University of California, San Francisco (UCSF): Controversies in Women's Health

SAN FRANCISCO – Pregnancy is one of the few relatively clear reasons to screen and treat for subclinical hypothyroidism, according to Dr. Elizabeth J. Murphy.

There are reasons to consider treating subclinical hypothyroidism in women other than pregnancy, but there’s no clear right or wrong answer in most cases, she said at a conference on women’s health sponsored by the University of California, San Francisco.

The Endocrine Society in 2012 recommended against universal thyroid screening of healthy women before pregnancy and said to screen those who are at high risk of thyroid disease, but they rated the evidence for those recommendations as poor (J. Clin. Endocrinol. Metab. 2012;97:2543-65).

For newly pregnant women, the guidelines offered a choice of two options, Dr. Murphy said: Screen all pregnant women by week 9 or at the first prenatal visit (with fair evidence to support this strategy), or screen only high-risk women unless that’s too burdensome, in which case, screen all pregnant women (with poor evidence behind this).

The American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice issued Opinion No. 381 in 2007 (and reaffirmed it in 2012) saying that routine screening for subclinical hypothyroidism is not currently recommended because there’s no evidence that routinely identifying and treating pregnant women with subclinical hypothyroidism improves outcomes (Obstet. Gynecol. 2007;110:959-60).

"I don’t agree with any of those, and I’m not the only one who doesn’t agree," said Dr. Murphy, chief of the division of endocrinology at San Francisco General Hospital.

A study of serum samples from 25,216 pregnant women and follow-up on their children at ages 7-9 years found lower IQ scores in the offspring of women with undiagnosed hypothyroidism during pregnancy, compared with women whose hypothyroidism was treated prior to pregnancy or euthyroid women in a control group (N. Engl. J. Med. 1999;341:549-55).

A more recent multinational, randomized trial of 21,846 women who were screened at a median of 12 weeks and 3 days of gestation reported that identifying and treating hypothyroidism did not improve the cognitive function of offspring at age 3, compared with a control group whose serum was analyzed after delivery (N. Engl. J. Med. 2012;366:493-501). That study was flawed, however, and "doesn’t provide useful data for prepregnancy screening. It only provides data for screening at 12 weeks," Dr. Murphy said.

The fetal thyroid develops at week 12, and the mother’s thyroid function needs to be in good shape before then, she explained. In addition, the median thyroid-stimulating hormone (TSH) level in the study was low, and half of the women in the study were enrolled not because they had a high TSH level but because they had a low level of free T4, an assay that is "notoriously unreliable in pregnancy," she said. "Many people recommend getting a total T4." It’s unclear whether many of the women who were considered to be hypothyroid truly were. Lastly, 3 years of age might be too young to assess cognitive function in the offspring, she said.

A huge study on the same subject is underway in China with plans to screen 21,500 pregnant women and treat 4,800 for hypothyroidism before pregnancy, she said.

A separate study suggested that both universal thyroid screening in pregnancy and risk-based screening are cost effective, compared with no screening (J. Clin. Endocrinol. Metabol. 2012;97:1536-46).

Guidelines from the American Thyroid Association in 2011 recommended treating pregnant women if the TSH level is greater than 10 mIU/L or if the patient is positive for thyroid peroxidase antibody (Thyroid 2011;21:1081-125). Most clinicians, however, probably would want to treat a woman in early pregnancy whose TSH level is 9 mIU/L, "especially with the IQ data that we have out there," Dr. Murphy said. "Congenital hypothyroidism, remember, is cretinism. It’s really good to have thyroid when your brain’s developing. I would definitely treat a woman with subclinical hypothyroidism who is pregnant."

Dr. Murphy reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Pregnancy is one of the few relatively clear reasons to screen and treat for subclinical hypothyroidism, according to Dr. Elizabeth J. Murphy.

There are reasons to consider treating subclinical hypothyroidism in women other than pregnancy, but there’s no clear right or wrong answer in most cases, she said at a conference on women’s health sponsored by the University of California, San Francisco.

The Endocrine Society in 2012 recommended against universal thyroid screening of healthy women before pregnancy and said to screen those who are at high risk of thyroid disease, but they rated the evidence for those recommendations as poor (J. Clin. Endocrinol. Metab. 2012;97:2543-65).

For newly pregnant women, the guidelines offered a choice of two options, Dr. Murphy said: Screen all pregnant women by week 9 or at the first prenatal visit (with fair evidence to support this strategy), or screen only high-risk women unless that’s too burdensome, in which case, screen all pregnant women (with poor evidence behind this).

The American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice issued Opinion No. 381 in 2007 (and reaffirmed it in 2012) saying that routine screening for subclinical hypothyroidism is not currently recommended because there’s no evidence that routinely identifying and treating pregnant women with subclinical hypothyroidism improves outcomes (Obstet. Gynecol. 2007;110:959-60).

"I don’t agree with any of those, and I’m not the only one who doesn’t agree," said Dr. Murphy, chief of the division of endocrinology at San Francisco General Hospital.

A study of serum samples from 25,216 pregnant women and follow-up on their children at ages 7-9 years found lower IQ scores in the offspring of women with undiagnosed hypothyroidism during pregnancy, compared with women whose hypothyroidism was treated prior to pregnancy or euthyroid women in a control group (N. Engl. J. Med. 1999;341:549-55).

A more recent multinational, randomized trial of 21,846 women who were screened at a median of 12 weeks and 3 days of gestation reported that identifying and treating hypothyroidism did not improve the cognitive function of offspring at age 3, compared with a control group whose serum was analyzed after delivery (N. Engl. J. Med. 2012;366:493-501). That study was flawed, however, and "doesn’t provide useful data for prepregnancy screening. It only provides data for screening at 12 weeks," Dr. Murphy said.

The fetal thyroid develops at week 12, and the mother’s thyroid function needs to be in good shape before then, she explained. In addition, the median thyroid-stimulating hormone (TSH) level in the study was low, and half of the women in the study were enrolled not because they had a high TSH level but because they had a low level of free T4, an assay that is "notoriously unreliable in pregnancy," she said. "Many people recommend getting a total T4." It’s unclear whether many of the women who were considered to be hypothyroid truly were. Lastly, 3 years of age might be too young to assess cognitive function in the offspring, she said.

A huge study on the same subject is underway in China with plans to screen 21,500 pregnant women and treat 4,800 for hypothyroidism before pregnancy, she said.

A separate study suggested that both universal thyroid screening in pregnancy and risk-based screening are cost effective, compared with no screening (J. Clin. Endocrinol. Metabol. 2012;97:1536-46).

Guidelines from the American Thyroid Association in 2011 recommended treating pregnant women if the TSH level is greater than 10 mIU/L or if the patient is positive for thyroid peroxidase antibody (Thyroid 2011;21:1081-125). Most clinicians, however, probably would want to treat a woman in early pregnancy whose TSH level is 9 mIU/L, "especially with the IQ data that we have out there," Dr. Murphy said. "Congenital hypothyroidism, remember, is cretinism. It’s really good to have thyroid when your brain’s developing. I would definitely treat a woman with subclinical hypothyroidism who is pregnant."

Dr. Murphy reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Pregnancy is one of the few relatively clear reasons to screen and treat for subclinical hypothyroidism, according to Dr. Elizabeth J. Murphy.

There are reasons to consider treating subclinical hypothyroidism in women other than pregnancy, but there’s no clear right or wrong answer in most cases, she said at a conference on women’s health sponsored by the University of California, San Francisco.

The Endocrine Society in 2012 recommended against universal thyroid screening of healthy women before pregnancy and said to screen those who are at high risk of thyroid disease, but they rated the evidence for those recommendations as poor (J. Clin. Endocrinol. Metab. 2012;97:2543-65).

For newly pregnant women, the guidelines offered a choice of two options, Dr. Murphy said: Screen all pregnant women by week 9 or at the first prenatal visit (with fair evidence to support this strategy), or screen only high-risk women unless that’s too burdensome, in which case, screen all pregnant women (with poor evidence behind this).

The American College of Obstetricians and Gynecologists (ACOG) Committee on Obstetric Practice issued Opinion No. 381 in 2007 (and reaffirmed it in 2012) saying that routine screening for subclinical hypothyroidism is not currently recommended because there’s no evidence that routinely identifying and treating pregnant women with subclinical hypothyroidism improves outcomes (Obstet. Gynecol. 2007;110:959-60).

"I don’t agree with any of those, and I’m not the only one who doesn’t agree," said Dr. Murphy, chief of the division of endocrinology at San Francisco General Hospital.

A study of serum samples from 25,216 pregnant women and follow-up on their children at ages 7-9 years found lower IQ scores in the offspring of women with undiagnosed hypothyroidism during pregnancy, compared with women whose hypothyroidism was treated prior to pregnancy or euthyroid women in a control group (N. Engl. J. Med. 1999;341:549-55).

A more recent multinational, randomized trial of 21,846 women who were screened at a median of 12 weeks and 3 days of gestation reported that identifying and treating hypothyroidism did not improve the cognitive function of offspring at age 3, compared with a control group whose serum was analyzed after delivery (N. Engl. J. Med. 2012;366:493-501). That study was flawed, however, and "doesn’t provide useful data for prepregnancy screening. It only provides data for screening at 12 weeks," Dr. Murphy said.

The fetal thyroid develops at week 12, and the mother’s thyroid function needs to be in good shape before then, she explained. In addition, the median thyroid-stimulating hormone (TSH) level in the study was low, and half of the women in the study were enrolled not because they had a high TSH level but because they had a low level of free T4, an assay that is "notoriously unreliable in pregnancy," she said. "Many people recommend getting a total T4." It’s unclear whether many of the women who were considered to be hypothyroid truly were. Lastly, 3 years of age might be too young to assess cognitive function in the offspring, she said.

A huge study on the same subject is underway in China with plans to screen 21,500 pregnant women and treat 4,800 for hypothyroidism before pregnancy, she said.

A separate study suggested that both universal thyroid screening in pregnancy and risk-based screening are cost effective, compared with no screening (J. Clin. Endocrinol. Metabol. 2012;97:1536-46).

Guidelines from the American Thyroid Association in 2011 recommended treating pregnant women if the TSH level is greater than 10 mIU/L or if the patient is positive for thyroid peroxidase antibody (Thyroid 2011;21:1081-125). Most clinicians, however, probably would want to treat a woman in early pregnancy whose TSH level is 9 mIU/L, "especially with the IQ data that we have out there," Dr. Murphy said. "Congenital hypothyroidism, remember, is cretinism. It’s really good to have thyroid when your brain’s developing. I would definitely treat a woman with subclinical hypothyroidism who is pregnant."

Dr. Murphy reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Make sure a woman who has uterine bleeding or abdominal pain in the first trimester of pregnancy gets an ultrasound the same day you see her, whether you do the ultrasound yourself, refer her to another physician for a same-day ultrasound, or send her to the emergency department, Dr. Rebecca Jackson advised.

The same-day ultrasound is essential to diagnose ectopic pregnancy early, Dr. Jackson said at a conference on women’s health sponsored by the University of California, San Francisco. The ultrasound is unlikely to show an ectopic pregnancy, but if you see an intrauterine pregnancy, "you’re done," she said.

Ectopic pregnancy occurs in 2% of pregnancies and is the leading cause of U.S. maternal deaths in the first trimester. "The key thing about ectopic pregnancy is that two-thirds of the women dying from an ectopic pregnancy had recently seen a clinician, but had an incorrect or delayed diagnosis," said Dr. Jackson, professor of obstetrics and gynecology at the university and chief of obstetrics and gynecology at San Francisco General Hospital.

If an ultrasound doesn’t show the location of the pregnancy, obtain serial quantitative beta-HCG levels to determine whether the pregnancy is normal or abnormal, she advised. "If it rises appropriately, it’s likely normal, but ectopics can also rise in the same way" as beta-HCG levels with intrauterine pregnancies, she said. "But if it drops or rises very little you know it’s abnormal."

Get a uterine aspiration in women with an abnormal beta-HCG level to look for placental tissue in the uterus, which indicates an intrauterine pregnancy, she said. If there’s no placental tissue in the uterus, treat for ectopic pregnancy.

There’s a shortcut in all of this to keep in mind, she added. If a woman presents with abnormal uterine bleeding or abdominal pain and she tests positive for pregnancy, ask if she desires the pregnancy. If not, you can skip the ultrasound and beta-HCG levels and go straight to the uterine aspiration, Dr. Jackson said.

These steps to diagnosing ectopic pregnancy may sound simple but in reality take ob.gyn. residents years to master. "There are so many flavors of how women present, and you combine that with their desires and their fertility desires, and it’s a really hard thing to manage," she said.

Only approximately 2% of ultrasounds done for possible ectopic pregnancy will show a gestational sac with a yolk sac or fetal pole visible outside the uterus, and thus be diagnostic, Dr. Jackson said. A normal adnexal exam does not exclude an ectopic pregnancy. An empty uterus on ultrasound and a beta-HCG level above the discriminatory zone suggests an ectopic pregnancy, and will be in 86% of cases. An ultrasound showing a complex mass and fluid in a cul-de-sac will be an ectopic pregnancy in 94% of cases. The main role of the ultrasound is to rule in an intrauterine pregnancy.

Diagnosing ectopic pregnancy early decreases the risk of rupture, which has been associated with decreased fertility and increased morbidity and mortality. "Just as an aside, rupture can occur at any level of beta-HCG and whether beta-HCG is rising or falling or plateauing, so that doesn’t help you," she said.

More treatment options are available if ectopic pregnancy is diagnosed early, including methotrexate or conservative surgical treatment, and methotrexate is more efficacious in earlier than in later ectopic pregnancy, Dr. Jackson said.

Methotrexate treatment, which is relatively new for ectopic pregnancy, "is not for everyone," she added. "It involves a lot of follow-up. Patient compliance is incredibly important. There’s still 5% who will rupture despite methotrexate treatment. And all of these things need to be explained to the patient so she can make an informed choice." Methotrexate is less effective than salpingostomy, and the efficacy of the drug decreases with increasing beta-HCG levels. Fifteen percent of patients treated with methotrexate will require a second dose.

A decrease in future intrauterine pregnancy rates in women with ectopic pregnancy is no different in those treated with methotrexate than in those treated with surgery, and the risk of a future ectopic pregnancy is increased by 10%-15% in both groups, she said.

Dr. Jackson reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Make sure a woman who has uterine bleeding or abdominal pain in the first trimester of pregnancy gets an ultrasound the same day you see her, whether you do the ultrasound yourself, refer her to another physician for a same-day ultrasound, or send her to the emergency department, Dr. Rebecca Jackson advised.

The same-day ultrasound is essential to diagnose ectopic pregnancy early, Dr. Jackson said at a conference on women’s health sponsored by the University of California, San Francisco. The ultrasound is unlikely to show an ectopic pregnancy, but if you see an intrauterine pregnancy, "you’re done," she said.

Ectopic pregnancy occurs in 2% of pregnancies and is the leading cause of U.S. maternal deaths in the first trimester. "The key thing about ectopic pregnancy is that two-thirds of the women dying from an ectopic pregnancy had recently seen a clinician, but had an incorrect or delayed diagnosis," said Dr. Jackson, professor of obstetrics and gynecology at the university and chief of obstetrics and gynecology at San Francisco General Hospital.

If an ultrasound doesn’t show the location of the pregnancy, obtain serial quantitative beta-HCG levels to determine whether the pregnancy is normal or abnormal, she advised. "If it rises appropriately, it’s likely normal, but ectopics can also rise in the same way" as beta-HCG levels with intrauterine pregnancies, she said. "But if it drops or rises very little you know it’s abnormal."

Get a uterine aspiration in women with an abnormal beta-HCG level to look for placental tissue in the uterus, which indicates an intrauterine pregnancy, she said. If there’s no placental tissue in the uterus, treat for ectopic pregnancy.

There’s a shortcut in all of this to keep in mind, she added. If a woman presents with abnormal uterine bleeding or abdominal pain and she tests positive for pregnancy, ask if she desires the pregnancy. If not, you can skip the ultrasound and beta-HCG levels and go straight to the uterine aspiration, Dr. Jackson said.

These steps to diagnosing ectopic pregnancy may sound simple but in reality take ob.gyn. residents years to master. "There are so many flavors of how women present, and you combine that with their desires and their fertility desires, and it’s a really hard thing to manage," she said.

Only approximately 2% of ultrasounds done for possible ectopic pregnancy will show a gestational sac with a yolk sac or fetal pole visible outside the uterus, and thus be diagnostic, Dr. Jackson said. A normal adnexal exam does not exclude an ectopic pregnancy. An empty uterus on ultrasound and a beta-HCG level above the discriminatory zone suggests an ectopic pregnancy, and will be in 86% of cases. An ultrasound showing a complex mass and fluid in a cul-de-sac will be an ectopic pregnancy in 94% of cases. The main role of the ultrasound is to rule in an intrauterine pregnancy.

Diagnosing ectopic pregnancy early decreases the risk of rupture, which has been associated with decreased fertility and increased morbidity and mortality. "Just as an aside, rupture can occur at any level of beta-HCG and whether beta-HCG is rising or falling or plateauing, so that doesn’t help you," she said.

More treatment options are available if ectopic pregnancy is diagnosed early, including methotrexate or conservative surgical treatment, and methotrexate is more efficacious in earlier than in later ectopic pregnancy, Dr. Jackson said.

Methotrexate treatment, which is relatively new for ectopic pregnancy, "is not for everyone," she added. "It involves a lot of follow-up. Patient compliance is incredibly important. There’s still 5% who will rupture despite methotrexate treatment. And all of these things need to be explained to the patient so she can make an informed choice." Methotrexate is less effective than salpingostomy, and the efficacy of the drug decreases with increasing beta-HCG levels. Fifteen percent of patients treated with methotrexate will require a second dose.

A decrease in future intrauterine pregnancy rates in women with ectopic pregnancy is no different in those treated with methotrexate than in those treated with surgery, and the risk of a future ectopic pregnancy is increased by 10%-15% in both groups, she said.

Dr. Jackson reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Make sure a woman who has uterine bleeding or abdominal pain in the first trimester of pregnancy gets an ultrasound the same day you see her, whether you do the ultrasound yourself, refer her to another physician for a same-day ultrasound, or send her to the emergency department, Dr. Rebecca Jackson advised.

The same-day ultrasound is essential to diagnose ectopic pregnancy early, Dr. Jackson said at a conference on women’s health sponsored by the University of California, San Francisco. The ultrasound is unlikely to show an ectopic pregnancy, but if you see an intrauterine pregnancy, "you’re done," she said.

Ectopic pregnancy occurs in 2% of pregnancies and is the leading cause of U.S. maternal deaths in the first trimester. "The key thing about ectopic pregnancy is that two-thirds of the women dying from an ectopic pregnancy had recently seen a clinician, but had an incorrect or delayed diagnosis," said Dr. Jackson, professor of obstetrics and gynecology at the university and chief of obstetrics and gynecology at San Francisco General Hospital.

If an ultrasound doesn’t show the location of the pregnancy, obtain serial quantitative beta-HCG levels to determine whether the pregnancy is normal or abnormal, she advised. "If it rises appropriately, it’s likely normal, but ectopics can also rise in the same way" as beta-HCG levels with intrauterine pregnancies, she said. "But if it drops or rises very little you know it’s abnormal."

Get a uterine aspiration in women with an abnormal beta-HCG level to look for placental tissue in the uterus, which indicates an intrauterine pregnancy, she said. If there’s no placental tissue in the uterus, treat for ectopic pregnancy.

There’s a shortcut in all of this to keep in mind, she added. If a woman presents with abnormal uterine bleeding or abdominal pain and she tests positive for pregnancy, ask if she desires the pregnancy. If not, you can skip the ultrasound and beta-HCG levels and go straight to the uterine aspiration, Dr. Jackson said.

These steps to diagnosing ectopic pregnancy may sound simple but in reality take ob.gyn. residents years to master. "There are so many flavors of how women present, and you combine that with their desires and their fertility desires, and it’s a really hard thing to manage," she said.

Only approximately 2% of ultrasounds done for possible ectopic pregnancy will show a gestational sac with a yolk sac or fetal pole visible outside the uterus, and thus be diagnostic, Dr. Jackson said. A normal adnexal exam does not exclude an ectopic pregnancy. An empty uterus on ultrasound and a beta-HCG level above the discriminatory zone suggests an ectopic pregnancy, and will be in 86% of cases. An ultrasound showing a complex mass and fluid in a cul-de-sac will be an ectopic pregnancy in 94% of cases. The main role of the ultrasound is to rule in an intrauterine pregnancy.

Diagnosing ectopic pregnancy early decreases the risk of rupture, which has been associated with decreased fertility and increased morbidity and mortality. "Just as an aside, rupture can occur at any level of beta-HCG and whether beta-HCG is rising or falling or plateauing, so that doesn’t help you," she said.

More treatment options are available if ectopic pregnancy is diagnosed early, including methotrexate or conservative surgical treatment, and methotrexate is more efficacious in earlier than in later ectopic pregnancy, Dr. Jackson said.

Methotrexate treatment, which is relatively new for ectopic pregnancy, "is not for everyone," she added. "It involves a lot of follow-up. Patient compliance is incredibly important. There’s still 5% who will rupture despite methotrexate treatment. And all of these things need to be explained to the patient so she can make an informed choice." Methotrexate is less effective than salpingostomy, and the efficacy of the drug decreases with increasing beta-HCG levels. Fifteen percent of patients treated with methotrexate will require a second dose.

A decrease in future intrauterine pregnancy rates in women with ectopic pregnancy is no different in those treated with methotrexate than in those treated with surgery, and the risk of a future ectopic pregnancy is increased by 10%-15% in both groups, she said.

Dr. Jackson reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Close adherence to guidelines for deciding when to do endometrial biopsies in women with abnormal uterine bleeding could mean ordering biopsies in 88% of perimenopausal women with bleeding, according to Dr. Rebecca Jackson.

Irregular uterine bleeding is "incredibly common," endometrial cancer is "relatively common," and models to predict which women with abnormal bleeding are at risk for endometrial cancer "have been examined and are not useful," said Dr. Jackson, professor of obstetrics and gynecology at the University of California, San Francisco, and chief of obstetrics and gynecology at San Francisco General Hospital. Without much data to go on, "we’re left with expert opinion," she said.

She offered the following approach employed at her institution in a presentation at a conference on women’s health sponsored by the university. "We’re heartened to see that UpToDate has the same approach," Dr. Jackson said, referring to the digital evidence-based clinical decision support tool.

American College of Obstetricians and Gynecologists Practice Bulletin 128 on the Diagnosis of Abnormal Uterine Bleeding in Reproductive-Aged Women recommends that endometrial tissue sampling be done in patients with abnormal uterine bleeding who are older than 45 years and in younger patients who have a history of unopposed estrogen exposure, failed medical management, and persistent abnormal uterine bleeding (Obstet. Gynecol. 2012;120:197-206).

During an average 4-year perimenopause, however, only 12% of women completely stop menstruating; 70% have short, irregular menses; and 18% have longer, heavier menses, studies have shown (Int. J. Fertil 1967;12:77-126; Acta Obstet. Gynecol. Scand. 1966;45:320-51).A close application of the ACOG guidelines could mean biopsies in all but 12% of perimenopausal women, she said.

Dr. Jackson said she takes endometrial biopsies in all postmenopausal women with any abnormal uterine bleeding except for bleeding that starts 4-6 months after initiating hormone therapy. Approximately 10% of postmenopausal women with bleeding have cancer. "That’s a very high pretest probability when you’re talking about cancer, way higher than when you think about an abnormal mammogram," she said. Offering a postmenopausal patient a choice between a biopsy and a transvaginal ultrasound is reasonable as long as either procedure is available quickly and the patient understands that she still may need an endometrial biopsy after an ultrasound.

In women with a recent onset of irregular bleeding, don’t jump to a biopsy too quickly for this very common phenomenon. "Consider treating her, and if it normalizes, there’s no need for an endometrial biopsy," she said.

She recommended a low threshold for biopsy in women older than 50 years who have recurrent irregular bleeding because the risk of cancer is going up with age, but consider not getting a biopsy if the periods are light and spacing out. Periods that happen every 2-3 months and last 2-3 days are "not a very worrisome pattern," she said. Endometrial cancer presents most commonly with menometrorrhagia and sometimes with intermenstrual bleeding, but rarely with regularly timed menses.

Dr. Jackson said she biopsies women aged 45-50 years if they have recurrent irregular bleeding plus at least one risk factor for endometrial cancer or they’ve had more than 6 months of menometrorrhagia.

In younger women, consider a biopsy if they’ve had a "long history" of untreated anovulatory bleeding, which could be 2 years or 5 years, she suggested. "We have a hard time getting consensus on that [definition of] long," she noted.

A Pap smear result showing atypical glandular cells or endometrial cells would be another reason to biopsy if the Pap smear was not done at the time of menses.

An endometrial biopsy is not perfectly sensitive, so "keep your radar up" even if the biopsy result is negative, and evaluate further if abnormal bleeding persists, she said.

Her search of the literature on less-aggressive strategies for endometrial biopsies turned up just one small prospective cohort study of 1,000 women with abnormal uterine bleeding who were eligible for endometrial biopsy under ACOG guidelines. Biopsies were performed in only 570 women who were postmenopausal or who had at least one risk factor for endometrial cancer (such as obesity or polycystic ovarian syndrome), and all were followed for 2 years. None of the women who did not undergo biopsy developed cancer or hyperplasia, but the study was underpowered to assess outcomes in those women, she said (J. Reprod. Med. 2001;46:831-4).

Dr. Jackson reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Close adherence to guidelines for deciding when to do endometrial biopsies in women with abnormal uterine bleeding could mean ordering biopsies in 88% of perimenopausal women with bleeding, according to Dr. Rebecca Jackson.

Irregular uterine bleeding is "incredibly common," endometrial cancer is "relatively common," and models to predict which women with abnormal bleeding are at risk for endometrial cancer "have been examined and are not useful," said Dr. Jackson, professor of obstetrics and gynecology at the University of California, San Francisco, and chief of obstetrics and gynecology at San Francisco General Hospital. Without much data to go on, "we’re left with expert opinion," she said.

She offered the following approach employed at her institution in a presentation at a conference on women’s health sponsored by the university. "We’re heartened to see that UpToDate has the same approach," Dr. Jackson said, referring to the digital evidence-based clinical decision support tool.

American College of Obstetricians and Gynecologists Practice Bulletin 128 on the Diagnosis of Abnormal Uterine Bleeding in Reproductive-Aged Women recommends that endometrial tissue sampling be done in patients with abnormal uterine bleeding who are older than 45 years and in younger patients who have a history of unopposed estrogen exposure, failed medical management, and persistent abnormal uterine bleeding (Obstet. Gynecol. 2012;120:197-206).

During an average 4-year perimenopause, however, only 12% of women completely stop menstruating; 70% have short, irregular menses; and 18% have longer, heavier menses, studies have shown (Int. J. Fertil 1967;12:77-126; Acta Obstet. Gynecol. Scand. 1966;45:320-51).A close application of the ACOG guidelines could mean biopsies in all but 12% of perimenopausal women, she said.

Dr. Jackson said she takes endometrial biopsies in all postmenopausal women with any abnormal uterine bleeding except for bleeding that starts 4-6 months after initiating hormone therapy. Approximately 10% of postmenopausal women with bleeding have cancer. "That’s a very high pretest probability when you’re talking about cancer, way higher than when you think about an abnormal mammogram," she said. Offering a postmenopausal patient a choice between a biopsy and a transvaginal ultrasound is reasonable as long as either procedure is available quickly and the patient understands that she still may need an endometrial biopsy after an ultrasound.

In women with a recent onset of irregular bleeding, don’t jump to a biopsy too quickly for this very common phenomenon. "Consider treating her, and if it normalizes, there’s no need for an endometrial biopsy," she said.

She recommended a low threshold for biopsy in women older than 50 years who have recurrent irregular bleeding because the risk of cancer is going up with age, but consider not getting a biopsy if the periods are light and spacing out. Periods that happen every 2-3 months and last 2-3 days are "not a very worrisome pattern," she said. Endometrial cancer presents most commonly with menometrorrhagia and sometimes with intermenstrual bleeding, but rarely with regularly timed menses.

Dr. Jackson said she biopsies women aged 45-50 years if they have recurrent irregular bleeding plus at least one risk factor for endometrial cancer or they’ve had more than 6 months of menometrorrhagia.

In younger women, consider a biopsy if they’ve had a "long history" of untreated anovulatory bleeding, which could be 2 years or 5 years, she suggested. "We have a hard time getting consensus on that [definition of] long," she noted.

A Pap smear result showing atypical glandular cells or endometrial cells would be another reason to biopsy if the Pap smear was not done at the time of menses.

An endometrial biopsy is not perfectly sensitive, so "keep your radar up" even if the biopsy result is negative, and evaluate further if abnormal bleeding persists, she said.

Her search of the literature on less-aggressive strategies for endometrial biopsies turned up just one small prospective cohort study of 1,000 women with abnormal uterine bleeding who were eligible for endometrial biopsy under ACOG guidelines. Biopsies were performed in only 570 women who were postmenopausal or who had at least one risk factor for endometrial cancer (such as obesity or polycystic ovarian syndrome), and all were followed for 2 years. None of the women who did not undergo biopsy developed cancer or hyperplasia, but the study was underpowered to assess outcomes in those women, she said (J. Reprod. Med. 2001;46:831-4).

Dr. Jackson reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Close adherence to guidelines for deciding when to do endometrial biopsies in women with abnormal uterine bleeding could mean ordering biopsies in 88% of perimenopausal women with bleeding, according to Dr. Rebecca Jackson.

Irregular uterine bleeding is "incredibly common," endometrial cancer is "relatively common," and models to predict which women with abnormal bleeding are at risk for endometrial cancer "have been examined and are not useful," said Dr. Jackson, professor of obstetrics and gynecology at the University of California, San Francisco, and chief of obstetrics and gynecology at San Francisco General Hospital. Without much data to go on, "we’re left with expert opinion," she said.

She offered the following approach employed at her institution in a presentation at a conference on women’s health sponsored by the university. "We’re heartened to see that UpToDate has the same approach," Dr. Jackson said, referring to the digital evidence-based clinical decision support tool.

American College of Obstetricians and Gynecologists Practice Bulletin 128 on the Diagnosis of Abnormal Uterine Bleeding in Reproductive-Aged Women recommends that endometrial tissue sampling be done in patients with abnormal uterine bleeding who are older than 45 years and in younger patients who have a history of unopposed estrogen exposure, failed medical management, and persistent abnormal uterine bleeding (Obstet. Gynecol. 2012;120:197-206).

During an average 4-year perimenopause, however, only 12% of women completely stop menstruating; 70% have short, irregular menses; and 18% have longer, heavier menses, studies have shown (Int. J. Fertil 1967;12:77-126; Acta Obstet. Gynecol. Scand. 1966;45:320-51).A close application of the ACOG guidelines could mean biopsies in all but 12% of perimenopausal women, she said.

Dr. Jackson said she takes endometrial biopsies in all postmenopausal women with any abnormal uterine bleeding except for bleeding that starts 4-6 months after initiating hormone therapy. Approximately 10% of postmenopausal women with bleeding have cancer. "That’s a very high pretest probability when you’re talking about cancer, way higher than when you think about an abnormal mammogram," she said. Offering a postmenopausal patient a choice between a biopsy and a transvaginal ultrasound is reasonable as long as either procedure is available quickly and the patient understands that she still may need an endometrial biopsy after an ultrasound.

In women with a recent onset of irregular bleeding, don’t jump to a biopsy too quickly for this very common phenomenon. "Consider treating her, and if it normalizes, there’s no need for an endometrial biopsy," she said.

She recommended a low threshold for biopsy in women older than 50 years who have recurrent irregular bleeding because the risk of cancer is going up with age, but consider not getting a biopsy if the periods are light and spacing out. Periods that happen every 2-3 months and last 2-3 days are "not a very worrisome pattern," she said. Endometrial cancer presents most commonly with menometrorrhagia and sometimes with intermenstrual bleeding, but rarely with regularly timed menses.

Dr. Jackson said she biopsies women aged 45-50 years if they have recurrent irregular bleeding plus at least one risk factor for endometrial cancer or they’ve had more than 6 months of menometrorrhagia.

In younger women, consider a biopsy if they’ve had a "long history" of untreated anovulatory bleeding, which could be 2 years or 5 years, she suggested. "We have a hard time getting consensus on that [definition of] long," she noted.

A Pap smear result showing atypical glandular cells or endometrial cells would be another reason to biopsy if the Pap smear was not done at the time of menses.

An endometrial biopsy is not perfectly sensitive, so "keep your radar up" even if the biopsy result is negative, and evaluate further if abnormal bleeding persists, she said.

Her search of the literature on less-aggressive strategies for endometrial biopsies turned up just one small prospective cohort study of 1,000 women with abnormal uterine bleeding who were eligible for endometrial biopsy under ACOG guidelines. Biopsies were performed in only 570 women who were postmenopausal or who had at least one risk factor for endometrial cancer (such as obesity or polycystic ovarian syndrome), and all were followed for 2 years. None of the women who did not undergo biopsy developed cancer or hyperplasia, but the study was underpowered to assess outcomes in those women, she said (J. Reprod. Med. 2001;46:831-4).

Dr. Jackson reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Because of significant limitations in the Food and Drug Administration’s pregnancy categories, it’s important to have another reliable resource handy to guide prescribing during pregnancy, Dr. Elizabeth S. Harleman believes.

Three out of four attendees at a conference on women’s health sponsored by the University of California, San Francisco, said that they use the FDA categories to determine a drug’s safety during pregnancy, an informal electronic poll at the meeting showed. There are good reasons for that, Dr. Harleman told the audience. The FDA categories are easily accessible, quick to read, and provide some information.

But they’re also hard to remember and don’t provide sufficient information, she added. "I think it’s going to become increasingly important, as we take care of more women with chronic diseases earlier in life, to think about the implications of conceiving while on the medications that we’re prescribing," said Dr. Harleman, of the department of medicine at the university.

The FDA categories do not provide any gradation of risk. Drugs in the A or B categories are not necessarily safer than category D drugs, she said. A medication can get a B categorization without any human data. The FDA categories give no information about dosing or the timing of administration. "If you give a drug in the first trimester, there may be very different implications than if you give a drug in the third trimester, and you can’t get that information from this classification system," she said.

There’s also no information on the change in risk from one category to another. "We don’t know if this increases the risk from 1% to 5% or from 1% to 80%," Dr. Harleman said. "It’s very hard to make an informed decision about prescribing a medication just using the FDA classification."

Approximately 60% of drugs in category X have no human data behind that classification. A drug can end up in category X simply because it has no utility during pregnancy, such as oral contraceptives. Physicians who don’t know that, however, may erroneously tell a woman who conceived while on an oral contraceptive that the drug increases her baby’s risk for malformation.

The FDA categories rarely get updated. "It’s really more of a legal system" than a helpful clinical tool, she said.

Half of pregnant women who are on medications take category C, D, or X drugs, studies have shown. One in six women of reproductive age receives a category D or X drug, mainly antibiotics, anticonvulsants, statins, benzodiazepines, or warfarin. A study of 488,175 women found that those taking category D or X drugs were no more likely to have documentation in their physicians’ charts of a discussion about contraception.

"In our hurried practices, sometimes it’s hard to remember this, but we need to think about which drugs are absolutely contraindicated and make sure that we are discussing them with our patients," Dr. Harleman said.

The main drugs to avoid during pregnancy are ACE inhibitors, tetracycline, fluoroquinolones, systemic retinoids, warfarin, valproic acid, nonsteroidal anti-inflammatory drugs, and live vaccines. "It’s a pretty short list," she said. "A lot of other drugs are safe in pregnancy; we may just not have as much familiarity with using them."

Dr. Harleman gave three pieces of advice on prescribing during pregnancy: Think hard before starting or stopping any medication. Remember that changes in blood volume and metabolism during pregnancy may mandate increased frequency of dosing or higher doses. And keep one of the following pregnancy prescribing resources available instead of relying solely on the FDA categories:

• The clinical reference tool Micromedex. It has an excellent "ReproRisk" section, she said (micromedex.com).

• Reprotox, a service of the nonprofit Reproductive Toxicology Center, Washington. It synthesizes all the published information on drug safety and provides quick-take summaries that Dr. Harleman believes are worth the low fee for use (reprotox.org/Default.aspx).

• The American College of Physicians’ "Medical Care of the Pregnant Patient," 2nd ed. (Hanover, Pa.: Sheridan Press, 2008) is a good source.

• Motherisk is a service affiliated with the Hospital for Sick Children, Toronto (motherisk.org).

• MotherToBaby is a service of the Organization of Teratology Information Specialists (mothertobaby.org).

• The reference guide "Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk," 9th ed. (Philadelphia: Lippincott Williams and Wilkins, 2011) is a good source.

• The book "Medications and Mother’s Milk" (Amarillo, Tex.: Hale Publishing, 2012) is helpful.

Dr. Harleman reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Because of significant limitations in the Food and Drug Administration’s pregnancy categories, it’s important to have another reliable resource handy to guide prescribing during pregnancy, Dr. Elizabeth S. Harleman believes.

Three out of four attendees at a conference on women’s health sponsored by the University of California, San Francisco, said that they use the FDA categories to determine a drug’s safety during pregnancy, an informal electronic poll at the meeting showed. There are good reasons for that, Dr. Harleman told the audience. The FDA categories are easily accessible, quick to read, and provide some information.

But they’re also hard to remember and don’t provide sufficient information, she added. "I think it’s going to become increasingly important, as we take care of more women with chronic diseases earlier in life, to think about the implications of conceiving while on the medications that we’re prescribing," said Dr. Harleman, of the department of medicine at the university.

The FDA categories do not provide any gradation of risk. Drugs in the A or B categories are not necessarily safer than category D drugs, she said. A medication can get a B categorization without any human data. The FDA categories give no information about dosing or the timing of administration. "If you give a drug in the first trimester, there may be very different implications than if you give a drug in the third trimester, and you can’t get that information from this classification system," she said.

There’s also no information on the change in risk from one category to another. "We don’t know if this increases the risk from 1% to 5% or from 1% to 80%," Dr. Harleman said. "It’s very hard to make an informed decision about prescribing a medication just using the FDA classification."

Approximately 60% of drugs in category X have no human data behind that classification. A drug can end up in category X simply because it has no utility during pregnancy, such as oral contraceptives. Physicians who don’t know that, however, may erroneously tell a woman who conceived while on an oral contraceptive that the drug increases her baby’s risk for malformation.

The FDA categories rarely get updated. "It’s really more of a legal system" than a helpful clinical tool, she said.

Half of pregnant women who are on medications take category C, D, or X drugs, studies have shown. One in six women of reproductive age receives a category D or X drug, mainly antibiotics, anticonvulsants, statins, benzodiazepines, or warfarin. A study of 488,175 women found that those taking category D or X drugs were no more likely to have documentation in their physicians’ charts of a discussion about contraception.

"In our hurried practices, sometimes it’s hard to remember this, but we need to think about which drugs are absolutely contraindicated and make sure that we are discussing them with our patients," Dr. Harleman said.

The main drugs to avoid during pregnancy are ACE inhibitors, tetracycline, fluoroquinolones, systemic retinoids, warfarin, valproic acid, nonsteroidal anti-inflammatory drugs, and live vaccines. "It’s a pretty short list," she said. "A lot of other drugs are safe in pregnancy; we may just not have as much familiarity with using them."

Dr. Harleman gave three pieces of advice on prescribing during pregnancy: Think hard before starting or stopping any medication. Remember that changes in blood volume and metabolism during pregnancy may mandate increased frequency of dosing or higher doses. And keep one of the following pregnancy prescribing resources available instead of relying solely on the FDA categories:

• The clinical reference tool Micromedex. It has an excellent "ReproRisk" section, she said (micromedex.com).

• Reprotox, a service of the nonprofit Reproductive Toxicology Center, Washington. It synthesizes all the published information on drug safety and provides quick-take summaries that Dr. Harleman believes are worth the low fee for use (reprotox.org/Default.aspx).

• The American College of Physicians’ "Medical Care of the Pregnant Patient," 2nd ed. (Hanover, Pa.: Sheridan Press, 2008) is a good source.

• Motherisk is a service affiliated with the Hospital for Sick Children, Toronto (motherisk.org).

• MotherToBaby is a service of the Organization of Teratology Information Specialists (mothertobaby.org).

• The reference guide "Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk," 9th ed. (Philadelphia: Lippincott Williams and Wilkins, 2011) is a good source.

• The book "Medications and Mother’s Milk" (Amarillo, Tex.: Hale Publishing, 2012) is helpful.

Dr. Harleman reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Because of significant limitations in the Food and Drug Administration’s pregnancy categories, it’s important to have another reliable resource handy to guide prescribing during pregnancy, Dr. Elizabeth S. Harleman believes.

Three out of four attendees at a conference on women’s health sponsored by the University of California, San Francisco, said that they use the FDA categories to determine a drug’s safety during pregnancy, an informal electronic poll at the meeting showed. There are good reasons for that, Dr. Harleman told the audience. The FDA categories are easily accessible, quick to read, and provide some information.

But they’re also hard to remember and don’t provide sufficient information, she added. "I think it’s going to become increasingly important, as we take care of more women with chronic diseases earlier in life, to think about the implications of conceiving while on the medications that we’re prescribing," said Dr. Harleman, of the department of medicine at the university.

The FDA categories do not provide any gradation of risk. Drugs in the A or B categories are not necessarily safer than category D drugs, she said. A medication can get a B categorization without any human data. The FDA categories give no information about dosing or the timing of administration. "If you give a drug in the first trimester, there may be very different implications than if you give a drug in the third trimester, and you can’t get that information from this classification system," she said.

There’s also no information on the change in risk from one category to another. "We don’t know if this increases the risk from 1% to 5% or from 1% to 80%," Dr. Harleman said. "It’s very hard to make an informed decision about prescribing a medication just using the FDA classification."

Approximately 60% of drugs in category X have no human data behind that classification. A drug can end up in category X simply because it has no utility during pregnancy, such as oral contraceptives. Physicians who don’t know that, however, may erroneously tell a woman who conceived while on an oral contraceptive that the drug increases her baby’s risk for malformation.

The FDA categories rarely get updated. "It’s really more of a legal system" than a helpful clinical tool, she said.

Half of pregnant women who are on medications take category C, D, or X drugs, studies have shown. One in six women of reproductive age receives a category D or X drug, mainly antibiotics, anticonvulsants, statins, benzodiazepines, or warfarin. A study of 488,175 women found that those taking category D or X drugs were no more likely to have documentation in their physicians’ charts of a discussion about contraception.

"In our hurried practices, sometimes it’s hard to remember this, but we need to think about which drugs are absolutely contraindicated and make sure that we are discussing them with our patients," Dr. Harleman said.

The main drugs to avoid during pregnancy are ACE inhibitors, tetracycline, fluoroquinolones, systemic retinoids, warfarin, valproic acid, nonsteroidal anti-inflammatory drugs, and live vaccines. "It’s a pretty short list," she said. "A lot of other drugs are safe in pregnancy; we may just not have as much familiarity with using them."

Dr. Harleman gave three pieces of advice on prescribing during pregnancy: Think hard before starting or stopping any medication. Remember that changes in blood volume and metabolism during pregnancy may mandate increased frequency of dosing or higher doses. And keep one of the following pregnancy prescribing resources available instead of relying solely on the FDA categories:

• The clinical reference tool Micromedex. It has an excellent "ReproRisk" section, she said (micromedex.com).

• Reprotox, a service of the nonprofit Reproductive Toxicology Center, Washington. It synthesizes all the published information on drug safety and provides quick-take summaries that Dr. Harleman believes are worth the low fee for use (reprotox.org/Default.aspx).

• The American College of Physicians’ "Medical Care of the Pregnant Patient," 2nd ed. (Hanover, Pa.: Sheridan Press, 2008) is a good source.

• Motherisk is a service affiliated with the Hospital for Sick Children, Toronto (motherisk.org).

• MotherToBaby is a service of the Organization of Teratology Information Specialists (mothertobaby.org).

• The reference guide "Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk," 9th ed. (Philadelphia: Lippincott Williams and Wilkins, 2011) is a good source.

• The book "Medications and Mother’s Milk" (Amarillo, Tex.: Hale Publishing, 2012) is helpful.

Dr. Harleman reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – The medical abortion regimen approved by the Food and Drug Administration is less effective and less convenient than an alternative evidence-based regimen, yet in some areas women are being denied access to the more effective regimen, Dr. Jody Steinauer said.

Some U.S. states are mandating that only the FDA-approved regimen be offered to women. "That is going to have a real impact on women’s care," she said at a conference on women’s health sponsored by the University of California, San Francisco.

The FDA-approved regimen is 92%-96% effective in causing abortions in pregnancies of less than 49 days, and in 50% of cases the abortion will be complete within 4 hours. The alternative regimen is 96%-99% effective for gestations of less than 63 days, with complete abortions in less than 4 hours in 93% of cases, said Dr. Steinauer of the university.

Sherry Boschert/Frontline Medical News

Two states – Arizona and Ohio – require that the FDA-approved regimen be used when prescribing the progesterone antagonist mifepristone for abortion, according to the Guttmacher Institute, which seeks to advance reproductive rights. Two other states – North Dakota and Oklahoma – passed similar laws that have been stayed by the courts.

Under the FDA-approved regimen, the woman is given 600 mg of mifepristone orally (three tablets of Mifeprex) in the clinic. That’s a higher dose than the 200 mg (one tablet) of mifepristone that has been shown to be effective and is also is taken in the clinic under the alternative regimen, Dr. Steinauer said. In both scenarios, the woman then goes home with pain medications to use as needed.

Two days later, according to the FDA-approved regimen, the woman is given 400 mcg of the prostaglandin misoprostol orally in the clinic to induce bleeding over the next 4-24 hours or more. "In the FDA-approved regimen as modeled by France, women have to pass the pregnancy in the clinic, so you would have to have a place for her to be bleeding," Dr. Steinauer said.

Under the alternative regimen, the woman places 800 mcg of misoprostol pills in the vagina or buccally to induce bleeding, but she can decide to take it anywhere from 6 hours to 3 days after taking the mifepristone and she can take the misoprostol at home. "There’s a lot of flexibility in when women take `miso,’ so they can decide when they will have bleeding," which can happen at home, she said.

The vaginal or buccal administration of misoprostol in the alternative regimen is "much more effective" than oral administration, she added.

The FDA regimen calls for follow-up on day 14. The alternative regimen again is more flexible, allowing follow-up in the range of days 3-14. The FDA says that the approved regimen can be used for gestations up to 7 weeks, while the gestational limit for the alternative regimen is 9 weeks.

Dr. Steinauer’s institution follows the alternative regimen. Patients may return for follow-up as soon as 3 days after taking the misoprostol, and they are instructed to call earlier if they experience unexpected symptoms.

Both the FDA regimen and the alternative regimen are safe, "and, given the higher efficacy of the evidence-based regimen," it might be safer than the FDA-approved one, she said.

On average, the alternative regimen is 97% effective, with incomplete abortion in 2% and continuing pregnancy in 1%, Dr. Steinauer said.

Studies on side effects from medical abortions show bleeding longer than 30 days in 9% of cases, bleeding before misoprostol (after mifepristone) in 21%-47%, abdominal pain requiring narcotics in 29%-73%, nausea in 20%-65%, vomiting in 10%-44%, diarrhea in 3%-29%, chills or fever in 7%-44%, headache in 27%-32%, dizziness in 12%-38%, and passage of the pregnancy before misoprostol in 4%, she said.

When asked to comment on the comparison of regimens, Dr. Eve Espey said that fewer side effects are seen with buccal or vaginal administration of misoprostol compared with taking the drug orally, and that the lower dose of mifepristone in the alternative regimen also may reduce side effects.

The comparison of regimens "is useful to clinicians who may be confused about the legal challenges to the ‘alternative’ or ‘evidence-based’ medical abortion regimen. Dr. Steinauer highlights the superiority of the alternative regimen: it uses less medication, making it less expensive with fewer side effects, and offers a more convenient schedule with fewer total visits for the patient," said Dr. Espey, an ob.gyn. at the University of New Mexico, Albuquerque. "Legal restrictions on the alternative medical abortion regimen are non–evidence based and are harmful to women."

When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.

When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*

Dr. Steinauer and Dr. Espey reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

* This story was updated 1/27/2014

SAN FRANCISCO – The medical abortion regimen approved by the Food and Drug Administration is less effective and less convenient than an alternative evidence-based regimen, yet in some areas women are being denied access to the more effective regimen, Dr. Jody Steinauer said.

Some U.S. states are mandating that only the FDA-approved regimen be offered to women. "That is going to have a real impact on women’s care," she said at a conference on women’s health sponsored by the University of California, San Francisco.

The FDA-approved regimen is 92%-96% effective in causing abortions in pregnancies of less than 49 days, and in 50% of cases the abortion will be complete within 4 hours. The alternative regimen is 96%-99% effective for gestations of less than 63 days, with complete abortions in less than 4 hours in 93% of cases, said Dr. Steinauer of the university.

Sherry Boschert/Frontline Medical News

Two states – Arizona and Ohio – require that the FDA-approved regimen be used when prescribing the progesterone antagonist mifepristone for abortion, according to the Guttmacher Institute, which seeks to advance reproductive rights. Two other states – North Dakota and Oklahoma – passed similar laws that have been stayed by the courts.

Under the FDA-approved regimen, the woman is given 600 mg of mifepristone orally (three tablets of Mifeprex) in the clinic. That’s a higher dose than the 200 mg (one tablet) of mifepristone that has been shown to be effective and is also is taken in the clinic under the alternative regimen, Dr. Steinauer said. In both scenarios, the woman then goes home with pain medications to use as needed.

Two days later, according to the FDA-approved regimen, the woman is given 400 mcg of the prostaglandin misoprostol orally in the clinic to induce bleeding over the next 4-24 hours or more. "In the FDA-approved regimen as modeled by France, women have to pass the pregnancy in the clinic, so you would have to have a place for her to be bleeding," Dr. Steinauer said.

Under the alternative regimen, the woman places 800 mcg of misoprostol pills in the vagina or buccally to induce bleeding, but she can decide to take it anywhere from 6 hours to 3 days after taking the mifepristone and she can take the misoprostol at home. "There’s a lot of flexibility in when women take `miso,’ so they can decide when they will have bleeding," which can happen at home, she said.

The vaginal or buccal administration of misoprostol in the alternative regimen is "much more effective" than oral administration, she added.

The FDA regimen calls for follow-up on day 14. The alternative regimen again is more flexible, allowing follow-up in the range of days 3-14. The FDA says that the approved regimen can be used for gestations up to 7 weeks, while the gestational limit for the alternative regimen is 9 weeks.

Dr. Steinauer’s institution follows the alternative regimen. Patients may return for follow-up as soon as 3 days after taking the misoprostol, and they are instructed to call earlier if they experience unexpected symptoms.

Both the FDA regimen and the alternative regimen are safe, "and, given the higher efficacy of the evidence-based regimen," it might be safer than the FDA-approved one, she said.

On average, the alternative regimen is 97% effective, with incomplete abortion in 2% and continuing pregnancy in 1%, Dr. Steinauer said.

Studies on side effects from medical abortions show bleeding longer than 30 days in 9% of cases, bleeding before misoprostol (after mifepristone) in 21%-47%, abdominal pain requiring narcotics in 29%-73%, nausea in 20%-65%, vomiting in 10%-44%, diarrhea in 3%-29%, chills or fever in 7%-44%, headache in 27%-32%, dizziness in 12%-38%, and passage of the pregnancy before misoprostol in 4%, she said.

When asked to comment on the comparison of regimens, Dr. Eve Espey said that fewer side effects are seen with buccal or vaginal administration of misoprostol compared with taking the drug orally, and that the lower dose of mifepristone in the alternative regimen also may reduce side effects.

The comparison of regimens "is useful to clinicians who may be confused about the legal challenges to the ‘alternative’ or ‘evidence-based’ medical abortion regimen. Dr. Steinauer highlights the superiority of the alternative regimen: it uses less medication, making it less expensive with fewer side effects, and offers a more convenient schedule with fewer total visits for the patient," said Dr. Espey, an ob.gyn. at the University of New Mexico, Albuquerque. "Legal restrictions on the alternative medical abortion regimen are non–evidence based and are harmful to women."

When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.

When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*

Dr. Steinauer and Dr. Espey reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

* This story was updated 1/27/2014

SAN FRANCISCO – The medical abortion regimen approved by the Food and Drug Administration is less effective and less convenient than an alternative evidence-based regimen, yet in some areas women are being denied access to the more effective regimen, Dr. Jody Steinauer said.

Some U.S. states are mandating that only the FDA-approved regimen be offered to women. "That is going to have a real impact on women’s care," she said at a conference on women’s health sponsored by the University of California, San Francisco.

The FDA-approved regimen is 92%-96% effective in causing abortions in pregnancies of less than 49 days, and in 50% of cases the abortion will be complete within 4 hours. The alternative regimen is 96%-99% effective for gestations of less than 63 days, with complete abortions in less than 4 hours in 93% of cases, said Dr. Steinauer of the university.

Sherry Boschert/Frontline Medical News

Two states – Arizona and Ohio – require that the FDA-approved regimen be used when prescribing the progesterone antagonist mifepristone for abortion, according to the Guttmacher Institute, which seeks to advance reproductive rights. Two other states – North Dakota and Oklahoma – passed similar laws that have been stayed by the courts.

Under the FDA-approved regimen, the woman is given 600 mg of mifepristone orally (three tablets of Mifeprex) in the clinic. That’s a higher dose than the 200 mg (one tablet) of mifepristone that has been shown to be effective and is also is taken in the clinic under the alternative regimen, Dr. Steinauer said. In both scenarios, the woman then goes home with pain medications to use as needed.

Two days later, according to the FDA-approved regimen, the woman is given 400 mcg of the prostaglandin misoprostol orally in the clinic to induce bleeding over the next 4-24 hours or more. "In the FDA-approved regimen as modeled by France, women have to pass the pregnancy in the clinic, so you would have to have a place for her to be bleeding," Dr. Steinauer said.

Under the alternative regimen, the woman places 800 mcg of misoprostol pills in the vagina or buccally to induce bleeding, but she can decide to take it anywhere from 6 hours to 3 days after taking the mifepristone and she can take the misoprostol at home. "There’s a lot of flexibility in when women take `miso,’ so they can decide when they will have bleeding," which can happen at home, she said.

The vaginal or buccal administration of misoprostol in the alternative regimen is "much more effective" than oral administration, she added.

The FDA regimen calls for follow-up on day 14. The alternative regimen again is more flexible, allowing follow-up in the range of days 3-14. The FDA says that the approved regimen can be used for gestations up to 7 weeks, while the gestational limit for the alternative regimen is 9 weeks.

Dr. Steinauer’s institution follows the alternative regimen. Patients may return for follow-up as soon as 3 days after taking the misoprostol, and they are instructed to call earlier if they experience unexpected symptoms.

Both the FDA regimen and the alternative regimen are safe, "and, given the higher efficacy of the evidence-based regimen," it might be safer than the FDA-approved one, she said.

On average, the alternative regimen is 97% effective, with incomplete abortion in 2% and continuing pregnancy in 1%, Dr. Steinauer said.

Studies on side effects from medical abortions show bleeding longer than 30 days in 9% of cases, bleeding before misoprostol (after mifepristone) in 21%-47%, abdominal pain requiring narcotics in 29%-73%, nausea in 20%-65%, vomiting in 10%-44%, diarrhea in 3%-29%, chills or fever in 7%-44%, headache in 27%-32%, dizziness in 12%-38%, and passage of the pregnancy before misoprostol in 4%, she said.

When asked to comment on the comparison of regimens, Dr. Eve Espey said that fewer side effects are seen with buccal or vaginal administration of misoprostol compared with taking the drug orally, and that the lower dose of mifepristone in the alternative regimen also may reduce side effects.

The comparison of regimens "is useful to clinicians who may be confused about the legal challenges to the ‘alternative’ or ‘evidence-based’ medical abortion regimen. Dr. Steinauer highlights the superiority of the alternative regimen: it uses less medication, making it less expensive with fewer side effects, and offers a more convenient schedule with fewer total visits for the patient," said Dr. Espey, an ob.gyn. at the University of New Mexico, Albuquerque. "Legal restrictions on the alternative medical abortion regimen are non–evidence based and are harmful to women."

When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.

When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*

Dr. Steinauer and Dr. Espey reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

* This story was updated 1/27/2014

SAN FRANCISCO – Selective serotonin reuptake inhibitor antidepressants can alleviate symptoms of premenstrual syndrome or premenstrual dysphoric disorder, but are far from first-line therapies for either disorder, according to Dr. Ellen Haller.

The first steps in treating PMS and PMDD are basic wellness strategies such as a healthy diet, smoking cessation, exercise, adequate sleep, and stress management, Dr. Haller said at a conference on women’s health sponsored by the University of California, San Francisco.

Calcium supplementation also has been shown to reduce total emotional and physical symptom scores by 48% in women with PMS compared with a 30% reduction from placebo in a multicenter, randomized placebo-controlled study of 497 patients. That study used 600 mg, twice daily, of calcium carbonate or placebo for three menstrual cycles, said Dr. Haller, professor of clinical psychiatry at the university.

The results of that study (Am. J. Obstet.Gynecol. 1998;179:444-52) have not been replicated, she added.

If wellness treatments and calcium supplementation don’t work, the next step for treating women with PMS may be an SSRI. A Cochrane review of 31 randomized controlled trials found that SSRIs are more effective than placebo in treating PMS (Cochrane Database Syst. Rev. 2013;6:CD001396). Treatment should be an SSRI antidepressant, Dr. Haller emphasized. Bupropion, which is a norepinephrine dopamine reuptake inhibitor, is not effective for these women.

Low-dose SSRIs may be taken daily or can be effective against emotional and physical symptoms if taken only during the luteal phase of menstruation, starting on day 14 of the cycle and stopping on day 1, the first day of menses, Dr. Haller said. Patients with PMS tend to respond more quickly and at lower doses than patients with depression, and usually don’t get withdrawal symptoms when stopping the SSRI on the luteal-phase dosing regimen.

In women with PMDD, there is a preliminary suggestion that an SSRI may be more effective than calcium supplements. A pilot study of 39 women with PMDD found that the SSRI fluoxetine was more effective than calcium or placebo for PMDD, though scores were significantly better than calcium only on just two of five symptom scales. The study compared fluoxetine 10 mg b.i.d., calcium carbonate 600 mg b.i.d., and placebo (J. Clin. Psychopharmacol. 2013;33:614-20).

Dr. Haller also advised avoiding progesterone-only or other combination oral contraceptives, most of which can worsen PMDD symptoms. The oral contraceptive Yaz (drospirenone 3 mg plus ethinyl estradiol 20 mcg) is an evidence-based option that is approved to treat PMDD.

In a double-blind, randomized placebo-controlled trial, 450 women with rigorously diagnosed PMDD spent 24 days on Yaz or placebo and 4 days on an inert pill per cycle for three menstrual cycles. The Yaz group had a significant 47% decrease in total symptom scores compared with a 38% decrease in the placebo group. Side effects, most commonly nausea and intermenstrual bleeding, prompted 15% on Yaz and 4% on placebo to drop out of the study (Obstet. Gynecol. 2005;106:492-501).

Significant PMS symptoms affect approximately 30% of women, but PMDD affects perhaps 3%-8%. PMDD typically starts in a woman’s 3rd decade (in her 20s) and worsens over time, Dr. Haller said. PMDD is a formal diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). The illness reduces quality of life and level of functioning during the late luteal phase of the menstrual cycle, affecting relationships, work, or school.

"We miss this diagnosis a lot of the time," she said. Missed diagnosis rates for PMDD are estimated to be as high as 90%.

Conversely, approximately 40% of patients who think they have PMDD actually experience premenstrual exacerbations of bipolar disorder, major depression, anxiety, or other psychiatric disorders with symptoms that can get worse during the late luteal phase.

To diagnose PMDD, first rule out other psychiatric disorders and other medical disorders such as hypothyroidism, Dr. Haller advised. Then, have patients prospectively record their symptoms on a daily symptom diary to track associations with the menstrual cycle.

Dr. Haller reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Selective serotonin reuptake inhibitor antidepressants can alleviate symptoms of premenstrual syndrome or premenstrual dysphoric disorder, but are far from first-line therapies for either disorder, according to Dr. Ellen Haller.

The first steps in treating PMS and PMDD are basic wellness strategies such as a healthy diet, smoking cessation, exercise, adequate sleep, and stress management, Dr. Haller said at a conference on women’s health sponsored by the University of California, San Francisco.

Calcium supplementation also has been shown to reduce total emotional and physical symptom scores by 48% in women with PMS compared with a 30% reduction from placebo in a multicenter, randomized placebo-controlled study of 497 patients. That study used 600 mg, twice daily, of calcium carbonate or placebo for three menstrual cycles, said Dr. Haller, professor of clinical psychiatry at the university.

The results of that study (Am. J. Obstet.Gynecol. 1998;179:444-52) have not been replicated, she added.

If wellness treatments and calcium supplementation don’t work, the next step for treating women with PMS may be an SSRI. A Cochrane review of 31 randomized controlled trials found that SSRIs are more effective than placebo in treating PMS (Cochrane Database Syst. Rev. 2013;6:CD001396). Treatment should be an SSRI antidepressant, Dr. Haller emphasized. Bupropion, which is a norepinephrine dopamine reuptake inhibitor, is not effective for these women.

Low-dose SSRIs may be taken daily or can be effective against emotional and physical symptoms if taken only during the luteal phase of menstruation, starting on day 14 of the cycle and stopping on day 1, the first day of menses, Dr. Haller said. Patients with PMS tend to respond more quickly and at lower doses than patients with depression, and usually don’t get withdrawal symptoms when stopping the SSRI on the luteal-phase dosing regimen.

In women with PMDD, there is a preliminary suggestion that an SSRI may be more effective than calcium supplements. A pilot study of 39 women with PMDD found that the SSRI fluoxetine was more effective than calcium or placebo for PMDD, though scores were significantly better than calcium only on just two of five symptom scales. The study compared fluoxetine 10 mg b.i.d., calcium carbonate 600 mg b.i.d., and placebo (J. Clin. Psychopharmacol. 2013;33:614-20).

Dr. Haller also advised avoiding progesterone-only or other combination oral contraceptives, most of which can worsen PMDD symptoms. The oral contraceptive Yaz (drospirenone 3 mg plus ethinyl estradiol 20 mcg) is an evidence-based option that is approved to treat PMDD.

In a double-blind, randomized placebo-controlled trial, 450 women with rigorously diagnosed PMDD spent 24 days on Yaz or placebo and 4 days on an inert pill per cycle for three menstrual cycles. The Yaz group had a significant 47% decrease in total symptom scores compared with a 38% decrease in the placebo group. Side effects, most commonly nausea and intermenstrual bleeding, prompted 15% on Yaz and 4% on placebo to drop out of the study (Obstet. Gynecol. 2005;106:492-501).

Significant PMS symptoms affect approximately 30% of women, but PMDD affects perhaps 3%-8%. PMDD typically starts in a woman’s 3rd decade (in her 20s) and worsens over time, Dr. Haller said. PMDD is a formal diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). The illness reduces quality of life and level of functioning during the late luteal phase of the menstrual cycle, affecting relationships, work, or school.

"We miss this diagnosis a lot of the time," she said. Missed diagnosis rates for PMDD are estimated to be as high as 90%.

Conversely, approximately 40% of patients who think they have PMDD actually experience premenstrual exacerbations of bipolar disorder, major depression, anxiety, or other psychiatric disorders with symptoms that can get worse during the late luteal phase.

To diagnose PMDD, first rule out other psychiatric disorders and other medical disorders such as hypothyroidism, Dr. Haller advised. Then, have patients prospectively record their symptoms on a daily symptom diary to track associations with the menstrual cycle.

Dr. Haller reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Selective serotonin reuptake inhibitor antidepressants can alleviate symptoms of premenstrual syndrome or premenstrual dysphoric disorder, but are far from first-line therapies for either disorder, according to Dr. Ellen Haller.

The first steps in treating PMS and PMDD are basic wellness strategies such as a healthy diet, smoking cessation, exercise, adequate sleep, and stress management, Dr. Haller said at a conference on women’s health sponsored by the University of California, San Francisco.

Calcium supplementation also has been shown to reduce total emotional and physical symptom scores by 48% in women with PMS compared with a 30% reduction from placebo in a multicenter, randomized placebo-controlled study of 497 patients. That study used 600 mg, twice daily, of calcium carbonate or placebo for three menstrual cycles, said Dr. Haller, professor of clinical psychiatry at the university.

The results of that study (Am. J. Obstet.Gynecol. 1998;179:444-52) have not been replicated, she added.

If wellness treatments and calcium supplementation don’t work, the next step for treating women with PMS may be an SSRI. A Cochrane review of 31 randomized controlled trials found that SSRIs are more effective than placebo in treating PMS (Cochrane Database Syst. Rev. 2013;6:CD001396). Treatment should be an SSRI antidepressant, Dr. Haller emphasized. Bupropion, which is a norepinephrine dopamine reuptake inhibitor, is not effective for these women.

Low-dose SSRIs may be taken daily or can be effective against emotional and physical symptoms if taken only during the luteal phase of menstruation, starting on day 14 of the cycle and stopping on day 1, the first day of menses, Dr. Haller said. Patients with PMS tend to respond more quickly and at lower doses than patients with depression, and usually don’t get withdrawal symptoms when stopping the SSRI on the luteal-phase dosing regimen.

In women with PMDD, there is a preliminary suggestion that an SSRI may be more effective than calcium supplements. A pilot study of 39 women with PMDD found that the SSRI fluoxetine was more effective than calcium or placebo for PMDD, though scores were significantly better than calcium only on just two of five symptom scales. The study compared fluoxetine 10 mg b.i.d., calcium carbonate 600 mg b.i.d., and placebo (J. Clin. Psychopharmacol. 2013;33:614-20).

Dr. Haller also advised avoiding progesterone-only or other combination oral contraceptives, most of which can worsen PMDD symptoms. The oral contraceptive Yaz (drospirenone 3 mg plus ethinyl estradiol 20 mcg) is an evidence-based option that is approved to treat PMDD.

In a double-blind, randomized placebo-controlled trial, 450 women with rigorously diagnosed PMDD spent 24 days on Yaz or placebo and 4 days on an inert pill per cycle for three menstrual cycles. The Yaz group had a significant 47% decrease in total symptom scores compared with a 38% decrease in the placebo group. Side effects, most commonly nausea and intermenstrual bleeding, prompted 15% on Yaz and 4% on placebo to drop out of the study (Obstet. Gynecol. 2005;106:492-501).

Significant PMS symptoms affect approximately 30% of women, but PMDD affects perhaps 3%-8%. PMDD typically starts in a woman’s 3rd decade (in her 20s) and worsens over time, Dr. Haller said. PMDD is a formal diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). The illness reduces quality of life and level of functioning during the late luteal phase of the menstrual cycle, affecting relationships, work, or school.

"We miss this diagnosis a lot of the time," she said. Missed diagnosis rates for PMDD are estimated to be as high as 90%.

Conversely, approximately 40% of patients who think they have PMDD actually experience premenstrual exacerbations of bipolar disorder, major depression, anxiety, or other psychiatric disorders with symptoms that can get worse during the late luteal phase.

To diagnose PMDD, first rule out other psychiatric disorders and other medical disorders such as hypothyroidism, Dr. Haller advised. Then, have patients prospectively record their symptoms on a daily symptom diary to track associations with the menstrual cycle.

Dr. Haller reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Beta-HCG values can vary widely in early pregnancy, and should not be used in isolation to declare a pregnancy to be abnormal, according to Dr. Jody Steinauer.

In 366 women with vaginal bleeding or pain who went on to have a normal intrauterine pregnancy, the lowest level of beta-HCG at which an intrauterine pregnancy could be seen was 390 mIU/mL. The same study reported that women with beta-HCG levels as high as 3,510 mIU/mL in whom no gestational sac can be seen may still have normal pregnancies (Obstet. Gynecol. 2013;121:65-70).

Sherry Boschert/Frontline Medical News

The widely accepted upper cutoff value is 1,500-2,000 mIU/mL, Dr. Steinauer said at a conference on women’s health sponsored by the University of California, San Francisco. Yet "it’s not a hard-and-fast rule. We have all heard of patients who had even higher beta-HCG levels and went on to have normal singleton pregnancies." On the lower end of beta-HCG values, the attitude may be "her beta-HCG is only 700 mIU/mL, so I’m not expecting to see a gestational sac" on ultrasound. Dr. Steinauer said.

In the current study, using a beta-HCG cutoff of 1,500 mIU/mL when no gestational sac can be seen would identify 80% of normal intrauterine pregnancies. A 2,000-mIU/mL cutoff would identify 91% of normal pregnancies. With either cutoff value, "there would have been a high proportion of normal pregnancies that were called abnormal," said Dr. Steinauer of the university.

New criteria released by the Society of Radiologists in Ultrasound for diagnosing a nonviable pregnancy early in the first trimester also address beta-HCG levels. If no gestational sac is visible at a beta-HCG level greater than 2,000 mIU/mL, an ectopic pregnancy is 19 times more likely than a viable pregnancy, but a nonviable intrauterine pregnancy still is twice as likely as an ectopic pregnancy (N. Engl. J. Med. 2013;369:1443-51).

Those estimates apply to the general U.S. population, Dr. Steinauer said, and may vary depending on patient population.

In women with beta-HCG levels of 2,000-3,000 mIU/mL, there will be 19 ectopic pregnancies and 38 nonviable pregnancies for every viable pregnancy. Yet as many as 2% of women with values this high can have viable pregnancies, according to the society’s criteria. Once the beta-HCG level climbs higher than 3,000 mIU/mL and no gestational sac is visible, an ectopic pregnancy is 70 times more likely than a viable pregnancy.

Ultrasound measurements of the yolk sac or fetal pole also can help diagnose early pregnancy loss, but these are more variable and thus less helpful than gestational sac measurements.

Studies have shown that when no embryo is seen with a mean gestational sac diameter of 2 mm, a diagnosis of early pregnancy loss will be false in 0.5% of cases in which no yolk sac is seen and in 0.4% of cases with a yolk sac. The false-positive rate approaches 0, however, with a mean gestational sac diameter of 21 mm, she said.

Several studies have shown that an inability to find cardiac activity when the fetal pole measures 5 mm does not confirm a diagnosis of early pregnancy loss because 8.3% of cases will be false positives under those criteria. A fetal pole measuring at least 5.3 mm with no cardiac activity, however, eliminates the possibility of a false-positive diagnosis.

The criteria released by the Society of Radiologists in Ultrasound express concern about the difficulty for an average ultrasonographer to detect fractions of millimeters in differences, so they allow a margin of error. The cutoff for a diagnosis of early pregnancy loss is extended to a mean gestational sac diameter of 25 mm with no embryo, or a fetal pole measuring 7 mm with no cardiac activity.

Dr. Steinauer reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Beta-HCG values can vary widely in early pregnancy, and should not be used in isolation to declare a pregnancy to be abnormal, according to Dr. Jody Steinauer.

In 366 women with vaginal bleeding or pain who went on to have a normal intrauterine pregnancy, the lowest level of beta-HCG at which an intrauterine pregnancy could be seen was 390 mIU/mL. The same study reported that women with beta-HCG levels as high as 3,510 mIU/mL in whom no gestational sac can be seen may still have normal pregnancies (Obstet. Gynecol. 2013;121:65-70).

Sherry Boschert/Frontline Medical News

The widely accepted upper cutoff value is 1,500-2,000 mIU/mL, Dr. Steinauer said at a conference on women’s health sponsored by the University of California, San Francisco. Yet "it’s not a hard-and-fast rule. We have all heard of patients who had even higher beta-HCG levels and went on to have normal singleton pregnancies." On the lower end of beta-HCG values, the attitude may be "her beta-HCG is only 700 mIU/mL, so I’m not expecting to see a gestational sac" on ultrasound. Dr. Steinauer said.

In the current study, using a beta-HCG cutoff of 1,500 mIU/mL when no gestational sac can be seen would identify 80% of normal intrauterine pregnancies. A 2,000-mIU/mL cutoff would identify 91% of normal pregnancies. With either cutoff value, "there would have been a high proportion of normal pregnancies that were called abnormal," said Dr. Steinauer of the university.

New criteria released by the Society of Radiologists in Ultrasound for diagnosing a nonviable pregnancy early in the first trimester also address beta-HCG levels. If no gestational sac is visible at a beta-HCG level greater than 2,000 mIU/mL, an ectopic pregnancy is 19 times more likely than a viable pregnancy, but a nonviable intrauterine pregnancy still is twice as likely as an ectopic pregnancy (N. Engl. J. Med. 2013;369:1443-51).

Those estimates apply to the general U.S. population, Dr. Steinauer said, and may vary depending on patient population.

In women with beta-HCG levels of 2,000-3,000 mIU/mL, there will be 19 ectopic pregnancies and 38 nonviable pregnancies for every viable pregnancy. Yet as many as 2% of women with values this high can have viable pregnancies, according to the society’s criteria. Once the beta-HCG level climbs higher than 3,000 mIU/mL and no gestational sac is visible, an ectopic pregnancy is 70 times more likely than a viable pregnancy.

Ultrasound measurements of the yolk sac or fetal pole also can help diagnose early pregnancy loss, but these are more variable and thus less helpful than gestational sac measurements.

Studies have shown that when no embryo is seen with a mean gestational sac diameter of 2 mm, a diagnosis of early pregnancy loss will be false in 0.5% of cases in which no yolk sac is seen and in 0.4% of cases with a yolk sac. The false-positive rate approaches 0, however, with a mean gestational sac diameter of 21 mm, she said.

Several studies have shown that an inability to find cardiac activity when the fetal pole measures 5 mm does not confirm a diagnosis of early pregnancy loss because 8.3% of cases will be false positives under those criteria. A fetal pole measuring at least 5.3 mm with no cardiac activity, however, eliminates the possibility of a false-positive diagnosis.

The criteria released by the Society of Radiologists in Ultrasound express concern about the difficulty for an average ultrasonographer to detect fractions of millimeters in differences, so they allow a margin of error. The cutoff for a diagnosis of early pregnancy loss is extended to a mean gestational sac diameter of 25 mm with no embryo, or a fetal pole measuring 7 mm with no cardiac activity.

Dr. Steinauer reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Beta-HCG values can vary widely in early pregnancy, and should not be used in isolation to declare a pregnancy to be abnormal, according to Dr. Jody Steinauer.

In 366 women with vaginal bleeding or pain who went on to have a normal intrauterine pregnancy, the lowest level of beta-HCG at which an intrauterine pregnancy could be seen was 390 mIU/mL. The same study reported that women with beta-HCG levels as high as 3,510 mIU/mL in whom no gestational sac can be seen may still have normal pregnancies (Obstet. Gynecol. 2013;121:65-70).

Sherry Boschert/Frontline Medical News

The widely accepted upper cutoff value is 1,500-2,000 mIU/mL, Dr. Steinauer said at a conference on women’s health sponsored by the University of California, San Francisco. Yet "it’s not a hard-and-fast rule. We have all heard of patients who had even higher beta-HCG levels and went on to have normal singleton pregnancies." On the lower end of beta-HCG values, the attitude may be "her beta-HCG is only 700 mIU/mL, so I’m not expecting to see a gestational sac" on ultrasound. Dr. Steinauer said.

In the current study, using a beta-HCG cutoff of 1,500 mIU/mL when no gestational sac can be seen would identify 80% of normal intrauterine pregnancies. A 2,000-mIU/mL cutoff would identify 91% of normal pregnancies. With either cutoff value, "there would have been a high proportion of normal pregnancies that were called abnormal," said Dr. Steinauer of the university.

New criteria released by the Society of Radiologists in Ultrasound for diagnosing a nonviable pregnancy early in the first trimester also address beta-HCG levels. If no gestational sac is visible at a beta-HCG level greater than 2,000 mIU/mL, an ectopic pregnancy is 19 times more likely than a viable pregnancy, but a nonviable intrauterine pregnancy still is twice as likely as an ectopic pregnancy (N. Engl. J. Med. 2013;369:1443-51).

Those estimates apply to the general U.S. population, Dr. Steinauer said, and may vary depending on patient population.

In women with beta-HCG levels of 2,000-3,000 mIU/mL, there will be 19 ectopic pregnancies and 38 nonviable pregnancies for every viable pregnancy. Yet as many as 2% of women with values this high can have viable pregnancies, according to the society’s criteria. Once the beta-HCG level climbs higher than 3,000 mIU/mL and no gestational sac is visible, an ectopic pregnancy is 70 times more likely than a viable pregnancy.

Ultrasound measurements of the yolk sac or fetal pole also can help diagnose early pregnancy loss, but these are more variable and thus less helpful than gestational sac measurements.

Studies have shown that when no embryo is seen with a mean gestational sac diameter of 2 mm, a diagnosis of early pregnancy loss will be false in 0.5% of cases in which no yolk sac is seen and in 0.4% of cases with a yolk sac. The false-positive rate approaches 0, however, with a mean gestational sac diameter of 21 mm, she said.

Several studies have shown that an inability to find cardiac activity when the fetal pole measures 5 mm does not confirm a diagnosis of early pregnancy loss because 8.3% of cases will be false positives under those criteria. A fetal pole measuring at least 5.3 mm with no cardiac activity, however, eliminates the possibility of a false-positive diagnosis.

The criteria released by the Society of Radiologists in Ultrasound express concern about the difficulty for an average ultrasonographer to detect fractions of millimeters in differences, so they allow a margin of error. The cutoff for a diagnosis of early pregnancy loss is extended to a mean gestational sac diameter of 25 mm with no embryo, or a fetal pole measuring 7 mm with no cardiac activity.

Dr. Steinauer reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Pop quiz: Do you know which contraceptive methods are safe for women who are postpartum or who smoke? How about for women who have diabetic nephropathy or migraine with aura?

Handy online tools and smart-phone apps from the Centers for Disease Control and Prevention now offer recommendations for contraceptive choices. The U.S. Medical Eligibility Criteria for Contraception, or MEC (MMWR 2010;59:1-6), now has a newer companion document, the U.S. Selected Practice Recommendations for Contraception, released by the U.S. Centers for Disease Control and Prevention (MMWR 2013;62:1-46), Dr. Jody Steinauer said at a conference on women’s health sponsored by the University of California, San Francisco.

The U.S. version of the MEC features four color-coded tables that compare contraceptive methods and more than 60 medical conditions or characteristics. Each pair of method and condition is scored for safety on a scale of 1-4.

A score of 1 (color-coded dark green) means there are no concerns about the method to be used in that scenario. A score of 2 (light green) means that generally the advantages outweigh the risks of the method, said Dr. Steinauer, of the university.

A score of 3 (pink) suggests there is a "relative contraindication" in which there are some concerns, but the advantages of using that contraceptive method outweigh the risks for that patient. "You might talk with the woman about using a different method and if she decides to use the method with a 3 score, you would counsel her about the risks but would still prescribe it," she said. A score of 4 (red) means there’s an absolute contraindication to the method for that condition.

The MEC is available in an app for iPhone or iPad. The app lists choices by condition or by method; the online tables can be printed out and the options viewed all at once, she said.

"We have these hanging around at our clinic, and all of the residents carry them on their iPhones as well," she said. "It’s a really useful document."

The companion Selected Practice Recommendations for Contraception provide advice on how to use contraceptive methods in clinical practice. For example, there are recommendations on how long to use a backup contraceptive method once it has been started, special considerations for each method, and what to do when there are missed or late doses.

Dr. Steinauer reported having no financial disclosures,

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Pop quiz: Do you know which contraceptive methods are safe for women who are postpartum or who smoke? How about for women who have diabetic nephropathy or migraine with aura?

Handy online tools and smart-phone apps from the Centers for Disease Control and Prevention now offer recommendations for contraceptive choices. The U.S. Medical Eligibility Criteria for Contraception, or MEC (MMWR 2010;59:1-6), now has a newer companion document, the U.S. Selected Practice Recommendations for Contraception, released by the U.S. Centers for Disease Control and Prevention (MMWR 2013;62:1-46), Dr. Jody Steinauer said at a conference on women’s health sponsored by the University of California, San Francisco.

The U.S. version of the MEC features four color-coded tables that compare contraceptive methods and more than 60 medical conditions or characteristics. Each pair of method and condition is scored for safety on a scale of 1-4.

A score of 1 (color-coded dark green) means there are no concerns about the method to be used in that scenario. A score of 2 (light green) means that generally the advantages outweigh the risks of the method, said Dr. Steinauer, of the university.

A score of 3 (pink) suggests there is a "relative contraindication" in which there are some concerns, but the advantages of using that contraceptive method outweigh the risks for that patient. "You might talk with the woman about using a different method and if she decides to use the method with a 3 score, you would counsel her about the risks but would still prescribe it," she said. A score of 4 (red) means there’s an absolute contraindication to the method for that condition.

The MEC is available in an app for iPhone or iPad. The app lists choices by condition or by method; the online tables can be printed out and the options viewed all at once, she said.

"We have these hanging around at our clinic, and all of the residents carry them on their iPhones as well," she said. "It’s a really useful document."

The companion Selected Practice Recommendations for Contraception provide advice on how to use contraceptive methods in clinical practice. For example, there are recommendations on how long to use a backup contraceptive method once it has been started, special considerations for each method, and what to do when there are missed or late doses.

Dr. Steinauer reported having no financial disclosures,

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Pop quiz: Do you know which contraceptive methods are safe for women who are postpartum or who smoke? How about for women who have diabetic nephropathy or migraine with aura?

Handy online tools and smart-phone apps from the Centers for Disease Control and Prevention now offer recommendations for contraceptive choices. The U.S. Medical Eligibility Criteria for Contraception, or MEC (MMWR 2010;59:1-6), now has a newer companion document, the U.S. Selected Practice Recommendations for Contraception, released by the U.S. Centers for Disease Control and Prevention (MMWR 2013;62:1-46), Dr. Jody Steinauer said at a conference on women’s health sponsored by the University of California, San Francisco.

The U.S. version of the MEC features four color-coded tables that compare contraceptive methods and more than 60 medical conditions or characteristics. Each pair of method and condition is scored for safety on a scale of 1-4.

A score of 1 (color-coded dark green) means there are no concerns about the method to be used in that scenario. A score of 2 (light green) means that generally the advantages outweigh the risks of the method, said Dr. Steinauer, of the university.

A score of 3 (pink) suggests there is a "relative contraindication" in which there are some concerns, but the advantages of using that contraceptive method outweigh the risks for that patient. "You might talk with the woman about using a different method and if she decides to use the method with a 3 score, you would counsel her about the risks but would still prescribe it," she said. A score of 4 (red) means there’s an absolute contraindication to the method for that condition.

The MEC is available in an app for iPhone or iPad. The app lists choices by condition or by method; the online tables can be printed out and the options viewed all at once, she said.

"We have these hanging around at our clinic, and all of the residents carry them on their iPhones as well," she said. "It’s a really useful document."

The companion Selected Practice Recommendations for Contraception provide advice on how to use contraceptive methods in clinical practice. For example, there are recommendations on how long to use a backup contraceptive method once it has been started, special considerations for each method, and what to do when there are missed or late doses.

Dr. Steinauer reported having no financial disclosures,

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Pop quiz: Do you know which contraceptive methods are safe for women who are postpartum or who smoke? How about for women who have diabetic nephropathy or migraine with aura?

Handy online tools and smart-phone apps from the Centers for Disease Control and Prevention now offer recommendations for contraceptive choices. The U.S. Medical Eligibility Criteria for Contraception, or MEC (MMWR 2010;59:1-6), now has a newer companion document, the U.S. Selected Practice Recommendations for Contraception, released by the U.S. Centers for Disease Control and Prevention (MMWR 2013;62:1-46), Dr. Jody Steinauer said at a conference on women’s health sponsored by the University of California, San Francisco.

Sherry Boschert/Frontline Medical News

The U.S. version of the MEC features four color-coded tables that compare contraceptive methods and more than 60 medical conditions or characteristics. Each pair of method and condition is scored for safety on a scale of 1-4.

A score of 1 (color-coded dark green) means there are no concerns about the method to be used in that scenario. A score of 2 (light green) means that generally the advantages outweigh the risks of the method, said Dr. Steinauer, of the university.

A score of 3 (pink) suggests there is a "relative contraindication" in which there are some concerns, but the advantages of using that contraceptive method outweigh the risks for that patient. "You might talk with the woman about using a different method and if she decides to use the method with a 3 score, you would counsel her about the risks but would still prescribe it," she said. A score of 4 (red) means there’s an absolute contraindication to the method for that condition.

The MEC is available in an app for iPhone or iPad. The app lists choices by condition or by method; the online tables can be printed out and the options viewed all at once, she said.

"We have these hanging around at our clinic, and all of the residents carry them on their iPhones as well," she said. "It’s a really useful document."

The companion Selected Practice Recommendations for Contraception provide advice on how to use contraceptive methods in clinical practice. For example, there are recommendations on how long to use a backup contraceptive method once it has been started, special considerations for each method, and what to do when there are missed or late doses.

Dr. Steinauer reported having no financial disclosures,

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Pop quiz: Do you know which contraceptive methods are safe for women who are postpartum or who smoke? How about for women who have diabetic nephropathy or migraine with aura?

Handy online tools and smart-phone apps from the Centers for Disease Control and Prevention now offer recommendations for contraceptive choices. The U.S. Medical Eligibility Criteria for Contraception, or MEC (MMWR 2010;59:1-6), now has a newer companion document, the U.S. Selected Practice Recommendations for Contraception, released by the U.S. Centers for Disease Control and Prevention (MMWR 2013;62:1-46), Dr. Jody Steinauer said at a conference on women’s health sponsored by the University of California, San Francisco.

Sherry Boschert/Frontline Medical News

The U.S. version of the MEC features four color-coded tables that compare contraceptive methods and more than 60 medical conditions or characteristics. Each pair of method and condition is scored for safety on a scale of 1-4.

A score of 1 (color-coded dark green) means there are no concerns about the method to be used in that scenario. A score of 2 (light green) means that generally the advantages outweigh the risks of the method, said Dr. Steinauer, of the university.

A score of 3 (pink) suggests there is a "relative contraindication" in which there are some concerns, but the advantages of using that contraceptive method outweigh the risks for that patient. "You might talk with the woman about using a different method and if she decides to use the method with a 3 score, you would counsel her about the risks but would still prescribe it," she said. A score of 4 (red) means there’s an absolute contraindication to the method for that condition.

The MEC is available in an app for iPhone or iPad. The app lists choices by condition or by method; the online tables can be printed out and the options viewed all at once, she said.

"We have these hanging around at our clinic, and all of the residents carry them on their iPhones as well," she said. "It’s a really useful document."

The companion Selected Practice Recommendations for Contraception provide advice on how to use contraceptive methods in clinical practice. For example, there are recommendations on how long to use a backup contraceptive method once it has been started, special considerations for each method, and what to do when there are missed or late doses.

Dr. Steinauer reported having no financial disclosures,

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Pop quiz: Do you know which contraceptive methods are safe for women who are postpartum or who smoke? How about for women who have diabetic nephropathy or migraine with aura?

Handy online tools and smart-phone apps from the Centers for Disease Control and Prevention now offer recommendations for contraceptive choices. The U.S. Medical Eligibility Criteria for Contraception, or MEC (MMWR 2010;59:1-6), now has a newer companion document, the U.S. Selected Practice Recommendations for Contraception, released by the U.S. Centers for Disease Control and Prevention (MMWR 2013;62:1-46), Dr. Jody Steinauer said at a conference on women’s health sponsored by the University of California, San Francisco.

Sherry Boschert/Frontline Medical News

The U.S. version of the MEC features four color-coded tables that compare contraceptive methods and more than 60 medical conditions or characteristics. Each pair of method and condition is scored for safety on a scale of 1-4.

A score of 1 (color-coded dark green) means there are no concerns about the method to be used in that scenario. A score of 2 (light green) means that generally the advantages outweigh the risks of the method, said Dr. Steinauer, of the university.

A score of 3 (pink) suggests there is a "relative contraindication" in which there are some concerns, but the advantages of using that contraceptive method outweigh the risks for that patient. "You might talk with the woman about using a different method and if she decides to use the method with a 3 score, you would counsel her about the risks but would still prescribe it," she said. A score of 4 (red) means there’s an absolute contraindication to the method for that condition.

The MEC is available in an app for iPhone or iPad. The app lists choices by condition or by method; the online tables can be printed out and the options viewed all at once, she said.

"We have these hanging around at our clinic, and all of the residents carry them on their iPhones as well," she said. "It’s a really useful document."

The companion Selected Practice Recommendations for Contraception provide advice on how to use contraceptive methods in clinical practice. For example, there are recommendations on how long to use a backup contraceptive method once it has been started, special considerations for each method, and what to do when there are missed or late doses.

Dr. Steinauer reported having no financial disclosures,

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A two-page questionnaire is more helpful than a tender-point exam for diagnosing fibromyalgia in clinical practice, according to Dr. Andrew Gross.

Tender point exams – pressing on the 18 tender points of the body as advised in the American College of Rheumatology’s fibromyalgia classification criteria – can make even healthy people flinch in pain. The exam may be useful when enrolling patients in studies, but "for the most part, I find this a complete waste of time," he said at a conference on women’s health sponsored by the University of California, San Francisco.

*Instead, Dr. Gross hands patients with suspected fibromyalgia a brief questionnaire based on the ACR’s modified Diagnostic Criteria for Fibromyalgia (J. Rheumatol. 2001;38:1113-22) and steps out of the room while the patient completes the form."I use this in clinical practice all the time," said Dr. Gross, director of the Rheumatology Clinic at the university.

Patients fill out the questionnaire by checking off areas of the body in which they’ve experienced pain in the past week (the Widespread Pain Index). Dr. Gross also asks patients to provide information about the severity of their symptoms using a scale of 0-3 (none to severe) to quantify their degree of fatigue, extent of waking from sleep feeling unrefreshed, and cognitive symptoms, giving a symptom severity score. He then reviews the questionnaire with patients to understand the extent and severity of symptoms, and often diagnoses fibromyalgia when he determines there is a widespread pain score of 7 or more areas of the body plus a symptom severity score of at least 5.

Dr. Gross gives the questionnaire to patients who have the three hallmarks of fibromyalgia – widespread pain present for longer than 3 months, fatigue, and poor sleep. "If someone has pain in multiple areas, right away I’m thinking about fibromyalgia," he said.

Other tip-offs to fibromyalgia include cognitive problems, pain unrelieved by changing the body’s position, or the complaint that a specific activity had consequences. For example, "I helped my sister move the other day and I was in bed for a week." Odd complaints are another tip-off. One patient recently told him, "My body feels like it has tinnitus."

Before diagnosing fibromyalgia, Dr. Gross evaluates the patient for other medical conditions that can cause pain and/or fatigue. In addition to a comprehensive patient interview and physical examination, he orders a limited panel of blood tests to evaluate for other conditions. These include tests for erythrocyte sedimentation rate and C-reactive protein tests, a CBC, a comprehensive metabolic panel, a fasting glucose test, thyroid hormone tests, hepatitis B and C tests, and in some populations an HIV test. He checks vitamin D levels because vitamin D deficiency can aggravate pain, though it doesn’t cause it. If the patient is having weakness, he’ll check the creatinine phosphokinase level. In rare cases he’ll test for antinuclear antibodies. He’ll sometimes order x-rays of affected areas to look for joint damage, and he biopsies skin lesions that are concerning, particularly rashes. If there are many persistent neurologic symptoms, he may order an electromyogram.

Multiple studies have shown that the number of medical tests and costs increase over time for patients with undiagnosed fibromyalgia but level off or decrease once the diagnosis is made. "People stop looking for Lyme disease or multiple sclerosis or whatever," he said.

Dr. Gross reported having no relevant financial disclosures.

*CLARIFICATION: This story was revised on 1/15/2014 to include new information provided by Dr. Gross after publication.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A two-page questionnaire is more helpful than a tender-point exam for diagnosing fibromyalgia in clinical practice, according to Dr. Andrew Gross.

Tender point exams – pressing on the 18 tender points of the body as advised in the American College of Rheumatology’s fibromyalgia classification criteria – can make even healthy people flinch in pain. The exam may be useful when enrolling patients in studies, but "for the most part, I find this a complete waste of time," he said at a conference on women’s health sponsored by the University of California, San Francisco.

*Instead, Dr. Gross hands patients with suspected fibromyalgia a brief questionnaire based on the ACR’s modified Diagnostic Criteria for Fibromyalgia (J. Rheumatol. 2001;38:1113-22) and steps out of the room while the patient completes the form."I use this in clinical practice all the time," said Dr. Gross, director of the Rheumatology Clinic at the university.

Patients fill out the questionnaire by checking off areas of the body in which they’ve experienced pain in the past week (the Widespread Pain Index). Dr. Gross also asks patients to provide information about the severity of their symptoms using a scale of 0-3 (none to severe) to quantify their degree of fatigue, extent of waking from sleep feeling unrefreshed, and cognitive symptoms, giving a symptom severity score. He then reviews the questionnaire with patients to understand the extent and severity of symptoms, and often diagnoses fibromyalgia when he determines there is a widespread pain score of 7 or more areas of the body plus a symptom severity score of at least 5.

Dr. Gross gives the questionnaire to patients who have the three hallmarks of fibromyalgia – widespread pain present for longer than 3 months, fatigue, and poor sleep. "If someone has pain in multiple areas, right away I’m thinking about fibromyalgia," he said.

Other tip-offs to fibromyalgia include cognitive problems, pain unrelieved by changing the body’s position, or the complaint that a specific activity had consequences. For example, "I helped my sister move the other day and I was in bed for a week." Odd complaints are another tip-off. One patient recently told him, "My body feels like it has tinnitus."

Before diagnosing fibromyalgia, Dr. Gross evaluates the patient for other medical conditions that can cause pain and/or fatigue. In addition to a comprehensive patient interview and physical examination, he orders a limited panel of blood tests to evaluate for other conditions. These include tests for erythrocyte sedimentation rate and C-reactive protein tests, a CBC, a comprehensive metabolic panel, a fasting glucose test, thyroid hormone tests, hepatitis B and C tests, and in some populations an HIV test. He checks vitamin D levels because vitamin D deficiency can aggravate pain, though it doesn’t cause it. If the patient is having weakness, he’ll check the creatinine phosphokinase level. In rare cases he’ll test for antinuclear antibodies. He’ll sometimes order x-rays of affected areas to look for joint damage, and he biopsies skin lesions that are concerning, particularly rashes. If there are many persistent neurologic symptoms, he may order an electromyogram.

Multiple studies have shown that the number of medical tests and costs increase over time for patients with undiagnosed fibromyalgia but level off or decrease once the diagnosis is made. "People stop looking for Lyme disease or multiple sclerosis or whatever," he said.

Dr. Gross reported having no relevant financial disclosures.

*CLARIFICATION: This story was revised on 1/15/2014 to include new information provided by Dr. Gross after publication.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – A two-page questionnaire is more helpful than a tender-point exam for diagnosing fibromyalgia in clinical practice, according to Dr. Andrew Gross.

Tender point exams – pressing on the 18 tender points of the body as advised in the American College of Rheumatology’s fibromyalgia classification criteria – can make even healthy people flinch in pain. The exam may be useful when enrolling patients in studies, but "for the most part, I find this a complete waste of time," he said at a conference on women’s health sponsored by the University of California, San Francisco.

*Instead, Dr. Gross hands patients with suspected fibromyalgia a brief questionnaire based on the ACR’s modified Diagnostic Criteria for Fibromyalgia (J. Rheumatol. 2001;38:1113-22) and steps out of the room while the patient completes the form."I use this in clinical practice all the time," said Dr. Gross, director of the Rheumatology Clinic at the university.

Patients fill out the questionnaire by checking off areas of the body in which they’ve experienced pain in the past week (the Widespread Pain Index). Dr. Gross also asks patients to provide information about the severity of their symptoms using a scale of 0-3 (none to severe) to quantify their degree of fatigue, extent of waking from sleep feeling unrefreshed, and cognitive symptoms, giving a symptom severity score. He then reviews the questionnaire with patients to understand the extent and severity of symptoms, and often diagnoses fibromyalgia when he determines there is a widespread pain score of 7 or more areas of the body plus a symptom severity score of at least 5.

Dr. Gross gives the questionnaire to patients who have the three hallmarks of fibromyalgia – widespread pain present for longer than 3 months, fatigue, and poor sleep. "If someone has pain in multiple areas, right away I’m thinking about fibromyalgia," he said.

Other tip-offs to fibromyalgia include cognitive problems, pain unrelieved by changing the body’s position, or the complaint that a specific activity had consequences. For example, "I helped my sister move the other day and I was in bed for a week." Odd complaints are another tip-off. One patient recently told him, "My body feels like it has tinnitus."

Before diagnosing fibromyalgia, Dr. Gross evaluates the patient for other medical conditions that can cause pain and/or fatigue. In addition to a comprehensive patient interview and physical examination, he orders a limited panel of blood tests to evaluate for other conditions. These include tests for erythrocyte sedimentation rate and C-reactive protein tests, a CBC, a comprehensive metabolic panel, a fasting glucose test, thyroid hormone tests, hepatitis B and C tests, and in some populations an HIV test. He checks vitamin D levels because vitamin D deficiency can aggravate pain, though it doesn’t cause it. If the patient is having weakness, he’ll check the creatinine phosphokinase level. In rare cases he’ll test for antinuclear antibodies. He’ll sometimes order x-rays of affected areas to look for joint damage, and he biopsies skin lesions that are concerning, particularly rashes. If there are many persistent neurologic symptoms, he may order an electromyogram.

Multiple studies have shown that the number of medical tests and costs increase over time for patients with undiagnosed fibromyalgia but level off or decrease once the diagnosis is made. "People stop looking for Lyme disease or multiple sclerosis or whatever," he said.

Dr. Gross reported having no relevant financial disclosures.

*CLARIFICATION: This story was revised on 1/15/2014 to include new information provided by Dr. Gross after publication.

[email protected]

On Twitter @sherryboschert