Sitagliptin Add-On Can Help Lower HbA1c Levels

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SEATTLE — Sitagliptin can be safely added to other oral diabetes medications, producing a drop in hemoglobin A1c levels that averages about 0.7%, according to a report at the annual meeting of the American Association of Clinical Endocrinologists.

In one trial, when 100 mg/day sitagliptin (Januvia) was added to metformin treatment (1,500 mg or greater per day) for 24 weeks, patients with type 2 diabetes had a mean reduction in HbA1c of 0.65% from a baseline mean of 8.0%.

In another trial, when sitagliptin was added to pioglitazone treatment, at a dose of 30 mg or greater per day, patients had a mean reduction in HbA1c of 0.7%, from a baseline HbA1c of 8.1%, Dr. Peter Stein said in a poster presentation.

Placebo controls in the studies had no decline in mean HbA1c in the group also on metformin, and a decline of about 0.1% in the group also on pioglitazone.

Of all the patients in the study who were also on metformin, 18% of the patients who took sitagliptin achieved an HbA1c level below 6.5%, as did 25% of those also on pioglitazone. In the controls, only about 5% achieved an HbA1c that low.

Almost 50% in both groups achieved an HbA1c level below 7.0% when sitagliptin was added, versus less than 30% of those that had placebo added to their treatment.

The presumed advantage of sitagliptin, a dipeptidyl peptidase 4 inhibitor which was approved in 2006, is that it is less likely to cause hypoglycemia and weight gain. In these trials, sitagliptin had a neutral effect on body weight and the incidence of hypoglycemia was not significantly different in the sitagliptin-treated and placebo-controlled patients (1.2% versus 0.9%), Dr. Stein, senior director in clinical research at Merck Research Laboratories, Rahway, N.J., said in the poster.

There also were no differences in adverse events or discontinuations in the trials, although the sitagliptin-treated patients did have a slight increase in white blood cell count due to an increase in neutrophils.

The studies were funded by Merck & Co.?

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SEATTLE — Sitagliptin can be safely added to other oral diabetes medications, producing a drop in hemoglobin A1c levels that averages about 0.7%, according to a report at the annual meeting of the American Association of Clinical Endocrinologists.

In one trial, when 100 mg/day sitagliptin (Januvia) was added to metformin treatment (1,500 mg or greater per day) for 24 weeks, patients with type 2 diabetes had a mean reduction in HbA1c of 0.65% from a baseline mean of 8.0%.

In another trial, when sitagliptin was added to pioglitazone treatment, at a dose of 30 mg or greater per day, patients had a mean reduction in HbA1c of 0.7%, from a baseline HbA1c of 8.1%, Dr. Peter Stein said in a poster presentation.

Placebo controls in the studies had no decline in mean HbA1c in the group also on metformin, and a decline of about 0.1% in the group also on pioglitazone.

Of all the patients in the study who were also on metformin, 18% of the patients who took sitagliptin achieved an HbA1c level below 6.5%, as did 25% of those also on pioglitazone. In the controls, only about 5% achieved an HbA1c that low.

Almost 50% in both groups achieved an HbA1c level below 7.0% when sitagliptin was added, versus less than 30% of those that had placebo added to their treatment.

The presumed advantage of sitagliptin, a dipeptidyl peptidase 4 inhibitor which was approved in 2006, is that it is less likely to cause hypoglycemia and weight gain. In these trials, sitagliptin had a neutral effect on body weight and the incidence of hypoglycemia was not significantly different in the sitagliptin-treated and placebo-controlled patients (1.2% versus 0.9%), Dr. Stein, senior director in clinical research at Merck Research Laboratories, Rahway, N.J., said in the poster.

There also were no differences in adverse events or discontinuations in the trials, although the sitagliptin-treated patients did have a slight increase in white blood cell count due to an increase in neutrophils.

The studies were funded by Merck & Co.?

SEATTLE — Sitagliptin can be safely added to other oral diabetes medications, producing a drop in hemoglobin A1c levels that averages about 0.7%, according to a report at the annual meeting of the American Association of Clinical Endocrinologists.

In one trial, when 100 mg/day sitagliptin (Januvia) was added to metformin treatment (1,500 mg or greater per day) for 24 weeks, patients with type 2 diabetes had a mean reduction in HbA1c of 0.65% from a baseline mean of 8.0%.

In another trial, when sitagliptin was added to pioglitazone treatment, at a dose of 30 mg or greater per day, patients had a mean reduction in HbA1c of 0.7%, from a baseline HbA1c of 8.1%, Dr. Peter Stein said in a poster presentation.

Placebo controls in the studies had no decline in mean HbA1c in the group also on metformin, and a decline of about 0.1% in the group also on pioglitazone.

Of all the patients in the study who were also on metformin, 18% of the patients who took sitagliptin achieved an HbA1c level below 6.5%, as did 25% of those also on pioglitazone. In the controls, only about 5% achieved an HbA1c that low.

Almost 50% in both groups achieved an HbA1c level below 7.0% when sitagliptin was added, versus less than 30% of those that had placebo added to their treatment.

The presumed advantage of sitagliptin, a dipeptidyl peptidase 4 inhibitor which was approved in 2006, is that it is less likely to cause hypoglycemia and weight gain. In these trials, sitagliptin had a neutral effect on body weight and the incidence of hypoglycemia was not significantly different in the sitagliptin-treated and placebo-controlled patients (1.2% versus 0.9%), Dr. Stein, senior director in clinical research at Merck Research Laboratories, Rahway, N.J., said in the poster.

There also were no differences in adverse events or discontinuations in the trials, although the sitagliptin-treated patients did have a slight increase in white blood cell count due to an increase in neutrophils.

The studies were funded by Merck & Co.?

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What Once Was Fibroid Gospel Now Is Myth

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LOS ANGELES — Just about everything once taught in medical schools about fibroids should now be recognized as myth, Dr. William Parker said at a meeting of the Obstetrical and Gynecological Assembly of Southern California.

Those myths include the idea that rapidly growing, apparent fibroids could be sarcoma, that all fibroids impair fertility, and that hysterectomy is better than myomectomy because fibroids just come back, said Dr. Parker, an obstetrician-gynecologist who practices in Santa Monica, Calif.

Speaking in a meeting session about alternatives to hysterectomy, Dr. Parker identified the misbegotten notions and made the following points:

Myth No. 1. A rapidly growing fibroid could be or become a leiomyosarcoma.

As a matter of fact, genetic studies have shown that different mutations create fibroids and cancer, and so one does not lead to the other, Dr. Parker said.

In a study he conducted in the early 1990s, in which he reviewed 1,332 patients admitted to the hospital for fibroid surgery, he found that only 3 of those women had a sarcoma. Of 371 patients with rapidly growing fibroids, only 1 had a sarcoma. Moreover, MRI with gadolinium enhancement and lactate dehydrogenase isoenzymes can be used to differentiate malignancies from fibroids, he added.

Myth No. 2. If you can't feel the ovaries because fibroids are in the way, you need to do a hysterectomy because if the patient develops ovarian cancer you would never pick it up.

This is not a good rationale because the clinical diagnosis of ovarian cancer is unreliable anyway, and no one ever suggests to heavy patients that they have a hysterectomy for this reason. Also, if one feels the need to examine the ovaries, there is ultrasound, Dr. Parker said.

Myth No. 3. Intramural fibroids will impair fertility so we need to take them out.

Most studies on this question are actually small series of patients, and that has made the situation somewhat confusing. However, in 2001, a meta-analysis combined studies to total 3,900 patients. The author concluded that intramural fibroids had no effect on any aspect of fertility, including pregnancy rates, implantation likelihood, or deliveries; but fibroids with a submucosal or intracavitary component decreased the likelihood of pregnancy by 70% and removing those fibroids increased the likelihood of pregnancy by 70%.

“Intramural fibroids by themselves do not cause infertility and removing them does not increase fertility,” Dr. Parker said.

Myth No. 4. Fibroids will just grow back after myomectomy, so one might as well do a hysterectomy.

There are many ways of looking at recurrence, and that includes ultrasound, he said. Ultrasound studies suggest that recurrence occurs in 50% of myomectomy cases. But ultrasound picks up fibroids that are small and often clinically insignificant.

In a meta-analysis of seven studies, with 872 women, only 11% of myomectomy patients needed reoperation, with follow-ups that ranged from 10 to 25 years.

That means the gynecologist can tell a 25- to 30-year-old woman that she has a 90% chance of never needing another operation for fibroids before she reaches menopause, Dr. Parker said.

Myth No. 5. Hysterectomy is safer than myomectomy.

Some studies indicate that bleeding problems occur more frequently in myomectomy with increasing uterine weights, but it appears that other complications occur at the same rate with either operation. In fact, hysterectomy actually may be more likely to have complications because with myomectomy the surgeon stays in the uterine space, not outside where there could be damage to the ureters, bowel, and/or bladder, Dr. Parker said.

Gynecologic surgeons have tended not to pay enough attention to bleeding, Dr. Parker asserted. Some of the steps he takes include treating anemic patients with epoetin alfa (Procrit), making transverse incisions in the myometrium to avoid the large arcuate arteries there, and not using a tunneling incision with myomectomy because difficulty in sealing the tunnels can lead to continued bleeding. Instead, he makes one incision for one or two fibroids and closes each when he is finished.

“I think a lot of the things we were taught about [fibroid surgery] were not correct, they were anecdotal,” Dr. Parker concluded.

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LOS ANGELES — Just about everything once taught in medical schools about fibroids should now be recognized as myth, Dr. William Parker said at a meeting of the Obstetrical and Gynecological Assembly of Southern California.

Those myths include the idea that rapidly growing, apparent fibroids could be sarcoma, that all fibroids impair fertility, and that hysterectomy is better than myomectomy because fibroids just come back, said Dr. Parker, an obstetrician-gynecologist who practices in Santa Monica, Calif.

Speaking in a meeting session about alternatives to hysterectomy, Dr. Parker identified the misbegotten notions and made the following points:

Myth No. 1. A rapidly growing fibroid could be or become a leiomyosarcoma.

As a matter of fact, genetic studies have shown that different mutations create fibroids and cancer, and so one does not lead to the other, Dr. Parker said.

In a study he conducted in the early 1990s, in which he reviewed 1,332 patients admitted to the hospital for fibroid surgery, he found that only 3 of those women had a sarcoma. Of 371 patients with rapidly growing fibroids, only 1 had a sarcoma. Moreover, MRI with gadolinium enhancement and lactate dehydrogenase isoenzymes can be used to differentiate malignancies from fibroids, he added.

Myth No. 2. If you can't feel the ovaries because fibroids are in the way, you need to do a hysterectomy because if the patient develops ovarian cancer you would never pick it up.

This is not a good rationale because the clinical diagnosis of ovarian cancer is unreliable anyway, and no one ever suggests to heavy patients that they have a hysterectomy for this reason. Also, if one feels the need to examine the ovaries, there is ultrasound, Dr. Parker said.

Myth No. 3. Intramural fibroids will impair fertility so we need to take them out.

Most studies on this question are actually small series of patients, and that has made the situation somewhat confusing. However, in 2001, a meta-analysis combined studies to total 3,900 patients. The author concluded that intramural fibroids had no effect on any aspect of fertility, including pregnancy rates, implantation likelihood, or deliveries; but fibroids with a submucosal or intracavitary component decreased the likelihood of pregnancy by 70% and removing those fibroids increased the likelihood of pregnancy by 70%.

“Intramural fibroids by themselves do not cause infertility and removing them does not increase fertility,” Dr. Parker said.

Myth No. 4. Fibroids will just grow back after myomectomy, so one might as well do a hysterectomy.

There are many ways of looking at recurrence, and that includes ultrasound, he said. Ultrasound studies suggest that recurrence occurs in 50% of myomectomy cases. But ultrasound picks up fibroids that are small and often clinically insignificant.

In a meta-analysis of seven studies, with 872 women, only 11% of myomectomy patients needed reoperation, with follow-ups that ranged from 10 to 25 years.

That means the gynecologist can tell a 25- to 30-year-old woman that she has a 90% chance of never needing another operation for fibroids before she reaches menopause, Dr. Parker said.

Myth No. 5. Hysterectomy is safer than myomectomy.

Some studies indicate that bleeding problems occur more frequently in myomectomy with increasing uterine weights, but it appears that other complications occur at the same rate with either operation. In fact, hysterectomy actually may be more likely to have complications because with myomectomy the surgeon stays in the uterine space, not outside where there could be damage to the ureters, bowel, and/or bladder, Dr. Parker said.

Gynecologic surgeons have tended not to pay enough attention to bleeding, Dr. Parker asserted. Some of the steps he takes include treating anemic patients with epoetin alfa (Procrit), making transverse incisions in the myometrium to avoid the large arcuate arteries there, and not using a tunneling incision with myomectomy because difficulty in sealing the tunnels can lead to continued bleeding. Instead, he makes one incision for one or two fibroids and closes each when he is finished.

“I think a lot of the things we were taught about [fibroid surgery] were not correct, they were anecdotal,” Dr. Parker concluded.

LOS ANGELES — Just about everything once taught in medical schools about fibroids should now be recognized as myth, Dr. William Parker said at a meeting of the Obstetrical and Gynecological Assembly of Southern California.

Those myths include the idea that rapidly growing, apparent fibroids could be sarcoma, that all fibroids impair fertility, and that hysterectomy is better than myomectomy because fibroids just come back, said Dr. Parker, an obstetrician-gynecologist who practices in Santa Monica, Calif.

Speaking in a meeting session about alternatives to hysterectomy, Dr. Parker identified the misbegotten notions and made the following points:

Myth No. 1. A rapidly growing fibroid could be or become a leiomyosarcoma.

As a matter of fact, genetic studies have shown that different mutations create fibroids and cancer, and so one does not lead to the other, Dr. Parker said.

In a study he conducted in the early 1990s, in which he reviewed 1,332 patients admitted to the hospital for fibroid surgery, he found that only 3 of those women had a sarcoma. Of 371 patients with rapidly growing fibroids, only 1 had a sarcoma. Moreover, MRI with gadolinium enhancement and lactate dehydrogenase isoenzymes can be used to differentiate malignancies from fibroids, he added.

Myth No. 2. If you can't feel the ovaries because fibroids are in the way, you need to do a hysterectomy because if the patient develops ovarian cancer you would never pick it up.

This is not a good rationale because the clinical diagnosis of ovarian cancer is unreliable anyway, and no one ever suggests to heavy patients that they have a hysterectomy for this reason. Also, if one feels the need to examine the ovaries, there is ultrasound, Dr. Parker said.

Myth No. 3. Intramural fibroids will impair fertility so we need to take them out.

Most studies on this question are actually small series of patients, and that has made the situation somewhat confusing. However, in 2001, a meta-analysis combined studies to total 3,900 patients. The author concluded that intramural fibroids had no effect on any aspect of fertility, including pregnancy rates, implantation likelihood, or deliveries; but fibroids with a submucosal or intracavitary component decreased the likelihood of pregnancy by 70% and removing those fibroids increased the likelihood of pregnancy by 70%.

“Intramural fibroids by themselves do not cause infertility and removing them does not increase fertility,” Dr. Parker said.

Myth No. 4. Fibroids will just grow back after myomectomy, so one might as well do a hysterectomy.

There are many ways of looking at recurrence, and that includes ultrasound, he said. Ultrasound studies suggest that recurrence occurs in 50% of myomectomy cases. But ultrasound picks up fibroids that are small and often clinically insignificant.

In a meta-analysis of seven studies, with 872 women, only 11% of myomectomy patients needed reoperation, with follow-ups that ranged from 10 to 25 years.

That means the gynecologist can tell a 25- to 30-year-old woman that she has a 90% chance of never needing another operation for fibroids before she reaches menopause, Dr. Parker said.

Myth No. 5. Hysterectomy is safer than myomectomy.

Some studies indicate that bleeding problems occur more frequently in myomectomy with increasing uterine weights, but it appears that other complications occur at the same rate with either operation. In fact, hysterectomy actually may be more likely to have complications because with myomectomy the surgeon stays in the uterine space, not outside where there could be damage to the ureters, bowel, and/or bladder, Dr. Parker said.

Gynecologic surgeons have tended not to pay enough attention to bleeding, Dr. Parker asserted. Some of the steps he takes include treating anemic patients with epoetin alfa (Procrit), making transverse incisions in the myometrium to avoid the large arcuate arteries there, and not using a tunneling incision with myomectomy because difficulty in sealing the tunnels can lead to continued bleeding. Instead, he makes one incision for one or two fibroids and closes each when he is finished.

“I think a lot of the things we were taught about [fibroid surgery] were not correct, they were anecdotal,” Dr. Parker concluded.

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Sitagliptin Add-On Helps Lower HbA1c

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Sitagliptin Add-On Helps Lower HbA1c

SEATTLE — Sitagliptin can be safely added to other oral diabetes medications, producing a drop in hemoglobin A1c levels that averages about 0.7%, according to a report at the annual meeting of the American Association of Clinical Endocrinologists.

In one trial, when 100 mg/day sitagliptin (Januvia) was added to metformin treatment (1,500 mg or greater per day) for 24 weeks, patients with type 2 diabetes had a mean reduction in HbA1c of 0.65% from a baseline mean of 8.0%.

In another trial, when sitagliptin was added to pioglitazone treatment, at a dose of 30 mg or greater per day, patients had a mean reduction in HbA1c of 0.7%, from a baseline HbA1c of 8.1%, Dr. Peter Stein senior director in clinical research at Merck Research Laboratories, Rahway, N.J., said in the poster presentation.

Placebo controls in the studies had no decline in mean HbA1c in the group that was also on metformin, and a decline of about 0.1% in the group that was also on pioglitazone.

Of the patients in the study who were also on metformin, 18% of the patients who took sitagliptin achieved an HbA1c level below 6.5%, as did 25% of those also on pioglitazone.

In the controls, only about 5% achieved an HbA1c that low. The studies were funded by Merck & Co.

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SEATTLE — Sitagliptin can be safely added to other oral diabetes medications, producing a drop in hemoglobin A1c levels that averages about 0.7%, according to a report at the annual meeting of the American Association of Clinical Endocrinologists.

In one trial, when 100 mg/day sitagliptin (Januvia) was added to metformin treatment (1,500 mg or greater per day) for 24 weeks, patients with type 2 diabetes had a mean reduction in HbA1c of 0.65% from a baseline mean of 8.0%.

In another trial, when sitagliptin was added to pioglitazone treatment, at a dose of 30 mg or greater per day, patients had a mean reduction in HbA1c of 0.7%, from a baseline HbA1c of 8.1%, Dr. Peter Stein senior director in clinical research at Merck Research Laboratories, Rahway, N.J., said in the poster presentation.

Placebo controls in the studies had no decline in mean HbA1c in the group that was also on metformin, and a decline of about 0.1% in the group that was also on pioglitazone.

Of the patients in the study who were also on metformin, 18% of the patients who took sitagliptin achieved an HbA1c level below 6.5%, as did 25% of those also on pioglitazone.

In the controls, only about 5% achieved an HbA1c that low. The studies were funded by Merck & Co.

SEATTLE — Sitagliptin can be safely added to other oral diabetes medications, producing a drop in hemoglobin A1c levels that averages about 0.7%, according to a report at the annual meeting of the American Association of Clinical Endocrinologists.

In one trial, when 100 mg/day sitagliptin (Januvia) was added to metformin treatment (1,500 mg or greater per day) for 24 weeks, patients with type 2 diabetes had a mean reduction in HbA1c of 0.65% from a baseline mean of 8.0%.

In another trial, when sitagliptin was added to pioglitazone treatment, at a dose of 30 mg or greater per day, patients had a mean reduction in HbA1c of 0.7%, from a baseline HbA1c of 8.1%, Dr. Peter Stein senior director in clinical research at Merck Research Laboratories, Rahway, N.J., said in the poster presentation.

Placebo controls in the studies had no decline in mean HbA1c in the group that was also on metformin, and a decline of about 0.1% in the group that was also on pioglitazone.

Of the patients in the study who were also on metformin, 18% of the patients who took sitagliptin achieved an HbA1c level below 6.5%, as did 25% of those also on pioglitazone.

In the controls, only about 5% achieved an HbA1c that low. The studies were funded by Merck & Co.

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Male Hypogonadism May Be More Prevalent Than Previously Thought

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SEATTLE — Low-testosterone problems are not as rare as one might think because they're associated with two common conditions: erectile dysfunction and metabolic syndrome, Dr. Richard F. Spark said at the annual meeting of the American Association of Clinical Endocrinologists.

“Some new developments indicate that there are a lot more patients with hypogonadism than we have been aware of,” said Dr. Spark, an endocrinologist at Beth Israel Deaconess Medical Center, Boston.

One of the first reports that erectile dysfunction could be associated with low testosterone was his own, published in 1980. He measured serum testosterone in 105 consecutive patients who were seen for what was then called impotence and found that 20 of them had low serum testosterone, and when they were treated for that, their erectile dysfunction went away (JAMA 1980;243:750–5).

In 2000, a meta-analysis of studies of testosterone replacement suggested that 57% of patients with erectile dysfunction treated with testosterone had resolution of their problem, including 64% of those with primary hypogonadism (J. Urol. 2000;164:371–5).

Testosterone has gotten a bad rap because of all of the press about athletes who abuse anabolic steroids, and because the controversies regarding estrogen/progesterone therapy for women have made people wary of hormone replacement, Dr. Spark said. “Until recently, the urologists had primarily insisted that there was no man [complaining of ED] in their practice who had low testosterone, and they all went on to have penile implants.”

Low testosterone has also been associated with type 2 diabetes and metabolic syndrome, Dr. Spark said. In a study of 103 men with type 2 diabetes, 33% had low testosterone levels, and low testosterone was found in all the age groups (J. Clin. Endocrinol. Metab. 2004;89:5462–8).

Individuals with metabolic syndrome have a 2.6 times higher risk of having low testosterone than does the general male population, and low testosterone has been shown to predict onset of type 2 diabetes. “One should check testosterone in metabolic syndrome patients and look for metabolic syndrome in low-testosterone patients,” he said.

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SEATTLE — Low-testosterone problems are not as rare as one might think because they're associated with two common conditions: erectile dysfunction and metabolic syndrome, Dr. Richard F. Spark said at the annual meeting of the American Association of Clinical Endocrinologists.

“Some new developments indicate that there are a lot more patients with hypogonadism than we have been aware of,” said Dr. Spark, an endocrinologist at Beth Israel Deaconess Medical Center, Boston.

One of the first reports that erectile dysfunction could be associated with low testosterone was his own, published in 1980. He measured serum testosterone in 105 consecutive patients who were seen for what was then called impotence and found that 20 of them had low serum testosterone, and when they were treated for that, their erectile dysfunction went away (JAMA 1980;243:750–5).

In 2000, a meta-analysis of studies of testosterone replacement suggested that 57% of patients with erectile dysfunction treated with testosterone had resolution of their problem, including 64% of those with primary hypogonadism (J. Urol. 2000;164:371–5).

Testosterone has gotten a bad rap because of all of the press about athletes who abuse anabolic steroids, and because the controversies regarding estrogen/progesterone therapy for women have made people wary of hormone replacement, Dr. Spark said. “Until recently, the urologists had primarily insisted that there was no man [complaining of ED] in their practice who had low testosterone, and they all went on to have penile implants.”

Low testosterone has also been associated with type 2 diabetes and metabolic syndrome, Dr. Spark said. In a study of 103 men with type 2 diabetes, 33% had low testosterone levels, and low testosterone was found in all the age groups (J. Clin. Endocrinol. Metab. 2004;89:5462–8).

Individuals with metabolic syndrome have a 2.6 times higher risk of having low testosterone than does the general male population, and low testosterone has been shown to predict onset of type 2 diabetes. “One should check testosterone in metabolic syndrome patients and look for metabolic syndrome in low-testosterone patients,” he said.

SEATTLE — Low-testosterone problems are not as rare as one might think because they're associated with two common conditions: erectile dysfunction and metabolic syndrome, Dr. Richard F. Spark said at the annual meeting of the American Association of Clinical Endocrinologists.

“Some new developments indicate that there are a lot more patients with hypogonadism than we have been aware of,” said Dr. Spark, an endocrinologist at Beth Israel Deaconess Medical Center, Boston.

One of the first reports that erectile dysfunction could be associated with low testosterone was his own, published in 1980. He measured serum testosterone in 105 consecutive patients who were seen for what was then called impotence and found that 20 of them had low serum testosterone, and when they were treated for that, their erectile dysfunction went away (JAMA 1980;243:750–5).

In 2000, a meta-analysis of studies of testosterone replacement suggested that 57% of patients with erectile dysfunction treated with testosterone had resolution of their problem, including 64% of those with primary hypogonadism (J. Urol. 2000;164:371–5).

Testosterone has gotten a bad rap because of all of the press about athletes who abuse anabolic steroids, and because the controversies regarding estrogen/progesterone therapy for women have made people wary of hormone replacement, Dr. Spark said. “Until recently, the urologists had primarily insisted that there was no man [complaining of ED] in their practice who had low testosterone, and they all went on to have penile implants.”

Low testosterone has also been associated with type 2 diabetes and metabolic syndrome, Dr. Spark said. In a study of 103 men with type 2 diabetes, 33% had low testosterone levels, and low testosterone was found in all the age groups (J. Clin. Endocrinol. Metab. 2004;89:5462–8).

Individuals with metabolic syndrome have a 2.6 times higher risk of having low testosterone than does the general male population, and low testosterone has been shown to predict onset of type 2 diabetes. “One should check testosterone in metabolic syndrome patients and look for metabolic syndrome in low-testosterone patients,” he said.

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Risk of PTSD Is Higher in Those With History of Family Problems

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SAN DIEGO – A high proportion of America's youth experience or witness a violent event, and a family history of substance abuse or mental health problems increase the risk that these youth will develop posttraumatic stress disorder or depression.

Those are the findings of a 7- to 8-year follow-up of subjects in the National Survey of Adolescents, Rochelle F. Hanson, Ph.D., said at a conference sponsored by the Chadwick Center for Children and Families at Children's Hospital and Health Center, San Diego.

The follow-up found that both experiencing/witnessing violence and a family history of substance abuse, mental health problems, or depression could put an adolescent at risk of PTSD or depression. They carry a risk individually, but in combination are worse. And clinicians who care for a victim should be aware of this, said Dr. Hanson, the director of clinical operations at the National Crime Victims Research and Treatment Center at the Medical University of South Carolina, Charleston.

“It is important to assess family environment because it does seem to be associated with risk for later mental health problems,” she said.

The follow-up reinterviewed 1,753 of the survey's initial 4,023 subjects, who were interviewed first when they were adolescents. Most of the subjects grew up in a central city area, and exposure to violence was fairly common. The violence defined in the survey had to be significant–more than a fistfight and a bloody nose, Dr. Hanson said.

In the follow-up interview, 8% reported having experienced a sexual assault, 20% reported having experienced a physical assault, and 35% had witnessed violence. In the initial survey, 37% of the respondents reported having witnessed violence.

An analysis of the responses from the second survey found that if individuals experienced or saw a physical assault, their risk of developing posttraumatic stress disorder symptoms was more than two times higher if they also had family alcohol/drug or mental health problems.

The risk was almost five times higher in those who experienced a rape if they also had a family history of alcohol/drug or mental health problems.

The findings for depression were similar.

The survey found that 25% of individuals who experienced a sexual assault had PTSD symptoms and about 15% who experienced a physical assault had PTSD.

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SAN DIEGO – A high proportion of America's youth experience or witness a violent event, and a family history of substance abuse or mental health problems increase the risk that these youth will develop posttraumatic stress disorder or depression.

Those are the findings of a 7- to 8-year follow-up of subjects in the National Survey of Adolescents, Rochelle F. Hanson, Ph.D., said at a conference sponsored by the Chadwick Center for Children and Families at Children's Hospital and Health Center, San Diego.

The follow-up found that both experiencing/witnessing violence and a family history of substance abuse, mental health problems, or depression could put an adolescent at risk of PTSD or depression. They carry a risk individually, but in combination are worse. And clinicians who care for a victim should be aware of this, said Dr. Hanson, the director of clinical operations at the National Crime Victims Research and Treatment Center at the Medical University of South Carolina, Charleston.

“It is important to assess family environment because it does seem to be associated with risk for later mental health problems,” she said.

The follow-up reinterviewed 1,753 of the survey's initial 4,023 subjects, who were interviewed first when they were adolescents. Most of the subjects grew up in a central city area, and exposure to violence was fairly common. The violence defined in the survey had to be significant–more than a fistfight and a bloody nose, Dr. Hanson said.

In the follow-up interview, 8% reported having experienced a sexual assault, 20% reported having experienced a physical assault, and 35% had witnessed violence. In the initial survey, 37% of the respondents reported having witnessed violence.

An analysis of the responses from the second survey found that if individuals experienced or saw a physical assault, their risk of developing posttraumatic stress disorder symptoms was more than two times higher if they also had family alcohol/drug or mental health problems.

The risk was almost five times higher in those who experienced a rape if they also had a family history of alcohol/drug or mental health problems.

The findings for depression were similar.

The survey found that 25% of individuals who experienced a sexual assault had PTSD symptoms and about 15% who experienced a physical assault had PTSD.

SAN DIEGO – A high proportion of America's youth experience or witness a violent event, and a family history of substance abuse or mental health problems increase the risk that these youth will develop posttraumatic stress disorder or depression.

Those are the findings of a 7- to 8-year follow-up of subjects in the National Survey of Adolescents, Rochelle F. Hanson, Ph.D., said at a conference sponsored by the Chadwick Center for Children and Families at Children's Hospital and Health Center, San Diego.

The follow-up found that both experiencing/witnessing violence and a family history of substance abuse, mental health problems, or depression could put an adolescent at risk of PTSD or depression. They carry a risk individually, but in combination are worse. And clinicians who care for a victim should be aware of this, said Dr. Hanson, the director of clinical operations at the National Crime Victims Research and Treatment Center at the Medical University of South Carolina, Charleston.

“It is important to assess family environment because it does seem to be associated with risk for later mental health problems,” she said.

The follow-up reinterviewed 1,753 of the survey's initial 4,023 subjects, who were interviewed first when they were adolescents. Most of the subjects grew up in a central city area, and exposure to violence was fairly common. The violence defined in the survey had to be significant–more than a fistfight and a bloody nose, Dr. Hanson said.

In the follow-up interview, 8% reported having experienced a sexual assault, 20% reported having experienced a physical assault, and 35% had witnessed violence. In the initial survey, 37% of the respondents reported having witnessed violence.

An analysis of the responses from the second survey found that if individuals experienced or saw a physical assault, their risk of developing posttraumatic stress disorder symptoms was more than two times higher if they also had family alcohol/drug or mental health problems.

The risk was almost five times higher in those who experienced a rape if they also had a family history of alcohol/drug or mental health problems.

The findings for depression were similar.

The survey found that 25% of individuals who experienced a sexual assault had PTSD symptoms and about 15% who experienced a physical assault had PTSD.

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European Consensus Statement Offered on Foam Sclerotherapy

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SAN DIEGO — European experts in foam sclerotherapy have updated their recommendations regarding how to perform foam sclerotherapy. Those recommendations include one that foam as viscous as possible should be used, and that only a 2%-3% mixture of polidocanol is needed for the greater saphenous vein, Dr. Nick Morrison said at the annual meeting of the American Venous Forum.

At the second European Consensus Meeting on Foam Sclerotherapy in April 2006, 26 European experts and 1 American expert were surveyed about their practices, and the survey was used to update recommendations originally made in 2003, said Dr. Morrison, president-elect of the American College of Phlebology and a surgeon who practices in Scottsdale, Ariz.

Dr. Morrison said the document that emerged from that survey included consensus statements on the following:

Access material. The majority of experts use direct puncture to access the great saphenous vein, and for the great and small saphenous vein, most use a needle or a short catheter for access, though some use larger needles or a long catheter for larger veins.

Access location. For the great saphenous vein accessed by direct puncture, the preferred access location of most experts is the proximal thigh. When a long catheter is used, however, access below the knee is preferred. For the small saphenous vein, access is preferred at the proximal or middle part of the calf.

Foam. Foam should be made as viscous as possible, and the amount of foam used should be small and limited, even if that means a second procedure, the experts concurred. The average amount of foam used by the experts per puncture was up to 6 mL, and the maximum volume was up to 8 mL. Eighty-five percent of the experts used less than 10 mL per session. The consensus was that 10 mL was the maximum amount of foam that should be used per leg and per session. Most experts use 2%-3% polidocanol, and most use liquid rather than foam for telangiectasias.

Foam preparation. For the preparation of foam, the Tessari and the DSS/Tessari methods are recommended in all indications. Most experts are using a 4:1 liquid:gas ratio, with air being the most commonly used gas component, though CO2 and O2 can also be used.

Safety. Most of the experts do not use a catheter with a balloon to control the flow of foam; in fact, some believe it is better to have some minor seep rather than a large bolus released at once when the balloon is deflated. A slight majority of the experts uses a limited amount of foam per puncture and per session to increase safety.

Most advise that the puncture site be a minimal distance of 8–10 cm from the saphenofemoral and saphenopopliteal junctions. Immediate compression over the puncture site should be avoided, and most experts use echographic control of foam location.

Contraindications. A relative contraindication is a patent foramen ovale. Patients with a known, asymptomatic foramen ovale should rest in a supine position longer, from 8 to 30 minutes.

Compression. The great majority of experts see a need for compression after treatment of a saphenous vein, its tributaries, perforating veins, and vascular malformations. About half of the experts use compression for treated reticular veins and telangiectasias.

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SAN DIEGO — European experts in foam sclerotherapy have updated their recommendations regarding how to perform foam sclerotherapy. Those recommendations include one that foam as viscous as possible should be used, and that only a 2%-3% mixture of polidocanol is needed for the greater saphenous vein, Dr. Nick Morrison said at the annual meeting of the American Venous Forum.

At the second European Consensus Meeting on Foam Sclerotherapy in April 2006, 26 European experts and 1 American expert were surveyed about their practices, and the survey was used to update recommendations originally made in 2003, said Dr. Morrison, president-elect of the American College of Phlebology and a surgeon who practices in Scottsdale, Ariz.

Dr. Morrison said the document that emerged from that survey included consensus statements on the following:

Access material. The majority of experts use direct puncture to access the great saphenous vein, and for the great and small saphenous vein, most use a needle or a short catheter for access, though some use larger needles or a long catheter for larger veins.

Access location. For the great saphenous vein accessed by direct puncture, the preferred access location of most experts is the proximal thigh. When a long catheter is used, however, access below the knee is preferred. For the small saphenous vein, access is preferred at the proximal or middle part of the calf.

Foam. Foam should be made as viscous as possible, and the amount of foam used should be small and limited, even if that means a second procedure, the experts concurred. The average amount of foam used by the experts per puncture was up to 6 mL, and the maximum volume was up to 8 mL. Eighty-five percent of the experts used less than 10 mL per session. The consensus was that 10 mL was the maximum amount of foam that should be used per leg and per session. Most experts use 2%-3% polidocanol, and most use liquid rather than foam for telangiectasias.

Foam preparation. For the preparation of foam, the Tessari and the DSS/Tessari methods are recommended in all indications. Most experts are using a 4:1 liquid:gas ratio, with air being the most commonly used gas component, though CO2 and O2 can also be used.

Safety. Most of the experts do not use a catheter with a balloon to control the flow of foam; in fact, some believe it is better to have some minor seep rather than a large bolus released at once when the balloon is deflated. A slight majority of the experts uses a limited amount of foam per puncture and per session to increase safety.

Most advise that the puncture site be a minimal distance of 8–10 cm from the saphenofemoral and saphenopopliteal junctions. Immediate compression over the puncture site should be avoided, and most experts use echographic control of foam location.

Contraindications. A relative contraindication is a patent foramen ovale. Patients with a known, asymptomatic foramen ovale should rest in a supine position longer, from 8 to 30 minutes.

Compression. The great majority of experts see a need for compression after treatment of a saphenous vein, its tributaries, perforating veins, and vascular malformations. About half of the experts use compression for treated reticular veins and telangiectasias.

SAN DIEGO — European experts in foam sclerotherapy have updated their recommendations regarding how to perform foam sclerotherapy. Those recommendations include one that foam as viscous as possible should be used, and that only a 2%-3% mixture of polidocanol is needed for the greater saphenous vein, Dr. Nick Morrison said at the annual meeting of the American Venous Forum.

At the second European Consensus Meeting on Foam Sclerotherapy in April 2006, 26 European experts and 1 American expert were surveyed about their practices, and the survey was used to update recommendations originally made in 2003, said Dr. Morrison, president-elect of the American College of Phlebology and a surgeon who practices in Scottsdale, Ariz.

Dr. Morrison said the document that emerged from that survey included consensus statements on the following:

Access material. The majority of experts use direct puncture to access the great saphenous vein, and for the great and small saphenous vein, most use a needle or a short catheter for access, though some use larger needles or a long catheter for larger veins.

Access location. For the great saphenous vein accessed by direct puncture, the preferred access location of most experts is the proximal thigh. When a long catheter is used, however, access below the knee is preferred. For the small saphenous vein, access is preferred at the proximal or middle part of the calf.

Foam. Foam should be made as viscous as possible, and the amount of foam used should be small and limited, even if that means a second procedure, the experts concurred. The average amount of foam used by the experts per puncture was up to 6 mL, and the maximum volume was up to 8 mL. Eighty-five percent of the experts used less than 10 mL per session. The consensus was that 10 mL was the maximum amount of foam that should be used per leg and per session. Most experts use 2%-3% polidocanol, and most use liquid rather than foam for telangiectasias.

Foam preparation. For the preparation of foam, the Tessari and the DSS/Tessari methods are recommended in all indications. Most experts are using a 4:1 liquid:gas ratio, with air being the most commonly used gas component, though CO2 and O2 can also be used.

Safety. Most of the experts do not use a catheter with a balloon to control the flow of foam; in fact, some believe it is better to have some minor seep rather than a large bolus released at once when the balloon is deflated. A slight majority of the experts uses a limited amount of foam per puncture and per session to increase safety.

Most advise that the puncture site be a minimal distance of 8–10 cm from the saphenofemoral and saphenopopliteal junctions. Immediate compression over the puncture site should be avoided, and most experts use echographic control of foam location.

Contraindications. A relative contraindication is a patent foramen ovale. Patients with a known, asymptomatic foramen ovale should rest in a supine position longer, from 8 to 30 minutes.

Compression. The great majority of experts see a need for compression after treatment of a saphenous vein, its tributaries, perforating veins, and vascular malformations. About half of the experts use compression for treated reticular veins and telangiectasias.

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Foamy Future Predicted for Treatment of Varicose Veins

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SAN DIEGO — Foam sclerotherapy will soon be considered the standard of care for treating varicose veins, if it isn't already, Dr. John Bergan predicted at the annual meeting of the American Venous Forum.

"We have reached the point where foam has taken over," said Dr. Bergan, professor of surgery at the University of California, San Diego. "Put your laser on eBay because you are not going to be told this, but foam can do everything."

Insurance companies still generally consider foam sclerotherapy an investigational technique. But over the last 10 years, there have been at least 50 articles dedicated to some aspect of, or experience with, the technique, Dr. Bergan said.

Those publications indicate efficacy of immediate and primary venous occlusion of better than 80%, and that foam is 10 times stronger than liquid. They suggest that repeating the procedure when it fails the first or second time produces a success rate approaching 95%, and recurrence occurs only about 20% of the time, at 5 years.

In at least 70% of cases with saphenous vein reflux, there is no need to treat or strip the saphenous vein, because treating the varicose veins with foam will resolve the reflux or cause the saphenous vein to occlude.

Moreover, severe complications are extremely rare and allergic reactions to polidocanol just do not occur, he added.

A couple of years ago, his group was planning to buy a laser, but their experience with foam changed their minds, Dr. Bergan said.

Since January 2002, his group has treated 869 patients with foam sclerotherapy, and the vein-closure success rate at 1 year, with one or two treatments, has been 90%. And that group of patients has included 66 patients with active leg ulcers, unstable healed ulcers, or disabling lipodermatosclerosis.

There have been 13 adverse events total, of which 4 were ocular symptoms (which resolved), 3 were cases of dry cough, 2 were cases of migraine, 2 were cases of chest pain, and 2 were myoclonus and giddiness. In addition, there were three cases of deep vein thrombosis (two gastrocnemius thrombi, one posterior tibial thrombosis). Since last year, the group has instituted a policy of keeping the treated legs elevated at 45 degrees for 10 minutes after injection, and in 134 patients, there have been no adverse events.

Foam is as effective as laser or radiofrequency ablation, he said. The big difference is cost, with the generator for laser or radiofrequency costing about $30,000 and foam costing about $10.

"The literature is here," he said. "If your insurance company gives you a hard time, call me. I'll give you 50 references, or you can find them yourself on PubMed."

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SAN DIEGO — Foam sclerotherapy will soon be considered the standard of care for treating varicose veins, if it isn't already, Dr. John Bergan predicted at the annual meeting of the American Venous Forum.

"We have reached the point where foam has taken over," said Dr. Bergan, professor of surgery at the University of California, San Diego. "Put your laser on eBay because you are not going to be told this, but foam can do everything."

Insurance companies still generally consider foam sclerotherapy an investigational technique. But over the last 10 years, there have been at least 50 articles dedicated to some aspect of, or experience with, the technique, Dr. Bergan said.

Those publications indicate efficacy of immediate and primary venous occlusion of better than 80%, and that foam is 10 times stronger than liquid. They suggest that repeating the procedure when it fails the first or second time produces a success rate approaching 95%, and recurrence occurs only about 20% of the time, at 5 years.

In at least 70% of cases with saphenous vein reflux, there is no need to treat or strip the saphenous vein, because treating the varicose veins with foam will resolve the reflux or cause the saphenous vein to occlude.

Moreover, severe complications are extremely rare and allergic reactions to polidocanol just do not occur, he added.

A couple of years ago, his group was planning to buy a laser, but their experience with foam changed their minds, Dr. Bergan said.

Since January 2002, his group has treated 869 patients with foam sclerotherapy, and the vein-closure success rate at 1 year, with one or two treatments, has been 90%. And that group of patients has included 66 patients with active leg ulcers, unstable healed ulcers, or disabling lipodermatosclerosis.

There have been 13 adverse events total, of which 4 were ocular symptoms (which resolved), 3 were cases of dry cough, 2 were cases of migraine, 2 were cases of chest pain, and 2 were myoclonus and giddiness. In addition, there were three cases of deep vein thrombosis (two gastrocnemius thrombi, one posterior tibial thrombosis). Since last year, the group has instituted a policy of keeping the treated legs elevated at 45 degrees for 10 minutes after injection, and in 134 patients, there have been no adverse events.

Foam is as effective as laser or radiofrequency ablation, he said. The big difference is cost, with the generator for laser or radiofrequency costing about $30,000 and foam costing about $10.

"The literature is here," he said. "If your insurance company gives you a hard time, call me. I'll give you 50 references, or you can find them yourself on PubMed."

SAN DIEGO — Foam sclerotherapy will soon be considered the standard of care for treating varicose veins, if it isn't already, Dr. John Bergan predicted at the annual meeting of the American Venous Forum.

"We have reached the point where foam has taken over," said Dr. Bergan, professor of surgery at the University of California, San Diego. "Put your laser on eBay because you are not going to be told this, but foam can do everything."

Insurance companies still generally consider foam sclerotherapy an investigational technique. But over the last 10 years, there have been at least 50 articles dedicated to some aspect of, or experience with, the technique, Dr. Bergan said.

Those publications indicate efficacy of immediate and primary venous occlusion of better than 80%, and that foam is 10 times stronger than liquid. They suggest that repeating the procedure when it fails the first or second time produces a success rate approaching 95%, and recurrence occurs only about 20% of the time, at 5 years.

In at least 70% of cases with saphenous vein reflux, there is no need to treat or strip the saphenous vein, because treating the varicose veins with foam will resolve the reflux or cause the saphenous vein to occlude.

Moreover, severe complications are extremely rare and allergic reactions to polidocanol just do not occur, he added.

A couple of years ago, his group was planning to buy a laser, but their experience with foam changed their minds, Dr. Bergan said.

Since January 2002, his group has treated 869 patients with foam sclerotherapy, and the vein-closure success rate at 1 year, with one or two treatments, has been 90%. And that group of patients has included 66 patients with active leg ulcers, unstable healed ulcers, or disabling lipodermatosclerosis.

There have been 13 adverse events total, of which 4 were ocular symptoms (which resolved), 3 were cases of dry cough, 2 were cases of migraine, 2 were cases of chest pain, and 2 were myoclonus and giddiness. In addition, there were three cases of deep vein thrombosis (two gastrocnemius thrombi, one posterior tibial thrombosis). Since last year, the group has instituted a policy of keeping the treated legs elevated at 45 degrees for 10 minutes after injection, and in 134 patients, there have been no adverse events.

Foam is as effective as laser or radiofrequency ablation, he said. The big difference is cost, with the generator for laser or radiofrequency costing about $30,000 and foam costing about $10.

"The literature is here," he said. "If your insurance company gives you a hard time, call me. I'll give you 50 references, or you can find them yourself on PubMed."

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Ultrasound Relieves Fibroid Symptoms for 2 Years

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LOS ANGELES — Patients treated with magnetic resonance-guided focused ultrasound for uterine fibroids who experience improvement maintain that improvement for 2 years, Dr. Bobbie S. Gostout said at the Obstetrical and Gynecological Assembly of Southern California.

“When you see a 48-year-old woman who wants to think about a hysterectomy, this is a great option to offer her as a bridge to menopause,” said Dr. Gostout of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn.

At the meeting, Dr. Gostout described the Mayo experience with 42 patients treated by the new modality who have now been followed out to 2 years.

Those 42 patients had a total of 55 treatments, though as time went on and the practitioners refined their technique there was less and less need for repeat procedures, Dr. Gostout said.

The procedures took an average of 3 hours, and only one patient had a length of stay longer than 5 hours.

None of the patients Dr. Gostout was involved with needed any pain medication stronger than an over-the-counter drug, she said.

Afterward, compared with matched total abdominal hysterectomy patients, the ultrasound patients had 83% fewer provider encounters, 66% fewer additional procedures, and 66% fewer additional diagnostic tests.

“It's not hard to care for these patients in your practice because they do so well,” Dr. Gostout said.

The patients' average score on a symptom severity scale was 61, where the average fibroid patient scores 50 on that particular scale. At 3 months, the average score had dropped to 38, and by 6 months, it had dropped to 34. “That's still true,” she said. “If patients are happy at 6 months they tend to remain happy at 24 months.”

At 24 months, the duration of bleeding experienced by the patients had dropped an average of 1 full day compared with baseline, when the mean was 6.1 days. Excess bleeding, which was defined as menstruation lasting longer than 7 days, declined by one half.

Moreover, 49% of patients who had pressure and urinary frequency as a symptom (37 patients) had complete resolution, and only 1 patient was not helped at all. Of 25 patients who had nocturia, 17 had complete resolution and only 2 had no improvement.

The one symptom that was not improved in any patients was menstrual spotting between periods.

Complications from the procedure included deep vein thrombosis in one patient, sciatic nerve pain in two patients, and diarrhea lasting 24–48 hours after the procedure in “occasional” patients, probably resulting from heating of the rectum during the procedure.

“This is by far the safest treatment I offer to my patients with uterine fibroids,” Dr. Gostout said.

She also noted that there have been eight pregnancies reported in women who have had the procedure; however, she still considers the treatment to be experimental for patients who want to have children.

Some patients who have the procedure get up off the table and describe having relief from their symptoms immediately, Dr. Gostout said. But more commonly, patients describe feeling ever-increasing relief with time, and the amount of time is highly variable.

“Most patients said they had gradual improvement over 3 months, and some had continued improvement for up to a year,” she said.

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LOS ANGELES — Patients treated with magnetic resonance-guided focused ultrasound for uterine fibroids who experience improvement maintain that improvement for 2 years, Dr. Bobbie S. Gostout said at the Obstetrical and Gynecological Assembly of Southern California.

“When you see a 48-year-old woman who wants to think about a hysterectomy, this is a great option to offer her as a bridge to menopause,” said Dr. Gostout of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn.

At the meeting, Dr. Gostout described the Mayo experience with 42 patients treated by the new modality who have now been followed out to 2 years.

Those 42 patients had a total of 55 treatments, though as time went on and the practitioners refined their technique there was less and less need for repeat procedures, Dr. Gostout said.

The procedures took an average of 3 hours, and only one patient had a length of stay longer than 5 hours.

None of the patients Dr. Gostout was involved with needed any pain medication stronger than an over-the-counter drug, she said.

Afterward, compared with matched total abdominal hysterectomy patients, the ultrasound patients had 83% fewer provider encounters, 66% fewer additional procedures, and 66% fewer additional diagnostic tests.

“It's not hard to care for these patients in your practice because they do so well,” Dr. Gostout said.

The patients' average score on a symptom severity scale was 61, where the average fibroid patient scores 50 on that particular scale. At 3 months, the average score had dropped to 38, and by 6 months, it had dropped to 34. “That's still true,” she said. “If patients are happy at 6 months they tend to remain happy at 24 months.”

At 24 months, the duration of bleeding experienced by the patients had dropped an average of 1 full day compared with baseline, when the mean was 6.1 days. Excess bleeding, which was defined as menstruation lasting longer than 7 days, declined by one half.

Moreover, 49% of patients who had pressure and urinary frequency as a symptom (37 patients) had complete resolution, and only 1 patient was not helped at all. Of 25 patients who had nocturia, 17 had complete resolution and only 2 had no improvement.

The one symptom that was not improved in any patients was menstrual spotting between periods.

Complications from the procedure included deep vein thrombosis in one patient, sciatic nerve pain in two patients, and diarrhea lasting 24–48 hours after the procedure in “occasional” patients, probably resulting from heating of the rectum during the procedure.

“This is by far the safest treatment I offer to my patients with uterine fibroids,” Dr. Gostout said.

She also noted that there have been eight pregnancies reported in women who have had the procedure; however, she still considers the treatment to be experimental for patients who want to have children.

Some patients who have the procedure get up off the table and describe having relief from their symptoms immediately, Dr. Gostout said. But more commonly, patients describe feeling ever-increasing relief with time, and the amount of time is highly variable.

“Most patients said they had gradual improvement over 3 months, and some had continued improvement for up to a year,” she said.

LOS ANGELES — Patients treated with magnetic resonance-guided focused ultrasound for uterine fibroids who experience improvement maintain that improvement for 2 years, Dr. Bobbie S. Gostout said at the Obstetrical and Gynecological Assembly of Southern California.

“When you see a 48-year-old woman who wants to think about a hysterectomy, this is a great option to offer her as a bridge to menopause,” said Dr. Gostout of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn.

At the meeting, Dr. Gostout described the Mayo experience with 42 patients treated by the new modality who have now been followed out to 2 years.

Those 42 patients had a total of 55 treatments, though as time went on and the practitioners refined their technique there was less and less need for repeat procedures, Dr. Gostout said.

The procedures took an average of 3 hours, and only one patient had a length of stay longer than 5 hours.

None of the patients Dr. Gostout was involved with needed any pain medication stronger than an over-the-counter drug, she said.

Afterward, compared with matched total abdominal hysterectomy patients, the ultrasound patients had 83% fewer provider encounters, 66% fewer additional procedures, and 66% fewer additional diagnostic tests.

“It's not hard to care for these patients in your practice because they do so well,” Dr. Gostout said.

The patients' average score on a symptom severity scale was 61, where the average fibroid patient scores 50 on that particular scale. At 3 months, the average score had dropped to 38, and by 6 months, it had dropped to 34. “That's still true,” she said. “If patients are happy at 6 months they tend to remain happy at 24 months.”

At 24 months, the duration of bleeding experienced by the patients had dropped an average of 1 full day compared with baseline, when the mean was 6.1 days. Excess bleeding, which was defined as menstruation lasting longer than 7 days, declined by one half.

Moreover, 49% of patients who had pressure and urinary frequency as a symptom (37 patients) had complete resolution, and only 1 patient was not helped at all. Of 25 patients who had nocturia, 17 had complete resolution and only 2 had no improvement.

The one symptom that was not improved in any patients was menstrual spotting between periods.

Complications from the procedure included deep vein thrombosis in one patient, sciatic nerve pain in two patients, and diarrhea lasting 24–48 hours after the procedure in “occasional” patients, probably resulting from heating of the rectum during the procedure.

“This is by far the safest treatment I offer to my patients with uterine fibroids,” Dr. Gostout said.

She also noted that there have been eight pregnancies reported in women who have had the procedure; however, she still considers the treatment to be experimental for patients who want to have children.

Some patients who have the procedure get up off the table and describe having relief from their symptoms immediately, Dr. Gostout said. But more commonly, patients describe feeling ever-increasing relief with time, and the amount of time is highly variable.

“Most patients said they had gradual improvement over 3 months, and some had continued improvement for up to a year,” she said.

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Diabetes Is Often Inadequately Managed During Pregnancy

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LOS ANGELES — Recent research shows that even relatively minor elevations in blood glucose in pregnancy can have severe effects, and that diabetes in pregnant women is not being controlled as well as it should be, Dr. Jorge H. Mestman said at the Obstetrical and Gynecological Assembly of Southern California.

A short time ago, many experts believed that the problems of diabetes in pregnancy had been addressed and that it was easy for patients to do well. But that is not really the case, said Dr. Mestman, director of the University of Southern California Center for Diabetes and Metabolic Diseases in Los Angeles.

One study looked at a Danish registry of pregnant women with diabetes and found that this group of patients had elevated rates of stillbirth and congenital malformation relative to the general population, largely because their blood glucose was not under control (Diabetes Care 2004;27:2819–23).

Another recent study, looking at pregnant women with diabetes in Canada, found much the same thing. Moreover, these researchers compared pregnancy outcomes from 1988 to 2002 and saw almost no improvement over that time (Obstet. Gynecol. 2006;108:644–50).

Two other studies published within the last 2 years have shown that good glucose control could improve those outcomes, Dr. Mestman said.

One of those studies randomly assigned 1,000 women with gestational diabetes, who were between 24 weeks' and 33 weeks' gestation, to routine diabetes care and education or to routine care plus insulin therapy. The researchers reported that care and insulin therapy reduced the perinatal complication rate to 1% vs. 4% for care and education (N. Engl. J. Med. 2005;352:2477–86).

The second study looked at women in a gestational diabetes program who delivered at term, and compared the outcomes of those who had good glucose control and suboptimal glucose control. Good glucose control had a very rigorous definition in the study—an average fasting glucose level below 95 mg/dL, an average 1-hour postprandial level below 140 mg/dL, and an average 2-hour postprandial level of below 120 mg/dL.

More than one-third of the women with poor control (1,118 subjects) had poor pregnancy outcomes—which included macrosomia, large-for-gestational-age infants, hypoglycemia, jaundice, or stillbirth—compared with only 24% of those with optimal control (2,030 subjects; Diabetes Care 2007;30:467–70).

Treatment of the infants in the intensive care unit and cesarean deliveries was also more common in the poorly controlled women.

Although there has been some concern about the use of oral diabetes drugs in pregnancy being associated with congenital abnormalities and neonatal hypoglycemia, Dr. Mestman said that based on the literature and his institution's experience, there is no risk and that what differences have been seen are probably result from glycemic control.

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LOS ANGELES — Recent research shows that even relatively minor elevations in blood glucose in pregnancy can have severe effects, and that diabetes in pregnant women is not being controlled as well as it should be, Dr. Jorge H. Mestman said at the Obstetrical and Gynecological Assembly of Southern California.

A short time ago, many experts believed that the problems of diabetes in pregnancy had been addressed and that it was easy for patients to do well. But that is not really the case, said Dr. Mestman, director of the University of Southern California Center for Diabetes and Metabolic Diseases in Los Angeles.

One study looked at a Danish registry of pregnant women with diabetes and found that this group of patients had elevated rates of stillbirth and congenital malformation relative to the general population, largely because their blood glucose was not under control (Diabetes Care 2004;27:2819–23).

Another recent study, looking at pregnant women with diabetes in Canada, found much the same thing. Moreover, these researchers compared pregnancy outcomes from 1988 to 2002 and saw almost no improvement over that time (Obstet. Gynecol. 2006;108:644–50).

Two other studies published within the last 2 years have shown that good glucose control could improve those outcomes, Dr. Mestman said.

One of those studies randomly assigned 1,000 women with gestational diabetes, who were between 24 weeks' and 33 weeks' gestation, to routine diabetes care and education or to routine care plus insulin therapy. The researchers reported that care and insulin therapy reduced the perinatal complication rate to 1% vs. 4% for care and education (N. Engl. J. Med. 2005;352:2477–86).

The second study looked at women in a gestational diabetes program who delivered at term, and compared the outcomes of those who had good glucose control and suboptimal glucose control. Good glucose control had a very rigorous definition in the study—an average fasting glucose level below 95 mg/dL, an average 1-hour postprandial level below 140 mg/dL, and an average 2-hour postprandial level of below 120 mg/dL.

More than one-third of the women with poor control (1,118 subjects) had poor pregnancy outcomes—which included macrosomia, large-for-gestational-age infants, hypoglycemia, jaundice, or stillbirth—compared with only 24% of those with optimal control (2,030 subjects; Diabetes Care 2007;30:467–70).

Treatment of the infants in the intensive care unit and cesarean deliveries was also more common in the poorly controlled women.

Although there has been some concern about the use of oral diabetes drugs in pregnancy being associated with congenital abnormalities and neonatal hypoglycemia, Dr. Mestman said that based on the literature and his institution's experience, there is no risk and that what differences have been seen are probably result from glycemic control.

LOS ANGELES — Recent research shows that even relatively minor elevations in blood glucose in pregnancy can have severe effects, and that diabetes in pregnant women is not being controlled as well as it should be, Dr. Jorge H. Mestman said at the Obstetrical and Gynecological Assembly of Southern California.

A short time ago, many experts believed that the problems of diabetes in pregnancy had been addressed and that it was easy for patients to do well. But that is not really the case, said Dr. Mestman, director of the University of Southern California Center for Diabetes and Metabolic Diseases in Los Angeles.

One study looked at a Danish registry of pregnant women with diabetes and found that this group of patients had elevated rates of stillbirth and congenital malformation relative to the general population, largely because their blood glucose was not under control (Diabetes Care 2004;27:2819–23).

Another recent study, looking at pregnant women with diabetes in Canada, found much the same thing. Moreover, these researchers compared pregnancy outcomes from 1988 to 2002 and saw almost no improvement over that time (Obstet. Gynecol. 2006;108:644–50).

Two other studies published within the last 2 years have shown that good glucose control could improve those outcomes, Dr. Mestman said.

One of those studies randomly assigned 1,000 women with gestational diabetes, who were between 24 weeks' and 33 weeks' gestation, to routine diabetes care and education or to routine care plus insulin therapy. The researchers reported that care and insulin therapy reduced the perinatal complication rate to 1% vs. 4% for care and education (N. Engl. J. Med. 2005;352:2477–86).

The second study looked at women in a gestational diabetes program who delivered at term, and compared the outcomes of those who had good glucose control and suboptimal glucose control. Good glucose control had a very rigorous definition in the study—an average fasting glucose level below 95 mg/dL, an average 1-hour postprandial level below 140 mg/dL, and an average 2-hour postprandial level of below 120 mg/dL.

More than one-third of the women with poor control (1,118 subjects) had poor pregnancy outcomes—which included macrosomia, large-for-gestational-age infants, hypoglycemia, jaundice, or stillbirth—compared with only 24% of those with optimal control (2,030 subjects; Diabetes Care 2007;30:467–70).

Treatment of the infants in the intensive care unit and cesarean deliveries was also more common in the poorly controlled women.

Although there has been some concern about the use of oral diabetes drugs in pregnancy being associated with congenital abnormalities and neonatal hypoglycemia, Dr. Mestman said that based on the literature and his institution's experience, there is no risk and that what differences have been seen are probably result from glycemic control.

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Should Pregnant Women Be Tested for Hypothyroidism?

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Should Pregnant Women Be Tested for Hypothyroidism?

LOS ANGELES — Recent evidence suggests many hypothyroid pregnant women are not identified as such by their medical providers, to the detriment of the mother and child, Dr. Jorge H. Mestman said at a meeting of the Obstetrical and Gynecological Assembly of Southern California.

The experts cannot reach a consensus on whether pregnant women should be routinely screened for thyroid disease, but even hypothyroidism that is subclinical prior to pregnancy appears to have a severe, negative impact on the pregnancy and child, said Dr. Mestman, director of the Center for Diabetes and Metabolic Diseases at the University of Southern California, Los Angeles.

“There is no agreement,” Dr. Mestman said. “You have to decide in your office if you are going to check everybody for thyroid disease in the same way as for diabetes.”

One important new study might not have been seen by many in the obstetrics community because it was published in an endocrinology journal, he noted. The investigators attempted to see if the strategy of identifying women at high risk of thyroid disease (those with a personal or family history) and performing thyroid testing only in those women would pick up most cases.

They enrolled 1,560 pregnant women on their first prenatal visit, and tested their thyroid function and determined whether they had thyroid antibodies. Forty were found to have elevated thyroid-stimulating hormone (TSH) levels. Of those, 70% were in the high-risk group due to a personal history of thyroid or autoimmune disease, or a family history of thyroid disease.

But 12 of the 40 had no history, and would not, therefore have received testing according to the protocol being examined by the study (J. Clin. Endocrinol. Metab. 2007;92:203–7).

Chronic thyroiditis occurs in between 5% and 20% of women of child-bearing age, Dr. Mestman said. Subclinical hypothyroidism—a normal thyroxine (T4) level but an elevated TSH—may have an incidence of 2%.

Many studies have shown that hypothyroidism, even subclinical hypothyroidism, is associated with a two- to fivefold higher risk of miscarriage and premature delivery.

One study found that at age 7–9 years, children of mothers who were hypothyroid in pregnancy had a mean IQ 4 points lower than controls. The mean IQ of children of women who were hypothyroid during pregnancy and not treated was 7 points less (N. Engl. J. Med. 1999;341:549–55).

The detrimental effects of hypothyroidism presumably occur because the mother produces all the thyroid hormone for her fetus during the first trimester at least, and fetal brains have been shown to have thyroid hormone receptors.

During the first trimester, T4 levels need to increase by 50%, which is why women who may be subclinical before conception can run into trouble. They cannot compensate for the increased demand.

By the second and third trimester, T4 levels return to normal; however, some women who become hypothyroid during the first trimester will become hypothyroid again after delivery. Those women will become hyperthyroid for the first 3 months after delivery, and then hypothyroid for approximately another 6 months. Of those, about 30% will become clinically hypothyroid within 5 years. All of these women should be followed for thyroid function after their pregnancy, Dr. Mestman said. The pattern can occur even after spontaneous abortion.

Treatment prevents pregnancy complications, Dr. Mestman said. In a series of 88 hypothyroid women, the pregnancy complication rate of those who never became euthyroid during their pregnancy was 32% (6 of 19 patients), compared with 17% in those women who became euthyroid but only after 20 weeks' gestation (7 of 42), and 5% in those who became euthyroid before 20 weeks (1 of 21).

One of the tragedies observed in that series concerned the 30% already on levothyroxine prior to their pregnancy, Dr. Mestman said. Some were told to stop all medications when they became pregnant and they stopped their thyroid medication.

“This is a very common practice in many, many places,” he said.

Another, more recent study also looked at the pregnancy complication rate in women who were euthyroid but who had thyroid peroxidase antibodies. They treated half of a group of 115 antibody-positive women with levothyroxine, and compared those women with 869 pregnant women who were antibody negative.

The treated antibody-positive women had a miscarriage rate of 3%, similar to the rate in the control group, 2%. But the untreated antibody-positive women had a rate of 14%. The treated women had a premature delivery rate of 7%, similar to the 8% for the control group. That compared with a rate of 22% for the untreated women.

 

 

Given those findings, Dr. Mestman recommended that pregnant, antibody-positive euthyroid women should be treated. The treatment should include a prenatal vitamin with 150 mcg of iodine. They should have TSH and T4 levels monitored every 4–6 weeks during the first 20 weeks of pregnancy. After 20 weeks, they should have their TSH and T4 measured once at 28 weeks and should take 50–75 mcg a day of levothyroxine. If the patient is already on levothyroxine, the dose should be increased by 25 mcg.

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LOS ANGELES — Recent evidence suggests many hypothyroid pregnant women are not identified as such by their medical providers, to the detriment of the mother and child, Dr. Jorge H. Mestman said at a meeting of the Obstetrical and Gynecological Assembly of Southern California.

The experts cannot reach a consensus on whether pregnant women should be routinely screened for thyroid disease, but even hypothyroidism that is subclinical prior to pregnancy appears to have a severe, negative impact on the pregnancy and child, said Dr. Mestman, director of the Center for Diabetes and Metabolic Diseases at the University of Southern California, Los Angeles.

“There is no agreement,” Dr. Mestman said. “You have to decide in your office if you are going to check everybody for thyroid disease in the same way as for diabetes.”

One important new study might not have been seen by many in the obstetrics community because it was published in an endocrinology journal, he noted. The investigators attempted to see if the strategy of identifying women at high risk of thyroid disease (those with a personal or family history) and performing thyroid testing only in those women would pick up most cases.

They enrolled 1,560 pregnant women on their first prenatal visit, and tested their thyroid function and determined whether they had thyroid antibodies. Forty were found to have elevated thyroid-stimulating hormone (TSH) levels. Of those, 70% were in the high-risk group due to a personal history of thyroid or autoimmune disease, or a family history of thyroid disease.

But 12 of the 40 had no history, and would not, therefore have received testing according to the protocol being examined by the study (J. Clin. Endocrinol. Metab. 2007;92:203–7).

Chronic thyroiditis occurs in between 5% and 20% of women of child-bearing age, Dr. Mestman said. Subclinical hypothyroidism—a normal thyroxine (T4) level but an elevated TSH—may have an incidence of 2%.

Many studies have shown that hypothyroidism, even subclinical hypothyroidism, is associated with a two- to fivefold higher risk of miscarriage and premature delivery.

One study found that at age 7–9 years, children of mothers who were hypothyroid in pregnancy had a mean IQ 4 points lower than controls. The mean IQ of children of women who were hypothyroid during pregnancy and not treated was 7 points less (N. Engl. J. Med. 1999;341:549–55).

The detrimental effects of hypothyroidism presumably occur because the mother produces all the thyroid hormone for her fetus during the first trimester at least, and fetal brains have been shown to have thyroid hormone receptors.

During the first trimester, T4 levels need to increase by 50%, which is why women who may be subclinical before conception can run into trouble. They cannot compensate for the increased demand.

By the second and third trimester, T4 levels return to normal; however, some women who become hypothyroid during the first trimester will become hypothyroid again after delivery. Those women will become hyperthyroid for the first 3 months after delivery, and then hypothyroid for approximately another 6 months. Of those, about 30% will become clinically hypothyroid within 5 years. All of these women should be followed for thyroid function after their pregnancy, Dr. Mestman said. The pattern can occur even after spontaneous abortion.

Treatment prevents pregnancy complications, Dr. Mestman said. In a series of 88 hypothyroid women, the pregnancy complication rate of those who never became euthyroid during their pregnancy was 32% (6 of 19 patients), compared with 17% in those women who became euthyroid but only after 20 weeks' gestation (7 of 42), and 5% in those who became euthyroid before 20 weeks (1 of 21).

One of the tragedies observed in that series concerned the 30% already on levothyroxine prior to their pregnancy, Dr. Mestman said. Some were told to stop all medications when they became pregnant and they stopped their thyroid medication.

“This is a very common practice in many, many places,” he said.

Another, more recent study also looked at the pregnancy complication rate in women who were euthyroid but who had thyroid peroxidase antibodies. They treated half of a group of 115 antibody-positive women with levothyroxine, and compared those women with 869 pregnant women who were antibody negative.

The treated antibody-positive women had a miscarriage rate of 3%, similar to the rate in the control group, 2%. But the untreated antibody-positive women had a rate of 14%. The treated women had a premature delivery rate of 7%, similar to the 8% for the control group. That compared with a rate of 22% for the untreated women.

 

 

Given those findings, Dr. Mestman recommended that pregnant, antibody-positive euthyroid women should be treated. The treatment should include a prenatal vitamin with 150 mcg of iodine. They should have TSH and T4 levels monitored every 4–6 weeks during the first 20 weeks of pregnancy. After 20 weeks, they should have their TSH and T4 measured once at 28 weeks and should take 50–75 mcg a day of levothyroxine. If the patient is already on levothyroxine, the dose should be increased by 25 mcg.

LOS ANGELES — Recent evidence suggests many hypothyroid pregnant women are not identified as such by their medical providers, to the detriment of the mother and child, Dr. Jorge H. Mestman said at a meeting of the Obstetrical and Gynecological Assembly of Southern California.

The experts cannot reach a consensus on whether pregnant women should be routinely screened for thyroid disease, but even hypothyroidism that is subclinical prior to pregnancy appears to have a severe, negative impact on the pregnancy and child, said Dr. Mestman, director of the Center for Diabetes and Metabolic Diseases at the University of Southern California, Los Angeles.

“There is no agreement,” Dr. Mestman said. “You have to decide in your office if you are going to check everybody for thyroid disease in the same way as for diabetes.”

One important new study might not have been seen by many in the obstetrics community because it was published in an endocrinology journal, he noted. The investigators attempted to see if the strategy of identifying women at high risk of thyroid disease (those with a personal or family history) and performing thyroid testing only in those women would pick up most cases.

They enrolled 1,560 pregnant women on their first prenatal visit, and tested their thyroid function and determined whether they had thyroid antibodies. Forty were found to have elevated thyroid-stimulating hormone (TSH) levels. Of those, 70% were in the high-risk group due to a personal history of thyroid or autoimmune disease, or a family history of thyroid disease.

But 12 of the 40 had no history, and would not, therefore have received testing according to the protocol being examined by the study (J. Clin. Endocrinol. Metab. 2007;92:203–7).

Chronic thyroiditis occurs in between 5% and 20% of women of child-bearing age, Dr. Mestman said. Subclinical hypothyroidism—a normal thyroxine (T4) level but an elevated TSH—may have an incidence of 2%.

Many studies have shown that hypothyroidism, even subclinical hypothyroidism, is associated with a two- to fivefold higher risk of miscarriage and premature delivery.

One study found that at age 7–9 years, children of mothers who were hypothyroid in pregnancy had a mean IQ 4 points lower than controls. The mean IQ of children of women who were hypothyroid during pregnancy and not treated was 7 points less (N. Engl. J. Med. 1999;341:549–55).

The detrimental effects of hypothyroidism presumably occur because the mother produces all the thyroid hormone for her fetus during the first trimester at least, and fetal brains have been shown to have thyroid hormone receptors.

During the first trimester, T4 levels need to increase by 50%, which is why women who may be subclinical before conception can run into trouble. They cannot compensate for the increased demand.

By the second and third trimester, T4 levels return to normal; however, some women who become hypothyroid during the first trimester will become hypothyroid again after delivery. Those women will become hyperthyroid for the first 3 months after delivery, and then hypothyroid for approximately another 6 months. Of those, about 30% will become clinically hypothyroid within 5 years. All of these women should be followed for thyroid function after their pregnancy, Dr. Mestman said. The pattern can occur even after spontaneous abortion.

Treatment prevents pregnancy complications, Dr. Mestman said. In a series of 88 hypothyroid women, the pregnancy complication rate of those who never became euthyroid during their pregnancy was 32% (6 of 19 patients), compared with 17% in those women who became euthyroid but only after 20 weeks' gestation (7 of 42), and 5% in those who became euthyroid before 20 weeks (1 of 21).

One of the tragedies observed in that series concerned the 30% already on levothyroxine prior to their pregnancy, Dr. Mestman said. Some were told to stop all medications when they became pregnant and they stopped their thyroid medication.

“This is a very common practice in many, many places,” he said.

Another, more recent study also looked at the pregnancy complication rate in women who were euthyroid but who had thyroid peroxidase antibodies. They treated half of a group of 115 antibody-positive women with levothyroxine, and compared those women with 869 pregnant women who were antibody negative.

The treated antibody-positive women had a miscarriage rate of 3%, similar to the rate in the control group, 2%. But the untreated antibody-positive women had a rate of 14%. The treated women had a premature delivery rate of 7%, similar to the 8% for the control group. That compared with a rate of 22% for the untreated women.

 

 

Given those findings, Dr. Mestman recommended that pregnant, antibody-positive euthyroid women should be treated. The treatment should include a prenatal vitamin with 150 mcg of iodine. They should have TSH and T4 levels monitored every 4–6 weeks during the first 20 weeks of pregnancy. After 20 weeks, they should have their TSH and T4 measured once at 28 weeks and should take 50–75 mcg a day of levothyroxine. If the patient is already on levothyroxine, the dose should be increased by 25 mcg.

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