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Long-Term Opioid Use Compatible With Driving
SAN FRANCISCO – On driving simulators, 51 patients on chronic opioids performed as well as 49 control subjects, preliminary data from an ongoing study found.
The conventional recommendation that patients taking chronic opioids should avoid driving may not be necessary, Dr. Asokumar Buvanendran and associates stated in a poster presentation at the annual meeting of the American Society of Anesthesiologists.
The randomly selected patients in the opioid group were taking 20–60 mg/day of opioids for chronic pain. They and the age-matched, randomly selected control subjects spent 3 minutes practicing on a driving simulator and then took a 12-minute test on the simulator in a quiet room. The study excluded subjects with any medical condition or other medication regimen that could affect driving skills.
There were no significant differences between groups in measures of attention, reaction time, or number of crashes, reported Dr. Buvanendran, an anesthesiologist at Rush University, Chicago.
Members of both groups veered a mean of 4 feet from the center line during simulated driving (a measure of attention). Even the best drivers had “accidents” because of the demanding structure of the driving course, and each group averaged five crashes per driver. Reaction times were 0.67 seconds in the opioid group and 0.69 seconds in the control group, a difference that was not statistically significant. Results for the two groups were statistically equivalent, separate analyses showed.
Chronic opioid use has increased in the past decade as physicians have become more attuned to the need to treat chronic pain, coinvestigator Jeffrey S. Kroin, Ph.D., said in an interview at the meeting. The doses used by the study patients are higher than starting doses and are more typical of doses taken by patients on opioids for 6 months or longer for problems such as complex regional pain syndrome, said Dr. Kroin, also of the university.
Package labels for opioids caution against driving and many other activities while on the medication, but these restrictions may be “ultraconservative” for patients on chronic therapy once they have adjusted to the drug.
“There may not be any true impairment,” he said. “Realistically, there are people who have been on chronic opioids for 10–20 years and have been driving. What should physicians be telling these people?”
Setting more reasonable restrictions on patients taking chronic opioids could greatly improve quality of life, coinvestigator Mario Moric, Ph.D., added in an interview.
If they're not allowed to drive, patients have more difficulty taking care of themselves, shopping for groceries, and getting to the clinic if they need help with a problem. These patients tend to get isolated.
“We want to take away a restriction that may not be that critical to their or anybody else's safety,” said Dr. Moric, also of the university.
Driving is one of the more complicated tasks that people do on a regular basis, as it requires many different sensory inputs, cognitive skills, and timely reactions. That made it a good task for assessing the functional effects of chronic opioids, he said.
The investigators also are starting a separate study of the effects of anesthesia on driving after ambulatory surgery. Typically, patients are told not to drive for at least 24 hours after ambulatory surgery, even if they feel fine, Dr. Kroin noted.
That restriction is “vestigial, because of the kinds of anesthetics that we used 40–50 years ago. It was true they had a long half-life,” but more modern anesthetic agents may not necessitate a 24-hour restriction on driving, he suggested.
Patients taking opioids performed as well as controls on a driving simulator. Courtesy Dr. Mario Moric
SAN FRANCISCO – On driving simulators, 51 patients on chronic opioids performed as well as 49 control subjects, preliminary data from an ongoing study found.
The conventional recommendation that patients taking chronic opioids should avoid driving may not be necessary, Dr. Asokumar Buvanendran and associates stated in a poster presentation at the annual meeting of the American Society of Anesthesiologists.
The randomly selected patients in the opioid group were taking 20–60 mg/day of opioids for chronic pain. They and the age-matched, randomly selected control subjects spent 3 minutes practicing on a driving simulator and then took a 12-minute test on the simulator in a quiet room. The study excluded subjects with any medical condition or other medication regimen that could affect driving skills.
There were no significant differences between groups in measures of attention, reaction time, or number of crashes, reported Dr. Buvanendran, an anesthesiologist at Rush University, Chicago.
Members of both groups veered a mean of 4 feet from the center line during simulated driving (a measure of attention). Even the best drivers had “accidents” because of the demanding structure of the driving course, and each group averaged five crashes per driver. Reaction times were 0.67 seconds in the opioid group and 0.69 seconds in the control group, a difference that was not statistically significant. Results for the two groups were statistically equivalent, separate analyses showed.
Chronic opioid use has increased in the past decade as physicians have become more attuned to the need to treat chronic pain, coinvestigator Jeffrey S. Kroin, Ph.D., said in an interview at the meeting. The doses used by the study patients are higher than starting doses and are more typical of doses taken by patients on opioids for 6 months or longer for problems such as complex regional pain syndrome, said Dr. Kroin, also of the university.
Package labels for opioids caution against driving and many other activities while on the medication, but these restrictions may be “ultraconservative” for patients on chronic therapy once they have adjusted to the drug.
“There may not be any true impairment,” he said. “Realistically, there are people who have been on chronic opioids for 10–20 years and have been driving. What should physicians be telling these people?”
Setting more reasonable restrictions on patients taking chronic opioids could greatly improve quality of life, coinvestigator Mario Moric, Ph.D., added in an interview.
If they're not allowed to drive, patients have more difficulty taking care of themselves, shopping for groceries, and getting to the clinic if they need help with a problem. These patients tend to get isolated.
“We want to take away a restriction that may not be that critical to their or anybody else's safety,” said Dr. Moric, also of the university.
Driving is one of the more complicated tasks that people do on a regular basis, as it requires many different sensory inputs, cognitive skills, and timely reactions. That made it a good task for assessing the functional effects of chronic opioids, he said.
The investigators also are starting a separate study of the effects of anesthesia on driving after ambulatory surgery. Typically, patients are told not to drive for at least 24 hours after ambulatory surgery, even if they feel fine, Dr. Kroin noted.
That restriction is “vestigial, because of the kinds of anesthetics that we used 40–50 years ago. It was true they had a long half-life,” but more modern anesthetic agents may not necessitate a 24-hour restriction on driving, he suggested.
Patients taking opioids performed as well as controls on a driving simulator. Courtesy Dr. Mario Moric
SAN FRANCISCO – On driving simulators, 51 patients on chronic opioids performed as well as 49 control subjects, preliminary data from an ongoing study found.
The conventional recommendation that patients taking chronic opioids should avoid driving may not be necessary, Dr. Asokumar Buvanendran and associates stated in a poster presentation at the annual meeting of the American Society of Anesthesiologists.
The randomly selected patients in the opioid group were taking 20–60 mg/day of opioids for chronic pain. They and the age-matched, randomly selected control subjects spent 3 minutes practicing on a driving simulator and then took a 12-minute test on the simulator in a quiet room. The study excluded subjects with any medical condition or other medication regimen that could affect driving skills.
There were no significant differences between groups in measures of attention, reaction time, or number of crashes, reported Dr. Buvanendran, an anesthesiologist at Rush University, Chicago.
Members of both groups veered a mean of 4 feet from the center line during simulated driving (a measure of attention). Even the best drivers had “accidents” because of the demanding structure of the driving course, and each group averaged five crashes per driver. Reaction times were 0.67 seconds in the opioid group and 0.69 seconds in the control group, a difference that was not statistically significant. Results for the two groups were statistically equivalent, separate analyses showed.
Chronic opioid use has increased in the past decade as physicians have become more attuned to the need to treat chronic pain, coinvestigator Jeffrey S. Kroin, Ph.D., said in an interview at the meeting. The doses used by the study patients are higher than starting doses and are more typical of doses taken by patients on opioids for 6 months or longer for problems such as complex regional pain syndrome, said Dr. Kroin, also of the university.
Package labels for opioids caution against driving and many other activities while on the medication, but these restrictions may be “ultraconservative” for patients on chronic therapy once they have adjusted to the drug.
“There may not be any true impairment,” he said. “Realistically, there are people who have been on chronic opioids for 10–20 years and have been driving. What should physicians be telling these people?”
Setting more reasonable restrictions on patients taking chronic opioids could greatly improve quality of life, coinvestigator Mario Moric, Ph.D., added in an interview.
If they're not allowed to drive, patients have more difficulty taking care of themselves, shopping for groceries, and getting to the clinic if they need help with a problem. These patients tend to get isolated.
“We want to take away a restriction that may not be that critical to their or anybody else's safety,” said Dr. Moric, also of the university.
Driving is one of the more complicated tasks that people do on a regular basis, as it requires many different sensory inputs, cognitive skills, and timely reactions. That made it a good task for assessing the functional effects of chronic opioids, he said.
The investigators also are starting a separate study of the effects of anesthesia on driving after ambulatory surgery. Typically, patients are told not to drive for at least 24 hours after ambulatory surgery, even if they feel fine, Dr. Kroin noted.
That restriction is “vestigial, because of the kinds of anesthetics that we used 40–50 years ago. It was true they had a long half-life,” but more modern anesthetic agents may not necessitate a 24-hour restriction on driving, he suggested.
Patients taking opioids performed as well as controls on a driving simulator. Courtesy Dr. Mario Moric
Non-Hodgkin's Lymphoma Helped by Immunomodulator + Radiotherapy
LOS ANGELES Two rare types of non-Hodgkin's lymphomas responded to treatment with intratumoral injections of an investigational immunomodulator plus radiotherapy in a pilot study of seven patients, Dr. Anjali V. Morales reported at the annual meeting of the Society for Investigative Dermatology.
Six patients with mycosis fungoides and one patient with primary cutaneous B-cell lymphoma (CBCL) underwent low-dose radiotherapy to a single tumor site on day 1 and 2 plus injections of CpG 7909 to the same tumor within 24 hours before and after the radiotherapy. This treatment regimen was repeated weekly for a total of nine sessions. Noninjected tumors were monitored to assess systemic effects of the treatment.
CpG 7909 is an agonist to the protein TLR 9 (toll-like receptor 9) and belongs to a new class of immunomodulators that activate B cells and plasmacytoid dendritic cells. It showed promise as monotherapy for cutaneous T-cell lymphoma in a previous trial, said Dr. Morales of Stanford (Calif.) University.
In the current study, the combination of CpG 7909 and low-dose radiotherapy produced partial responses in two patients with mycosis fungoides and the one patient with CBCL. Another patient with mycosis fungoides showed a minor response, and the other three patients had stable disease, she reported.
A partial response was defined as greater than a 50% reduction in tumor volume or severity-weighted assessment tool (SWAT) score, compared with baseline. A minor response was defined as a 25%-50% reduction in tumor volume or SWAT score, compared with baseline.
The responses appeared after 6-9 weeks in patients with mycosis fungoides and after 4 weeks in the patient with CBCL. "We did note that responses were short-lived," so the protocol has been amended to enhance the systemic antitumor response, Dr. Morales said.
The investigators are enrolling patients now in a study that will administer low-dose radiotherapy and CpG 7909 injections to one tumor site on day 1 and 2, followed by two weekly CpG 7909 injections. At week 4, a second tumor site will be treated with radiotherapy and injections, followed by four weekly injections of CpG 7909. Nontreated lesions will be assessed for response.
The treatment appeared to be well tolerated, with grade 1-2 adverse events in all patients, she said. These included erythema, pain, and induration at the injection sites plus fever and fatigue in all patients. Six patients reported myalgia and arthralgia, three complained of headache, and one had nausea.
Researchers have theorized that intratumoral injection of CpG 7909 activates dendritic cells, which migrate to lymph nodes and promote a systemic antitumor immune response.
The study was initiated by Stanford faculty and funded by the National Institutes of Health, Dr. Morales said.
LOS ANGELES Two rare types of non-Hodgkin's lymphomas responded to treatment with intratumoral injections of an investigational immunomodulator plus radiotherapy in a pilot study of seven patients, Dr. Anjali V. Morales reported at the annual meeting of the Society for Investigative Dermatology.
Six patients with mycosis fungoides and one patient with primary cutaneous B-cell lymphoma (CBCL) underwent low-dose radiotherapy to a single tumor site on day 1 and 2 plus injections of CpG 7909 to the same tumor within 24 hours before and after the radiotherapy. This treatment regimen was repeated weekly for a total of nine sessions. Noninjected tumors were monitored to assess systemic effects of the treatment.
CpG 7909 is an agonist to the protein TLR 9 (toll-like receptor 9) and belongs to a new class of immunomodulators that activate B cells and plasmacytoid dendritic cells. It showed promise as monotherapy for cutaneous T-cell lymphoma in a previous trial, said Dr. Morales of Stanford (Calif.) University.
In the current study, the combination of CpG 7909 and low-dose radiotherapy produced partial responses in two patients with mycosis fungoides and the one patient with CBCL. Another patient with mycosis fungoides showed a minor response, and the other three patients had stable disease, she reported.
A partial response was defined as greater than a 50% reduction in tumor volume or severity-weighted assessment tool (SWAT) score, compared with baseline. A minor response was defined as a 25%-50% reduction in tumor volume or SWAT score, compared with baseline.
The responses appeared after 6-9 weeks in patients with mycosis fungoides and after 4 weeks in the patient with CBCL. "We did note that responses were short-lived," so the protocol has been amended to enhance the systemic antitumor response, Dr. Morales said.
The investigators are enrolling patients now in a study that will administer low-dose radiotherapy and CpG 7909 injections to one tumor site on day 1 and 2, followed by two weekly CpG 7909 injections. At week 4, a second tumor site will be treated with radiotherapy and injections, followed by four weekly injections of CpG 7909. Nontreated lesions will be assessed for response.
The treatment appeared to be well tolerated, with grade 1-2 adverse events in all patients, she said. These included erythema, pain, and induration at the injection sites plus fever and fatigue in all patients. Six patients reported myalgia and arthralgia, three complained of headache, and one had nausea.
Researchers have theorized that intratumoral injection of CpG 7909 activates dendritic cells, which migrate to lymph nodes and promote a systemic antitumor immune response.
The study was initiated by Stanford faculty and funded by the National Institutes of Health, Dr. Morales said.
LOS ANGELES Two rare types of non-Hodgkin's lymphomas responded to treatment with intratumoral injections of an investigational immunomodulator plus radiotherapy in a pilot study of seven patients, Dr. Anjali V. Morales reported at the annual meeting of the Society for Investigative Dermatology.
Six patients with mycosis fungoides and one patient with primary cutaneous B-cell lymphoma (CBCL) underwent low-dose radiotherapy to a single tumor site on day 1 and 2 plus injections of CpG 7909 to the same tumor within 24 hours before and after the radiotherapy. This treatment regimen was repeated weekly for a total of nine sessions. Noninjected tumors were monitored to assess systemic effects of the treatment.
CpG 7909 is an agonist to the protein TLR 9 (toll-like receptor 9) and belongs to a new class of immunomodulators that activate B cells and plasmacytoid dendritic cells. It showed promise as monotherapy for cutaneous T-cell lymphoma in a previous trial, said Dr. Morales of Stanford (Calif.) University.
In the current study, the combination of CpG 7909 and low-dose radiotherapy produced partial responses in two patients with mycosis fungoides and the one patient with CBCL. Another patient with mycosis fungoides showed a minor response, and the other three patients had stable disease, she reported.
A partial response was defined as greater than a 50% reduction in tumor volume or severity-weighted assessment tool (SWAT) score, compared with baseline. A minor response was defined as a 25%-50% reduction in tumor volume or SWAT score, compared with baseline.
The responses appeared after 6-9 weeks in patients with mycosis fungoides and after 4 weeks in the patient with CBCL. "We did note that responses were short-lived," so the protocol has been amended to enhance the systemic antitumor response, Dr. Morales said.
The investigators are enrolling patients now in a study that will administer low-dose radiotherapy and CpG 7909 injections to one tumor site on day 1 and 2, followed by two weekly CpG 7909 injections. At week 4, a second tumor site will be treated with radiotherapy and injections, followed by four weekly injections of CpG 7909. Nontreated lesions will be assessed for response.
The treatment appeared to be well tolerated, with grade 1-2 adverse events in all patients, she said. These included erythema, pain, and induration at the injection sites plus fever and fatigue in all patients. Six patients reported myalgia and arthralgia, three complained of headache, and one had nausea.
Researchers have theorized that intratumoral injection of CpG 7909 activates dendritic cells, which migrate to lymph nodes and promote a systemic antitumor immune response.
The study was initiated by Stanford faculty and funded by the National Institutes of Health, Dr. Morales said.
Ginger, Vitamin B6 Can Help Nausea in Pregnancy
SAN FRANCISCO – Multiple clinical trials have shown that both ginger and vitamin B6 can safely help reduce the nausea and vomiting of “morning sickness” in pregnancy.
Cathi Dennehy, Pharm.D., reviewed the evidence for the efficacy and safety of the two supplements at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.
PIGinger. Six randomized, controlled trials found significant reductions in nausea and vomiting during pregnancy in women who took powdered ginger, ginger syrup, or ginger extract products for 4-21 days. Four trials found greater reductions in nausea and vomiting, compared with placebo, and two trials found effects that were equivalent to treatment with 30 mg or 75 mg per day of vitamin B6 (with no placebo arm in those studies).
The most common dose was 1 g per day of powdered ginger, which comes in capsules containing 250-500 mg each. Patients took divided doses b.i.d. or q.i.d. depending on the capsule size.
The studies included 26-291 women each. Four trials that included a total of 265 women found no increased risk of negative birth outcomes in the ginger groups. Most of the women in these studies used ginger during the first trimester of pregnancy, but some studies included women up to the 20th week of gestation and after the critical developmental stages, which might have diluted the findings regarding safety. A separate observational study that focused strictly on ginger use during the first trimester also found no increase in adverse events.
Side effects are rare but may include GI upset, heartburn, flatulence, or bloating. Much higher doses of ginger (2.5 g/day or higher) can produce antiplatelet effects.
Two previous studies–one in rats and the other an in vitro study–had raised some concerns about possible mutagenic properties or some increase in early embryonic loss. However, “there is quite a bit of evidence in clinical trials” to support the safety of ginger in pregnancy, said Dr. Dennehy of the university's School of Pharmacy.
PIVitamin B6. Two randomized, controlled trials (with 59 and 342 patients, respectively) found that vitamin B6 supplements worked significantly better than placebo to decrease severe nausea and vomiting in pregnancy or to decrease overall nausea scores and vomiting in the first 3 days of use.
Bendectin, a product that combined vitamin B6, an antihistamine, and an anticholinergic, was pulled off the U.S. market in the early 1980s after lawsuits alleged that it caused limb deformities in children. Plaintiff victories on those charges were overturned on appeal. Moreover, late last year, the FDA took the unusual step of publishing a notice in the Federal Register stating that Bendectin had not been withdrawn from the market for safety or health reasons. The move was widely seen as an invitation for a pharmaceutical manufacturer to begin selling the drug again.
Today, a similar product called Diclectin is sold in Canada and combines vitamin B6 with doxylamine. A meta-analysis of 170,000 exposures to Diclectin found no adverse effects on fetuses. “Overall, it looks like vitamin B6 is a safe product to use” in pregnancy, Dr. Dennehy said.
Dr. Dennehy also reviewed the prospect of peppermint tea as a morning-sickness palliative. There are no trials of peppermint tea either in general use or during pregnancy, she said, but a small randomized controlled study of peppermint oil for postoperative pain found it to be more effective than placebo. Peppermint oil relaxes GI smooth muscle, and commonly is used for irritable bowel syndrome.
Peppermint oil also decreases lower esophageal sphincter tone, increases bile flow, and can worsen gastroesophageal reflux disease, “which can get problematic during pregnancy,” she said. “You wouldn't want to give this to someone who already was complaining of those types of symptoms.”
Peppermint “likely is safe as a tea formulation in pregnancy,” Dr. Dennehy concluded.
Three separate studies in the past decade suggest that 7%-13% of women use herbal preparations during pregnancy for a variety of indications, a practice that is more common in Australia and some European countries than in the United States. However, a year 2000 survey of certified nurse-midwives in North Carolina found that 73% recommended herbal products in pregnancy, most commonly for nausea and vomiting, Dr. Dennehy noted.
“There is quite a bit of evidence in clinical trials” to support the safety of ginger in pregnancy, says Dr. Cathi Dennehy. ©Tasha/Fotolia.com
SAN FRANCISCO – Multiple clinical trials have shown that both ginger and vitamin B6 can safely help reduce the nausea and vomiting of “morning sickness” in pregnancy.
Cathi Dennehy, Pharm.D., reviewed the evidence for the efficacy and safety of the two supplements at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.
PIGinger. Six randomized, controlled trials found significant reductions in nausea and vomiting during pregnancy in women who took powdered ginger, ginger syrup, or ginger extract products for 4-21 days. Four trials found greater reductions in nausea and vomiting, compared with placebo, and two trials found effects that were equivalent to treatment with 30 mg or 75 mg per day of vitamin B6 (with no placebo arm in those studies).
The most common dose was 1 g per day of powdered ginger, which comes in capsules containing 250-500 mg each. Patients took divided doses b.i.d. or q.i.d. depending on the capsule size.
The studies included 26-291 women each. Four trials that included a total of 265 women found no increased risk of negative birth outcomes in the ginger groups. Most of the women in these studies used ginger during the first trimester of pregnancy, but some studies included women up to the 20th week of gestation and after the critical developmental stages, which might have diluted the findings regarding safety. A separate observational study that focused strictly on ginger use during the first trimester also found no increase in adverse events.
Side effects are rare but may include GI upset, heartburn, flatulence, or bloating. Much higher doses of ginger (2.5 g/day or higher) can produce antiplatelet effects.
Two previous studies–one in rats and the other an in vitro study–had raised some concerns about possible mutagenic properties or some increase in early embryonic loss. However, “there is quite a bit of evidence in clinical trials” to support the safety of ginger in pregnancy, said Dr. Dennehy of the university's School of Pharmacy.
PIVitamin B6. Two randomized, controlled trials (with 59 and 342 patients, respectively) found that vitamin B6 supplements worked significantly better than placebo to decrease severe nausea and vomiting in pregnancy or to decrease overall nausea scores and vomiting in the first 3 days of use.
Bendectin, a product that combined vitamin B6, an antihistamine, and an anticholinergic, was pulled off the U.S. market in the early 1980s after lawsuits alleged that it caused limb deformities in children. Plaintiff victories on those charges were overturned on appeal. Moreover, late last year, the FDA took the unusual step of publishing a notice in the Federal Register stating that Bendectin had not been withdrawn from the market for safety or health reasons. The move was widely seen as an invitation for a pharmaceutical manufacturer to begin selling the drug again.
Today, a similar product called Diclectin is sold in Canada and combines vitamin B6 with doxylamine. A meta-analysis of 170,000 exposures to Diclectin found no adverse effects on fetuses. “Overall, it looks like vitamin B6 is a safe product to use” in pregnancy, Dr. Dennehy said.
Dr. Dennehy also reviewed the prospect of peppermint tea as a morning-sickness palliative. There are no trials of peppermint tea either in general use or during pregnancy, she said, but a small randomized controlled study of peppermint oil for postoperative pain found it to be more effective than placebo. Peppermint oil relaxes GI smooth muscle, and commonly is used for irritable bowel syndrome.
Peppermint oil also decreases lower esophageal sphincter tone, increases bile flow, and can worsen gastroesophageal reflux disease, “which can get problematic during pregnancy,” she said. “You wouldn't want to give this to someone who already was complaining of those types of symptoms.”
Peppermint “likely is safe as a tea formulation in pregnancy,” Dr. Dennehy concluded.
Three separate studies in the past decade suggest that 7%-13% of women use herbal preparations during pregnancy for a variety of indications, a practice that is more common in Australia and some European countries than in the United States. However, a year 2000 survey of certified nurse-midwives in North Carolina found that 73% recommended herbal products in pregnancy, most commonly for nausea and vomiting, Dr. Dennehy noted.
“There is quite a bit of evidence in clinical trials” to support the safety of ginger in pregnancy, says Dr. Cathi Dennehy. ©Tasha/Fotolia.com
SAN FRANCISCO – Multiple clinical trials have shown that both ginger and vitamin B6 can safely help reduce the nausea and vomiting of “morning sickness” in pregnancy.
Cathi Dennehy, Pharm.D., reviewed the evidence for the efficacy and safety of the two supplements at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.
PIGinger. Six randomized, controlled trials found significant reductions in nausea and vomiting during pregnancy in women who took powdered ginger, ginger syrup, or ginger extract products for 4-21 days. Four trials found greater reductions in nausea and vomiting, compared with placebo, and two trials found effects that were equivalent to treatment with 30 mg or 75 mg per day of vitamin B6 (with no placebo arm in those studies).
The most common dose was 1 g per day of powdered ginger, which comes in capsules containing 250-500 mg each. Patients took divided doses b.i.d. or q.i.d. depending on the capsule size.
The studies included 26-291 women each. Four trials that included a total of 265 women found no increased risk of negative birth outcomes in the ginger groups. Most of the women in these studies used ginger during the first trimester of pregnancy, but some studies included women up to the 20th week of gestation and after the critical developmental stages, which might have diluted the findings regarding safety. A separate observational study that focused strictly on ginger use during the first trimester also found no increase in adverse events.
Side effects are rare but may include GI upset, heartburn, flatulence, or bloating. Much higher doses of ginger (2.5 g/day or higher) can produce antiplatelet effects.
Two previous studies–one in rats and the other an in vitro study–had raised some concerns about possible mutagenic properties or some increase in early embryonic loss. However, “there is quite a bit of evidence in clinical trials” to support the safety of ginger in pregnancy, said Dr. Dennehy of the university's School of Pharmacy.
PIVitamin B6. Two randomized, controlled trials (with 59 and 342 patients, respectively) found that vitamin B6 supplements worked significantly better than placebo to decrease severe nausea and vomiting in pregnancy or to decrease overall nausea scores and vomiting in the first 3 days of use.
Bendectin, a product that combined vitamin B6, an antihistamine, and an anticholinergic, was pulled off the U.S. market in the early 1980s after lawsuits alleged that it caused limb deformities in children. Plaintiff victories on those charges were overturned on appeal. Moreover, late last year, the FDA took the unusual step of publishing a notice in the Federal Register stating that Bendectin had not been withdrawn from the market for safety or health reasons. The move was widely seen as an invitation for a pharmaceutical manufacturer to begin selling the drug again.
Today, a similar product called Diclectin is sold in Canada and combines vitamin B6 with doxylamine. A meta-analysis of 170,000 exposures to Diclectin found no adverse effects on fetuses. “Overall, it looks like vitamin B6 is a safe product to use” in pregnancy, Dr. Dennehy said.
Dr. Dennehy also reviewed the prospect of peppermint tea as a morning-sickness palliative. There are no trials of peppermint tea either in general use or during pregnancy, she said, but a small randomized controlled study of peppermint oil for postoperative pain found it to be more effective than placebo. Peppermint oil relaxes GI smooth muscle, and commonly is used for irritable bowel syndrome.
Peppermint oil also decreases lower esophageal sphincter tone, increases bile flow, and can worsen gastroesophageal reflux disease, “which can get problematic during pregnancy,” she said. “You wouldn't want to give this to someone who already was complaining of those types of symptoms.”
Peppermint “likely is safe as a tea formulation in pregnancy,” Dr. Dennehy concluded.
Three separate studies in the past decade suggest that 7%-13% of women use herbal preparations during pregnancy for a variety of indications, a practice that is more common in Australia and some European countries than in the United States. However, a year 2000 survey of certified nurse-midwives in North Carolina found that 73% recommended herbal products in pregnancy, most commonly for nausea and vomiting, Dr. Dennehy noted.
“There is quite a bit of evidence in clinical trials” to support the safety of ginger in pregnancy, says Dr. Cathi Dennehy. ©Tasha/Fotolia.com
Hair Biopsy Might Assist in Diagnosing Trichotillomania
SAN FRANCISCO — Few patients will admit that they compulsively pull out their hair, but a hair biopsy can help make the diagnosis of trichotillomania, Dr. Pearl C. Kwong said at a meeting sponsored by Skin Disease Education Foundation.
Clinically, the missing hair may be barely noticeable or may show signs of regrowth, such as uneven hair lengths. In contrast, hairs lost from alopecia areata will be about the same length if they regrow. If a patient picks hair from a favored area of the scalp, a “Friar Tuck” sign can be a clue to trichotillomania, she said. Patients usually have no skin abnormalities elsewhere.
Both children and adults with this impulse control disorder typically deny hair-pulling, and parents may be unwilling to accept a possible diagnosis of trichotillomania, said Dr. Kwong, a dermatologist in Jacksonville, Fla.
A hair biopsy can help with diagnosis. On histology, a high frequency of telogen hairs and a high frequency of noninflamed catagen hairs are typical.
Accurate data on the prevalence of trichotillomania are hard to get because people hide the disorder, but it is estimated to affect 8 million people in the United States. The mean age of onset seems to be 8 years in boys and 12 years in girls, and 1%–2% of college students have experienced or currently have symptoms. Adults with trichotillomania often report that the disorder started at a young age, even as young as 1 year old, and it is more likely to be diagnosed in women than in men.
In infants or young children, pulling or twisting the hair usually is self-limited and is a benign form of trichotillomania. It may be a sign of psychosocial stress or an underlying psychological problem, however, and can become a chronic condition.
Adolescents and adults diagnosed with trichotillomania tend to have a poorer prognosis, with chronic remissions and exacerbations. Patients may avoid social situations or have GI complaints. “There's usually underlying psychopathology in that family,” Dr. Kwong said.
Although scalp hair is the most common target, hair-pulling may focus on any hairy parts of the body, including eyelashes, eyebrows, or hair in pubic, perirectal, or armpit areas.
In young children, treat trichotillomania as a short-term habit disorder by cutting the hair very short (like a crew cut in boys) and applying Vaseline to the hair. “They stop because it's so slippery they can't pull,” Dr. Kwong said.
Referral to psychiatry, psychology, or developmental and behavioral pediatrics should be considered, especially in patients older than young children. Trichotillomania has been associated with obsessive control disorder, personality disorders, body dysmorphic disorder, schizophrenia, and mental retardation.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
SAN FRANCISCO — Few patients will admit that they compulsively pull out their hair, but a hair biopsy can help make the diagnosis of trichotillomania, Dr. Pearl C. Kwong said at a meeting sponsored by Skin Disease Education Foundation.
Clinically, the missing hair may be barely noticeable or may show signs of regrowth, such as uneven hair lengths. In contrast, hairs lost from alopecia areata will be about the same length if they regrow. If a patient picks hair from a favored area of the scalp, a “Friar Tuck” sign can be a clue to trichotillomania, she said. Patients usually have no skin abnormalities elsewhere.
Both children and adults with this impulse control disorder typically deny hair-pulling, and parents may be unwilling to accept a possible diagnosis of trichotillomania, said Dr. Kwong, a dermatologist in Jacksonville, Fla.
A hair biopsy can help with diagnosis. On histology, a high frequency of telogen hairs and a high frequency of noninflamed catagen hairs are typical.
Accurate data on the prevalence of trichotillomania are hard to get because people hide the disorder, but it is estimated to affect 8 million people in the United States. The mean age of onset seems to be 8 years in boys and 12 years in girls, and 1%–2% of college students have experienced or currently have symptoms. Adults with trichotillomania often report that the disorder started at a young age, even as young as 1 year old, and it is more likely to be diagnosed in women than in men.
In infants or young children, pulling or twisting the hair usually is self-limited and is a benign form of trichotillomania. It may be a sign of psychosocial stress or an underlying psychological problem, however, and can become a chronic condition.
Adolescents and adults diagnosed with trichotillomania tend to have a poorer prognosis, with chronic remissions and exacerbations. Patients may avoid social situations or have GI complaints. “There's usually underlying psychopathology in that family,” Dr. Kwong said.
Although scalp hair is the most common target, hair-pulling may focus on any hairy parts of the body, including eyelashes, eyebrows, or hair in pubic, perirectal, or armpit areas.
In young children, treat trichotillomania as a short-term habit disorder by cutting the hair very short (like a crew cut in boys) and applying Vaseline to the hair. “They stop because it's so slippery they can't pull,” Dr. Kwong said.
Referral to psychiatry, psychology, or developmental and behavioral pediatrics should be considered, especially in patients older than young children. Trichotillomania has been associated with obsessive control disorder, personality disorders, body dysmorphic disorder, schizophrenia, and mental retardation.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
SAN FRANCISCO — Few patients will admit that they compulsively pull out their hair, but a hair biopsy can help make the diagnosis of trichotillomania, Dr. Pearl C. Kwong said at a meeting sponsored by Skin Disease Education Foundation.
Clinically, the missing hair may be barely noticeable or may show signs of regrowth, such as uneven hair lengths. In contrast, hairs lost from alopecia areata will be about the same length if they regrow. If a patient picks hair from a favored area of the scalp, a “Friar Tuck” sign can be a clue to trichotillomania, she said. Patients usually have no skin abnormalities elsewhere.
Both children and adults with this impulse control disorder typically deny hair-pulling, and parents may be unwilling to accept a possible diagnosis of trichotillomania, said Dr. Kwong, a dermatologist in Jacksonville, Fla.
A hair biopsy can help with diagnosis. On histology, a high frequency of telogen hairs and a high frequency of noninflamed catagen hairs are typical.
Accurate data on the prevalence of trichotillomania are hard to get because people hide the disorder, but it is estimated to affect 8 million people in the United States. The mean age of onset seems to be 8 years in boys and 12 years in girls, and 1%–2% of college students have experienced or currently have symptoms. Adults with trichotillomania often report that the disorder started at a young age, even as young as 1 year old, and it is more likely to be diagnosed in women than in men.
In infants or young children, pulling or twisting the hair usually is self-limited and is a benign form of trichotillomania. It may be a sign of psychosocial stress or an underlying psychological problem, however, and can become a chronic condition.
Adolescents and adults diagnosed with trichotillomania tend to have a poorer prognosis, with chronic remissions and exacerbations. Patients may avoid social situations or have GI complaints. “There's usually underlying psychopathology in that family,” Dr. Kwong said.
Although scalp hair is the most common target, hair-pulling may focus on any hairy parts of the body, including eyelashes, eyebrows, or hair in pubic, perirectal, or armpit areas.
In young children, treat trichotillomania as a short-term habit disorder by cutting the hair very short (like a crew cut in boys) and applying Vaseline to the hair. “They stop because it's so slippery they can't pull,” Dr. Kwong said.
Referral to psychiatry, psychology, or developmental and behavioral pediatrics should be considered, especially in patients older than young children. Trichotillomania has been associated with obsessive control disorder, personality disorders, body dysmorphic disorder, schizophrenia, and mental retardation.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
Anger Management for Boys Increases Emotional Vocabulary
SAN FRANCISCO – An anger management intervention that was designed specifically for boys significantly improved their emotional vocabulary, according to preliminary results reported by Aimee Coonerty-Femiano at the annual meeting of the American Psychological Association.
Fourteen eighth-grade boys in a rural school district who were referred by a psychologist or guidance counselor met weekly for 44-minute group sessions with an anger management counselor for 8 weeks. One group of seven boys pursued the anger management program, and the other seven waited 8 weeks before starting the program, serving as a control group.
The intervention teaches that anger is secondary to other emotions, and uses concepts from cognitive-behavioral therapy to teach about connections between thoughts, feelings, and behavior. The program also raises awareness about differences between boys and girls related to emotions, said Ms. Coonerty-Femiano, a doctoral student at Boston College, and her associates.
The first treatment group significantly improved its emotional vocabulary score from four to eight emotions at the end of 8 weeks, she said. When the delayed-treatment (control) group went through the program, its emotional vocabulary score increased significantly from five to eight emotions.
One of the most successful strategies employed by the intervention was a questionnaire at the start that asked what media the boys consumed, and those media were incorporated into the intervention, she said.
Topics and exercises were introduced using examples of emotional experiences and reactions from the “South Park” television cartoon show and movies starring Adam Sandler. These references to the popular culture engaged the boys' attention and participation.
In one exercise, boys in the intervention group sorted “feeling cards” representing different emotions by categorizing them as emotions experienced by boys or girls or “not sure.”
In another exercise, cards representing events that triggered anger generated discussion of the boys' thoughts and feelings at the time of the event, how they reacted, and how they felt about their reaction.
Participants in the program had a variety of diagnoses, including depression, attention-deficit/hyperactivity disorder, bipolar disorder, and oppositional-defiant disorder. Half the boys already were in individual therapy, and half were taking medications for a disorder.
Anecdotally, after the study, the names of boys in the intervention group came up less often in weekly meetings of school guidance counselors, where the boys initially had been flagged for intervention. “I'm not sure if that's due to the group, but we would like to think so,” she said.
Besides increasing emotional vocabulary, the intervention changed awareness of other feelings that accompany anger, and awareness of obstacles faced specifically by boys when expressing emotions. Themes that emerged from participants' comments were that boys don't like being vulnerable, and that strategies are needed to make a safe environment for them to express feelings, she said.
The program raises awareness about differences between boys and girls related to emotions. MS. COONERTY-FEMIANO
SAN FRANCISCO – An anger management intervention that was designed specifically for boys significantly improved their emotional vocabulary, according to preliminary results reported by Aimee Coonerty-Femiano at the annual meeting of the American Psychological Association.
Fourteen eighth-grade boys in a rural school district who were referred by a psychologist or guidance counselor met weekly for 44-minute group sessions with an anger management counselor for 8 weeks. One group of seven boys pursued the anger management program, and the other seven waited 8 weeks before starting the program, serving as a control group.
The intervention teaches that anger is secondary to other emotions, and uses concepts from cognitive-behavioral therapy to teach about connections between thoughts, feelings, and behavior. The program also raises awareness about differences between boys and girls related to emotions, said Ms. Coonerty-Femiano, a doctoral student at Boston College, and her associates.
The first treatment group significantly improved its emotional vocabulary score from four to eight emotions at the end of 8 weeks, she said. When the delayed-treatment (control) group went through the program, its emotional vocabulary score increased significantly from five to eight emotions.
One of the most successful strategies employed by the intervention was a questionnaire at the start that asked what media the boys consumed, and those media were incorporated into the intervention, she said.
Topics and exercises were introduced using examples of emotional experiences and reactions from the “South Park” television cartoon show and movies starring Adam Sandler. These references to the popular culture engaged the boys' attention and participation.
In one exercise, boys in the intervention group sorted “feeling cards” representing different emotions by categorizing them as emotions experienced by boys or girls or “not sure.”
In another exercise, cards representing events that triggered anger generated discussion of the boys' thoughts and feelings at the time of the event, how they reacted, and how they felt about their reaction.
Participants in the program had a variety of diagnoses, including depression, attention-deficit/hyperactivity disorder, bipolar disorder, and oppositional-defiant disorder. Half the boys already were in individual therapy, and half were taking medications for a disorder.
Anecdotally, after the study, the names of boys in the intervention group came up less often in weekly meetings of school guidance counselors, where the boys initially had been flagged for intervention. “I'm not sure if that's due to the group, but we would like to think so,” she said.
Besides increasing emotional vocabulary, the intervention changed awareness of other feelings that accompany anger, and awareness of obstacles faced specifically by boys when expressing emotions. Themes that emerged from participants' comments were that boys don't like being vulnerable, and that strategies are needed to make a safe environment for them to express feelings, she said.
The program raises awareness about differences between boys and girls related to emotions. MS. COONERTY-FEMIANO
SAN FRANCISCO – An anger management intervention that was designed specifically for boys significantly improved their emotional vocabulary, according to preliminary results reported by Aimee Coonerty-Femiano at the annual meeting of the American Psychological Association.
Fourteen eighth-grade boys in a rural school district who were referred by a psychologist or guidance counselor met weekly for 44-minute group sessions with an anger management counselor for 8 weeks. One group of seven boys pursued the anger management program, and the other seven waited 8 weeks before starting the program, serving as a control group.
The intervention teaches that anger is secondary to other emotions, and uses concepts from cognitive-behavioral therapy to teach about connections between thoughts, feelings, and behavior. The program also raises awareness about differences between boys and girls related to emotions, said Ms. Coonerty-Femiano, a doctoral student at Boston College, and her associates.
The first treatment group significantly improved its emotional vocabulary score from four to eight emotions at the end of 8 weeks, she said. When the delayed-treatment (control) group went through the program, its emotional vocabulary score increased significantly from five to eight emotions.
One of the most successful strategies employed by the intervention was a questionnaire at the start that asked what media the boys consumed, and those media were incorporated into the intervention, she said.
Topics and exercises were introduced using examples of emotional experiences and reactions from the “South Park” television cartoon show and movies starring Adam Sandler. These references to the popular culture engaged the boys' attention and participation.
In one exercise, boys in the intervention group sorted “feeling cards” representing different emotions by categorizing them as emotions experienced by boys or girls or “not sure.”
In another exercise, cards representing events that triggered anger generated discussion of the boys' thoughts and feelings at the time of the event, how they reacted, and how they felt about their reaction.
Participants in the program had a variety of diagnoses, including depression, attention-deficit/hyperactivity disorder, bipolar disorder, and oppositional-defiant disorder. Half the boys already were in individual therapy, and half were taking medications for a disorder.
Anecdotally, after the study, the names of boys in the intervention group came up less often in weekly meetings of school guidance counselors, where the boys initially had been flagged for intervention. “I'm not sure if that's due to the group, but we would like to think so,” she said.
Besides increasing emotional vocabulary, the intervention changed awareness of other feelings that accompany anger, and awareness of obstacles faced specifically by boys when expressing emotions. Themes that emerged from participants' comments were that boys don't like being vulnerable, and that strategies are needed to make a safe environment for them to express feelings, she said.
The program raises awareness about differences between boys and girls related to emotions. MS. COONERTY-FEMIANO
Ambiguous Genitalia Management: It Takes a Team
It's one of the first things that parents want to know when a baby is born: girl or boy?
When the answer isn't clear, physicians walk into a mine field of choices that could have lifelong repercussions for the child and the parents.
Psychiatrists, psychologists, and social workers today play a much bigger role–and surgeons less of a role–in the care of people with disorders of sex development, compared with past management practices.
“I think the field has revolutionized in the last 10-15 years. The impetus for that largely came from patients themselves,” said Dr. Joel Frader, a pediatrician at Children's Memorial Hospital and Northwestern University, Chicago.
The revolution is still in progress, with a bit of chaos in the streets. A dearth of research data to inform guidelines leaves clinicians with little to follow besides opinion-based consensus statements and their instincts.
“Because the ultimate outcomes are unpredictable from our standpoint, there is no standard of care. We don't really know what to do clinically. We're not sure what to do psychologically. Yet mothers and fathers have to go ahead and raise their child. It's a very difficult situation,” said Dr. William G. Reiner, a psychiatrist and urologist who is director of the psychosocial development clinic at the University of Oklahoma Health Sciences Center, Oklahoma City.
Some key points of agreement, however, inform current practices: Don't rush to surgery. Integrate psychological care for the family and the child. Consult a multidisciplinary team (preferably at an experienced center) that may include a pediatric endocrinologist, pediatric urologist or surgeon, gynecologist, child psychiatrist or psychologist, geneticist, neonatologist, social worker, nurses, and medical ethicist if needed. Be honest with parents and patients. Emphasize functional rather than cosmetic results in any treatment. Make management patient-centered and consider the long-term physical, psychological, and sexual well-being of the patient.
“The single biggest change is our recognition that the infant born with anomalous genitalia is a real, live human being, not a blank slate,” Dr. Reiner said. “We have no idea what that child is going to be like at age 5, or 15, or 50.”
A decade ago, Dr. Frader recalled, training manuals and textbooks for general pediatricians or pediatric endocrinologists referred to the problems now called disorders of sex development (DSD) as psychological emergencies.
“That sets a very inappropriate tone. There's nothing emergent in 99.9% of these cases,” he said. A small minority of babies with congenital adrenal hyperplasia will have life-threatening endocrinologic disturbances that have nothing to do with the appearance of the genitalia. “So there's never a surgical emergency,” he stressed.
Dr. William Byne, a psychiatrist at Mount Sinai School of Medicine in New York, added, “If there's a psychosocial emergency in the delivery room, a mental health professional should be brought in. The birth of an intersex child is rarely a medical emergency. We should not rush to make irreversible medical decisions at a time of crisis.”
Unfortunately, he and other experts agreed, there are not enough mental health providers trained to handle DSD.
Dr. Byne, Dr. Frader, and Dr. Reiner contributed to the 2006 Clinical Guidelines for the Management of Disorders of Sex Development in Childhood, which was produced by a consortium of clinicians, patients, and parents and published by the Intersex Society of North America (www.dsdguidelines.org
Dr. Reiner also was 1 of 50 U.S. and European experts who produced the separate Consensus Statement on Management of Intersex Disorders from the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology around the same time (Pediatrics 2006;118:e488-500).
In the past–and sometimes today–intersex newborns would be separated from mothers while a paternalistic cadre of physicians kept parents uninformed until the physicians declared how they would “fix” the child's problem, usually by surgically altering the genitalia. Most intersex children were never told of their condition.
“The medical model has been that sexual ambiguity is incompatible with their psychological health,” said Cheryl Chase, executive director of the Intersex Society of North America, Rohnert Park, Calif., while speaking at the annual meeting of the American Psychological Association in San Francisco.
Parents, in consultation with their clinical team, can assign the child a gender without resorting to surgery, the recent guidelines note.
The veil of secrecy that physicians once placed around the parents and the child does not conform with today's ethics of informed consent, Dr. Byne said. Clinicians should stress what is good about the child when discussing the DSD with parents, encourage them to give the child a gender-neutral name, and promote bonding with the child.
Not informing patients of their DSD as they grow up can lead to psychiatric crises when they discover during puberty or adulthood what their parents and physicians haven't told them. Dr. Byne has treated a number of suicidal adults whose problems included a huge sense of betrayal after discovering their DSD history.
Although it is commonly believed that cosmetic surgery on intersex children in the first year of life relieves parental distress and improves the attachment between the child and the parents, there is scant evidence for this. Almost anything a surgeon does to “fix” a young child with DSD will interfere in the long run with the patient's ability to experience sexual pleasure, said Dr. Frader.
The “vast majority” of patients with DSD do have reconstructive surgery in the first year of life, said Dr. John P. Gearhart, professor and chief of pediatric urology at Johns Hopkins University, Baltimore.
Some surgeries are done for functional reasons (like ensuring proper urinary drainage to avoid infections), and others are done to make the baby “look normal,” he said. Dr. Gearhart called the birth of an intersex child “a true emergency situation” in an article he coauthored that has been criticized by other DSD experts (Urol. Int. 2005;75:291-7).
Dr. Reiner said, “I think most of the children are going to want surgery, but what surgery isn't clear.” The consortium's clinical guidelines recommend delaying surgery or hormonal treatment until the patient can participate in the decision, which usually means until puberty.
Others take a middle ground, saying evaluation must include assessment of the parents' ability to cope with the stress of genital ambiguity in their child. Some parents will demand surgery even when it is not being recommended. “I've seen it happen,” Dr. Reiner said.
Not informing patients of their disorders as they grow up can lead to psychiatric crises later on. DR. BYNE
It's one of the first things that parents want to know when a baby is born: girl or boy?
When the answer isn't clear, physicians walk into a mine field of choices that could have lifelong repercussions for the child and the parents.
Psychiatrists, psychologists, and social workers today play a much bigger role–and surgeons less of a role–in the care of people with disorders of sex development, compared with past management practices.
“I think the field has revolutionized in the last 10-15 years. The impetus for that largely came from patients themselves,” said Dr. Joel Frader, a pediatrician at Children's Memorial Hospital and Northwestern University, Chicago.
The revolution is still in progress, with a bit of chaos in the streets. A dearth of research data to inform guidelines leaves clinicians with little to follow besides opinion-based consensus statements and their instincts.
“Because the ultimate outcomes are unpredictable from our standpoint, there is no standard of care. We don't really know what to do clinically. We're not sure what to do psychologically. Yet mothers and fathers have to go ahead and raise their child. It's a very difficult situation,” said Dr. William G. Reiner, a psychiatrist and urologist who is director of the psychosocial development clinic at the University of Oklahoma Health Sciences Center, Oklahoma City.
Some key points of agreement, however, inform current practices: Don't rush to surgery. Integrate psychological care for the family and the child. Consult a multidisciplinary team (preferably at an experienced center) that may include a pediatric endocrinologist, pediatric urologist or surgeon, gynecologist, child psychiatrist or psychologist, geneticist, neonatologist, social worker, nurses, and medical ethicist if needed. Be honest with parents and patients. Emphasize functional rather than cosmetic results in any treatment. Make management patient-centered and consider the long-term physical, psychological, and sexual well-being of the patient.
“The single biggest change is our recognition that the infant born with anomalous genitalia is a real, live human being, not a blank slate,” Dr. Reiner said. “We have no idea what that child is going to be like at age 5, or 15, or 50.”
A decade ago, Dr. Frader recalled, training manuals and textbooks for general pediatricians or pediatric endocrinologists referred to the problems now called disorders of sex development (DSD) as psychological emergencies.
“That sets a very inappropriate tone. There's nothing emergent in 99.9% of these cases,” he said. A small minority of babies with congenital adrenal hyperplasia will have life-threatening endocrinologic disturbances that have nothing to do with the appearance of the genitalia. “So there's never a surgical emergency,” he stressed.
Dr. William Byne, a psychiatrist at Mount Sinai School of Medicine in New York, added, “If there's a psychosocial emergency in the delivery room, a mental health professional should be brought in. The birth of an intersex child is rarely a medical emergency. We should not rush to make irreversible medical decisions at a time of crisis.”
Unfortunately, he and other experts agreed, there are not enough mental health providers trained to handle DSD.
Dr. Byne, Dr. Frader, and Dr. Reiner contributed to the 2006 Clinical Guidelines for the Management of Disorders of Sex Development in Childhood, which was produced by a consortium of clinicians, patients, and parents and published by the Intersex Society of North America (www.dsdguidelines.org
Dr. Reiner also was 1 of 50 U.S. and European experts who produced the separate Consensus Statement on Management of Intersex Disorders from the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology around the same time (Pediatrics 2006;118:e488-500).
In the past–and sometimes today–intersex newborns would be separated from mothers while a paternalistic cadre of physicians kept parents uninformed until the physicians declared how they would “fix” the child's problem, usually by surgically altering the genitalia. Most intersex children were never told of their condition.
“The medical model has been that sexual ambiguity is incompatible with their psychological health,” said Cheryl Chase, executive director of the Intersex Society of North America, Rohnert Park, Calif., while speaking at the annual meeting of the American Psychological Association in San Francisco.
Parents, in consultation with their clinical team, can assign the child a gender without resorting to surgery, the recent guidelines note.
The veil of secrecy that physicians once placed around the parents and the child does not conform with today's ethics of informed consent, Dr. Byne said. Clinicians should stress what is good about the child when discussing the DSD with parents, encourage them to give the child a gender-neutral name, and promote bonding with the child.
Not informing patients of their DSD as they grow up can lead to psychiatric crises when they discover during puberty or adulthood what their parents and physicians haven't told them. Dr. Byne has treated a number of suicidal adults whose problems included a huge sense of betrayal after discovering their DSD history.
Although it is commonly believed that cosmetic surgery on intersex children in the first year of life relieves parental distress and improves the attachment between the child and the parents, there is scant evidence for this. Almost anything a surgeon does to “fix” a young child with DSD will interfere in the long run with the patient's ability to experience sexual pleasure, said Dr. Frader.
The “vast majority” of patients with DSD do have reconstructive surgery in the first year of life, said Dr. John P. Gearhart, professor and chief of pediatric urology at Johns Hopkins University, Baltimore.
Some surgeries are done for functional reasons (like ensuring proper urinary drainage to avoid infections), and others are done to make the baby “look normal,” he said. Dr. Gearhart called the birth of an intersex child “a true emergency situation” in an article he coauthored that has been criticized by other DSD experts (Urol. Int. 2005;75:291-7).
Dr. Reiner said, “I think most of the children are going to want surgery, but what surgery isn't clear.” The consortium's clinical guidelines recommend delaying surgery or hormonal treatment until the patient can participate in the decision, which usually means until puberty.
Others take a middle ground, saying evaluation must include assessment of the parents' ability to cope with the stress of genital ambiguity in their child. Some parents will demand surgery even when it is not being recommended. “I've seen it happen,” Dr. Reiner said.
Not informing patients of their disorders as they grow up can lead to psychiatric crises later on. DR. BYNE
It's one of the first things that parents want to know when a baby is born: girl or boy?
When the answer isn't clear, physicians walk into a mine field of choices that could have lifelong repercussions for the child and the parents.
Psychiatrists, psychologists, and social workers today play a much bigger role–and surgeons less of a role–in the care of people with disorders of sex development, compared with past management practices.
“I think the field has revolutionized in the last 10-15 years. The impetus for that largely came from patients themselves,” said Dr. Joel Frader, a pediatrician at Children's Memorial Hospital and Northwestern University, Chicago.
The revolution is still in progress, with a bit of chaos in the streets. A dearth of research data to inform guidelines leaves clinicians with little to follow besides opinion-based consensus statements and their instincts.
“Because the ultimate outcomes are unpredictable from our standpoint, there is no standard of care. We don't really know what to do clinically. We're not sure what to do psychologically. Yet mothers and fathers have to go ahead and raise their child. It's a very difficult situation,” said Dr. William G. Reiner, a psychiatrist and urologist who is director of the psychosocial development clinic at the University of Oklahoma Health Sciences Center, Oklahoma City.
Some key points of agreement, however, inform current practices: Don't rush to surgery. Integrate psychological care for the family and the child. Consult a multidisciplinary team (preferably at an experienced center) that may include a pediatric endocrinologist, pediatric urologist or surgeon, gynecologist, child psychiatrist or psychologist, geneticist, neonatologist, social worker, nurses, and medical ethicist if needed. Be honest with parents and patients. Emphasize functional rather than cosmetic results in any treatment. Make management patient-centered and consider the long-term physical, psychological, and sexual well-being of the patient.
“The single biggest change is our recognition that the infant born with anomalous genitalia is a real, live human being, not a blank slate,” Dr. Reiner said. “We have no idea what that child is going to be like at age 5, or 15, or 50.”
A decade ago, Dr. Frader recalled, training manuals and textbooks for general pediatricians or pediatric endocrinologists referred to the problems now called disorders of sex development (DSD) as psychological emergencies.
“That sets a very inappropriate tone. There's nothing emergent in 99.9% of these cases,” he said. A small minority of babies with congenital adrenal hyperplasia will have life-threatening endocrinologic disturbances that have nothing to do with the appearance of the genitalia. “So there's never a surgical emergency,” he stressed.
Dr. William Byne, a psychiatrist at Mount Sinai School of Medicine in New York, added, “If there's a psychosocial emergency in the delivery room, a mental health professional should be brought in. The birth of an intersex child is rarely a medical emergency. We should not rush to make irreversible medical decisions at a time of crisis.”
Unfortunately, he and other experts agreed, there are not enough mental health providers trained to handle DSD.
Dr. Byne, Dr. Frader, and Dr. Reiner contributed to the 2006 Clinical Guidelines for the Management of Disorders of Sex Development in Childhood, which was produced by a consortium of clinicians, patients, and parents and published by the Intersex Society of North America (www.dsdguidelines.org
Dr. Reiner also was 1 of 50 U.S. and European experts who produced the separate Consensus Statement on Management of Intersex Disorders from the Lawson Wilkins Pediatric Endocrine Society and the European Society for Paediatric Endocrinology around the same time (Pediatrics 2006;118:e488-500).
In the past–and sometimes today–intersex newborns would be separated from mothers while a paternalistic cadre of physicians kept parents uninformed until the physicians declared how they would “fix” the child's problem, usually by surgically altering the genitalia. Most intersex children were never told of their condition.
“The medical model has been that sexual ambiguity is incompatible with their psychological health,” said Cheryl Chase, executive director of the Intersex Society of North America, Rohnert Park, Calif., while speaking at the annual meeting of the American Psychological Association in San Francisco.
Parents, in consultation with their clinical team, can assign the child a gender without resorting to surgery, the recent guidelines note.
The veil of secrecy that physicians once placed around the parents and the child does not conform with today's ethics of informed consent, Dr. Byne said. Clinicians should stress what is good about the child when discussing the DSD with parents, encourage them to give the child a gender-neutral name, and promote bonding with the child.
Not informing patients of their DSD as they grow up can lead to psychiatric crises when they discover during puberty or adulthood what their parents and physicians haven't told them. Dr. Byne has treated a number of suicidal adults whose problems included a huge sense of betrayal after discovering their DSD history.
Although it is commonly believed that cosmetic surgery on intersex children in the first year of life relieves parental distress and improves the attachment between the child and the parents, there is scant evidence for this. Almost anything a surgeon does to “fix” a young child with DSD will interfere in the long run with the patient's ability to experience sexual pleasure, said Dr. Frader.
The “vast majority” of patients with DSD do have reconstructive surgery in the first year of life, said Dr. John P. Gearhart, professor and chief of pediatric urology at Johns Hopkins University, Baltimore.
Some surgeries are done for functional reasons (like ensuring proper urinary drainage to avoid infections), and others are done to make the baby “look normal,” he said. Dr. Gearhart called the birth of an intersex child “a true emergency situation” in an article he coauthored that has been criticized by other DSD experts (Urol. Int. 2005;75:291-7).
Dr. Reiner said, “I think most of the children are going to want surgery, but what surgery isn't clear.” The consortium's clinical guidelines recommend delaying surgery or hormonal treatment until the patient can participate in the decision, which usually means until puberty.
Others take a middle ground, saying evaluation must include assessment of the parents' ability to cope with the stress of genital ambiguity in their child. Some parents will demand surgery even when it is not being recommended. “I've seen it happen,” Dr. Reiner said.
Not informing patients of their disorders as they grow up can lead to psychiatric crises later on. DR. BYNE
Think 'Four P's' When Making Allergic Contact Diagnosis
SAN FRANCISCO Allergic contact dermatitis looks like other forms of dermatitis, but the history and some visual clues can help make the diagnosis, Dr. Anna L. Bruckner said at a meeting sponsored by Skin Disease Education Foundation.
A history of exposure to common contact allergens, such as a recent run-in with poison ivy, poison oak, or poison sumac, may be all that is needed. A history of contact with other common allergens provides support for suspicions of allergic contact dermatitis. These allergens include nickel and topical antibiotics such as neomycin, gentamicin, and bacitracin.
In addition, said Dr. Bruckner of the pediatric dermatology clinic at Lucile Packard Children's Hospital in Palo Alto, Calif., the following "four P's" point to allergic contact dermatitis in children:
▸ Persistence. A rash that "doesn't respond to therapy like you would expect"coming back time and again in the same place despite treatment with topical steroidsmay be an allergic contact dermatitis, she said.
An allergic contact dermatitis begins 1224 hours after exposure to the allergen, peaks at 35 days, and may last 34 weeks if untreated.
▸ Place. A rash that is localized to an area not considered a typical location for dermatitis should raise suspicion, especially if an area where contact with a suspected allergen could be imagined.
Allergic contact dermatitis on a child's face or eyelids is caused most commonly by neomycin; fragrances; preservatives in creams, soaps or shampoos; or thimerosal in eyedrops. Nickel (in jewelry or jeans fasteners) is the most common cause of allergic contact dermatitis in the infraumbilical area and on the earlobes, neck, and wrists.
Compounds used in rubber production can produce allergic responses in the waistband area or on the dorsum of the feet, where leather also is a suspect because of an agent used in leather tanning. In the axillae, preservatives or fragrances in deodorant may cause allergic dermatitis.
▸ Pattern. Think of allergic contact dermatitis when there is a distinct pattern of eruption that is unusual for dermatitis, such as a linear rash. Dermatitis that is localized to the face, or that appears symmetrically on earlobes or on the dorsum of the hands or feet, may be a tip-off to allergic contact dermatitis.
Dr. Bruckner described a 7-year-old patient with a several-year history of a ring-shaped eruption on the posterior thighs and upper buttocks, which is "an area that we don't typically think about with atopic dermatitis." The rash cleared repeatedly with topical steroids but always returned, except for a rash-free summer he spent in India. This was toilet-seat dermatitis, a relatively common reaction to wood toilet seats that is caused by either the lacquer in the seat or the resin in the wood itself.
▸ Patch testing. If the etiology isn't apparent, epicutaneous patch testing may help determine whether allergic contact dermatitis is the culprit.
Besides nickel, preservatives, fragrances, rubber products, and leather, other common contact allergens include topical antibiotics (neomycin, bacitracin, and gentamicin); lanolin used in cosmetics; disperse dyes used to color the elastic waistbands of disposable diapers; and p-phenylenediamine (a component of hair dye, temporary tattoos, and hennalike products).
Allergic contact dermatitis may account for up to 20% of all cases of childhood dermatitis, although the exact incidence and prevalence are unknown. It can occur at all ages but is relatively uncommon in younger children; the prevalence increases as children age and have more exposures to potential allergens, she said.
Studies of asymptomatic children suggest that up to 25% are sensitized to one of several common contact allergens. Among children with dermatitis, up to 60% will have positive patch test reactions, studies suggest, but "whether or not those are clinically relevant is unclear," Dr. Bruckner noted.
Topical corticosteroids are the mainstay of treatment, but systemic steroids may be needed if the rash covers more than 10% of skin surface. With either option, treating for a full 23 weeks is important to avoid rebound dermatitis.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
A ring-shaped pattern on the posterior thighs and buttocks is consistent with allergic reaction to a wooden toilet seat. COURTESY DR. ANNA L. BRUCKNER
SAN FRANCISCO Allergic contact dermatitis looks like other forms of dermatitis, but the history and some visual clues can help make the diagnosis, Dr. Anna L. Bruckner said at a meeting sponsored by Skin Disease Education Foundation.
A history of exposure to common contact allergens, such as a recent run-in with poison ivy, poison oak, or poison sumac, may be all that is needed. A history of contact with other common allergens provides support for suspicions of allergic contact dermatitis. These allergens include nickel and topical antibiotics such as neomycin, gentamicin, and bacitracin.
In addition, said Dr. Bruckner of the pediatric dermatology clinic at Lucile Packard Children's Hospital in Palo Alto, Calif., the following "four P's" point to allergic contact dermatitis in children:
▸ Persistence. A rash that "doesn't respond to therapy like you would expect"coming back time and again in the same place despite treatment with topical steroidsmay be an allergic contact dermatitis, she said.
An allergic contact dermatitis begins 1224 hours after exposure to the allergen, peaks at 35 days, and may last 34 weeks if untreated.
▸ Place. A rash that is localized to an area not considered a typical location for dermatitis should raise suspicion, especially if an area where contact with a suspected allergen could be imagined.
Allergic contact dermatitis on a child's face or eyelids is caused most commonly by neomycin; fragrances; preservatives in creams, soaps or shampoos; or thimerosal in eyedrops. Nickel (in jewelry or jeans fasteners) is the most common cause of allergic contact dermatitis in the infraumbilical area and on the earlobes, neck, and wrists.
Compounds used in rubber production can produce allergic responses in the waistband area or on the dorsum of the feet, where leather also is a suspect because of an agent used in leather tanning. In the axillae, preservatives or fragrances in deodorant may cause allergic dermatitis.
▸ Pattern. Think of allergic contact dermatitis when there is a distinct pattern of eruption that is unusual for dermatitis, such as a linear rash. Dermatitis that is localized to the face, or that appears symmetrically on earlobes or on the dorsum of the hands or feet, may be a tip-off to allergic contact dermatitis.
Dr. Bruckner described a 7-year-old patient with a several-year history of a ring-shaped eruption on the posterior thighs and upper buttocks, which is "an area that we don't typically think about with atopic dermatitis." The rash cleared repeatedly with topical steroids but always returned, except for a rash-free summer he spent in India. This was toilet-seat dermatitis, a relatively common reaction to wood toilet seats that is caused by either the lacquer in the seat or the resin in the wood itself.
▸ Patch testing. If the etiology isn't apparent, epicutaneous patch testing may help determine whether allergic contact dermatitis is the culprit.
Besides nickel, preservatives, fragrances, rubber products, and leather, other common contact allergens include topical antibiotics (neomycin, bacitracin, and gentamicin); lanolin used in cosmetics; disperse dyes used to color the elastic waistbands of disposable diapers; and p-phenylenediamine (a component of hair dye, temporary tattoos, and hennalike products).
Allergic contact dermatitis may account for up to 20% of all cases of childhood dermatitis, although the exact incidence and prevalence are unknown. It can occur at all ages but is relatively uncommon in younger children; the prevalence increases as children age and have more exposures to potential allergens, she said.
Studies of asymptomatic children suggest that up to 25% are sensitized to one of several common contact allergens. Among children with dermatitis, up to 60% will have positive patch test reactions, studies suggest, but "whether or not those are clinically relevant is unclear," Dr. Bruckner noted.
Topical corticosteroids are the mainstay of treatment, but systemic steroids may be needed if the rash covers more than 10% of skin surface. With either option, treating for a full 23 weeks is important to avoid rebound dermatitis.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
A ring-shaped pattern on the posterior thighs and buttocks is consistent with allergic reaction to a wooden toilet seat. COURTESY DR. ANNA L. BRUCKNER
SAN FRANCISCO Allergic contact dermatitis looks like other forms of dermatitis, but the history and some visual clues can help make the diagnosis, Dr. Anna L. Bruckner said at a meeting sponsored by Skin Disease Education Foundation.
A history of exposure to common contact allergens, such as a recent run-in with poison ivy, poison oak, or poison sumac, may be all that is needed. A history of contact with other common allergens provides support for suspicions of allergic contact dermatitis. These allergens include nickel and topical antibiotics such as neomycin, gentamicin, and bacitracin.
In addition, said Dr. Bruckner of the pediatric dermatology clinic at Lucile Packard Children's Hospital in Palo Alto, Calif., the following "four P's" point to allergic contact dermatitis in children:
▸ Persistence. A rash that "doesn't respond to therapy like you would expect"coming back time and again in the same place despite treatment with topical steroidsmay be an allergic contact dermatitis, she said.
An allergic contact dermatitis begins 1224 hours after exposure to the allergen, peaks at 35 days, and may last 34 weeks if untreated.
▸ Place. A rash that is localized to an area not considered a typical location for dermatitis should raise suspicion, especially if an area where contact with a suspected allergen could be imagined.
Allergic contact dermatitis on a child's face or eyelids is caused most commonly by neomycin; fragrances; preservatives in creams, soaps or shampoos; or thimerosal in eyedrops. Nickel (in jewelry or jeans fasteners) is the most common cause of allergic contact dermatitis in the infraumbilical area and on the earlobes, neck, and wrists.
Compounds used in rubber production can produce allergic responses in the waistband area or on the dorsum of the feet, where leather also is a suspect because of an agent used in leather tanning. In the axillae, preservatives or fragrances in deodorant may cause allergic dermatitis.
▸ Pattern. Think of allergic contact dermatitis when there is a distinct pattern of eruption that is unusual for dermatitis, such as a linear rash. Dermatitis that is localized to the face, or that appears symmetrically on earlobes or on the dorsum of the hands or feet, may be a tip-off to allergic contact dermatitis.
Dr. Bruckner described a 7-year-old patient with a several-year history of a ring-shaped eruption on the posterior thighs and upper buttocks, which is "an area that we don't typically think about with atopic dermatitis." The rash cleared repeatedly with topical steroids but always returned, except for a rash-free summer he spent in India. This was toilet-seat dermatitis, a relatively common reaction to wood toilet seats that is caused by either the lacquer in the seat or the resin in the wood itself.
▸ Patch testing. If the etiology isn't apparent, epicutaneous patch testing may help determine whether allergic contact dermatitis is the culprit.
Besides nickel, preservatives, fragrances, rubber products, and leather, other common contact allergens include topical antibiotics (neomycin, bacitracin, and gentamicin); lanolin used in cosmetics; disperse dyes used to color the elastic waistbands of disposable diapers; and p-phenylenediamine (a component of hair dye, temporary tattoos, and hennalike products).
Allergic contact dermatitis may account for up to 20% of all cases of childhood dermatitis, although the exact incidence and prevalence are unknown. It can occur at all ages but is relatively uncommon in younger children; the prevalence increases as children age and have more exposures to potential allergens, she said.
Studies of asymptomatic children suggest that up to 25% are sensitized to one of several common contact allergens. Among children with dermatitis, up to 60% will have positive patch test reactions, studies suggest, but "whether or not those are clinically relevant is unclear," Dr. Bruckner noted.
Topical corticosteroids are the mainstay of treatment, but systemic steroids may be needed if the rash covers more than 10% of skin surface. With either option, treating for a full 23 weeks is important to avoid rebound dermatitis.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
A ring-shaped pattern on the posterior thighs and buttocks is consistent with allergic reaction to a wooden toilet seat. COURTESY DR. ANNA L. BRUCKNER
Don't Choose Cesarean to Lower Incontinence Risk
SAN FRANCISCO — Several studies have shown that women who develop urinary incontinence during pregnancy are more likely to have postpartum and long-term incontinence. A separate randomized, controlled study suggests that cesarean delivery may protect against development of postpartum urinary incontinence.
Does that mean that women with incontinence during pregnancy should be delivered by C-section to keep the incontinence from getting worse?
No, said Dr. Sharon K. Knight at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco. In general, 3 months after delivery the prevalence of postpartum incontinence is 9%–31%, and the incidence is 7%–15%, data suggest.
Studies show that about half of women develop transient urinary incontinence during pregnancy, which increases the risk for postpartum incontinence. The same studies report that the mode of delivery did not affect the risk of incontinence, said Dr. Knight of the university.
The one randomized study that suggested cesarean delivery might decrease the risk of postpartum incontinence had methodological problems and found a short-term benefit only in women who had no previous incontinence, she added.
That study randomized women to a trial of labor or cesarean delivery for breech babies, and the incontinence rate was a secondary outcome measure. Three months after delivery, the vaginal delivery group had nearly twice the rate of incontinence as the C-section group, but that difference had disappeared by the 2-year follow-up (Am. J. Obstet. Gynecol. 2004;191:917–27). Many of these women went on to have more babies after the study, which complicates the 2-year results because it's unknown whether they were delivered vaginally or by cesarean section, Dr. Knight noted.
Retrospective studies of women who delivered exclusively by one mode or the other have produced conflicting results on incontinence rates, but the largest population-based studies found no difference based on mode of delivery, she said.
Epidemiologic studies report that primiparous women have twice the rate of stress incontinence as nulliparous women.
By ages 50–65 years, “just being a woman puts you at high risk of having urinary incontinence,” Dr. Knight said.
SAN FRANCISCO — Several studies have shown that women who develop urinary incontinence during pregnancy are more likely to have postpartum and long-term incontinence. A separate randomized, controlled study suggests that cesarean delivery may protect against development of postpartum urinary incontinence.
Does that mean that women with incontinence during pregnancy should be delivered by C-section to keep the incontinence from getting worse?
No, said Dr. Sharon K. Knight at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco. In general, 3 months after delivery the prevalence of postpartum incontinence is 9%–31%, and the incidence is 7%–15%, data suggest.
Studies show that about half of women develop transient urinary incontinence during pregnancy, which increases the risk for postpartum incontinence. The same studies report that the mode of delivery did not affect the risk of incontinence, said Dr. Knight of the university.
The one randomized study that suggested cesarean delivery might decrease the risk of postpartum incontinence had methodological problems and found a short-term benefit only in women who had no previous incontinence, she added.
That study randomized women to a trial of labor or cesarean delivery for breech babies, and the incontinence rate was a secondary outcome measure. Three months after delivery, the vaginal delivery group had nearly twice the rate of incontinence as the C-section group, but that difference had disappeared by the 2-year follow-up (Am. J. Obstet. Gynecol. 2004;191:917–27). Many of these women went on to have more babies after the study, which complicates the 2-year results because it's unknown whether they were delivered vaginally or by cesarean section, Dr. Knight noted.
Retrospective studies of women who delivered exclusively by one mode or the other have produced conflicting results on incontinence rates, but the largest population-based studies found no difference based on mode of delivery, she said.
Epidemiologic studies report that primiparous women have twice the rate of stress incontinence as nulliparous women.
By ages 50–65 years, “just being a woman puts you at high risk of having urinary incontinence,” Dr. Knight said.
SAN FRANCISCO — Several studies have shown that women who develop urinary incontinence during pregnancy are more likely to have postpartum and long-term incontinence. A separate randomized, controlled study suggests that cesarean delivery may protect against development of postpartum urinary incontinence.
Does that mean that women with incontinence during pregnancy should be delivered by C-section to keep the incontinence from getting worse?
No, said Dr. Sharon K. Knight at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco. In general, 3 months after delivery the prevalence of postpartum incontinence is 9%–31%, and the incidence is 7%–15%, data suggest.
Studies show that about half of women develop transient urinary incontinence during pregnancy, which increases the risk for postpartum incontinence. The same studies report that the mode of delivery did not affect the risk of incontinence, said Dr. Knight of the university.
The one randomized study that suggested cesarean delivery might decrease the risk of postpartum incontinence had methodological problems and found a short-term benefit only in women who had no previous incontinence, she added.
That study randomized women to a trial of labor or cesarean delivery for breech babies, and the incontinence rate was a secondary outcome measure. Three months after delivery, the vaginal delivery group had nearly twice the rate of incontinence as the C-section group, but that difference had disappeared by the 2-year follow-up (Am. J. Obstet. Gynecol. 2004;191:917–27). Many of these women went on to have more babies after the study, which complicates the 2-year results because it's unknown whether they were delivered vaginally or by cesarean section, Dr. Knight noted.
Retrospective studies of women who delivered exclusively by one mode or the other have produced conflicting results on incontinence rates, but the largest population-based studies found no difference based on mode of delivery, she said.
Epidemiologic studies report that primiparous women have twice the rate of stress incontinence as nulliparous women.
By ages 50–65 years, “just being a woman puts you at high risk of having urinary incontinence,” Dr. Knight said.
Upper Limit of TSH Reference Range Debated
Providers looking for a defined upper limit of the statistically normal reference range for serum thyroid-stimulating hormone in apparently healthy, nonpregnant individuals—a measurement beyond which a patient might be followed or worked up for hypothyroidism—will be hard pressed to find a consensus around any single number.
Whichever number is used for that cutoff could have enormous public health implications by including or excluding millions of people from being considered to have “normal” thyroid-stimulating hormone (TSH) levels. Spirited debate in the past few years continues, with providers and laboratories using different numbers at different institutions. Consider:
▸ The Mayo Clinic, Rochester, Minn., sets the upper limit for the TSH reference range at 5 mU/L.
▸ The Southern California Kaiser Permanente Medical Group sets the upper limit at 4 mU/L.
▸ The University of Southern California, Los Angeles, recently lowered its cutoff to 3 mU/L.
▸ Some thyroid experts advocate for the upper limit to be even lower—2.5 mU/L.
What difference does a number make? Possibly quite a bit.
A study of TSH measurements in 75,882 patients without diagnoses of thyroid disease at the Mayo Clinic found that lowering the upper limit of normal from 5 mU/L to 3 mU/L would quadruple the number of patients classified as having elevated TSH concentrations, or “biochemical hypothyroidism,” from 5% to 20% of the cohort, Dr. Stefan K. Grebe and associates reported (JAMA 2003;290:3195–6).
This change could greatly increase unnecessary monitoring and treatment, as well as possible side effects from overdosing, said Dr. Grebe, director of the endocrine laboratory at the Mayo Clinic.
More appropriately, a patient with an elevated TSH measurement should be checked for thyroid antibodies and have the TSH level confirmed on a separate blood specimen drawn 1–2 months later before treatment is considered.
While there's remarkable agreement in the medical community that the lower limit of the reference range (below which someone might be evaluated for hyperthyroidism) hovers around 0.3 mIU/L, debates rages on both the appropriate upper limit and on what level of TSH elevation above that upper limit should be treated.
If you base the TSH reference range on a population that excludes anyone with a personal or family history of thyroid disease, the upper limit of normal settles around 4–5 mU/L, Dr. Grebe noted. More strenuous criteria in the National Health and Nutrition Examination Survey III (NHANES III) that also excluded anyone with a predisposition to thyroid dysfunction (evidenced by the presence of thyroid antibodies) produced a reference range upper limit of around 3.5 mU/L.
Around 20% of people with mild TSH elevations who have ultrasound evidence of occult thyroid dysfunction will have no thyroid antibodies detected, however, suggesting that the upper limit of the reference range in NHANES III is inflated by this subgroup, said Carole Spencer, Ph.D. A more appropriate upper limit probably is 2.5 mU/L, she argued in a recent analysis of the NHANES III data that was published online and accepted for print publication (J. Clin. Endocrinol. Metab. 2007 [Epub doi:10.1210/jc.2007-0287]).
“Because you've got these people with mild degrees of thyroid dysfunction contaminating the calculation, you cannot use population data to get a really clean TSH upper limit,” explained Dr. Spencer, one of the most vocal proponents of setting an empirical reference range of 0.3–3 mU/L and a professor of medicine at the University of Southern California, Los Angeles.
Guidelines that have attempted to deal with the diagnosis and management of subclinical hypothyroidism have been surrounded by controversy.
The American Association of Clinical Endocrinologists, the American Thyroid Association, and the Endocrine Society sponsored an evidence-based consensus conference in 2002. Among its conclusions, the panel recommended against routine screening for subclinical thyroid dysfunction in the general population or in women who are currently or planning to be pregnant, and against routine treatment of patients with serum TSH levels of 4.5–10 mU/L because of insufficient evidence that this is beneficial (JAMA 2004;291:228–38).
The three sponsoring organizations subsequently disowned those conclusions in a statement arguing that there's no evidence for a lack of benefit either, so providers should consider individual patient factors in determining the need for TSH testing and treatment. The potential benefits of early detection and treatment of subclinical thyroid dysfunction outweigh potential side effects, the authors stated (Endocr. Pract. 2004;10:497–501).Thyroxine treatment is believed to be fairly safe, but overdosing in the elderly can increase their risk for cardiac arrythmia or osteoporosis,
Dr. Martin Surks, professor of medicine and pathology at Albert Einstein College of Medicine, New York, and lead author of the consensus conference statement, said studies suggest that around 20% of patients taking thyroid medication are overdosed. There are no studies specifically designed to show that thyroid hormone therapy is safe in people with mild TSH elevations, he said.
“There is a lot of controversy over whether these minimally raised levels of TSH affect anyone badly,” Dr. Surks added. “They may even be beneficial,” one published study suggests. “Nobody knows.”
Three meta-analyses published this year reached divergent conclusions, with two saying mildly elevated TSH levels increased the risk of cardiac complications, and one reporting no increased risks. “That tells you the data are no good,” Dr. Surks said.
He and his associates will publish a new analysis of the NHANES III data this fall concluding that a significant share of the elderly people whose TSH levels were designated as elevated were inappropriately classified.
As for setting the upper limits on TSH low, Dr. Shireen Fatemi, director of endocrinology at the Panorama City (Calif.) Kaiser Permanente Medical Center, said that it's important to treat case by case. “You can't make a strong case either way” to treat or not treat mildly elevated TSH levels, she said. “Take the whole patient into consideration.”
'You can't make a strong case either way' to treat or not treat mildly elevated TSH levels. DR. FATEMI
Providers looking for a defined upper limit of the statistically normal reference range for serum thyroid-stimulating hormone in apparently healthy, nonpregnant individuals—a measurement beyond which a patient might be followed or worked up for hypothyroidism—will be hard pressed to find a consensus around any single number.
Whichever number is used for that cutoff could have enormous public health implications by including or excluding millions of people from being considered to have “normal” thyroid-stimulating hormone (TSH) levels. Spirited debate in the past few years continues, with providers and laboratories using different numbers at different institutions. Consider:
▸ The Mayo Clinic, Rochester, Minn., sets the upper limit for the TSH reference range at 5 mU/L.
▸ The Southern California Kaiser Permanente Medical Group sets the upper limit at 4 mU/L.
▸ The University of Southern California, Los Angeles, recently lowered its cutoff to 3 mU/L.
▸ Some thyroid experts advocate for the upper limit to be even lower—2.5 mU/L.
What difference does a number make? Possibly quite a bit.
A study of TSH measurements in 75,882 patients without diagnoses of thyroid disease at the Mayo Clinic found that lowering the upper limit of normal from 5 mU/L to 3 mU/L would quadruple the number of patients classified as having elevated TSH concentrations, or “biochemical hypothyroidism,” from 5% to 20% of the cohort, Dr. Stefan K. Grebe and associates reported (JAMA 2003;290:3195–6).
This change could greatly increase unnecessary monitoring and treatment, as well as possible side effects from overdosing, said Dr. Grebe, director of the endocrine laboratory at the Mayo Clinic.
More appropriately, a patient with an elevated TSH measurement should be checked for thyroid antibodies and have the TSH level confirmed on a separate blood specimen drawn 1–2 months later before treatment is considered.
While there's remarkable agreement in the medical community that the lower limit of the reference range (below which someone might be evaluated for hyperthyroidism) hovers around 0.3 mIU/L, debates rages on both the appropriate upper limit and on what level of TSH elevation above that upper limit should be treated.
If you base the TSH reference range on a population that excludes anyone with a personal or family history of thyroid disease, the upper limit of normal settles around 4–5 mU/L, Dr. Grebe noted. More strenuous criteria in the National Health and Nutrition Examination Survey III (NHANES III) that also excluded anyone with a predisposition to thyroid dysfunction (evidenced by the presence of thyroid antibodies) produced a reference range upper limit of around 3.5 mU/L.
Around 20% of people with mild TSH elevations who have ultrasound evidence of occult thyroid dysfunction will have no thyroid antibodies detected, however, suggesting that the upper limit of the reference range in NHANES III is inflated by this subgroup, said Carole Spencer, Ph.D. A more appropriate upper limit probably is 2.5 mU/L, she argued in a recent analysis of the NHANES III data that was published online and accepted for print publication (J. Clin. Endocrinol. Metab. 2007 [Epub doi:10.1210/jc.2007-0287]).
“Because you've got these people with mild degrees of thyroid dysfunction contaminating the calculation, you cannot use population data to get a really clean TSH upper limit,” explained Dr. Spencer, one of the most vocal proponents of setting an empirical reference range of 0.3–3 mU/L and a professor of medicine at the University of Southern California, Los Angeles.
Guidelines that have attempted to deal with the diagnosis and management of subclinical hypothyroidism have been surrounded by controversy.
The American Association of Clinical Endocrinologists, the American Thyroid Association, and the Endocrine Society sponsored an evidence-based consensus conference in 2002. Among its conclusions, the panel recommended against routine screening for subclinical thyroid dysfunction in the general population or in women who are currently or planning to be pregnant, and against routine treatment of patients with serum TSH levels of 4.5–10 mU/L because of insufficient evidence that this is beneficial (JAMA 2004;291:228–38).
The three sponsoring organizations subsequently disowned those conclusions in a statement arguing that there's no evidence for a lack of benefit either, so providers should consider individual patient factors in determining the need for TSH testing and treatment. The potential benefits of early detection and treatment of subclinical thyroid dysfunction outweigh potential side effects, the authors stated (Endocr. Pract. 2004;10:497–501).Thyroxine treatment is believed to be fairly safe, but overdosing in the elderly can increase their risk for cardiac arrythmia or osteoporosis,
Dr. Martin Surks, professor of medicine and pathology at Albert Einstein College of Medicine, New York, and lead author of the consensus conference statement, said studies suggest that around 20% of patients taking thyroid medication are overdosed. There are no studies specifically designed to show that thyroid hormone therapy is safe in people with mild TSH elevations, he said.
“There is a lot of controversy over whether these minimally raised levels of TSH affect anyone badly,” Dr. Surks added. “They may even be beneficial,” one published study suggests. “Nobody knows.”
Three meta-analyses published this year reached divergent conclusions, with two saying mildly elevated TSH levels increased the risk of cardiac complications, and one reporting no increased risks. “That tells you the data are no good,” Dr. Surks said.
He and his associates will publish a new analysis of the NHANES III data this fall concluding that a significant share of the elderly people whose TSH levels were designated as elevated were inappropriately classified.
As for setting the upper limits on TSH low, Dr. Shireen Fatemi, director of endocrinology at the Panorama City (Calif.) Kaiser Permanente Medical Center, said that it's important to treat case by case. “You can't make a strong case either way” to treat or not treat mildly elevated TSH levels, she said. “Take the whole patient into consideration.”
'You can't make a strong case either way' to treat or not treat mildly elevated TSH levels. DR. FATEMI
Providers looking for a defined upper limit of the statistically normal reference range for serum thyroid-stimulating hormone in apparently healthy, nonpregnant individuals—a measurement beyond which a patient might be followed or worked up for hypothyroidism—will be hard pressed to find a consensus around any single number.
Whichever number is used for that cutoff could have enormous public health implications by including or excluding millions of people from being considered to have “normal” thyroid-stimulating hormone (TSH) levels. Spirited debate in the past few years continues, with providers and laboratories using different numbers at different institutions. Consider:
▸ The Mayo Clinic, Rochester, Minn., sets the upper limit for the TSH reference range at 5 mU/L.
▸ The Southern California Kaiser Permanente Medical Group sets the upper limit at 4 mU/L.
▸ The University of Southern California, Los Angeles, recently lowered its cutoff to 3 mU/L.
▸ Some thyroid experts advocate for the upper limit to be even lower—2.5 mU/L.
What difference does a number make? Possibly quite a bit.
A study of TSH measurements in 75,882 patients without diagnoses of thyroid disease at the Mayo Clinic found that lowering the upper limit of normal from 5 mU/L to 3 mU/L would quadruple the number of patients classified as having elevated TSH concentrations, or “biochemical hypothyroidism,” from 5% to 20% of the cohort, Dr. Stefan K. Grebe and associates reported (JAMA 2003;290:3195–6).
This change could greatly increase unnecessary monitoring and treatment, as well as possible side effects from overdosing, said Dr. Grebe, director of the endocrine laboratory at the Mayo Clinic.
More appropriately, a patient with an elevated TSH measurement should be checked for thyroid antibodies and have the TSH level confirmed on a separate blood specimen drawn 1–2 months later before treatment is considered.
While there's remarkable agreement in the medical community that the lower limit of the reference range (below which someone might be evaluated for hyperthyroidism) hovers around 0.3 mIU/L, debates rages on both the appropriate upper limit and on what level of TSH elevation above that upper limit should be treated.
If you base the TSH reference range on a population that excludes anyone with a personal or family history of thyroid disease, the upper limit of normal settles around 4–5 mU/L, Dr. Grebe noted. More strenuous criteria in the National Health and Nutrition Examination Survey III (NHANES III) that also excluded anyone with a predisposition to thyroid dysfunction (evidenced by the presence of thyroid antibodies) produced a reference range upper limit of around 3.5 mU/L.
Around 20% of people with mild TSH elevations who have ultrasound evidence of occult thyroid dysfunction will have no thyroid antibodies detected, however, suggesting that the upper limit of the reference range in NHANES III is inflated by this subgroup, said Carole Spencer, Ph.D. A more appropriate upper limit probably is 2.5 mU/L, she argued in a recent analysis of the NHANES III data that was published online and accepted for print publication (J. Clin. Endocrinol. Metab. 2007 [Epub doi:10.1210/jc.2007-0287]).
“Because you've got these people with mild degrees of thyroid dysfunction contaminating the calculation, you cannot use population data to get a really clean TSH upper limit,” explained Dr. Spencer, one of the most vocal proponents of setting an empirical reference range of 0.3–3 mU/L and a professor of medicine at the University of Southern California, Los Angeles.
Guidelines that have attempted to deal with the diagnosis and management of subclinical hypothyroidism have been surrounded by controversy.
The American Association of Clinical Endocrinologists, the American Thyroid Association, and the Endocrine Society sponsored an evidence-based consensus conference in 2002. Among its conclusions, the panel recommended against routine screening for subclinical thyroid dysfunction in the general population or in women who are currently or planning to be pregnant, and against routine treatment of patients with serum TSH levels of 4.5–10 mU/L because of insufficient evidence that this is beneficial (JAMA 2004;291:228–38).
The three sponsoring organizations subsequently disowned those conclusions in a statement arguing that there's no evidence for a lack of benefit either, so providers should consider individual patient factors in determining the need for TSH testing and treatment. The potential benefits of early detection and treatment of subclinical thyroid dysfunction outweigh potential side effects, the authors stated (Endocr. Pract. 2004;10:497–501).Thyroxine treatment is believed to be fairly safe, but overdosing in the elderly can increase their risk for cardiac arrythmia or osteoporosis,
Dr. Martin Surks, professor of medicine and pathology at Albert Einstein College of Medicine, New York, and lead author of the consensus conference statement, said studies suggest that around 20% of patients taking thyroid medication are overdosed. There are no studies specifically designed to show that thyroid hormone therapy is safe in people with mild TSH elevations, he said.
“There is a lot of controversy over whether these minimally raised levels of TSH affect anyone badly,” Dr. Surks added. “They may even be beneficial,” one published study suggests. “Nobody knows.”
Three meta-analyses published this year reached divergent conclusions, with two saying mildly elevated TSH levels increased the risk of cardiac complications, and one reporting no increased risks. “That tells you the data are no good,” Dr. Surks said.
He and his associates will publish a new analysis of the NHANES III data this fall concluding that a significant share of the elderly people whose TSH levels were designated as elevated were inappropriately classified.
As for setting the upper limits on TSH low, Dr. Shireen Fatemi, director of endocrinology at the Panorama City (Calif.) Kaiser Permanente Medical Center, said that it's important to treat case by case. “You can't make a strong case either way” to treat or not treat mildly elevated TSH levels, she said. “Take the whole patient into consideration.”
'You can't make a strong case either way' to treat or not treat mildly elevated TSH levels. DR. FATEMI
Data Said to Favor Treating Mild Preeclampsia
SAN FRANCISCO — Experts have clashed in the past few years over whether to treat mild preeclampsia, but the data support treatment, Dr. William M. Gilbert said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.
There's widespread agreement that giving magnesium sulfate to pregnant women with severe preeclampsia is beneficial. Until recently, however, studies grouped together patients with any severity of disease or focused exclusively on severe preeclampsia.
One medical journal took the unusual step in 2003 of publishing a randomized, controlled trial of magnesium sulfate for mild preeclampsia despite the study being underpowered to show statistical significance. The 220-patient study found no difference in outcomes (Obstet. Gynecol. 2003;101:217–20). The editors emphasized that a large, randomized, controlled trial should be undertaken to see if treatment would benefit patients with mild preeclampsia, “which is most of the disease we see,” said Dr. Gilbert, professor of obstetrics and gynecology at the University of California, Davis.
That led to a 2004 editorial in another journal saying that previous studies that had addressed either only severe preeclampsia or all levels of preeclampsia combined did not show a decrease in the risk of maternal or neonatal morbidity after magnesium sulfate treatment.
“I would disagree with that statement entirely,” commented Dr. Gilbert. The editorial argued that because the significance of the 2003 study on mild preeclampsia was not clear, magnesium sulfate should not be given routinely to patients with mild preeclampsia (Am. J. Obstet. Gynecol. 2004;190:1520–6).
That editorial put clinicians in a tight spot—damned if they treated mild preeclampsia, damned if they didn't treat it and patients had strokes, seizures, or other adverse outcomes, Dr. Gilbert said.
To the rescue came a 2006 study from a hospital that gave magnesium sulfate to all preeclamptic patients for a 5-year period and then treated only severe disease in the following 4.5 years. The incidence of eclampsia more than doubled and the risk of maternal or neonatal morbidity secondary to seizures increased when patients with mild preeclampsia went untreated, compared with treating all preeclampsia (Obstet. Gynecol. 2006;108:826–32).
Among the 6,431 women with preeclampsia in the second half of the study, 1 of every 358 women treated for severe preeclampsia developed seizures, compared with 1 of every 92 women with untreated mild preeclampsia. The study found no serious toxicity from magnesium sulfate treatment.
“Women with mild disease who did not get magnesium sulfate had a much higher risk than women with severe disease who got magnesium,” Dr. Gilbert noted.
Before treating, be sure you've got a diagnosis of preeclampsia, which requires a consistently elevated blood pressure and ruling out other causes of high blood pressure, he added. Some clinicians treat prematurely based on one reading that shows mildly elevated blood pressure, when taking a second reading between contractions or giving an epidural dose will lower the blood pressure reading to normal ranges.
On the other hand, “If I have a woman who comes in with a blood pressure of 220/120 mm Hg, I'm not going to wait 6 hours to get a second reading,” but will go ahead and start magnesium sulfate, he said.
Magnesium sulfate treatment traditionally has been continued for 24 hours after delivery because about a third of women with preeclampsia will seize post partum, usually within the first 24 hours. A randomized study of 200 patients found, however, that 12 hours of postpartum treatment was as good as 24 hours in patients with mild disease—those with relatively lower blood pressures and no gestational diabetes (Obstet. Gynecol. 2006;108:833–8).
SAN FRANCISCO — Experts have clashed in the past few years over whether to treat mild preeclampsia, but the data support treatment, Dr. William M. Gilbert said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.
There's widespread agreement that giving magnesium sulfate to pregnant women with severe preeclampsia is beneficial. Until recently, however, studies grouped together patients with any severity of disease or focused exclusively on severe preeclampsia.
One medical journal took the unusual step in 2003 of publishing a randomized, controlled trial of magnesium sulfate for mild preeclampsia despite the study being underpowered to show statistical significance. The 220-patient study found no difference in outcomes (Obstet. Gynecol. 2003;101:217–20). The editors emphasized that a large, randomized, controlled trial should be undertaken to see if treatment would benefit patients with mild preeclampsia, “which is most of the disease we see,” said Dr. Gilbert, professor of obstetrics and gynecology at the University of California, Davis.
That led to a 2004 editorial in another journal saying that previous studies that had addressed either only severe preeclampsia or all levels of preeclampsia combined did not show a decrease in the risk of maternal or neonatal morbidity after magnesium sulfate treatment.
“I would disagree with that statement entirely,” commented Dr. Gilbert. The editorial argued that because the significance of the 2003 study on mild preeclampsia was not clear, magnesium sulfate should not be given routinely to patients with mild preeclampsia (Am. J. Obstet. Gynecol. 2004;190:1520–6).
That editorial put clinicians in a tight spot—damned if they treated mild preeclampsia, damned if they didn't treat it and patients had strokes, seizures, or other adverse outcomes, Dr. Gilbert said.
To the rescue came a 2006 study from a hospital that gave magnesium sulfate to all preeclamptic patients for a 5-year period and then treated only severe disease in the following 4.5 years. The incidence of eclampsia more than doubled and the risk of maternal or neonatal morbidity secondary to seizures increased when patients with mild preeclampsia went untreated, compared with treating all preeclampsia (Obstet. Gynecol. 2006;108:826–32).
Among the 6,431 women with preeclampsia in the second half of the study, 1 of every 358 women treated for severe preeclampsia developed seizures, compared with 1 of every 92 women with untreated mild preeclampsia. The study found no serious toxicity from magnesium sulfate treatment.
“Women with mild disease who did not get magnesium sulfate had a much higher risk than women with severe disease who got magnesium,” Dr. Gilbert noted.
Before treating, be sure you've got a diagnosis of preeclampsia, which requires a consistently elevated blood pressure and ruling out other causes of high blood pressure, he added. Some clinicians treat prematurely based on one reading that shows mildly elevated blood pressure, when taking a second reading between contractions or giving an epidural dose will lower the blood pressure reading to normal ranges.
On the other hand, “If I have a woman who comes in with a blood pressure of 220/120 mm Hg, I'm not going to wait 6 hours to get a second reading,” but will go ahead and start magnesium sulfate, he said.
Magnesium sulfate treatment traditionally has been continued for 24 hours after delivery because about a third of women with preeclampsia will seize post partum, usually within the first 24 hours. A randomized study of 200 patients found, however, that 12 hours of postpartum treatment was as good as 24 hours in patients with mild disease—those with relatively lower blood pressures and no gestational diabetes (Obstet. Gynecol. 2006;108:833–8).
SAN FRANCISCO — Experts have clashed in the past few years over whether to treat mild preeclampsia, but the data support treatment, Dr. William M. Gilbert said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.
There's widespread agreement that giving magnesium sulfate to pregnant women with severe preeclampsia is beneficial. Until recently, however, studies grouped together patients with any severity of disease or focused exclusively on severe preeclampsia.
One medical journal took the unusual step in 2003 of publishing a randomized, controlled trial of magnesium sulfate for mild preeclampsia despite the study being underpowered to show statistical significance. The 220-patient study found no difference in outcomes (Obstet. Gynecol. 2003;101:217–20). The editors emphasized that a large, randomized, controlled trial should be undertaken to see if treatment would benefit patients with mild preeclampsia, “which is most of the disease we see,” said Dr. Gilbert, professor of obstetrics and gynecology at the University of California, Davis.
That led to a 2004 editorial in another journal saying that previous studies that had addressed either only severe preeclampsia or all levels of preeclampsia combined did not show a decrease in the risk of maternal or neonatal morbidity after magnesium sulfate treatment.
“I would disagree with that statement entirely,” commented Dr. Gilbert. The editorial argued that because the significance of the 2003 study on mild preeclampsia was not clear, magnesium sulfate should not be given routinely to patients with mild preeclampsia (Am. J. Obstet. Gynecol. 2004;190:1520–6).
That editorial put clinicians in a tight spot—damned if they treated mild preeclampsia, damned if they didn't treat it and patients had strokes, seizures, or other adverse outcomes, Dr. Gilbert said.
To the rescue came a 2006 study from a hospital that gave magnesium sulfate to all preeclamptic patients for a 5-year period and then treated only severe disease in the following 4.5 years. The incidence of eclampsia more than doubled and the risk of maternal or neonatal morbidity secondary to seizures increased when patients with mild preeclampsia went untreated, compared with treating all preeclampsia (Obstet. Gynecol. 2006;108:826–32).
Among the 6,431 women with preeclampsia in the second half of the study, 1 of every 358 women treated for severe preeclampsia developed seizures, compared with 1 of every 92 women with untreated mild preeclampsia. The study found no serious toxicity from magnesium sulfate treatment.
“Women with mild disease who did not get magnesium sulfate had a much higher risk than women with severe disease who got magnesium,” Dr. Gilbert noted.
Before treating, be sure you've got a diagnosis of preeclampsia, which requires a consistently elevated blood pressure and ruling out other causes of high blood pressure, he added. Some clinicians treat prematurely based on one reading that shows mildly elevated blood pressure, when taking a second reading between contractions or giving an epidural dose will lower the blood pressure reading to normal ranges.
On the other hand, “If I have a woman who comes in with a blood pressure of 220/120 mm Hg, I'm not going to wait 6 hours to get a second reading,” but will go ahead and start magnesium sulfate, he said.
Magnesium sulfate treatment traditionally has been continued for 24 hours after delivery because about a third of women with preeclampsia will seize post partum, usually within the first 24 hours. A randomized study of 200 patients found, however, that 12 hours of postpartum treatment was as good as 24 hours in patients with mild disease—those with relatively lower blood pressures and no gestational diabetes (Obstet. Gynecol. 2006;108:833–8).