From Medscape Medical News
Laurie Barclay, MD
September 23, 2009 —- Regular exercise during pregnancy may lower the risk for excessive birth weight, according to the results of a cohort study reported in the October issue of Obstetrics & Gynecology.
"Despite extensive literature on the relationship between regular exercise during pregnancy and mean birth weight, the results are ambiguous and lack consistency," write Katrine Mari Owe, MSci, from Norwegian School of Sport Sciences in Oslo, Norway, and colleagues. "Both a positive and negative association with newborn birth weight have been suggested....The aim of the present study was to estimate, in a prospective cohort of pregnant women, the association of regular exercise, performed before and during pregnancy, with excessive newborn birth weight."
This analysis included data from 36,869 singleton pregnancies lasting at least 37 weeks among participants in the Norwegian Mother and Child Cohort Study. Two questionnaires administered during pregnancy weeks 17 and 30 provided data on regular exercise, and linkage to the Medical Birth Registry of Norway provided information regarding newborn birth weight. Excessive newborn birth weight, defined as birth weight at or above the 90th percentile, was the primary endpoint of the study. Associations were estimated separately for nulliparous (n = 16,064) and multiparous (n = 20,805) women with use of logistic regression analyses.
Of 4033 newborns (10.9%) with excessive birth weight, 2263 (56.1%) were born to multiparous women. Regular exercise (at least 3 times per week) in pregnancy weeks 17 and 30 was inversely associated with excessive newborn birth weight in nulliparous women (adjusted odds ratio [aOR], 0.72; 95% confidence interval [CI], 0.56 - 0.93 and aOR, 0.77; 95% CI 0.61 - 0.96, respectively).
"Regular exercise performed before pregnancy did not affect the probability of delivering newborns with an excessive birth weight in nulliparous or multiparous women," the study authors write.
"Regular exercise during pregnancy reduces the odds of giving birth to newborns with excessive birth weight by 23–28%."
Limitations of this study include indirect assessment of regular exercise with use of self-administered questionnaires, low response rate in the Norwegian Mother and Child Cohort Study, and possible confounding factors.
"Although our results indicate a protective effect of regular exercise during pregnancy, there seems to be an urgent need for randomized controlled trials with high methodological and interventional quality to be carried out to study the causal relationship between regular exercise in pregnancy and excessive newborn birth weight," the study authors conclude.
The Norwegian Mother and Child Cohort Study is supported by the Norwegian Ministry of Health, National Institutes of Health/National Institute of Environmental Health Sciences, National Institutes of Health/National Institute of Neurological Disorders and Stroke, and the Norwegian Research Council/Functional Genomics Project (FUGE). The study authors have disclosed no relevant financial relationships.
Obstet Gynecol. 2009;114:770-776.
Sunday, September 27, 2009
Monday, September 14, 2009
FDA Approves Blood Test That Helps Detect Ovarian Cancer
From Medscape Medical News
Yael Waknine
September 14, 2009 — The US Food and Drug Administration (FDA) has approved a novel blood test (OVA1, Vermillion Inc and Quest Diagnostics) to help detect ovarian cancer in adult women with pelvic tumors that are known to need surgery.
The test consolidates immunoassay results for 5 proteins known to change with ovarian cancer, rating the likelihood of malignancy on a scale of 1 to 10.
"OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy," the company said in a news release.
Identifying potentially malignant cases before surgery allows involvement of a gynecologic oncologist, which can improve patient outcome.
According to the FDA, ovarian cancer patients have demonstrated improved survival when the surgery is performed by gynecologic oncologists rather than general gynecologists or surgeons.
"Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications," noted Jeffrey Shuren, MD, JD, acting director of the FDA's Center for Devices and Radiological Health.
OVA1 should only be used to compliment other diagnostic and clinical procedures; the test is not indicated for screening purposes or to achieve a definite diagnosis of ovarian cancer.
Yael Waknine
September 14, 2009 — The US Food and Drug Administration (FDA) has approved a novel blood test (OVA1, Vermillion Inc and Quest Diagnostics) to help detect ovarian cancer in adult women with pelvic tumors that are known to need surgery.
The test consolidates immunoassay results for 5 proteins known to change with ovarian cancer, rating the likelihood of malignancy on a scale of 1 to 10.
"OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy," the company said in a news release.
Identifying potentially malignant cases before surgery allows involvement of a gynecologic oncologist, which can improve patient outcome.
According to the FDA, ovarian cancer patients have demonstrated improved survival when the surgery is performed by gynecologic oncologists rather than general gynecologists or surgeons.
"Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications," noted Jeffrey Shuren, MD, JD, acting director of the FDA's Center for Devices and Radiological Health.
OVA1 should only be used to compliment other diagnostic and clinical procedures; the test is not indicated for screening purposes or to achieve a definite diagnosis of ovarian cancer.
Friday, September 11, 2009
Elective Induction of Labor at 41 Weeks or Longer May Reduce Risk for Cesarean Delivery
From Medscape Medical News
Laurie Barclay, MD
August 17, 2009 — Elective induction of labor at 41 weeks of gestation or later is associated with a decreased risk for cesarean delivery and meconium-stained amniotic fluid, according to the results of a systematic review reported in the August 18 issue of the Annals of Internal Medicine. However, the reviewers warn against translating these findings to actual practice.
"The rates of induction of labor and elective induction of labor are increasing," write Aaron B. Caughey, MD, MPP, MPH, PhD, from Stanford University in California, and colleagues. "Whether elective induction of labor improves outcomes or simply leads to greater complications and health care costs is commonly debated in the literature."
The goal of this review was to compare the benefits and harms of elective induction of labor with those of expectant management of pregnancy. The reviewers searched Medline through February 2009; Web of Science, CINAHL, and the Cochrane Central Register of Controlled Trials through March 2009; reference lists of retrieved studies; and previously published systematic reviews for English-language articles describing experimental and observational studies of elective induction of labor.
Two of the reviewers abstracted information regarding study design, patient characteristics, methodologic quality, and outcomes including cesarean delivery and maternal and neonatal morbidity. Of 6117 articles identified, 36 met inclusion criteria, of which 11 were randomized controlled trials (RCTs) and 25 were observational studies.
Compared with elective induction of labor, expectant management of pregnancy was associated in 9 RCTs with a higher odds ratio (OR) of cesarean delivery (OR, 1.22; 95% confidence interval [CI], 1.07 – 1.39; absolute risk difference, 1.9 percentage points; 95% CI, 0.2 – 3.7 percentage points). Risk for cesarean delivery was higher in women at or beyond 41 completed weeks of gestation who were managed expectantly (OR, 1.21; 95% CI, 1.01 – 1.46). However, this difference was not statistically significant in women at less than 41 completed weeks of gestation (OR, 1.73; 95% CI, 0.67 – 4.5).
Compared with women who had elective induction of labor, those who were managed expectantly were more likely to have meconium-stained amniotic fluid (OR, 2.04; 95% CI, 1.34 – 3.09).
"RCTs suggest that elective induction of labor at 41 weeks of gestation and beyond is associated with a decreased risk for cesarean delivery and meconium-stained amniotic fluid," the review authors write. "There are concerns about the translation of these findings into actual practice; thus, future studies should examine elective induction of labor in settings where most obstetric care is provided."
Limitations of this review include that there were no recent RCTs of elective induction of labor at less than 41 weeks of gestation. The 2 studies conducted at less than 41 weeks of gestation were of poor quality, and the findings could not be generalized to current practice.
In an accompanying editorial, George A. Macones, MD, MSCE, from Washington University in St. Louis School of Medicine in Missouri, notes the need for well-designed RCTs of induction vs expectant management at 39 to 41 weeks that are sufficiently powered to evaluate critical subgroups, such as parity and cervical examination at randomization. In addition to studying rates of cesarean delivery, he also recommends studying the effect of new strategies on healthcare utilization and costs.
"Elective inductions are on the rise," Dr. Macones writes. "This development may not be as bad as obstetricians have traditionally believed. I hope that Caughey and colleagues' excellent systematic review will spur obstetricians to rethink and, more important, to more carefully research the role of elective induction of labor at and beyond 39 weeks."
Ann Intern Med. 2009;151:252–263, 281–282.
Laurie Barclay, MD
August 17, 2009 — Elective induction of labor at 41 weeks of gestation or later is associated with a decreased risk for cesarean delivery and meconium-stained amniotic fluid, according to the results of a systematic review reported in the August 18 issue of the Annals of Internal Medicine. However, the reviewers warn against translating these findings to actual practice.
"The rates of induction of labor and elective induction of labor are increasing," write Aaron B. Caughey, MD, MPP, MPH, PhD, from Stanford University in California, and colleagues. "Whether elective induction of labor improves outcomes or simply leads to greater complications and health care costs is commonly debated in the literature."
The goal of this review was to compare the benefits and harms of elective induction of labor with those of expectant management of pregnancy. The reviewers searched Medline through February 2009; Web of Science, CINAHL, and the Cochrane Central Register of Controlled Trials through March 2009; reference lists of retrieved studies; and previously published systematic reviews for English-language articles describing experimental and observational studies of elective induction of labor.
Two of the reviewers abstracted information regarding study design, patient characteristics, methodologic quality, and outcomes including cesarean delivery and maternal and neonatal morbidity. Of 6117 articles identified, 36 met inclusion criteria, of which 11 were randomized controlled trials (RCTs) and 25 were observational studies.
Compared with elective induction of labor, expectant management of pregnancy was associated in 9 RCTs with a higher odds ratio (OR) of cesarean delivery (OR, 1.22; 95% confidence interval [CI], 1.07 – 1.39; absolute risk difference, 1.9 percentage points; 95% CI, 0.2 – 3.7 percentage points). Risk for cesarean delivery was higher in women at or beyond 41 completed weeks of gestation who were managed expectantly (OR, 1.21; 95% CI, 1.01 – 1.46). However, this difference was not statistically significant in women at less than 41 completed weeks of gestation (OR, 1.73; 95% CI, 0.67 – 4.5).
Compared with women who had elective induction of labor, those who were managed expectantly were more likely to have meconium-stained amniotic fluid (OR, 2.04; 95% CI, 1.34 – 3.09).
"RCTs suggest that elective induction of labor at 41 weeks of gestation and beyond is associated with a decreased risk for cesarean delivery and meconium-stained amniotic fluid," the review authors write. "There are concerns about the translation of these findings into actual practice; thus, future studies should examine elective induction of labor in settings where most obstetric care is provided."
Limitations of this review include that there were no recent RCTs of elective induction of labor at less than 41 weeks of gestation. The 2 studies conducted at less than 41 weeks of gestation were of poor quality, and the findings could not be generalized to current practice.
In an accompanying editorial, George A. Macones, MD, MSCE, from Washington University in St. Louis School of Medicine in Missouri, notes the need for well-designed RCTs of induction vs expectant management at 39 to 41 weeks that are sufficiently powered to evaluate critical subgroups, such as parity and cervical examination at randomization. In addition to studying rates of cesarean delivery, he also recommends studying the effect of new strategies on healthcare utilization and costs.
"Elective inductions are on the rise," Dr. Macones writes. "This development may not be as bad as obstetricians have traditionally believed. I hope that Caughey and colleagues' excellent systematic review will spur obstetricians to rethink and, more important, to more carefully research the role of elective induction of labor at and beyond 39 weeks."
Ann Intern Med. 2009;151:252–263, 281–282.
Depression and Pregnancy: New Report Weighs Treatment Options
From Medscape Medical News
Deborah Brauser
August 21, 2009 — A joint report from the American Psychiatric Association (APA) and the American College of Obstetricians and Gynecologists (ACOG) aims to provide a new resource for clinicians who care for pregnant women who either have or are at risk of developing major depressive disorder.
"In terms of birth outcomes, the literature suggests that it's likely that both depression as well as antidepressant treatment confer risks and may be associated with adverse birth outcomes. However, the data looking at both of these together are insufficient at this point," Dr. Yonkers added.
In addition, the authors write that available research has not yet adequately controlled for other factors that may influence birth outcomes, including maternal illness or problematic health behaviors. The use of multiple medications during pregnancy also makes it difficult to assess the effect of a single compound, such as an antidepressant, on maternal and fetal outcomes.
According to the report, between 14% and 23% of pregnant women experience depressive symptoms, and approximately 13% of women in 2003 took an antidepressant at some time during pregnancy. "Thus, clinicians and patients need up-to-date information to assist with decisions about depression treatment during pregnancy," the authors write.
At the end of the review, the investigators found that although both depressive symptoms and antidepressant exposure are associated with fetal growth changes and shorter gestation periods, the majority of the studies that evaluated antidepressant risks were unable to control for the possible effects of a depressive disorder.
The researchers also found that:
Neonates born to mothers with a depressive disorder have an increased risk for irritability, less activity and attentiveness, and fewer facial expressions compared with those born to mothers without depression.
Several studies report fetal malformations in association with first-trimester antidepressant exposure, but there is no specific pattern of defects for individual medications or class of agents.
The association between paroxetine and cardiac defects is more often found in studies that included all malformations, rather than clinically significant malformations.
Late gestational use of selective serotonin reuptake inhibitor antidepressants is associated with transitory neonatal signs and an increased risk for persistent pulmonary hypertension in the newborn.
Most of the studies did not show an association between tricyclic antidepressant use in pregnancy and structural malformations, but tricyclic antidepressants are associated with increased perinatal complications such as jitteriness, irritability, and convulsions in neonates.
The report also recommends several treatment algorithms. These common scenarios include the following.
Women Thinking About Getting Pregnant
Tapering and discontinuing medication for those with mild or no depressive symptoms for 6 months or longer.
This discontinuation may not be appropriate for women with a history of severe or recurrent depression (or who have psychosis, bipolar disorder, other psychiatric illness requiring medication, or a history of suicide attempts).
Pregnant Women Currently on Medication for Depression
After a consultation between their psychiatrist and obstetrician/gynecologist (to discuss risks), psychiatrically stable women who prefer to stay on medication may be able to do so.
For those who want to discontinue medication and are not experiencing symptoms, tapering and discontinuation may be attempted. However, women with a history of recurrent depression are at a high risk for relapse.
Those with recurrent depression or symptoms despite their medication may benefit from psychotherapy to replace or augment medication.
Women with severe depression should remain on medication. If a patient refuses, alternative treatment and monitoring should be in place, preferably before discontinuation.
Pregnant Women Not Currently on Medication for Depression
For those who want to avoid antidepressant medication, psychotherapy may be beneficial.
For those who prefer taking medication, risks and benefits of treatment choices should be evaluated and discussed.
In addition, regardless of circumstances, any pregnant woman with suicidal or psychotic symptoms should seek an immediate consultation with a psychiatrist for treatment.
"In the past, reproductive health practitioners have felt ill equipped to treat these patients because of the lack of available guidance concerning the management of depressed women during pregnancy. Many people — physicians and women alike — will be glad to know that their choices go beyond medication or nothing," ACOG President Gerald F. Joseph, Jr, MD, said in a statement.
Limitations of this report are that only a minority of the studies reviewed included information on maternal psychiatric illness. Studies with detailed information regarding diagnoses and antidepressant use were usually smaller and had limited power to find important associations.
In addition, confounding factors that influence birth outcomes, such as poor prenatal care and drug, alcohol, and nicotine use, were variably controlled.
"This is a report intended to reach out to psychiatrists as well as obstetrician-gynecologists," said Dr. Yonkers. "We developed algorithms which I think reflect the fact that there are multiple issues to consider and [that] there should be no knee-jerk response in managing a woman who is depressed and pregnant or contemplating pregnancy. Psychiatric history and a woman's preference are among the important features that should be taken into consideration."
Gen Hosp Psychiatry. 2009;31(5):403–413.
Obstet Gynecol. 2009;114(3):703–713.
Deborah Brauser
August 21, 2009 — A joint report from the American Psychiatric Association (APA) and the American College of Obstetricians and Gynecologists (ACOG) aims to provide a new resource for clinicians who care for pregnant women who either have or are at risk of developing major depressive disorder.
"In terms of birth outcomes, the literature suggests that it's likely that both depression as well as antidepressant treatment confer risks and may be associated with adverse birth outcomes. However, the data looking at both of these together are insufficient at this point," Dr. Yonkers added.
In addition, the authors write that available research has not yet adequately controlled for other factors that may influence birth outcomes, including maternal illness or problematic health behaviors. The use of multiple medications during pregnancy also makes it difficult to assess the effect of a single compound, such as an antidepressant, on maternal and fetal outcomes.
According to the report, between 14% and 23% of pregnant women experience depressive symptoms, and approximately 13% of women in 2003 took an antidepressant at some time during pregnancy. "Thus, clinicians and patients need up-to-date information to assist with decisions about depression treatment during pregnancy," the authors write.
At the end of the review, the investigators found that although both depressive symptoms and antidepressant exposure are associated with fetal growth changes and shorter gestation periods, the majority of the studies that evaluated antidepressant risks were unable to control for the possible effects of a depressive disorder.
The researchers also found that:
Neonates born to mothers with a depressive disorder have an increased risk for irritability, less activity and attentiveness, and fewer facial expressions compared with those born to mothers without depression.
Several studies report fetal malformations in association with first-trimester antidepressant exposure, but there is no specific pattern of defects for individual medications or class of agents.
The association between paroxetine and cardiac defects is more often found in studies that included all malformations, rather than clinically significant malformations.
Late gestational use of selective serotonin reuptake inhibitor antidepressants is associated with transitory neonatal signs and an increased risk for persistent pulmonary hypertension in the newborn.
Most of the studies did not show an association between tricyclic antidepressant use in pregnancy and structural malformations, but tricyclic antidepressants are associated with increased perinatal complications such as jitteriness, irritability, and convulsions in neonates.
The report also recommends several treatment algorithms. These common scenarios include the following.
Women Thinking About Getting Pregnant
Tapering and discontinuing medication for those with mild or no depressive symptoms for 6 months or longer.
This discontinuation may not be appropriate for women with a history of severe or recurrent depression (or who have psychosis, bipolar disorder, other psychiatric illness requiring medication, or a history of suicide attempts).
Pregnant Women Currently on Medication for Depression
After a consultation between their psychiatrist and obstetrician/gynecologist (to discuss risks), psychiatrically stable women who prefer to stay on medication may be able to do so.
For those who want to discontinue medication and are not experiencing symptoms, tapering and discontinuation may be attempted. However, women with a history of recurrent depression are at a high risk for relapse.
Those with recurrent depression or symptoms despite their medication may benefit from psychotherapy to replace or augment medication.
Women with severe depression should remain on medication. If a patient refuses, alternative treatment and monitoring should be in place, preferably before discontinuation.
Pregnant Women Not Currently on Medication for Depression
For those who want to avoid antidepressant medication, psychotherapy may be beneficial.
For those who prefer taking medication, risks and benefits of treatment choices should be evaluated and discussed.
In addition, regardless of circumstances, any pregnant woman with suicidal or psychotic symptoms should seek an immediate consultation with a psychiatrist for treatment.
"In the past, reproductive health practitioners have felt ill equipped to treat these patients because of the lack of available guidance concerning the management of depressed women during pregnancy. Many people — physicians and women alike — will be glad to know that their choices go beyond medication or nothing," ACOG President Gerald F. Joseph, Jr, MD, said in a statement.
Limitations of this report are that only a minority of the studies reviewed included information on maternal psychiatric illness. Studies with detailed information regarding diagnoses and antidepressant use were usually smaller and had limited power to find important associations.
In addition, confounding factors that influence birth outcomes, such as poor prenatal care and drug, alcohol, and nicotine use, were variably controlled.
"This is a report intended to reach out to psychiatrists as well as obstetrician-gynecologists," said Dr. Yonkers. "We developed algorithms which I think reflect the fact that there are multiple issues to consider and [that] there should be no knee-jerk response in managing a woman who is depressed and pregnant or contemplating pregnancy. Psychiatric history and a woman's preference are among the important features that should be taken into consideration."
Gen Hosp Psychiatry. 2009;31(5):403–413.
Obstet Gynecol. 2009;114(3):703–713.
Thursday, September 10, 2009
First Trial of H1N1 Vaccine for Pregnant Women to Begin This Week
From Medscape Medical News
Martha Kerr
September 10, 2009 — The first clinical trial of a 2009 influenza A (H1N1) candidate vaccine for pregnant women will launch this week, according to the National Institute of Allergy and Infectious Diseases (NIAID).
"Data indicate that pregnant women are at higher risk for complications from the 2009 H1N1 influenza virus . . . so this trial will provide critical information for public-health planning," NIAID director Anthony S. Fauci, MD, said in an NIAID announcement.
Centers for Disease Control and Prevention (CDC) figures show that 45 deaths from H1N1 influenza occurred between mid-April and mid-June of this year. Of these, 6 (13%) were in pregnant women. During the first month of the H1N1 influenza outbreak this year, pregnant women were 4 times more likely to be hospitalized with the flu than the general population.
"Women are at higher risk of developing severe illness if they become infected with influenza virus while pregnant, which is why they are strongly encouraged to receive the seasonal influenza vaccine every year," Dr. Fauci said.
The CDC's Advisory Committee on Immunization Practices has recommended that pregnant women be among the top-priority groups and receive the H1N1 vaccine as soon as one becomes available.
The trial will involve up to 120 pregnant women, aged 18 and 39 years, who are between 14 and 34 weeks' gestation.
Subjects will receive either 15 or 30 µg of a vaccine manufactured by Sanofi Pasteur. It will be administered in 2 doses, given 21 days apart, using the same trial design as that for the H1N1 vaccine that began in August.
The vaccine contains inactivated virus and has no thimerosal or adjuvant added.
Safety will be monitored continuously, as will immune response to the vaccine, including antibody production. Umbilical cord blood will be collected at delivery to assess the transfer of maternal antibodies to the infant.
The NIAID-funded national network of Vaccine and Treatment Evaluation Units (VTEUs) is conducting the trial at 6 sites: Baylor College of Medicine VTEU in Houston, Texas; Group Health Cooperative Center for Health Studies VTEU in Seattle, Washington; Saint Louis University VTEU, in Missouri; Vanderbilt University VTEU in Nashville, Tennessee; Duke University in Durham, North Carolina; and Scott and White Memorial Hospital and Clinic in Temple, Texas.
The NIAID is also planning to conduct trials in pregnant women of other candidate 2009 H1N1 influenza vaccines made by other manufacturers.
Detailed information about this study can be found on the ClinicalTrials.gov Web site.
Martha Kerr
September 10, 2009 — The first clinical trial of a 2009 influenza A (H1N1) candidate vaccine for pregnant women will launch this week, according to the National Institute of Allergy and Infectious Diseases (NIAID).
"Data indicate that pregnant women are at higher risk for complications from the 2009 H1N1 influenza virus . . . so this trial will provide critical information for public-health planning," NIAID director Anthony S. Fauci, MD, said in an NIAID announcement.
Centers for Disease Control and Prevention (CDC) figures show that 45 deaths from H1N1 influenza occurred between mid-April and mid-June of this year. Of these, 6 (13%) were in pregnant women. During the first month of the H1N1 influenza outbreak this year, pregnant women were 4 times more likely to be hospitalized with the flu than the general population.
"Women are at higher risk of developing severe illness if they become infected with influenza virus while pregnant, which is why they are strongly encouraged to receive the seasonal influenza vaccine every year," Dr. Fauci said.
The CDC's Advisory Committee on Immunization Practices has recommended that pregnant women be among the top-priority groups and receive the H1N1 vaccine as soon as one becomes available.
The trial will involve up to 120 pregnant women, aged 18 and 39 years, who are between 14 and 34 weeks' gestation.
Subjects will receive either 15 or 30 µg of a vaccine manufactured by Sanofi Pasteur. It will be administered in 2 doses, given 21 days apart, using the same trial design as that for the H1N1 vaccine that began in August.
The vaccine contains inactivated virus and has no thimerosal or adjuvant added.
Safety will be monitored continuously, as will immune response to the vaccine, including antibody production. Umbilical cord blood will be collected at delivery to assess the transfer of maternal antibodies to the infant.
The NIAID-funded national network of Vaccine and Treatment Evaluation Units (VTEUs) is conducting the trial at 6 sites: Baylor College of Medicine VTEU in Houston, Texas; Group Health Cooperative Center for Health Studies VTEU in Seattle, Washington; Saint Louis University VTEU, in Missouri; Vanderbilt University VTEU in Nashville, Tennessee; Duke University in Durham, North Carolina; and Scott and White Memorial Hospital and Clinic in Temple, Texas.
The NIAID is also planning to conduct trials in pregnant women of other candidate 2009 H1N1 influenza vaccines made by other manufacturers.
Detailed information about this study can be found on the ClinicalTrials.gov Web site.
Risk for Breast Cancer Recurrence Decreased by Lifestyle Changes
From Medscape Medical News
Roxanne Nelson
September 9, 2009 — Breast cancer survivors might be able to reduce their risk for contralateral breast cancer by making lifestyle modifications. A new study published online September 8 in the Journal of Clinical Oncology has found that obesity, alcohol use, and smoking all significantly increase the risk for second primary invasive contralateral breast cancer among breast cancer survivors.
Researchers from the Fred Hutchinson Cancer Research Center in Seattle, Washington, found that obese women had a 50% increased risk for contralateral breast cancer, and those who consumed 7 or more alcoholic drinks per week had a 90% increased risk. Survivors who currently smoked had a 120% increased risk of developing a second breast cancer.
The risk was particularly high in women who were current smokers and who consumed at least 1 alcoholic beverage a day. The authors found that this subgroup of women had a 7.2-fold (95% confidence interval [CI], 1.9 to 26.5) elevated risk for contralateral breast cancer.
Limited Data on Role of Lifestyle in Preventing Second Cancer
There is substantial evidence that modifiable lifestyle factors play a significant role in the risk for primary breast cancer. As recently reported by Medscape Oncology, an updated version of the American Institute for Cancer Research/World Cancer Research Fund's report, Food, Nutrition, Physical Activity, and the Prevention of Cancer: A Global Perspective, reaffirmed that factors such as maintaining a healthy weight, exercising regularly, and limiting consumption of alcoholic beverages can reduce the risk of developing breast cancer.
However, information on lifestyle factors and their role in preventing contralateral disease in survivors is more limited. The authors point out that although adjuvant hormone therapy can lower the risk by 47%, little is known about other factors that are within the patient's control.
Reducing the risk for a second cancer is of considerable concern, they note, because breast cancer survivors have a risk of developing a contralateral breast cancer that is 2 to 6 times greater than that of women in the general population developing a first breast cancer. Therefore, identifying potentially modifiable risk factors is of public-health relevance and of individual importance to breast cancer survivors, the authors note.
"But 1 issue in our study was that while some of the smokers stopped smoking, few of the drinkers changed their drinking habits, and few of the obese women lost weight, so we could not directly assess the impact that changing these habits had on reducing risk of a second breast cancer," lead author Christopher I. Li, MD, PhD, associate member of the Public Health Sciences Division at the Hutchinson Center, told Medscape Oncology.
"That said, the evidence regarding obesity and alcohol use and risk of a first breast cancer does suggest that reducing body weight and reducing alcohol consumption does lower risk of first breast cancer, so I would expect that changing these things could also reduce the risk of second breast cancer," he added.
Obesity, Alcohol Use, and Smoking Increase Risk
In this study, Dr. Li and colleagues evaluated the effect of obesity, alcohol consumption, and smoking on risk for second primary invasive contralateral breast cancer among breast cancer survivors.
The cohort consisted of 365 women who were diagnosed with an estrogen-receptor (ER)-positive first primary invasive breast cancer and a second primary contralateral invasive breast cancer, and 726 matched controls who were diagnosed with only an ER-positive first primary invasive breast cancer.
Information regarding obesity, alcohol use, and smoking was acquired from medical-record reviews and from interviews with the participants. The researchers then used conditional logistic regression to assess the association of these 3 factors and the risk for a second cancer.
They found that compared with women who had a body mass index (BMI) lower than 25.0 kg/m2, those with a BMI of 30.0 kg/m2 or above had a higher risk for contralateral breast cancer (odds ratio [OR], 1.4; 95% CI, 1.0 to 2.1).
The consumption of alcohol was also positively related to an increased risk for a second cancer (OR, 1.9; 95% CI, 1.1 to 3.2) when evaluated at both the first diagnosis of breast cancer and during the interval between first breast cancer diagnosis and reference date.
In similar fashion, current smokers had an elevated risk for contralateral breast cancer (OR, 2.2; 95% CI, 1.2 to 4.0) at first breast cancer diagnosis and at reference date, compared with women who had never smoked. The association between smoking and cancer risk did not vary by pack-years, the authors note. A small number of women were smokers at the time of their first diagnosis but quit by their reference date (14 patients and 29 control subjects), and this did not seem to influence the risk of developing a second breast cancer.
This observation suggests that recent smoking is the most relevant to risk, the authors note. "There were also too few women who were exsmokers and who started smoking again after their first breast cancer diagnosis for us to be able to assess this aspect," said Dr. Li.
Impact of Hormone Therapy Unclear
Despite having ER-positive primary cancers, 30% of the control women and 39.5% of the patients with contralateral disease were not treated with adjuvant hormone therapy. However, the researchers explain that this cohort included patients who received their first breast cancer diagnosis nearly 2 decades ago. At that time, the use of hormone therapy differed from what it is now, and as a result, fewer women received this type of treatment or for the amount of time needed for it to confer maximal clinical benefit.
But given the low rates of hormonal therapy use in this cohort, "it is reasonable to ask whether the relationship between weight and alcohol use seen in this study would be maintained in women with ER-positive tumors treated according to current adjuvant therapy guidelines," writes Jennifer A. Ligibel, MD, from the Dana-Farber Cancer Institute, Harvard Medical School, in Boston, Massachusetts, in an editorial.
"Thus, further work is needed to define the impact of modifiable factors on the risk of second primary breast cancers from modern observational data sets including women treated with modern hormonal therapy regimens," she notes.
The study was funded by a grant from the National Cancer Institute. The study authors and editorialist have disclosed no relevant financial relationships.
J Clin Oncol. Published online before print September 8, 2009.
Roxanne Nelson
September 9, 2009 — Breast cancer survivors might be able to reduce their risk for contralateral breast cancer by making lifestyle modifications. A new study published online September 8 in the Journal of Clinical Oncology has found that obesity, alcohol use, and smoking all significantly increase the risk for second primary invasive contralateral breast cancer among breast cancer survivors.
Researchers from the Fred Hutchinson Cancer Research Center in Seattle, Washington, found that obese women had a 50% increased risk for contralateral breast cancer, and those who consumed 7 or more alcoholic drinks per week had a 90% increased risk. Survivors who currently smoked had a 120% increased risk of developing a second breast cancer.
The risk was particularly high in women who were current smokers and who consumed at least 1 alcoholic beverage a day. The authors found that this subgroup of women had a 7.2-fold (95% confidence interval [CI], 1.9 to 26.5) elevated risk for contralateral breast cancer.
Limited Data on Role of Lifestyle in Preventing Second Cancer
There is substantial evidence that modifiable lifestyle factors play a significant role in the risk for primary breast cancer. As recently reported by Medscape Oncology, an updated version of the American Institute for Cancer Research/World Cancer Research Fund's report, Food, Nutrition, Physical Activity, and the Prevention of Cancer: A Global Perspective, reaffirmed that factors such as maintaining a healthy weight, exercising regularly, and limiting consumption of alcoholic beverages can reduce the risk of developing breast cancer.
However, information on lifestyle factors and their role in preventing contralateral disease in survivors is more limited. The authors point out that although adjuvant hormone therapy can lower the risk by 47%, little is known about other factors that are within the patient's control.
Reducing the risk for a second cancer is of considerable concern, they note, because breast cancer survivors have a risk of developing a contralateral breast cancer that is 2 to 6 times greater than that of women in the general population developing a first breast cancer. Therefore, identifying potentially modifiable risk factors is of public-health relevance and of individual importance to breast cancer survivors, the authors note.
"But 1 issue in our study was that while some of the smokers stopped smoking, few of the drinkers changed their drinking habits, and few of the obese women lost weight, so we could not directly assess the impact that changing these habits had on reducing risk of a second breast cancer," lead author Christopher I. Li, MD, PhD, associate member of the Public Health Sciences Division at the Hutchinson Center, told Medscape Oncology.
"That said, the evidence regarding obesity and alcohol use and risk of a first breast cancer does suggest that reducing body weight and reducing alcohol consumption does lower risk of first breast cancer, so I would expect that changing these things could also reduce the risk of second breast cancer," he added.
Obesity, Alcohol Use, and Smoking Increase Risk
In this study, Dr. Li and colleagues evaluated the effect of obesity, alcohol consumption, and smoking on risk for second primary invasive contralateral breast cancer among breast cancer survivors.
The cohort consisted of 365 women who were diagnosed with an estrogen-receptor (ER)-positive first primary invasive breast cancer and a second primary contralateral invasive breast cancer, and 726 matched controls who were diagnosed with only an ER-positive first primary invasive breast cancer.
Information regarding obesity, alcohol use, and smoking was acquired from medical-record reviews and from interviews with the participants. The researchers then used conditional logistic regression to assess the association of these 3 factors and the risk for a second cancer.
They found that compared with women who had a body mass index (BMI) lower than 25.0 kg/m2, those with a BMI of 30.0 kg/m2 or above had a higher risk for contralateral breast cancer (odds ratio [OR], 1.4; 95% CI, 1.0 to 2.1).
The consumption of alcohol was also positively related to an increased risk for a second cancer (OR, 1.9; 95% CI, 1.1 to 3.2) when evaluated at both the first diagnosis of breast cancer and during the interval between first breast cancer diagnosis and reference date.
In similar fashion, current smokers had an elevated risk for contralateral breast cancer (OR, 2.2; 95% CI, 1.2 to 4.0) at first breast cancer diagnosis and at reference date, compared with women who had never smoked. The association between smoking and cancer risk did not vary by pack-years, the authors note. A small number of women were smokers at the time of their first diagnosis but quit by their reference date (14 patients and 29 control subjects), and this did not seem to influence the risk of developing a second breast cancer.
This observation suggests that recent smoking is the most relevant to risk, the authors note. "There were also too few women who were exsmokers and who started smoking again after their first breast cancer diagnosis for us to be able to assess this aspect," said Dr. Li.
Impact of Hormone Therapy Unclear
Despite having ER-positive primary cancers, 30% of the control women and 39.5% of the patients with contralateral disease were not treated with adjuvant hormone therapy. However, the researchers explain that this cohort included patients who received their first breast cancer diagnosis nearly 2 decades ago. At that time, the use of hormone therapy differed from what it is now, and as a result, fewer women received this type of treatment or for the amount of time needed for it to confer maximal clinical benefit.
But given the low rates of hormonal therapy use in this cohort, "it is reasonable to ask whether the relationship between weight and alcohol use seen in this study would be maintained in women with ER-positive tumors treated according to current adjuvant therapy guidelines," writes Jennifer A. Ligibel, MD, from the Dana-Farber Cancer Institute, Harvard Medical School, in Boston, Massachusetts, in an editorial.
"Thus, further work is needed to define the impact of modifiable factors on the risk of second primary breast cancers from modern observational data sets including women treated with modern hormonal therapy regimens," she notes.
The study was funded by a grant from the National Cancer Institute. The study authors and editorialist have disclosed no relevant financial relationships.
J Clin Oncol. Published online before print September 8, 2009.
Saturday, September 5, 2009
Osteoporosis Risk in Premenopausal Women
From Pharmacotherapy
Sheryl E Vondracek, Pharm.D., FCCP; Laura B. Hansen, Pharm.D., FCCP; Michael T. McDermott, M.D.
Abstract
Although clinically significant bone loss and fractures in healthy premenopausal women are rare, more women are seeking evaluation for osteoporosis from their health care providers. As pharmacists are in an ideal position to influence the management of premenopausal women with osteoporosis, it is important that pharmacists understand the available data on bone loss, fractures, and risk factors and secondary causes for osteoporosis, as well as when to recommend testing and treatment in premenopausal women. Limited data are available; therefore, we conducted a MEDLINE search of the literature from January 1993-August 2008.
Studies evaluating bone loss, fractures, and fracture risk in healthy premenopausal women were targeted and summarized; most recommendations are based on expert opinion. A small but statistically significant loss in bone mineral density of 0.25-1%/year by dual-energy x-ray absorptiometry is seen healthy premenopausal women; the clinical significance of this is unknown.
Whereas absolute fracture risk is low, premenopausal fractures appear to increase postmenopausal fracture risk by 1.5-3-fold. Risk factors for low bone density appear to be similar between pre- and postmenopausal women.
Bone density screening in healthy premenopausal women is not recommended, but bone mineral density testing is advisable for those who have conditions or who receive drug therapy that may cause secondary bone loss.
Lifestyle modification emphasizing bone-healthy habits such as adequate calcium and vitamin D nutrition, regular exercise, limitation of caffeine and alcohol consumption, and avoidance of tobacco are essential to the management of osteoporosis risk.
The efficacy and safety of osteoporosis drugs have not been adequately demonstrated in premenopausal women. Therefore, pharmacologic interventions cannot be recommended in young women with low bone mass but may be considered in those having a more significant fracture risk, such as those with a previous low-trauma fracture or an identified secondary cause for bone loss.
Sheryl E Vondracek, Pharm.D., FCCP; Laura B. Hansen, Pharm.D., FCCP; Michael T. McDermott, M.D.
Abstract
Although clinically significant bone loss and fractures in healthy premenopausal women are rare, more women are seeking evaluation for osteoporosis from their health care providers. As pharmacists are in an ideal position to influence the management of premenopausal women with osteoporosis, it is important that pharmacists understand the available data on bone loss, fractures, and risk factors and secondary causes for osteoporosis, as well as when to recommend testing and treatment in premenopausal women. Limited data are available; therefore, we conducted a MEDLINE search of the literature from January 1993-August 2008.
Studies evaluating bone loss, fractures, and fracture risk in healthy premenopausal women were targeted and summarized; most recommendations are based on expert opinion. A small but statistically significant loss in bone mineral density of 0.25-1%/year by dual-energy x-ray absorptiometry is seen healthy premenopausal women; the clinical significance of this is unknown.
Whereas absolute fracture risk is low, premenopausal fractures appear to increase postmenopausal fracture risk by 1.5-3-fold. Risk factors for low bone density appear to be similar between pre- and postmenopausal women.
Bone density screening in healthy premenopausal women is not recommended, but bone mineral density testing is advisable for those who have conditions or who receive drug therapy that may cause secondary bone loss.
Lifestyle modification emphasizing bone-healthy habits such as adequate calcium and vitamin D nutrition, regular exercise, limitation of caffeine and alcohol consumption, and avoidance of tobacco are essential to the management of osteoporosis risk.
The efficacy and safety of osteoporosis drugs have not been adequately demonstrated in premenopausal women. Therefore, pharmacologic interventions cannot be recommended in young women with low bone mass but may be considered in those having a more significant fracture risk, such as those with a previous low-trauma fracture or an identified secondary cause for bone loss.
Friday, September 4, 2009
New Data Confirm Lifestyle Changes Can Dramatically Reduce Risk for Breast Cancer
From Medscape Medical News
Roxanne Nelson
September 3, 2009 — New data have confirmed that lifestyle factors play a significant role in the risk for breast cancer. An updated version of the American Institute for Cancer Research/World Cancer Research Fund's (AICR/WCRF) report, Food, Nutrition, Physical Activity, and the Prevention of Cancer: A Global Perspective, reaffirms that factors such as maintaining a healthy weight, breastfeeding, exercising regularly, and limiting consumption of alcoholic beverages can reduce the risk for breast cancer.
The 2007 report is considered to be the most comprehensive scientific analysis of cancer prevention and causation ever undertaken, as previously reported by Medscape Oncology. The original paper reviewed 873 studies on breast cancer, and since that time, information from 81 new breast-cancer-related studies has been added to the database.
"This study represents the clearest picture we have ever had on how lifestyle affects a woman's risk of breast cancer," said Martin Wiseman, MD, medical and scientific adviser for AICR and WCRF, in a statement.
By maintaining a healthy weight, being physically active, and limiting the amount of alcohol they drink, women can dramatically reduce their risk.
"We are now more certain than ever that by maintaining a healthy weight, being physically active, and limiting the amount of alcohol they drink, women can dramatically reduce their risk," he added.
An AICR policy report issued in February 2009 estimated the percentage of cancers that could be prevented by incorporating the recommendations of the 2007 report. Overall, the report concluded that about one third of the most common cancers could be prevented by following AICR recommendations on body weight, physical activity, and diet.
They reported that 38% of cases of breast cancer in the United States could be prevented through diet, activity, and healthy weight. Based on figures from the American Cancer Society, that percentage extrapolates to about 70,000 new cases of breast cancer prevented each year.
Continuous Update Project Adds to Research
The report on breast cancer is part of the Continuous Update Project, the long-term goal of which is to continuously update the findings of the AICR/WCRF 2007 report. "When we published our 2007 report, we knew that we wanted to keep it a living document, so that its recommendations could always reflect the latest science without going out of date," explained Glen Weldon, director of communications at AICR. "That's what the Continuous Update Project is about."
For the Continuous Update Project, a smaller expert panel will collect and analyze new reports and combine the new data with the those from studies already in the database. "This will be done on a cancer-by-cancer basis," Mr. Weldon told Medscape Oncology. "Breast cancer was the most studied cancer in the years since the 2007 report, so that was the one we started with."
An independent systematic literature-review team identified an additional 81 breast cancer studies that met the criteria for inclusion. The expert panel then reviewed the new data, combined evidence, and determined that the new data only strengthened the 2007 report's conclusions.
Breast Feeding, Body Weight, Alcohol Consumption Affect Risk
In the updated chapter on breast cancer, the panel reached several conclusions regarding lifestyle/diet and breast cancer risk. They found "convincing evidence" that:
lactation protects against breast cancer at all ages
alcoholic drinks are a cause of breast cancer at all ages, and
body fatness is a cause of postmenopausal breast cancer.
In addition, there is convincing evidence that factors that lead to greater attained adult height or its consequences are a cause of postmenopausal breast cancer. The authors clarify that although adult attained height is unlikely to directly modify the risk for cancer, it is "a marker for genetic, environmental, hormonal, and nutritional factors affecting growth during the period from preconception to completion of linear growth."
Physical activity probably protects against postmenopausal breast cancer, and there is limited evidence suggesting that it protects against premenopausal breast cancer, the experts note.
Based on these conclusions, the AICR recommends the following for reducing the risk for breast cancer:
Because of the link between excess body fat and cancer, the goal is to be as lean as possible within the normal range of body weight.
Be physically active as part of everyday life.
Limit alcohol consumption to 1 drink per day for women (2 drinks for men).
Mothers should breastfeed exclusively for up to 6 months and then add other liquids and foods. Evidence is convincing that mothers who breastfeed reduce their risk for breast cancer, and there is also probable evidence that children who are breastfed have a lower risk of gaining excess weight as they grow.
World Cancer Research Fund/American Institute for Cancer Research. The Second Expert Report, Food, Nutrition, Physical Activity, and the Prevention of Cancer: A Global Perspective. Washington, DC: AICR; 2009.
Roxanne Nelson
September 3, 2009 — New data have confirmed that lifestyle factors play a significant role in the risk for breast cancer. An updated version of the American Institute for Cancer Research/World Cancer Research Fund's (AICR/WCRF) report, Food, Nutrition, Physical Activity, and the Prevention of Cancer: A Global Perspective, reaffirms that factors such as maintaining a healthy weight, breastfeeding, exercising regularly, and limiting consumption of alcoholic beverages can reduce the risk for breast cancer.
The 2007 report is considered to be the most comprehensive scientific analysis of cancer prevention and causation ever undertaken, as previously reported by Medscape Oncology. The original paper reviewed 873 studies on breast cancer, and since that time, information from 81 new breast-cancer-related studies has been added to the database.
"This study represents the clearest picture we have ever had on how lifestyle affects a woman's risk of breast cancer," said Martin Wiseman, MD, medical and scientific adviser for AICR and WCRF, in a statement.
By maintaining a healthy weight, being physically active, and limiting the amount of alcohol they drink, women can dramatically reduce their risk.
"We are now more certain than ever that by maintaining a healthy weight, being physically active, and limiting the amount of alcohol they drink, women can dramatically reduce their risk," he added.
An AICR policy report issued in February 2009 estimated the percentage of cancers that could be prevented by incorporating the recommendations of the 2007 report. Overall, the report concluded that about one third of the most common cancers could be prevented by following AICR recommendations on body weight, physical activity, and diet.
They reported that 38% of cases of breast cancer in the United States could be prevented through diet, activity, and healthy weight. Based on figures from the American Cancer Society, that percentage extrapolates to about 70,000 new cases of breast cancer prevented each year.
Continuous Update Project Adds to Research
The report on breast cancer is part of the Continuous Update Project, the long-term goal of which is to continuously update the findings of the AICR/WCRF 2007 report. "When we published our 2007 report, we knew that we wanted to keep it a living document, so that its recommendations could always reflect the latest science without going out of date," explained Glen Weldon, director of communications at AICR. "That's what the Continuous Update Project is about."
For the Continuous Update Project, a smaller expert panel will collect and analyze new reports and combine the new data with the those from studies already in the database. "This will be done on a cancer-by-cancer basis," Mr. Weldon told Medscape Oncology. "Breast cancer was the most studied cancer in the years since the 2007 report, so that was the one we started with."
An independent systematic literature-review team identified an additional 81 breast cancer studies that met the criteria for inclusion. The expert panel then reviewed the new data, combined evidence, and determined that the new data only strengthened the 2007 report's conclusions.
Breast Feeding, Body Weight, Alcohol Consumption Affect Risk
In the updated chapter on breast cancer, the panel reached several conclusions regarding lifestyle/diet and breast cancer risk. They found "convincing evidence" that:
lactation protects against breast cancer at all ages
alcoholic drinks are a cause of breast cancer at all ages, and
body fatness is a cause of postmenopausal breast cancer.
In addition, there is convincing evidence that factors that lead to greater attained adult height or its consequences are a cause of postmenopausal breast cancer. The authors clarify that although adult attained height is unlikely to directly modify the risk for cancer, it is "a marker for genetic, environmental, hormonal, and nutritional factors affecting growth during the period from preconception to completion of linear growth."
Physical activity probably protects against postmenopausal breast cancer, and there is limited evidence suggesting that it protects against premenopausal breast cancer, the experts note.
Based on these conclusions, the AICR recommends the following for reducing the risk for breast cancer:
Because of the link between excess body fat and cancer, the goal is to be as lean as possible within the normal range of body weight.
Be physically active as part of everyday life.
Limit alcohol consumption to 1 drink per day for women (2 drinks for men).
Mothers should breastfeed exclusively for up to 6 months and then add other liquids and foods. Evidence is convincing that mothers who breastfeed reduce their risk for breast cancer, and there is also probable evidence that children who are breastfed have a lower risk of gaining excess weight as they grow.
World Cancer Research Fund/American Institute for Cancer Research. The Second Expert Report, Food, Nutrition, Physical Activity, and the Prevention of Cancer: A Global Perspective. Washington, DC: AICR; 2009.
Shampoos
From Dermatitis
Matthew Zirwas; Jessica Moennich
Abstract
Shampoos are used almost universally in developed countries to wash the hair on a daily basis. A number of known contact allergens are used as ingredients in shampoos, and contact allergy due to shampoos is a well known entity. Patch testing can be used to identify ingredients to which patients are allergic, after which the physician can help the patient to find a shampoo that is free of the ingredients to which they are allergic. The ingredients used in shampoos have not been systematically reviewed in recent years in the United States. We use a database of products sold at a major drug store to quantify the most frequent allergens used in shampoos.
The allergens most commonly present, in order of prevalence are as follows: fragrance, cocamidopropyl betaine, ethylchloroisothiazolinone/methylisothiazolinone, formaldehyde releasers, propylene glycol, vitamin E, parabens, benzophenones, iodopropynyl butylcarbamate, and methyldibromoglutaronitrile/phenoxyethanol.
Introduction
Shampoo is the most commonly used product on the hair and scalp, and as a result, many different formulations are marketed on the basis of consumer-specific concerns such as hair manageability, problems associated with age and gender, and certain scalp problems such as dandruff and psoriasis. Shampoos are typically composed of 10 to 30 ingredients although products with as few as four ingredients are available, as are products with many more than 30 ingredients. Several types of ingredients are particularly important, including "surfactants" that aid in cleansing and lathering, "conditioners" and "active ingredients" that affect the hair and scalp, and "additives" that stabilize the product, add consumer appeal, and modify the effect of the surfactant.[1]
Although generally well tolerated, allergic contact dermatitis (ACD) due to ingredients in shampoo is a well-known entity.[2] ACD from shampoo can present as eyelid dermatitis, facial dermatitis, neck dermatitis, scalp dermatitis, dermatitis of the upper back, or dermatitis in more than one of these areas, often leading to difficulty in clinical diagnosis. Another confounding factor is that because of significant similarities in the ingredients of one shampoo to those of another, a patient who suspects shampoo allergy and thus changes products may change to another product that also contains the ingredient to which he or she is allergic and thus experience no improvement after the switch. This history often leads patients (and sometimes physicians) to erroneously assume that because the dermatitis did not improve following a change in shampoo, shampoo allergy is not the etiologic factor in the dermatitis.
Patch-testing for shampoo allergy can be challenging. Many of the relevant allergens are also irritants, which leads to possible false-positive results on patch testing.[3] Also, numerous allergens in shampoos are not included in current screening series, which makes it necessary to test with additional panels and to consider testing with the patient's own shampoo.[4] However, patch-testing directly with shampoos is fraught with difficulty because there may not be a dilution that is dilute enough to avoid false-positive irritant reactions while still being concentrated enough to avoid false-negative reactions.
Following a positive patch-test result, finding shampoos that are free of the detected allergens can be problematic for patients owing to the widespread use of a number of common allergens in many shampoos. We sought to systematically evaluate the potentially allergenic ingredients currently used in shampoos that are widely available in the United States. This information should be helpful to clinicians who detect allergy to substances that may be shampoo ingredients by allowing them to better assess the likelihood of past, present, and future exposure to these allergens in shampoos.
for detailed article see:
http://www.medscape.com/viewarticle/706406_5
Matthew Zirwas; Jessica Moennich
Abstract
Shampoos are used almost universally in developed countries to wash the hair on a daily basis. A number of known contact allergens are used as ingredients in shampoos, and contact allergy due to shampoos is a well known entity. Patch testing can be used to identify ingredients to which patients are allergic, after which the physician can help the patient to find a shampoo that is free of the ingredients to which they are allergic. The ingredients used in shampoos have not been systematically reviewed in recent years in the United States. We use a database of products sold at a major drug store to quantify the most frequent allergens used in shampoos.
The allergens most commonly present, in order of prevalence are as follows: fragrance, cocamidopropyl betaine, ethylchloroisothiazolinone/methylisothiazolinone, formaldehyde releasers, propylene glycol, vitamin E, parabens, benzophenones, iodopropynyl butylcarbamate, and methyldibromoglutaronitrile/phenoxyethanol.
Introduction
Shampoo is the most commonly used product on the hair and scalp, and as a result, many different formulations are marketed on the basis of consumer-specific concerns such as hair manageability, problems associated with age and gender, and certain scalp problems such as dandruff and psoriasis. Shampoos are typically composed of 10 to 30 ingredients although products with as few as four ingredients are available, as are products with many more than 30 ingredients. Several types of ingredients are particularly important, including "surfactants" that aid in cleansing and lathering, "conditioners" and "active ingredients" that affect the hair and scalp, and "additives" that stabilize the product, add consumer appeal, and modify the effect of the surfactant.[1]
Although generally well tolerated, allergic contact dermatitis (ACD) due to ingredients in shampoo is a well-known entity.[2] ACD from shampoo can present as eyelid dermatitis, facial dermatitis, neck dermatitis, scalp dermatitis, dermatitis of the upper back, or dermatitis in more than one of these areas, often leading to difficulty in clinical diagnosis. Another confounding factor is that because of significant similarities in the ingredients of one shampoo to those of another, a patient who suspects shampoo allergy and thus changes products may change to another product that also contains the ingredient to which he or she is allergic and thus experience no improvement after the switch. This history often leads patients (and sometimes physicians) to erroneously assume that because the dermatitis did not improve following a change in shampoo, shampoo allergy is not the etiologic factor in the dermatitis.
Patch-testing for shampoo allergy can be challenging. Many of the relevant allergens are also irritants, which leads to possible false-positive results on patch testing.[3] Also, numerous allergens in shampoos are not included in current screening series, which makes it necessary to test with additional panels and to consider testing with the patient's own shampoo.[4] However, patch-testing directly with shampoos is fraught with difficulty because there may not be a dilution that is dilute enough to avoid false-positive irritant reactions while still being concentrated enough to avoid false-negative reactions.
Following a positive patch-test result, finding shampoos that are free of the detected allergens can be problematic for patients owing to the widespread use of a number of common allergens in many shampoos. We sought to systematically evaluate the potentially allergenic ingredients currently used in shampoos that are widely available in the United States. This information should be helpful to clinicians who detect allergy to substances that may be shampoo ingredients by allowing them to better assess the likelihood of past, present, and future exposure to these allergens in shampoos.
for detailed article see:
http://www.medscape.com/viewarticle/706406_5
Thursday, September 3, 2009
Adjuvant Hormonal Therapy for Breast Cancer May Affect Contralateral Breast Cancer Risk
From Medscape Medical News
Laurie Barclay, MD
September 1, 2009 — Long-term adjuvant hormonal therapy for breast cancer may affect the risk for contralateral estrogen receptor (ER)–positive or ER-negative tumors, according to the results of a population-based, nested case-control study reported in the August 25 online issue of Cancer Research.
"Compared with the breast cancer risk women in the general population have, breast cancer survivors have a substantially higher risk of developing a second primary contralateral breast cancer," write Christopher I. Li, MD, PhD, from the Fred Hutchinson Cancer Research Center in Seattle, Washington, and colleagues. "Adjuvant hormonal therapy reduces this risk, but preliminary data indicate that it may also increase risk of hormone receptor–negative contralateral tumors."
The study sample consisted of 367 women diagnosed with both first primary ER-positive invasive breast cancer and second primary contralateral breast cancer (case patients) and 728 matched women diagnosed only with a first breast cancer (control subjects). Telephone interviews and medical record review allowed collection of data on adjuvant hormonal therapy, other treatments, and breast cancer risk factors. Associations between adjuvant hormonal therapy and the risk for hormone receptor–specific subtypes of contralateral breast cancer were measured with two-sided statistical tests with use of conditional logistic regression.
Among case patients, 303 had ER-positive breast cancer and 52 had ER-negative breast cancer. Women who used adjuvant tamoxifen for at least 5 years had a lower risk for ER-positive contralateral breast cancer (odds ratio [OR], 0.4; 95% confidence interval [CI], 0.3 - 0.7) but a 4.4-fold (95% CI, 1.03 - 19.0) increased risk for ER-negative contralateral breast cancer vs women not treated with hormonal therapy. Tamoxifen use for less than 5 years did not appear to affect the risk for contralateral ER-negative breast cancer.
"Although adjuvant hormonal therapy has clear benefits, risk of the relatively uncommon outcome of ER-negative contralateral breast cancer may now need to be tallied among its risks," the study authors write. "This is of clinical concern given the poorer prognosis of ER– compared with ER+ tumors."
Limitations of the study include recall bias, possibly insufficient statistical power to determine a dose-response relationship for the relatively rare outcome of an ER-negative second primary contralateral tumor, relatively small sample size, and lack of generalizability to users of other types of hormonal therapy.
"The considerable benefits of adjuvant hormonal therapy for women with hormone receptor–positive breast cancer are clear as they confer substantially reduced risks of breast cancer recurrence, contralateral breast cancer, and mortality," the study authors conclude. "Nevertheless, risk of a hormone receptor–negative contralateral breast cancer may now need to be tallied among the risks of treatment with tamoxifen, and further studies are needed to determine if other hormonal therapies and the increasingly used aromatase inhibitors in particular, also carry this risk."
The National Cancer Institute supported this study. The study authors have disclosed no relevant financial relationships.
Cancer Res. Published online August 25, 2009. Abstract
Laurie Barclay, MD
September 1, 2009 — Long-term adjuvant hormonal therapy for breast cancer may affect the risk for contralateral estrogen receptor (ER)–positive or ER-negative tumors, according to the results of a population-based, nested case-control study reported in the August 25 online issue of Cancer Research.
"Compared with the breast cancer risk women in the general population have, breast cancer survivors have a substantially higher risk of developing a second primary contralateral breast cancer," write Christopher I. Li, MD, PhD, from the Fred Hutchinson Cancer Research Center in Seattle, Washington, and colleagues. "Adjuvant hormonal therapy reduces this risk, but preliminary data indicate that it may also increase risk of hormone receptor–negative contralateral tumors."
The study sample consisted of 367 women diagnosed with both first primary ER-positive invasive breast cancer and second primary contralateral breast cancer (case patients) and 728 matched women diagnosed only with a first breast cancer (control subjects). Telephone interviews and medical record review allowed collection of data on adjuvant hormonal therapy, other treatments, and breast cancer risk factors. Associations between adjuvant hormonal therapy and the risk for hormone receptor–specific subtypes of contralateral breast cancer were measured with two-sided statistical tests with use of conditional logistic regression.
Among case patients, 303 had ER-positive breast cancer and 52 had ER-negative breast cancer. Women who used adjuvant tamoxifen for at least 5 years had a lower risk for ER-positive contralateral breast cancer (odds ratio [OR], 0.4; 95% confidence interval [CI], 0.3 - 0.7) but a 4.4-fold (95% CI, 1.03 - 19.0) increased risk for ER-negative contralateral breast cancer vs women not treated with hormonal therapy. Tamoxifen use for less than 5 years did not appear to affect the risk for contralateral ER-negative breast cancer.
"Although adjuvant hormonal therapy has clear benefits, risk of the relatively uncommon outcome of ER-negative contralateral breast cancer may now need to be tallied among its risks," the study authors write. "This is of clinical concern given the poorer prognosis of ER– compared with ER+ tumors."
Limitations of the study include recall bias, possibly insufficient statistical power to determine a dose-response relationship for the relatively rare outcome of an ER-negative second primary contralateral tumor, relatively small sample size, and lack of generalizability to users of other types of hormonal therapy.
"The considerable benefits of adjuvant hormonal therapy for women with hormone receptor–positive breast cancer are clear as they confer substantially reduced risks of breast cancer recurrence, contralateral breast cancer, and mortality," the study authors conclude. "Nevertheless, risk of a hormone receptor–negative contralateral breast cancer may now need to be tallied among the risks of treatment with tamoxifen, and further studies are needed to determine if other hormonal therapies and the increasingly used aromatase inhibitors in particular, also carry this risk."
The National Cancer Institute supported this study. The study authors have disclosed no relevant financial relationships.
Cancer Res. Published online August 25, 2009. Abstract
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