Damian McNamara

LAKE BUENA VISTA, FLA. — Soy supplements improved somatic and urogenital symptoms of menopause to the same degree as did low-dose combination hormone therapy in a small, randomized, double-blind controlled trial.

A total of 60 women who were 1–13 years past menopause were randomized to one of three groups: soy supplements containing about 90 mg of isoflavones; estradiol 1 mg/norethindrone 0.5 mg; or placebo daily.

After 16 weeks, women in the two treatment groups had significant somatic and urogenital symptom improvements, compared with baseline on the Menopause Rating Scale (MRS).

The changes were also significant, compared with scores among women taking placebo.

The findings suggest a role for dietary soy supplementation for improving hot flashes, joint and muscle pain, and vaginal dryness, with results equivalent to hormone therapy, said gynecologist Adriana O. Pedro.

“I thought that hormone replacement would be better than soy—so I was surprised,” said Dr. Pedro, of the State University of Campinas (Brazil), during a poster session at the annual meeting of the North American Menopause Society.

Women taking hormone therapy fared better, however, in terms of cardiovascular health markers. Women on the low-dose combination hormone therapy showed improvement in total cholesterol and low-density lipoprotein levels; these levels were unchanged in those who got soy supplements.

In addition, total cholesterol decreased 12%, compared with baseline, in the hormone treatment group but remained unchanged in the soy supplement and placebo groups.

The LDL cholesterol level decreased 18% in the hormone therapy group and, again, did not change in the other groups.

“There was no change with soy—probably because they had normal lipid profiles at baseline,” Dr. Pedro said.

Levels of triglycerides, HDL cholesterol, and glucose; body mass index; blood pressure; and abdominal/hip ratio did not change significantly, compared with baseline, in any group.

Total MRS scores were reduced in all groups by 16 weeks. In addition, follicle-stimulating hormone decreased and 17β-estradiol increased, compared with baseline, but only in the hormone replacement group. Psychological symptoms did not change over the treatment period in the soy, hormone replacement, or placebo groups.

Data analysis is ongoing. “We just analyzed symptoms and lipid profiles so far,” Dr. Pedro said. In the future, they plan to publish additional findings for these postmenopausal women regarding any changes in quality of life, vaginal pH, vaginal cytology, or bladder symptoms.

The study was funded by the São Paulo (Brazil) Foundation for the Support of Research.

LAKE BUENA VISTA, FLA. — Soy supplements improved somatic and urogenital symptoms of menopause to the same degree as did low-dose combination hormone therapy in a small, randomized, double-blind controlled trial.

A total of 60 women who were 1–13 years past menopause were randomized to one of three groups: soy supplements containing about 90 mg of isoflavones; estradiol 1 mg/norethindrone 0.5 mg; or placebo daily.

After 16 weeks, women in the two treatment groups had significant somatic and urogenital symptom improvements, compared with baseline on the Menopause Rating Scale (MRS).

The changes were also significant, compared with scores among women taking placebo.

The findings suggest a role for dietary soy supplementation for improving hot flashes, joint and muscle pain, and vaginal dryness, with results equivalent to hormone therapy, said gynecologist Adriana O. Pedro.

“I thought that hormone replacement would be better than soy—so I was surprised,” said Dr. Pedro, of the State University of Campinas (Brazil), during a poster session at the annual meeting of the North American Menopause Society.

Women taking hormone therapy fared better, however, in terms of cardiovascular health markers. Women on the low-dose combination hormone therapy showed improvement in total cholesterol and low-density lipoprotein levels; these levels were unchanged in those who got soy supplements.

In addition, total cholesterol decreased 12%, compared with baseline, in the hormone treatment group but remained unchanged in the soy supplement and placebo groups.

The LDL cholesterol level decreased 18% in the hormone therapy group and, again, did not change in the other groups.

“There was no change with soy—probably because they had normal lipid profiles at baseline,” Dr. Pedro said.

Levels of triglycerides, HDL cholesterol, and glucose; body mass index; blood pressure; and abdominal/hip ratio did not change significantly, compared with baseline, in any group.

Total MRS scores were reduced in all groups by 16 weeks. In addition, follicle-stimulating hormone decreased and 17β-estradiol increased, compared with baseline, but only in the hormone replacement group. Psychological symptoms did not change over the treatment period in the soy, hormone replacement, or placebo groups.

Data analysis is ongoing. “We just analyzed symptoms and lipid profiles so far,” Dr. Pedro said. In the future, they plan to publish additional findings for these postmenopausal women regarding any changes in quality of life, vaginal pH, vaginal cytology, or bladder symptoms.

The study was funded by the São Paulo (Brazil) Foundation for the Support of Research.

LAKE BUENA VISTA, FLA. — Soy supplements improved somatic and urogenital symptoms of menopause to the same degree as did low-dose combination hormone therapy in a small, randomized, double-blind controlled trial.

A total of 60 women who were 1–13 years past menopause were randomized to one of three groups: soy supplements containing about 90 mg of isoflavones; estradiol 1 mg/norethindrone 0.5 mg; or placebo daily.

After 16 weeks, women in the two treatment groups had significant somatic and urogenital symptom improvements, compared with baseline on the Menopause Rating Scale (MRS).

The changes were also significant, compared with scores among women taking placebo.

The findings suggest a role for dietary soy supplementation for improving hot flashes, joint and muscle pain, and vaginal dryness, with results equivalent to hormone therapy, said gynecologist Adriana O. Pedro.

“I thought that hormone replacement would be better than soy—so I was surprised,” said Dr. Pedro, of the State University of Campinas (Brazil), during a poster session at the annual meeting of the North American Menopause Society.

Women taking hormone therapy fared better, however, in terms of cardiovascular health markers. Women on the low-dose combination hormone therapy showed improvement in total cholesterol and low-density lipoprotein levels; these levels were unchanged in those who got soy supplements.

In addition, total cholesterol decreased 12%, compared with baseline, in the hormone treatment group but remained unchanged in the soy supplement and placebo groups.

The LDL cholesterol level decreased 18% in the hormone therapy group and, again, did not change in the other groups.

“There was no change with soy—probably because they had normal lipid profiles at baseline,” Dr. Pedro said.

Levels of triglycerides, HDL cholesterol, and glucose; body mass index; blood pressure; and abdominal/hip ratio did not change significantly, compared with baseline, in any group.

Total MRS scores were reduced in all groups by 16 weeks. In addition, follicle-stimulating hormone decreased and 17β-estradiol increased, compared with baseline, but only in the hormone replacement group. Psychological symptoms did not change over the treatment period in the soy, hormone replacement, or placebo groups.

Data analysis is ongoing. “We just analyzed symptoms and lipid profiles so far,” Dr. Pedro said. In the future, they plan to publish additional findings for these postmenopausal women regarding any changes in quality of life, vaginal pH, vaginal cytology, or bladder symptoms.

The study was funded by the São Paulo (Brazil) Foundation for the Support of Research.

ORLANDO — The incidence of inflammatory bowel disease is rising in children and adolescents, a retrospective study of 272 newly diagnosed pediatric patients indicates, and children of all races, ethnicities, genders, and ages can be affected.

Researchers overseas have shown an increasing incidence of inflammatory bowel disease (IBD) in children, for example, in Sweden (Eur. J. Gen. Pract. 2006;12:88–90) and Taiwan (J. Formos. Med. Assoc. 2004;103:685–91).

“I wanted to see if this is also happening in the U.S.,” Dr. Hoda Malaty said in an interview at her poster during the annual meeting of the American College of Gastroenterology. “I have a great interest in IBD in children because there are a lot of gaps in the literature.”

Dr. Malaty and her associates assessed 272 children with a first diagnosis of IBD who were enrolled in a disease registry at Texas Children's Hospital during 1991–2002. The investigators compared patients based on two time periods: 1991–1996 versus 1997–2002. The ratio was 1.2 boys to each girl.

The overall incidence of IBD increased from 1% to 2.5% from the first time period to the second. “It's on the rise. It increased about three times,” said Dr. Malaty, a pediatrician within the department of medicine, section of gastroenterology and hepatology, Texas Children's Hospital and Baylor College of Medicine, Houston. She had no relevant disclosures, and UCB Inc. supported the study.

A total of 56% of patients in the cohort had Crohn's disease, 22% had ulcerative colitis, and 22% had indeterminate colitis. There was no significant difference in mean age at diagnosis between children with Crohn's disease (11.7 years) and those with ulcerative colitis (10.4 years).

Another U.S. pediatric IBD study was done in Wisconsin (J. Pediatr. 2003;143: 525–31), “but they didn't look at race or ethnicity,” Dr. Malaty said. Using census data for the denominator, she and her associates found a significantly higher incidence of IBD in white children (4.15 per 100,000 per year), compared with African American children (1.83), or Hispanic children (0.61). Although Crohn's disease was more common than ulcerative colitis in all groups, the difference was particularly pronounced in African American children.

“IBD was not diagnosed in children for a long time,” Dr. Malaty said. “It was thought to be an adult, Caucasian, Jewish disease.” Now the disease can be diagnosed histologically, pathologically, and/or with endoscopy in children as young as 1 year, she said. “It is no longer difficult to diagnose.”

Symptoms, such as abdominal pain and rectal bleeding, are not specific enough for diagnosis, Dr. Malaty said. “You have to think twice if symptoms persist.” The general physician should refer a patient with continued symptoms to a pediatric gastroenterologist to obtain biopsies during endoscopy and/or colonoscopy, she said. A limitation in the number of pediatric gastroenterologists, however, is an additional challenge.

ORLANDO — The incidence of inflammatory bowel disease is rising in children and adolescents, a retrospective study of 272 newly diagnosed pediatric patients indicates, and children of all races, ethnicities, genders, and ages can be affected.

Researchers overseas have shown an increasing incidence of inflammatory bowel disease (IBD) in children, for example, in Sweden (Eur. J. Gen. Pract. 2006;12:88–90) and Taiwan (J. Formos. Med. Assoc. 2004;103:685–91).

“I wanted to see if this is also happening in the U.S.,” Dr. Hoda Malaty said in an interview at her poster during the annual meeting of the American College of Gastroenterology. “I have a great interest in IBD in children because there are a lot of gaps in the literature.”

Dr. Malaty and her associates assessed 272 children with a first diagnosis of IBD who were enrolled in a disease registry at Texas Children's Hospital during 1991–2002. The investigators compared patients based on two time periods: 1991–1996 versus 1997–2002. The ratio was 1.2 boys to each girl.

The overall incidence of IBD increased from 1% to 2.5% from the first time period to the second. “It's on the rise. It increased about three times,” said Dr. Malaty, a pediatrician within the department of medicine, section of gastroenterology and hepatology, Texas Children's Hospital and Baylor College of Medicine, Houston. She had no relevant disclosures, and UCB Inc. supported the study.

A total of 56% of patients in the cohort had Crohn's disease, 22% had ulcerative colitis, and 22% had indeterminate colitis. There was no significant difference in mean age at diagnosis between children with Crohn's disease (11.7 years) and those with ulcerative colitis (10.4 years).

Another U.S. pediatric IBD study was done in Wisconsin (J. Pediatr. 2003;143: 525–31), “but they didn't look at race or ethnicity,” Dr. Malaty said. Using census data for the denominator, she and her associates found a significantly higher incidence of IBD in white children (4.15 per 100,000 per year), compared with African American children (1.83), or Hispanic children (0.61). Although Crohn's disease was more common than ulcerative colitis in all groups, the difference was particularly pronounced in African American children.

“IBD was not diagnosed in children for a long time,” Dr. Malaty said. “It was thought to be an adult, Caucasian, Jewish disease.” Now the disease can be diagnosed histologically, pathologically, and/or with endoscopy in children as young as 1 year, she said. “It is no longer difficult to diagnose.”

Symptoms, such as abdominal pain and rectal bleeding, are not specific enough for diagnosis, Dr. Malaty said. “You have to think twice if symptoms persist.” The general physician should refer a patient with continued symptoms to a pediatric gastroenterologist to obtain biopsies during endoscopy and/or colonoscopy, she said. A limitation in the number of pediatric gastroenterologists, however, is an additional challenge.

ORLANDO — The incidence of inflammatory bowel disease is rising in children and adolescents, a retrospective study of 272 newly diagnosed pediatric patients indicates, and children of all races, ethnicities, genders, and ages can be affected.

Researchers overseas have shown an increasing incidence of inflammatory bowel disease (IBD) in children, for example, in Sweden (Eur. J. Gen. Pract. 2006;12:88–90) and Taiwan (J. Formos. Med. Assoc. 2004;103:685–91).

“I wanted to see if this is also happening in the U.S.,” Dr. Hoda Malaty said in an interview at her poster during the annual meeting of the American College of Gastroenterology. “I have a great interest in IBD in children because there are a lot of gaps in the literature.”

Dr. Malaty and her associates assessed 272 children with a first diagnosis of IBD who were enrolled in a disease registry at Texas Children's Hospital during 1991–2002. The investigators compared patients based on two time periods: 1991–1996 versus 1997–2002. The ratio was 1.2 boys to each girl.

The overall incidence of IBD increased from 1% to 2.5% from the first time period to the second. “It's on the rise. It increased about three times,” said Dr. Malaty, a pediatrician within the department of medicine, section of gastroenterology and hepatology, Texas Children's Hospital and Baylor College of Medicine, Houston. She had no relevant disclosures, and UCB Inc. supported the study.

A total of 56% of patients in the cohort had Crohn's disease, 22% had ulcerative colitis, and 22% had indeterminate colitis. There was no significant difference in mean age at diagnosis between children with Crohn's disease (11.7 years) and those with ulcerative colitis (10.4 years).

Another U.S. pediatric IBD study was done in Wisconsin (J. Pediatr. 2003;143: 525–31), “but they didn't look at race or ethnicity,” Dr. Malaty said. Using census data for the denominator, she and her associates found a significantly higher incidence of IBD in white children (4.15 per 100,000 per year), compared with African American children (1.83), or Hispanic children (0.61). Although Crohn's disease was more common than ulcerative colitis in all groups, the difference was particularly pronounced in African American children.

“IBD was not diagnosed in children for a long time,” Dr. Malaty said. “It was thought to be an adult, Caucasian, Jewish disease.” Now the disease can be diagnosed histologically, pathologically, and/or with endoscopy in children as young as 1 year, she said. “It is no longer difficult to diagnose.”

Symptoms, such as abdominal pain and rectal bleeding, are not specific enough for diagnosis, Dr. Malaty said. “You have to think twice if symptoms persist.” The general physician should refer a patient with continued symptoms to a pediatric gastroenterologist to obtain biopsies during endoscopy and/or colonoscopy, she said. A limitation in the number of pediatric gastroenterologists, however, is an additional challenge.

ORLANDO — Children and adolescents with irritable bowel syndrome reported significant improvements in symptoms and quality of life with the use of a proprietary probiotic mixture, compared with placebo, in a randomized, double-blind, crossover trial.

Probiotics have shown some efficacy in adults with irritable bowel syndrome (IBS), said Dr. Stefano Guandalini. However, the probiotic Lactobacillus GG has yielded conflicting results in pediatric IBS studies.

Data from a randomized, double-blind trial showed no superiority over placebo for relief of abdominal pain among children with IBS (J. Pediatr. 2005;147:197–201), whereas data from another study demonstrated that a modest increase in treatment success and reduced frequency of pain with the probiotic compared with placebo (Aliment. Pharmacol. Ther. 2007;25:177–84).

Dr. Guandalini presented results of the first pediatric study of VSL#3—a patented preparation of live, freeze-dried lactic acid bacteria (VSL Pharmaceuticals Inc./Sigma-Tau Consumer Products)—at the annual meeting of the American College of Gastroenterology.

A total of 59 children aged 4 years to 18 years (mean, 12.5 years) completed the trial. Researchers recruited the 35 boys and 24 girls from seven pediatric gastroenterology practices in the United States, Italy, and India.

After a 2-week baseline period, the participants were randomized to probiotic treatment or placebo. The treatment group received one sachet of VSL#3, containing 450 billion lyophilized bacteria, once daily (children up to 11 years of age) or twice daily (children aged 12 years to 18 years). The placebo was identical to the probiotic in terms of appearance and taste.

After 6 weeks of treatment and then a 2-week washout period, patients switched to the other group for an additional 6 weeks of the study.

There were “no untoward side effects in any patients,” suggesting that the probiotic is safe to use, said Dr. Guandalini, professor of pediatrics at the University of Chicago and chief of the pediatric gastroenterology, hepatology, and nutrition section at the university's Comer Children's Hospital.

Patients were assessed at baseline and at 2, 4, and 6 weeks of each phase. Children and adolescents who were treated with VSL#3 reported significant improvements in IBS symptoms, the primary end point. At 6 weeks, they improved from a mean of 4.0 at baseline to 2.4 on the SGARC (Subject's Global Assessment of Relief for Children) index. Although there was a placebo effect (scores improved from 4.0 to 3.3), the change from baseline to 6 weeks was not significant.

The probiotic also was associated with significant improvements, compared with placebo, in three out of four secondary outcomes. For example, abdominal pain/discomfort improved significantly from a baseline score of 2.6 to 1.2 at 6 weeks, compared with a nonsignificant change from 2.1 to 1.6 in the placebo group.

However, abdominal bloating/gassiness improved significantly in both groups. The treatment group scores improved from 2.9 to 1.1 after 6 weeks, whereas placebo group scores improved from 2.2 to 1.5.

In addition, there was no significant difference between groups in occurrence of diarrhea or constipation, “although the slope trended in favor of probiotic treatment,” Dr. Guandalini said. Stool pattern score improved from 2.8 to 1.2 with the probiotic and from 2.2 to 1.3 with placebo at 6 weeks.

“VSL#3 may well have a role in alleviating symptoms and improving quality of life in children with IBS, especially in light of the extreme paucity of currently available means of treatment that can be considered safe and effective in children,” Dr. Guandalini said. “We think probiotic mixture VSL#3 was safe and effective in children with IBS.”

'VSL#3 may well have a role in alleviating symptoms and improving quality of life in children with IBS.' DR. GUANDALINI

ORLANDO — Children and adolescents with irritable bowel syndrome reported significant improvements in symptoms and quality of life with the use of a proprietary probiotic mixture, compared with placebo, in a randomized, double-blind, crossover trial.

Probiotics have shown some efficacy in adults with irritable bowel syndrome (IBS), said Dr. Stefano Guandalini. However, the probiotic Lactobacillus GG has yielded conflicting results in pediatric IBS studies.

Data from a randomized, double-blind trial showed no superiority over placebo for relief of abdominal pain among children with IBS (J. Pediatr. 2005;147:197–201), whereas data from another study demonstrated that a modest increase in treatment success and reduced frequency of pain with the probiotic compared with placebo (Aliment. Pharmacol. Ther. 2007;25:177–84).

Dr. Guandalini presented results of the first pediatric study of VSL#3—a patented preparation of live, freeze-dried lactic acid bacteria (VSL Pharmaceuticals Inc./Sigma-Tau Consumer Products)—at the annual meeting of the American College of Gastroenterology.

A total of 59 children aged 4 years to 18 years (mean, 12.5 years) completed the trial. Researchers recruited the 35 boys and 24 girls from seven pediatric gastroenterology practices in the United States, Italy, and India.

After a 2-week baseline period, the participants were randomized to probiotic treatment or placebo. The treatment group received one sachet of VSL#3, containing 450 billion lyophilized bacteria, once daily (children up to 11 years of age) or twice daily (children aged 12 years to 18 years). The placebo was identical to the probiotic in terms of appearance and taste.

After 6 weeks of treatment and then a 2-week washout period, patients switched to the other group for an additional 6 weeks of the study.

There were “no untoward side effects in any patients,” suggesting that the probiotic is safe to use, said Dr. Guandalini, professor of pediatrics at the University of Chicago and chief of the pediatric gastroenterology, hepatology, and nutrition section at the university's Comer Children's Hospital.

Patients were assessed at baseline and at 2, 4, and 6 weeks of each phase. Children and adolescents who were treated with VSL#3 reported significant improvements in IBS symptoms, the primary end point. At 6 weeks, they improved from a mean of 4.0 at baseline to 2.4 on the SGARC (Subject's Global Assessment of Relief for Children) index. Although there was a placebo effect (scores improved from 4.0 to 3.3), the change from baseline to 6 weeks was not significant.

The probiotic also was associated with significant improvements, compared with placebo, in three out of four secondary outcomes. For example, abdominal pain/discomfort improved significantly from a baseline score of 2.6 to 1.2 at 6 weeks, compared with a nonsignificant change from 2.1 to 1.6 in the placebo group.

However, abdominal bloating/gassiness improved significantly in both groups. The treatment group scores improved from 2.9 to 1.1 after 6 weeks, whereas placebo group scores improved from 2.2 to 1.5.

In addition, there was no significant difference between groups in occurrence of diarrhea or constipation, “although the slope trended in favor of probiotic treatment,” Dr. Guandalini said. Stool pattern score improved from 2.8 to 1.2 with the probiotic and from 2.2 to 1.3 with placebo at 6 weeks.

“VSL#3 may well have a role in alleviating symptoms and improving quality of life in children with IBS, especially in light of the extreme paucity of currently available means of treatment that can be considered safe and effective in children,” Dr. Guandalini said. “We think probiotic mixture VSL#3 was safe and effective in children with IBS.”

'VSL#3 may well have a role in alleviating symptoms and improving quality of life in children with IBS.' DR. GUANDALINI

ORLANDO — Children and adolescents with irritable bowel syndrome reported significant improvements in symptoms and quality of life with the use of a proprietary probiotic mixture, compared with placebo, in a randomized, double-blind, crossover trial.

Probiotics have shown some efficacy in adults with irritable bowel syndrome (IBS), said Dr. Stefano Guandalini. However, the probiotic Lactobacillus GG has yielded conflicting results in pediatric IBS studies.

Data from a randomized, double-blind trial showed no superiority over placebo for relief of abdominal pain among children with IBS (J. Pediatr. 2005;147:197–201), whereas data from another study demonstrated that a modest increase in treatment success and reduced frequency of pain with the probiotic compared with placebo (Aliment. Pharmacol. Ther. 2007;25:177–84).

Dr. Guandalini presented results of the first pediatric study of VSL#3—a patented preparation of live, freeze-dried lactic acid bacteria (VSL Pharmaceuticals Inc./Sigma-Tau Consumer Products)—at the annual meeting of the American College of Gastroenterology.

A total of 59 children aged 4 years to 18 years (mean, 12.5 years) completed the trial. Researchers recruited the 35 boys and 24 girls from seven pediatric gastroenterology practices in the United States, Italy, and India.

After a 2-week baseline period, the participants were randomized to probiotic treatment or placebo. The treatment group received one sachet of VSL#3, containing 450 billion lyophilized bacteria, once daily (children up to 11 years of age) or twice daily (children aged 12 years to 18 years). The placebo was identical to the probiotic in terms of appearance and taste.

After 6 weeks of treatment and then a 2-week washout period, patients switched to the other group for an additional 6 weeks of the study.

There were “no untoward side effects in any patients,” suggesting that the probiotic is safe to use, said Dr. Guandalini, professor of pediatrics at the University of Chicago and chief of the pediatric gastroenterology, hepatology, and nutrition section at the university's Comer Children's Hospital.

Patients were assessed at baseline and at 2, 4, and 6 weeks of each phase. Children and adolescents who were treated with VSL#3 reported significant improvements in IBS symptoms, the primary end point. At 6 weeks, they improved from a mean of 4.0 at baseline to 2.4 on the SGARC (Subject's Global Assessment of Relief for Children) index. Although there was a placebo effect (scores improved from 4.0 to 3.3), the change from baseline to 6 weeks was not significant.

The probiotic also was associated with significant improvements, compared with placebo, in three out of four secondary outcomes. For example, abdominal pain/discomfort improved significantly from a baseline score of 2.6 to 1.2 at 6 weeks, compared with a nonsignificant change from 2.1 to 1.6 in the placebo group.

However, abdominal bloating/gassiness improved significantly in both groups. The treatment group scores improved from 2.9 to 1.1 after 6 weeks, whereas placebo group scores improved from 2.2 to 1.5.

In addition, there was no significant difference between groups in occurrence of diarrhea or constipation, “although the slope trended in favor of probiotic treatment,” Dr. Guandalini said. Stool pattern score improved from 2.8 to 1.2 with the probiotic and from 2.2 to 1.3 with placebo at 6 weeks.

“VSL#3 may well have a role in alleviating symptoms and improving quality of life in children with IBS, especially in light of the extreme paucity of currently available means of treatment that can be considered safe and effective in children,” Dr. Guandalini said. “We think probiotic mixture VSL#3 was safe and effective in children with IBS.”

'VSL#3 may well have a role in alleviating symptoms and improving quality of life in children with IBS.' DR. GUANDALINI

ORLANDO — When counseling postmenopausal women about hormone therapy, frame the discussion in terms of absolute rather than relative risks, a principal investigator of the Women's Health Initiative said.

“Hormone therapy still has a clinical role in treatment of moderate to severe hot flashes and other menopausal symptoms,” Dr. JoAnn E. Manson said. “Recently menopausal women tend to be the best candidates due to low absolute risks and a greater frequency of symptoms. Very often the results of the WHI are discussed in terms of relative risk,” she said. For example, the widely publicized findings were that women taking estrogen plus progestin therapy had a 29% increase in coronary heart disease risk, 41% for stroke, 113% for pulmonary embolism, and 26% for breast cancer (JAMA 2002;288:321–33).

From the perspective of absolute risk, stroke occurs in about 1 in 1,000 women aged 50–59 years in the general population. “For a woman struggling with severe vasomotor symptoms and sleep trouble … telling her the risk will increase from 1 in 1,000 to 1.4 in 1,000 sounds better than telling her the stroke risk will increase 40%,” Dr. Manson said at the annual meeting of the North American Menopause Society.

That is not to say that the risk should be dismissed, she qualified. “It is still an important risk and should not be discounted.”

WHI researchers also found that adverse effects increased with age. “The number of excess cases of stroke or pulmonary embolism that would be caused by hormone therapy would be much less in younger women,” said Dr. Manson, chair of the division of preventive medicine, Brigham and Women's Hospital, and professor of medicine and women's health at Harvard Medical School, both in Boston.

In 2006, in an estrogen-only trial, “we did see a difference between younger and older women for outcomes of coronary heart disease death or MI,” Dr. Manson said (Arch. Intern. Med. 2006;166:357–65). Compared with women not taking estrogen, the relative risk of cardiac death or MI was 0.63 among women aged 50–59 years, 0.94 for women aged 60–69, and 1.11 in women aged 70–79.

In a more recent study, they found the hazard ratio for coronary heart disease among women on hormone therapy was 0.93 for the younger age group, 0.98 for women aged 60–69, and 1.26 for women aged 70–79 (JAMA 2007;297:1465–77). The differences were not significant.

However, Dr. Manson and her associates also found a statistically significant 30% reduction in total mortality in 50- to 59-year-olds. Specifically, younger women taking hormone therapy had a 0.70 hazard ratio for mortality, compared with 1.05 for women aged 60–69 years and 1.14 for women aged 70–79.

Hormone therapy may have a neutral or beneficial effect on the heart if started during early menopause, when the arteries and endothelium are likely to be relatively healthy, Dr. Manson suggested. In contrast, therapy may be associated with a deleterious effect if started in late menopause, when advanced atherosclerosis and unstable plaques may be present.

The implication is not that recently menopausal patients should take hormone therapy to prevent coronary artery disease, Dr. Manson said. Rather, the results could reassure younger women about cardiac risks when they are pondering short-term therapy to ameliorate vasomotor symptoms.

The cardiovascular risks associated with estrogen and progestin may diminish after therapy is stopped, according to another secondary analysis (JAMA 2008;299:1036–45).

Saying 'the risk will increase from 1 in 1,000 to 1.4 in 1,000 sounds better than [saying it] will increase 40%.' DR. MANSON

ORLANDO — When counseling postmenopausal women about hormone therapy, frame the discussion in terms of absolute rather than relative risks, a principal investigator of the Women's Health Initiative said.

“Hormone therapy still has a clinical role in treatment of moderate to severe hot flashes and other menopausal symptoms,” Dr. JoAnn E. Manson said. “Recently menopausal women tend to be the best candidates due to low absolute risks and a greater frequency of symptoms. Very often the results of the WHI are discussed in terms of relative risk,” she said. For example, the widely publicized findings were that women taking estrogen plus progestin therapy had a 29% increase in coronary heart disease risk, 41% for stroke, 113% for pulmonary embolism, and 26% for breast cancer (JAMA 2002;288:321–33).

From the perspective of absolute risk, stroke occurs in about 1 in 1,000 women aged 50–59 years in the general population. “For a woman struggling with severe vasomotor symptoms and sleep trouble … telling her the risk will increase from 1 in 1,000 to 1.4 in 1,000 sounds better than telling her the stroke risk will increase 40%,” Dr. Manson said at the annual meeting of the North American Menopause Society.

That is not to say that the risk should be dismissed, she qualified. “It is still an important risk and should not be discounted.”

WHI researchers also found that adverse effects increased with age. “The number of excess cases of stroke or pulmonary embolism that would be caused by hormone therapy would be much less in younger women,” said Dr. Manson, chair of the division of preventive medicine, Brigham and Women's Hospital, and professor of medicine and women's health at Harvard Medical School, both in Boston.

In 2006, in an estrogen-only trial, “we did see a difference between younger and older women for outcomes of coronary heart disease death or MI,” Dr. Manson said (Arch. Intern. Med. 2006;166:357–65). Compared with women not taking estrogen, the relative risk of cardiac death or MI was 0.63 among women aged 50–59 years, 0.94 for women aged 60–69, and 1.11 in women aged 70–79.

In a more recent study, they found the hazard ratio for coronary heart disease among women on hormone therapy was 0.93 for the younger age group, 0.98 for women aged 60–69, and 1.26 for women aged 70–79 (JAMA 2007;297:1465–77). The differences were not significant.

However, Dr. Manson and her associates also found a statistically significant 30% reduction in total mortality in 50- to 59-year-olds. Specifically, younger women taking hormone therapy had a 0.70 hazard ratio for mortality, compared with 1.05 for women aged 60–69 years and 1.14 for women aged 70–79.

Hormone therapy may have a neutral or beneficial effect on the heart if started during early menopause, when the arteries and endothelium are likely to be relatively healthy, Dr. Manson suggested. In contrast, therapy may be associated with a deleterious effect if started in late menopause, when advanced atherosclerosis and unstable plaques may be present.

The implication is not that recently menopausal patients should take hormone therapy to prevent coronary artery disease, Dr. Manson said. Rather, the results could reassure younger women about cardiac risks when they are pondering short-term therapy to ameliorate vasomotor symptoms.

The cardiovascular risks associated with estrogen and progestin may diminish after therapy is stopped, according to another secondary analysis (JAMA 2008;299:1036–45).

Saying 'the risk will increase from 1 in 1,000 to 1.4 in 1,000 sounds better than [saying it] will increase 40%.' DR. MANSON

ORLANDO — When counseling postmenopausal women about hormone therapy, frame the discussion in terms of absolute rather than relative risks, a principal investigator of the Women's Health Initiative said.

“Hormone therapy still has a clinical role in treatment of moderate to severe hot flashes and other menopausal symptoms,” Dr. JoAnn E. Manson said. “Recently menopausal women tend to be the best candidates due to low absolute risks and a greater frequency of symptoms. Very often the results of the WHI are discussed in terms of relative risk,” she said. For example, the widely publicized findings were that women taking estrogen plus progestin therapy had a 29% increase in coronary heart disease risk, 41% for stroke, 113% for pulmonary embolism, and 26% for breast cancer (JAMA 2002;288:321–33).

From the perspective of absolute risk, stroke occurs in about 1 in 1,000 women aged 50–59 years in the general population. “For a woman struggling with severe vasomotor symptoms and sleep trouble … telling her the risk will increase from 1 in 1,000 to 1.4 in 1,000 sounds better than telling her the stroke risk will increase 40%,” Dr. Manson said at the annual meeting of the North American Menopause Society.

That is not to say that the risk should be dismissed, she qualified. “It is still an important risk and should not be discounted.”

WHI researchers also found that adverse effects increased with age. “The number of excess cases of stroke or pulmonary embolism that would be caused by hormone therapy would be much less in younger women,” said Dr. Manson, chair of the division of preventive medicine, Brigham and Women's Hospital, and professor of medicine and women's health at Harvard Medical School, both in Boston.

In 2006, in an estrogen-only trial, “we did see a difference between younger and older women for outcomes of coronary heart disease death or MI,” Dr. Manson said (Arch. Intern. Med. 2006;166:357–65). Compared with women not taking estrogen, the relative risk of cardiac death or MI was 0.63 among women aged 50–59 years, 0.94 for women aged 60–69, and 1.11 in women aged 70–79.

In a more recent study, they found the hazard ratio for coronary heart disease among women on hormone therapy was 0.93 for the younger age group, 0.98 for women aged 60–69, and 1.26 for women aged 70–79 (JAMA 2007;297:1465–77). The differences were not significant.

However, Dr. Manson and her associates also found a statistically significant 30% reduction in total mortality in 50- to 59-year-olds. Specifically, younger women taking hormone therapy had a 0.70 hazard ratio for mortality, compared with 1.05 for women aged 60–69 years and 1.14 for women aged 70–79.

Hormone therapy may have a neutral or beneficial effect on the heart if started during early menopause, when the arteries and endothelium are likely to be relatively healthy, Dr. Manson suggested. In contrast, therapy may be associated with a deleterious effect if started in late menopause, when advanced atherosclerosis and unstable plaques may be present.

The implication is not that recently menopausal patients should take hormone therapy to prevent coronary artery disease, Dr. Manson said. Rather, the results could reassure younger women about cardiac risks when they are pondering short-term therapy to ameliorate vasomotor symptoms.

The cardiovascular risks associated with estrogen and progestin may diminish after therapy is stopped, according to another secondary analysis (JAMA 2008;299:1036–45).

Saying 'the risk will increase from 1 in 1,000 to 1.4 in 1,000 sounds better than [saying it] will increase 40%.' DR. MANSON

LAKE BUENA VISTA, FLA. — Soy supplements improved somatic and urogenital symptoms of menopause to the same degree as did low-dose combination hormone therapy, in a small, randomized, double-blind controlled trial.

A total of 60 women who were 1–13 years past menopause were randomized to one of three groups: soy supplements containing isoflavones 90 mg; estradiol 1 mg/norethindrone 0.5 mg; or placebo daily.

After 16 weeks, women in the two treatment groups had significant somatic and urogenital symptom improvements, compared with baseline on the Menopause Rating Scale and compared with scores among women taking placebo.

The findings suggest a role for dietary soy supplementation for improving hot flashes, joint and muscle pain, and vaginal dryness, with results equivalent to hormone therapy, Dr. Adriana O. Pedro said. “I thought hormone replacement would be better than soy, so I was surprised.”

Women taking hormone therapy fared better, however, in terms of cardiovascular health markers. Women on the low-dose combination hormone therapy showed improvement in total cholesterol and low-density lipoprotein levels; these levels were unchanged in those who got soy supplements.

In addition, total cholesterol decreased 12%, compared with baseline, in the hormone treatment group but remained unchanged in the soy supplement and placebo groups. The LDL cholesterol level decreased 18% in the hormone therapy group and did not change in the other groups.

“There was no change with soy—probably because they had normal lipid profiles at baseline,” Dr. Pedro of the State University of Campinas (Brazil) said during a poster session at the annual meeting of the North American Menopause Society.

Psychological symptoms did not change over the treatment period in the soy, hormone replacement, or placebo groups.

The study was funded by the São Paulo (Brazil) Foundation for the Support of Research. Data analysis is ongoing, and they plan to publish additional findings.

LAKE BUENA VISTA, FLA. — Soy supplements improved somatic and urogenital symptoms of menopause to the same degree as did low-dose combination hormone therapy, in a small, randomized, double-blind controlled trial.

A total of 60 women who were 1–13 years past menopause were randomized to one of three groups: soy supplements containing isoflavones 90 mg; estradiol 1 mg/norethindrone 0.5 mg; or placebo daily.

After 16 weeks, women in the two treatment groups had significant somatic and urogenital symptom improvements, compared with baseline on the Menopause Rating Scale and compared with scores among women taking placebo.

The findings suggest a role for dietary soy supplementation for improving hot flashes, joint and muscle pain, and vaginal dryness, with results equivalent to hormone therapy, Dr. Adriana O. Pedro said. “I thought hormone replacement would be better than soy, so I was surprised.”

Women taking hormone therapy fared better, however, in terms of cardiovascular health markers. Women on the low-dose combination hormone therapy showed improvement in total cholesterol and low-density lipoprotein levels; these levels were unchanged in those who got soy supplements.

In addition, total cholesterol decreased 12%, compared with baseline, in the hormone treatment group but remained unchanged in the soy supplement and placebo groups. The LDL cholesterol level decreased 18% in the hormone therapy group and did not change in the other groups.

“There was no change with soy—probably because they had normal lipid profiles at baseline,” Dr. Pedro of the State University of Campinas (Brazil) said during a poster session at the annual meeting of the North American Menopause Society.

Psychological symptoms did not change over the treatment period in the soy, hormone replacement, or placebo groups.

The study was funded by the São Paulo (Brazil) Foundation for the Support of Research. Data analysis is ongoing, and they plan to publish additional findings.

LAKE BUENA VISTA, FLA. — Soy supplements improved somatic and urogenital symptoms of menopause to the same degree as did low-dose combination hormone therapy, in a small, randomized, double-blind controlled trial.

A total of 60 women who were 1–13 years past menopause were randomized to one of three groups: soy supplements containing isoflavones 90 mg; estradiol 1 mg/norethindrone 0.5 mg; or placebo daily.

After 16 weeks, women in the two treatment groups had significant somatic and urogenital symptom improvements, compared with baseline on the Menopause Rating Scale and compared with scores among women taking placebo.

The findings suggest a role for dietary soy supplementation for improving hot flashes, joint and muscle pain, and vaginal dryness, with results equivalent to hormone therapy, Dr. Adriana O. Pedro said. “I thought hormone replacement would be better than soy, so I was surprised.”

Women taking hormone therapy fared better, however, in terms of cardiovascular health markers. Women on the low-dose combination hormone therapy showed improvement in total cholesterol and low-density lipoprotein levels; these levels were unchanged in those who got soy supplements.

In addition, total cholesterol decreased 12%, compared with baseline, in the hormone treatment group but remained unchanged in the soy supplement and placebo groups. The LDL cholesterol level decreased 18% in the hormone therapy group and did not change in the other groups.

“There was no change with soy—probably because they had normal lipid profiles at baseline,” Dr. Pedro of the State University of Campinas (Brazil) said during a poster session at the annual meeting of the North American Menopause Society.

Psychological symptoms did not change over the treatment period in the soy, hormone replacement, or placebo groups.

The study was funded by the São Paulo (Brazil) Foundation for the Support of Research. Data analysis is ongoing, and they plan to publish additional findings.

ORLANDO — The Framingham stroke risk score can predict a high-risk postmenopausal woman's likelihood of a future cerebrovascular event with raloxifene use, according to new analysis of data from the Raloxifene Use for the Heart (RUTH)study.

Investigators in 26 countries enrolled 10,101 women at risk for a major coronary event in RUTH. A total of 5,031 women had documented coronary heart disease and the remaining 5,070 had multiple coronary heart disease risk factors (Am. J. Cardiol. 2002;90:1204–10). Although overall stroke risk was not significantly different between women randomized to raloxifene versus placebo, a higher number of fatal stroke events occurred in the treatment group, 59, compared with 39 in the placebo group during a mean of 5.6 years follow-up (N. Engl. J. Med. 2006:355:125–37).

Investigators launched a second study to see how this increased risk associated with raloxifene (hazard ratio, 1.49; absolute risk increase, 0.7 per 1,000 woman-years) would apply to women stratified by baseline Framingham stroke scale score.

David Cox, Ph.D., and his associates retrospectively calculated 10-year cumulative risk. He presented findings at the annual meeting of the North American Menopause Society. Eli Lilly & Co. supported the study, and Dr. Cox is a clinical research scientist for the company.

Not surprisingly, risks appeared to congregate in the third and fourth highest quartiles of Framingham score risk. However, there were no significant differences between treatment groups in either all strokes or nonfatal strokes, regardless of baseline Framingham score.

Regarding fatal stroke, Dr. Cox said, “after 2 years, you start to see a split between placebo and raloxifene for risk of fatal stroke by Framingham stroke risk score in RUTH. We think the pattern and data would suggest most of the excess risk was among those in the upper half of risk.” Specifically, women who scored a 13 or greater on the Framingham tool at baseline (the median) were at increased risk of stroke death, compared with women who scored lower.

A meeting attendee asked at what age raloxifene should no longer be considered, offering 70 years as an example. “Even at age 70, she might not have enough risk factors,” Dr. Cox said. “But it depends on the risk factor.” For example, he said, “atrial fibrillation would put her over the 13 score.”

Dr. Cox and his colleagues also retrospectively assessed application of the Framingham risk score to 7,705 postmenopausal women with osteoporosis randomized to raloxifene or placebo in the Multiple Outcomes of Raloxifene Evaluation (MORE) study (JAMA 2002;287:847–57). In this study, raloxifene was not associated with an increase in rate of all strokes (hazard ratio, 0.71) or stroke death (HR, 0.57). He noted that the MORE population was generally lower risk than women in RUTH, with baseline Framingham scores of less than 13 in 80%.

Raloxifene's effect on the stroke death rate might differ by baseline stroke risk, Dr. Cox said. Assessing cumulative stroke risk may help target raloxifene treatment to postmenopausal women with the most favorable risk-benefit profile.

ORLANDO — The Framingham stroke risk score can predict a high-risk postmenopausal woman's likelihood of a future cerebrovascular event with raloxifene use, according to new analysis of data from the Raloxifene Use for the Heart (RUTH)study.

Investigators in 26 countries enrolled 10,101 women at risk for a major coronary event in RUTH. A total of 5,031 women had documented coronary heart disease and the remaining 5,070 had multiple coronary heart disease risk factors (Am. J. Cardiol. 2002;90:1204–10). Although overall stroke risk was not significantly different between women randomized to raloxifene versus placebo, a higher number of fatal stroke events occurred in the treatment group, 59, compared with 39 in the placebo group during a mean of 5.6 years follow-up (N. Engl. J. Med. 2006:355:125–37).

Investigators launched a second study to see how this increased risk associated with raloxifene (hazard ratio, 1.49; absolute risk increase, 0.7 per 1,000 woman-years) would apply to women stratified by baseline Framingham stroke scale score.

David Cox, Ph.D., and his associates retrospectively calculated 10-year cumulative risk. He presented findings at the annual meeting of the North American Menopause Society. Eli Lilly & Co. supported the study, and Dr. Cox is a clinical research scientist for the company.

Not surprisingly, risks appeared to congregate in the third and fourth highest quartiles of Framingham score risk. However, there were no significant differences between treatment groups in either all strokes or nonfatal strokes, regardless of baseline Framingham score.

Regarding fatal stroke, Dr. Cox said, “after 2 years, you start to see a split between placebo and raloxifene for risk of fatal stroke by Framingham stroke risk score in RUTH. We think the pattern and data would suggest most of the excess risk was among those in the upper half of risk.” Specifically, women who scored a 13 or greater on the Framingham tool at baseline (the median) were at increased risk of stroke death, compared with women who scored lower.

A meeting attendee asked at what age raloxifene should no longer be considered, offering 70 years as an example. “Even at age 70, she might not have enough risk factors,” Dr. Cox said. “But it depends on the risk factor.” For example, he said, “atrial fibrillation would put her over the 13 score.”

Dr. Cox and his colleagues also retrospectively assessed application of the Framingham risk score to 7,705 postmenopausal women with osteoporosis randomized to raloxifene or placebo in the Multiple Outcomes of Raloxifene Evaluation (MORE) study (JAMA 2002;287:847–57). In this study, raloxifene was not associated with an increase in rate of all strokes (hazard ratio, 0.71) or stroke death (HR, 0.57). He noted that the MORE population was generally lower risk than women in RUTH, with baseline Framingham scores of less than 13 in 80%.

Raloxifene's effect on the stroke death rate might differ by baseline stroke risk, Dr. Cox said. Assessing cumulative stroke risk may help target raloxifene treatment to postmenopausal women with the most favorable risk-benefit profile.

ORLANDO — The Framingham stroke risk score can predict a high-risk postmenopausal woman's likelihood of a future cerebrovascular event with raloxifene use, according to new analysis of data from the Raloxifene Use for the Heart (RUTH)study.

Investigators in 26 countries enrolled 10,101 women at risk for a major coronary event in RUTH. A total of 5,031 women had documented coronary heart disease and the remaining 5,070 had multiple coronary heart disease risk factors (Am. J. Cardiol. 2002;90:1204–10). Although overall stroke risk was not significantly different between women randomized to raloxifene versus placebo, a higher number of fatal stroke events occurred in the treatment group, 59, compared with 39 in the placebo group during a mean of 5.6 years follow-up (N. Engl. J. Med. 2006:355:125–37).

Investigators launched a second study to see how this increased risk associated with raloxifene (hazard ratio, 1.49; absolute risk increase, 0.7 per 1,000 woman-years) would apply to women stratified by baseline Framingham stroke scale score.

David Cox, Ph.D., and his associates retrospectively calculated 10-year cumulative risk. He presented findings at the annual meeting of the North American Menopause Society. Eli Lilly & Co. supported the study, and Dr. Cox is a clinical research scientist for the company.

Not surprisingly, risks appeared to congregate in the third and fourth highest quartiles of Framingham score risk. However, there were no significant differences between treatment groups in either all strokes or nonfatal strokes, regardless of baseline Framingham score.

Regarding fatal stroke, Dr. Cox said, “after 2 years, you start to see a split between placebo and raloxifene for risk of fatal stroke by Framingham stroke risk score in RUTH. We think the pattern and data would suggest most of the excess risk was among those in the upper half of risk.” Specifically, women who scored a 13 or greater on the Framingham tool at baseline (the median) were at increased risk of stroke death, compared with women who scored lower.

A meeting attendee asked at what age raloxifene should no longer be considered, offering 70 years as an example. “Even at age 70, she might not have enough risk factors,” Dr. Cox said. “But it depends on the risk factor.” For example, he said, “atrial fibrillation would put her over the 13 score.”

Dr. Cox and his colleagues also retrospectively assessed application of the Framingham risk score to 7,705 postmenopausal women with osteoporosis randomized to raloxifene or placebo in the Multiple Outcomes of Raloxifene Evaluation (MORE) study (JAMA 2002;287:847–57). In this study, raloxifene was not associated with an increase in rate of all strokes (hazard ratio, 0.71) or stroke death (HR, 0.57). He noted that the MORE population was generally lower risk than women in RUTH, with baseline Framingham scores of less than 13 in 80%.

Raloxifene's effect on the stroke death rate might differ by baseline stroke risk, Dr. Cox said. Assessing cumulative stroke risk may help target raloxifene treatment to postmenopausal women with the most favorable risk-benefit profile.

The full report costs about $50 and is available at www.nap.edu

Changes in the maximum shift length for residents, increases in mandatory time off, and inclusion of all moonlighting in total work hours are among the recommendations made in a report issued by the Institute of Medicine last month.

The institute did not recommend changing the average weekly maximum of 80 hours, and it favored retention of the policy allowing a maximum of 88 hours for programs demonstrating a sound educational rationale, while continuing to restrict emergency department residents to a 60-hour work week that includes maximum 12-hour shifts followed by at least 12 hours off.

In the 323-page report, “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety,” the IOM committee estimated that it would cost about $1.7 billion to hire support staff, other clinicians, or additional residents to cover the cost of current residents' excess time. Nearly one-quarter of the total amount would go toward bringing residency programs into compliance with the 2003 limits.

Since July 2003, when the Accreditation Council for Graduate Medical Education (ACGME) first implemented the work hour restrictions, residents have been allowed to work 30-hour shifts consisting of up to 24 hours for admitting patients and 6 hours for transitional and educational activities. In contrast, the Institute of Medicine (IOM) recommends that the 30 hours include 16 hours for admitting patients, followed by a 5-hour protected period for sleep between 10:00 p.m. and 8:00 a.m. The remaining time may be used for transitional and educational activities. A simpler, second option is a 16-hour shift with no protected sleep time.

One problem was the 24 plus 6—a lot of sleep literature shows that after 16 hours your performance falls off. So 16 hours is the line in the sand for these researchers,” Dr. Tim C. Flynn, vice chair of the ACGME. Dr. Flynn, professor and associate dean of vascular surgery at the University of Florida in Gainesville, emphasized that his comments were his own and did not reflect the position of the ACGME.

The IOM also cited the compliance issue. “A lack of adherence to current limits on duty hours is common and underreported,” the committee authors wrote in an IOM Report Brief.

“Therefore, the committee recommends changes to ACGME monitoring practices, including unannounced visits and strengthened whistleblower processes to encourage resident reporting of violations of limits and undue pressure to work too long.” The council plans to meet in March 2009 to review the evidence, Dr. Flynn added.

Other recommendations include confining in-house call to every third night without averaging (the ACGME limits permit averaging); limiting the frequency of in-hospital night shifts to four nights, with 48 hours off after three or four consecutive nights of duty; and specifying mandatory time off as 5 days per month, 1 day per week, and at least one 48-hour period per month.

“ACGME had a great battle over moonlighting in the original 2003 rules,” Dr. Flynn said. “This calls for all time off—all moonlighting now counts.'

The full report costs about $50 and is available at www.nap.edu

Changes in the maximum shift length for residents, increases in mandatory time off, and inclusion of all moonlighting in total work hours are among the recommendations made in a report issued by the Institute of Medicine last month.

The institute did not recommend changing the average weekly maximum of 80 hours, and it favored retention of the policy allowing a maximum of 88 hours for programs demonstrating a sound educational rationale, while continuing to restrict emergency department residents to a 60-hour work week that includes maximum 12-hour shifts followed by at least 12 hours off.

In the 323-page report, “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety,” the IOM committee estimated that it would cost about $1.7 billion to hire support staff, other clinicians, or additional residents to cover the cost of current residents' excess time. Nearly one-quarter of the total amount would go toward bringing residency programs into compliance with the 2003 limits.

Since July 2003, when the Accreditation Council for Graduate Medical Education (ACGME) first implemented the work hour restrictions, residents have been allowed to work 30-hour shifts consisting of up to 24 hours for admitting patients and 6 hours for transitional and educational activities. In contrast, the Institute of Medicine (IOM) recommends that the 30 hours include 16 hours for admitting patients, followed by a 5-hour protected period for sleep between 10:00 p.m. and 8:00 a.m. The remaining time may be used for transitional and educational activities. A simpler, second option is a 16-hour shift with no protected sleep time.

One problem was the 24 plus 6—a lot of sleep literature shows that after 16 hours your performance falls off. So 16 hours is the line in the sand for these researchers,” Dr. Tim C. Flynn, vice chair of the ACGME. Dr. Flynn, professor and associate dean of vascular surgery at the University of Florida in Gainesville, emphasized that his comments were his own and did not reflect the position of the ACGME.

The IOM also cited the compliance issue. “A lack of adherence to current limits on duty hours is common and underreported,” the committee authors wrote in an IOM Report Brief.

“Therefore, the committee recommends changes to ACGME monitoring practices, including unannounced visits and strengthened whistleblower processes to encourage resident reporting of violations of limits and undue pressure to work too long.” The council plans to meet in March 2009 to review the evidence, Dr. Flynn added.

Other recommendations include confining in-house call to every third night without averaging (the ACGME limits permit averaging); limiting the frequency of in-hospital night shifts to four nights, with 48 hours off after three or four consecutive nights of duty; and specifying mandatory time off as 5 days per month, 1 day per week, and at least one 48-hour period per month.

“ACGME had a great battle over moonlighting in the original 2003 rules,” Dr. Flynn said. “This calls for all time off—all moonlighting now counts.'

The full report costs about $50 and is available at www.nap.edu

Changes in the maximum shift length for residents, increases in mandatory time off, and inclusion of all moonlighting in total work hours are among the recommendations made in a report issued by the Institute of Medicine last month.

The institute did not recommend changing the average weekly maximum of 80 hours, and it favored retention of the policy allowing a maximum of 88 hours for programs demonstrating a sound educational rationale, while continuing to restrict emergency department residents to a 60-hour work week that includes maximum 12-hour shifts followed by at least 12 hours off.

In the 323-page report, “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety,” the IOM committee estimated that it would cost about $1.7 billion to hire support staff, other clinicians, or additional residents to cover the cost of current residents' excess time. Nearly one-quarter of the total amount would go toward bringing residency programs into compliance with the 2003 limits.

Since July 2003, when the Accreditation Council for Graduate Medical Education (ACGME) first implemented the work hour restrictions, residents have been allowed to work 30-hour shifts consisting of up to 24 hours for admitting patients and 6 hours for transitional and educational activities. In contrast, the Institute of Medicine (IOM) recommends that the 30 hours include 16 hours for admitting patients, followed by a 5-hour protected period for sleep between 10:00 p.m. and 8:00 a.m. The remaining time may be used for transitional and educational activities. A simpler, second option is a 16-hour shift with no protected sleep time.

One problem was the 24 plus 6—a lot of sleep literature shows that after 16 hours your performance falls off. So 16 hours is the line in the sand for these researchers,” Dr. Tim C. Flynn, vice chair of the ACGME. Dr. Flynn, professor and associate dean of vascular surgery at the University of Florida in Gainesville, emphasized that his comments were his own and did not reflect the position of the ACGME.

The IOM also cited the compliance issue. “A lack of adherence to current limits on duty hours is common and underreported,” the committee authors wrote in an IOM Report Brief.

“Therefore, the committee recommends changes to ACGME monitoring practices, including unannounced visits and strengthened whistleblower processes to encourage resident reporting of violations of limits and undue pressure to work too long.” The council plans to meet in March 2009 to review the evidence, Dr. Flynn added.

Other recommendations include confining in-house call to every third night without averaging (the ACGME limits permit averaging); limiting the frequency of in-hospital night shifts to four nights, with 48 hours off after three or four consecutive nights of duty; and specifying mandatory time off as 5 days per month, 1 day per week, and at least one 48-hour period per month.

“ACGME had a great battle over moonlighting in the original 2003 rules,” Dr. Flynn said. “This calls for all time off—all moonlighting now counts.'

PALM BEACH, FLA. — Pharmacologic prophylaxis against venous thromboembolism is not mandatory for average-risk patients undergoing laparoscopic Roux-en-Y gastric bypass, according to data on more than 900 procedures.

“Pneumatic compression devices, early ambulation, and a relatively short operative time are effective prophylaxes against VTE,” Dr. Ronald H. Clements said.

As a follow-up to their earlier report of one deep vein thrombosis (DVT) among 380 patients (Surg. Endosc. 2004;18:1082–4), Dr. Clements and his associates continued to collect data on 957 consecutive laparoscopic Roux-en-Y gastric bypasses performed at the University of Alabama at Birmingham since 2000. Dr. Clements, a laparoscopic surgeon, presented the findings at the annual meeting of the Southern Surgical Association.

The study cohort was 83% women and 80% white. Mean age was 41 years, mean body mass index was 49 kg/m

The researchers followed all but one patient for 30 days. Among the 956 patients, there were three DVTs, one nonfatal pulmonary thromboembolism, and seven instances of major bleeding. Two patients with bleeding required reoperation, four had transfusions, and one required no intervention. One patient died of causes unrelated to DVT.

Venous thromboembolism (VTE) is a leading cause of postoperative mortality following bariatric surgery, but is “very rare: 3–7 [in] every 1,000 patients,” said study discussant Dr. Hiram C. Polk Jr., citing an unpublished study of 966,000 patients within his hospital consortium database. Elastic stockings were the most common intervention in his study. “The dangers of prophylaxis outweigh the risks of what you are trying to prevent,” said Dr. Polk, professor of surgery at the University of Louisville (Ky.).

The study “is important for the bariatric surgeon who chooses to use compression and early ambulation alone. You don't have to always use heparin,” said Dr. Bruce D. Schirmer, a general surgeon at the University of Virginia, Charlottesville, who was another study discussant. Chemoprophylaxis is still warranted for high-risk patients, he added.

But Dr. Spence M. Taylor, chair of surgery at the University of South Carolina, Greenville, took a different view. “I'm aware of at least six consensus statements for prophylaxis for DVT, and without fail, they all say chemoprophylaxis is the treatment of choice.”

Dr. Clements replied: “I don't think these obese patients fall into all those guidelines. I don't think most of you would use prophylaxis for the morbidly obese [patient undergoing] removal of a gallbladder, so I don't think you should do it for bypass, either.”

The consensus statements overlook or include only level II evidence for gastric bypass, he said, reiterating that his findings do not apply to the highest-risk patients. “I'm talking about the average person who comes to me for gastric bypass who is not at high risk” for VTE.

Citing the low incidence (0.1%–0.8%) of pulmonary embolism in this study, Dr. Taylor said, “It's conceivable you don't have enough patients yet.” Dr. Clements responded, “It's a low incidence, and that is the point of the paper. We are not saying compression devices are superior, simply that they are equivalent.”

Good follow-up and applicability of the findings to most patients undergoing gastric bypass are strengths of the study, Dr. Clements said. Limitations include the retrospective design and detection of VTE as clinically evident disease only.

“The biggest problem with your manuscript is physical examination for DVT,” Dr. Taylor said. “Don't some patients get swollen legs after surgery [even without VTE]? Don't some get shortness of breath?” Still, “from an objective standpoint, 106 minutes for bariatric procedures is an accomplishment.”

PALM BEACH, FLA. — Pharmacologic prophylaxis against venous thromboembolism is not mandatory for average-risk patients undergoing laparoscopic Roux-en-Y gastric bypass, according to data on more than 900 procedures.

“Pneumatic compression devices, early ambulation, and a relatively short operative time are effective prophylaxes against VTE,” Dr. Ronald H. Clements said.

As a follow-up to their earlier report of one deep vein thrombosis (DVT) among 380 patients (Surg. Endosc. 2004;18:1082–4), Dr. Clements and his associates continued to collect data on 957 consecutive laparoscopic Roux-en-Y gastric bypasses performed at the University of Alabama at Birmingham since 2000. Dr. Clements, a laparoscopic surgeon, presented the findings at the annual meeting of the Southern Surgical Association.

The study cohort was 83% women and 80% white. Mean age was 41 years, mean body mass index was 49 kg/m

The researchers followed all but one patient for 30 days. Among the 956 patients, there were three DVTs, one nonfatal pulmonary thromboembolism, and seven instances of major bleeding. Two patients with bleeding required reoperation, four had transfusions, and one required no intervention. One patient died of causes unrelated to DVT.

Venous thromboembolism (VTE) is a leading cause of postoperative mortality following bariatric surgery, but is “very rare: 3–7 [in] every 1,000 patients,” said study discussant Dr. Hiram C. Polk Jr., citing an unpublished study of 966,000 patients within his hospital consortium database. Elastic stockings were the most common intervention in his study. “The dangers of prophylaxis outweigh the risks of what you are trying to prevent,” said Dr. Polk, professor of surgery at the University of Louisville (Ky.).

The study “is important for the bariatric surgeon who chooses to use compression and early ambulation alone. You don't have to always use heparin,” said Dr. Bruce D. Schirmer, a general surgeon at the University of Virginia, Charlottesville, who was another study discussant. Chemoprophylaxis is still warranted for high-risk patients, he added.

But Dr. Spence M. Taylor, chair of surgery at the University of South Carolina, Greenville, took a different view. “I'm aware of at least six consensus statements for prophylaxis for DVT, and without fail, they all say chemoprophylaxis is the treatment of choice.”

Dr. Clements replied: “I don't think these obese patients fall into all those guidelines. I don't think most of you would use prophylaxis for the morbidly obese [patient undergoing] removal of a gallbladder, so I don't think you should do it for bypass, either.”

The consensus statements overlook or include only level II evidence for gastric bypass, he said, reiterating that his findings do not apply to the highest-risk patients. “I'm talking about the average person who comes to me for gastric bypass who is not at high risk” for VTE.

Citing the low incidence (0.1%–0.8%) of pulmonary embolism in this study, Dr. Taylor said, “It's conceivable you don't have enough patients yet.” Dr. Clements responded, “It's a low incidence, and that is the point of the paper. We are not saying compression devices are superior, simply that they are equivalent.”

Good follow-up and applicability of the findings to most patients undergoing gastric bypass are strengths of the study, Dr. Clements said. Limitations include the retrospective design and detection of VTE as clinically evident disease only.

“The biggest problem with your manuscript is physical examination for DVT,” Dr. Taylor said. “Don't some patients get swollen legs after surgery [even without VTE]? Don't some get shortness of breath?” Still, “from an objective standpoint, 106 minutes for bariatric procedures is an accomplishment.”

PALM BEACH, FLA. — Pharmacologic prophylaxis against venous thromboembolism is not mandatory for average-risk patients undergoing laparoscopic Roux-en-Y gastric bypass, according to data on more than 900 procedures.

“Pneumatic compression devices, early ambulation, and a relatively short operative time are effective prophylaxes against VTE,” Dr. Ronald H. Clements said.

As a follow-up to their earlier report of one deep vein thrombosis (DVT) among 380 patients (Surg. Endosc. 2004;18:1082–4), Dr. Clements and his associates continued to collect data on 957 consecutive laparoscopic Roux-en-Y gastric bypasses performed at the University of Alabama at Birmingham since 2000. Dr. Clements, a laparoscopic surgeon, presented the findings at the annual meeting of the Southern Surgical Association.

The study cohort was 83% women and 80% white. Mean age was 41 years, mean body mass index was 49 kg/m

The researchers followed all but one patient for 30 days. Among the 956 patients, there were three DVTs, one nonfatal pulmonary thromboembolism, and seven instances of major bleeding. Two patients with bleeding required reoperation, four had transfusions, and one required no intervention. One patient died of causes unrelated to DVT.

Venous thromboembolism (VTE) is a leading cause of postoperative mortality following bariatric surgery, but is “very rare: 3–7 [in] every 1,000 patients,” said study discussant Dr. Hiram C. Polk Jr., citing an unpublished study of 966,000 patients within his hospital consortium database. Elastic stockings were the most common intervention in his study. “The dangers of prophylaxis outweigh the risks of what you are trying to prevent,” said Dr. Polk, professor of surgery at the University of Louisville (Ky.).

The study “is important for the bariatric surgeon who chooses to use compression and early ambulation alone. You don't have to always use heparin,” said Dr. Bruce D. Schirmer, a general surgeon at the University of Virginia, Charlottesville, who was another study discussant. Chemoprophylaxis is still warranted for high-risk patients, he added.

But Dr. Spence M. Taylor, chair of surgery at the University of South Carolina, Greenville, took a different view. “I'm aware of at least six consensus statements for prophylaxis for DVT, and without fail, they all say chemoprophylaxis is the treatment of choice.”

Dr. Clements replied: “I don't think these obese patients fall into all those guidelines. I don't think most of you would use prophylaxis for the morbidly obese [patient undergoing] removal of a gallbladder, so I don't think you should do it for bypass, either.”

The consensus statements overlook or include only level II evidence for gastric bypass, he said, reiterating that his findings do not apply to the highest-risk patients. “I'm talking about the average person who comes to me for gastric bypass who is not at high risk” for VTE.

Citing the low incidence (0.1%–0.8%) of pulmonary embolism in this study, Dr. Taylor said, “It's conceivable you don't have enough patients yet.” Dr. Clements responded, “It's a low incidence, and that is the point of the paper. We are not saying compression devices are superior, simply that they are equivalent.”

Good follow-up and applicability of the findings to most patients undergoing gastric bypass are strengths of the study, Dr. Clements said. Limitations include the retrospective design and detection of VTE as clinically evident disease only.

“The biggest problem with your manuscript is physical examination for DVT,” Dr. Taylor said. “Don't some patients get swollen legs after surgery [even without VTE]? Don't some get shortness of breath?” Still, “from an objective standpoint, 106 minutes for bariatric procedures is an accomplishment.”

ORLANDO — Patients on proton pump inhibitor therapy before abdominal cancer surgery were four times more likely to have postoperative infections than were those not taking such medication, according to a prospective, observational study.

Patients taking preoperative proton pump inhibitors (PPIs) also had significantly elevated serum levels of tumor necrosis factor (TNF)-α before and immediately after hemihepatectomy, as well as the day after surgery. Pneumonia and wound infections made up the majority of postoperative infections in the PPI group.

“There is evidence that PPIs have an effect on the immune system, especially TNF-α,” Dr. Felix Kork said in an interview. Other researchers have shown that TNF-α impairs the immune system (J. Gastrointest. Surg. 2007;11:1506–14), yet the exact mechanism of interaction between PPI use and this cytokine remains unknown. Inflammation could play a role, particularly with postoperative pneumonia, he added.

These findings from patients at Charité Medical University of Berlin need to be confirmed before physicians consider preoperative suspension of PPIs, said Dr. Kork, an anesthesiology and intensive-care medicine resident. “We should investigate this further—whether or not it helps to stop PPIs,” he said in a poster presented at the annual meeting of the American Society of Anesthesiologists.

Previously, researchers demonstrated that PPIs alter the expression of cytokines in antrum cells (Inflamm. Res. 2006;55:476–80). Also, polymorphisms of TNF-α have been shown to reduce eradication of Helicobacter pylori (Scand. J. Immunol. 2008;67:57–62).

Among the 166 patients who completed the current study, Dr. Kork and his colleagues found that 13 of 44 (30%) in the preoperative PPI group developed a postoperative infection, versus only 10 of 122 (8%) of the non-PPI patients. This difference was significant (odds ratio, 4.13).

“Those patients preoperatively taking PPIs also have an elevated total length of stay,” Dr. Kork said. This difference was statistically significant, compared with patients not taking PPIs before surgery, he said, although he did not present the number of days associated with length of stay.

Length of ICU stay did not differ significantly between groups, he added.

'We should investigate this further—whether or not it helps to stop PPIs.' DR. KORK

ORLANDO — Patients on proton pump inhibitor therapy before abdominal cancer surgery were four times more likely to have postoperative infections than were those not taking such medication, according to a prospective, observational study.

Patients taking preoperative proton pump inhibitors (PPIs) also had significantly elevated serum levels of tumor necrosis factor (TNF)-α before and immediately after hemihepatectomy, as well as the day after surgery. Pneumonia and wound infections made up the majority of postoperative infections in the PPI group.

“There is evidence that PPIs have an effect on the immune system, especially TNF-α,” Dr. Felix Kork said in an interview. Other researchers have shown that TNF-α impairs the immune system (J. Gastrointest. Surg. 2007;11:1506–14), yet the exact mechanism of interaction between PPI use and this cytokine remains unknown. Inflammation could play a role, particularly with postoperative pneumonia, he added.

These findings from patients at Charité Medical University of Berlin need to be confirmed before physicians consider preoperative suspension of PPIs, said Dr. Kork, an anesthesiology and intensive-care medicine resident. “We should investigate this further—whether or not it helps to stop PPIs,” he said in a poster presented at the annual meeting of the American Society of Anesthesiologists.

Previously, researchers demonstrated that PPIs alter the expression of cytokines in antrum cells (Inflamm. Res. 2006;55:476–80). Also, polymorphisms of TNF-α have been shown to reduce eradication of Helicobacter pylori (Scand. J. Immunol. 2008;67:57–62).

Among the 166 patients who completed the current study, Dr. Kork and his colleagues found that 13 of 44 (30%) in the preoperative PPI group developed a postoperative infection, versus only 10 of 122 (8%) of the non-PPI patients. This difference was significant (odds ratio, 4.13).

“Those patients preoperatively taking PPIs also have an elevated total length of stay,” Dr. Kork said. This difference was statistically significant, compared with patients not taking PPIs before surgery, he said, although he did not present the number of days associated with length of stay.

Length of ICU stay did not differ significantly between groups, he added.

'We should investigate this further—whether or not it helps to stop PPIs.' DR. KORK

ORLANDO — Patients on proton pump inhibitor therapy before abdominal cancer surgery were four times more likely to have postoperative infections than were those not taking such medication, according to a prospective, observational study.

Patients taking preoperative proton pump inhibitors (PPIs) also had significantly elevated serum levels of tumor necrosis factor (TNF)-α before and immediately after hemihepatectomy, as well as the day after surgery. Pneumonia and wound infections made up the majority of postoperative infections in the PPI group.

“There is evidence that PPIs have an effect on the immune system, especially TNF-α,” Dr. Felix Kork said in an interview. Other researchers have shown that TNF-α impairs the immune system (J. Gastrointest. Surg. 2007;11:1506–14), yet the exact mechanism of interaction between PPI use and this cytokine remains unknown. Inflammation could play a role, particularly with postoperative pneumonia, he added.

These findings from patients at Charité Medical University of Berlin need to be confirmed before physicians consider preoperative suspension of PPIs, said Dr. Kork, an anesthesiology and intensive-care medicine resident. “We should investigate this further—whether or not it helps to stop PPIs,” he said in a poster presented at the annual meeting of the American Society of Anesthesiologists.

Previously, researchers demonstrated that PPIs alter the expression of cytokines in antrum cells (Inflamm. Res. 2006;55:476–80). Also, polymorphisms of TNF-α have been shown to reduce eradication of Helicobacter pylori (Scand. J. Immunol. 2008;67:57–62).

Among the 166 patients who completed the current study, Dr. Kork and his colleagues found that 13 of 44 (30%) in the preoperative PPI group developed a postoperative infection, versus only 10 of 122 (8%) of the non-PPI patients. This difference was significant (odds ratio, 4.13).

“Those patients preoperatively taking PPIs also have an elevated total length of stay,” Dr. Kork said. This difference was statistically significant, compared with patients not taking PPIs before surgery, he said, although he did not present the number of days associated with length of stay.

Length of ICU stay did not differ significantly between groups, he added.

'We should investigate this further—whether or not it helps to stop PPIs.' DR. KORK

LAKE BUENA VISTA, FLA. — Men-opausal status and use of hormone therapy can influence the presentation and treatment of major depression, according to Dr. Susan G. Kornstein, professor of psychiatry and obstetrics-gynecology at Virginia Commonwealth University, Richmond.

Dr. Kornstein and her associates evaluated differences in depression by menopausal status using data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, sponsored by the National Institute of Mental Health. “We looked at whether major depressive disorder presents differently in the pre-, peri-, and postmenopausal period,” said Dr. Kornstein, also executive director of the Institute for Women's Health and the Mood Disorders Institute at VCU Medical Center.

The study included 948 premenopausal, 376 perimenopausal, and 566 postmenopausal participants. Women taking hormone therapy were excluded.

Postmenopausal women were less likely to have a family history of depression and more likely to experience an older age of depression onset and more medical comorbidity.

“Depression presenting in postmenopausal women may be more related to general medical comorbidity or hormonal factors or aging as opposed to a lifelong depressive disorder,” she said.

Dr. Kornstein and her colleagues also compared 177 women taking hormone therapy with 566 women not taking hormone therapy. “Women taking hormone therapy were more likely to have recurrent depression and greater general medical comorbidity. But more interaction with health care providers may have led to more opportunities to be prescribed hormone therapy.”

Participants taking hormone therapy reported better physical health and were less likely to report sympathetic arousal or melancholic features of depression. “This can point to some benefit of hormone therapy on depressive symptoms, although estrogen is not a treatment for depression in postmenopausal women,” Dr. Kornstein said. “But we can say that hormone therapy does not seem to worsen depressive symptoms.”

In perimenopausal women, estrogen has been shown to be an effective treatment for depression, when used either alone or in combination with antidepressants; however, risks and benefits of estrogen use must be weighed (Arch. Gen. Psychiatry 2001;58:529–34; Expert Rev. Neurother. 2007;10:1285–93). In contrast, estrogen alone has been shown to be ineffective in postmenopausal depression (Psychiatry 2004;55:406–12).

“The literature suggests psychotherapy is as effective as medication for mild to moderate depression, and the combination may be superior to either alone” (N. Engl. J. Med. 2000;342:1462–70; Psychiatr. Ann. 2002;32:465–76). Psychotherapy may also have a “long-term benefit in preventing relapse of depression,” Dr. Kornstein said (Am. J. Psychiatry 2004;161:1872–6).

LAKE BUENA VISTA, FLA. — Men-opausal status and use of hormone therapy can influence the presentation and treatment of major depression, according to Dr. Susan G. Kornstein, professor of psychiatry and obstetrics-gynecology at Virginia Commonwealth University, Richmond.

Dr. Kornstein and her associates evaluated differences in depression by menopausal status using data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, sponsored by the National Institute of Mental Health. “We looked at whether major depressive disorder presents differently in the pre-, peri-, and postmenopausal period,” said Dr. Kornstein, also executive director of the Institute for Women's Health and the Mood Disorders Institute at VCU Medical Center.

The study included 948 premenopausal, 376 perimenopausal, and 566 postmenopausal participants. Women taking hormone therapy were excluded.

Postmenopausal women were less likely to have a family history of depression and more likely to experience an older age of depression onset and more medical comorbidity.

“Depression presenting in postmenopausal women may be more related to general medical comorbidity or hormonal factors or aging as opposed to a lifelong depressive disorder,” she said.

Dr. Kornstein and her colleagues also compared 177 women taking hormone therapy with 566 women not taking hormone therapy. “Women taking hormone therapy were more likely to have recurrent depression and greater general medical comorbidity. But more interaction with health care providers may have led to more opportunities to be prescribed hormone therapy.”

Participants taking hormone therapy reported better physical health and were less likely to report sympathetic arousal or melancholic features of depression. “This can point to some benefit of hormone therapy on depressive symptoms, although estrogen is not a treatment for depression in postmenopausal women,” Dr. Kornstein said. “But we can say that hormone therapy does not seem to worsen depressive symptoms.”

In perimenopausal women, estrogen has been shown to be an effective treatment for depression, when used either alone or in combination with antidepressants; however, risks and benefits of estrogen use must be weighed (Arch. Gen. Psychiatry 2001;58:529–34; Expert Rev. Neurother. 2007;10:1285–93). In contrast, estrogen alone has been shown to be ineffective in postmenopausal depression (Psychiatry 2004;55:406–12).

“The literature suggests psychotherapy is as effective as medication for mild to moderate depression, and the combination may be superior to either alone” (N. Engl. J. Med. 2000;342:1462–70; Psychiatr. Ann. 2002;32:465–76). Psychotherapy may also have a “long-term benefit in preventing relapse of depression,” Dr. Kornstein said (Am. J. Psychiatry 2004;161:1872–6).

LAKE BUENA VISTA, FLA. — Men-opausal status and use of hormone therapy can influence the presentation and treatment of major depression, according to Dr. Susan G. Kornstein, professor of psychiatry and obstetrics-gynecology at Virginia Commonwealth University, Richmond.

Dr. Kornstein and her associates evaluated differences in depression by menopausal status using data from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, sponsored by the National Institute of Mental Health. “We looked at whether major depressive disorder presents differently in the pre-, peri-, and postmenopausal period,” said Dr. Kornstein, also executive director of the Institute for Women's Health and the Mood Disorders Institute at VCU Medical Center.

The study included 948 premenopausal, 376 perimenopausal, and 566 postmenopausal participants. Women taking hormone therapy were excluded.

Postmenopausal women were less likely to have a family history of depression and more likely to experience an older age of depression onset and more medical comorbidity.

“Depression presenting in postmenopausal women may be more related to general medical comorbidity or hormonal factors or aging as opposed to a lifelong depressive disorder,” she said.

Dr. Kornstein and her colleagues also compared 177 women taking hormone therapy with 566 women not taking hormone therapy. “Women taking hormone therapy were more likely to have recurrent depression and greater general medical comorbidity. But more interaction with health care providers may have led to more opportunities to be prescribed hormone therapy.”

Participants taking hormone therapy reported better physical health and were less likely to report sympathetic arousal or melancholic features of depression. “This can point to some benefit of hormone therapy on depressive symptoms, although estrogen is not a treatment for depression in postmenopausal women,” Dr. Kornstein said. “But we can say that hormone therapy does not seem to worsen depressive symptoms.”

In perimenopausal women, estrogen has been shown to be an effective treatment for depression, when used either alone or in combination with antidepressants; however, risks and benefits of estrogen use must be weighed (Arch. Gen. Psychiatry 2001;58:529–34; Expert Rev. Neurother. 2007;10:1285–93). In contrast, estrogen alone has been shown to be ineffective in postmenopausal depression (Psychiatry 2004;55:406–12).

“The literature suggests psychotherapy is as effective as medication for mild to moderate depression, and the combination may be superior to either alone” (N. Engl. J. Med. 2000;342:1462–70; Psychiatr. Ann. 2002;32:465–76). Psychotherapy may also have a “long-term benefit in preventing relapse of depression,” Dr. Kornstein said (Am. J. Psychiatry 2004;161:1872–6).