Kate Johnson

PHILADELPHIA — Recommendations on assisted reproductive technologies issued by the President's Council on Bioethics in 2004 aim to prevent “renegade investigators from doing unethical procedures” and are unlikely to meet with opposition from most fertility experts, according to Marian Damewood, M.D., immediate past president of the American Society for Reproductive Medicine.

“The government regulation that has been proposed is on specific targeted legislative measures, such as preventing human/animal combinations from being born. And I don't think anyone would disagree with those measures,” Dr. Damewood said in an interview after the council's chairman, Leon Kass, M.D., discussed the recommendations during a presentation at the ASRM's annual meeting.

The council's recommendations—published as part of a report, “Reproduction and Responsibility: The Regulation of New Biotechnologies,” released in March, 2004—fall into three categories:

▸ The pursuit of longitudinal studies and data collection to monitor the health and well-being of women affected by assisted reproductive technology procedures.

▸ The strengthening of monitoring systems to track success rates and adverse events and ensure compliance with professional guidelines.

▸ A moratorium on “questionable” practices, such as the creation of human/animal hybrids. This category prompted the report's strongest recommendations, with calls to prohibit mixing of human and animal gametes for the purpose of procreation and the transfer of gametes between humans and animals.

“We are also concerned about overly burdensome regulation and its possible costs and drawbacks,” said Dr. Kass, a biomedical ethicist at the University of Chicago. Although the council believes it understands a great deal about today's assisted reproductive technology landscape, “it would be premature to recommend dramatic legal or institutional change” until it gathers more information.

The recommendations in the report were unanimously supported in “an otherwise very divided council,” Dr. Kass added.

Despite unanimous agreement within the council on these points, several ASRM members told this newspaper that they had some concerns about the report.

“You see time and time again how legislation may initially look fairly harmless, but by the time people have tacked more and more things onto it, can become a very serious issue with long-term consequences,” said J. Michael Putman, M.D., of the Baylor Center for Reproductive Health, Dallas.

“Everything suggested so far has been unanimously supported. These are things that you really don't argue with. But there are concerns any time you try to legislate medical and ethical issues that once you have a legislative body in place, what looked like it wasn't an issue may suddenly become one,” he said.

Dr. Putman gave the example of how the long-term acceptance of egg donation may evolve, an issue also raised by Kutluk Oktay, M.D. “We don't want legislation that targets extreme cases to be overinterpreted and expanded to limit routine procedures,” he told this newspaper.

Dr. Damewood emphasized that having a formal body oversee the general practice of infertility treatment would not be desirable or necessary. “We feel that the ASRM and other professional societies, as well as individual practitioners, are ethical people and will continue to practice in that domain without having a formal body to oversee 99% of their activity,” she said.

But government involvement in the field should not be seen as entirely negative, she added. “We also need to note the positive side in that the report calls for government-funded longitudinal studies of children born from various types of assisted reproductive technologies, which would be very good.”

PHILADELPHIA — Recommendations on assisted reproductive technologies issued by the President's Council on Bioethics in 2004 aim to prevent “renegade investigators from doing unethical procedures” and are unlikely to meet with opposition from most fertility experts, according to Marian Damewood, M.D., immediate past president of the American Society for Reproductive Medicine.

“The government regulation that has been proposed is on specific targeted legislative measures, such as preventing human/animal combinations from being born. And I don't think anyone would disagree with those measures,” Dr. Damewood said in an interview after the council's chairman, Leon Kass, M.D., discussed the recommendations during a presentation at the ASRM's annual meeting.

The council's recommendations—published as part of a report, “Reproduction and Responsibility: The Regulation of New Biotechnologies,” released in March, 2004—fall into three categories:

▸ The pursuit of longitudinal studies and data collection to monitor the health and well-being of women affected by assisted reproductive technology procedures.

▸ The strengthening of monitoring systems to track success rates and adverse events and ensure compliance with professional guidelines.

▸ A moratorium on “questionable” practices, such as the creation of human/animal hybrids. This category prompted the report's strongest recommendations, with calls to prohibit mixing of human and animal gametes for the purpose of procreation and the transfer of gametes between humans and animals.

“We are also concerned about overly burdensome regulation and its possible costs and drawbacks,” said Dr. Kass, a biomedical ethicist at the University of Chicago. Although the council believes it understands a great deal about today's assisted reproductive technology landscape, “it would be premature to recommend dramatic legal or institutional change” until it gathers more information.

The recommendations in the report were unanimously supported in “an otherwise very divided council,” Dr. Kass added.

Despite unanimous agreement within the council on these points, several ASRM members told this newspaper that they had some concerns about the report.

“You see time and time again how legislation may initially look fairly harmless, but by the time people have tacked more and more things onto it, can become a very serious issue with long-term consequences,” said J. Michael Putman, M.D., of the Baylor Center for Reproductive Health, Dallas.

“Everything suggested so far has been unanimously supported. These are things that you really don't argue with. But there are concerns any time you try to legislate medical and ethical issues that once you have a legislative body in place, what looked like it wasn't an issue may suddenly become one,” he said.

Dr. Putman gave the example of how the long-term acceptance of egg donation may evolve, an issue also raised by Kutluk Oktay, M.D. “We don't want legislation that targets extreme cases to be overinterpreted and expanded to limit routine procedures,” he told this newspaper.

Dr. Damewood emphasized that having a formal body oversee the general practice of infertility treatment would not be desirable or necessary. “We feel that the ASRM and other professional societies, as well as individual practitioners, are ethical people and will continue to practice in that domain without having a formal body to oversee 99% of their activity,” she said.

But government involvement in the field should not be seen as entirely negative, she added. “We also need to note the positive side in that the report calls for government-funded longitudinal studies of children born from various types of assisted reproductive technologies, which would be very good.”

PHILADELPHIA — Recommendations on assisted reproductive technologies issued by the President's Council on Bioethics in 2004 aim to prevent “renegade investigators from doing unethical procedures” and are unlikely to meet with opposition from most fertility experts, according to Marian Damewood, M.D., immediate past president of the American Society for Reproductive Medicine.

“The government regulation that has been proposed is on specific targeted legislative measures, such as preventing human/animal combinations from being born. And I don't think anyone would disagree with those measures,” Dr. Damewood said in an interview after the council's chairman, Leon Kass, M.D., discussed the recommendations during a presentation at the ASRM's annual meeting.

The council's recommendations—published as part of a report, “Reproduction and Responsibility: The Regulation of New Biotechnologies,” released in March, 2004—fall into three categories:

▸ The pursuit of longitudinal studies and data collection to monitor the health and well-being of women affected by assisted reproductive technology procedures.

▸ The strengthening of monitoring systems to track success rates and adverse events and ensure compliance with professional guidelines.

▸ A moratorium on “questionable” practices, such as the creation of human/animal hybrids. This category prompted the report's strongest recommendations, with calls to prohibit mixing of human and animal gametes for the purpose of procreation and the transfer of gametes between humans and animals.

“We are also concerned about overly burdensome regulation and its possible costs and drawbacks,” said Dr. Kass, a biomedical ethicist at the University of Chicago. Although the council believes it understands a great deal about today's assisted reproductive technology landscape, “it would be premature to recommend dramatic legal or institutional change” until it gathers more information.

The recommendations in the report were unanimously supported in “an otherwise very divided council,” Dr. Kass added.

Despite unanimous agreement within the council on these points, several ASRM members told this newspaper that they had some concerns about the report.

“You see time and time again how legislation may initially look fairly harmless, but by the time people have tacked more and more things onto it, can become a very serious issue with long-term consequences,” said J. Michael Putman, M.D., of the Baylor Center for Reproductive Health, Dallas.

“Everything suggested so far has been unanimously supported. These are things that you really don't argue with. But there are concerns any time you try to legislate medical and ethical issues that once you have a legislative body in place, what looked like it wasn't an issue may suddenly become one,” he said.

Dr. Putman gave the example of how the long-term acceptance of egg donation may evolve, an issue also raised by Kutluk Oktay, M.D. “We don't want legislation that targets extreme cases to be overinterpreted and expanded to limit routine procedures,” he told this newspaper.

Dr. Damewood emphasized that having a formal body oversee the general practice of infertility treatment would not be desirable or necessary. “We feel that the ASRM and other professional societies, as well as individual practitioners, are ethical people and will continue to practice in that domain without having a formal body to oversee 99% of their activity,” she said.

But government involvement in the field should not be seen as entirely negative, she added. “We also need to note the positive side in that the report calls for government-funded longitudinal studies of children born from various types of assisted reproductive technologies, which would be very good.”

Oral estrogen therapy significantly increases the risk of gallbladder disease and gallbladder-related procedures, according to a new analysis of data from the Women's Health Initiative.

The results “demonstrate for the first time in a randomized, double-blind trial, in otherwise healthy postmenopausal women, that the risk of adverse biliary tract outcomes was substantially increased” by estrogen alone or estrogen plus progestin, reported Dominic J. Cirillo of the University of Iowa, Iowa City, and his colleagues (JAMA 2005;293:330-9).

“These findings suggest that oral estrogens are causally associated with gallbladder diseases,” they reported.

According to Wulf H. Utian, M.D., executive director of the North American Menopause Society, the WHI data on gallbladder disease are not surprising. “This is exactly in line with what we've known for easily 25 years and doesn't change anything in terms of what physicians have been doing in practice,” he said in an interview. “It's a confirmation. It shows the risk is no greater than what was originally identified and may even be slightly lower … If it weren't for the fact that it is WHI data, most journals would have probably rejected the paper, saying, 'What's new?'”

In this WHI analysis, 8,376 women who had undergone hysterectomy were randomized to 0.625 mg/day of conjugated equine estrogens or placebo. Another 14,203 women without hysterectomy were randomized to estrogen plus progestin, given as CEE plus 2.5 mg/day of medroxyprogesterone acetate.

Mean follow-up was about 7.1 years in the estrogen-only arm and about 5.6 years in the combination therapy arm. The annual incidence of any gallbladder event (cholecystitis, cholelithiasis, or cholecystectomy) was 78 per 10,000 person-years for women in the estrogen-alone group, compared with 47 per 10,000 person years for those on placebo. This meant that there was an excess of 31 events per 10,000 women annually with estrogen use, for a hazard ratio of 1.67.

For women in the combination therapy arm, the incidence was 55 per 10,000 person-years for the treatment group, compared with 35 per 10,000 person-years in the placebo group. This meant there was an excess of 20 events per 10,000 women annually with estrogen use, for a hazard ratio of 1.59.

In both the estrogen-alone and the combination therapy groups, the vast majority of gallbladder procedures were cholecystectomies (hazard ratios of 1.93 in the estrogen alone group and 1.67 in the combination therapy group). Gallbladder diseases were evenly divided between cholecystitis (hazard ratios of 1.8 and 1.54, respectively) and cholelithiasis (hazard ratios of 1.86 and 1.68, respectively). The magnitude of the effect was not influenced greatly by the presence or absence of progestins, the authors reported.

The findings are “in the same direction, but of a greater magnitude” than the findings of the Heart and Estrogen/progestin Replacement Study (HERS), which showed a 38% increase in hospitalizations for gallbladder disease, they noted.

The current analysis of the WHI data “suggest that the risk continues to increase with longer exposure” to combination therapy,” the authors noted.

They added that unlike the HERS trial, women in the WHI did not have preexisting cardiovascular disease and were geographically dispersed across 40 clinical sites.

“Therefore, these results should be more generalizable to healthy postmenopausal women in the United States without previous gallbladder disease,” the researchers noted. “The increased risk for gallbladder events should be addressed in the decision-making process for women considering menopausal hormone therapy.”

The study authors note that their findings cannot necessarily be extrapolated to other types of estrogen therapy and other routes of administration.

Dr. Utian said there are some good indications in the basic literature that transdermal estrogens are safer in this regard. However, the authors note there's at least one study that found that “exogenous estrogens, given either transdermally or orally, affected physiologic markers in a pattern that favored gallstone formation” (J. Clin. Endocrinol. Metab. 1998;83:410-4). “Further study is needed to help determine if transdermal administration of estrogen therapy has the same effect on biliary tract outcomes, since the first pass effect would be lessened,” they noted.

Oral estrogen therapy significantly increases the risk of gallbladder disease and gallbladder-related procedures, according to a new analysis of data from the Women's Health Initiative.

The results “demonstrate for the first time in a randomized, double-blind trial, in otherwise healthy postmenopausal women, that the risk of adverse biliary tract outcomes was substantially increased” by estrogen alone or estrogen plus progestin, reported Dominic J. Cirillo of the University of Iowa, Iowa City, and his colleagues (JAMA 2005;293:330-9).

“These findings suggest that oral estrogens are causally associated with gallbladder diseases,” they reported.

According to Wulf H. Utian, M.D., executive director of the North American Menopause Society, the WHI data on gallbladder disease are not surprising. “This is exactly in line with what we've known for easily 25 years and doesn't change anything in terms of what physicians have been doing in practice,” he said in an interview. “It's a confirmation. It shows the risk is no greater than what was originally identified and may even be slightly lower … If it weren't for the fact that it is WHI data, most journals would have probably rejected the paper, saying, 'What's new?'”

In this WHI analysis, 8,376 women who had undergone hysterectomy were randomized to 0.625 mg/day of conjugated equine estrogens or placebo. Another 14,203 women without hysterectomy were randomized to estrogen plus progestin, given as CEE plus 2.5 mg/day of medroxyprogesterone acetate.

Mean follow-up was about 7.1 years in the estrogen-only arm and about 5.6 years in the combination therapy arm. The annual incidence of any gallbladder event (cholecystitis, cholelithiasis, or cholecystectomy) was 78 per 10,000 person-years for women in the estrogen-alone group, compared with 47 per 10,000 person years for those on placebo. This meant that there was an excess of 31 events per 10,000 women annually with estrogen use, for a hazard ratio of 1.67.

For women in the combination therapy arm, the incidence was 55 per 10,000 person-years for the treatment group, compared with 35 per 10,000 person-years in the placebo group. This meant there was an excess of 20 events per 10,000 women annually with estrogen use, for a hazard ratio of 1.59.

In both the estrogen-alone and the combination therapy groups, the vast majority of gallbladder procedures were cholecystectomies (hazard ratios of 1.93 in the estrogen alone group and 1.67 in the combination therapy group). Gallbladder diseases were evenly divided between cholecystitis (hazard ratios of 1.8 and 1.54, respectively) and cholelithiasis (hazard ratios of 1.86 and 1.68, respectively). The magnitude of the effect was not influenced greatly by the presence or absence of progestins, the authors reported.

The findings are “in the same direction, but of a greater magnitude” than the findings of the Heart and Estrogen/progestin Replacement Study (HERS), which showed a 38% increase in hospitalizations for gallbladder disease, they noted.

The current analysis of the WHI data “suggest that the risk continues to increase with longer exposure” to combination therapy,” the authors noted.

They added that unlike the HERS trial, women in the WHI did not have preexisting cardiovascular disease and were geographically dispersed across 40 clinical sites.

“Therefore, these results should be more generalizable to healthy postmenopausal women in the United States without previous gallbladder disease,” the researchers noted. “The increased risk for gallbladder events should be addressed in the decision-making process for women considering menopausal hormone therapy.”

The study authors note that their findings cannot necessarily be extrapolated to other types of estrogen therapy and other routes of administration.

Dr. Utian said there are some good indications in the basic literature that transdermal estrogens are safer in this regard. However, the authors note there's at least one study that found that “exogenous estrogens, given either transdermally or orally, affected physiologic markers in a pattern that favored gallstone formation” (J. Clin. Endocrinol. Metab. 1998;83:410-4). “Further study is needed to help determine if transdermal administration of estrogen therapy has the same effect on biliary tract outcomes, since the first pass effect would be lessened,” they noted.

Oral estrogen therapy significantly increases the risk of gallbladder disease and gallbladder-related procedures, according to a new analysis of data from the Women's Health Initiative.

The results “demonstrate for the first time in a randomized, double-blind trial, in otherwise healthy postmenopausal women, that the risk of adverse biliary tract outcomes was substantially increased” by estrogen alone or estrogen plus progestin, reported Dominic J. Cirillo of the University of Iowa, Iowa City, and his colleagues (JAMA 2005;293:330-9).

“These findings suggest that oral estrogens are causally associated with gallbladder diseases,” they reported.

According to Wulf H. Utian, M.D., executive director of the North American Menopause Society, the WHI data on gallbladder disease are not surprising. “This is exactly in line with what we've known for easily 25 years and doesn't change anything in terms of what physicians have been doing in practice,” he said in an interview. “It's a confirmation. It shows the risk is no greater than what was originally identified and may even be slightly lower … If it weren't for the fact that it is WHI data, most journals would have probably rejected the paper, saying, 'What's new?'”

In this WHI analysis, 8,376 women who had undergone hysterectomy were randomized to 0.625 mg/day of conjugated equine estrogens or placebo. Another 14,203 women without hysterectomy were randomized to estrogen plus progestin, given as CEE plus 2.5 mg/day of medroxyprogesterone acetate.

Mean follow-up was about 7.1 years in the estrogen-only arm and about 5.6 years in the combination therapy arm. The annual incidence of any gallbladder event (cholecystitis, cholelithiasis, or cholecystectomy) was 78 per 10,000 person-years for women in the estrogen-alone group, compared with 47 per 10,000 person years for those on placebo. This meant that there was an excess of 31 events per 10,000 women annually with estrogen use, for a hazard ratio of 1.67.

For women in the combination therapy arm, the incidence was 55 per 10,000 person-years for the treatment group, compared with 35 per 10,000 person-years in the placebo group. This meant there was an excess of 20 events per 10,000 women annually with estrogen use, for a hazard ratio of 1.59.

In both the estrogen-alone and the combination therapy groups, the vast majority of gallbladder procedures were cholecystectomies (hazard ratios of 1.93 in the estrogen alone group and 1.67 in the combination therapy group). Gallbladder diseases were evenly divided between cholecystitis (hazard ratios of 1.8 and 1.54, respectively) and cholelithiasis (hazard ratios of 1.86 and 1.68, respectively). The magnitude of the effect was not influenced greatly by the presence or absence of progestins, the authors reported.

The findings are “in the same direction, but of a greater magnitude” than the findings of the Heart and Estrogen/progestin Replacement Study (HERS), which showed a 38% increase in hospitalizations for gallbladder disease, they noted.

The current analysis of the WHI data “suggest that the risk continues to increase with longer exposure” to combination therapy,” the authors noted.

They added that unlike the HERS trial, women in the WHI did not have preexisting cardiovascular disease and were geographically dispersed across 40 clinical sites.

“Therefore, these results should be more generalizable to healthy postmenopausal women in the United States without previous gallbladder disease,” the researchers noted. “The increased risk for gallbladder events should be addressed in the decision-making process for women considering menopausal hormone therapy.”

The study authors note that their findings cannot necessarily be extrapolated to other types of estrogen therapy and other routes of administration.

Dr. Utian said there are some good indications in the basic literature that transdermal estrogens are safer in this regard. However, the authors note there's at least one study that found that “exogenous estrogens, given either transdermally or orally, affected physiologic markers in a pattern that favored gallstone formation” (J. Clin. Endocrinol. Metab. 1998;83:410-4). “Further study is needed to help determine if transdermal administration of estrogen therapy has the same effect on biliary tract outcomes, since the first pass effect would be lessened,” they noted.

MONT TREMBLANT, QUE. — Photodynamic therapy for port wine stains could improve the low success rates of traditional pulsed dye laser therapy, because it overcomes the barrier of thermal confinement, according to J. Stuart Nelson, M.D., who spoke at a symposium on cutaneous laser surgery sponsored by SkinCare Physicians of Chestnut Hill.

"The problem we have with current treatment is that port wine stains are made up of blood vessels of very different sizes—but based on the pulse duration and the wavelength of the laser treatment you choose, you only get thermal confinement of certain blood vessels," said Dr. Nelson of the Beckman Laser Institute at the University of California, Irvine.

"If you inject photosensitizers intravenously into the port wine stain's blood vessels and then you irradiate with the wavelength that is absorbed by the photosensitizer, you get destruction of the endothelial cells, wherever the photosensitizer is," he said in an interview.

His group has internal review board approval to use this approach under an experimental protocol that excludes children, facial lesions, and lesions larger than 2 cm.

"It boils down to us working out the appropriate drug and light dissymmetry parameters for human skin. We are currently using a benzoporphyrin derivative called verteporfin with great success. This is a drug used for macular degeneration, which is confined to the vascular compartment, where we want it, and has also had extensive clinical use—so there are no issues there," he said.

But Dr. Nelson stressed that the key to safety with this approach is real-time in situ vascular monitoring using a technique called optical Doppler flow tomography.

"What happens in PDT is that you get a slowing down of the blood flow as the endothelial cells are injured. And so what we wanted to be able to do is to monitor that change in blood flow. You can't just arbitrarily irradiate; otherwise, you are going to get into problems. The good thing about PDT is that is destroys all the blood vessels, but that is the dangerous thing about it too," he said.

MONT TREMBLANT, QUE. — Photodynamic therapy for port wine stains could improve the low success rates of traditional pulsed dye laser therapy, because it overcomes the barrier of thermal confinement, according to J. Stuart Nelson, M.D., who spoke at a symposium on cutaneous laser surgery sponsored by SkinCare Physicians of Chestnut Hill.

"The problem we have with current treatment is that port wine stains are made up of blood vessels of very different sizes—but based on the pulse duration and the wavelength of the laser treatment you choose, you only get thermal confinement of certain blood vessels," said Dr. Nelson of the Beckman Laser Institute at the University of California, Irvine.

"If you inject photosensitizers intravenously into the port wine stain's blood vessels and then you irradiate with the wavelength that is absorbed by the photosensitizer, you get destruction of the endothelial cells, wherever the photosensitizer is," he said in an interview.

His group has internal review board approval to use this approach under an experimental protocol that excludes children, facial lesions, and lesions larger than 2 cm.

"It boils down to us working out the appropriate drug and light dissymmetry parameters for human skin. We are currently using a benzoporphyrin derivative called verteporfin with great success. This is a drug used for macular degeneration, which is confined to the vascular compartment, where we want it, and has also had extensive clinical use—so there are no issues there," he said.

But Dr. Nelson stressed that the key to safety with this approach is real-time in situ vascular monitoring using a technique called optical Doppler flow tomography.

"What happens in PDT is that you get a slowing down of the blood flow as the endothelial cells are injured. And so what we wanted to be able to do is to monitor that change in blood flow. You can't just arbitrarily irradiate; otherwise, you are going to get into problems. The good thing about PDT is that is destroys all the blood vessels, but that is the dangerous thing about it too," he said.

MONT TREMBLANT, QUE. — Photodynamic therapy for port wine stains could improve the low success rates of traditional pulsed dye laser therapy, because it overcomes the barrier of thermal confinement, according to J. Stuart Nelson, M.D., who spoke at a symposium on cutaneous laser surgery sponsored by SkinCare Physicians of Chestnut Hill.

"The problem we have with current treatment is that port wine stains are made up of blood vessels of very different sizes—but based on the pulse duration and the wavelength of the laser treatment you choose, you only get thermal confinement of certain blood vessels," said Dr. Nelson of the Beckman Laser Institute at the University of California, Irvine.

"If you inject photosensitizers intravenously into the port wine stain's blood vessels and then you irradiate with the wavelength that is absorbed by the photosensitizer, you get destruction of the endothelial cells, wherever the photosensitizer is," he said in an interview.

His group has internal review board approval to use this approach under an experimental protocol that excludes children, facial lesions, and lesions larger than 2 cm.

"It boils down to us working out the appropriate drug and light dissymmetry parameters for human skin. We are currently using a benzoporphyrin derivative called verteporfin with great success. This is a drug used for macular degeneration, which is confined to the vascular compartment, where we want it, and has also had extensive clinical use—so there are no issues there," he said.

But Dr. Nelson stressed that the key to safety with this approach is real-time in situ vascular monitoring using a technique called optical Doppler flow tomography.

"What happens in PDT is that you get a slowing down of the blood flow as the endothelial cells are injured. And so what we wanted to be able to do is to monitor that change in blood flow. You can't just arbitrarily irradiate; otherwise, you are going to get into problems. The good thing about PDT is that is destroys all the blood vessels, but that is the dangerous thing about it too," he said.

PHILADELPHIA — Discontinuation of hormonal contraceptives should be the first-line approach in addressing sexual dysfunction in women using these agents. Susan Sarajari, M.D., outlined her study of 20 women who experienced improved sexual function after discontinuing hormonal contraception.

“This is the first trial that correlates serum androgen changes with specific domains of sexual function,” she said at the annual meeting of the American Society for Reproductive Medicine.

About 15% of hormonal contraceptive users report sexual dysfunction in the form of low libido, vaginal dryness, impaired orgasm, and decreased arousal. “This may be the result of changes in serum androgens,” said Dr. Sarajari, a fellow in reproductive endocrinology and infertility at the University of California, Los Angeles, Medical Center.

Her study measured baseline total testosterone, free testosterone, and sex hormone-binding globulin (SHBG) in premenopausal women (mean age 34) who had been using hormonal contraceptives for at least 6 months. Most women had been taking oral contraceptives, but one had been using a contraceptive patch and one had been using a contraceptive vaginal ring.

The serum levels were assessed again 4 months after the women discontinued using contraception. Patients also completed questionnaires at baseline and at the end of the study, which assessed sexual function, related distress, and sexual desire and energy.

Mean total and free testosterone levels increased, while SHBG rose significantly after contraceptive discontinuation. These changes coincided with an increase in sexual energy, decrease in sexual distress, and an improvement in global sexual function scores.

“There was significant improvement in arousal, lubrication, orgasm, and satisfaction,” she said, noting that the “antiandrogenic” profiles of hormonal contraceptives that are promoted by drug companies are not entirely beneficial.

But she says the fact that sexual dysfunction can be reversed with discontinuation of hormonal contraceptives is encouraging.

“We don't recommend testosterone supplementation ad lib, or at all, until the cause of someone's sexual dysfunction is investigated, Dr. Sarajari said.

PHILADELPHIA — Discontinuation of hormonal contraceptives should be the first-line approach in addressing sexual dysfunction in women using these agents. Susan Sarajari, M.D., outlined her study of 20 women who experienced improved sexual function after discontinuing hormonal contraception.

“This is the first trial that correlates serum androgen changes with specific domains of sexual function,” she said at the annual meeting of the American Society for Reproductive Medicine.

About 15% of hormonal contraceptive users report sexual dysfunction in the form of low libido, vaginal dryness, impaired orgasm, and decreased arousal. “This may be the result of changes in serum androgens,” said Dr. Sarajari, a fellow in reproductive endocrinology and infertility at the University of California, Los Angeles, Medical Center.

Her study measured baseline total testosterone, free testosterone, and sex hormone-binding globulin (SHBG) in premenopausal women (mean age 34) who had been using hormonal contraceptives for at least 6 months. Most women had been taking oral contraceptives, but one had been using a contraceptive patch and one had been using a contraceptive vaginal ring.

The serum levels were assessed again 4 months after the women discontinued using contraception. Patients also completed questionnaires at baseline and at the end of the study, which assessed sexual function, related distress, and sexual desire and energy.

Mean total and free testosterone levels increased, while SHBG rose significantly after contraceptive discontinuation. These changes coincided with an increase in sexual energy, decrease in sexual distress, and an improvement in global sexual function scores.

“There was significant improvement in arousal, lubrication, orgasm, and satisfaction,” she said, noting that the “antiandrogenic” profiles of hormonal contraceptives that are promoted by drug companies are not entirely beneficial.

But she says the fact that sexual dysfunction can be reversed with discontinuation of hormonal contraceptives is encouraging.

“We don't recommend testosterone supplementation ad lib, or at all, until the cause of someone's sexual dysfunction is investigated, Dr. Sarajari said.

PHILADELPHIA — Discontinuation of hormonal contraceptives should be the first-line approach in addressing sexual dysfunction in women using these agents. Susan Sarajari, M.D., outlined her study of 20 women who experienced improved sexual function after discontinuing hormonal contraception.

“This is the first trial that correlates serum androgen changes with specific domains of sexual function,” she said at the annual meeting of the American Society for Reproductive Medicine.

About 15% of hormonal contraceptive users report sexual dysfunction in the form of low libido, vaginal dryness, impaired orgasm, and decreased arousal. “This may be the result of changes in serum androgens,” said Dr. Sarajari, a fellow in reproductive endocrinology and infertility at the University of California, Los Angeles, Medical Center.

Her study measured baseline total testosterone, free testosterone, and sex hormone-binding globulin (SHBG) in premenopausal women (mean age 34) who had been using hormonal contraceptives for at least 6 months. Most women had been taking oral contraceptives, but one had been using a contraceptive patch and one had been using a contraceptive vaginal ring.

The serum levels were assessed again 4 months after the women discontinued using contraception. Patients also completed questionnaires at baseline and at the end of the study, which assessed sexual function, related distress, and sexual desire and energy.

Mean total and free testosterone levels increased, while SHBG rose significantly after contraceptive discontinuation. These changes coincided with an increase in sexual energy, decrease in sexual distress, and an improvement in global sexual function scores.

“There was significant improvement in arousal, lubrication, orgasm, and satisfaction,” she said, noting that the “antiandrogenic” profiles of hormonal contraceptives that are promoted by drug companies are not entirely beneficial.

But she says the fact that sexual dysfunction can be reversed with discontinuation of hormonal contraceptives is encouraging.

“We don't recommend testosterone supplementation ad lib, or at all, until the cause of someone's sexual dysfunction is investigated, Dr. Sarajari said.

CHICAGO — Women who are obese when they are diagnosed with early stage breast cancer have poorer outcomes than do women of normal weight—yet another reason for physicians to encourage weight control in their patients, according to Penny R. Anderson, M.D., a radiation oncologist at Fox Chase Cancer Center in Philadelphia.

“Obesity at the time of diagnosis significantly predicts poorer outcomes,” she reported at the annual meeting of the Radiological Society of North America. “We found an increased risk of breast cancer death and distant metastases in obese women, compared with normal-weight patients, although they did not present with more advanced-stage disease.”

The study included more than 2,000 women with stage I/II breast cancer who underwent lumpectomy, axillary dissection, and radiation therapy with or without systemic therapy.

The median age of the women was 58 years, with 22% considered normal weight, 43% considered overweight, and 35% considered obese.

The study, which had a median follow-up of 61 months, compared women in the three weight categories to determine independent predictors of local failure, distant metastases, cause-specific survival, and overall survival.

It found that the actuarial 5-year rates of distant metastases, cause-specific survival, and overall survival were the worst in obese women. (See table.)

There were some statistically significant baseline differences between the weight groups, with the obese group comprising more women who were older and postmenopausal. However, there were no statistically significant differences between the groups in terms of tumor size or number of involved lymph nodes, she said. In addition, the local failure rate was no worse in the obese women.

“Interventions to enhance weight control can have a beneficial effect on breast cancer outcome,” she concluded.

CHICAGO — Women who are obese when they are diagnosed with early stage breast cancer have poorer outcomes than do women of normal weight—yet another reason for physicians to encourage weight control in their patients, according to Penny R. Anderson, M.D., a radiation oncologist at Fox Chase Cancer Center in Philadelphia.

“Obesity at the time of diagnosis significantly predicts poorer outcomes,” she reported at the annual meeting of the Radiological Society of North America. “We found an increased risk of breast cancer death and distant metastases in obese women, compared with normal-weight patients, although they did not present with more advanced-stage disease.”

The study included more than 2,000 women with stage I/II breast cancer who underwent lumpectomy, axillary dissection, and radiation therapy with or without systemic therapy.

The median age of the women was 58 years, with 22% considered normal weight, 43% considered overweight, and 35% considered obese.

The study, which had a median follow-up of 61 months, compared women in the three weight categories to determine independent predictors of local failure, distant metastases, cause-specific survival, and overall survival.

It found that the actuarial 5-year rates of distant metastases, cause-specific survival, and overall survival were the worst in obese women. (See table.)

There were some statistically significant baseline differences between the weight groups, with the obese group comprising more women who were older and postmenopausal. However, there were no statistically significant differences between the groups in terms of tumor size or number of involved lymph nodes, she said. In addition, the local failure rate was no worse in the obese women.

“Interventions to enhance weight control can have a beneficial effect on breast cancer outcome,” she concluded.

CHICAGO — Women who are obese when they are diagnosed with early stage breast cancer have poorer outcomes than do women of normal weight—yet another reason for physicians to encourage weight control in their patients, according to Penny R. Anderson, M.D., a radiation oncologist at Fox Chase Cancer Center in Philadelphia.

“Obesity at the time of diagnosis significantly predicts poorer outcomes,” she reported at the annual meeting of the Radiological Society of North America. “We found an increased risk of breast cancer death and distant metastases in obese women, compared with normal-weight patients, although they did not present with more advanced-stage disease.”

The study included more than 2,000 women with stage I/II breast cancer who underwent lumpectomy, axillary dissection, and radiation therapy with or without systemic therapy.

The median age of the women was 58 years, with 22% considered normal weight, 43% considered overweight, and 35% considered obese.

The study, which had a median follow-up of 61 months, compared women in the three weight categories to determine independent predictors of local failure, distant metastases, cause-specific survival, and overall survival.

It found that the actuarial 5-year rates of distant metastases, cause-specific survival, and overall survival were the worst in obese women. (See table.)

There were some statistically significant baseline differences between the weight groups, with the obese group comprising more women who were older and postmenopausal. However, there were no statistically significant differences between the groups in terms of tumor size or number of involved lymph nodes, she said. In addition, the local failure rate was no worse in the obese women.

“Interventions to enhance weight control can have a beneficial effect on breast cancer outcome,” she concluded.

QUEBEC CITY — One-third of menopausal women with diabetes do not receive annual screening mammography, according to results of a large study.

“Even though they had more frequent visits to physicians, compared with healthy women, women with diabetes have a 32% lower likelihood of getting mammograms,” said Lorraine Lipscombe, M.D., a research fellow at the Institute for Clinical Evaluative Sciences, Toronto.

The retrospective study included approximately 69,000 women with diabetes, aged between 50 and 69 years, and compared them with about 663,000 controls of the same age, she reported at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

The women's medical records were taken from a provincial database as well as the Ontario Diabetes Database and tracked for 2 years, starting from their first physician visit to determine whether they had a screening mammogram, said Dr. Lipscombe, also of Sunnybrook and Women's College Health Sciences Centre, Toronto.

Compared with healthy women, those with diabetes had more physician visits per year (nine versus seven) and were more likely to see a specialist (29% versus 11%). However, significantly fewer diabetic women had at least one screening mammogram during the study period (38% vs. 47%, odds ratio 0.68).

This finding is of particular concern in light of evidence that suggests there may be an increased risk of breast cancer in women with diabetes, Dr. Lipscombe told this newspaper.

The mechanism for this increased risk may be a higher rate of obesity in this population, which can predispose women to breast cancer. It may also be related to insulin exposure, she said.

“Not just treatment with insulin, but possibly also the fact that there is a state of insulin resistance for many years before the onset of diabetes. This means that the body makes more insulin than normal, and because insulin is a growth factor it can increase the risk of breast cancer,” she said.

The study results suggest that primary preventive care may be suboptimal in diabetes patients, and physicians should consider ways to ensure that patients get regular mammography reminders, according to Dr. Lipscombe.

QUEBEC CITY — One-third of menopausal women with diabetes do not receive annual screening mammography, according to results of a large study.

“Even though they had more frequent visits to physicians, compared with healthy women, women with diabetes have a 32% lower likelihood of getting mammograms,” said Lorraine Lipscombe, M.D., a research fellow at the Institute for Clinical Evaluative Sciences, Toronto.

The retrospective study included approximately 69,000 women with diabetes, aged between 50 and 69 years, and compared them with about 663,000 controls of the same age, she reported at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

The women's medical records were taken from a provincial database as well as the Ontario Diabetes Database and tracked for 2 years, starting from their first physician visit to determine whether they had a screening mammogram, said Dr. Lipscombe, also of Sunnybrook and Women's College Health Sciences Centre, Toronto.

Compared with healthy women, those with diabetes had more physician visits per year (nine versus seven) and were more likely to see a specialist (29% versus 11%). However, significantly fewer diabetic women had at least one screening mammogram during the study period (38% vs. 47%, odds ratio 0.68).

This finding is of particular concern in light of evidence that suggests there may be an increased risk of breast cancer in women with diabetes, Dr. Lipscombe told this newspaper.

The mechanism for this increased risk may be a higher rate of obesity in this population, which can predispose women to breast cancer. It may also be related to insulin exposure, she said.

“Not just treatment with insulin, but possibly also the fact that there is a state of insulin resistance for many years before the onset of diabetes. This means that the body makes more insulin than normal, and because insulin is a growth factor it can increase the risk of breast cancer,” she said.

The study results suggest that primary preventive care may be suboptimal in diabetes patients, and physicians should consider ways to ensure that patients get regular mammography reminders, according to Dr. Lipscombe.

QUEBEC CITY — One-third of menopausal women with diabetes do not receive annual screening mammography, according to results of a large study.

“Even though they had more frequent visits to physicians, compared with healthy women, women with diabetes have a 32% lower likelihood of getting mammograms,” said Lorraine Lipscombe, M.D., a research fellow at the Institute for Clinical Evaluative Sciences, Toronto.

The retrospective study included approximately 69,000 women with diabetes, aged between 50 and 69 years, and compared them with about 663,000 controls of the same age, she reported at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

The women's medical records were taken from a provincial database as well as the Ontario Diabetes Database and tracked for 2 years, starting from their first physician visit to determine whether they had a screening mammogram, said Dr. Lipscombe, also of Sunnybrook and Women's College Health Sciences Centre, Toronto.

Compared with healthy women, those with diabetes had more physician visits per year (nine versus seven) and were more likely to see a specialist (29% versus 11%). However, significantly fewer diabetic women had at least one screening mammogram during the study period (38% vs. 47%, odds ratio 0.68).

This finding is of particular concern in light of evidence that suggests there may be an increased risk of breast cancer in women with diabetes, Dr. Lipscombe told this newspaper.

The mechanism for this increased risk may be a higher rate of obesity in this population, which can predispose women to breast cancer. It may also be related to insulin exposure, she said.

“Not just treatment with insulin, but possibly also the fact that there is a state of insulin resistance for many years before the onset of diabetes. This means that the body makes more insulin than normal, and because insulin is a growth factor it can increase the risk of breast cancer,” she said.

The study results suggest that primary preventive care may be suboptimal in diabetes patients, and physicians should consider ways to ensure that patients get regular mammography reminders, according to Dr. Lipscombe.

CHICAGO — Autologous stem cells injected into the female urethra and urethral sphincter can stop urinary leakage for up to 2 years, according to new research.

The novel, minimally invasive approach, essentially “reconstructs” the lower urinary tract, said Ferdinand Frauscher, M.D., head of uroradiology at Innsbruck (Austria) University Hospital.

“We believe we have developed a long-lasting and effective treatment that is especially promising, because it is generated from the patient's own body,” he said at the annual meeting of the Radiological Society of North America.

Dr. Frauscher's team treated a cohort of 20 women, aged 36–84 years, who had minor to severe stress urinary incontinence. At 1 year post procedure, 18 (90%) remained continent, with 1 patient maintaining continence for a little more than 2 years, he said.

The technique involves obtaining muscle and connective tissue stem cells from a biopsy of the patient's arm and then culturing them for 6 weeks to yield roughly 50 million myoblasts and 50 million fibroblasts.

In a 15- to 20-minute outpatient procedure, the patient is given local or general anesthesia, and the myoblasts are injected directly into the urethral sphincter. The fibroblasts are first mixed with collagen and then injected into the urethral submucosa.

“We used transurethral three-dimensional ultrasound guidance for the procedure,” said Dr. Frauscher. “With real-time ultrasound, we were able to see exactly where [to place] the new cells.”

Many of the patients regained continence within 24 hours of the procedure.

“During the first days after the procedure, there is a bulking effect from the injection of the fibroblasts, which stay in place because they are mixed with collagen. But after that, the myoblast cells reproduce quickly to form new muscle tissue,” said Dr. Frauscher, also of the department of radiology at the Medical University of Innsbruck.

Endoluminal ultrasound showed a doubling of urethral and sphincter muscle thickness within 1 month of the procedure, while contractility of the sphincter muscle also increased, he said.

Of the two patients who did not regain continence, one improved. The other patient, aged 84, experienced no change.

In elderly women, cell reproduction may be less efficient, and it may be necessary to culture as many as 70 million cells, rather than 50 million, for transplant Dr. Frauscher said.

CHICAGO — Autologous stem cells injected into the female urethra and urethral sphincter can stop urinary leakage for up to 2 years, according to new research.

The novel, minimally invasive approach, essentially “reconstructs” the lower urinary tract, said Ferdinand Frauscher, M.D., head of uroradiology at Innsbruck (Austria) University Hospital.

“We believe we have developed a long-lasting and effective treatment that is especially promising, because it is generated from the patient's own body,” he said at the annual meeting of the Radiological Society of North America.

Dr. Frauscher's team treated a cohort of 20 women, aged 36–84 years, who had minor to severe stress urinary incontinence. At 1 year post procedure, 18 (90%) remained continent, with 1 patient maintaining continence for a little more than 2 years, he said.

The technique involves obtaining muscle and connective tissue stem cells from a biopsy of the patient's arm and then culturing them for 6 weeks to yield roughly 50 million myoblasts and 50 million fibroblasts.

In a 15- to 20-minute outpatient procedure, the patient is given local or general anesthesia, and the myoblasts are injected directly into the urethral sphincter. The fibroblasts are first mixed with collagen and then injected into the urethral submucosa.

“We used transurethral three-dimensional ultrasound guidance for the procedure,” said Dr. Frauscher. “With real-time ultrasound, we were able to see exactly where [to place] the new cells.”

Many of the patients regained continence within 24 hours of the procedure.

“During the first days after the procedure, there is a bulking effect from the injection of the fibroblasts, which stay in place because they are mixed with collagen. But after that, the myoblast cells reproduce quickly to form new muscle tissue,” said Dr. Frauscher, also of the department of radiology at the Medical University of Innsbruck.

Endoluminal ultrasound showed a doubling of urethral and sphincter muscle thickness within 1 month of the procedure, while contractility of the sphincter muscle also increased, he said.

Of the two patients who did not regain continence, one improved. The other patient, aged 84, experienced no change.

In elderly women, cell reproduction may be less efficient, and it may be necessary to culture as many as 70 million cells, rather than 50 million, for transplant Dr. Frauscher said.

CHICAGO — Autologous stem cells injected into the female urethra and urethral sphincter can stop urinary leakage for up to 2 years, according to new research.

The novel, minimally invasive approach, essentially “reconstructs” the lower urinary tract, said Ferdinand Frauscher, M.D., head of uroradiology at Innsbruck (Austria) University Hospital.

“We believe we have developed a long-lasting and effective treatment that is especially promising, because it is generated from the patient's own body,” he said at the annual meeting of the Radiological Society of North America.

Dr. Frauscher's team treated a cohort of 20 women, aged 36–84 years, who had minor to severe stress urinary incontinence. At 1 year post procedure, 18 (90%) remained continent, with 1 patient maintaining continence for a little more than 2 years, he said.

The technique involves obtaining muscle and connective tissue stem cells from a biopsy of the patient's arm and then culturing them for 6 weeks to yield roughly 50 million myoblasts and 50 million fibroblasts.

In a 15- to 20-minute outpatient procedure, the patient is given local or general anesthesia, and the myoblasts are injected directly into the urethral sphincter. The fibroblasts are first mixed with collagen and then injected into the urethral submucosa.

“We used transurethral three-dimensional ultrasound guidance for the procedure,” said Dr. Frauscher. “With real-time ultrasound, we were able to see exactly where [to place] the new cells.”

Many of the patients regained continence within 24 hours of the procedure.

“During the first days after the procedure, there is a bulking effect from the injection of the fibroblasts, which stay in place because they are mixed with collagen. But after that, the myoblast cells reproduce quickly to form new muscle tissue,” said Dr. Frauscher, also of the department of radiology at the Medical University of Innsbruck.

Endoluminal ultrasound showed a doubling of urethral and sphincter muscle thickness within 1 month of the procedure, while contractility of the sphincter muscle also increased, he said.

Of the two patients who did not regain continence, one improved. The other patient, aged 84, experienced no change.

In elderly women, cell reproduction may be less efficient, and it may be necessary to culture as many as 70 million cells, rather than 50 million, for transplant Dr. Frauscher said.

Adolescents with chronic fatigue syndrome show significant improvement with cognitive-behavioral therapy, according to the first randomized controlled trial involving this age group.

“These results endorse the findings of previous studies on the efficacy of CBT for adults with chronic fatigue syndrome,” reported Maja Stulemeijer and colleagues at University Medical Centre Nijmegen (the Netherlands).

Only one uncontrolled study in adolescents suggests that cognitive-behavioral therapy can reduce chronic fatigue, according to the researchers (BMJ 2005; 330:14).

“We believe that our results can be generalized to other adolescents who fulfill the diagnostic criteria for chronic fatigue syndrome,” they noted.

The study followed 69 patients, aged 10–17 years, who met U.S. Centers for Disease Control and Prevention criteria for chronic fatigue syndrome.

Patients were randomized to either immediate therapy, or to remain on a waiting list for therapy. The intervention involved 10 individual sessions over 5 months, and therapy patients underwent one of two treatment protocols depending on whether they were considered active or passive patients.

Active patients were described as alternating between periods of activity and periods of rest; passive patients were described as spending most of their time lying down and as going out infrequently.

For active patients, treatment started with teaching them to recognize and accept their fatigue and reduce their activity level accordingly. This was followed by a gradual increase in activity.

Passive patients started immediately with a systematic program of activity building. “In such patients it is thought to be counterproductive to reduce activity levels any further or to reinforce the patient's need to respect limitations,” according to the investigators.

Measures of fatigue and functional impairment decreased more significantly in the therapy group, compared with the untreated group. School attendance improved significantly more in the therapy group, with 58% of these patients returning to school full time, compared with 29% of patients on the waiting list for therapy.

Participants in the therapy group also reported significantly less muscle pain, headache, unrefreshing sleep, and impaired concentration. They were also less likely to feel ill after exercise, compared with patients on the waiting list.

There were no significant differences in outcomes between patients in the active or passive treatment protocols. However, the authors noted that patients in all arms of the study continued to report symptoms.

Adolescents with chronic fatigue syndrome show significant improvement with cognitive-behavioral therapy, according to the first randomized controlled trial involving this age group.

“These results endorse the findings of previous studies on the efficacy of CBT for adults with chronic fatigue syndrome,” reported Maja Stulemeijer and colleagues at University Medical Centre Nijmegen (the Netherlands).

Only one uncontrolled study in adolescents suggests that cognitive-behavioral therapy can reduce chronic fatigue, according to the researchers (BMJ 2005; 330:14).

“We believe that our results can be generalized to other adolescents who fulfill the diagnostic criteria for chronic fatigue syndrome,” they noted.

The study followed 69 patients, aged 10–17 years, who met U.S. Centers for Disease Control and Prevention criteria for chronic fatigue syndrome.

Patients were randomized to either immediate therapy, or to remain on a waiting list for therapy. The intervention involved 10 individual sessions over 5 months, and therapy patients underwent one of two treatment protocols depending on whether they were considered active or passive patients.

Active patients were described as alternating between periods of activity and periods of rest; passive patients were described as spending most of their time lying down and as going out infrequently.

For active patients, treatment started with teaching them to recognize and accept their fatigue and reduce their activity level accordingly. This was followed by a gradual increase in activity.

Passive patients started immediately with a systematic program of activity building. “In such patients it is thought to be counterproductive to reduce activity levels any further or to reinforce the patient's need to respect limitations,” according to the investigators.

Measures of fatigue and functional impairment decreased more significantly in the therapy group, compared with the untreated group. School attendance improved significantly more in the therapy group, with 58% of these patients returning to school full time, compared with 29% of patients on the waiting list for therapy.

Participants in the therapy group also reported significantly less muscle pain, headache, unrefreshing sleep, and impaired concentration. They were also less likely to feel ill after exercise, compared with patients on the waiting list.

There were no significant differences in outcomes between patients in the active or passive treatment protocols. However, the authors noted that patients in all arms of the study continued to report symptoms.

Adolescents with chronic fatigue syndrome show significant improvement with cognitive-behavioral therapy, according to the first randomized controlled trial involving this age group.

“These results endorse the findings of previous studies on the efficacy of CBT for adults with chronic fatigue syndrome,” reported Maja Stulemeijer and colleagues at University Medical Centre Nijmegen (the Netherlands).

Only one uncontrolled study in adolescents suggests that cognitive-behavioral therapy can reduce chronic fatigue, according to the researchers (BMJ 2005; 330:14).

“We believe that our results can be generalized to other adolescents who fulfill the diagnostic criteria for chronic fatigue syndrome,” they noted.

The study followed 69 patients, aged 10–17 years, who met U.S. Centers for Disease Control and Prevention criteria for chronic fatigue syndrome.

Patients were randomized to either immediate therapy, or to remain on a waiting list for therapy. The intervention involved 10 individual sessions over 5 months, and therapy patients underwent one of two treatment protocols depending on whether they were considered active or passive patients.

Active patients were described as alternating between periods of activity and periods of rest; passive patients were described as spending most of their time lying down and as going out infrequently.

For active patients, treatment started with teaching them to recognize and accept their fatigue and reduce their activity level accordingly. This was followed by a gradual increase in activity.

Passive patients started immediately with a systematic program of activity building. “In such patients it is thought to be counterproductive to reduce activity levels any further or to reinforce the patient's need to respect limitations,” according to the investigators.

Measures of fatigue and functional impairment decreased more significantly in the therapy group, compared with the untreated group. School attendance improved significantly more in the therapy group, with 58% of these patients returning to school full time, compared with 29% of patients on the waiting list for therapy.

Participants in the therapy group also reported significantly less muscle pain, headache, unrefreshing sleep, and impaired concentration. They were also less likely to feel ill after exercise, compared with patients on the waiting list.

There were no significant differences in outcomes between patients in the active or passive treatment protocols. However, the authors noted that patients in all arms of the study continued to report symptoms.

CHICAGO — Magnetic resonance imaging detects more breast cancers than mammography in high-risk women, according to the first international study comparing the two screening methods.

“Our results support the benefit of MRI screening, not as a replacement, but as a complement to mammography in high-risk women,” said Constance D. Lehman, M.D., lead investigator of the International Breast Magnetic Resonance Consortium Trial. She presented the findings at the annual meeting of the Radiological Society of North America.

The study included 367 women aged 25 and older, with a mean age of 45, from 13 sites. The women who participated were considered to be at high risk for breast cancer, with at least a 25% lifetime risk.

The participants underwent a clinical breast exam, mammography, and MRI, within a 90-day period.

In 90% of the study population, the mammogram and MRI findings agreed.

A total of 329 women had negative findings on both tests, and 1 woman had positive findings on both tests, resulting in a biopsy and detection of a cancer, Dr. Lehman said.

However, 8% (30 women) had negative mammograms but positive findings on MRI. Of these women, 23 had biopsies, and 3 cancers were detected.

In addition, 2% (seven women) had positive mammograms but negative MRI findings. Of these, three had biopsies, and no cancers were detected.

A total of four cancers were detected in the study cohort—three infiltrating ductal carcinomas and one ductal carcinoma in situ—for a rate of 1.1% and a benign biopsy rate of 5%.

Although MRI alone had a diagnostic yield of 1.1%, meaning it could detect 11 cancers in 1,000 high-risk women, the diagnostic yield of mammography alone was 0.3%, meaning it could detect only 3 cancers in this same group.

Although three of the four cancers were in women who had negative mammograms but positive MRIs, this does not weaken the value of mammograms, Dr. Lehman said.

“We're trying to encourage physicians not to trust a negative mammogram and thus rule out the need for a biopsy in this population,” she said at a press briefing.

“But we are also not at the point where a negative MRI can overrule a positive mammogram.

“If we see calcification on a mammogram, there is a significant risk of cancer even when the MRI is negative,” said Dr. Lehman, director of breast imaging at the University of Washington, Seattle.

“It is the radiologist's role to recommend or rule out a biopsy. We are trying to encourage communication with radiologists to this effect,” Dr. Lehman commented.

There is no evidence that the benefits of combining MRI and mammography apply to the general population, in whom mammography performs well, she said.

But mammography is not optimal in younger women, who tend to have dense breast tissue—and high-risk women need to begin regular screening when they are young.

CHICAGO — Magnetic resonance imaging detects more breast cancers than mammography in high-risk women, according to the first international study comparing the two screening methods.

“Our results support the benefit of MRI screening, not as a replacement, but as a complement to mammography in high-risk women,” said Constance D. Lehman, M.D., lead investigator of the International Breast Magnetic Resonance Consortium Trial. She presented the findings at the annual meeting of the Radiological Society of North America.

The study included 367 women aged 25 and older, with a mean age of 45, from 13 sites. The women who participated were considered to be at high risk for breast cancer, with at least a 25% lifetime risk.

The participants underwent a clinical breast exam, mammography, and MRI, within a 90-day period.

In 90% of the study population, the mammogram and MRI findings agreed.

A total of 329 women had negative findings on both tests, and 1 woman had positive findings on both tests, resulting in a biopsy and detection of a cancer, Dr. Lehman said.

However, 8% (30 women) had negative mammograms but positive findings on MRI. Of these women, 23 had biopsies, and 3 cancers were detected.

In addition, 2% (seven women) had positive mammograms but negative MRI findings. Of these, three had biopsies, and no cancers were detected.

A total of four cancers were detected in the study cohort—three infiltrating ductal carcinomas and one ductal carcinoma in situ—for a rate of 1.1% and a benign biopsy rate of 5%.

Although MRI alone had a diagnostic yield of 1.1%, meaning it could detect 11 cancers in 1,000 high-risk women, the diagnostic yield of mammography alone was 0.3%, meaning it could detect only 3 cancers in this same group.

Although three of the four cancers were in women who had negative mammograms but positive MRIs, this does not weaken the value of mammograms, Dr. Lehman said.

“We're trying to encourage physicians not to trust a negative mammogram and thus rule out the need for a biopsy in this population,” she said at a press briefing.

“But we are also not at the point where a negative MRI can overrule a positive mammogram.

“If we see calcification on a mammogram, there is a significant risk of cancer even when the MRI is negative,” said Dr. Lehman, director of breast imaging at the University of Washington, Seattle.

“It is the radiologist's role to recommend or rule out a biopsy. We are trying to encourage communication with radiologists to this effect,” Dr. Lehman commented.

There is no evidence that the benefits of combining MRI and mammography apply to the general population, in whom mammography performs well, she said.

But mammography is not optimal in younger women, who tend to have dense breast tissue—and high-risk women need to begin regular screening when they are young.

CHICAGO — Magnetic resonance imaging detects more breast cancers than mammography in high-risk women, according to the first international study comparing the two screening methods.

“Our results support the benefit of MRI screening, not as a replacement, but as a complement to mammography in high-risk women,” said Constance D. Lehman, M.D., lead investigator of the International Breast Magnetic Resonance Consortium Trial. She presented the findings at the annual meeting of the Radiological Society of North America.

The study included 367 women aged 25 and older, with a mean age of 45, from 13 sites. The women who participated were considered to be at high risk for breast cancer, with at least a 25% lifetime risk.

The participants underwent a clinical breast exam, mammography, and MRI, within a 90-day period.

In 90% of the study population, the mammogram and MRI findings agreed.

A total of 329 women had negative findings on both tests, and 1 woman had positive findings on both tests, resulting in a biopsy and detection of a cancer, Dr. Lehman said.

However, 8% (30 women) had negative mammograms but positive findings on MRI. Of these women, 23 had biopsies, and 3 cancers were detected.

In addition, 2% (seven women) had positive mammograms but negative MRI findings. Of these, three had biopsies, and no cancers were detected.

A total of four cancers were detected in the study cohort—three infiltrating ductal carcinomas and one ductal carcinoma in situ—for a rate of 1.1% and a benign biopsy rate of 5%.

Although MRI alone had a diagnostic yield of 1.1%, meaning it could detect 11 cancers in 1,000 high-risk women, the diagnostic yield of mammography alone was 0.3%, meaning it could detect only 3 cancers in this same group.

Although three of the four cancers were in women who had negative mammograms but positive MRIs, this does not weaken the value of mammograms, Dr. Lehman said.

“We're trying to encourage physicians not to trust a negative mammogram and thus rule out the need for a biopsy in this population,” she said at a press briefing.

“But we are also not at the point where a negative MRI can overrule a positive mammogram.

“If we see calcification on a mammogram, there is a significant risk of cancer even when the MRI is negative,” said Dr. Lehman, director of breast imaging at the University of Washington, Seattle.

“It is the radiologist's role to recommend or rule out a biopsy. We are trying to encourage communication with radiologists to this effect,” Dr. Lehman commented.

There is no evidence that the benefits of combining MRI and mammography apply to the general population, in whom mammography performs well, she said.

But mammography is not optimal in younger women, who tend to have dense breast tissue—and high-risk women need to begin regular screening when they are young.

QUEBEC CITY — The management of diabetes is compromised by “clinical inertia” in responding to a patient's elevated hemoglobin A_1c levels, according to a new study.

“Over half of the patients in our study were not prescribed any change at all in their medications after a poor HbA_1c reading,” said Baiju Shah, M.D., of the Institute for Clinical Evaluative Sciences, Toronto. “This is what has been described in the literature as the phenomenon of clinical inertia—when the physician recognizes a problem but doesn't do anything about it.”

Dr. Shah's retrospective study analyzed the responses of physicians to their diabetes patients' elevated HbA_1c results. He presented the findings in a poster at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

The 1,170 patients were aged 65 years or older, had non-insulin requiring type 2 diabetes, and had an HbA_1c level above 8%, indicating poor glycemic control.

A comparison was made of the medications prescribed to each patient during the 4 months preceding the unfavorable HbA_1c test result and during the 4 months after the test.

Drug intensification was defined as the addition of a new oral drug, an increase in the dose of an oral drug, or the initiation of insulin.

“We were looking for any increase in medication. It didn't matter if it was inadequate, as long as there was some change indicating that the physician had responded to the test result,” Dr. Shah told this newspaper.

Half the patients were seeing primary care physicians (defined in Canada as mostly family physicians), and half were seeing endocrinologists, internists, or geriatricians (all classified as specialists in Canada).

Most of these patients with elevated HbA_1c levels did not have an increase in medication (55% of patients seeing endocrinologists, internists, and geriatricians; 63% of patients seeing primary care physicians).

Although all physicians were about equal in terms of adding new oral drugs or increasing the dosage of oral drugs, there was a difference in their approach to initiating insulin.

Of patients seeing endocrinologists, intern-ists, and geriatricians, 9% were started on insulin, vs. 2% of patients seeing primary care physicians, he said.

The phenomenon of clinical inertia has been described in the context of other conditions such as hypertension and hypercholesterolemia, as well as in other aspects of diabetes care, he said.

“In this study, there is no question that a lack of medication adjustment in response to a poor HbA_1c result could partly be the choice of the patients who were already taking a lot of medications and didn't want to add another,” he said.

“But many times, it is also the physicians,” Dr. Shah added. “They get distracted by other things that they need to address with the patient, or they may interpret a result as getting slightly better, when really it is not.”

QUEBEC CITY — The management of diabetes is compromised by “clinical inertia” in responding to a patient's elevated hemoglobin A_1c levels, according to a new study.

“Over half of the patients in our study were not prescribed any change at all in their medications after a poor HbA_1c reading,” said Baiju Shah, M.D., of the Institute for Clinical Evaluative Sciences, Toronto. “This is what has been described in the literature as the phenomenon of clinical inertia—when the physician recognizes a problem but doesn't do anything about it.”

Dr. Shah's retrospective study analyzed the responses of physicians to their diabetes patients' elevated HbA_1c results. He presented the findings in a poster at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

The 1,170 patients were aged 65 years or older, had non-insulin requiring type 2 diabetes, and had an HbA_1c level above 8%, indicating poor glycemic control.

A comparison was made of the medications prescribed to each patient during the 4 months preceding the unfavorable HbA_1c test result and during the 4 months after the test.

Drug intensification was defined as the addition of a new oral drug, an increase in the dose of an oral drug, or the initiation of insulin.

“We were looking for any increase in medication. It didn't matter if it was inadequate, as long as there was some change indicating that the physician had responded to the test result,” Dr. Shah told this newspaper.

Half the patients were seeing primary care physicians (defined in Canada as mostly family physicians), and half were seeing endocrinologists, internists, or geriatricians (all classified as specialists in Canada).

Most of these patients with elevated HbA_1c levels did not have an increase in medication (55% of patients seeing endocrinologists, internists, and geriatricians; 63% of patients seeing primary care physicians).

Although all physicians were about equal in terms of adding new oral drugs or increasing the dosage of oral drugs, there was a difference in their approach to initiating insulin.

Of patients seeing endocrinologists, intern-ists, and geriatricians, 9% were started on insulin, vs. 2% of patients seeing primary care physicians, he said.

The phenomenon of clinical inertia has been described in the context of other conditions such as hypertension and hypercholesterolemia, as well as in other aspects of diabetes care, he said.

“In this study, there is no question that a lack of medication adjustment in response to a poor HbA_1c result could partly be the choice of the patients who were already taking a lot of medications and didn't want to add another,” he said.

“But many times, it is also the physicians,” Dr. Shah added. “They get distracted by other things that they need to address with the patient, or they may interpret a result as getting slightly better, when really it is not.”

QUEBEC CITY — The management of diabetes is compromised by “clinical inertia” in responding to a patient's elevated hemoglobin A_1c levels, according to a new study.

“Over half of the patients in our study were not prescribed any change at all in their medications after a poor HbA_1c reading,” said Baiju Shah, M.D., of the Institute for Clinical Evaluative Sciences, Toronto. “This is what has been described in the literature as the phenomenon of clinical inertia—when the physician recognizes a problem but doesn't do anything about it.”

Dr. Shah's retrospective study analyzed the responses of physicians to their diabetes patients' elevated HbA_1c results. He presented the findings in a poster at the joint annual meeting of the Canadian Diabetes Association and the Canadian Society of Endocrinology and Metabolism.

The 1,170 patients were aged 65 years or older, had non-insulin requiring type 2 diabetes, and had an HbA_1c level above 8%, indicating poor glycemic control.

A comparison was made of the medications prescribed to each patient during the 4 months preceding the unfavorable HbA_1c test result and during the 4 months after the test.

Drug intensification was defined as the addition of a new oral drug, an increase in the dose of an oral drug, or the initiation of insulin.

“We were looking for any increase in medication. It didn't matter if it was inadequate, as long as there was some change indicating that the physician had responded to the test result,” Dr. Shah told this newspaper.

Half the patients were seeing primary care physicians (defined in Canada as mostly family physicians), and half were seeing endocrinologists, internists, or geriatricians (all classified as specialists in Canada).

Most of these patients with elevated HbA_1c levels did not have an increase in medication (55% of patients seeing endocrinologists, internists, and geriatricians; 63% of patients seeing primary care physicians).

Although all physicians were about equal in terms of adding new oral drugs or increasing the dosage of oral drugs, there was a difference in their approach to initiating insulin.

Of patients seeing endocrinologists, intern-ists, and geriatricians, 9% were started on insulin, vs. 2% of patients seeing primary care physicians, he said.

The phenomenon of clinical inertia has been described in the context of other conditions such as hypertension and hypercholesterolemia, as well as in other aspects of diabetes care, he said.

“In this study, there is no question that a lack of medication adjustment in response to a poor HbA_1c result could partly be the choice of the patients who were already taking a lot of medications and didn't want to add another,” he said.

“But many times, it is also the physicians,” Dr. Shah added. “They get distracted by other things that they need to address with the patient, or they may interpret a result as getting slightly better, when really it is not.”