Michele G. Sullivan

SAN FRANCISCO — Two brief mental state exams can reliably differentiate delirium from dementia in the elderly patient.

Because delirium usually is caused by an organic illness, confusional symptoms may disappear once the underlying problem is treated, said Dr. Allen Yuen, director of emergency medicine at Epworth Hospital, Melbourne. Dementia, the product of a progressive disease, is largely untreatable.

“Poor differentiation between the confusional states is associated with poor outcomes in the patients, with increased morbidity and mortality, longer hospital stays, and functional decline,” he said at the 12th International Conference on Emergency Medicine.

There are three types of confusion in the elderly patient, Dr. Yuen said at the meeting, which was hosted by the American College of Emergency Physicians. Delirium is characterized by the sudden onset of symptoms. Patients may appear either drowsy or agitated. They can exhibit variable short-term memory, poor attention, disorganized thoughts, and even hallucinations.

The underlying causes can range from serious cardiovascular disorders, such as cerebral ischemia, pulmonary embolism, and myocardial infarction, to such seemingly innocuous problems as a urinary tract infection, pain, cold, urinary retention, and constipation.

Dementia is a state of chronic confusion induced by a long-term neurologic illness such as Alzheimer's disease. This is progressive and irreversible. Short-term memory is impaired, and the patient may not be able to perform simple tasks when asked. Language may be impaired. Family members may report aggression or personality changes.

Acute or chronic confusion occurs when a treatable illness, such as infection, brings on acute delirium in a patient with dementia.

A combination of the Confusion Assessment Method (CAM) and the Mini-Mental State Exam (MMSE) is highly effective in differentiating the types of confusion, Dr. Yuen said. “A positive CAM and an MMSE score of more than 25 are strongly predictive of delirium,” he said.

CAM has a sensitivity of 95%-100% and a specificity of up to 95% for diagnosing delirium in the elderly. It relies on observations both by family members or caretakers and providers to assess four symptoms: acute confusional onset, inattention, disorganized thinking, and altered level of consciousness. The diagnosis of delirium by CAM requires the presence of both the first and second feature and at least one of the other two.

The MMSE, while not considered a diagnostic tool, does identify patients with cognitive impairment suggestive of dementia. The screen measures orientation, short-term memory, calculation ability, and language. A score of 18–26 indicates mild dementia, although, highly educated patients with early dementia may still achieve a score of up to 30, Dr. Yuen noted.

The usual battery of tests—complete blood count, electrolytes, blood urea nitrogen and glucose, liver function, C-reactive protein, and urinalysis—often will reveal the physical problem that is underlying delirium. A chest x-ray, electrocardiogram, and brain CT may be helpful as well.

Drugs and restraints should be avoided or kept to the absolute minimum needed to ensure the patient's safety, Dr. Yuen said. Use restraints only for extreme agitation, aggressiveness, or risk of self-harm, not to prevent injury or falls, he advised, adding that “they're not effective for this and may even contribute to falls if used inappropriately.”

Drugs should be considered only for hallucinations or delusions that may increase the risk of harm to self or others, Dr. Yuen said. “Don't use them routinely, and use them only until the cause of the delirium is reversed.”

SAN FRANCISCO — Two brief mental state exams can reliably differentiate delirium from dementia in the elderly patient.

Because delirium usually is caused by an organic illness, confusional symptoms may disappear once the underlying problem is treated, said Dr. Allen Yuen, director of emergency medicine at Epworth Hospital, Melbourne. Dementia, the product of a progressive disease, is largely untreatable.

“Poor differentiation between the confusional states is associated with poor outcomes in the patients, with increased morbidity and mortality, longer hospital stays, and functional decline,” he said at the 12th International Conference on Emergency Medicine.

There are three types of confusion in the elderly patient, Dr. Yuen said at the meeting, which was hosted by the American College of Emergency Physicians. Delirium is characterized by the sudden onset of symptoms. Patients may appear either drowsy or agitated. They can exhibit variable short-term memory, poor attention, disorganized thoughts, and even hallucinations.

The underlying causes can range from serious cardiovascular disorders, such as cerebral ischemia, pulmonary embolism, and myocardial infarction, to such seemingly innocuous problems as a urinary tract infection, pain, cold, urinary retention, and constipation.

Dementia is a state of chronic confusion induced by a long-term neurologic illness such as Alzheimer's disease. This is progressive and irreversible. Short-term memory is impaired, and the patient may not be able to perform simple tasks when asked. Language may be impaired. Family members may report aggression or personality changes.

Acute or chronic confusion occurs when a treatable illness, such as infection, brings on acute delirium in a patient with dementia.

A combination of the Confusion Assessment Method (CAM) and the Mini-Mental State Exam (MMSE) is highly effective in differentiating the types of confusion, Dr. Yuen said. “A positive CAM and an MMSE score of more than 25 are strongly predictive of delirium,” he said.

CAM has a sensitivity of 95%-100% and a specificity of up to 95% for diagnosing delirium in the elderly. It relies on observations both by family members or caretakers and providers to assess four symptoms: acute confusional onset, inattention, disorganized thinking, and altered level of consciousness. The diagnosis of delirium by CAM requires the presence of both the first and second feature and at least one of the other two.

The MMSE, while not considered a diagnostic tool, does identify patients with cognitive impairment suggestive of dementia. The screen measures orientation, short-term memory, calculation ability, and language. A score of 18–26 indicates mild dementia, although, highly educated patients with early dementia may still achieve a score of up to 30, Dr. Yuen noted.

The usual battery of tests—complete blood count, electrolytes, blood urea nitrogen and glucose, liver function, C-reactive protein, and urinalysis—often will reveal the physical problem that is underlying delirium. A chest x-ray, electrocardiogram, and brain CT may be helpful as well.

Drugs and restraints should be avoided or kept to the absolute minimum needed to ensure the patient's safety, Dr. Yuen said. Use restraints only for extreme agitation, aggressiveness, or risk of self-harm, not to prevent injury or falls, he advised, adding that “they're not effective for this and may even contribute to falls if used inappropriately.”

Drugs should be considered only for hallucinations or delusions that may increase the risk of harm to self or others, Dr. Yuen said. “Don't use them routinely, and use them only until the cause of the delirium is reversed.”

SAN FRANCISCO — Two brief mental state exams can reliably differentiate delirium from dementia in the elderly patient.

Because delirium usually is caused by an organic illness, confusional symptoms may disappear once the underlying problem is treated, said Dr. Allen Yuen, director of emergency medicine at Epworth Hospital, Melbourne. Dementia, the product of a progressive disease, is largely untreatable.

“Poor differentiation between the confusional states is associated with poor outcomes in the patients, with increased morbidity and mortality, longer hospital stays, and functional decline,” he said at the 12th International Conference on Emergency Medicine.

There are three types of confusion in the elderly patient, Dr. Yuen said at the meeting, which was hosted by the American College of Emergency Physicians. Delirium is characterized by the sudden onset of symptoms. Patients may appear either drowsy or agitated. They can exhibit variable short-term memory, poor attention, disorganized thoughts, and even hallucinations.

The underlying causes can range from serious cardiovascular disorders, such as cerebral ischemia, pulmonary embolism, and myocardial infarction, to such seemingly innocuous problems as a urinary tract infection, pain, cold, urinary retention, and constipation.

Dementia is a state of chronic confusion induced by a long-term neurologic illness such as Alzheimer's disease. This is progressive and irreversible. Short-term memory is impaired, and the patient may not be able to perform simple tasks when asked. Language may be impaired. Family members may report aggression or personality changes.

Acute or chronic confusion occurs when a treatable illness, such as infection, brings on acute delirium in a patient with dementia.

A combination of the Confusion Assessment Method (CAM) and the Mini-Mental State Exam (MMSE) is highly effective in differentiating the types of confusion, Dr. Yuen said. “A positive CAM and an MMSE score of more than 25 are strongly predictive of delirium,” he said.

CAM has a sensitivity of 95%-100% and a specificity of up to 95% for diagnosing delirium in the elderly. It relies on observations both by family members or caretakers and providers to assess four symptoms: acute confusional onset, inattention, disorganized thinking, and altered level of consciousness. The diagnosis of delirium by CAM requires the presence of both the first and second feature and at least one of the other two.

The MMSE, while not considered a diagnostic tool, does identify patients with cognitive impairment suggestive of dementia. The screen measures orientation, short-term memory, calculation ability, and language. A score of 18–26 indicates mild dementia, although, highly educated patients with early dementia may still achieve a score of up to 30, Dr. Yuen noted.

The usual battery of tests—complete blood count, electrolytes, blood urea nitrogen and glucose, liver function, C-reactive protein, and urinalysis—often will reveal the physical problem that is underlying delirium. A chest x-ray, electrocardiogram, and brain CT may be helpful as well.

Drugs and restraints should be avoided or kept to the absolute minimum needed to ensure the patient's safety, Dr. Yuen said. Use restraints only for extreme agitation, aggressiveness, or risk of self-harm, not to prevent injury or falls, he advised, adding that “they're not effective for this and may even contribute to falls if used inappropriately.”

Drugs should be considered only for hallucinations or delusions that may increase the risk of harm to self or others, Dr. Yuen said. “Don't use them routinely, and use them only until the cause of the delirium is reversed.”

Eosinophilic esophagitis occurs in patients of every age, who can present with various symptoms including heartburn, abdominal pain, and nausea in addition to the more commonly seen dysphagia.

“Many physicians often think of eosinophilic esophagitis [EE] as a disease diagnosed in children and young adults,” wrote Dr. Robert Kapel of Danbury (Conn.) Hospital and his colleagues. “Our series demonstrates that EE is a disease which spares no age group.”

The investigators wrote that their series of 363 EE cases from 26 U.S. states is the largest yet, and they describe a disease entity with a more varied age of onset and symptomatic presentation than previously thought. “Our study highlights the need to consider this disease in patients with presentations other than dysphagia, as well as in older patients,” they said.

Dr. Kapel and his coauthors extracted their data from a national database referred to Caris Diagnostics which contains information on all patients and, which provides gastroenterology services to freestanding endoscopy centers around the country. From January 2002 through May 2006, the database included 414,600 GI pathology cases from 217 centers. Almost all of the cases (98%) were adults.

The investigators searched these cases for confirmed diagnoses of EE based on eosinophil counts on pathology slides. Cases were defined as having a mean eosinophil count of 20 in five high-powered fields, or, when five fields were unavailable, a mean of 30 or more eosinophils in two to four fields.

By using these criteria, the investigators found 363 cases of EE. The ages of cases varied widely, from 14 months to 98 years, with a mean of 38 years. A total of 321 EE patients were adults.

Most of the EE cases were male (74%). In fact, gender was a very strong predictor of EE, in that males had a threefold increased risk, compared with females. Age did not alter this risk factor; among the 42 pediatric cases, 33 (79%) were male, while among the adults, 74% were male.

The diagnosis of EE was significantly more common in children, amounting to 3% of the pediatric GI cases overall, versus 0.4% of the adult GI cases overall.

The investigators divided the peak eosinophil counts into tertiles of 20–59, 60–100, and more than 100 per high-powered field. Almost half of the cases (46%) had a peak mucosal eosinophil count exceeding 100 per field. Neither age nor gender was significantly associated with the distribution of the peak counts. Patients whose primary indication for endoscopy was dysphagia were slightly more likely to have higher peak mucosal eosinophil counts than those who did not report dysphagia.

Among adults, dysphagia was the most common indication for endoscopy (70%), followed by gastroesophageal reflux disease/heartburn (27%) and abdominal pain/dyspepsia (31%). Among children, however, the indications for endoscopy were more varied: 38% had GERD/heartburn, 31% had abdominal pain/dyspepsia, 26% had dysphagia, and 14% had nausea/vomiting.

“Adults reported dysphagia more than all other indications combined, whereas in children, it was only the third most common indication, suggesting that these groups differ in their clinical presentations,” the investigators said (Gastroenterology 2008;134:1316–21).

The authors also noted that the prevalence of EE increased significantly over the study period among patients who had dysphagia as the primary indication for endoscopy. These prevalence figures were 0.1% in 2002, 0.9% in 2003, 1.2% in 2004, and 1.9% in 2005.

“There are two possible explanations for this trend. The first is that the prevalence truly is increasing, representing an epidemic of sorts. The second is that gastroenterologists have become knowledgeable about the disease, and their choice of whom to biopsy has become more targeted,” the authors said.

Eosinophilic esophagitis occurs in patients of every age, who can present with various symptoms including heartburn, abdominal pain, and nausea in addition to the more commonly seen dysphagia.

“Many physicians often think of eosinophilic esophagitis [EE] as a disease diagnosed in children and young adults,” wrote Dr. Robert Kapel of Danbury (Conn.) Hospital and his colleagues. “Our series demonstrates that EE is a disease which spares no age group.”

The investigators wrote that their series of 363 EE cases from 26 U.S. states is the largest yet, and they describe a disease entity with a more varied age of onset and symptomatic presentation than previously thought. “Our study highlights the need to consider this disease in patients with presentations other than dysphagia, as well as in older patients,” they said.

Dr. Kapel and his coauthors extracted their data from a national database referred to Caris Diagnostics which contains information on all patients and, which provides gastroenterology services to freestanding endoscopy centers around the country. From January 2002 through May 2006, the database included 414,600 GI pathology cases from 217 centers. Almost all of the cases (98%) were adults.

The investigators searched these cases for confirmed diagnoses of EE based on eosinophil counts on pathology slides. Cases were defined as having a mean eosinophil count of 20 in five high-powered fields, or, when five fields were unavailable, a mean of 30 or more eosinophils in two to four fields.

By using these criteria, the investigators found 363 cases of EE. The ages of cases varied widely, from 14 months to 98 years, with a mean of 38 years. A total of 321 EE patients were adults.

Most of the EE cases were male (74%). In fact, gender was a very strong predictor of EE, in that males had a threefold increased risk, compared with females. Age did not alter this risk factor; among the 42 pediatric cases, 33 (79%) were male, while among the adults, 74% were male.

The diagnosis of EE was significantly more common in children, amounting to 3% of the pediatric GI cases overall, versus 0.4% of the adult GI cases overall.

The investigators divided the peak eosinophil counts into tertiles of 20–59, 60–100, and more than 100 per high-powered field. Almost half of the cases (46%) had a peak mucosal eosinophil count exceeding 100 per field. Neither age nor gender was significantly associated with the distribution of the peak counts. Patients whose primary indication for endoscopy was dysphagia were slightly more likely to have higher peak mucosal eosinophil counts than those who did not report dysphagia.

Among adults, dysphagia was the most common indication for endoscopy (70%), followed by gastroesophageal reflux disease/heartburn (27%) and abdominal pain/dyspepsia (31%). Among children, however, the indications for endoscopy were more varied: 38% had GERD/heartburn, 31% had abdominal pain/dyspepsia, 26% had dysphagia, and 14% had nausea/vomiting.

“Adults reported dysphagia more than all other indications combined, whereas in children, it was only the third most common indication, suggesting that these groups differ in their clinical presentations,” the investigators said (Gastroenterology 2008;134:1316–21).

The authors also noted that the prevalence of EE increased significantly over the study period among patients who had dysphagia as the primary indication for endoscopy. These prevalence figures were 0.1% in 2002, 0.9% in 2003, 1.2% in 2004, and 1.9% in 2005.

“There are two possible explanations for this trend. The first is that the prevalence truly is increasing, representing an epidemic of sorts. The second is that gastroenterologists have become knowledgeable about the disease, and their choice of whom to biopsy has become more targeted,” the authors said.

Eosinophilic esophagitis occurs in patients of every age, who can present with various symptoms including heartburn, abdominal pain, and nausea in addition to the more commonly seen dysphagia.

“Many physicians often think of eosinophilic esophagitis [EE] as a disease diagnosed in children and young adults,” wrote Dr. Robert Kapel of Danbury (Conn.) Hospital and his colleagues. “Our series demonstrates that EE is a disease which spares no age group.”

The investigators wrote that their series of 363 EE cases from 26 U.S. states is the largest yet, and they describe a disease entity with a more varied age of onset and symptomatic presentation than previously thought. “Our study highlights the need to consider this disease in patients with presentations other than dysphagia, as well as in older patients,” they said.

Dr. Kapel and his coauthors extracted their data from a national database referred to Caris Diagnostics which contains information on all patients and, which provides gastroenterology services to freestanding endoscopy centers around the country. From January 2002 through May 2006, the database included 414,600 GI pathology cases from 217 centers. Almost all of the cases (98%) were adults.

The investigators searched these cases for confirmed diagnoses of EE based on eosinophil counts on pathology slides. Cases were defined as having a mean eosinophil count of 20 in five high-powered fields, or, when five fields were unavailable, a mean of 30 or more eosinophils in two to four fields.

By using these criteria, the investigators found 363 cases of EE. The ages of cases varied widely, from 14 months to 98 years, with a mean of 38 years. A total of 321 EE patients were adults.

Most of the EE cases were male (74%). In fact, gender was a very strong predictor of EE, in that males had a threefold increased risk, compared with females. Age did not alter this risk factor; among the 42 pediatric cases, 33 (79%) were male, while among the adults, 74% were male.

The diagnosis of EE was significantly more common in children, amounting to 3% of the pediatric GI cases overall, versus 0.4% of the adult GI cases overall.

The investigators divided the peak eosinophil counts into tertiles of 20–59, 60–100, and more than 100 per high-powered field. Almost half of the cases (46%) had a peak mucosal eosinophil count exceeding 100 per field. Neither age nor gender was significantly associated with the distribution of the peak counts. Patients whose primary indication for endoscopy was dysphagia were slightly more likely to have higher peak mucosal eosinophil counts than those who did not report dysphagia.

Among adults, dysphagia was the most common indication for endoscopy (70%), followed by gastroesophageal reflux disease/heartburn (27%) and abdominal pain/dyspepsia (31%). Among children, however, the indications for endoscopy were more varied: 38% had GERD/heartburn, 31% had abdominal pain/dyspepsia, 26% had dysphagia, and 14% had nausea/vomiting.

“Adults reported dysphagia more than all other indications combined, whereas in children, it was only the third most common indication, suggesting that these groups differ in their clinical presentations,” the investigators said (Gastroenterology 2008;134:1316–21).

The authors also noted that the prevalence of EE increased significantly over the study period among patients who had dysphagia as the primary indication for endoscopy. These prevalence figures were 0.1% in 2002, 0.9% in 2003, 1.2% in 2004, and 1.9% in 2005.

“There are two possible explanations for this trend. The first is that the prevalence truly is increasing, representing an epidemic of sorts. The second is that gastroenterologists have become knowledgeable about the disease, and their choice of whom to biopsy has become more targeted,” the authors said.

CHICAGO — Bisexual college women were 60% more likely to report having a sexually transmitted disease during the past year than were heterosexual college women, and more than four times more likely to have an STD than lesbians, according to a study of 30,000 sexually active women.

“It's not clear whether it's the gender of their sex partners, the number of their sex partners, or the combination of these factors that increases their STD risk,” Lisa L. Lindley, Dr.P.H., said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. “We need more research to understand the elevated sexual risk-taking of bisexual college women.”

Her study of 30,000 sexually active college women also concluded that lesbian students were significantly less likely than either heterosexual or bisexual students to have had a routine gynecologic exam during the past year—a finding that prompts concern about the future sexual health of this group. “Educational efforts targeting lesbians must address the behavioral risk for STDs, safer sex practices, and the importance of regular gynecological exams and Pap tests,” said Dr. Lindley of the Arnold School of Public Health at the University of South Carolina, Columbia.

Dr. Lindley drew her data from the spring 2006 National College Health Assessment, a survey of 117 postsecondary institutions, which included data on 95,000 male and female college students.

The majority of sexually active college women in the analysis were white (78%). Blacks and Hispanics comprised 10% of the sample, while students of other races and ethnicities rounded out the group. Most of the women (94%) were heterosexual; 1% described themselves as lesbians, 3% as bisexual, and 1% said they were unsure of their sexual orientation.

Sexually active college women who had sex only with men during the past year had an average of two sex partners, as did college women who had sex only with women. However, women who reported sex partners of both genders during the past year had an average of five sex partners.

The women also reported whether they had acquired an STD in the past year (HPV/genital warts, chlamydia, genital herpes, gonorrhea, and/or HIV). No significant differences were reported in the incidence of each STD based on students' sexual orientation, with the exception of HPV/genital warts. Lesbians were least likely to report having HPV/genital warts, while, compared with lesbians, heterosexual women had a fourfold increased risk, bisexual women had a sixfold increased risk, and college women who were unsure of their sexual orientation had a fivefold increased risk.

When all the STDs were taken together, lesbian women had the lowest risk of infection—a 62% decreased risk, compared with heterosexual women. Bisexual women were 60% more likely to have an STD than heterosexual women were. But, compared with lesbian women with their very low rate, bisexual women were four times more likely to have an STD.

Lesbian women were also the least likely to have had a routine gynecologic exam in the past year. While 73% of heterosexual women and 67% of bisexual women had an exam, only 46% of lesbian women did. “Therefore, it's likely that more lesbian women have an STD but don't know it,” Dr. Lindley said.

The analysis also pointed up an interesting dichotomy between the women's self-proclaimed sexual orientation and their actual sexual behaviors, Dr. Lindley noted. For example, 5% of women who self-identified as lesbians reported having only male sexual contacts in the past year, and 10% of lesbians reported having sex partners of both genders. Among bisexual women, 56% reported sexual contact with only men in the past year, and 10% reported sexual contact with only women; 35% of these women had sex with both men and women in the studied year.

“It's vital that college and sexual health professionals understand the difference between sexual orientation, sexual identity, and sexual behavior,” Dr Lindley said. “When assessing STD risk, it is vital to ask about sexual behaviors and not make assumptions based on how these women identify.”

Dr. Lindley reported that she had no financial disclosures.

CHICAGO — Bisexual college women were 60% more likely to report having a sexually transmitted disease during the past year than were heterosexual college women, and more than four times more likely to have an STD than lesbians, according to a study of 30,000 sexually active women.

“It's not clear whether it's the gender of their sex partners, the number of their sex partners, or the combination of these factors that increases their STD risk,” Lisa L. Lindley, Dr.P.H., said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. “We need more research to understand the elevated sexual risk-taking of bisexual college women.”

Her study of 30,000 sexually active college women also concluded that lesbian students were significantly less likely than either heterosexual or bisexual students to have had a routine gynecologic exam during the past year—a finding that prompts concern about the future sexual health of this group. “Educational efforts targeting lesbians must address the behavioral risk for STDs, safer sex practices, and the importance of regular gynecological exams and Pap tests,” said Dr. Lindley of the Arnold School of Public Health at the University of South Carolina, Columbia.

Dr. Lindley drew her data from the spring 2006 National College Health Assessment, a survey of 117 postsecondary institutions, which included data on 95,000 male and female college students.

The majority of sexually active college women in the analysis were white (78%). Blacks and Hispanics comprised 10% of the sample, while students of other races and ethnicities rounded out the group. Most of the women (94%) were heterosexual; 1% described themselves as lesbians, 3% as bisexual, and 1% said they were unsure of their sexual orientation.

Sexually active college women who had sex only with men during the past year had an average of two sex partners, as did college women who had sex only with women. However, women who reported sex partners of both genders during the past year had an average of five sex partners.

The women also reported whether they had acquired an STD in the past year (HPV/genital warts, chlamydia, genital herpes, gonorrhea, and/or HIV). No significant differences were reported in the incidence of each STD based on students' sexual orientation, with the exception of HPV/genital warts. Lesbians were least likely to report having HPV/genital warts, while, compared with lesbians, heterosexual women had a fourfold increased risk, bisexual women had a sixfold increased risk, and college women who were unsure of their sexual orientation had a fivefold increased risk.

When all the STDs were taken together, lesbian women had the lowest risk of infection—a 62% decreased risk, compared with heterosexual women. Bisexual women were 60% more likely to have an STD than heterosexual women were. But, compared with lesbian women with their very low rate, bisexual women were four times more likely to have an STD.

Lesbian women were also the least likely to have had a routine gynecologic exam in the past year. While 73% of heterosexual women and 67% of bisexual women had an exam, only 46% of lesbian women did. “Therefore, it's likely that more lesbian women have an STD but don't know it,” Dr. Lindley said.

The analysis also pointed up an interesting dichotomy between the women's self-proclaimed sexual orientation and their actual sexual behaviors, Dr. Lindley noted. For example, 5% of women who self-identified as lesbians reported having only male sexual contacts in the past year, and 10% of lesbians reported having sex partners of both genders. Among bisexual women, 56% reported sexual contact with only men in the past year, and 10% reported sexual contact with only women; 35% of these women had sex with both men and women in the studied year.

“It's vital that college and sexual health professionals understand the difference between sexual orientation, sexual identity, and sexual behavior,” Dr Lindley said. “When assessing STD risk, it is vital to ask about sexual behaviors and not make assumptions based on how these women identify.”

Dr. Lindley reported that she had no financial disclosures.

CHICAGO — Bisexual college women were 60% more likely to report having a sexually transmitted disease during the past year than were heterosexual college women, and more than four times more likely to have an STD than lesbians, according to a study of 30,000 sexually active women.

“It's not clear whether it's the gender of their sex partners, the number of their sex partners, or the combination of these factors that increases their STD risk,” Lisa L. Lindley, Dr.P.H., said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. “We need more research to understand the elevated sexual risk-taking of bisexual college women.”

Her study of 30,000 sexually active college women also concluded that lesbian students were significantly less likely than either heterosexual or bisexual students to have had a routine gynecologic exam during the past year—a finding that prompts concern about the future sexual health of this group. “Educational efforts targeting lesbians must address the behavioral risk for STDs, safer sex practices, and the importance of regular gynecological exams and Pap tests,” said Dr. Lindley of the Arnold School of Public Health at the University of South Carolina, Columbia.

Dr. Lindley drew her data from the spring 2006 National College Health Assessment, a survey of 117 postsecondary institutions, which included data on 95,000 male and female college students.

The majority of sexually active college women in the analysis were white (78%). Blacks and Hispanics comprised 10% of the sample, while students of other races and ethnicities rounded out the group. Most of the women (94%) were heterosexual; 1% described themselves as lesbians, 3% as bisexual, and 1% said they were unsure of their sexual orientation.

Sexually active college women who had sex only with men during the past year had an average of two sex partners, as did college women who had sex only with women. However, women who reported sex partners of both genders during the past year had an average of five sex partners.

The women also reported whether they had acquired an STD in the past year (HPV/genital warts, chlamydia, genital herpes, gonorrhea, and/or HIV). No significant differences were reported in the incidence of each STD based on students' sexual orientation, with the exception of HPV/genital warts. Lesbians were least likely to report having HPV/genital warts, while, compared with lesbians, heterosexual women had a fourfold increased risk, bisexual women had a sixfold increased risk, and college women who were unsure of their sexual orientation had a fivefold increased risk.

When all the STDs were taken together, lesbian women had the lowest risk of infection—a 62% decreased risk, compared with heterosexual women. Bisexual women were 60% more likely to have an STD than heterosexual women were. But, compared with lesbian women with their very low rate, bisexual women were four times more likely to have an STD.

Lesbian women were also the least likely to have had a routine gynecologic exam in the past year. While 73% of heterosexual women and 67% of bisexual women had an exam, only 46% of lesbian women did. “Therefore, it's likely that more lesbian women have an STD but don't know it,” Dr. Lindley said.

The analysis also pointed up an interesting dichotomy between the women's self-proclaimed sexual orientation and their actual sexual behaviors, Dr. Lindley noted. For example, 5% of women who self-identified as lesbians reported having only male sexual contacts in the past year, and 10% of lesbians reported having sex partners of both genders. Among bisexual women, 56% reported sexual contact with only men in the past year, and 10% reported sexual contact with only women; 35% of these women had sex with both men and women in the studied year.

“It's vital that college and sexual health professionals understand the difference between sexual orientation, sexual identity, and sexual behavior,” Dr Lindley said. “When assessing STD risk, it is vital to ask about sexual behaviors and not make assumptions based on how these women identify.”

Dr. Lindley reported that she had no financial disclosures.

CHICAGO — Only 27% of women requesting emergency contraception received screening for chlamydia and gonorrhea, and of those who were screened, 12% were positive for at least one infection, according to the findings of a study conducted in 10 New York City-based sexual health clinics.

“Emergency contraception visits represent an important opportunity to improve STD testing and treatment. … Screening more women who request emergency contraception should be a high priority,” said the study's lead investigator, Shoshanna Handel, a public health official with the Centers for Disease Control and Prevention and the New York City Department of Health and Mental Hygiene.

Clinic visit data from a 19-month period were analyzed. During that time, 3,758 women made 4,657 requests for emergency contraception (EC). For 66% of these women, EC was the main reason for the visit, Ms. Handel said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

The patients' median age was 21 years, but 12% of the requests came from women younger than 18 years, who are unable to buy EC at a pharmacy without a prescription. More than 75% of the requests came from women aged 25 years or younger, precisely the group for which the CDC has recommended annual chlamydia and gonorrhea screening.

Overall, 27% of the EC visits included testing; 11% of these patients tested positive for chlamydia and 2% for gonorrhea. Women aged 25 and younger were significantly more likely to test positive than women older than 25 were (14% vs. 7%), a finding Ms. Handel said “is consistent with surveillance data showing that gonorrhea and chlamydia case rates are highest among women under age 25.”

When she separated the visits into EC-only requests and visits that included EC and other services, she found a significant difference in how often screening was offered. “At the EC-only visits, only 4% of women were screened. But at the EC-plus visits, 71% were screened.”

After reviewing the analysis last October, the New York City STD clinics changed their screening policy for women seeking EC, Ms. Handel said. “Our previous protocol stressed expedited EC access. Now we offer chlamydia and gonorrhea screening as a package with emergency contraception.”

In the 3 months following the new protocol, Ms. Handel said the clinics increased their STD screening significantly among women seeking EC.

“During the follow-up period, our chlamydia and gonorrhea screening rates were 57%, compared to only 27% before the change.”

CHICAGO — Only 27% of women requesting emergency contraception received screening for chlamydia and gonorrhea, and of those who were screened, 12% were positive for at least one infection, according to the findings of a study conducted in 10 New York City-based sexual health clinics.

“Emergency contraception visits represent an important opportunity to improve STD testing and treatment. … Screening more women who request emergency contraception should be a high priority,” said the study's lead investigator, Shoshanna Handel, a public health official with the Centers for Disease Control and Prevention and the New York City Department of Health and Mental Hygiene.

Clinic visit data from a 19-month period were analyzed. During that time, 3,758 women made 4,657 requests for emergency contraception (EC). For 66% of these women, EC was the main reason for the visit, Ms. Handel said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

The patients' median age was 21 years, but 12% of the requests came from women younger than 18 years, who are unable to buy EC at a pharmacy without a prescription. More than 75% of the requests came from women aged 25 years or younger, precisely the group for which the CDC has recommended annual chlamydia and gonorrhea screening.

Overall, 27% of the EC visits included testing; 11% of these patients tested positive for chlamydia and 2% for gonorrhea. Women aged 25 and younger were significantly more likely to test positive than women older than 25 were (14% vs. 7%), a finding Ms. Handel said “is consistent with surveillance data showing that gonorrhea and chlamydia case rates are highest among women under age 25.”

When she separated the visits into EC-only requests and visits that included EC and other services, she found a significant difference in how often screening was offered. “At the EC-only visits, only 4% of women were screened. But at the EC-plus visits, 71% were screened.”

After reviewing the analysis last October, the New York City STD clinics changed their screening policy for women seeking EC, Ms. Handel said. “Our previous protocol stressed expedited EC access. Now we offer chlamydia and gonorrhea screening as a package with emergency contraception.”

In the 3 months following the new protocol, Ms. Handel said the clinics increased their STD screening significantly among women seeking EC.

“During the follow-up period, our chlamydia and gonorrhea screening rates were 57%, compared to only 27% before the change.”

CHICAGO — Only 27% of women requesting emergency contraception received screening for chlamydia and gonorrhea, and of those who were screened, 12% were positive for at least one infection, according to the findings of a study conducted in 10 New York City-based sexual health clinics.

“Emergency contraception visits represent an important opportunity to improve STD testing and treatment. … Screening more women who request emergency contraception should be a high priority,” said the study's lead investigator, Shoshanna Handel, a public health official with the Centers for Disease Control and Prevention and the New York City Department of Health and Mental Hygiene.

Clinic visit data from a 19-month period were analyzed. During that time, 3,758 women made 4,657 requests for emergency contraception (EC). For 66% of these women, EC was the main reason for the visit, Ms. Handel said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

The patients' median age was 21 years, but 12% of the requests came from women younger than 18 years, who are unable to buy EC at a pharmacy without a prescription. More than 75% of the requests came from women aged 25 years or younger, precisely the group for which the CDC has recommended annual chlamydia and gonorrhea screening.

Overall, 27% of the EC visits included testing; 11% of these patients tested positive for chlamydia and 2% for gonorrhea. Women aged 25 and younger were significantly more likely to test positive than women older than 25 were (14% vs. 7%), a finding Ms. Handel said “is consistent with surveillance data showing that gonorrhea and chlamydia case rates are highest among women under age 25.”

When she separated the visits into EC-only requests and visits that included EC and other services, she found a significant difference in how often screening was offered. “At the EC-only visits, only 4% of women were screened. But at the EC-plus visits, 71% were screened.”

After reviewing the analysis last October, the New York City STD clinics changed their screening policy for women seeking EC, Ms. Handel said. “Our previous protocol stressed expedited EC access. Now we offer chlamydia and gonorrhea screening as a package with emergency contraception.”

In the 3 months following the new protocol, Ms. Handel said the clinics increased their STD screening significantly among women seeking EC.

“During the follow-up period, our chlamydia and gonorrhea screening rates were 57%, compared to only 27% before the change.”

CHICAGO — The biggest risk factor for bacterial vaginosis among gay or bisexual women is having a sex partner with a history of the infection—an association that increases the chances of bacterial vaginosis by more than 400%, Dr. Jeanne Marrazzo said at a meeting on the prevention of sexually transmitted diseases.

Sharing sexual toys almost doubled the risk of developing bacterial vaginosis (BV) among these women, said Dr. Marrazzo of the University of Washington, Seattle. And although this association was not statistically significant, when it is combined with the risk of a partner's positive history, it suggests that the exchange of vaginal fluids plays a key role in the development of BV for this population, she said.

Dr. Marrazzo presented the preliminary results of a 1-year longitudinal study examining the rates of bacterial vaginosis in 335 women, including 47 couples (94 women). Their median age was 25 years; 88% were white. Most (305) reported sexual activity within the last 3 months; of these, 276 reported having had at least one female partner, and 18% reported both male and female partners. For those reporting sex with a male within the last 3 months, only 25% reported having used a condom.

A third of the women had a history of bacterial vaginosis—a somewhat high prevalence, especially in light of the group's very low rate of douching (6%), a behavior that is strongly associated with the infection. Dr. Marrazzo said.

All of the women completed a detailed computer survey of their sexual habits. Their symptoms were assessed clinically by Amsel criteria; bacterial vaginosis was confirmed with Gram stain of vaginal fluid and Nugent criteria. The overall prevalence of BV was 29%, which is higher than that usually seen at clinics in the United States, Dr. Marrazzo said. Of these women, 40% were symptomatic at the time of clinical assessment.

All of the sexually active women had experienced receptive vaginal or oral sex, including penetration with fingers, a penis, or toys; 40% had experienced receptive anal sex with fingers, penis, or toys; and 22% reported sharing a vaginal toy with a female partner.

In the univariate analysis, only having a partner with a history of BV was associated with a significant increase in the risk of developing BV (odds ratio 5.0). Other positive but nonsignificant associations included age younger than 26 years, sharing a sex toy (OR 2.0), and using vaginal lubricant (OR 2.0).

In the multivariate analysis, having a partner with a history of BV was still significantly associated with an increased risk (OR 4.5). Shared vaginal toys and the use of vaginal lubricant were still associated with a nonsignificant doubling of risk.

“We did not see any significant relationships with the two most consistently prominent risk factors, race and douching,” Dr. Marrazzo said. “Sexual activity did seem to be important, but not the behaviors that we expected.”

She then examined the prevalence of BV in the subset of 47 couples in the study. Partners were negative for BV in 22 couples, discordant in 5, and positive in 20.

“This degree of concordance for the presence or absence of the infection is strikingly different than what we would expect if we calculated the likelihood of BV based on the overall population prevalence,” Dr. Marrazzo said. “If [it were] just a random sample, it would be about 13 couples negative, 11 discordant, and 24 positive. This supports the idea that there may be some mechanistic process involved in being in a sexual relationship with a woman with BV.”

The association with sexual toys and vaginal lubricant is difficult to untangle, she said, because the two are most often used simultaneously. She noted that one of the most popular brands of lubricant contains hexachloradine, which may interfere with normal vaginal flora. In addition, “the pH of the most commonly used lubricants ranges from 5.8 to 6.1, so they may modify the vaginal pH directly, and if used persistently, they may contribute to the increased risk,” said Dr. Marrazzo.

CHICAGO — The biggest risk factor for bacterial vaginosis among gay or bisexual women is having a sex partner with a history of the infection—an association that increases the chances of bacterial vaginosis by more than 400%, Dr. Jeanne Marrazzo said at a meeting on the prevention of sexually transmitted diseases.

Sharing sexual toys almost doubled the risk of developing bacterial vaginosis (BV) among these women, said Dr. Marrazzo of the University of Washington, Seattle. And although this association was not statistically significant, when it is combined with the risk of a partner's positive history, it suggests that the exchange of vaginal fluids plays a key role in the development of BV for this population, she said.

Dr. Marrazzo presented the preliminary results of a 1-year longitudinal study examining the rates of bacterial vaginosis in 335 women, including 47 couples (94 women). Their median age was 25 years; 88% were white. Most (305) reported sexual activity within the last 3 months; of these, 276 reported having had at least one female partner, and 18% reported both male and female partners. For those reporting sex with a male within the last 3 months, only 25% reported having used a condom.

A third of the women had a history of bacterial vaginosis—a somewhat high prevalence, especially in light of the group's very low rate of douching (6%), a behavior that is strongly associated with the infection. Dr. Marrazzo said.

All of the women completed a detailed computer survey of their sexual habits. Their symptoms were assessed clinically by Amsel criteria; bacterial vaginosis was confirmed with Gram stain of vaginal fluid and Nugent criteria. The overall prevalence of BV was 29%, which is higher than that usually seen at clinics in the United States, Dr. Marrazzo said. Of these women, 40% were symptomatic at the time of clinical assessment.

All of the sexually active women had experienced receptive vaginal or oral sex, including penetration with fingers, a penis, or toys; 40% had experienced receptive anal sex with fingers, penis, or toys; and 22% reported sharing a vaginal toy with a female partner.

In the univariate analysis, only having a partner with a history of BV was associated with a significant increase in the risk of developing BV (odds ratio 5.0). Other positive but nonsignificant associations included age younger than 26 years, sharing a sex toy (OR 2.0), and using vaginal lubricant (OR 2.0).

In the multivariate analysis, having a partner with a history of BV was still significantly associated with an increased risk (OR 4.5). Shared vaginal toys and the use of vaginal lubricant were still associated with a nonsignificant doubling of risk.

“We did not see any significant relationships with the two most consistently prominent risk factors, race and douching,” Dr. Marrazzo said. “Sexual activity did seem to be important, but not the behaviors that we expected.”

She then examined the prevalence of BV in the subset of 47 couples in the study. Partners were negative for BV in 22 couples, discordant in 5, and positive in 20.

“This degree of concordance for the presence or absence of the infection is strikingly different than what we would expect if we calculated the likelihood of BV based on the overall population prevalence,” Dr. Marrazzo said. “If [it were] just a random sample, it would be about 13 couples negative, 11 discordant, and 24 positive. This supports the idea that there may be some mechanistic process involved in being in a sexual relationship with a woman with BV.”

The association with sexual toys and vaginal lubricant is difficult to untangle, she said, because the two are most often used simultaneously. She noted that one of the most popular brands of lubricant contains hexachloradine, which may interfere with normal vaginal flora. In addition, “the pH of the most commonly used lubricants ranges from 5.8 to 6.1, so they may modify the vaginal pH directly, and if used persistently, they may contribute to the increased risk,” said Dr. Marrazzo.

CHICAGO — The biggest risk factor for bacterial vaginosis among gay or bisexual women is having a sex partner with a history of the infection—an association that increases the chances of bacterial vaginosis by more than 400%, Dr. Jeanne Marrazzo said at a meeting on the prevention of sexually transmitted diseases.

Sharing sexual toys almost doubled the risk of developing bacterial vaginosis (BV) among these women, said Dr. Marrazzo of the University of Washington, Seattle. And although this association was not statistically significant, when it is combined with the risk of a partner's positive history, it suggests that the exchange of vaginal fluids plays a key role in the development of BV for this population, she said.

Dr. Marrazzo presented the preliminary results of a 1-year longitudinal study examining the rates of bacterial vaginosis in 335 women, including 47 couples (94 women). Their median age was 25 years; 88% were white. Most (305) reported sexual activity within the last 3 months; of these, 276 reported having had at least one female partner, and 18% reported both male and female partners. For those reporting sex with a male within the last 3 months, only 25% reported having used a condom.

A third of the women had a history of bacterial vaginosis—a somewhat high prevalence, especially in light of the group's very low rate of douching (6%), a behavior that is strongly associated with the infection. Dr. Marrazzo said.

All of the women completed a detailed computer survey of their sexual habits. Their symptoms were assessed clinically by Amsel criteria; bacterial vaginosis was confirmed with Gram stain of vaginal fluid and Nugent criteria. The overall prevalence of BV was 29%, which is higher than that usually seen at clinics in the United States, Dr. Marrazzo said. Of these women, 40% were symptomatic at the time of clinical assessment.

All of the sexually active women had experienced receptive vaginal or oral sex, including penetration with fingers, a penis, or toys; 40% had experienced receptive anal sex with fingers, penis, or toys; and 22% reported sharing a vaginal toy with a female partner.

In the univariate analysis, only having a partner with a history of BV was associated with a significant increase in the risk of developing BV (odds ratio 5.0). Other positive but nonsignificant associations included age younger than 26 years, sharing a sex toy (OR 2.0), and using vaginal lubricant (OR 2.0).

In the multivariate analysis, having a partner with a history of BV was still significantly associated with an increased risk (OR 4.5). Shared vaginal toys and the use of vaginal lubricant were still associated with a nonsignificant doubling of risk.

“We did not see any significant relationships with the two most consistently prominent risk factors, race and douching,” Dr. Marrazzo said. “Sexual activity did seem to be important, but not the behaviors that we expected.”

She then examined the prevalence of BV in the subset of 47 couples in the study. Partners were negative for BV in 22 couples, discordant in 5, and positive in 20.

“This degree of concordance for the presence or absence of the infection is strikingly different than what we would expect if we calculated the likelihood of BV based on the overall population prevalence,” Dr. Marrazzo said. “If [it were] just a random sample, it would be about 13 couples negative, 11 discordant, and 24 positive. This supports the idea that there may be some mechanistic process involved in being in a sexual relationship with a woman with BV.”

The association with sexual toys and vaginal lubricant is difficult to untangle, she said, because the two are most often used simultaneously. She noted that one of the most popular brands of lubricant contains hexachloradine, which may interfere with normal vaginal flora. In addition, “the pH of the most commonly used lubricants ranges from 5.8 to 6.1, so they may modify the vaginal pH directly, and if used persistently, they may contribute to the increased risk,” said Dr. Marrazzo.

CHICAGO — Women with bacterial vaginosis might face a higher risk of acquiring herpes simplex type 2 infections, said Dr. Emilia Koumans, a public health official with the Centers for Disease Control and Prevention.

Her cross-sectional study couldn't assess the temporal relationship between the two infections, but it found that the prevalence of herpes simplex type 2 (HSV-2) infections was significantly higher in women with bacterial vaginosis (BV) than in those without BV, she reported at a meeting on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Koumans analyzed data for all sexually active women aged 20–49 years who were included in the 2001–2004 National Health and Nutrition Examination Survey. The women completed a detailed health survey and provided self-collected vaginal swabs for the diagnosis of sexually transmitted infections. They also provided serum samples for HSV-2 serotyping.

Overall BV and HSV-2 prevalence varied significantly by age, race, and number of lifetime sexual partners. For those aged 20–29 years, prevalence of BV was 33% and HSV-2, 17%. For those aged 30–39, prevalence for both was 27%. For those aged 40–49, prevalence of BV was 30% and HSV-2, 34%.

HSV-2/BV coinfections were significantly more common in blacks (66%) than in whites or Mexican Americans (29% and 19%, respectively). Coinfections were also more common in those reporting 10 or more lifetime sexual partners (58% vs. 40% for those with 5–9 partners and 20% for those with 1–4 partners).

HSV-2 was significantly more common in those with BV than in those without BV (37% vs. 23%). The association was strong after controlling for age, race, and number of lifetime sexual partners. Dr. Koumans reported no financial disclosures.

CHICAGO — Women with bacterial vaginosis might face a higher risk of acquiring herpes simplex type 2 infections, said Dr. Emilia Koumans, a public health official with the Centers for Disease Control and Prevention.

Her cross-sectional study couldn't assess the temporal relationship between the two infections, but it found that the prevalence of herpes simplex type 2 (HSV-2) infections was significantly higher in women with bacterial vaginosis (BV) than in those without BV, she reported at a meeting on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Koumans analyzed data for all sexually active women aged 20–49 years who were included in the 2001–2004 National Health and Nutrition Examination Survey. The women completed a detailed health survey and provided self-collected vaginal swabs for the diagnosis of sexually transmitted infections. They also provided serum samples for HSV-2 serotyping.

Overall BV and HSV-2 prevalence varied significantly by age, race, and number of lifetime sexual partners. For those aged 20–29 years, prevalence of BV was 33% and HSV-2, 17%. For those aged 30–39, prevalence for both was 27%. For those aged 40–49, prevalence of BV was 30% and HSV-2, 34%.

HSV-2/BV coinfections were significantly more common in blacks (66%) than in whites or Mexican Americans (29% and 19%, respectively). Coinfections were also more common in those reporting 10 or more lifetime sexual partners (58% vs. 40% for those with 5–9 partners and 20% for those with 1–4 partners).

HSV-2 was significantly more common in those with BV than in those without BV (37% vs. 23%). The association was strong after controlling for age, race, and number of lifetime sexual partners. Dr. Koumans reported no financial disclosures.

CHICAGO — Women with bacterial vaginosis might face a higher risk of acquiring herpes simplex type 2 infections, said Dr. Emilia Koumans, a public health official with the Centers for Disease Control and Prevention.

Her cross-sectional study couldn't assess the temporal relationship between the two infections, but it found that the prevalence of herpes simplex type 2 (HSV-2) infections was significantly higher in women with bacterial vaginosis (BV) than in those without BV, she reported at a meeting on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Koumans analyzed data for all sexually active women aged 20–49 years who were included in the 2001–2004 National Health and Nutrition Examination Survey. The women completed a detailed health survey and provided self-collected vaginal swabs for the diagnosis of sexually transmitted infections. They also provided serum samples for HSV-2 serotyping.

Overall BV and HSV-2 prevalence varied significantly by age, race, and number of lifetime sexual partners. For those aged 20–29 years, prevalence of BV was 33% and HSV-2, 17%. For those aged 30–39, prevalence for both was 27%. For those aged 40–49, prevalence of BV was 30% and HSV-2, 34%.

HSV-2/BV coinfections were significantly more common in blacks (66%) than in whites or Mexican Americans (29% and 19%, respectively). Coinfections were also more common in those reporting 10 or more lifetime sexual partners (58% vs. 40% for those with 5–9 partners and 20% for those with 1–4 partners).

HSV-2 was significantly more common in those with BV than in those without BV (37% vs. 23%). The association was strong after controlling for age, race, and number of lifetime sexual partners. Dr. Koumans reported no financial disclosures.

CHICAGO — Despite visiting a sexual health clinic for screening tests, up to 35% of sexually active gay men might still have undiagnosed gonorrhea infections, Kristen Mahle said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

The undiagnosed rectal infections, as well as undiagnosed gonorrhea infections of the pharynx and urethra, occur because many clinics don't routinely screen asymptomatic men at all possible sites of exposure, said Ms. Mahle of the Centers for Disease Control and Prevention. “[Most] gonorrhea infections at nongenital sites are asymptomatic. Clinics conducting routine gonorrhea screenings for sexually active men who have sex with men should screen based on behavior, not just on symptoms.”

Her analysis drew on data from the Men Who Have Sex With Men Prevalence Monitoring Project. This 4-year study included data on 89,500 visits to STD and gay men's health clinics in eight U.S. cities. Participants were aged 15–65 years.

In all tested men—symptomatic and asymptomatic—the urethral gonorrhea rate was 1%, the rectal gonorrhea rate was 5%, and that of pharyngeal gonorrhea, 3%.

Almost half of the men (48%) were asymptomatic at their clinic visit, yet 7% of the urethral infections, 26% of the rectal infections, and 11% of the pharyngeal infections were in that group. However, only 52% of asymptomatic men who reported exposure were tested at all three sites. Most of those reporting urethral exposure were tested at the urethra (91%), but only 64% of those reporting rectal exposure received rectal testing, and 74% of those reporting pharyngeal exposure received pharyngeal testing. Ms. Mahle concluded 9% of the urethral infections, 35% of the rectal infections, and 25% of the pharyngeal infections went undiagnosed.

CHICAGO — Despite visiting a sexual health clinic for screening tests, up to 35% of sexually active gay men might still have undiagnosed gonorrhea infections, Kristen Mahle said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

The undiagnosed rectal infections, as well as undiagnosed gonorrhea infections of the pharynx and urethra, occur because many clinics don't routinely screen asymptomatic men at all possible sites of exposure, said Ms. Mahle of the Centers for Disease Control and Prevention. “[Most] gonorrhea infections at nongenital sites are asymptomatic. Clinics conducting routine gonorrhea screenings for sexually active men who have sex with men should screen based on behavior, not just on symptoms.”

Her analysis drew on data from the Men Who Have Sex With Men Prevalence Monitoring Project. This 4-year study included data on 89,500 visits to STD and gay men's health clinics in eight U.S. cities. Participants were aged 15–65 years.

In all tested men—symptomatic and asymptomatic—the urethral gonorrhea rate was 1%, the rectal gonorrhea rate was 5%, and that of pharyngeal gonorrhea, 3%.

Almost half of the men (48%) were asymptomatic at their clinic visit, yet 7% of the urethral infections, 26% of the rectal infections, and 11% of the pharyngeal infections were in that group. However, only 52% of asymptomatic men who reported exposure were tested at all three sites. Most of those reporting urethral exposure were tested at the urethra (91%), but only 64% of those reporting rectal exposure received rectal testing, and 74% of those reporting pharyngeal exposure received pharyngeal testing. Ms. Mahle concluded 9% of the urethral infections, 35% of the rectal infections, and 25% of the pharyngeal infections went undiagnosed.

CHICAGO — Despite visiting a sexual health clinic for screening tests, up to 35% of sexually active gay men might still have undiagnosed gonorrhea infections, Kristen Mahle said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

The undiagnosed rectal infections, as well as undiagnosed gonorrhea infections of the pharynx and urethra, occur because many clinics don't routinely screen asymptomatic men at all possible sites of exposure, said Ms. Mahle of the Centers for Disease Control and Prevention. “[Most] gonorrhea infections at nongenital sites are asymptomatic. Clinics conducting routine gonorrhea screenings for sexually active men who have sex with men should screen based on behavior, not just on symptoms.”

Her analysis drew on data from the Men Who Have Sex With Men Prevalence Monitoring Project. This 4-year study included data on 89,500 visits to STD and gay men's health clinics in eight U.S. cities. Participants were aged 15–65 years.

In all tested men—symptomatic and asymptomatic—the urethral gonorrhea rate was 1%, the rectal gonorrhea rate was 5%, and that of pharyngeal gonorrhea, 3%.

Almost half of the men (48%) were asymptomatic at their clinic visit, yet 7% of the urethral infections, 26% of the rectal infections, and 11% of the pharyngeal infections were in that group. However, only 52% of asymptomatic men who reported exposure were tested at all three sites. Most of those reporting urethral exposure were tested at the urethra (91%), but only 64% of those reporting rectal exposure received rectal testing, and 74% of those reporting pharyngeal exposure received pharyngeal testing. Ms. Mahle concluded 9% of the urethral infections, 35% of the rectal infections, and 25% of the pharyngeal infections went undiagnosed.

Cholinesterase inhibitors and memantine are not one-size-fits-all drugs that can be prescribed to every patient with dementia and should only be employed after assessing each drug's risk/benefit profile in light of an individual patient's needs, according to a new set of clinical guidelines.

“The most important thing to keep in mind is that there is no cure for dementia,” said Dr. Amir Qaseem, author of the guidelines and a member of the Joint American College of Physicians/American Academy of Family Physicians Panel on Dementia.

“These drugs can only alleviate symptoms and may slightly delay progression. But they should not be prescribed to every dementia patient because the benefits are very modest and some patients may not show benefit at all, and all the drugs carry potential harms.”

Although many patients do show statistically significant improvements while taking the drugs, most of those changes are small and not clinically meaningful, according to the guidelines (Ann. Intern. Med. 2008;148:370–8).

The panel also concluded that there is insufficient evidence to recommended one drug over another for the treatment of dementia. Instead, “the choice of therapy should be based on an evaluation of adverse events, tolerability, and cost, because there is no evidence that one treatment is more effective than another,” Dr. Qaseem said in an interview.

The recommendations are particularly important for primary care physicians, who care for most patients with dementia, said Dr. William Thies, vice president of medical and scientific affairs for the Alzheimer's Association.

“The bulk of dementia patients are being managed by primary care physicians, and this is only going to increase as we deal with the oncoming tidal wave of Alzheimer's patients over the coming decades,” he said in an interview. “As these guidelines point out, the emphasis when treating these patients should be that the physician, patient, and family work together as a unit to decide the best use of a medication and also, the best time to stop.”

The guidelines panel mined data from 59 studies that examined any of the five drugs approved for dementia treatment in the United States (donepezil, rivastigmine, galantamine, tacrine, and memantine). Drugs were assessed for their effects on symptoms (cognition, function, and behavior), quality of life, and their adverse event profile. The results of this evidence review accompany the guidelines (Ann. Int. Med. 2008;148:379–97).

The largest body of high-quality evidence was seen for donepezil: Twenty-four studies compared it with either placebo or vitamin E. Most showed statistically significant effects in favor of the drug for at least one measure of cognition. Improvements in function also were reported. Nine studies also showed that these improvements were clinically meaningful. “These findings are important because although the average improvement in cognition … did not reach statistical significance, a subset of patients may have clinical improvement,” the panel noted. Up to 57% of patients discontinued their donepezil because of adverse events; the most commonly reported were gastrointestinal upset and muscle cramps.

Ten studies examined the use of galantamine. The drug was associated with statistically significant, but not clinically important, improvements in cognition and behavior. Withdrawal because of adverse events ranged from 8% to 57%, with the most common being gastrointestinal symptoms, eating disorders, weight loss, and dizziness.

Rivastigmine was assessed in nine placebo-controlled studies. Overall, there was significant but very inconsistent cognitive benefit, and no significant benefits on behavior or quality of life. Up to 29% of patients withdrew because of adverse events, including dizziness, nausea and vomiting, diarrhea, weight loss, and headache.

Eight studies examined the use of tacrine; seven were placebo-controlled and one compared tacrine with idebenone. One trial showed a significant cognitive benefit, and three showed significant benefit in function; there were no effects on behavior or quality of life. Up to 55% of patients discontinued the drug, which was associated with serious adverse events, including hepatic abnormalities and abnormal liver enzymes. The panel concluded that there was insufficient evidence to substantiate any benefit of tacrine on cognition or behavior.

Memantine, the only neuropeptide-modifying agent available in the United States, was assessed in five studies, all of which compared the drug with placebo. Three trials showed significant, but not clinically important, improvements in cognition.

One study showed significant improvements in behavior, and three showed significant quality of life benefits. The withdrawal rate varied from 9% to 12%. Adverse events included nausea, dizziness, diarrhea, and agitation. The panel found only three high-quality head-to-head trials. Two pitted donepezil against galantamine. One 52-week study showed no significant difference in the primary outcome of function. The other, an 8-week trial, favored galantamine for cognition.

The third trial compared donepezil with rivastigmine over 2 years. Patients taking rivastigmine fared significantly better in function and some measures of behavior, but experienced more adverse events than did those receiving donepezil.

The guideline writing panel attempted to address the appropriate duration of therapy; however, the response to pharmacotherapy varies so widely. Generally, the beneficial effect from any of the drugs–disease stabilization or symptom improvement–will be apparent within 3 months of initiating treatment but will be temporary. When slowing decline is no longer a therapeutic goal, “treatment with a cholinesterase inhibitor or memantine is no longer appropriate.”

Honest communication at the time of diagnosis is the best way to optimize medical therapy, according to Dr. David A. Smith, professor of family medicine at Texas A&M University, College Station. When families and patients understand up front that the benefit from these drugs will be modest and temporary, they are more likely to stick with the treatment plan, squeezing every possible benefit from it. “A lot of people do get started on these drugs, but the dropout rate is huge, because there is this expectation of large benefit,” he said. “But it's important to remember that even small changes in cognition and behavior can roll into bigger changes over time, like in the rate of institutionalization.”

Dr. Thies agreed. Despite their limitations, these drugs are the best that we have, and you don't want patients to throw away the only opportunity that we do have, he said. “You want the patient and family to go into therapy with a rational view of what is going to happen. The more they know about what to expect, the better they will do.”

Early diagnosis is key to getting everyone on the same page about expectations, Dr. Thies said. “If someone with Alzheimer's is to get into this discussion in a rational fashion, early diagnosis is critical. That way, patients can be involved in determining not only the course of therapy, but [also] can express their opinions on placement and end-of-life care. All these questions become much easier if the patient is involved, rather than having the family guess about his wishes at a later point.”

Cholinesterase inhibitors and memantine are not one-size-fits-all drugs that can be prescribed to every patient with dementia and should only be employed after assessing each drug's risk/benefit profile in light of an individual patient's needs, according to a new set of clinical guidelines.

“The most important thing to keep in mind is that there is no cure for dementia,” said Dr. Amir Qaseem, author of the guidelines and a member of the Joint American College of Physicians/American Academy of Family Physicians Panel on Dementia.

“These drugs can only alleviate symptoms and may slightly delay progression. But they should not be prescribed to every dementia patient because the benefits are very modest and some patients may not show benefit at all, and all the drugs carry potential harms.”

Although many patients do show statistically significant improvements while taking the drugs, most of those changes are small and not clinically meaningful, according to the guidelines (Ann. Intern. Med. 2008;148:370–8).

The panel also concluded that there is insufficient evidence to recommended one drug over another for the treatment of dementia. Instead, “the choice of therapy should be based on an evaluation of adverse events, tolerability, and cost, because there is no evidence that one treatment is more effective than another,” Dr. Qaseem said in an interview.

The recommendations are particularly important for primary care physicians, who care for most patients with dementia, said Dr. William Thies, vice president of medical and scientific affairs for the Alzheimer's Association.

“The bulk of dementia patients are being managed by primary care physicians, and this is only going to increase as we deal with the oncoming tidal wave of Alzheimer's patients over the coming decades,” he said in an interview. “As these guidelines point out, the emphasis when treating these patients should be that the physician, patient, and family work together as a unit to decide the best use of a medication and also, the best time to stop.”

The guidelines panel mined data from 59 studies that examined any of the five drugs approved for dementia treatment in the United States (donepezil, rivastigmine, galantamine, tacrine, and memantine). Drugs were assessed for their effects on symptoms (cognition, function, and behavior), quality of life, and their adverse event profile. The results of this evidence review accompany the guidelines (Ann. Int. Med. 2008;148:379–97).

The largest body of high-quality evidence was seen for donepezil: Twenty-four studies compared it with either placebo or vitamin E. Most showed statistically significant effects in favor of the drug for at least one measure of cognition. Improvements in function also were reported. Nine studies also showed that these improvements were clinically meaningful. “These findings are important because although the average improvement in cognition … did not reach statistical significance, a subset of patients may have clinical improvement,” the panel noted. Up to 57% of patients discontinued their donepezil because of adverse events; the most commonly reported were gastrointestinal upset and muscle cramps.

Ten studies examined the use of galantamine. The drug was associated with statistically significant, but not clinically important, improvements in cognition and behavior. Withdrawal because of adverse events ranged from 8% to 57%, with the most common being gastrointestinal symptoms, eating disorders, weight loss, and dizziness.

Rivastigmine was assessed in nine placebo-controlled studies. Overall, there was significant but very inconsistent cognitive benefit, and no significant benefits on behavior or quality of life. Up to 29% of patients withdrew because of adverse events, including dizziness, nausea and vomiting, diarrhea, weight loss, and headache.

Eight studies examined the use of tacrine; seven were placebo-controlled and one compared tacrine with idebenone. One trial showed a significant cognitive benefit, and three showed significant benefit in function; there were no effects on behavior or quality of life. Up to 55% of patients discontinued the drug, which was associated with serious adverse events, including hepatic abnormalities and abnormal liver enzymes. The panel concluded that there was insufficient evidence to substantiate any benefit of tacrine on cognition or behavior.

Memantine, the only neuropeptide-modifying agent available in the United States, was assessed in five studies, all of which compared the drug with placebo. Three trials showed significant, but not clinically important, improvements in cognition.

One study showed significant improvements in behavior, and three showed significant quality of life benefits. The withdrawal rate varied from 9% to 12%. Adverse events included nausea, dizziness, diarrhea, and agitation. The panel found only three high-quality head-to-head trials. Two pitted donepezil against galantamine. One 52-week study showed no significant difference in the primary outcome of function. The other, an 8-week trial, favored galantamine for cognition.

The third trial compared donepezil with rivastigmine over 2 years. Patients taking rivastigmine fared significantly better in function and some measures of behavior, but experienced more adverse events than did those receiving donepezil.

The guideline writing panel attempted to address the appropriate duration of therapy; however, the response to pharmacotherapy varies so widely. Generally, the beneficial effect from any of the drugs–disease stabilization or symptom improvement–will be apparent within 3 months of initiating treatment but will be temporary. When slowing decline is no longer a therapeutic goal, “treatment with a cholinesterase inhibitor or memantine is no longer appropriate.”

Honest communication at the time of diagnosis is the best way to optimize medical therapy, according to Dr. David A. Smith, professor of family medicine at Texas A&M University, College Station. When families and patients understand up front that the benefit from these drugs will be modest and temporary, they are more likely to stick with the treatment plan, squeezing every possible benefit from it. “A lot of people do get started on these drugs, but the dropout rate is huge, because there is this expectation of large benefit,” he said. “But it's important to remember that even small changes in cognition and behavior can roll into bigger changes over time, like in the rate of institutionalization.”

Dr. Thies agreed. Despite their limitations, these drugs are the best that we have, and you don't want patients to throw away the only opportunity that we do have, he said. “You want the patient and family to go into therapy with a rational view of what is going to happen. The more they know about what to expect, the better they will do.”

Early diagnosis is key to getting everyone on the same page about expectations, Dr. Thies said. “If someone with Alzheimer's is to get into this discussion in a rational fashion, early diagnosis is critical. That way, patients can be involved in determining not only the course of therapy, but [also] can express their opinions on placement and end-of-life care. All these questions become much easier if the patient is involved, rather than having the family guess about his wishes at a later point.”

Cholinesterase inhibitors and memantine are not one-size-fits-all drugs that can be prescribed to every patient with dementia and should only be employed after assessing each drug's risk/benefit profile in light of an individual patient's needs, according to a new set of clinical guidelines.

“The most important thing to keep in mind is that there is no cure for dementia,” said Dr. Amir Qaseem, author of the guidelines and a member of the Joint American College of Physicians/American Academy of Family Physicians Panel on Dementia.

“These drugs can only alleviate symptoms and may slightly delay progression. But they should not be prescribed to every dementia patient because the benefits are very modest and some patients may not show benefit at all, and all the drugs carry potential harms.”

Although many patients do show statistically significant improvements while taking the drugs, most of those changes are small and not clinically meaningful, according to the guidelines (Ann. Intern. Med. 2008;148:370–8).

The panel also concluded that there is insufficient evidence to recommended one drug over another for the treatment of dementia. Instead, “the choice of therapy should be based on an evaluation of adverse events, tolerability, and cost, because there is no evidence that one treatment is more effective than another,” Dr. Qaseem said in an interview.

The recommendations are particularly important for primary care physicians, who care for most patients with dementia, said Dr. William Thies, vice president of medical and scientific affairs for the Alzheimer's Association.

“The bulk of dementia patients are being managed by primary care physicians, and this is only going to increase as we deal with the oncoming tidal wave of Alzheimer's patients over the coming decades,” he said in an interview. “As these guidelines point out, the emphasis when treating these patients should be that the physician, patient, and family work together as a unit to decide the best use of a medication and also, the best time to stop.”

The guidelines panel mined data from 59 studies that examined any of the five drugs approved for dementia treatment in the United States (donepezil, rivastigmine, galantamine, tacrine, and memantine). Drugs were assessed for their effects on symptoms (cognition, function, and behavior), quality of life, and their adverse event profile. The results of this evidence review accompany the guidelines (Ann. Int. Med. 2008;148:379–97).

The largest body of high-quality evidence was seen for donepezil: Twenty-four studies compared it with either placebo or vitamin E. Most showed statistically significant effects in favor of the drug for at least one measure of cognition. Improvements in function also were reported. Nine studies also showed that these improvements were clinically meaningful. “These findings are important because although the average improvement in cognition … did not reach statistical significance, a subset of patients may have clinical improvement,” the panel noted. Up to 57% of patients discontinued their donepezil because of adverse events; the most commonly reported were gastrointestinal upset and muscle cramps.

Ten studies examined the use of galantamine. The drug was associated with statistically significant, but not clinically important, improvements in cognition and behavior. Withdrawal because of adverse events ranged from 8% to 57%, with the most common being gastrointestinal symptoms, eating disorders, weight loss, and dizziness.

Rivastigmine was assessed in nine placebo-controlled studies. Overall, there was significant but very inconsistent cognitive benefit, and no significant benefits on behavior or quality of life. Up to 29% of patients withdrew because of adverse events, including dizziness, nausea and vomiting, diarrhea, weight loss, and headache.

Eight studies examined the use of tacrine; seven were placebo-controlled and one compared tacrine with idebenone. One trial showed a significant cognitive benefit, and three showed significant benefit in function; there were no effects on behavior or quality of life. Up to 55% of patients discontinued the drug, which was associated with serious adverse events, including hepatic abnormalities and abnormal liver enzymes. The panel concluded that there was insufficient evidence to substantiate any benefit of tacrine on cognition or behavior.

Memantine, the only neuropeptide-modifying agent available in the United States, was assessed in five studies, all of which compared the drug with placebo. Three trials showed significant, but not clinically important, improvements in cognition.

One study showed significant improvements in behavior, and three showed significant quality of life benefits. The withdrawal rate varied from 9% to 12%. Adverse events included nausea, dizziness, diarrhea, and agitation. The panel found only three high-quality head-to-head trials. Two pitted donepezil against galantamine. One 52-week study showed no significant difference in the primary outcome of function. The other, an 8-week trial, favored galantamine for cognition.

The third trial compared donepezil with rivastigmine over 2 years. Patients taking rivastigmine fared significantly better in function and some measures of behavior, but experienced more adverse events than did those receiving donepezil.

The guideline writing panel attempted to address the appropriate duration of therapy; however, the response to pharmacotherapy varies so widely. Generally, the beneficial effect from any of the drugs–disease stabilization or symptom improvement–will be apparent within 3 months of initiating treatment but will be temporary. When slowing decline is no longer a therapeutic goal, “treatment with a cholinesterase inhibitor or memantine is no longer appropriate.”

Honest communication at the time of diagnosis is the best way to optimize medical therapy, according to Dr. David A. Smith, professor of family medicine at Texas A&M University, College Station. When families and patients understand up front that the benefit from these drugs will be modest and temporary, they are more likely to stick with the treatment plan, squeezing every possible benefit from it. “A lot of people do get started on these drugs, but the dropout rate is huge, because there is this expectation of large benefit,” he said. “But it's important to remember that even small changes in cognition and behavior can roll into bigger changes over time, like in the rate of institutionalization.”

Dr. Thies agreed. Despite their limitations, these drugs are the best that we have, and you don't want patients to throw away the only opportunity that we do have, he said. “You want the patient and family to go into therapy with a rational view of what is going to happen. The more they know about what to expect, the better they will do.”

Early diagnosis is key to getting everyone on the same page about expectations, Dr. Thies said. “If someone with Alzheimer's is to get into this discussion in a rational fashion, early diagnosis is critical. That way, patients can be involved in determining not only the course of therapy, but [also] can express their opinions on placement and end-of-life care. All these questions become much easier if the patient is involved, rather than having the family guess about his wishes at a later point.”

BOSTON — Erythropoietin is quickly becoming an integral part of hepatitis C treatment regimens, despite a lack of firm data supporting its long-term clinical benefit, Dr. Eric Yoshida said at the annual meeting of the American Association for the Study of Liver Diseases.

Only a few studies have prospectively examined the effect of erythropoietin in these patients, and whereas the studies have shown statistically significant improvements in terms of increasing hemoglobin levels and allowing for maintenance of ribavirin dosage, opinions vary on whether these differences translate into clinical benefit.

“Does this mean there is no place for erythropoietin for these patients? No, I don't think so. I think what it means is that we should treat the patient—not the numbers,” said Dr. Yoshida, head of gastroenterology at the University of British Columbia, Vancouver.

Ribavirin, considered a mainstay of antiviral therapy for hepatitis patients, can cause a dose-dependent hemolytic anemia.

Guidelines suggest decreasing the dosage of ribavirin when hemoglobin levels fall below 12 g/dL, and discontinuing the drug if levels fall below 8.5 g/dL.

But because ribavirin is so important to sustained viral response, some patients persist with their ribavirin even when they develop an anemia that significantly impairs their quality of life, Dr. Yoshida said.

He reviewed three studies that have examined the effect of erythropoietin in hepatitis C patients.

The first study, a 2003 placebo-controlled trial, randomized 64 patients to either standard of care (placebo) or weekly erythropoietin injections for 16 weeks. At baseline, the mean hemoglobin level was 11 g/dL in both groups (Am. J. Gastroenterol. 2003;98:2491–9).

At the study's end, patients receiving erythropoietin had significantly higher mean hemoglobin levels (14 g/dL versus 11 g/dL). Additionally, ribavirin dosage was similar in both groups, indicating that those taking the study drug were able to maintain their ribavirin dosage.

By the end of the trial, undetectable HCV RNA was seen in 69% of erythropoietin-treated patients and 60% of placebo patients. However, Dr. Yoshida pointed out, there was an unexpectedly high dropout rate (42% of erythropoietin patients and 50% of placebo patients). The dropout rate makes it difficult to conclude that the difference in percentage of patients with undetectable HCV RNA was related to erythropoietin therapy.

A second study, published in 2004, randomized 185 patients to placebo or erythropoietin for 8 weeks. After 8 weeks, eligible patients from both groups entered into an 8-week open-label trial (Gastroenterology 2004;126:1302–11).

By the end of the first 8 weeks, significantly more erythropoietin-treated patients than placebo patients were still taking their baseline ribavirin dose (88% versus 60%, respectively). At the end of the crossover phase, prior placebo patients had increased their ribavirin dosage significantly, from a mean of 852 mg/day to a mean of 921 mg/day.

Baseline hemoglobin levels (11 g/dL in both groups) rose to 13 g/dL in the erythropoietin group by the end of the first 8 weeks, but remained unchanged in the placebo group.

By the end of the open-label phase, mean hemoglobin levels in prior placebo patients were the same as those in patients who had taken erythropoietin for the entire study (13 g/dL).

A post hoc analysis concluded that erythropoietin-treated patients also reported significant improvements in their quality of life (Hepatology 2004;40:1450–8). The importance of quality-of-life benefits should not be underestimated in hepatitis patients, Dr. Yoshida said, because quality-of-life scores of HCV patients on treatment can be lower than those of patients with diabetes and heart failure.

The study did not find significant differences between groups in HCV RNA levels.

These trials raise yet more questions, Dr. Yoshida said. The hemoglobin level that should trigger erythropoietin treatment is still unclear. “Should the availability of erythropoietin change the hemoglobin threshold, especially when improved undetectable HCV RNA, sustained viral response, and survival have not been documented with its use?” Others might argue that starting the drug when patients have higher hemoglobin levels that are just starting to slide would be beneficial, he said.

There are also no firm data on the duration of erythropoietin treatment that is beneficial, and the studies performed to date offer little guidance.

The drug is expensive as well, adding almost $16,500 per year to the cost of treatment for hepatitis C, according to a cost-effectiveness study that Dr. Yoshida cited (Clin. Gastroenterol. Hepatol. 2005;3:1034–42). But that study also concluded that if a third-party payer covered $50,000 for every quality-of-life year gained with erythropoietin therapy, 86% of patients would still be treated “within budget.”

Still, noted Dr. Yoshida, the drug's expense along with its unproven survival benefit are enough to signal caution to many health care providers, especially those in countries with socialized health care systems.

“Hopefully, future trials will address these questions,” he said.

Dr. Yoshida's review was summarized in the Annals of Pharmacotherapy (2007;41:268–75).

He declared no financial interest in any hematopoietic agent.

BOSTON — Erythropoietin is quickly becoming an integral part of hepatitis C treatment regimens, despite a lack of firm data supporting its long-term clinical benefit, Dr. Eric Yoshida said at the annual meeting of the American Association for the Study of Liver Diseases.

Only a few studies have prospectively examined the effect of erythropoietin in these patients, and whereas the studies have shown statistically significant improvements in terms of increasing hemoglobin levels and allowing for maintenance of ribavirin dosage, opinions vary on whether these differences translate into clinical benefit.

“Does this mean there is no place for erythropoietin for these patients? No, I don't think so. I think what it means is that we should treat the patient—not the numbers,” said Dr. Yoshida, head of gastroenterology at the University of British Columbia, Vancouver.

Ribavirin, considered a mainstay of antiviral therapy for hepatitis patients, can cause a dose-dependent hemolytic anemia.

Guidelines suggest decreasing the dosage of ribavirin when hemoglobin levels fall below 12 g/dL, and discontinuing the drug if levels fall below 8.5 g/dL.

But because ribavirin is so important to sustained viral response, some patients persist with their ribavirin even when they develop an anemia that significantly impairs their quality of life, Dr. Yoshida said.

He reviewed three studies that have examined the effect of erythropoietin in hepatitis C patients.

The first study, a 2003 placebo-controlled trial, randomized 64 patients to either standard of care (placebo) or weekly erythropoietin injections for 16 weeks. At baseline, the mean hemoglobin level was 11 g/dL in both groups (Am. J. Gastroenterol. 2003;98:2491–9).

At the study's end, patients receiving erythropoietin had significantly higher mean hemoglobin levels (14 g/dL versus 11 g/dL). Additionally, ribavirin dosage was similar in both groups, indicating that those taking the study drug were able to maintain their ribavirin dosage.

By the end of the trial, undetectable HCV RNA was seen in 69% of erythropoietin-treated patients and 60% of placebo patients. However, Dr. Yoshida pointed out, there was an unexpectedly high dropout rate (42% of erythropoietin patients and 50% of placebo patients). The dropout rate makes it difficult to conclude that the difference in percentage of patients with undetectable HCV RNA was related to erythropoietin therapy.

A second study, published in 2004, randomized 185 patients to placebo or erythropoietin for 8 weeks. After 8 weeks, eligible patients from both groups entered into an 8-week open-label trial (Gastroenterology 2004;126:1302–11).

By the end of the first 8 weeks, significantly more erythropoietin-treated patients than placebo patients were still taking their baseline ribavirin dose (88% versus 60%, respectively). At the end of the crossover phase, prior placebo patients had increased their ribavirin dosage significantly, from a mean of 852 mg/day to a mean of 921 mg/day.

Baseline hemoglobin levels (11 g/dL in both groups) rose to 13 g/dL in the erythropoietin group by the end of the first 8 weeks, but remained unchanged in the placebo group.

By the end of the open-label phase, mean hemoglobin levels in prior placebo patients were the same as those in patients who had taken erythropoietin for the entire study (13 g/dL).

A post hoc analysis concluded that erythropoietin-treated patients also reported significant improvements in their quality of life (Hepatology 2004;40:1450–8). The importance of quality-of-life benefits should not be underestimated in hepatitis patients, Dr. Yoshida said, because quality-of-life scores of HCV patients on treatment can be lower than those of patients with diabetes and heart failure.

The study did not find significant differences between groups in HCV RNA levels.

These trials raise yet more questions, Dr. Yoshida said. The hemoglobin level that should trigger erythropoietin treatment is still unclear. “Should the availability of erythropoietin change the hemoglobin threshold, especially when improved undetectable HCV RNA, sustained viral response, and survival have not been documented with its use?” Others might argue that starting the drug when patients have higher hemoglobin levels that are just starting to slide would be beneficial, he said.

There are also no firm data on the duration of erythropoietin treatment that is beneficial, and the studies performed to date offer little guidance.

The drug is expensive as well, adding almost $16,500 per year to the cost of treatment for hepatitis C, according to a cost-effectiveness study that Dr. Yoshida cited (Clin. Gastroenterol. Hepatol. 2005;3:1034–42). But that study also concluded that if a third-party payer covered $50,000 for every quality-of-life year gained with erythropoietin therapy, 86% of patients would still be treated “within budget.”

Still, noted Dr. Yoshida, the drug's expense along with its unproven survival benefit are enough to signal caution to many health care providers, especially those in countries with socialized health care systems.

“Hopefully, future trials will address these questions,” he said.

Dr. Yoshida's review was summarized in the Annals of Pharmacotherapy (2007;41:268–75).

He declared no financial interest in any hematopoietic agent.

BOSTON — Erythropoietin is quickly becoming an integral part of hepatitis C treatment regimens, despite a lack of firm data supporting its long-term clinical benefit, Dr. Eric Yoshida said at the annual meeting of the American Association for the Study of Liver Diseases.

Only a few studies have prospectively examined the effect of erythropoietin in these patients, and whereas the studies have shown statistically significant improvements in terms of increasing hemoglobin levels and allowing for maintenance of ribavirin dosage, opinions vary on whether these differences translate into clinical benefit.

“Does this mean there is no place for erythropoietin for these patients? No, I don't think so. I think what it means is that we should treat the patient—not the numbers,” said Dr. Yoshida, head of gastroenterology at the University of British Columbia, Vancouver.

Ribavirin, considered a mainstay of antiviral therapy for hepatitis patients, can cause a dose-dependent hemolytic anemia.

Guidelines suggest decreasing the dosage of ribavirin when hemoglobin levels fall below 12 g/dL, and discontinuing the drug if levels fall below 8.5 g/dL.

But because ribavirin is so important to sustained viral response, some patients persist with their ribavirin even when they develop an anemia that significantly impairs their quality of life, Dr. Yoshida said.

He reviewed three studies that have examined the effect of erythropoietin in hepatitis C patients.

The first study, a 2003 placebo-controlled trial, randomized 64 patients to either standard of care (placebo) or weekly erythropoietin injections for 16 weeks. At baseline, the mean hemoglobin level was 11 g/dL in both groups (Am. J. Gastroenterol. 2003;98:2491–9).

At the study's end, patients receiving erythropoietin had significantly higher mean hemoglobin levels (14 g/dL versus 11 g/dL). Additionally, ribavirin dosage was similar in both groups, indicating that those taking the study drug were able to maintain their ribavirin dosage.

By the end of the trial, undetectable HCV RNA was seen in 69% of erythropoietin-treated patients and 60% of placebo patients. However, Dr. Yoshida pointed out, there was an unexpectedly high dropout rate (42% of erythropoietin patients and 50% of placebo patients). The dropout rate makes it difficult to conclude that the difference in percentage of patients with undetectable HCV RNA was related to erythropoietin therapy.

A second study, published in 2004, randomized 185 patients to placebo or erythropoietin for 8 weeks. After 8 weeks, eligible patients from both groups entered into an 8-week open-label trial (Gastroenterology 2004;126:1302–11).

By the end of the first 8 weeks, significantly more erythropoietin-treated patients than placebo patients were still taking their baseline ribavirin dose (88% versus 60%, respectively). At the end of the crossover phase, prior placebo patients had increased their ribavirin dosage significantly, from a mean of 852 mg/day to a mean of 921 mg/day.

Baseline hemoglobin levels (11 g/dL in both groups) rose to 13 g/dL in the erythropoietin group by the end of the first 8 weeks, but remained unchanged in the placebo group.

By the end of the open-label phase, mean hemoglobin levels in prior placebo patients were the same as those in patients who had taken erythropoietin for the entire study (13 g/dL).

A post hoc analysis concluded that erythropoietin-treated patients also reported significant improvements in their quality of life (Hepatology 2004;40:1450–8). The importance of quality-of-life benefits should not be underestimated in hepatitis patients, Dr. Yoshida said, because quality-of-life scores of HCV patients on treatment can be lower than those of patients with diabetes and heart failure.

The study did not find significant differences between groups in HCV RNA levels.

These trials raise yet more questions, Dr. Yoshida said. The hemoglobin level that should trigger erythropoietin treatment is still unclear. “Should the availability of erythropoietin change the hemoglobin threshold, especially when improved undetectable HCV RNA, sustained viral response, and survival have not been documented with its use?” Others might argue that starting the drug when patients have higher hemoglobin levels that are just starting to slide would be beneficial, he said.

There are also no firm data on the duration of erythropoietin treatment that is beneficial, and the studies performed to date offer little guidance.

The drug is expensive as well, adding almost $16,500 per year to the cost of treatment for hepatitis C, according to a cost-effectiveness study that Dr. Yoshida cited (Clin. Gastroenterol. Hepatol. 2005;3:1034–42). But that study also concluded that if a third-party payer covered $50,000 for every quality-of-life year gained with erythropoietin therapy, 86% of patients would still be treated “within budget.”

Still, noted Dr. Yoshida, the drug's expense along with its unproven survival benefit are enough to signal caution to many health care providers, especially those in countries with socialized health care systems.

“Hopefully, future trials will address these questions,” he said.

Dr. Yoshida's review was summarized in the Annals of Pharmacotherapy (2007;41:268–75).

He declared no financial interest in any hematopoietic agent.

CHICAGO — Safety concerns and lack of efficacy continue to dash researchers' hopes of a vaginal microbicide that would protect women from sexually transmitted diseases and HIV.

“In the last year, we have had some major, huge disappointments,” Dr. Jeanne Marrazzo said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. “It has proven very, very difficult to deliver a broad-spectrum microbicide while preserving safety and protecting the integrity of the vaginal mucosa as well as the vaginal flora.”

The last 24 months have seen the closure of four highly anticipated studies—one of them when the data safety and monitoring committee actually found an increased risk of HIV among women taking the active product.

Two phase III studies involved cellulose sulfate, a topical microbicide gel, said Dr. Marrazzo, an infectious disease specialist at the University of Washington, Seattle. The trials, which comprised 2,600 women, were being conducted in Africa and India.

The first study, sponsored by CONRAD—an organization established jointly by the U.S. Agency for International Development and Eastern Virginia Medical School, Norfolk—was halted in January 2007 because of a higher number of HIV infections in the active group, compared with the placebo group. In light of those findings, Family Health International, a nonprofit international public health agency, halted its own cellulose sulfate trial.

FHI's research had suffered a previous setback in 2006, when it closed its trial of Savvy gel, a vaginal microbicide tested in a phase II randomized, controlled trial of 2,150 women in Nigeria. The investigators saw no evidence that the product was effective in preventing infections.

A similar disappointment occurred at a microbicide research meeting in New Delhi in February, when the Population Council, an international nonprofit research institution, released negative data on its phase III, randomized controlled trial of Carraguard. The seaweed-based vaginal gel was being tested as an HIV and STD preventative.

That trial enrolled 6,200 women in South Africa, and investigators found that although the product was safe, it was not effective for preventing HIV infections; 134 new infections occurred in the experimental arm, compared with 151 new infections in the placebo arm.

“The positive thing is that this study did get completed, and the gel might have a future use as a vehicle for another microbicide,” Dr. Marrazzo said.

Only the HIV results were released at the February meeting, she said, but researchers aren't hopeful that the results for other STDs will be any better. “I think it will be a surprise if Carraguard does prevent these other infections.”

Three studies are ongoing, she noted. The National Institute of Allergy and Infectious Diseases is studying BufferGel, a gel designed to maintain vaginal acidity at a level that deactivates HIV particles, and PRO 2000/5, a gel that inhibits viral entry into susceptible cells. Both of these agents will be tested at seven sites (one in the United States and six in Africa). The patient cohort of 3,100 will be followed for up to 30 months. “The study population has been fully enrolled since last summer, and we hope to have results by the end of this year or early 2009,” Dr. Marrazzo said.

The U.K. Microbicide Development Program is also looking at PRO 2000/5 in a larger study of 9,600 women. Results are expected in 2009 or 2010.

Because of the disappointing results with microbicides and increased pressure to find a prophylactic approach to HIV infection, researchers are now focusing much more attention on vaginal antiretrovirals, especially tenofovir, Dr. Marrazzo said. “This is exciting, but also scary because some women who use these drugs prophylactically will contract HIV, and there is a possibility that they will then show early treatment resistance to tenofovir, which is the backbone of antiretroviral therapy.”

A gel containing 1% tenofovir is getting the most attention, Dr. Marrazzo said. “Some data presented at the New Delhi meeting showed that it was very safe, had no local inflammatory response, and doesn't change the vaginal microflora. It is absorbed, however, and so there are questions about later resistance.”

The National Institutes of Health are now launching the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study. VOICE will enroll 4,200 women at 10 African sites. The women will be randomized to active compounds or placebo in one of three arms: once-daily oral tenofovir, a daily two-drug oral antiretroviral regimen, or once-daily 1% tenofovir vaginal gel.

Any trial that asks young, healthy, HIV-negative women to take an antiretroviral drug for an unknown benefit raises concern, Dr. Marrazzo noted. “But if you are a 16-year-old girl in South Africa, your chances of getting HIV are extraordinarily high. The annual seroconversion rate there is 6%. When you look at the risk of becoming infected, balanced against a potentially toxic prophylactic regimen, it becomes a very complex decision.”

Dr. Marrazzo did not report any financial conflicts of interest.

CHICAGO — Safety concerns and lack of efficacy continue to dash researchers' hopes of a vaginal microbicide that would protect women from sexually transmitted diseases and HIV.

“In the last year, we have had some major, huge disappointments,” Dr. Jeanne Marrazzo said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. “It has proven very, very difficult to deliver a broad-spectrum microbicide while preserving safety and protecting the integrity of the vaginal mucosa as well as the vaginal flora.”

The last 24 months have seen the closure of four highly anticipated studies—one of them when the data safety and monitoring committee actually found an increased risk of HIV among women taking the active product.

Two phase III studies involved cellulose sulfate, a topical microbicide gel, said Dr. Marrazzo, an infectious disease specialist at the University of Washington, Seattle. The trials, which comprised 2,600 women, were being conducted in Africa and India.

The first study, sponsored by CONRAD—an organization established jointly by the U.S. Agency for International Development and Eastern Virginia Medical School, Norfolk—was halted in January 2007 because of a higher number of HIV infections in the active group, compared with the placebo group. In light of those findings, Family Health International, a nonprofit international public health agency, halted its own cellulose sulfate trial.

FHI's research had suffered a previous setback in 2006, when it closed its trial of Savvy gel, a vaginal microbicide tested in a phase II randomized, controlled trial of 2,150 women in Nigeria. The investigators saw no evidence that the product was effective in preventing infections.

A similar disappointment occurred at a microbicide research meeting in New Delhi in February, when the Population Council, an international nonprofit research institution, released negative data on its phase III, randomized controlled trial of Carraguard. The seaweed-based vaginal gel was being tested as an HIV and STD preventative.

That trial enrolled 6,200 women in South Africa, and investigators found that although the product was safe, it was not effective for preventing HIV infections; 134 new infections occurred in the experimental arm, compared with 151 new infections in the placebo arm.

“The positive thing is that this study did get completed, and the gel might have a future use as a vehicle for another microbicide,” Dr. Marrazzo said.

Only the HIV results were released at the February meeting, she said, but researchers aren't hopeful that the results for other STDs will be any better. “I think it will be a surprise if Carraguard does prevent these other infections.”

Three studies are ongoing, she noted. The National Institute of Allergy and Infectious Diseases is studying BufferGel, a gel designed to maintain vaginal acidity at a level that deactivates HIV particles, and PRO 2000/5, a gel that inhibits viral entry into susceptible cells. Both of these agents will be tested at seven sites (one in the United States and six in Africa). The patient cohort of 3,100 will be followed for up to 30 months. “The study population has been fully enrolled since last summer, and we hope to have results by the end of this year or early 2009,” Dr. Marrazzo said.

The U.K. Microbicide Development Program is also looking at PRO 2000/5 in a larger study of 9,600 women. Results are expected in 2009 or 2010.

Because of the disappointing results with microbicides and increased pressure to find a prophylactic approach to HIV infection, researchers are now focusing much more attention on vaginal antiretrovirals, especially tenofovir, Dr. Marrazzo said. “This is exciting, but also scary because some women who use these drugs prophylactically will contract HIV, and there is a possibility that they will then show early treatment resistance to tenofovir, which is the backbone of antiretroviral therapy.”

A gel containing 1% tenofovir is getting the most attention, Dr. Marrazzo said. “Some data presented at the New Delhi meeting showed that it was very safe, had no local inflammatory response, and doesn't change the vaginal microflora. It is absorbed, however, and so there are questions about later resistance.”

The National Institutes of Health are now launching the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study. VOICE will enroll 4,200 women at 10 African sites. The women will be randomized to active compounds or placebo in one of three arms: once-daily oral tenofovir, a daily two-drug oral antiretroviral regimen, or once-daily 1% tenofovir vaginal gel.

Any trial that asks young, healthy, HIV-negative women to take an antiretroviral drug for an unknown benefit raises concern, Dr. Marrazzo noted. “But if you are a 16-year-old girl in South Africa, your chances of getting HIV are extraordinarily high. The annual seroconversion rate there is 6%. When you look at the risk of becoming infected, balanced against a potentially toxic prophylactic regimen, it becomes a very complex decision.”

Dr. Marrazzo did not report any financial conflicts of interest.

CHICAGO — Safety concerns and lack of efficacy continue to dash researchers' hopes of a vaginal microbicide that would protect women from sexually transmitted diseases and HIV.

“In the last year, we have had some major, huge disappointments,” Dr. Jeanne Marrazzo said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. “It has proven very, very difficult to deliver a broad-spectrum microbicide while preserving safety and protecting the integrity of the vaginal mucosa as well as the vaginal flora.”

The last 24 months have seen the closure of four highly anticipated studies—one of them when the data safety and monitoring committee actually found an increased risk of HIV among women taking the active product.

Two phase III studies involved cellulose sulfate, a topical microbicide gel, said Dr. Marrazzo, an infectious disease specialist at the University of Washington, Seattle. The trials, which comprised 2,600 women, were being conducted in Africa and India.

The first study, sponsored by CONRAD—an organization established jointly by the U.S. Agency for International Development and Eastern Virginia Medical School, Norfolk—was halted in January 2007 because of a higher number of HIV infections in the active group, compared with the placebo group. In light of those findings, Family Health International, a nonprofit international public health agency, halted its own cellulose sulfate trial.

FHI's research had suffered a previous setback in 2006, when it closed its trial of Savvy gel, a vaginal microbicide tested in a phase II randomized, controlled trial of 2,150 women in Nigeria. The investigators saw no evidence that the product was effective in preventing infections.

A similar disappointment occurred at a microbicide research meeting in New Delhi in February, when the Population Council, an international nonprofit research institution, released negative data on its phase III, randomized controlled trial of Carraguard. The seaweed-based vaginal gel was being tested as an HIV and STD preventative.

That trial enrolled 6,200 women in South Africa, and investigators found that although the product was safe, it was not effective for preventing HIV infections; 134 new infections occurred in the experimental arm, compared with 151 new infections in the placebo arm.

“The positive thing is that this study did get completed, and the gel might have a future use as a vehicle for another microbicide,” Dr. Marrazzo said.

Only the HIV results were released at the February meeting, she said, but researchers aren't hopeful that the results for other STDs will be any better. “I think it will be a surprise if Carraguard does prevent these other infections.”

Three studies are ongoing, she noted. The National Institute of Allergy and Infectious Diseases is studying BufferGel, a gel designed to maintain vaginal acidity at a level that deactivates HIV particles, and PRO 2000/5, a gel that inhibits viral entry into susceptible cells. Both of these agents will be tested at seven sites (one in the United States and six in Africa). The patient cohort of 3,100 will be followed for up to 30 months. “The study population has been fully enrolled since last summer, and we hope to have results by the end of this year or early 2009,” Dr. Marrazzo said.

The U.K. Microbicide Development Program is also looking at PRO 2000/5 in a larger study of 9,600 women. Results are expected in 2009 or 2010.

Because of the disappointing results with microbicides and increased pressure to find a prophylactic approach to HIV infection, researchers are now focusing much more attention on vaginal antiretrovirals, especially tenofovir, Dr. Marrazzo said. “This is exciting, but also scary because some women who use these drugs prophylactically will contract HIV, and there is a possibility that they will then show early treatment resistance to tenofovir, which is the backbone of antiretroviral therapy.”

A gel containing 1% tenofovir is getting the most attention, Dr. Marrazzo said. “Some data presented at the New Delhi meeting showed that it was very safe, had no local inflammatory response, and doesn't change the vaginal microflora. It is absorbed, however, and so there are questions about later resistance.”

The National Institutes of Health are now launching the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study. VOICE will enroll 4,200 women at 10 African sites. The women will be randomized to active compounds or placebo in one of three arms: once-daily oral tenofovir, a daily two-drug oral antiretroviral regimen, or once-daily 1% tenofovir vaginal gel.

Any trial that asks young, healthy, HIV-negative women to take an antiretroviral drug for an unknown benefit raises concern, Dr. Marrazzo noted. “But if you are a 16-year-old girl in South Africa, your chances of getting HIV are extraordinarily high. The annual seroconversion rate there is 6%. When you look at the risk of becoming infected, balanced against a potentially toxic prophylactic regimen, it becomes a very complex decision.”

Dr. Marrazzo did not report any financial conflicts of interest.