmental factors conducive to sleep. Sleep restriction imposed a schedule of when a patient could be in bed. The stimulus control module restricted bedroom activities to those compatible with sleep. The therapy addressed patient beliefs and fears about sleep, and the progressive relaxation techniques aimed to teach patients to control muscular tension via exercises.

Cognitive-behavioral therapy led to greater improvements in a variety of sleep measures than did zopiclone in adults with insomnia, Norwegian researchers report.

Børge Sivertsen, Psy.D., of the University of Bergen, Norway, and his colleagues found in a randomized, double-blinded, placebo-controlled trial that among older patients randomly assigned to CBT, sleep efficiency, total wake time, and duration of slow-wave sleep were all significantly more improved by 6 weeks and 6 months than were patients taking zopiclone (JAMA 2006;295:2851–8).

A total of 45 patients enrolled from a Norwegian clinic received either CBT (18 patients), zopiclone (15 patients), or a placebo (12 patients). The mean age of the patients was 61 years.

Sleep measures were assessed at 6 weeks, which was the end of the treatment protocol. These measures were also assessed at 6 months, via polysomnography (PSG) and patient-reported sleep diaries filled out each morning for 2 weeks, at baseline, and at the two subsequent assessment points.

At 6 weeks, PSG data showed that subjects on CBT had a mean 52% improvement in total wake time, which rose to 56% at 6 months; those on zopiclone had a 4% and 10% improvement, respectively. Diary-reported data showed that the subjects believed the efficacy of both treatments to be even greater, with self-reported wake-time reductions in the CBT group of 34% and 51% at the two time points, and 16% and 27% for the zopiclone group.

Similarly, mean sleep efficiency, the ratio of total sleep time to time spent in bed multiplied by 100, improved by 9% and 11% at 6 weeks and 6 months, as assessed by PSG. The investigators found that efficiency actually decreased by 1% at both points among the zopiclone group. PSG-measured time spent in slow-wave sleep was improved by a mean of 34 minutes by 6 months in the CBT group, versus a loss of 23 minutes at 6 months in the zopiclone group.

Total sleep time as assessed via PSG actually decreased among both groups (and in the placebo group), even though the participants recorded improvements in their diaries. However, none of these data reached statistical significance.

“We found that CBT was more effective immediately and long-term, compared with both zopiclone and placebo in older adults with chronic primary insomnia,” the investigators concluded. This finding comes despite the clinical dominance of medications to treat insomnia in primary care, they noted.

The CBT arm underwent five treatment modules. Sleep hygiene education addressed exercise, diet and alcohol use, and environmental factors conducive to sleep. Sleep restriction imposed a schedule of when a patient could be in bed. The stimulus control module restricted bedroom activities to those compatible with sleep. The therapy addressed patient beliefs and fears about sleep, and the progressive relaxation techniques aimed to teach patients to control muscular tension via exercises.

Elevated homocysteine levels may not be a risk factor for cognitive decline in older patients, despite previous evidence, reported Jennifer A. McMahon, Ph.D.

She and her colleagues at the University of Otago, New Zealand, conducted a 2-year randomized, double-blind, placebo-controlled trial to assess the effect of homocysteine lowering on the cognitive abilities of people aged older than 65 years through neuropsychological tests (N. Engl. J. Med. 2006;354:2764–72).

The researchers found that the reduction of plasma homocysteine in the studied elderly population was not associated with significant differences from placebo in various measures of cognitive ability.

A total of 253 participants (mean age 74 years) completed the study. To be enrolled, the patients were required to have a fasting homocysteine level of at least 13 μmol/L and a normal plasma creatinine level; to be free of suspected dementia, current depression treatment, history of stroke/transient ischemic attack, and diabetes; and to not be taking B-vitamin supplements or medications that can affect folate metabolism.

The investigators then gave the treatment group (127 patients) a daily supplement comprising 1,000 mcg folate, 500 mcg B₁₂, and 10 mg B₆. The mean homocysteine level, with this regimen, was 4.36 mol/L lower in the vitamin group than in the placebo group (126 patients), over the course of the study.

But when the cognitive tests–the Mini-Mental State Examination, the Wechsler Paragraph Recall test, and others–were administered at 1 and 2 years and adjustment for sex and education, differences between the two groups were not significant–except for those on the Reitan Trail Making Test.

On that test, participants in the vitamin group actually performed worse (took longer to complete the test) than did the placebo group (P = .007). The investigators remarked that this might be a chance finding, however.

Moreover, when the investigators combined the results of all the tests using a generalized estimating equation that was adjusted for baseline value, gender, and education, the resulting score for the vitamin group was lower than that of the placebo group–a finding that the investigators noted contradicts “the weight of a substantial body of observational evidence.”

However, this difference barely reached significance (P = .05). Baseline characteristics of the patients were similar.

Elevated homocysteine levels may not be a risk factor for cognitive decline in older patients, despite previous evidence, reported Jennifer A. McMahon, Ph.D.

She and her colleagues at the University of Otago, New Zealand, conducted a 2-year randomized, double-blind, placebo-controlled trial to assess the effect of homocysteine lowering on the cognitive abilities of people aged older than 65 years through neuropsychological tests (N. Engl. J. Med. 2006;354:2764–72).

The researchers found that the reduction of plasma homocysteine in the studied elderly population was not associated with significant differences from placebo in various measures of cognitive ability.

A total of 253 participants (mean age 74 years) completed the study. To be enrolled, the patients were required to have a fasting homocysteine level of at least 13 μmol/L and a normal plasma creatinine level; to be free of suspected dementia, current depression treatment, history of stroke/transient ischemic attack, and diabetes; and to not be taking B-vitamin supplements or medications that can affect folate metabolism.

The investigators then gave the treatment group (127 patients) a daily supplement comprising 1,000 mcg folate, 500 mcg B₁₂, and 10 mg B₆. The mean homocysteine level, with this regimen, was 4.36 mol/L lower in the vitamin group than in the placebo group (126 patients), over the course of the study.

But when the cognitive tests–the Mini-Mental State Examination, the Wechsler Paragraph Recall test, and others–were administered at 1 and 2 years and adjustment for sex and education, differences between the two groups were not significant–except for those on the Reitan Trail Making Test.

On that test, participants in the vitamin group actually performed worse (took longer to complete the test) than did the placebo group (P = .007). The investigators remarked that this might be a chance finding, however.

Moreover, when the investigators combined the results of all the tests using a generalized estimating equation that was adjusted for baseline value, gender, and education, the resulting score for the vitamin group was lower than that of the placebo group–a finding that the investigators noted contradicts “the weight of a substantial body of observational evidence.”

However, this difference barely reached significance (P = .05). Baseline characteristics of the patients were similar.

Elevated homocysteine levels may not be a risk factor for cognitive decline in older patients, despite previous evidence, reported Jennifer A. McMahon, Ph.D.

She and her colleagues at the University of Otago, New Zealand, conducted a 2-year randomized, double-blind, placebo-controlled trial to assess the effect of homocysteine lowering on the cognitive abilities of people aged older than 65 years through neuropsychological tests (N. Engl. J. Med. 2006;354:2764–72).

The researchers found that the reduction of plasma homocysteine in the studied elderly population was not associated with significant differences from placebo in various measures of cognitive ability.

A total of 253 participants (mean age 74 years) completed the study. To be enrolled, the patients were required to have a fasting homocysteine level of at least 13 μmol/L and a normal plasma creatinine level; to be free of suspected dementia, current depression treatment, history of stroke/transient ischemic attack, and diabetes; and to not be taking B-vitamin supplements or medications that can affect folate metabolism.

The investigators then gave the treatment group (127 patients) a daily supplement comprising 1,000 mcg folate, 500 mcg B₁₂, and 10 mg B₆. The mean homocysteine level, with this regimen, was 4.36 mol/L lower in the vitamin group than in the placebo group (126 patients), over the course of the study.

But when the cognitive tests–the Mini-Mental State Examination, the Wechsler Paragraph Recall test, and others–were administered at 1 and 2 years and adjustment for sex and education, differences between the two groups were not significant–except for those on the Reitan Trail Making Test.

On that test, participants in the vitamin group actually performed worse (took longer to complete the test) than did the placebo group (P = .007). The investigators remarked that this might be a chance finding, however.

Moreover, when the investigators combined the results of all the tests using a generalized estimating equation that was adjusted for baseline value, gender, and education, the resulting score for the vitamin group was lower than that of the placebo group–a finding that the investigators noted contradicts “the weight of a substantial body of observational evidence.”

However, this difference barely reached significance (P = .05). Baseline characteristics of the patients were similar.