Lower Leg Pain Alleviated By Pelvic Congestion Tx

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Pelvic pain related to pelvic venous congestion often occurs in women with symptomatic lower extremity venous reflux. Treating ovarian venous incompetence with embolotherapy can not only reduce associated pelvic pain, but can also significantly reduce the pain associated with lower extremity reflux, according to Carl M. Black, M.D.

Because the disorders occur together in so many women, he recommends that women with complex nonsaphenous superficial lower extremity venous insufficiency be questioned regarding concomitant symptoms of pelvic congestion.

“These are some of the most complex varicose vein patients you will ever see,” Dr. Black of the Intermountain Vein Center, Provo, Utah, said in an interview. “It's very, very hard to make them happy and their problems tend to get worked up piecemeal and a more comprehensive approach may significantly improve their ultimate outcome.”

Symptoms of pelvic congestion syndrome are heaviness in the pelvis with standing, low abdominal pain, painful varicosities in branches around the labia and vulva, and varicosities that emerge from the gluteal region and extend into the legs.

“About 16% of the women with varicose veins will say they have pelvic pain that cycles with their leg pain—when their pelvis feels bad, their leg veins bulge more and feel worse,” Dr. Black said. “As you define it more, it is classical pelvic congestion.”

At the annual meeting of the Society of Interventional Radiology, Dr. Black presented the results of a study evaluating transcatheter embolization in patients with both disorders.

The study group consisted of 160 women with symptomatic lower extremity superficial reflux. Their mean age was about 39 years, with a mean of three pregnancies. Each patient received a thorough lower extremity venous duplex ultrasound, which included evaluation of atypical transpelvic venous reflux. Clinical and ultrasonographic findings suggested pelvic congestion syndrome in 26 (16%) of the women. All 26 had complex nonsaphenous patterns of lower extremity venous reflux.

Twenty-four of these patients then underwent venography, which confirmed ovarian venous insufficiency in 22 (94%). These 22 patients had embolotherapy on the insufficient pelvic veins. Embolization was successful in 100%.

After pelvic embolization, 19 (86%) reported relief or significant reduction in pelvic pain and 14 (63%) reported reduction of both pelvic and lower extremity pain. After subsequent comprehensive treatment of remaining identifiable sources of lower extremity venous reflux, 20 of the 22 patients (91%) reported sustained overall treatment satisfaction at follow-up with approximately 60% of patients having been followed out to between 6 and 12 months.

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Pelvic pain related to pelvic venous congestion often occurs in women with symptomatic lower extremity venous reflux. Treating ovarian venous incompetence with embolotherapy can not only reduce associated pelvic pain, but can also significantly reduce the pain associated with lower extremity reflux, according to Carl M. Black, M.D.

Because the disorders occur together in so many women, he recommends that women with complex nonsaphenous superficial lower extremity venous insufficiency be questioned regarding concomitant symptoms of pelvic congestion.

“These are some of the most complex varicose vein patients you will ever see,” Dr. Black of the Intermountain Vein Center, Provo, Utah, said in an interview. “It's very, very hard to make them happy and their problems tend to get worked up piecemeal and a more comprehensive approach may significantly improve their ultimate outcome.”

Symptoms of pelvic congestion syndrome are heaviness in the pelvis with standing, low abdominal pain, painful varicosities in branches around the labia and vulva, and varicosities that emerge from the gluteal region and extend into the legs.

“About 16% of the women with varicose veins will say they have pelvic pain that cycles with their leg pain—when their pelvis feels bad, their leg veins bulge more and feel worse,” Dr. Black said. “As you define it more, it is classical pelvic congestion.”

At the annual meeting of the Society of Interventional Radiology, Dr. Black presented the results of a study evaluating transcatheter embolization in patients with both disorders.

The study group consisted of 160 women with symptomatic lower extremity superficial reflux. Their mean age was about 39 years, with a mean of three pregnancies. Each patient received a thorough lower extremity venous duplex ultrasound, which included evaluation of atypical transpelvic venous reflux. Clinical and ultrasonographic findings suggested pelvic congestion syndrome in 26 (16%) of the women. All 26 had complex nonsaphenous patterns of lower extremity venous reflux.

Twenty-four of these patients then underwent venography, which confirmed ovarian venous insufficiency in 22 (94%). These 22 patients had embolotherapy on the insufficient pelvic veins. Embolization was successful in 100%.

After pelvic embolization, 19 (86%) reported relief or significant reduction in pelvic pain and 14 (63%) reported reduction of both pelvic and lower extremity pain. After subsequent comprehensive treatment of remaining identifiable sources of lower extremity venous reflux, 20 of the 22 patients (91%) reported sustained overall treatment satisfaction at follow-up with approximately 60% of patients having been followed out to between 6 and 12 months.

Pelvic pain related to pelvic venous congestion often occurs in women with symptomatic lower extremity venous reflux. Treating ovarian venous incompetence with embolotherapy can not only reduce associated pelvic pain, but can also significantly reduce the pain associated with lower extremity reflux, according to Carl M. Black, M.D.

Because the disorders occur together in so many women, he recommends that women with complex nonsaphenous superficial lower extremity venous insufficiency be questioned regarding concomitant symptoms of pelvic congestion.

“These are some of the most complex varicose vein patients you will ever see,” Dr. Black of the Intermountain Vein Center, Provo, Utah, said in an interview. “It's very, very hard to make them happy and their problems tend to get worked up piecemeal and a more comprehensive approach may significantly improve their ultimate outcome.”

Symptoms of pelvic congestion syndrome are heaviness in the pelvis with standing, low abdominal pain, painful varicosities in branches around the labia and vulva, and varicosities that emerge from the gluteal region and extend into the legs.

“About 16% of the women with varicose veins will say they have pelvic pain that cycles with their leg pain—when their pelvis feels bad, their leg veins bulge more and feel worse,” Dr. Black said. “As you define it more, it is classical pelvic congestion.”

At the annual meeting of the Society of Interventional Radiology, Dr. Black presented the results of a study evaluating transcatheter embolization in patients with both disorders.

The study group consisted of 160 women with symptomatic lower extremity superficial reflux. Their mean age was about 39 years, with a mean of three pregnancies. Each patient received a thorough lower extremity venous duplex ultrasound, which included evaluation of atypical transpelvic venous reflux. Clinical and ultrasonographic findings suggested pelvic congestion syndrome in 26 (16%) of the women. All 26 had complex nonsaphenous patterns of lower extremity venous reflux.

Twenty-four of these patients then underwent venography, which confirmed ovarian venous insufficiency in 22 (94%). These 22 patients had embolotherapy on the insufficient pelvic veins. Embolization was successful in 100%.

After pelvic embolization, 19 (86%) reported relief or significant reduction in pelvic pain and 14 (63%) reported reduction of both pelvic and lower extremity pain. After subsequent comprehensive treatment of remaining identifiable sources of lower extremity venous reflux, 20 of the 22 patients (91%) reported sustained overall treatment satisfaction at follow-up with approximately 60% of patients having been followed out to between 6 and 12 months.

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Embolotherapy Eases Pain From Pelvic Congestion

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Pelvic congestion syndrome is a real disease entity that affects up to 16% of American women, and can be successfully treated with transfemoral embolotherapy, according to researchers who presented data at the annual meeting of the Society of Interventional Radiology.

About 10% of gynecologic visits are due to chronic, noncyclic pelvic pain of greater than 6 months' duration, and a third of gynecologic laparoscopies are performed to investigate such pain. The differential diagnosis usually includes endometriosis, fibroids, adenomyosis, cysts, and tumors, among other potential causes. Pelvic congestion syndrome (PCS)—pelvic vein insufficiency that causes pooling of blood in the uterine and ovarian veins—is not often on the list, said Hyun S. “Kevin” Kim, M.D., of Johns Hopkins University, Baltimore

Even standard imaging studies don't always identify the disorder, Dr. Kim said in an interview.

“Only 40% of laparoscopic studies were able to visualize abnormal veins. On MRI, only 59% were diagnosed.”

Because PCS is difficult to diagnose, many physicians write off the symptoms—dull, typically unilateral pain that worsens during the day and with standing, dyspareunia, and dysuria—as psychosomatic, Dr. Kim said.

Varicocele, the male counterpart of PCS, has no such stigma, he added. In men, the gonadal vein terminates in the testicle, so the painful venous abnormalities are usually visually apparent. “This condition is accepted in men, because it occurs outside the body and we can see it. In women it's hidden, and this, I think, is part of the reason for misdiagnosis or underdiagnosis.”

The best way to diagnose PCS is with direct venography, said Dr. Kim, who presented the results of his long-term follow-up study on transcatheter embolization for the disorder at the meeting.

He performed 262 transfemoral ovarian venographies on 131 women (mean age 34 years) with chronic pelvic pain. Overall, 20% had a prior hysterectomy. About one-third of the patients had previous pregnancies; the rest were nulliparous. Venography confirmed the clinical suspicion of PCS in 127 of those women. The diagnostic criteria for PCS are:

▸ Ovarian vein, uterine vein, and utero-ovarian arcade venous engorgement greater than 5 mm in diameter.

▸ Free reflux of contrast in ovarian vein with incompetent valves.

▸ Filling of veins across the midline or filling of vulvar and/or thigh varicosities.

▸ Stagnant clearance of contrast from pelvic veins (more than 1 minute).

Patients with a confirmed diagnosis underwent baseline levels of follicle-stimulating hormone, estradiol, and luteinizing hormone, and transcatheter embolotherapy of the insufficient veins. This was done as an outpatient procedure. There were no major complications.

By a mean 45 months' follow-up, there was a mean pain decrease of 4.7 points on a visual analog scale. Most of the patients (85%) reported improvement, which was significant in 80%, moderate in 14%, and mild in 6%. There was no change in 12%, and pain was worse in 3%.

Women who reported pain improvement also reported significant improvement in symptoms such as dyspareunia, urinary frequency, and menstrual pain. A comparison of patient subgroups showed no differences in outcome between the nulliparous women and those with prior pregnancy.

There were no differences between preoperative and follow-up hormone levels; four patients attempted to conceive after the procedure, and two successful pregnancies resulted.

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Pelvic congestion syndrome is a real disease entity that affects up to 16% of American women, and can be successfully treated with transfemoral embolotherapy, according to researchers who presented data at the annual meeting of the Society of Interventional Radiology.

About 10% of gynecologic visits are due to chronic, noncyclic pelvic pain of greater than 6 months' duration, and a third of gynecologic laparoscopies are performed to investigate such pain. The differential diagnosis usually includes endometriosis, fibroids, adenomyosis, cysts, and tumors, among other potential causes. Pelvic congestion syndrome (PCS)—pelvic vein insufficiency that causes pooling of blood in the uterine and ovarian veins—is not often on the list, said Hyun S. “Kevin” Kim, M.D., of Johns Hopkins University, Baltimore

Even standard imaging studies don't always identify the disorder, Dr. Kim said in an interview.

“Only 40% of laparoscopic studies were able to visualize abnormal veins. On MRI, only 59% were diagnosed.”

Because PCS is difficult to diagnose, many physicians write off the symptoms—dull, typically unilateral pain that worsens during the day and with standing, dyspareunia, and dysuria—as psychosomatic, Dr. Kim said.

Varicocele, the male counterpart of PCS, has no such stigma, he added. In men, the gonadal vein terminates in the testicle, so the painful venous abnormalities are usually visually apparent. “This condition is accepted in men, because it occurs outside the body and we can see it. In women it's hidden, and this, I think, is part of the reason for misdiagnosis or underdiagnosis.”

The best way to diagnose PCS is with direct venography, said Dr. Kim, who presented the results of his long-term follow-up study on transcatheter embolization for the disorder at the meeting.

He performed 262 transfemoral ovarian venographies on 131 women (mean age 34 years) with chronic pelvic pain. Overall, 20% had a prior hysterectomy. About one-third of the patients had previous pregnancies; the rest were nulliparous. Venography confirmed the clinical suspicion of PCS in 127 of those women. The diagnostic criteria for PCS are:

▸ Ovarian vein, uterine vein, and utero-ovarian arcade venous engorgement greater than 5 mm in diameter.

▸ Free reflux of contrast in ovarian vein with incompetent valves.

▸ Filling of veins across the midline or filling of vulvar and/or thigh varicosities.

▸ Stagnant clearance of contrast from pelvic veins (more than 1 minute).

Patients with a confirmed diagnosis underwent baseline levels of follicle-stimulating hormone, estradiol, and luteinizing hormone, and transcatheter embolotherapy of the insufficient veins. This was done as an outpatient procedure. There were no major complications.

By a mean 45 months' follow-up, there was a mean pain decrease of 4.7 points on a visual analog scale. Most of the patients (85%) reported improvement, which was significant in 80%, moderate in 14%, and mild in 6%. There was no change in 12%, and pain was worse in 3%.

Women who reported pain improvement also reported significant improvement in symptoms such as dyspareunia, urinary frequency, and menstrual pain. A comparison of patient subgroups showed no differences in outcome between the nulliparous women and those with prior pregnancy.

There were no differences between preoperative and follow-up hormone levels; four patients attempted to conceive after the procedure, and two successful pregnancies resulted.

Pelvic congestion syndrome is a real disease entity that affects up to 16% of American women, and can be successfully treated with transfemoral embolotherapy, according to researchers who presented data at the annual meeting of the Society of Interventional Radiology.

About 10% of gynecologic visits are due to chronic, noncyclic pelvic pain of greater than 6 months' duration, and a third of gynecologic laparoscopies are performed to investigate such pain. The differential diagnosis usually includes endometriosis, fibroids, adenomyosis, cysts, and tumors, among other potential causes. Pelvic congestion syndrome (PCS)—pelvic vein insufficiency that causes pooling of blood in the uterine and ovarian veins—is not often on the list, said Hyun S. “Kevin” Kim, M.D., of Johns Hopkins University, Baltimore

Even standard imaging studies don't always identify the disorder, Dr. Kim said in an interview.

“Only 40% of laparoscopic studies were able to visualize abnormal veins. On MRI, only 59% were diagnosed.”

Because PCS is difficult to diagnose, many physicians write off the symptoms—dull, typically unilateral pain that worsens during the day and with standing, dyspareunia, and dysuria—as psychosomatic, Dr. Kim said.

Varicocele, the male counterpart of PCS, has no such stigma, he added. In men, the gonadal vein terminates in the testicle, so the painful venous abnormalities are usually visually apparent. “This condition is accepted in men, because it occurs outside the body and we can see it. In women it's hidden, and this, I think, is part of the reason for misdiagnosis or underdiagnosis.”

The best way to diagnose PCS is with direct venography, said Dr. Kim, who presented the results of his long-term follow-up study on transcatheter embolization for the disorder at the meeting.

He performed 262 transfemoral ovarian venographies on 131 women (mean age 34 years) with chronic pelvic pain. Overall, 20% had a prior hysterectomy. About one-third of the patients had previous pregnancies; the rest were nulliparous. Venography confirmed the clinical suspicion of PCS in 127 of those women. The diagnostic criteria for PCS are:

▸ Ovarian vein, uterine vein, and utero-ovarian arcade venous engorgement greater than 5 mm in diameter.

▸ Free reflux of contrast in ovarian vein with incompetent valves.

▸ Filling of veins across the midline or filling of vulvar and/or thigh varicosities.

▸ Stagnant clearance of contrast from pelvic veins (more than 1 minute).

Patients with a confirmed diagnosis underwent baseline levels of follicle-stimulating hormone, estradiol, and luteinizing hormone, and transcatheter embolotherapy of the insufficient veins. This was done as an outpatient procedure. There were no major complications.

By a mean 45 months' follow-up, there was a mean pain decrease of 4.7 points on a visual analog scale. Most of the patients (85%) reported improvement, which was significant in 80%, moderate in 14%, and mild in 6%. There was no change in 12%, and pain was worse in 3%.

Women who reported pain improvement also reported significant improvement in symptoms such as dyspareunia, urinary frequency, and menstrual pain. A comparison of patient subgroups showed no differences in outcome between the nulliparous women and those with prior pregnancy.

There were no differences between preoperative and follow-up hormone levels; four patients attempted to conceive after the procedure, and two successful pregnancies resulted.

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New Treatment Approved for Endometriosis Pain : Depo subQ provera 104 is as effective as leuprolide acetate and is associated with fewer side effects.

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New Treatment Approved for Endometriosis Pain : Depo subQ provera 104 is as effective as leuprolide acetate and is associated with fewer side effects.

Subcutaneous medroxyprogesterone acetate has been approved for the treatment of endometriosis-related pelvic pain. It is the first new treatment to be approved for this indication in 15 years.

Depo subQ provera 104 (DMPA-SC), which contains 104 mg medroxyprogesterone acetate, treats endometriosis pain as effectively as leuprolide acetate, but is associated with significantly less bone loss and fewer vasomotor symptoms, according to data provided by Pfizer Inc., which manufactures the agent.

The Food and Drug Administration granted approval for the endometriosis pain indication in March. Depo subQ provera 104 received FDA approval for use as a contraceptive in December 2004. Pfizer said depo subQ provera 104 would be widely available this month.

Depo subQ provera 104 is a new formulation of medroxyprogesterone acetate, which is the active ingredient in Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable suspension), but with 30% less hormone.

Depo subQ provera 104 is available in prefilled syringes each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension.

Administered by subcutaneous injection four times a year (every 12–14 weeks), DMPA-SC halts menstruation, which results in thinner, more compact endometrial tissue, the company said. This in turn halts the growth of endometrial implants, relieving endometriosis-associated pain.

The package insert contains a black box warning concerning possible bone loss: Women who use DMPA-SC may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of depo subQ provera 104 during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk of osteoporotic fracture in later life. Depo subQ provera 104 should be used as a long-term birth control method (that is, longer than 2 years) only if other birth control methods are inadequate.

Pfizer's phase III randomized controlled trial showed that DMPA-SC is associated with significantly less bone loss than leuprolide acetate for depot suspension, the only other drug approved for treatment of endometriosis-related pain.

The 18-month study included 274 women aged 18–49 years who had diagnoses of endometriosis-associated pelvic pain. They were randomized to 6 months of treatment with either DMPA-SC (104 mg every 3 months) or leuprolide (11.25 mg IM every 3 months), and 12 months of follow-up.

There were no significant differences in pain symptom reduction. Women in both groups showed some bone mineral density declines at the end of treatment, but the mean losses were significantly less for women taking DMPA-SC in both the femur (0.3% vs. 1.65%) and the spine (1.1% vs. 3.95%).

In women who had been taking DMPA-SC, bone mineral density return to pretreatment levels 12 months after discontinuing treatment. Those who had been taking leuprolide showed continued bone mineral density losses of 1.3% in the femur and 1.7% in the spine.

DMPA-SC was also associated with significantly fewer vasomotor symptoms, especially hot flashes.

It's important to remember that the only cure for endometriosis is aggressive surgical excision, David Redwine, M.D., Endometriosis Association advisor, said in an interview. Surgery has been repeatedly shown to have a cure rate of about 60% in even resistant cases.

“Excision is the only treatment which has documentation of cure, although this information is typically withheld from patients as they consider their treatment options. The result is that patients undergo repeated rounds of medical therapies without eradication of their disease,” Dr. Redwine said. “Depo subQ 104 adds another form of medical therapy for endometriosis to be used by physicians who cannot treat the disease effectively by surgery.”

The bone loss associated with any hormonal therapy for symptoms is worrisome, he said, especially in women who are still actively laying down bone. “I am concerned about young women being exposed to medicines that do not treat a disease and that can produce systemic side effects, the permanency of which are not fully known,” said Dr. Redwine, medical director of the endometriosis treatment program at St. Charles Medical Center in Bend, Ore.

Daniel Watts, a Pfizer spokesman, said depo subQ provera 104 will offer a much-needed alternative to women who don't elect surgery.

“Not all patients are appropriate candidates for surgery,” Watts said in an interview with this newspaper.

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Subcutaneous medroxyprogesterone acetate has been approved for the treatment of endometriosis-related pelvic pain. It is the first new treatment to be approved for this indication in 15 years.

Depo subQ provera 104 (DMPA-SC), which contains 104 mg medroxyprogesterone acetate, treats endometriosis pain as effectively as leuprolide acetate, but is associated with significantly less bone loss and fewer vasomotor symptoms, according to data provided by Pfizer Inc., which manufactures the agent.

The Food and Drug Administration granted approval for the endometriosis pain indication in March. Depo subQ provera 104 received FDA approval for use as a contraceptive in December 2004. Pfizer said depo subQ provera 104 would be widely available this month.

Depo subQ provera 104 is a new formulation of medroxyprogesterone acetate, which is the active ingredient in Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable suspension), but with 30% less hormone.

Depo subQ provera 104 is available in prefilled syringes each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension.

Administered by subcutaneous injection four times a year (every 12–14 weeks), DMPA-SC halts menstruation, which results in thinner, more compact endometrial tissue, the company said. This in turn halts the growth of endometrial implants, relieving endometriosis-associated pain.

The package insert contains a black box warning concerning possible bone loss: Women who use DMPA-SC may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of depo subQ provera 104 during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk of osteoporotic fracture in later life. Depo subQ provera 104 should be used as a long-term birth control method (that is, longer than 2 years) only if other birth control methods are inadequate.

Pfizer's phase III randomized controlled trial showed that DMPA-SC is associated with significantly less bone loss than leuprolide acetate for depot suspension, the only other drug approved for treatment of endometriosis-related pain.

The 18-month study included 274 women aged 18–49 years who had diagnoses of endometriosis-associated pelvic pain. They were randomized to 6 months of treatment with either DMPA-SC (104 mg every 3 months) or leuprolide (11.25 mg IM every 3 months), and 12 months of follow-up.

There were no significant differences in pain symptom reduction. Women in both groups showed some bone mineral density declines at the end of treatment, but the mean losses were significantly less for women taking DMPA-SC in both the femur (0.3% vs. 1.65%) and the spine (1.1% vs. 3.95%).

In women who had been taking DMPA-SC, bone mineral density return to pretreatment levels 12 months after discontinuing treatment. Those who had been taking leuprolide showed continued bone mineral density losses of 1.3% in the femur and 1.7% in the spine.

DMPA-SC was also associated with significantly fewer vasomotor symptoms, especially hot flashes.

It's important to remember that the only cure for endometriosis is aggressive surgical excision, David Redwine, M.D., Endometriosis Association advisor, said in an interview. Surgery has been repeatedly shown to have a cure rate of about 60% in even resistant cases.

“Excision is the only treatment which has documentation of cure, although this information is typically withheld from patients as they consider their treatment options. The result is that patients undergo repeated rounds of medical therapies without eradication of their disease,” Dr. Redwine said. “Depo subQ 104 adds another form of medical therapy for endometriosis to be used by physicians who cannot treat the disease effectively by surgery.”

The bone loss associated with any hormonal therapy for symptoms is worrisome, he said, especially in women who are still actively laying down bone. “I am concerned about young women being exposed to medicines that do not treat a disease and that can produce systemic side effects, the permanency of which are not fully known,” said Dr. Redwine, medical director of the endometriosis treatment program at St. Charles Medical Center in Bend, Ore.

Daniel Watts, a Pfizer spokesman, said depo subQ provera 104 will offer a much-needed alternative to women who don't elect surgery.

“Not all patients are appropriate candidates for surgery,” Watts said in an interview with this newspaper.

Subcutaneous medroxyprogesterone acetate has been approved for the treatment of endometriosis-related pelvic pain. It is the first new treatment to be approved for this indication in 15 years.

Depo subQ provera 104 (DMPA-SC), which contains 104 mg medroxyprogesterone acetate, treats endometriosis pain as effectively as leuprolide acetate, but is associated with significantly less bone loss and fewer vasomotor symptoms, according to data provided by Pfizer Inc., which manufactures the agent.

The Food and Drug Administration granted approval for the endometriosis pain indication in March. Depo subQ provera 104 received FDA approval for use as a contraceptive in December 2004. Pfizer said depo subQ provera 104 would be widely available this month.

Depo subQ provera 104 is a new formulation of medroxyprogesterone acetate, which is the active ingredient in Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable suspension), but with 30% less hormone.

Depo subQ provera 104 is available in prefilled syringes each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension.

Administered by subcutaneous injection four times a year (every 12–14 weeks), DMPA-SC halts menstruation, which results in thinner, more compact endometrial tissue, the company said. This in turn halts the growth of endometrial implants, relieving endometriosis-associated pain.

The package insert contains a black box warning concerning possible bone loss: Women who use DMPA-SC may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of depo subQ provera 104 during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk of osteoporotic fracture in later life. Depo subQ provera 104 should be used as a long-term birth control method (that is, longer than 2 years) only if other birth control methods are inadequate.

Pfizer's phase III randomized controlled trial showed that DMPA-SC is associated with significantly less bone loss than leuprolide acetate for depot suspension, the only other drug approved for treatment of endometriosis-related pain.

The 18-month study included 274 women aged 18–49 years who had diagnoses of endometriosis-associated pelvic pain. They were randomized to 6 months of treatment with either DMPA-SC (104 mg every 3 months) or leuprolide (11.25 mg IM every 3 months), and 12 months of follow-up.

There were no significant differences in pain symptom reduction. Women in both groups showed some bone mineral density declines at the end of treatment, but the mean losses were significantly less for women taking DMPA-SC in both the femur (0.3% vs. 1.65%) and the spine (1.1% vs. 3.95%).

In women who had been taking DMPA-SC, bone mineral density return to pretreatment levels 12 months after discontinuing treatment. Those who had been taking leuprolide showed continued bone mineral density losses of 1.3% in the femur and 1.7% in the spine.

DMPA-SC was also associated with significantly fewer vasomotor symptoms, especially hot flashes.

It's important to remember that the only cure for endometriosis is aggressive surgical excision, David Redwine, M.D., Endometriosis Association advisor, said in an interview. Surgery has been repeatedly shown to have a cure rate of about 60% in even resistant cases.

“Excision is the only treatment which has documentation of cure, although this information is typically withheld from patients as they consider their treatment options. The result is that patients undergo repeated rounds of medical therapies without eradication of their disease,” Dr. Redwine said. “Depo subQ 104 adds another form of medical therapy for endometriosis to be used by physicians who cannot treat the disease effectively by surgery.”

The bone loss associated with any hormonal therapy for symptoms is worrisome, he said, especially in women who are still actively laying down bone. “I am concerned about young women being exposed to medicines that do not treat a disease and that can produce systemic side effects, the permanency of which are not fully known,” said Dr. Redwine, medical director of the endometriosis treatment program at St. Charles Medical Center in Bend, Ore.

Daniel Watts, a Pfizer spokesman, said depo subQ provera 104 will offer a much-needed alternative to women who don't elect surgery.

“Not all patients are appropriate candidates for surgery,” Watts said in an interview with this newspaper.

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Treating Pelvic Congestion Eases Leg Venous Reflux Pain

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Treating Pelvic Congestion Eases Leg Venous Reflux Pain

Pelvic pain related to pelvic venous congestion often occurs in women with symptomatic lower extremity venous reflux. Treating ovarian venous incompetence with embolotherapy can not only reduce associated pelvic pain, but can also significantly reduce the pain associated with lower extremity reflux, according to Carl M. Black, M.D.

Because the disorders often occur together, Dr. Black of Provo, Utah, recommends that those with complex nonsaphenous superficial lower extremity venous insufficiency be questioned regarding concomitant symptoms of pelvic congestion.

Symptoms of pelvic congestion syndrome are heaviness in the pelvis with standing, low abdominal pain, painful varicosities in branches around the labia and vulva, and varicosities that emerge from the gluteal region and extend into the legs. “About 16% of women with varicose veins will say they have pelvic pain that cycles with their leg pain,” he said in an interview.

At the annual meeting of the Society of Interventional Radiology, Dr. Black presented the results of a study evaluating transcatheter embolization in patients with both disorders and included 160 women with symptomatic lower extremity superficial reflux. Each patient received a lower extremity venous duplex ultrasound, which included evaluation of atypical transpelvic venous reflux. Clinical and ultrasonographic findings suggested pelvic congestion syndrome in 26 (16%) women. All 26 had complex nonsaphenous patterns of lower extremity venous reflux.

Twenty-four of these patients underwent venography, which confirmed ovarian venous insufficiency in 22. These 22 patients had embolotherapy on the insufficient pelvic veins. Embolization was successful in 100%. After embolization, 19 (86%) had relief or significant reduction in pelvic pain and 14 (63%) reported reduction of both pelvic and lower extremity pain. After subsequent comprehensive treatment of remaining identifiable sources of lower extremity venous reflux, 20 of the 22 patients reported sustained overall treatment satisfaction, with 60% of patients having been followed between 6 and 12 months.

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Pelvic pain related to pelvic venous congestion often occurs in women with symptomatic lower extremity venous reflux. Treating ovarian venous incompetence with embolotherapy can not only reduce associated pelvic pain, but can also significantly reduce the pain associated with lower extremity reflux, according to Carl M. Black, M.D.

Because the disorders often occur together, Dr. Black of Provo, Utah, recommends that those with complex nonsaphenous superficial lower extremity venous insufficiency be questioned regarding concomitant symptoms of pelvic congestion.

Symptoms of pelvic congestion syndrome are heaviness in the pelvis with standing, low abdominal pain, painful varicosities in branches around the labia and vulva, and varicosities that emerge from the gluteal region and extend into the legs. “About 16% of women with varicose veins will say they have pelvic pain that cycles with their leg pain,” he said in an interview.

At the annual meeting of the Society of Interventional Radiology, Dr. Black presented the results of a study evaluating transcatheter embolization in patients with both disorders and included 160 women with symptomatic lower extremity superficial reflux. Each patient received a lower extremity venous duplex ultrasound, which included evaluation of atypical transpelvic venous reflux. Clinical and ultrasonographic findings suggested pelvic congestion syndrome in 26 (16%) women. All 26 had complex nonsaphenous patterns of lower extremity venous reflux.

Twenty-four of these patients underwent venography, which confirmed ovarian venous insufficiency in 22. These 22 patients had embolotherapy on the insufficient pelvic veins. Embolization was successful in 100%. After embolization, 19 (86%) had relief or significant reduction in pelvic pain and 14 (63%) reported reduction of both pelvic and lower extremity pain. After subsequent comprehensive treatment of remaining identifiable sources of lower extremity venous reflux, 20 of the 22 patients reported sustained overall treatment satisfaction, with 60% of patients having been followed between 6 and 12 months.

Pelvic pain related to pelvic venous congestion often occurs in women with symptomatic lower extremity venous reflux. Treating ovarian venous incompetence with embolotherapy can not only reduce associated pelvic pain, but can also significantly reduce the pain associated with lower extremity reflux, according to Carl M. Black, M.D.

Because the disorders often occur together, Dr. Black of Provo, Utah, recommends that those with complex nonsaphenous superficial lower extremity venous insufficiency be questioned regarding concomitant symptoms of pelvic congestion.

Symptoms of pelvic congestion syndrome are heaviness in the pelvis with standing, low abdominal pain, painful varicosities in branches around the labia and vulva, and varicosities that emerge from the gluteal region and extend into the legs. “About 16% of women with varicose veins will say they have pelvic pain that cycles with their leg pain,” he said in an interview.

At the annual meeting of the Society of Interventional Radiology, Dr. Black presented the results of a study evaluating transcatheter embolization in patients with both disorders and included 160 women with symptomatic lower extremity superficial reflux. Each patient received a lower extremity venous duplex ultrasound, which included evaluation of atypical transpelvic venous reflux. Clinical and ultrasonographic findings suggested pelvic congestion syndrome in 26 (16%) women. All 26 had complex nonsaphenous patterns of lower extremity venous reflux.

Twenty-four of these patients underwent venography, which confirmed ovarian venous insufficiency in 22. These 22 patients had embolotherapy on the insufficient pelvic veins. Embolization was successful in 100%. After embolization, 19 (86%) had relief or significant reduction in pelvic pain and 14 (63%) reported reduction of both pelvic and lower extremity pain. After subsequent comprehensive treatment of remaining identifiable sources of lower extremity venous reflux, 20 of the 22 patients reported sustained overall treatment satisfaction, with 60% of patients having been followed between 6 and 12 months.

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Embolotherapy Eases Pelvic Congestion : In 131 women who had the procedure, 85% reported improvement at a mean 45 months' follow-up.

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Pelvic congestion syndrome is a real disease entity that affects up to 16% of American women, and can be successfully treated with transfemoral embolotherapy, according to researchers who presented data at the annual meeting of the Society of Interventional Radiology.

About 10% of gynecologic visits are due to chronic, noncyclic pelvic pain of greater than 6 months' duration, and a third of gynecologic laparoscopies are performed to investigate such pain. The differential diagnosis usually includes endometriosis, fibroids, adenomyosis, cysts, and tumors, among other potential causes. Pelvic congestion syndrome (PCS)—pelvic vein insufficiency that causes pooling of blood in the uterine and ovarian veins—is not often on the list, said Hyun S. “Kevin” Kim, M.D., of Johns Hopkins University, Baltimore.

Even standard imaging studies don't always identify the disorder, Dr. Kim said in an interview.

“Only 40% of laparoscopic studies were able to visualize abnormal veins. On MRI, only 59% were diagnosed. This is because these venous abnormalities are caused by physiologic conditions that change during the exam; when you lie down, your heart is at the same level as your pelvis, and all the blood will be quickly decompressed,” Dr. Kim said.

Because PCS is difficult to diagnose, many physicians write off the symptoms—dull, typically unilateral pain that worsens during the day and with standing, dyspareunia, and dysuria—as psychosomatic, said Dr. Kim.

Varicocele, the male counterpart of PCS, has no such stigma, he added. In men, the gonadal vein terminates in the testicle, so the painful venous abnormalities are usually visually apparent.

“This condition is accepted in men, because it occurs outside the body and we can see it. In women it's hidden, and this, I think, is part of the reason for misdiagnosis or underdiagnosis,” Dr. Kim said.

Many women with chronic pelvic pain undergo ineffective therapies, including hormonal treatment, or hysterectomy with or without oophorectomy. Hysterectomy is not always effective for pain relief in PCS; about 33% have residual pain by 1 year, and there is a 20% incidence of recurrent pain.

The best way to diagnose PCS is with direct venography, said Dr. Kim, who presented the results of his long-term follow-up study on transcatheter embolization for the disorder at the meeting.

He performed 262 transfemoral ovarian venographies on 131 women (mean age 34 years) with chronic pelvic pain. Twenty percent had a prior hysterectomy. About one-third of the patients had previous pregnancies; the rest were nulliparous.

Venography confirmed the clinical suspicion of PCS in 127 of those women. The diagnostic criteria for OCS are:

PIOvarian vein, uterine vein, and utero-ovarian arcade venous engorgement greater than 5 mm in diameter.

PIFree reflux of contrast in ovarian vein with incompetent valves.

PIFilling of veins across the midline or filling of vulvar and/or thigh varicosities.

PIStagnant clearance of contrast from pelvic veins (more than 1 minute).

Patients with a confirmed diagnosis underwent baseline levels of follicle-stimulating hormone, estradiol, and luteinizing hormone, and transcatheter embolotherapy of the insufficient veins. This was done as an outpatient procedure. There were no major complications.

By a mean 45 months' follow-up, there was a mean pain decrease of 4.7 points on a visual analog scale. Most of the patients (85%) reported improvement, which was significant in 80%, moderate in 14%, and mild in 6%. There was no change in 12%, and pain was worse in 3%.

Women who reported pain improvement also reported significant improvement in other symptoms, including dyspareunia, urinary frequency, and menstrual pain.

When patient subgroups were compared, there were no differences in outcome between the nulliparous women and those with prior pregnancy or those who had hysterectomy and those who had not.

There were no differences between preoperative and follow-up hormone levels; four patients attempted to conceive after the procedure, and two successful pregnancies resulted.

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Pelvic congestion syndrome is a real disease entity that affects up to 16% of American women, and can be successfully treated with transfemoral embolotherapy, according to researchers who presented data at the annual meeting of the Society of Interventional Radiology.

About 10% of gynecologic visits are due to chronic, noncyclic pelvic pain of greater than 6 months' duration, and a third of gynecologic laparoscopies are performed to investigate such pain. The differential diagnosis usually includes endometriosis, fibroids, adenomyosis, cysts, and tumors, among other potential causes. Pelvic congestion syndrome (PCS)—pelvic vein insufficiency that causes pooling of blood in the uterine and ovarian veins—is not often on the list, said Hyun S. “Kevin” Kim, M.D., of Johns Hopkins University, Baltimore.

Even standard imaging studies don't always identify the disorder, Dr. Kim said in an interview.

“Only 40% of laparoscopic studies were able to visualize abnormal veins. On MRI, only 59% were diagnosed. This is because these venous abnormalities are caused by physiologic conditions that change during the exam; when you lie down, your heart is at the same level as your pelvis, and all the blood will be quickly decompressed,” Dr. Kim said.

Because PCS is difficult to diagnose, many physicians write off the symptoms—dull, typically unilateral pain that worsens during the day and with standing, dyspareunia, and dysuria—as psychosomatic, said Dr. Kim.

Varicocele, the male counterpart of PCS, has no such stigma, he added. In men, the gonadal vein terminates in the testicle, so the painful venous abnormalities are usually visually apparent.

“This condition is accepted in men, because it occurs outside the body and we can see it. In women it's hidden, and this, I think, is part of the reason for misdiagnosis or underdiagnosis,” Dr. Kim said.

Many women with chronic pelvic pain undergo ineffective therapies, including hormonal treatment, or hysterectomy with or without oophorectomy. Hysterectomy is not always effective for pain relief in PCS; about 33% have residual pain by 1 year, and there is a 20% incidence of recurrent pain.

The best way to diagnose PCS is with direct venography, said Dr. Kim, who presented the results of his long-term follow-up study on transcatheter embolization for the disorder at the meeting.

He performed 262 transfemoral ovarian venographies on 131 women (mean age 34 years) with chronic pelvic pain. Twenty percent had a prior hysterectomy. About one-third of the patients had previous pregnancies; the rest were nulliparous.

Venography confirmed the clinical suspicion of PCS in 127 of those women. The diagnostic criteria for OCS are:

PIOvarian vein, uterine vein, and utero-ovarian arcade venous engorgement greater than 5 mm in diameter.

PIFree reflux of contrast in ovarian vein with incompetent valves.

PIFilling of veins across the midline or filling of vulvar and/or thigh varicosities.

PIStagnant clearance of contrast from pelvic veins (more than 1 minute).

Patients with a confirmed diagnosis underwent baseline levels of follicle-stimulating hormone, estradiol, and luteinizing hormone, and transcatheter embolotherapy of the insufficient veins. This was done as an outpatient procedure. There were no major complications.

By a mean 45 months' follow-up, there was a mean pain decrease of 4.7 points on a visual analog scale. Most of the patients (85%) reported improvement, which was significant in 80%, moderate in 14%, and mild in 6%. There was no change in 12%, and pain was worse in 3%.

Women who reported pain improvement also reported significant improvement in other symptoms, including dyspareunia, urinary frequency, and menstrual pain.

When patient subgroups were compared, there were no differences in outcome between the nulliparous women and those with prior pregnancy or those who had hysterectomy and those who had not.

There were no differences between preoperative and follow-up hormone levels; four patients attempted to conceive after the procedure, and two successful pregnancies resulted.

Pelvic congestion syndrome is a real disease entity that affects up to 16% of American women, and can be successfully treated with transfemoral embolotherapy, according to researchers who presented data at the annual meeting of the Society of Interventional Radiology.

About 10% of gynecologic visits are due to chronic, noncyclic pelvic pain of greater than 6 months' duration, and a third of gynecologic laparoscopies are performed to investigate such pain. The differential diagnosis usually includes endometriosis, fibroids, adenomyosis, cysts, and tumors, among other potential causes. Pelvic congestion syndrome (PCS)—pelvic vein insufficiency that causes pooling of blood in the uterine and ovarian veins—is not often on the list, said Hyun S. “Kevin” Kim, M.D., of Johns Hopkins University, Baltimore.

Even standard imaging studies don't always identify the disorder, Dr. Kim said in an interview.

“Only 40% of laparoscopic studies were able to visualize abnormal veins. On MRI, only 59% were diagnosed. This is because these venous abnormalities are caused by physiologic conditions that change during the exam; when you lie down, your heart is at the same level as your pelvis, and all the blood will be quickly decompressed,” Dr. Kim said.

Because PCS is difficult to diagnose, many physicians write off the symptoms—dull, typically unilateral pain that worsens during the day and with standing, dyspareunia, and dysuria—as psychosomatic, said Dr. Kim.

Varicocele, the male counterpart of PCS, has no such stigma, he added. In men, the gonadal vein terminates in the testicle, so the painful venous abnormalities are usually visually apparent.

“This condition is accepted in men, because it occurs outside the body and we can see it. In women it's hidden, and this, I think, is part of the reason for misdiagnosis or underdiagnosis,” Dr. Kim said.

Many women with chronic pelvic pain undergo ineffective therapies, including hormonal treatment, or hysterectomy with or without oophorectomy. Hysterectomy is not always effective for pain relief in PCS; about 33% have residual pain by 1 year, and there is a 20% incidence of recurrent pain.

The best way to diagnose PCS is with direct venography, said Dr. Kim, who presented the results of his long-term follow-up study on transcatheter embolization for the disorder at the meeting.

He performed 262 transfemoral ovarian venographies on 131 women (mean age 34 years) with chronic pelvic pain. Twenty percent had a prior hysterectomy. About one-third of the patients had previous pregnancies; the rest were nulliparous.

Venography confirmed the clinical suspicion of PCS in 127 of those women. The diagnostic criteria for OCS are:

PIOvarian vein, uterine vein, and utero-ovarian arcade venous engorgement greater than 5 mm in diameter.

PIFree reflux of contrast in ovarian vein with incompetent valves.

PIFilling of veins across the midline or filling of vulvar and/or thigh varicosities.

PIStagnant clearance of contrast from pelvic veins (more than 1 minute).

Patients with a confirmed diagnosis underwent baseline levels of follicle-stimulating hormone, estradiol, and luteinizing hormone, and transcatheter embolotherapy of the insufficient veins. This was done as an outpatient procedure. There were no major complications.

By a mean 45 months' follow-up, there was a mean pain decrease of 4.7 points on a visual analog scale. Most of the patients (85%) reported improvement, which was significant in 80%, moderate in 14%, and mild in 6%. There was no change in 12%, and pain was worse in 3%.

Women who reported pain improvement also reported significant improvement in other symptoms, including dyspareunia, urinary frequency, and menstrual pain.

When patient subgroups were compared, there were no differences in outcome between the nulliparous women and those with prior pregnancy or those who had hysterectomy and those who had not.

There were no differences between preoperative and follow-up hormone levels; four patients attempted to conceive after the procedure, and two successful pregnancies resulted.

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Possible Genetic Basis for Racial Disparities in Endometrial Ca

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Differences in gene expression may be at least partially responsible for the differences in endometrial cancer survival rates and tumor aggression seen between black and white women, results of two studies suggest.

Many previous studies have ascribed racial disparities in endometrial cancer outcome to less aggressive treatment. The two new studies, which were presented at the annual meeting of the Society of Gynecologic Oncologists, identified a racial disparity in endometrial cancer even in a health care setting where patients receive similar care and suggested a genetic role for differences in outcome, according to Lt. Col. C.G. Larry Maxwell, MC, USA, the studies' lead investigator.

In the first study, the investigators compared tumor aggression and survival rates between 168 blacks and 997 whites with stage III, IV, or recurrent endometrial cancer. The data were drawn from four randomized controlled treatment trials performed by the Gynecologic Oncology Group of Roswell Park Cancer Institute, Buffalo, N.Y.

All patients received chemotherapy with doxorubicin alone or in combination with paclitaxel and/or cisplatin.

Blacks were more likely to have advanced stage disease and poorly differentiated and nonendometrioid tumors—all of which are associated with increased mortality. After adjusting for clinical and treatment factors using multivariate regression, blacks had a 25% increased relative risk of death, compared with whites. The overall survival rate was 10.6 months for blacks and 12.2 months for whites.

“This study clearly shows a survival disadvantage for blacks, even when they are treated as aggressively as whites,” Dr. Maxwell, director of the Gynecologic Disease Center at Walter Reed Army Medical Center, Washington, said in an interview.

“This is extremely important because many prior investigators primarily have attributed the poor survival in African Americans to unequal treatment,” he added.

The second study examined gene expression in 45 fresh frozen endometrial tumors. No differences in expression were found between the races in the first analysis, which included early-stage tumors. But when the researchers analyzed only the 28 advanced tumors (stage II, III, or IV; 10 black, 14 white), clustering emerged. There were 325 genetic transcripts that were differently expressed between the groups, and 66 were differentially expressed by at least twofold.

Among these genes were phosphoserine phosphatase (PSPH), which was most unregulated; Ras-related associated with diabetes (RRAD); and two genes associated with insulin-like growth factor, insulin-like growth factor 1 receptor (IGF1R) and a variant, IMP-2.

The IGF1R is a very important finding, as IGF can support the growth of cancer cells, especially endometrial cancer cells. There also may be a link between some of these differentially expressed genes and obesity, diabetes, and hormonal milieu, he said.

PSPH is an enzyme that catalyzes the last step in the biosynthesis of serine from carbohydrates, he noted. “One paper has linked it to gastric carcinoma metastasis.”

The studies' conclusions do not mean that blacks and whites are genetically different, Dr. Maxwell stressed—only that the genes are differently expressed. “The genes may be structurally similar, but there may be environmental influences between the two races that result in epigenetic modulation of gene upregulation or downregulation,” he said. “Genes have promoters that can be affected by environmental exposures, such as diet or hormones.”

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Differences in gene expression may be at least partially responsible for the differences in endometrial cancer survival rates and tumor aggression seen between black and white women, results of two studies suggest.

Many previous studies have ascribed racial disparities in endometrial cancer outcome to less aggressive treatment. The two new studies, which were presented at the annual meeting of the Society of Gynecologic Oncologists, identified a racial disparity in endometrial cancer even in a health care setting where patients receive similar care and suggested a genetic role for differences in outcome, according to Lt. Col. C.G. Larry Maxwell, MC, USA, the studies' lead investigator.

In the first study, the investigators compared tumor aggression and survival rates between 168 blacks and 997 whites with stage III, IV, or recurrent endometrial cancer. The data were drawn from four randomized controlled treatment trials performed by the Gynecologic Oncology Group of Roswell Park Cancer Institute, Buffalo, N.Y.

All patients received chemotherapy with doxorubicin alone or in combination with paclitaxel and/or cisplatin.

Blacks were more likely to have advanced stage disease and poorly differentiated and nonendometrioid tumors—all of which are associated with increased mortality. After adjusting for clinical and treatment factors using multivariate regression, blacks had a 25% increased relative risk of death, compared with whites. The overall survival rate was 10.6 months for blacks and 12.2 months for whites.

“This study clearly shows a survival disadvantage for blacks, even when they are treated as aggressively as whites,” Dr. Maxwell, director of the Gynecologic Disease Center at Walter Reed Army Medical Center, Washington, said in an interview.

“This is extremely important because many prior investigators primarily have attributed the poor survival in African Americans to unequal treatment,” he added.

The second study examined gene expression in 45 fresh frozen endometrial tumors. No differences in expression were found between the races in the first analysis, which included early-stage tumors. But when the researchers analyzed only the 28 advanced tumors (stage II, III, or IV; 10 black, 14 white), clustering emerged. There were 325 genetic transcripts that were differently expressed between the groups, and 66 were differentially expressed by at least twofold.

Among these genes were phosphoserine phosphatase (PSPH), which was most unregulated; Ras-related associated with diabetes (RRAD); and two genes associated with insulin-like growth factor, insulin-like growth factor 1 receptor (IGF1R) and a variant, IMP-2.

The IGF1R is a very important finding, as IGF can support the growth of cancer cells, especially endometrial cancer cells. There also may be a link between some of these differentially expressed genes and obesity, diabetes, and hormonal milieu, he said.

PSPH is an enzyme that catalyzes the last step in the biosynthesis of serine from carbohydrates, he noted. “One paper has linked it to gastric carcinoma metastasis.”

The studies' conclusions do not mean that blacks and whites are genetically different, Dr. Maxwell stressed—only that the genes are differently expressed. “The genes may be structurally similar, but there may be environmental influences between the two races that result in epigenetic modulation of gene upregulation or downregulation,” he said. “Genes have promoters that can be affected by environmental exposures, such as diet or hormones.”

Differences in gene expression may be at least partially responsible for the differences in endometrial cancer survival rates and tumor aggression seen between black and white women, results of two studies suggest.

Many previous studies have ascribed racial disparities in endometrial cancer outcome to less aggressive treatment. The two new studies, which were presented at the annual meeting of the Society of Gynecologic Oncologists, identified a racial disparity in endometrial cancer even in a health care setting where patients receive similar care and suggested a genetic role for differences in outcome, according to Lt. Col. C.G. Larry Maxwell, MC, USA, the studies' lead investigator.

In the first study, the investigators compared tumor aggression and survival rates between 168 blacks and 997 whites with stage III, IV, or recurrent endometrial cancer. The data were drawn from four randomized controlled treatment trials performed by the Gynecologic Oncology Group of Roswell Park Cancer Institute, Buffalo, N.Y.

All patients received chemotherapy with doxorubicin alone or in combination with paclitaxel and/or cisplatin.

Blacks were more likely to have advanced stage disease and poorly differentiated and nonendometrioid tumors—all of which are associated with increased mortality. After adjusting for clinical and treatment factors using multivariate regression, blacks had a 25% increased relative risk of death, compared with whites. The overall survival rate was 10.6 months for blacks and 12.2 months for whites.

“This study clearly shows a survival disadvantage for blacks, even when they are treated as aggressively as whites,” Dr. Maxwell, director of the Gynecologic Disease Center at Walter Reed Army Medical Center, Washington, said in an interview.

“This is extremely important because many prior investigators primarily have attributed the poor survival in African Americans to unequal treatment,” he added.

The second study examined gene expression in 45 fresh frozen endometrial tumors. No differences in expression were found between the races in the first analysis, which included early-stage tumors. But when the researchers analyzed only the 28 advanced tumors (stage II, III, or IV; 10 black, 14 white), clustering emerged. There were 325 genetic transcripts that were differently expressed between the groups, and 66 were differentially expressed by at least twofold.

Among these genes were phosphoserine phosphatase (PSPH), which was most unregulated; Ras-related associated with diabetes (RRAD); and two genes associated with insulin-like growth factor, insulin-like growth factor 1 receptor (IGF1R) and a variant, IMP-2.

The IGF1R is a very important finding, as IGF can support the growth of cancer cells, especially endometrial cancer cells. There also may be a link between some of these differentially expressed genes and obesity, diabetes, and hormonal milieu, he said.

PSPH is an enzyme that catalyzes the last step in the biosynthesis of serine from carbohydrates, he noted. “One paper has linked it to gastric carcinoma metastasis.”

The studies' conclusions do not mean that blacks and whites are genetically different, Dr. Maxwell stressed—only that the genes are differently expressed. “The genes may be structurally similar, but there may be environmental influences between the two races that result in epigenetic modulation of gene upregulation or downregulation,” he said. “Genes have promoters that can be affected by environmental exposures, such as diet or hormones.”

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Suicide Attempt May Precede First Seizure

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NEW ORLEANS — Suicide attempt is associated with a fourfold increase in the risk of developing a first unprovoked seizure in adults and children older than 3 years, Dale Hesdorffer, Ph.D., said at the annual meeting of the American Epilepsy Society.

Major depression is associated with almost a doubling in the risk of first unprovoked seizure, she said.

“There's clearly an underlying susceptibility for all these problems,” said Dr. Hesdorffer of Columbia University, New York City.

“This has been shown in several studies, but we don't know what it could be. It's completely undetermined at this point.”

Dr. Hesdorffer presented the results of an Icelandic population-based case-control study that compared the rates of depression and suicide attempt and the number of depressive symptoms in subjects with and without a first unprovoked seizure. The study included 387 cases and 773 controls. Major depression prior to the onset of seizure occurred in 11% of cases and 6% of controls.

Among the cases, 6% had made a suicide attempt, compared with only 2% of controls. The association remained significant even after controlling for age, gender, number of depressive symptoms, and alcohol intake.

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NEW ORLEANS — Suicide attempt is associated with a fourfold increase in the risk of developing a first unprovoked seizure in adults and children older than 3 years, Dale Hesdorffer, Ph.D., said at the annual meeting of the American Epilepsy Society.

Major depression is associated with almost a doubling in the risk of first unprovoked seizure, she said.

“There's clearly an underlying susceptibility for all these problems,” said Dr. Hesdorffer of Columbia University, New York City.

“This has been shown in several studies, but we don't know what it could be. It's completely undetermined at this point.”

Dr. Hesdorffer presented the results of an Icelandic population-based case-control study that compared the rates of depression and suicide attempt and the number of depressive symptoms in subjects with and without a first unprovoked seizure. The study included 387 cases and 773 controls. Major depression prior to the onset of seizure occurred in 11% of cases and 6% of controls.

Among the cases, 6% had made a suicide attempt, compared with only 2% of controls. The association remained significant even after controlling for age, gender, number of depressive symptoms, and alcohol intake.

NEW ORLEANS — Suicide attempt is associated with a fourfold increase in the risk of developing a first unprovoked seizure in adults and children older than 3 years, Dale Hesdorffer, Ph.D., said at the annual meeting of the American Epilepsy Society.

Major depression is associated with almost a doubling in the risk of first unprovoked seizure, she said.

“There's clearly an underlying susceptibility for all these problems,” said Dr. Hesdorffer of Columbia University, New York City.

“This has been shown in several studies, but we don't know what it could be. It's completely undetermined at this point.”

Dr. Hesdorffer presented the results of an Icelandic population-based case-control study that compared the rates of depression and suicide attempt and the number of depressive symptoms in subjects with and without a first unprovoked seizure. The study included 387 cases and 773 controls. Major depression prior to the onset of seizure occurred in 11% of cases and 6% of controls.

Among the cases, 6% had made a suicide attempt, compared with only 2% of controls. The association remained significant even after controlling for age, gender, number of depressive symptoms, and alcohol intake.

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Sarcoidosis on Black Skin 'Can Really Fool You'

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NEW ORLEANS — Because of its myriad presentations on black skin, sarcoidosis can be called “the great imitator,” Rebat Halder, M.D., said at the annual meeting of the American Academy of Dermatology.

“The appearance on the skin can have many different morphologies,” said Dr. Halder, chair of the department of dermatology at Howard University, Washington.

“It can really fool you: The lesions can be macular, papular, ichthyosiform, nodular, ulcerative, vesicular, annular, or it can simply present as areas of hypopigmentation with no apparent inflammation.”

Sarcoidosis, characterized by noncaseating epithelioid granulomas that may affect any organ system, is uncommon in any group of patients. However, it is about 16 times more common in blacks than in whites, with an incidence of 35-65/100,000 among blacks. Black women in their fourth decade are most commonly affected, with an incidence of about 100/100,000, Dr. Halder said in an interview.

The etiology of sarcoidosis is unknown, although familial clustering has been observed.

For unknown reasons, sarcoidosis is often more aggressive and difficult to treat in blacks. They have a higher rate of relapse, are more likely to experience multiorgan involvement, and have a slightly higher mortality rate than whites.

About 90% of patients have lung involvement, usually fibrosis due to granulomatous lesions.

Skin lesions appear in about 35% of patients. Other affected organs are the eyes, liver, heart, central nervous system, and spleen.

Any suspicious lesions should be biopsied. Typically, histology will show characteristic noncaseating granulomas. Since so many patients have lung involvement, a chest x-ray is imperative, Dr. Halder said. “If you suspect a skin lesion is sarcoidosis, you must search for the disease elsewhere in the body.”

Papular sarcoidosis consists of red-brown papules usually occurring on the face, around the eyes, nose, mouth, and nape of neck.

The papules can be larger, or quite fine, with the skin assuming a sandpaperlike texture, Dr. Halder said.

Lupus pernio lesions are red or purple indurated plaques usually occurring around the nose. These lesions can affect the nasal cartilage or bone and upper respiratory system as well.

Plaquelike sarcoidosis can occur anywhere on the skin, but is most common on the back of the neck and on the arms and legs.

This condition is characterized by round or oval, red-brown to purple, infiltrated plaques.

Ulcerative sarcoidosis can be especially debilitating, especially when it occurs on the palms of the hands or soles of the feet.

These lesions are small but can become quite deep, Dr. Halder commented.

Vesicular sarcoidosis can occur anywhere on the skin and can easily be confused with other blistering diseases or with skin infections.

Hypopigmented sarcoidosis is especially difficult to recognize, he said. “This presents only as areas of the skin without pigment. You would have to consider sarcoidosis along with hypopigmented cutaneous T-cell lymphoma, vitiligo, or tinea versicolor. Again, biopsy is crucial to diagnosis.”

Treatment for skin lesions usually consists of topical or intralesional steroids.

Extensive or recalcitrant disease requires more aggressive treatment, which includes drugs such as oral steroids, methotrexate, allopurinol, thalidomide, or oral retinoids.

There has been some success with infliximab as well, Dr. Halder said.

Adjunctive phototherapy is useful for hypopigmented sarcoidosis, the investigator said.

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NEW ORLEANS — Because of its myriad presentations on black skin, sarcoidosis can be called “the great imitator,” Rebat Halder, M.D., said at the annual meeting of the American Academy of Dermatology.

“The appearance on the skin can have many different morphologies,” said Dr. Halder, chair of the department of dermatology at Howard University, Washington.

“It can really fool you: The lesions can be macular, papular, ichthyosiform, nodular, ulcerative, vesicular, annular, or it can simply present as areas of hypopigmentation with no apparent inflammation.”

Sarcoidosis, characterized by noncaseating epithelioid granulomas that may affect any organ system, is uncommon in any group of patients. However, it is about 16 times more common in blacks than in whites, with an incidence of 35-65/100,000 among blacks. Black women in their fourth decade are most commonly affected, with an incidence of about 100/100,000, Dr. Halder said in an interview.

The etiology of sarcoidosis is unknown, although familial clustering has been observed.

For unknown reasons, sarcoidosis is often more aggressive and difficult to treat in blacks. They have a higher rate of relapse, are more likely to experience multiorgan involvement, and have a slightly higher mortality rate than whites.

About 90% of patients have lung involvement, usually fibrosis due to granulomatous lesions.

Skin lesions appear in about 35% of patients. Other affected organs are the eyes, liver, heart, central nervous system, and spleen.

Any suspicious lesions should be biopsied. Typically, histology will show characteristic noncaseating granulomas. Since so many patients have lung involvement, a chest x-ray is imperative, Dr. Halder said. “If you suspect a skin lesion is sarcoidosis, you must search for the disease elsewhere in the body.”

Papular sarcoidosis consists of red-brown papules usually occurring on the face, around the eyes, nose, mouth, and nape of neck.

The papules can be larger, or quite fine, with the skin assuming a sandpaperlike texture, Dr. Halder said.

Lupus pernio lesions are red or purple indurated plaques usually occurring around the nose. These lesions can affect the nasal cartilage or bone and upper respiratory system as well.

Plaquelike sarcoidosis can occur anywhere on the skin, but is most common on the back of the neck and on the arms and legs.

This condition is characterized by round or oval, red-brown to purple, infiltrated plaques.

Ulcerative sarcoidosis can be especially debilitating, especially when it occurs on the palms of the hands or soles of the feet.

These lesions are small but can become quite deep, Dr. Halder commented.

Vesicular sarcoidosis can occur anywhere on the skin and can easily be confused with other blistering diseases or with skin infections.

Hypopigmented sarcoidosis is especially difficult to recognize, he said. “This presents only as areas of the skin without pigment. You would have to consider sarcoidosis along with hypopigmented cutaneous T-cell lymphoma, vitiligo, or tinea versicolor. Again, biopsy is crucial to diagnosis.”

Treatment for skin lesions usually consists of topical or intralesional steroids.

Extensive or recalcitrant disease requires more aggressive treatment, which includes drugs such as oral steroids, methotrexate, allopurinol, thalidomide, or oral retinoids.

There has been some success with infliximab as well, Dr. Halder said.

Adjunctive phototherapy is useful for hypopigmented sarcoidosis, the investigator said.

NEW ORLEANS — Because of its myriad presentations on black skin, sarcoidosis can be called “the great imitator,” Rebat Halder, M.D., said at the annual meeting of the American Academy of Dermatology.

“The appearance on the skin can have many different morphologies,” said Dr. Halder, chair of the department of dermatology at Howard University, Washington.

“It can really fool you: The lesions can be macular, papular, ichthyosiform, nodular, ulcerative, vesicular, annular, or it can simply present as areas of hypopigmentation with no apparent inflammation.”

Sarcoidosis, characterized by noncaseating epithelioid granulomas that may affect any organ system, is uncommon in any group of patients. However, it is about 16 times more common in blacks than in whites, with an incidence of 35-65/100,000 among blacks. Black women in their fourth decade are most commonly affected, with an incidence of about 100/100,000, Dr. Halder said in an interview.

The etiology of sarcoidosis is unknown, although familial clustering has been observed.

For unknown reasons, sarcoidosis is often more aggressive and difficult to treat in blacks. They have a higher rate of relapse, are more likely to experience multiorgan involvement, and have a slightly higher mortality rate than whites.

About 90% of patients have lung involvement, usually fibrosis due to granulomatous lesions.

Skin lesions appear in about 35% of patients. Other affected organs are the eyes, liver, heart, central nervous system, and spleen.

Any suspicious lesions should be biopsied. Typically, histology will show characteristic noncaseating granulomas. Since so many patients have lung involvement, a chest x-ray is imperative, Dr. Halder said. “If you suspect a skin lesion is sarcoidosis, you must search for the disease elsewhere in the body.”

Papular sarcoidosis consists of red-brown papules usually occurring on the face, around the eyes, nose, mouth, and nape of neck.

The papules can be larger, or quite fine, with the skin assuming a sandpaperlike texture, Dr. Halder said.

Lupus pernio lesions are red or purple indurated plaques usually occurring around the nose. These lesions can affect the nasal cartilage or bone and upper respiratory system as well.

Plaquelike sarcoidosis can occur anywhere on the skin, but is most common on the back of the neck and on the arms and legs.

This condition is characterized by round or oval, red-brown to purple, infiltrated plaques.

Ulcerative sarcoidosis can be especially debilitating, especially when it occurs on the palms of the hands or soles of the feet.

These lesions are small but can become quite deep, Dr. Halder commented.

Vesicular sarcoidosis can occur anywhere on the skin and can easily be confused with other blistering diseases or with skin infections.

Hypopigmented sarcoidosis is especially difficult to recognize, he said. “This presents only as areas of the skin without pigment. You would have to consider sarcoidosis along with hypopigmented cutaneous T-cell lymphoma, vitiligo, or tinea versicolor. Again, biopsy is crucial to diagnosis.”

Treatment for skin lesions usually consists of topical or intralesional steroids.

Extensive or recalcitrant disease requires more aggressive treatment, which includes drugs such as oral steroids, methotrexate, allopurinol, thalidomide, or oral retinoids.

There has been some success with infliximab as well, Dr. Halder said.

Adjunctive phototherapy is useful for hypopigmented sarcoidosis, the investigator said.

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Aspirin Is Better Than Warfarin for Intracranial Arterial Stenosis Patients

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High-dose aspirin is just as effective as warfarin in treating intracranial arterial stenosis, and appears much safer, Marc Chimowitz, M.B., and colleagues have reported.

“The common practice of administering warfarin rather than aspirin for symptomatic intracranial arterial stenosis is not supported by the results of this trial,” said Dr. Chimowitz of Emory University, Atlanta.

Enrollment in the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial ended early because of the high rate of serious adverse events in the warfarin patients. In addition to being safer for patients, the researchers said, aspirin therapy did not require constant monitoring of international normalized ratios (INRs) and treatment of warfarin-associated bleeding. Aspirin also is much cheaper, they noted (N. Engl. J. Med. 2005;352:1305-16).

Ralph Sacco, M.D., an investigator in the Northern Manhattan Stroke Study, noted in an interview that the WASID trial's findings add to existing data to dispel beliefs about the benefit of warfarin for certain stroke populations.

The conclusion that warfarin provides no survival benefit over aspirin, but confers added risk, is more expensive, and requires intensive monitoring, should reshape its risk/benefit profile for some patients, said Dr. Sacco, professor of neurology and epidemiology at Columbia University, New York.

Dr. Chimowitz and his associates reported on the trial's final analysis that included 569 patients with symptomatic intracranial arterial stenosis who were randomized to either warfarin 5 mg daily or aspirin 650 mg twice daily.

The patients' mean age was about 63 years; about 61% were men. All had a history of either stroke or transient ischemic attack caused by 50%-90% stenosis of a major intracranial artery. The mean follow-up was 1.8 years.

The primary outcome—stroke, brain hemorrhage, or death from vascular causes other than stroke—occurred in 22% (62) of the aspirin patients and 21.8% (63) of the warfarin patients. Myocardial infarction or sudden death occurred significantly more often in the warfarin group than in the aspirin group (7.3% vs. 2.9%).

The overall rate of death was significantly higher in the warfarin group than in the aspirin group: 5.9% (17) vs. 4.3% (12). However, chance probably accounted for some of the deaths that were higher in the warfarin group, especially the six cancers. Major hemorrhages occurred significantly more often in the warfarin group (8.3% vs 3.2%).

Dr. Sacco noted that warfarin is “clearly indicated” for cardioembolic stroke. “This has been made clear in multiple studies, which were actually so positive that they were the springboard for these other studies looking at warfarin in different populations.”

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High-dose aspirin is just as effective as warfarin in treating intracranial arterial stenosis, and appears much safer, Marc Chimowitz, M.B., and colleagues have reported.

“The common practice of administering warfarin rather than aspirin for symptomatic intracranial arterial stenosis is not supported by the results of this trial,” said Dr. Chimowitz of Emory University, Atlanta.

Enrollment in the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial ended early because of the high rate of serious adverse events in the warfarin patients. In addition to being safer for patients, the researchers said, aspirin therapy did not require constant monitoring of international normalized ratios (INRs) and treatment of warfarin-associated bleeding. Aspirin also is much cheaper, they noted (N. Engl. J. Med. 2005;352:1305-16).

Ralph Sacco, M.D., an investigator in the Northern Manhattan Stroke Study, noted in an interview that the WASID trial's findings add to existing data to dispel beliefs about the benefit of warfarin for certain stroke populations.

The conclusion that warfarin provides no survival benefit over aspirin, but confers added risk, is more expensive, and requires intensive monitoring, should reshape its risk/benefit profile for some patients, said Dr. Sacco, professor of neurology and epidemiology at Columbia University, New York.

Dr. Chimowitz and his associates reported on the trial's final analysis that included 569 patients with symptomatic intracranial arterial stenosis who were randomized to either warfarin 5 mg daily or aspirin 650 mg twice daily.

The patients' mean age was about 63 years; about 61% were men. All had a history of either stroke or transient ischemic attack caused by 50%-90% stenosis of a major intracranial artery. The mean follow-up was 1.8 years.

The primary outcome—stroke, brain hemorrhage, or death from vascular causes other than stroke—occurred in 22% (62) of the aspirin patients and 21.8% (63) of the warfarin patients. Myocardial infarction or sudden death occurred significantly more often in the warfarin group than in the aspirin group (7.3% vs. 2.9%).

The overall rate of death was significantly higher in the warfarin group than in the aspirin group: 5.9% (17) vs. 4.3% (12). However, chance probably accounted for some of the deaths that were higher in the warfarin group, especially the six cancers. Major hemorrhages occurred significantly more often in the warfarin group (8.3% vs 3.2%).

Dr. Sacco noted that warfarin is “clearly indicated” for cardioembolic stroke. “This has been made clear in multiple studies, which were actually so positive that they were the springboard for these other studies looking at warfarin in different populations.”

High-dose aspirin is just as effective as warfarin in treating intracranial arterial stenosis, and appears much safer, Marc Chimowitz, M.B., and colleagues have reported.

“The common practice of administering warfarin rather than aspirin for symptomatic intracranial arterial stenosis is not supported by the results of this trial,” said Dr. Chimowitz of Emory University, Atlanta.

Enrollment in the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial ended early because of the high rate of serious adverse events in the warfarin patients. In addition to being safer for patients, the researchers said, aspirin therapy did not require constant monitoring of international normalized ratios (INRs) and treatment of warfarin-associated bleeding. Aspirin also is much cheaper, they noted (N. Engl. J. Med. 2005;352:1305-16).

Ralph Sacco, M.D., an investigator in the Northern Manhattan Stroke Study, noted in an interview that the WASID trial's findings add to existing data to dispel beliefs about the benefit of warfarin for certain stroke populations.

The conclusion that warfarin provides no survival benefit over aspirin, but confers added risk, is more expensive, and requires intensive monitoring, should reshape its risk/benefit profile for some patients, said Dr. Sacco, professor of neurology and epidemiology at Columbia University, New York.

Dr. Chimowitz and his associates reported on the trial's final analysis that included 569 patients with symptomatic intracranial arterial stenosis who were randomized to either warfarin 5 mg daily or aspirin 650 mg twice daily.

The patients' mean age was about 63 years; about 61% were men. All had a history of either stroke or transient ischemic attack caused by 50%-90% stenosis of a major intracranial artery. The mean follow-up was 1.8 years.

The primary outcome—stroke, brain hemorrhage, or death from vascular causes other than stroke—occurred in 22% (62) of the aspirin patients and 21.8% (63) of the warfarin patients. Myocardial infarction or sudden death occurred significantly more often in the warfarin group than in the aspirin group (7.3% vs. 2.9%).

The overall rate of death was significantly higher in the warfarin group than in the aspirin group: 5.9% (17) vs. 4.3% (12). However, chance probably accounted for some of the deaths that were higher in the warfarin group, especially the six cancers. Major hemorrhages occurred significantly more often in the warfarin group (8.3% vs 3.2%).

Dr. Sacco noted that warfarin is “clearly indicated” for cardioembolic stroke. “This has been made clear in multiple studies, which were actually so positive that they were the springboard for these other studies looking at warfarin in different populations.”

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Abstinence Pledges Don't Protect Against STDs

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Teens who take a sexual abstinence pledge delay their sexual debut for a few years, but they have just as many sexually transmitted infections as nonpledgers, probably because they are more likely to engage in noncoital sex and aren't as likely to use a condom during any sexual activity.

Hannah Brückner, Ph.D., and Peter Bearman, Ph.D., said their findings might put a new spin on programs that stress abstinence as the only way to avoid STDs and pregnancy. “The all-or-nothing approach … may create additional barriers to knowledge and protection for adolescents. For example, the emphasis on virginity may encourage adolescents to limit their sexual activity to noncoital behaviors, which may nevertheless expose them to risks of infection” (J. Adolesc. Health 2005;36:271-8).

Health care behavior by pledgers further complicates the problem, they noted. “It is important to know that pledgers are less likely than nonpledgers to be tested for STDs and to have ever seen a doctor because they are worried about an STD,” said the investigators of Yale University, New Haven, Conn. and Columbia University, New York.

The researchers extracted data gathered from 2001 to 2002, during the third wave of the National Longitudinal Study of Adolescent Health. During this wave, respondents were age 18-24 years. A total of 11,471 respondents provided urine samples for STD testing (chlamydia, gonorrhea, and trichomoniasis). An additional 3,317 sexually active female respondents were randomly selected for human papilloma virus (HPV) testing.

Pledge status was collected from all three waves of the survey. Nonpledgers reported no abstinence pledge during any of the waves. Consistent pledgers reported pledging during all waves or pledging for the first time during wave 3. Inconsistent pledgers reported pledging during an early wave but not a subsequent wave.

Most of the group (80%) were nonpledgers. Only 7% were consistent pledgers; 13% were inconsistent pledgers.

Consistent and inconsistent pledgers delayed their time to first coitus by several years, compared with nonpledgers. Among nonpledgers, 75% reported first intercourse by age 18. Inconsistent pledgers reached the 75th percentile by age 20, and consistent pledgers by age 24.

Male pledgers delayed intercourse the longest. By age 25, 25% of consistent male pledgers were still virgins, compared with 15% of inconsistent pledgers and 7% of nonpledgers. By age 25, 21% of female consistent pledgers were still virgins, compared with 10% of inconsistent pledgers and 6% of nonpledgers.

Delaying first intercourse had no significant effect on STD incidence in the groups, however. About 6.9% of nonpledgers, 6.4% of inconsistent pledgers, and 4.6% of consistent pledgers tested positive for trichomoniasis, chlamydia, and/or gonorrhea.

For HPV infection, the rates were 26.5% among nonpledgers, 28.5% among inconsistent pledgers, and 26.7% among consistent pledgers.

Pledgers did have fewer sexual partners than nonpledgers (average of 1.5 partners vs. 2.4 partners), and were not exposed as long to STD risk. However, they were more likely to engage in noncoital sexual contact.

About 3% of respondents reported oral sex but no vaginal sex. About 2% of nonpledgers fell into that group, compared with 13% of consistent pledgers and 5% of inconsistent pledgers. About 0.7% of nonpledgers reported anal sex but not vaginal sex, compared with 1.2% of pledgers.

About 1% of male nonpledgers reported anal, but not vaginal, sex, compared with 3% of male inconsistent pledgers and 4% of male consistent pledgers.

Condom use during these experiences was very low for all respondents: Only 4% reported using a condom during oral sex, and about 30% reported using one for anal sex.

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Teens who take a sexual abstinence pledge delay their sexual debut for a few years, but they have just as many sexually transmitted infections as nonpledgers, probably because they are more likely to engage in noncoital sex and aren't as likely to use a condom during any sexual activity.

Hannah Brückner, Ph.D., and Peter Bearman, Ph.D., said their findings might put a new spin on programs that stress abstinence as the only way to avoid STDs and pregnancy. “The all-or-nothing approach … may create additional barriers to knowledge and protection for adolescents. For example, the emphasis on virginity may encourage adolescents to limit their sexual activity to noncoital behaviors, which may nevertheless expose them to risks of infection” (J. Adolesc. Health 2005;36:271-8).

Health care behavior by pledgers further complicates the problem, they noted. “It is important to know that pledgers are less likely than nonpledgers to be tested for STDs and to have ever seen a doctor because they are worried about an STD,” said the investigators of Yale University, New Haven, Conn. and Columbia University, New York.

The researchers extracted data gathered from 2001 to 2002, during the third wave of the National Longitudinal Study of Adolescent Health. During this wave, respondents were age 18-24 years. A total of 11,471 respondents provided urine samples for STD testing (chlamydia, gonorrhea, and trichomoniasis). An additional 3,317 sexually active female respondents were randomly selected for human papilloma virus (HPV) testing.

Pledge status was collected from all three waves of the survey. Nonpledgers reported no abstinence pledge during any of the waves. Consistent pledgers reported pledging during all waves or pledging for the first time during wave 3. Inconsistent pledgers reported pledging during an early wave but not a subsequent wave.

Most of the group (80%) were nonpledgers. Only 7% were consistent pledgers; 13% were inconsistent pledgers.

Consistent and inconsistent pledgers delayed their time to first coitus by several years, compared with nonpledgers. Among nonpledgers, 75% reported first intercourse by age 18. Inconsistent pledgers reached the 75th percentile by age 20, and consistent pledgers by age 24.

Male pledgers delayed intercourse the longest. By age 25, 25% of consistent male pledgers were still virgins, compared with 15% of inconsistent pledgers and 7% of nonpledgers. By age 25, 21% of female consistent pledgers were still virgins, compared with 10% of inconsistent pledgers and 6% of nonpledgers.

Delaying first intercourse had no significant effect on STD incidence in the groups, however. About 6.9% of nonpledgers, 6.4% of inconsistent pledgers, and 4.6% of consistent pledgers tested positive for trichomoniasis, chlamydia, and/or gonorrhea.

For HPV infection, the rates were 26.5% among nonpledgers, 28.5% among inconsistent pledgers, and 26.7% among consistent pledgers.

Pledgers did have fewer sexual partners than nonpledgers (average of 1.5 partners vs. 2.4 partners), and were not exposed as long to STD risk. However, they were more likely to engage in noncoital sexual contact.

About 3% of respondents reported oral sex but no vaginal sex. About 2% of nonpledgers fell into that group, compared with 13% of consistent pledgers and 5% of inconsistent pledgers. About 0.7% of nonpledgers reported anal sex but not vaginal sex, compared with 1.2% of pledgers.

About 1% of male nonpledgers reported anal, but not vaginal, sex, compared with 3% of male inconsistent pledgers and 4% of male consistent pledgers.

Condom use during these experiences was very low for all respondents: Only 4% reported using a condom during oral sex, and about 30% reported using one for anal sex.

Teens who take a sexual abstinence pledge delay their sexual debut for a few years, but they have just as many sexually transmitted infections as nonpledgers, probably because they are more likely to engage in noncoital sex and aren't as likely to use a condom during any sexual activity.

Hannah Brückner, Ph.D., and Peter Bearman, Ph.D., said their findings might put a new spin on programs that stress abstinence as the only way to avoid STDs and pregnancy. “The all-or-nothing approach … may create additional barriers to knowledge and protection for adolescents. For example, the emphasis on virginity may encourage adolescents to limit their sexual activity to noncoital behaviors, which may nevertheless expose them to risks of infection” (J. Adolesc. Health 2005;36:271-8).

Health care behavior by pledgers further complicates the problem, they noted. “It is important to know that pledgers are less likely than nonpledgers to be tested for STDs and to have ever seen a doctor because they are worried about an STD,” said the investigators of Yale University, New Haven, Conn. and Columbia University, New York.

The researchers extracted data gathered from 2001 to 2002, during the third wave of the National Longitudinal Study of Adolescent Health. During this wave, respondents were age 18-24 years. A total of 11,471 respondents provided urine samples for STD testing (chlamydia, gonorrhea, and trichomoniasis). An additional 3,317 sexually active female respondents were randomly selected for human papilloma virus (HPV) testing.

Pledge status was collected from all three waves of the survey. Nonpledgers reported no abstinence pledge during any of the waves. Consistent pledgers reported pledging during all waves or pledging for the first time during wave 3. Inconsistent pledgers reported pledging during an early wave but not a subsequent wave.

Most of the group (80%) were nonpledgers. Only 7% were consistent pledgers; 13% were inconsistent pledgers.

Consistent and inconsistent pledgers delayed their time to first coitus by several years, compared with nonpledgers. Among nonpledgers, 75% reported first intercourse by age 18. Inconsistent pledgers reached the 75th percentile by age 20, and consistent pledgers by age 24.

Male pledgers delayed intercourse the longest. By age 25, 25% of consistent male pledgers were still virgins, compared with 15% of inconsistent pledgers and 7% of nonpledgers. By age 25, 21% of female consistent pledgers were still virgins, compared with 10% of inconsistent pledgers and 6% of nonpledgers.

Delaying first intercourse had no significant effect on STD incidence in the groups, however. About 6.9% of nonpledgers, 6.4% of inconsistent pledgers, and 4.6% of consistent pledgers tested positive for trichomoniasis, chlamydia, and/or gonorrhea.

For HPV infection, the rates were 26.5% among nonpledgers, 28.5% among inconsistent pledgers, and 26.7% among consistent pledgers.

Pledgers did have fewer sexual partners than nonpledgers (average of 1.5 partners vs. 2.4 partners), and were not exposed as long to STD risk. However, they were more likely to engage in noncoital sexual contact.

About 3% of respondents reported oral sex but no vaginal sex. About 2% of nonpledgers fell into that group, compared with 13% of consistent pledgers and 5% of inconsistent pledgers. About 0.7% of nonpledgers reported anal sex but not vaginal sex, compared with 1.2% of pledgers.

About 1% of male nonpledgers reported anal, but not vaginal, sex, compared with 3% of male inconsistent pledgers and 4% of male consistent pledgers.

Condom use during these experiences was very low for all respondents: Only 4% reported using a condom during oral sex, and about 30% reported using one for anal sex.

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