Sharon Worcester

ORLANDO, FLA. — Metabolic syndrome may be a greater risk factor for stroke and vascular events in women than in men, and limited access to social resources appears to contribute to its development, Bernadette Boden-Albala, Ph.D., reported at an international conference on women, heart disease, and stroke.

In the longitudinal Northern Manhattan Study (NOMAS) of 3,297 adult community residents who were stroke-free at study entry and followed for a mean of 5 years, nearly 46% of the 2,077 women and 35% of the men met the criteria for metabolic syndrome at study entry, said Dr. Boden-Albala, assistant professor of neurology and public health at the Neurological Institute, New York.

After adjustment for age, race/ethnicity, education, and risk factors, the estimated effect of metabolic syndrome on vascular events—including ischemic stroke, heart attack, and vascular death—was significantly greater in women (hazard ratio 1.8) than in men (1.4). The hazard ratios for stroke risk associated with metabolic syndrome were 2.0 for women and 1.1 for men.

Metabolic syndrome accounted for 27% of vascular events and 30% of stroke events in women in the study, she said during a news conference at the meeting.

Metabolic syndrome was more prevalent in Hispanic women (48%) than in white (36%) or black (34%) women. In a multivariable logistic regression, after adjustment for age, the women with metabolic syndrome were significantly more likely to be Hispanic (hazard ratio 1.6), socially isolated (1.4), Medicaid users (1.3), and physically inactive (1.3)—all factors that Dr. Boden-Albala said represent reduced access to social resources.

The findings are important, given that women and minorities account for the majority of the 47 million Americans with metabolic syndrome, and they suggest that women may be more vulnerable than men to the risks associated with metabolic syndrome, she said.

ORLANDO, FLA. — Metabolic syndrome may be a greater risk factor for stroke and vascular events in women than in men, and limited access to social resources appears to contribute to its development, Bernadette Boden-Albala, Ph.D., reported at an international conference on women, heart disease, and stroke.

In the longitudinal Northern Manhattan Study (NOMAS) of 3,297 adult community residents who were stroke-free at study entry and followed for a mean of 5 years, nearly 46% of the 2,077 women and 35% of the men met the criteria for metabolic syndrome at study entry, said Dr. Boden-Albala, assistant professor of neurology and public health at the Neurological Institute, New York.

After adjustment for age, race/ethnicity, education, and risk factors, the estimated effect of metabolic syndrome on vascular events—including ischemic stroke, heart attack, and vascular death—was significantly greater in women (hazard ratio 1.8) than in men (1.4). The hazard ratios for stroke risk associated with metabolic syndrome were 2.0 for women and 1.1 for men.

Metabolic syndrome accounted for 27% of vascular events and 30% of stroke events in women in the study, she said during a news conference at the meeting.

Metabolic syndrome was more prevalent in Hispanic women (48%) than in white (36%) or black (34%) women. In a multivariable logistic regression, after adjustment for age, the women with metabolic syndrome were significantly more likely to be Hispanic (hazard ratio 1.6), socially isolated (1.4), Medicaid users (1.3), and physically inactive (1.3)—all factors that Dr. Boden-Albala said represent reduced access to social resources.

The findings are important, given that women and minorities account for the majority of the 47 million Americans with metabolic syndrome, and they suggest that women may be more vulnerable than men to the risks associated with metabolic syndrome, she said.

ORLANDO, FLA. — Metabolic syndrome may be a greater risk factor for stroke and vascular events in women than in men, and limited access to social resources appears to contribute to its development, Bernadette Boden-Albala, Ph.D., reported at an international conference on women, heart disease, and stroke.

In the longitudinal Northern Manhattan Study (NOMAS) of 3,297 adult community residents who were stroke-free at study entry and followed for a mean of 5 years, nearly 46% of the 2,077 women and 35% of the men met the criteria for metabolic syndrome at study entry, said Dr. Boden-Albala, assistant professor of neurology and public health at the Neurological Institute, New York.

After adjustment for age, race/ethnicity, education, and risk factors, the estimated effect of metabolic syndrome on vascular events—including ischemic stroke, heart attack, and vascular death—was significantly greater in women (hazard ratio 1.8) than in men (1.4). The hazard ratios for stroke risk associated with metabolic syndrome were 2.0 for women and 1.1 for men.

Metabolic syndrome accounted for 27% of vascular events and 30% of stroke events in women in the study, she said during a news conference at the meeting.

Metabolic syndrome was more prevalent in Hispanic women (48%) than in white (36%) or black (34%) women. In a multivariable logistic regression, after adjustment for age, the women with metabolic syndrome were significantly more likely to be Hispanic (hazard ratio 1.6), socially isolated (1.4), Medicaid users (1.3), and physically inactive (1.3)—all factors that Dr. Boden-Albala said represent reduced access to social resources.

The findings are important, given that women and minorities account for the majority of the 47 million Americans with metabolic syndrome, and they suggest that women may be more vulnerable than men to the risks associated with metabolic syndrome, she said.

FORT LAUDERDALE, FLA. — Prevention is the best medicine when it comes to enterocele formation, so consider performing a McCall's culdoplasty in all patients undergoing vaginal hysterectomy, G. Willy Davila, M.D., advised.

“I almost always do McCall's culdoplasty when I do a vaginal hysterectomy, and so should you,” Dr. Davila said at a symposium on pelvic floor disorders, sponsored by the Cleveland Clinic Florida.

The procedure—which involves opening the vaginal cuff and suturing the full thickness of the vaginal mucosa, peritoneum, and uterosacral ligaments—results in elevation of the vaginal apex. It has been shown to help prevent posthysterectomy prolapse and recurrent prolapse, according to Dr. Davila, chair of the clinic's department of gynecology and head of the section of urogynecology and reconstructive pelvic surgery.

In patients with an existing enterocele, this culdoplasty technique can also be used for repair, although additional sutures may be needed. Permanent sutures are recommended.

If a discrete tear of the endopelvic fascia from the vaginal apex is noted in relationship to the enterocele, the fascia should also be reattached to the apex to correct the enterocele.

Cystoscopy should be performed to ensure that the ureters are not compromised. In addition, tagging the uterosacral ligaments so you know exactly where they are can help you to avoid ureteral injury in the vast majority of cases, he said.

FORT LAUDERDALE, FLA. — Prevention is the best medicine when it comes to enterocele formation, so consider performing a McCall's culdoplasty in all patients undergoing vaginal hysterectomy, G. Willy Davila, M.D., advised.

“I almost always do McCall's culdoplasty when I do a vaginal hysterectomy, and so should you,” Dr. Davila said at a symposium on pelvic floor disorders, sponsored by the Cleveland Clinic Florida.

The procedure—which involves opening the vaginal cuff and suturing the full thickness of the vaginal mucosa, peritoneum, and uterosacral ligaments—results in elevation of the vaginal apex. It has been shown to help prevent posthysterectomy prolapse and recurrent prolapse, according to Dr. Davila, chair of the clinic's department of gynecology and head of the section of urogynecology and reconstructive pelvic surgery.

In patients with an existing enterocele, this culdoplasty technique can also be used for repair, although additional sutures may be needed. Permanent sutures are recommended.

If a discrete tear of the endopelvic fascia from the vaginal apex is noted in relationship to the enterocele, the fascia should also be reattached to the apex to correct the enterocele.

Cystoscopy should be performed to ensure that the ureters are not compromised. In addition, tagging the uterosacral ligaments so you know exactly where they are can help you to avoid ureteral injury in the vast majority of cases, he said.

FORT LAUDERDALE, FLA. — Prevention is the best medicine when it comes to enterocele formation, so consider performing a McCall's culdoplasty in all patients undergoing vaginal hysterectomy, G. Willy Davila, M.D., advised.

“I almost always do McCall's culdoplasty when I do a vaginal hysterectomy, and so should you,” Dr. Davila said at a symposium on pelvic floor disorders, sponsored by the Cleveland Clinic Florida.

The procedure—which involves opening the vaginal cuff and suturing the full thickness of the vaginal mucosa, peritoneum, and uterosacral ligaments—results in elevation of the vaginal apex. It has been shown to help prevent posthysterectomy prolapse and recurrent prolapse, according to Dr. Davila, chair of the clinic's department of gynecology and head of the section of urogynecology and reconstructive pelvic surgery.

In patients with an existing enterocele, this culdoplasty technique can also be used for repair, although additional sutures may be needed. Permanent sutures are recommended.

If a discrete tear of the endopelvic fascia from the vaginal apex is noted in relationship to the enterocele, the fascia should also be reattached to the apex to correct the enterocele.

Cystoscopy should be performed to ensure that the ureters are not compromised. In addition, tagging the uterosacral ligaments so you know exactly where they are can help you to avoid ureteral injury in the vast majority of cases, he said.

FORT LAUDERDALE, FLA. — The key to successful treatment of true rectal prolapse is an individualized approach, and in many cases that means a multidisciplinary approach, Eric G. Weiss, M.D., said at a symposium on pelvic floor disorders sponsored by the Cleveland Clinic Florida.

That's because the majority of women with rectal prolapse have concomitant genital prolapse and/or urinary incontinence. In addition, expanding knowledge of pelvic floor function—and the evolution of the concept of the pelvic floor as a single functioning unit with anterior and posterior components—has led to a greater effort to treat these conditions simultaneously. At the Cleveland Clinic Florida, about 65% of women with rectal prolapse also have urinary incontinence, and about 34% have genital prolapse, said Dr. Weiss, a colorectal surgeon and director of surgical endoscopy at the clinic.

The evaluation of women presenting with rectal prolapse, then, should include a complete vaginal pelvic examination by a urogynecologist, he said.

The evaluation should also differentiate between hemorrhoids and rectal prolapse, which are often confused.

Many women are referred for hemorrhoids when they actually have true rectal prolapse—or full thickness prolapse of the rectum through the anal sphincters. The reverse is also true, with some women with hemorrhoids being misdiagnosed with prolapse.

Rectal prolapse will often have a target-like appearance with circular folds of tissue circumferentially protruding from the anus— often up to 10-15 cm. Hemorrhoids, which can include mucosal prolapse, have radial folds that rarely protrude more than 5 cm.

The anorectal evaluation of patients with suspected rectal prolapse should be performed in the prone jack-knife position, in which the prolapse may be immediately evident.

But in some patients it may also be necessary to perform the examination with the patient in a squatting position, with the patient pushing down to demonstrate the prolapse.

Anal sphincter tone at rest and squeezing should be evaluated to assess damage from chronic prolapse, and a digital examination is necessary to check for palpable masses.

Conditions such as fecal incontinence and constipation—the presence of which should be elicited during a thorough history—are secondary to the prolapse. These will resolve following correction of the prolapse unless they are due to another condition, such as pudendal neuropathy.

To rule out colonic pathology, perform a complete endoscopic evaluation, and colonoscopy should be considered in older patients.

When the prolapse is not demonstrable during the evaluation, defecography is useful for identifying rectoceles and other pathology that might be affecting evacuation.

If surgery is being considered, a cardiovascular assessment is important to determine if the patient is a good candidate.

The type of surgery selected depends largely on patient age and health, Dr. Weiss said.

Abdominal approaches typically are more effective, but are associated with greater morbidity. Therefore, they are typically reserved for younger patients with a good surgical risk profile. Perineal procedures are associated with more recurrences, but usually are a safer option for the elderly and other higher risk patients.

The abdominal approaches use posterior mobilization of the rectum with fixation to the sacrum. Rectopexy is most common, and other approaches include anterior resection, and combined sigmoid resection and rectopexy. Complication rates range from 15% to 29%, and mortality ranges from 0% to 2%. Recurrence rates are low, ranging from 2% to 12%.

A common complication with rectopexy is constipation, but some data suggest this may be overcome by using the combined rectopexy/sigmoid resection procedure, Dr. Weiss noted.

The perineal approach usually involves rectosigmoidectomy. Studies suggest that perineal rectosigmoidectomy outcomes are improved when levatorplasty is also performed.

In one Cleveland Clinic Florida series of 84 patients with severe fecal incontinence and rectal prolapse treated over a 7-year period, those who were treated with both had significantly lower recurrence rates and decreased incontinence scores, compared with those who underwent only perineal rectosigmoidectomy, Dr. Weiss noted.

The recurrence rate there for all perineal procedures is about 13%, compared with 5% for perineal rectosigmoidectomy with levatorplasty, and the recurrence-free interval was longer in this group of patients, he added.

Another perineal option is the Delorme procedure, which involves circumferential incision of the mucosa of the prolapsed rectal wall just above the dentate line, and circumferential dissection in the submucosal layer of the prolapsed bowel as far up as possible. This is followed by plication of the muscular layer of the prolapsed muscle and coloanal anastomosis.

FORT LAUDERDALE, FLA. — The key to successful treatment of true rectal prolapse is an individualized approach, and in many cases that means a multidisciplinary approach, Eric G. Weiss, M.D., said at a symposium on pelvic floor disorders sponsored by the Cleveland Clinic Florida.

That's because the majority of women with rectal prolapse have concomitant genital prolapse and/or urinary incontinence. In addition, expanding knowledge of pelvic floor function—and the evolution of the concept of the pelvic floor as a single functioning unit with anterior and posterior components—has led to a greater effort to treat these conditions simultaneously. At the Cleveland Clinic Florida, about 65% of women with rectal prolapse also have urinary incontinence, and about 34% have genital prolapse, said Dr. Weiss, a colorectal surgeon and director of surgical endoscopy at the clinic.

The evaluation of women presenting with rectal prolapse, then, should include a complete vaginal pelvic examination by a urogynecologist, he said.

The evaluation should also differentiate between hemorrhoids and rectal prolapse, which are often confused.

Many women are referred for hemorrhoids when they actually have true rectal prolapse—or full thickness prolapse of the rectum through the anal sphincters. The reverse is also true, with some women with hemorrhoids being misdiagnosed with prolapse.

Rectal prolapse will often have a target-like appearance with circular folds of tissue circumferentially protruding from the anus— often up to 10-15 cm. Hemorrhoids, which can include mucosal prolapse, have radial folds that rarely protrude more than 5 cm.

The anorectal evaluation of patients with suspected rectal prolapse should be performed in the prone jack-knife position, in which the prolapse may be immediately evident.

But in some patients it may also be necessary to perform the examination with the patient in a squatting position, with the patient pushing down to demonstrate the prolapse.

Anal sphincter tone at rest and squeezing should be evaluated to assess damage from chronic prolapse, and a digital examination is necessary to check for palpable masses.

Conditions such as fecal incontinence and constipation—the presence of which should be elicited during a thorough history—are secondary to the prolapse. These will resolve following correction of the prolapse unless they are due to another condition, such as pudendal neuropathy.

To rule out colonic pathology, perform a complete endoscopic evaluation, and colonoscopy should be considered in older patients.

When the prolapse is not demonstrable during the evaluation, defecography is useful for identifying rectoceles and other pathology that might be affecting evacuation.

If surgery is being considered, a cardiovascular assessment is important to determine if the patient is a good candidate.

The type of surgery selected depends largely on patient age and health, Dr. Weiss said.

Abdominal approaches typically are more effective, but are associated with greater morbidity. Therefore, they are typically reserved for younger patients with a good surgical risk profile. Perineal procedures are associated with more recurrences, but usually are a safer option for the elderly and other higher risk patients.

The abdominal approaches use posterior mobilization of the rectum with fixation to the sacrum. Rectopexy is most common, and other approaches include anterior resection, and combined sigmoid resection and rectopexy. Complication rates range from 15% to 29%, and mortality ranges from 0% to 2%. Recurrence rates are low, ranging from 2% to 12%.

A common complication with rectopexy is constipation, but some data suggest this may be overcome by using the combined rectopexy/sigmoid resection procedure, Dr. Weiss noted.

The perineal approach usually involves rectosigmoidectomy. Studies suggest that perineal rectosigmoidectomy outcomes are improved when levatorplasty is also performed.

In one Cleveland Clinic Florida series of 84 patients with severe fecal incontinence and rectal prolapse treated over a 7-year period, those who were treated with both had significantly lower recurrence rates and decreased incontinence scores, compared with those who underwent only perineal rectosigmoidectomy, Dr. Weiss noted.

The recurrence rate there for all perineal procedures is about 13%, compared with 5% for perineal rectosigmoidectomy with levatorplasty, and the recurrence-free interval was longer in this group of patients, he added.

Another perineal option is the Delorme procedure, which involves circumferential incision of the mucosa of the prolapsed rectal wall just above the dentate line, and circumferential dissection in the submucosal layer of the prolapsed bowel as far up as possible. This is followed by plication of the muscular layer of the prolapsed muscle and coloanal anastomosis.

FORT LAUDERDALE, FLA. — The key to successful treatment of true rectal prolapse is an individualized approach, and in many cases that means a multidisciplinary approach, Eric G. Weiss, M.D., said at a symposium on pelvic floor disorders sponsored by the Cleveland Clinic Florida.

That's because the majority of women with rectal prolapse have concomitant genital prolapse and/or urinary incontinence. In addition, expanding knowledge of pelvic floor function—and the evolution of the concept of the pelvic floor as a single functioning unit with anterior and posterior components—has led to a greater effort to treat these conditions simultaneously. At the Cleveland Clinic Florida, about 65% of women with rectal prolapse also have urinary incontinence, and about 34% have genital prolapse, said Dr. Weiss, a colorectal surgeon and director of surgical endoscopy at the clinic.

The evaluation of women presenting with rectal prolapse, then, should include a complete vaginal pelvic examination by a urogynecologist, he said.

The evaluation should also differentiate between hemorrhoids and rectal prolapse, which are often confused.

Many women are referred for hemorrhoids when they actually have true rectal prolapse—or full thickness prolapse of the rectum through the anal sphincters. The reverse is also true, with some women with hemorrhoids being misdiagnosed with prolapse.

Rectal prolapse will often have a target-like appearance with circular folds of tissue circumferentially protruding from the anus— often up to 10-15 cm. Hemorrhoids, which can include mucosal prolapse, have radial folds that rarely protrude more than 5 cm.

The anorectal evaluation of patients with suspected rectal prolapse should be performed in the prone jack-knife position, in which the prolapse may be immediately evident.

But in some patients it may also be necessary to perform the examination with the patient in a squatting position, with the patient pushing down to demonstrate the prolapse.

Anal sphincter tone at rest and squeezing should be evaluated to assess damage from chronic prolapse, and a digital examination is necessary to check for palpable masses.

Conditions such as fecal incontinence and constipation—the presence of which should be elicited during a thorough history—are secondary to the prolapse. These will resolve following correction of the prolapse unless they are due to another condition, such as pudendal neuropathy.

To rule out colonic pathology, perform a complete endoscopic evaluation, and colonoscopy should be considered in older patients.

When the prolapse is not demonstrable during the evaluation, defecography is useful for identifying rectoceles and other pathology that might be affecting evacuation.

If surgery is being considered, a cardiovascular assessment is important to determine if the patient is a good candidate.

The type of surgery selected depends largely on patient age and health, Dr. Weiss said.

Abdominal approaches typically are more effective, but are associated with greater morbidity. Therefore, they are typically reserved for younger patients with a good surgical risk profile. Perineal procedures are associated with more recurrences, but usually are a safer option for the elderly and other higher risk patients.

The abdominal approaches use posterior mobilization of the rectum with fixation to the sacrum. Rectopexy is most common, and other approaches include anterior resection, and combined sigmoid resection and rectopexy. Complication rates range from 15% to 29%, and mortality ranges from 0% to 2%. Recurrence rates are low, ranging from 2% to 12%.

A common complication with rectopexy is constipation, but some data suggest this may be overcome by using the combined rectopexy/sigmoid resection procedure, Dr. Weiss noted.

The perineal approach usually involves rectosigmoidectomy. Studies suggest that perineal rectosigmoidectomy outcomes are improved when levatorplasty is also performed.

In one Cleveland Clinic Florida series of 84 patients with severe fecal incontinence and rectal prolapse treated over a 7-year period, those who were treated with both had significantly lower recurrence rates and decreased incontinence scores, compared with those who underwent only perineal rectosigmoidectomy, Dr. Weiss noted.

The recurrence rate there for all perineal procedures is about 13%, compared with 5% for perineal rectosigmoidectomy with levatorplasty, and the recurrence-free interval was longer in this group of patients, he added.

Another perineal option is the Delorme procedure, which involves circumferential incision of the mucosa of the prolapsed rectal wall just above the dentate line, and circumferential dissection in the submucosal layer of the prolapsed bowel as far up as possible. This is followed by plication of the muscular layer of the prolapsed muscle and coloanal anastomosis.

FORT LAUDERDALE, FLA. — Patients presenting with anal pain pose a diagnostic challenge, but a careful, detailed history will lead to the correct diagnosis in 90% of cases, Dana R. Sands, M.D., said at a symposium on pelvic floor disorders sponsored by the Cleveland Clinic Florida.

Ask patients about the quality of their pain, as well as the location, the presence of radiating pain, and the duration of pain, advised Dr. Sands, associate staff surgeon at the Cleveland Clinic Florida, Weston.

Also, associated symptoms—such as changes in bowel habits and bleeding, a history of similar pain, medication use, and information about sexual practices— can help in nailing down a diagnosis.

Among the differential diagnoses are:

▸ Hemorrhoids. Most patients presenting with anal pain have been referred for, or believe they have, hemorrhoids. In some cases hemorrhoids are the cause of the pain, but it is important to keep in mind that only external thrombosing hemorrhoids or prolapsed internal hemorrhoids will cause pain. The pain may be described as acute in onset, short-term, and associated with occasional bright red bleeding and the sensation of a lump around the anal canal, Dr. Sands said.

If the pain is severe, excision can usually be accomplished in the office setting, but prolapsed, irreducible internal hemorrhoids can become gangrenous and pose a surgical emergency.

▸ Anal abscesses. Pain associated with anal abscesses is insidious in onset and is usually associated with fever, swelling, and drainage. Patients may have a history of a previous abscess. Evaluation and treatment is entirely dependent on the location of the abscess, as various spaces around the anal canal can harbor abscesses.

The most common type is a perianal abscess, which can usually be drained easily. Unexplained anal pain is often attributed to internal hemorrhoids or fissures, but may be due to an internal abscess. Such pain warrants examination of the patient under anesthesia, Dr. Sands stressed.

▸ Fissures. Patients with anal fissures describe severe pain, bright red blood from the rectum, and pain for 3-4 hours following a bowel movement. There is no associated fever and usually no drainage. Patients may describe being afraid to move their bowels, and the history may include an episode of diarrhea or constipation. Many patients have had long-term anal pain, indicating chronic fissures.

Patients with fissures are in agony—and are “terribly afraid and extremely anxious” about undergoing an anal examination, Dr. Sands said.

In most cases, the diagnosis can be made by visual inspection of the anal verge with the patient in the prone jackknife position. The digital examination usually cannot be tolerated and can be reserved for after the patient has been treated and the pain is improved or resolved.

▸ Tumors. Pain associated with anal cancer is insidious in onset. Patients do not complain of fever or prolapse, but may describe a recent change in bowel habits. A lesion may be noted on the anal margin, or digital examination may reveal a palpable mass.

Low-lying rectal cancers can also cause anal pain, and may be associated with fecal urgency, bloody stool, swelling, weight loss, and a change in the caliber of the stool. The tumor may be palpable on digital examination; pay careful attention to the posterior midline, which is the location where rectal cancer is most often missed, Dr. Sands noted at the meeting.

Patients with unexplained anal pain and no obvious benign condition who cannot tolerate an office examination should be examined under anesthesia, she said.

▸ Stenosis. This painful condition has a slow onset and can result from overly aggressive anal surgery, such as hemorrhoidectomy. Radiation injury to the anal canal and Crohn's disease also can cause stenosis. The patient complains of painful bowel movements and a change in the caliber of the stool, but not of fever or prolapse.

▸ Infection. Sexually transmitted diseases are a common cause of anal pain. Ulcerations around the anal canal may signal an STD. Ask about potential exposures during the history, examine external genitalia for additional clues to the diagnosis, and follow up with appropriate cultures and biopsies, Dr. Sands advised.

▸ Proctalgia. This is a diagnosis of exclusion in patients presenting with rectal pain and pressure. They describe increased pain after bowel movement, but not of bleeding or fever. They may describe long-term pain.

“I find this is reproducible on palpation of the levator muscles,” said Dr. Sands, noting that patients may also have associated anal hypertonia.

A good endoscopic evaluation is important in these patients, and once organic pathology is ruled out, a diagnosis of proctalgia is appropriate, she said.

FORT LAUDERDALE, FLA. — Patients presenting with anal pain pose a diagnostic challenge, but a careful, detailed history will lead to the correct diagnosis in 90% of cases, Dana R. Sands, M.D., said at a symposium on pelvic floor disorders sponsored by the Cleveland Clinic Florida.

Ask patients about the quality of their pain, as well as the location, the presence of radiating pain, and the duration of pain, advised Dr. Sands, associate staff surgeon at the Cleveland Clinic Florida, Weston.

Also, associated symptoms—such as changes in bowel habits and bleeding, a history of similar pain, medication use, and information about sexual practices— can help in nailing down a diagnosis.

Among the differential diagnoses are:

▸ Hemorrhoids. Most patients presenting with anal pain have been referred for, or believe they have, hemorrhoids. In some cases hemorrhoids are the cause of the pain, but it is important to keep in mind that only external thrombosing hemorrhoids or prolapsed internal hemorrhoids will cause pain. The pain may be described as acute in onset, short-term, and associated with occasional bright red bleeding and the sensation of a lump around the anal canal, Dr. Sands said.

If the pain is severe, excision can usually be accomplished in the office setting, but prolapsed, irreducible internal hemorrhoids can become gangrenous and pose a surgical emergency.

▸ Anal abscesses. Pain associated with anal abscesses is insidious in onset and is usually associated with fever, swelling, and drainage. Patients may have a history of a previous abscess. Evaluation and treatment is entirely dependent on the location of the abscess, as various spaces around the anal canal can harbor abscesses.

The most common type is a perianal abscess, which can usually be drained easily. Unexplained anal pain is often attributed to internal hemorrhoids or fissures, but may be due to an internal abscess. Such pain warrants examination of the patient under anesthesia, Dr. Sands stressed.

▸ Fissures. Patients with anal fissures describe severe pain, bright red blood from the rectum, and pain for 3-4 hours following a bowel movement. There is no associated fever and usually no drainage. Patients may describe being afraid to move their bowels, and the history may include an episode of diarrhea or constipation. Many patients have had long-term anal pain, indicating chronic fissures.

Patients with fissures are in agony—and are “terribly afraid and extremely anxious” about undergoing an anal examination, Dr. Sands said.

In most cases, the diagnosis can be made by visual inspection of the anal verge with the patient in the prone jackknife position. The digital examination usually cannot be tolerated and can be reserved for after the patient has been treated and the pain is improved or resolved.

▸ Tumors. Pain associated with anal cancer is insidious in onset. Patients do not complain of fever or prolapse, but may describe a recent change in bowel habits. A lesion may be noted on the anal margin, or digital examination may reveal a palpable mass.

Low-lying rectal cancers can also cause anal pain, and may be associated with fecal urgency, bloody stool, swelling, weight loss, and a change in the caliber of the stool. The tumor may be palpable on digital examination; pay careful attention to the posterior midline, which is the location where rectal cancer is most often missed, Dr. Sands noted at the meeting.

Patients with unexplained anal pain and no obvious benign condition who cannot tolerate an office examination should be examined under anesthesia, she said.

▸ Stenosis. This painful condition has a slow onset and can result from overly aggressive anal surgery, such as hemorrhoidectomy. Radiation injury to the anal canal and Crohn's disease also can cause stenosis. The patient complains of painful bowel movements and a change in the caliber of the stool, but not of fever or prolapse.

▸ Infection. Sexually transmitted diseases are a common cause of anal pain. Ulcerations around the anal canal may signal an STD. Ask about potential exposures during the history, examine external genitalia for additional clues to the diagnosis, and follow up with appropriate cultures and biopsies, Dr. Sands advised.

▸ Proctalgia. This is a diagnosis of exclusion in patients presenting with rectal pain and pressure. They describe increased pain after bowel movement, but not of bleeding or fever. They may describe long-term pain.

“I find this is reproducible on palpation of the levator muscles,” said Dr. Sands, noting that patients may also have associated anal hypertonia.

A good endoscopic evaluation is important in these patients, and once organic pathology is ruled out, a diagnosis of proctalgia is appropriate, she said.

FORT LAUDERDALE, FLA. — Patients presenting with anal pain pose a diagnostic challenge, but a careful, detailed history will lead to the correct diagnosis in 90% of cases, Dana R. Sands, M.D., said at a symposium on pelvic floor disorders sponsored by the Cleveland Clinic Florida.

Ask patients about the quality of their pain, as well as the location, the presence of radiating pain, and the duration of pain, advised Dr. Sands, associate staff surgeon at the Cleveland Clinic Florida, Weston.

Also, associated symptoms—such as changes in bowel habits and bleeding, a history of similar pain, medication use, and information about sexual practices— can help in nailing down a diagnosis.

Among the differential diagnoses are:

▸ Hemorrhoids. Most patients presenting with anal pain have been referred for, or believe they have, hemorrhoids. In some cases hemorrhoids are the cause of the pain, but it is important to keep in mind that only external thrombosing hemorrhoids or prolapsed internal hemorrhoids will cause pain. The pain may be described as acute in onset, short-term, and associated with occasional bright red bleeding and the sensation of a lump around the anal canal, Dr. Sands said.

If the pain is severe, excision can usually be accomplished in the office setting, but prolapsed, irreducible internal hemorrhoids can become gangrenous and pose a surgical emergency.

▸ Anal abscesses. Pain associated with anal abscesses is insidious in onset and is usually associated with fever, swelling, and drainage. Patients may have a history of a previous abscess. Evaluation and treatment is entirely dependent on the location of the abscess, as various spaces around the anal canal can harbor abscesses.

The most common type is a perianal abscess, which can usually be drained easily. Unexplained anal pain is often attributed to internal hemorrhoids or fissures, but may be due to an internal abscess. Such pain warrants examination of the patient under anesthesia, Dr. Sands stressed.

▸ Fissures. Patients with anal fissures describe severe pain, bright red blood from the rectum, and pain for 3-4 hours following a bowel movement. There is no associated fever and usually no drainage. Patients may describe being afraid to move their bowels, and the history may include an episode of diarrhea or constipation. Many patients have had long-term anal pain, indicating chronic fissures.

Patients with fissures are in agony—and are “terribly afraid and extremely anxious” about undergoing an anal examination, Dr. Sands said.

In most cases, the diagnosis can be made by visual inspection of the anal verge with the patient in the prone jackknife position. The digital examination usually cannot be tolerated and can be reserved for after the patient has been treated and the pain is improved or resolved.

▸ Tumors. Pain associated with anal cancer is insidious in onset. Patients do not complain of fever or prolapse, but may describe a recent change in bowel habits. A lesion may be noted on the anal margin, or digital examination may reveal a palpable mass.

Low-lying rectal cancers can also cause anal pain, and may be associated with fecal urgency, bloody stool, swelling, weight loss, and a change in the caliber of the stool. The tumor may be palpable on digital examination; pay careful attention to the posterior midline, which is the location where rectal cancer is most often missed, Dr. Sands noted at the meeting.

Patients with unexplained anal pain and no obvious benign condition who cannot tolerate an office examination should be examined under anesthesia, she said.

▸ Stenosis. This painful condition has a slow onset and can result from overly aggressive anal surgery, such as hemorrhoidectomy. Radiation injury to the anal canal and Crohn's disease also can cause stenosis. The patient complains of painful bowel movements and a change in the caliber of the stool, but not of fever or prolapse.

▸ Infection. Sexually transmitted diseases are a common cause of anal pain. Ulcerations around the anal canal may signal an STD. Ask about potential exposures during the history, examine external genitalia for additional clues to the diagnosis, and follow up with appropriate cultures and biopsies, Dr. Sands advised.

▸ Proctalgia. This is a diagnosis of exclusion in patients presenting with rectal pain and pressure. They describe increased pain after bowel movement, but not of bleeding or fever. They may describe long-term pain.

“I find this is reproducible on palpation of the levator muscles,” said Dr. Sands, noting that patients may also have associated anal hypertonia.

A good endoscopic evaluation is important in these patients, and once organic pathology is ruled out, a diagnosis of proctalgia is appropriate, she said.

ORLANDO, FLA. — Declining estrogen levels during late perimenopause and postmenopause substantially affect the peripheral vasculature, recent study data suggest.

Specifically, lower estrogen levels during these periods were associated with larger common carotid artery (CCA) adventitial diameter, Rachel P. Wildman, Ph.D., reported at an international conference on women, heart disease, and stroke.

This can be problematic, because greater baseline dilation limits the future ability to dilate and compensate for adverse conditions such as increased blood pressure, explained Dr. Wildman of Tulane University, New Orleans.

In 377 white and African American women from the Pittsburgh and Chicago sites of the Study of Women's Health Across the Nation (SWAN), an ongoing multiethnic, multisite longitudinal study of the menopausal transition, the cross-sectional relationship between the CCA adventitial diameter and both menopausal status and sex hormones was assessed.

Artery diameter was measured using B-mode ultrasound, and sex-hormone tests evaluated levels of estrogen, testosterone, FSH, sex hormone binding globulin, the free androgen index, testosterone not bound by sex hormone binding globulin, and androgen excess.

The women had a mean age of 50 years, and 149 were in late perimenopause or postmenopause. These women, compared with those in pre- or early perimenopause, had significantly higher total and LDL cholesterol, lower HDL cholesterol, lower estrogen, and higher androgen excess levels.

CCA adventitial diameter in the late perimenopausal and postmenopausal women were significantly larger overall, compared with those in pre- or early perimenopause (6.84 mm vs. 6.70 mm), but the differences appeared to be limited to those with higher baseline cholesterol levels.

As for the relationship between sex hormones and CCA adventitial diameter, only decreased estrogen levels were significantly associated with increased diameters, but in the subset of patients with systolic blood pressure over 140 mm Hg, decreased androgen levels were also strongly associated with larger diameter.

The findings suggest that the menopausal transition with its accompanying decrease in estrogen levels is associated with decreased vascular tone, and it appears that women with higher cholesterol and blood pressure are at the greatest risk, she said,

Follow-up data in the SWAN participants are being collected by the investigators for further evaluation of these interactions.

ORLANDO, FLA. — Declining estrogen levels during late perimenopause and postmenopause substantially affect the peripheral vasculature, recent study data suggest.

Specifically, lower estrogen levels during these periods were associated with larger common carotid artery (CCA) adventitial diameter, Rachel P. Wildman, Ph.D., reported at an international conference on women, heart disease, and stroke.

This can be problematic, because greater baseline dilation limits the future ability to dilate and compensate for adverse conditions such as increased blood pressure, explained Dr. Wildman of Tulane University, New Orleans.

In 377 white and African American women from the Pittsburgh and Chicago sites of the Study of Women's Health Across the Nation (SWAN), an ongoing multiethnic, multisite longitudinal study of the menopausal transition, the cross-sectional relationship between the CCA adventitial diameter and both menopausal status and sex hormones was assessed.

Artery diameter was measured using B-mode ultrasound, and sex-hormone tests evaluated levels of estrogen, testosterone, FSH, sex hormone binding globulin, the free androgen index, testosterone not bound by sex hormone binding globulin, and androgen excess.

The women had a mean age of 50 years, and 149 were in late perimenopause or postmenopause. These women, compared with those in pre- or early perimenopause, had significantly higher total and LDL cholesterol, lower HDL cholesterol, lower estrogen, and higher androgen excess levels.

CCA adventitial diameter in the late perimenopausal and postmenopausal women were significantly larger overall, compared with those in pre- or early perimenopause (6.84 mm vs. 6.70 mm), but the differences appeared to be limited to those with higher baseline cholesterol levels.

As for the relationship between sex hormones and CCA adventitial diameter, only decreased estrogen levels were significantly associated with increased diameters, but in the subset of patients with systolic blood pressure over 140 mm Hg, decreased androgen levels were also strongly associated with larger diameter.

The findings suggest that the menopausal transition with its accompanying decrease in estrogen levels is associated with decreased vascular tone, and it appears that women with higher cholesterol and blood pressure are at the greatest risk, she said,

Follow-up data in the SWAN participants are being collected by the investigators for further evaluation of these interactions.

ORLANDO, FLA. — Declining estrogen levels during late perimenopause and postmenopause substantially affect the peripheral vasculature, recent study data suggest.

Specifically, lower estrogen levels during these periods were associated with larger common carotid artery (CCA) adventitial diameter, Rachel P. Wildman, Ph.D., reported at an international conference on women, heart disease, and stroke.

This can be problematic, because greater baseline dilation limits the future ability to dilate and compensate for adverse conditions such as increased blood pressure, explained Dr. Wildman of Tulane University, New Orleans.

In 377 white and African American women from the Pittsburgh and Chicago sites of the Study of Women's Health Across the Nation (SWAN), an ongoing multiethnic, multisite longitudinal study of the menopausal transition, the cross-sectional relationship between the CCA adventitial diameter and both menopausal status and sex hormones was assessed.

Artery diameter was measured using B-mode ultrasound, and sex-hormone tests evaluated levels of estrogen, testosterone, FSH, sex hormone binding globulin, the free androgen index, testosterone not bound by sex hormone binding globulin, and androgen excess.

The women had a mean age of 50 years, and 149 were in late perimenopause or postmenopause. These women, compared with those in pre- or early perimenopause, had significantly higher total and LDL cholesterol, lower HDL cholesterol, lower estrogen, and higher androgen excess levels.

CCA adventitial diameter in the late perimenopausal and postmenopausal women were significantly larger overall, compared with those in pre- or early perimenopause (6.84 mm vs. 6.70 mm), but the differences appeared to be limited to those with higher baseline cholesterol levels.

As for the relationship between sex hormones and CCA adventitial diameter, only decreased estrogen levels were significantly associated with increased diameters, but in the subset of patients with systolic blood pressure over 140 mm Hg, decreased androgen levels were also strongly associated with larger diameter.

The findings suggest that the menopausal transition with its accompanying decrease in estrogen levels is associated with decreased vascular tone, and it appears that women with higher cholesterol and blood pressure are at the greatest risk, she said,

Follow-up data in the SWAN participants are being collected by the investigators for further evaluation of these interactions.

ORLANDO, FLA. — Pregnancy-induced hypertension and polycystic ovarian syndrome may be risk markers for later development of metabolic syndrome, Stephen Franks, M.D., said at an international conference on women, heart disease, and stroke.

The findings are important because they suggest that identification of those at risk for metabolic syndrome, and interventions to reduce that risk, can begin as early as adolescence, when polycystic ovarian syndrome (PCOS) typically emerges, said Dr. Franks of the Imperial College London.

The prevalence of metabolic syndrome in women is “staggeringly high,” and the hazard ratio for cardiovascular mortality in women with metabolic syndrome is nearly 2.8. For diabetes, the hazard ratio is 6.3.

“So there is an enormously increased risk of heart disease and diabetes; it would be very useful if we could try to predict [metabolic syndrome] and identify those factors that alert us to the possibility of a high risk for metabolic syndrome,” Dr. Franks said.

Several studies show that pregnancy-induced hypertension—including gestational hypertension and preeclampsia—is associated with increased prevalence of markers of metabolic syndrome as well as a higher lifetime risk of heart disease. In one study of nearly 2,700 women with prior gestational hypertension or preeclampsia and an average age of 31 years, the conditions were shown to be associated with increased systolic and diastolic blood pressure, as well as higher body mass index, waist-hip ratio, and other metabolic syndrome markers, compared with a reference population.

PCOS, which affects more than 5% of women of reproductive age, also appears to be associated with risk for metabolic syndrome. Since it presents so early, it may be the first identifiable sign predicting metabolic syndrome, Dr. Franks said.

The definitions of metabolic syndrome vary from study to study, so it is difficult to say just how common metabolic syndrome is in those with PCOS, but one review article suggests the prevalence is about 50% among obese women with PCOS, he said.

Obesity, which is already established as a marker for metabolic syndrome, also appears to act as an amplifier of other etiologic factors, including pregnancy-induced hypertension and PCOS.

Furthermore, at least one study showed that PCOS patients who are obese in their teen years and who remain obese in adulthood have an even greater risk of developing metabolic syndrome.

A fundamental abnormality seen in obese PCOS patients is increased insulin resistance and higher insulin levels, compared with age- and weight-matched controls. In the normal population, as body mass index increases insulin levels also increase, but in PCOS this curve is steeper. In one study of more than 300 women with an average age of 57 years and a history of PCOS, the risk of diabetes was increased nearly threefold compared with controls.

Estimates of PCOS prevalence in young women range from 10% to 40% and the relationship between PCOS and obesity suggests the prevalence is set to increase.

“Adults are getting fatter, children are getting fatter, and obese children become obese adults,” Dr. Franks said.

But there is hope, because even modest reductions in weight with caloric restriction and exercise is proven to modify a woman's risk profile, he said.

Young women with PCOS or pregnancy-induced hypertension—particularly those who are obese—should be identified as being at risk for metabolic syndrome, and interventions should be initiated.

“Diet and lifestyle [changes], however difficult they are to implement, undoubtedly work and are the treatment of choice,” he said.

ORLANDO, FLA. — Pregnancy-induced hypertension and polycystic ovarian syndrome may be risk markers for later development of metabolic syndrome, Stephen Franks, M.D., said at an international conference on women, heart disease, and stroke.

The findings are important because they suggest that identification of those at risk for metabolic syndrome, and interventions to reduce that risk, can begin as early as adolescence, when polycystic ovarian syndrome (PCOS) typically emerges, said Dr. Franks of the Imperial College London.

The prevalence of metabolic syndrome in women is “staggeringly high,” and the hazard ratio for cardiovascular mortality in women with metabolic syndrome is nearly 2.8. For diabetes, the hazard ratio is 6.3.

“So there is an enormously increased risk of heart disease and diabetes; it would be very useful if we could try to predict [metabolic syndrome] and identify those factors that alert us to the possibility of a high risk for metabolic syndrome,” Dr. Franks said.

Several studies show that pregnancy-induced hypertension—including gestational hypertension and preeclampsia—is associated with increased prevalence of markers of metabolic syndrome as well as a higher lifetime risk of heart disease. In one study of nearly 2,700 women with prior gestational hypertension or preeclampsia and an average age of 31 years, the conditions were shown to be associated with increased systolic and diastolic blood pressure, as well as higher body mass index, waist-hip ratio, and other metabolic syndrome markers, compared with a reference population.

PCOS, which affects more than 5% of women of reproductive age, also appears to be associated with risk for metabolic syndrome. Since it presents so early, it may be the first identifiable sign predicting metabolic syndrome, Dr. Franks said.

The definitions of metabolic syndrome vary from study to study, so it is difficult to say just how common metabolic syndrome is in those with PCOS, but one review article suggests the prevalence is about 50% among obese women with PCOS, he said.

Obesity, which is already established as a marker for metabolic syndrome, also appears to act as an amplifier of other etiologic factors, including pregnancy-induced hypertension and PCOS.

Furthermore, at least one study showed that PCOS patients who are obese in their teen years and who remain obese in adulthood have an even greater risk of developing metabolic syndrome.

A fundamental abnormality seen in obese PCOS patients is increased insulin resistance and higher insulin levels, compared with age- and weight-matched controls. In the normal population, as body mass index increases insulin levels also increase, but in PCOS this curve is steeper. In one study of more than 300 women with an average age of 57 years and a history of PCOS, the risk of diabetes was increased nearly threefold compared with controls.

Estimates of PCOS prevalence in young women range from 10% to 40% and the relationship between PCOS and obesity suggests the prevalence is set to increase.

“Adults are getting fatter, children are getting fatter, and obese children become obese adults,” Dr. Franks said.

But there is hope, because even modest reductions in weight with caloric restriction and exercise is proven to modify a woman's risk profile, he said.

Young women with PCOS or pregnancy-induced hypertension—particularly those who are obese—should be identified as being at risk for metabolic syndrome, and interventions should be initiated.

“Diet and lifestyle [changes], however difficult they are to implement, undoubtedly work and are the treatment of choice,” he said.

ORLANDO, FLA. — Pregnancy-induced hypertension and polycystic ovarian syndrome may be risk markers for later development of metabolic syndrome, Stephen Franks, M.D., said at an international conference on women, heart disease, and stroke.

The findings are important because they suggest that identification of those at risk for metabolic syndrome, and interventions to reduce that risk, can begin as early as adolescence, when polycystic ovarian syndrome (PCOS) typically emerges, said Dr. Franks of the Imperial College London.

The prevalence of metabolic syndrome in women is “staggeringly high,” and the hazard ratio for cardiovascular mortality in women with metabolic syndrome is nearly 2.8. For diabetes, the hazard ratio is 6.3.

“So there is an enormously increased risk of heart disease and diabetes; it would be very useful if we could try to predict [metabolic syndrome] and identify those factors that alert us to the possibility of a high risk for metabolic syndrome,” Dr. Franks said.

Several studies show that pregnancy-induced hypertension—including gestational hypertension and preeclampsia—is associated with increased prevalence of markers of metabolic syndrome as well as a higher lifetime risk of heart disease. In one study of nearly 2,700 women with prior gestational hypertension or preeclampsia and an average age of 31 years, the conditions were shown to be associated with increased systolic and diastolic blood pressure, as well as higher body mass index, waist-hip ratio, and other metabolic syndrome markers, compared with a reference population.

PCOS, which affects more than 5% of women of reproductive age, also appears to be associated with risk for metabolic syndrome. Since it presents so early, it may be the first identifiable sign predicting metabolic syndrome, Dr. Franks said.

The definitions of metabolic syndrome vary from study to study, so it is difficult to say just how common metabolic syndrome is in those with PCOS, but one review article suggests the prevalence is about 50% among obese women with PCOS, he said.

Obesity, which is already established as a marker for metabolic syndrome, also appears to act as an amplifier of other etiologic factors, including pregnancy-induced hypertension and PCOS.

Furthermore, at least one study showed that PCOS patients who are obese in their teen years and who remain obese in adulthood have an even greater risk of developing metabolic syndrome.

A fundamental abnormality seen in obese PCOS patients is increased insulin resistance and higher insulin levels, compared with age- and weight-matched controls. In the normal population, as body mass index increases insulin levels also increase, but in PCOS this curve is steeper. In one study of more than 300 women with an average age of 57 years and a history of PCOS, the risk of diabetes was increased nearly threefold compared with controls.

Estimates of PCOS prevalence in young women range from 10% to 40% and the relationship between PCOS and obesity suggests the prevalence is set to increase.

“Adults are getting fatter, children are getting fatter, and obese children become obese adults,” Dr. Franks said.

But there is hope, because even modest reductions in weight with caloric restriction and exercise is proven to modify a woman's risk profile, he said.

Young women with PCOS or pregnancy-induced hypertension—particularly those who are obese—should be identified as being at risk for metabolic syndrome, and interventions should be initiated.

“Diet and lifestyle [changes], however difficult they are to implement, undoubtedly work and are the treatment of choice,” he said.

ORLANDO, FLA. — Corticosteroid use may increase the risk of complications leading to colectomy and death in patients with Clostridium difficile colitis, Sherri L. Burgess, M.D., said at the annual meeting of the American College of Gastroenterology.

Dr. Burgess and her colleagues conducted a case-control chart review of 181 adult patients with confirmed C. difficile colitis. Of these patients, 55 received corticosteroid medications for the treatment of other medical conditions, and 126 did not receive corticosteroids.

The mortality rate was significantly higher in the corticosteroid group, compared with the group not treated with these drugs (40% vs. 15%), as was the colectomy rate (16% vs. 3%), said Dr. Burgess of St. Vincent Charity Hospital, Cleveland.

Furthermore, six of nine patients (67%) who underwent colectomy in the corticosteroid group died, compared with one of four patients (25%) in the control group, she said.

“In our study, we could not explain [the differences] by other patient characteristics or comorbidity,” Dr. Burgess explained.

Patients who developed severe outcomes were generally older, but this was true in both groups. Although serum albumin concentrations were lower in patients who required a colectomy or who died, there was no significant difference in albumin levels between those who did and those who did not receive corticosteroids.

Also, there were greater proportions of women, patients with chronic obstructive pulmonary disease, and patients with heart failure in the corticosteroid group, but this did not appear to influence the risk for severe outcomes, Dr. Burgess said.

The findings suggest that a host immune response to corticosteroids may increase the risk of poor outcomes in patients with severe C. difficile infection.

Additional studies to confirm these results are warranted, Dr. Burgess concluded.

ORLANDO, FLA. — Corticosteroid use may increase the risk of complications leading to colectomy and death in patients with Clostridium difficile colitis, Sherri L. Burgess, M.D., said at the annual meeting of the American College of Gastroenterology.

Dr. Burgess and her colleagues conducted a case-control chart review of 181 adult patients with confirmed C. difficile colitis. Of these patients, 55 received corticosteroid medications for the treatment of other medical conditions, and 126 did not receive corticosteroids.

The mortality rate was significantly higher in the corticosteroid group, compared with the group not treated with these drugs (40% vs. 15%), as was the colectomy rate (16% vs. 3%), said Dr. Burgess of St. Vincent Charity Hospital, Cleveland.

Furthermore, six of nine patients (67%) who underwent colectomy in the corticosteroid group died, compared with one of four patients (25%) in the control group, she said.

“In our study, we could not explain [the differences] by other patient characteristics or comorbidity,” Dr. Burgess explained.

Patients who developed severe outcomes were generally older, but this was true in both groups. Although serum albumin concentrations were lower in patients who required a colectomy or who died, there was no significant difference in albumin levels between those who did and those who did not receive corticosteroids.

Also, there were greater proportions of women, patients with chronic obstructive pulmonary disease, and patients with heart failure in the corticosteroid group, but this did not appear to influence the risk for severe outcomes, Dr. Burgess said.

The findings suggest that a host immune response to corticosteroids may increase the risk of poor outcomes in patients with severe C. difficile infection.

Additional studies to confirm these results are warranted, Dr. Burgess concluded.

ORLANDO, FLA. — Corticosteroid use may increase the risk of complications leading to colectomy and death in patients with Clostridium difficile colitis, Sherri L. Burgess, M.D., said at the annual meeting of the American College of Gastroenterology.

Dr. Burgess and her colleagues conducted a case-control chart review of 181 adult patients with confirmed C. difficile colitis. Of these patients, 55 received corticosteroid medications for the treatment of other medical conditions, and 126 did not receive corticosteroids.

The mortality rate was significantly higher in the corticosteroid group, compared with the group not treated with these drugs (40% vs. 15%), as was the colectomy rate (16% vs. 3%), said Dr. Burgess of St. Vincent Charity Hospital, Cleveland.

Furthermore, six of nine patients (67%) who underwent colectomy in the corticosteroid group died, compared with one of four patients (25%) in the control group, she said.

“In our study, we could not explain [the differences] by other patient characteristics or comorbidity,” Dr. Burgess explained.

Patients who developed severe outcomes were generally older, but this was true in both groups. Although serum albumin concentrations were lower in patients who required a colectomy or who died, there was no significant difference in albumin levels between those who did and those who did not receive corticosteroids.

Also, there were greater proportions of women, patients with chronic obstructive pulmonary disease, and patients with heart failure in the corticosteroid group, but this did not appear to influence the risk for severe outcomes, Dr. Burgess said.

The findings suggest that a host immune response to corticosteroids may increase the risk of poor outcomes in patients with severe C. difficile infection.

Additional studies to confirm these results are warranted, Dr. Burgess concluded.

ORLANDO, FLA. — Enteryx, an implantable copolymer approved by the Food and Drug Administration for the treatment of gastroesophageal reflux disease symptoms in 2003, appears to have durable efficacy and safety, David Johnson, M.D., reported in a poster at the annual meeting of the American College of Gastroenterology.

Of 300 patients participating in a 36-month, FDA-mandated postmarket study, 64 patients have completed 24 months of follow-up. Of these, 43 completely eliminated the use of proton pump inhibitor therapy and 3 others reduced their use of PPI therapy by at least 50%, said Dr. Johnson of Eastern Virginia School of Medicine, Norfolk.

The patients, who had well characterized GERD symptoms and were PPI dependent prior to the injection of Enteryx (Boston Scientific Corp.) into the lower esophageal sphincter, also had a median improvement of 80% in GERD health-related quality of life heartburn scores, and a median improvement of 88% in regurgitation scores, compared with baseline scores prior to initiation of PPI therapy, he noted.

No new device-related adverse events occurred during follow-up, and the observed clinical benefits were stable at 6, 12, and 24 months, he said.

ORLANDO, FLA. — Enteryx, an implantable copolymer approved by the Food and Drug Administration for the treatment of gastroesophageal reflux disease symptoms in 2003, appears to have durable efficacy and safety, David Johnson, M.D., reported in a poster at the annual meeting of the American College of Gastroenterology.

Of 300 patients participating in a 36-month, FDA-mandated postmarket study, 64 patients have completed 24 months of follow-up. Of these, 43 completely eliminated the use of proton pump inhibitor therapy and 3 others reduced their use of PPI therapy by at least 50%, said Dr. Johnson of Eastern Virginia School of Medicine, Norfolk.

The patients, who had well characterized GERD symptoms and were PPI dependent prior to the injection of Enteryx (Boston Scientific Corp.) into the lower esophageal sphincter, also had a median improvement of 80% in GERD health-related quality of life heartburn scores, and a median improvement of 88% in regurgitation scores, compared with baseline scores prior to initiation of PPI therapy, he noted.

No new device-related adverse events occurred during follow-up, and the observed clinical benefits were stable at 6, 12, and 24 months, he said.

ORLANDO, FLA. — Enteryx, an implantable copolymer approved by the Food and Drug Administration for the treatment of gastroesophageal reflux disease symptoms in 2003, appears to have durable efficacy and safety, David Johnson, M.D., reported in a poster at the annual meeting of the American College of Gastroenterology.

Of 300 patients participating in a 36-month, FDA-mandated postmarket study, 64 patients have completed 24 months of follow-up. Of these, 43 completely eliminated the use of proton pump inhibitor therapy and 3 others reduced their use of PPI therapy by at least 50%, said Dr. Johnson of Eastern Virginia School of Medicine, Norfolk.

The patients, who had well characterized GERD symptoms and were PPI dependent prior to the injection of Enteryx (Boston Scientific Corp.) into the lower esophageal sphincter, also had a median improvement of 80% in GERD health-related quality of life heartburn scores, and a median improvement of 88% in regurgitation scores, compared with baseline scores prior to initiation of PPI therapy, he noted.

No new device-related adverse events occurred during follow-up, and the observed clinical benefits were stable at 6, 12, and 24 months, he said.

ORLANDO, FLA. — Cilansetron is safe and effective and improves health-related quality of life in patients with diarrhea-predominant irritable bowel syndrome, according to two studies presented at the annual meeting of the American College of Gastroenterology.

In one double-blind, randomized, placebo-controlled study, a 2-mg dose of the 5-hydroxytryptamine (HT)3 receptor antagonist used three times daily was well tolerated and significantly improved symptoms in both men and women treated for up to 3 months.

A total of 692 patients were enrolled in the study. Adequate relief during at least half of the study weeks was reported by 49% of those in the treatment group and 28% of those in the placebo group, reported Philip B. Miner, M.D., president and medical director of the Oklahoma Foundation for Digestive Research, Oklahoma City.

Those in the treatment group reported significantly more relief from abdominal pain and discomfort (52% vs. 37%), and from abnormal bowel habits (51% vs. 26%) during the study. Solvay Pharmaceuticals GmbH, which is developing the drug for the treatment of IBS, sponsored this research.

Adverse events causing withdrawal from the study occurred in 12% of patients in the treatment group and 6% of those in the placebo group. Constipation, abdominal pain, and headache were the most common complaints leading to withdrawal from the treatment group, but no serious complications resulted from treatment, Dr. Miner said.

In another double-blind study, cilansetron improved health-related quality of life.

A total of 792 patients were randomized to receive placebo or treatment with 2 mg cilansetron three times daily for 6 months. A 34-item IBS-specific quality of life measure (the IBS-QOL) was administered at baseline and at the end of the study, Douglas A. Drossman, M.D., of the University of North Carolina, Chapel Hill, reported in a poster.

The baseline mean overall IBS-QOL scores were 55 in the treatment group and 55.5 in the placebo group. Higher scores on the 100-point scale indicate better quality of life; at the end-of-study assessment, scores had increased by about 18 points in the treatment group, which was a significantly greater jump than was the 10-point increase in the placebo group.

The differences in baseline and end-of-study scores for the cilansetron vs. the placebo groups were significant for seven of eight subscales, with the greatest differences seen in the scales measuring interference with activity (22-point vs. 11-point increase), food avoidance (19-point vs. 8-point increase), and dysphoria (22-point vs. 13-point increase). These measures showed the lowest levels of quality of life at baseline, with scores ranging from 44 to 49 points.

Only the subscale measuring the sexual effects of IBS showed no significant improvement with treatment vs. placebo (7-point vs. 4-point increase). This measure had the highest quality of life score at baseline at 76 points in both groups, Dr. Drossman noted.

The findings suggest that cilansetron improves overall health-related quality of life in addition to relieving specific symptoms of IBS, he said.

ORLANDO, FLA. — Cilansetron is safe and effective and improves health-related quality of life in patients with diarrhea-predominant irritable bowel syndrome, according to two studies presented at the annual meeting of the American College of Gastroenterology.

In one double-blind, randomized, placebo-controlled study, a 2-mg dose of the 5-hydroxytryptamine (HT)3 receptor antagonist used three times daily was well tolerated and significantly improved symptoms in both men and women treated for up to 3 months.

A total of 692 patients were enrolled in the study. Adequate relief during at least half of the study weeks was reported by 49% of those in the treatment group and 28% of those in the placebo group, reported Philip B. Miner, M.D., president and medical director of the Oklahoma Foundation for Digestive Research, Oklahoma City.

Those in the treatment group reported significantly more relief from abdominal pain and discomfort (52% vs. 37%), and from abnormal bowel habits (51% vs. 26%) during the study. Solvay Pharmaceuticals GmbH, which is developing the drug for the treatment of IBS, sponsored this research.

Adverse events causing withdrawal from the study occurred in 12% of patients in the treatment group and 6% of those in the placebo group. Constipation, abdominal pain, and headache were the most common complaints leading to withdrawal from the treatment group, but no serious complications resulted from treatment, Dr. Miner said.

In another double-blind study, cilansetron improved health-related quality of life.

A total of 792 patients were randomized to receive placebo or treatment with 2 mg cilansetron three times daily for 6 months. A 34-item IBS-specific quality of life measure (the IBS-QOL) was administered at baseline and at the end of the study, Douglas A. Drossman, M.D., of the University of North Carolina, Chapel Hill, reported in a poster.

The baseline mean overall IBS-QOL scores were 55 in the treatment group and 55.5 in the placebo group. Higher scores on the 100-point scale indicate better quality of life; at the end-of-study assessment, scores had increased by about 18 points in the treatment group, which was a significantly greater jump than was the 10-point increase in the placebo group.

The differences in baseline and end-of-study scores for the cilansetron vs. the placebo groups were significant for seven of eight subscales, with the greatest differences seen in the scales measuring interference with activity (22-point vs. 11-point increase), food avoidance (19-point vs. 8-point increase), and dysphoria (22-point vs. 13-point increase). These measures showed the lowest levels of quality of life at baseline, with scores ranging from 44 to 49 points.

Only the subscale measuring the sexual effects of IBS showed no significant improvement with treatment vs. placebo (7-point vs. 4-point increase). This measure had the highest quality of life score at baseline at 76 points in both groups, Dr. Drossman noted.

The findings suggest that cilansetron improves overall health-related quality of life in addition to relieving specific symptoms of IBS, he said.

ORLANDO, FLA. — Cilansetron is safe and effective and improves health-related quality of life in patients with diarrhea-predominant irritable bowel syndrome, according to two studies presented at the annual meeting of the American College of Gastroenterology.

In one double-blind, randomized, placebo-controlled study, a 2-mg dose of the 5-hydroxytryptamine (HT)3 receptor antagonist used three times daily was well tolerated and significantly improved symptoms in both men and women treated for up to 3 months.

A total of 692 patients were enrolled in the study. Adequate relief during at least half of the study weeks was reported by 49% of those in the treatment group and 28% of those in the placebo group, reported Philip B. Miner, M.D., president and medical director of the Oklahoma Foundation for Digestive Research, Oklahoma City.

Those in the treatment group reported significantly more relief from abdominal pain and discomfort (52% vs. 37%), and from abnormal bowel habits (51% vs. 26%) during the study. Solvay Pharmaceuticals GmbH, which is developing the drug for the treatment of IBS, sponsored this research.

Adverse events causing withdrawal from the study occurred in 12% of patients in the treatment group and 6% of those in the placebo group. Constipation, abdominal pain, and headache were the most common complaints leading to withdrawal from the treatment group, but no serious complications resulted from treatment, Dr. Miner said.

In another double-blind study, cilansetron improved health-related quality of life.

A total of 792 patients were randomized to receive placebo or treatment with 2 mg cilansetron three times daily for 6 months. A 34-item IBS-specific quality of life measure (the IBS-QOL) was administered at baseline and at the end of the study, Douglas A. Drossman, M.D., of the University of North Carolina, Chapel Hill, reported in a poster.

The baseline mean overall IBS-QOL scores were 55 in the treatment group and 55.5 in the placebo group. Higher scores on the 100-point scale indicate better quality of life; at the end-of-study assessment, scores had increased by about 18 points in the treatment group, which was a significantly greater jump than was the 10-point increase in the placebo group.

The differences in baseline and end-of-study scores for the cilansetron vs. the placebo groups were significant for seven of eight subscales, with the greatest differences seen in the scales measuring interference with activity (22-point vs. 11-point increase), food avoidance (19-point vs. 8-point increase), and dysphoria (22-point vs. 13-point increase). These measures showed the lowest levels of quality of life at baseline, with scores ranging from 44 to 49 points.

Only the subscale measuring the sexual effects of IBS showed no significant improvement with treatment vs. placebo (7-point vs. 4-point increase). This measure had the highest quality of life score at baseline at 76 points in both groups, Dr. Drossman noted.

The findings suggest that cilansetron improves overall health-related quality of life in addition to relieving specific symptoms of IBS, he said.

Smallpox Vaccine

A cell-cultured smallpox vaccine can provide a safe and immunogenic alternative to the currently approved calf-lymph derived vaccine, a randomized controlled study suggests.

Of 350 vaccinia-naive and non-naive volunteers studied, 349 had evidence of successful immunization, reported Richard N. Greenberg, M.D., of the Veterans Affairs Medical Center in Lexington, Ky., and his colleagues. A total of 250 participants received equivalent doses of either the cell-cultured vaccine or the calf-lymph-derived vaccine (Dryvax), and the remaining 100 patients received the cell-cultured vaccine in varying dilutions. Adverse events and the extent of humoral and cellular immune responses were similar in the two vaccine groups, and the cell-cultured vaccine was effective at a dose 50 times lower than the dose of Dryvax (Lancet 2005;365:398-409).

The findings are important, because government organizations say more smallpox vaccine is needed, and because the manufacture of Dryvax—last produced in 1982—is unacceptable now. Poor controls in manufacturing leave it open to contamination with the infectious agent associated with the prion disease bovine spongiform encephalitis, the investigators explained.

SARS Recommendations

Another outbreak of severe acute respiratory syndrome is likely, and research is needed to better understand the etiology and to establish more specific treatment options, according to an expert panel convened by the National Heart, Lung, and Blood Institute, the Centers for Disease Control and Prevention, and the National Institute of Allergy and Infectious Diseases.

The multidisciplinary panel, convened to develop recommendations for treatment and study of respiratory failure associated with SARS, addressed topics such as the lack of proven value and need for study of antivirals, the importance of antibiotics in people with suspected SARS, the need for a lung-protective ventilatory strategy in patients with SARS that progresses to acute respiratory distress syndrome, and the need for a placebo-controlled trial of corticosteroids for SARS. The panel also addressed adjuvant treatments, noting the benefits of prophylaxis for deep venous thrombosis and stress ulcers (Am. J. Respir. Crit. Care Med. 2005;171:518-26).

An emergency clinical research infrastructure and development of a SARS patient registry are also needed, as is preparation for collection and storage of biological samples from patients, the panel concluded.

Pleural Infection Treatment

Intrapleural streptokinase was of no benefit in patients with pleural infection in a randomized, placebo-controlled trial.

In 427 patients who received either placebo or 25,000 IU of intrapleural streptokinase twice daily for 3 days, the proportion of patients who died or required drainage surgery at 3 months was similar in the two groups (27% of 221 in the placebo group and 31% of 206 in the streptokinase group). Median length of hospital stay was also similar in the two groups (12 and 13 days in the placebo and streptokinase groups, respectively), reported Nicholas A. Maskell, M.R.C.P., of Oxford Radcliffe Hospital, Headington (England), and his colleagues.

Outcomes, as measured with lung function tests and radiographs, also did not differ between the groups. However, those in the treatment group had significantly more serious adverse events, including chest pain, fever, and allergic reactions; 7% in the streptokinase group and 3% in the placebo group experienced such events, the investigators noted (N. Engl. J. Med. 2005;352:865-74).

Although intrapleural streptokinase is widely used in patients with pleural infection on the basis of small studies that showed some benefit, this larger, randomized trial suggests it should generally be avoided in these patients, the investigators concluded.

Infliximab and TB

Patients with infliximab-induced tuberculosis may be at increased risk of a paradoxical response to anti-tuberculous therapy, Carolina Garcia Videl, M.D, of the University of Barcelona (Spain) and her colleagues reported.

A retrospective analysis of 284 patients treated with infliximab showed that 6 developed tuberculosis during a 42-month observation period, and 4 of these had a paradoxical response to the anti-TB therapy—that is, they experienced otherwise unexplained clinical deterioration after initial improvement during the therapy(Clin. Infect. Dis. 2005;756-9).

Patients who experience this effect should remain on their anti-TB therapy for a prolonged period of 9-12 months, and may respond to early addition of corticosteroids to the treatment regimen, they said.

Smallpox Vaccine

A cell-cultured smallpox vaccine can provide a safe and immunogenic alternative to the currently approved calf-lymph derived vaccine, a randomized controlled study suggests.

Of 350 vaccinia-naive and non-naive volunteers studied, 349 had evidence of successful immunization, reported Richard N. Greenberg, M.D., of the Veterans Affairs Medical Center in Lexington, Ky., and his colleagues. A total of 250 participants received equivalent doses of either the cell-cultured vaccine or the calf-lymph-derived vaccine (Dryvax), and the remaining 100 patients received the cell-cultured vaccine in varying dilutions. Adverse events and the extent of humoral and cellular immune responses were similar in the two vaccine groups, and the cell-cultured vaccine was effective at a dose 50 times lower than the dose of Dryvax (Lancet 2005;365:398-409).

The findings are important, because government organizations say more smallpox vaccine is needed, and because the manufacture of Dryvax—last produced in 1982—is unacceptable now. Poor controls in manufacturing leave it open to contamination with the infectious agent associated with the prion disease bovine spongiform encephalitis, the investigators explained.

SARS Recommendations

Another outbreak of severe acute respiratory syndrome is likely, and research is needed to better understand the etiology and to establish more specific treatment options, according to an expert panel convened by the National Heart, Lung, and Blood Institute, the Centers for Disease Control and Prevention, and the National Institute of Allergy and Infectious Diseases.

The multidisciplinary panel, convened to develop recommendations for treatment and study of respiratory failure associated with SARS, addressed topics such as the lack of proven value and need for study of antivirals, the importance of antibiotics in people with suspected SARS, the need for a lung-protective ventilatory strategy in patients with SARS that progresses to acute respiratory distress syndrome, and the need for a placebo-controlled trial of corticosteroids for SARS. The panel also addressed adjuvant treatments, noting the benefits of prophylaxis for deep venous thrombosis and stress ulcers (Am. J. Respir. Crit. Care Med. 2005;171:518-26).

An emergency clinical research infrastructure and development of a SARS patient registry are also needed, as is preparation for collection and storage of biological samples from patients, the panel concluded.

Pleural Infection Treatment

Intrapleural streptokinase was of no benefit in patients with pleural infection in a randomized, placebo-controlled trial.

In 427 patients who received either placebo or 25,000 IU of intrapleural streptokinase twice daily for 3 days, the proportion of patients who died or required drainage surgery at 3 months was similar in the two groups (27% of 221 in the placebo group and 31% of 206 in the streptokinase group). Median length of hospital stay was also similar in the two groups (12 and 13 days in the placebo and streptokinase groups, respectively), reported Nicholas A. Maskell, M.R.C.P., of Oxford Radcliffe Hospital, Headington (England), and his colleagues.

Outcomes, as measured with lung function tests and radiographs, also did not differ between the groups. However, those in the treatment group had significantly more serious adverse events, including chest pain, fever, and allergic reactions; 7% in the streptokinase group and 3% in the placebo group experienced such events, the investigators noted (N. Engl. J. Med. 2005;352:865-74).

Although intrapleural streptokinase is widely used in patients with pleural infection on the basis of small studies that showed some benefit, this larger, randomized trial suggests it should generally be avoided in these patients, the investigators concluded.

Infliximab and TB

Patients with infliximab-induced tuberculosis may be at increased risk of a paradoxical response to anti-tuberculous therapy, Carolina Garcia Videl, M.D, of the University of Barcelona (Spain) and her colleagues reported.

A retrospective analysis of 284 patients treated with infliximab showed that 6 developed tuberculosis during a 42-month observation period, and 4 of these had a paradoxical response to the anti-TB therapy—that is, they experienced otherwise unexplained clinical deterioration after initial improvement during the therapy(Clin. Infect. Dis. 2005;756-9).

Patients who experience this effect should remain on their anti-TB therapy for a prolonged period of 9-12 months, and may respond to early addition of corticosteroids to the treatment regimen, they said.

Smallpox Vaccine

A cell-cultured smallpox vaccine can provide a safe and immunogenic alternative to the currently approved calf-lymph derived vaccine, a randomized controlled study suggests.

Of 350 vaccinia-naive and non-naive volunteers studied, 349 had evidence of successful immunization, reported Richard N. Greenberg, M.D., of the Veterans Affairs Medical Center in Lexington, Ky., and his colleagues. A total of 250 participants received equivalent doses of either the cell-cultured vaccine or the calf-lymph-derived vaccine (Dryvax), and the remaining 100 patients received the cell-cultured vaccine in varying dilutions. Adverse events and the extent of humoral and cellular immune responses were similar in the two vaccine groups, and the cell-cultured vaccine was effective at a dose 50 times lower than the dose of Dryvax (Lancet 2005;365:398-409).

The findings are important, because government organizations say more smallpox vaccine is needed, and because the manufacture of Dryvax—last produced in 1982—is unacceptable now. Poor controls in manufacturing leave it open to contamination with the infectious agent associated with the prion disease bovine spongiform encephalitis, the investigators explained.

SARS Recommendations

Another outbreak of severe acute respiratory syndrome is likely, and research is needed to better understand the etiology and to establish more specific treatment options, according to an expert panel convened by the National Heart, Lung, and Blood Institute, the Centers for Disease Control and Prevention, and the National Institute of Allergy and Infectious Diseases.

The multidisciplinary panel, convened to develop recommendations for treatment and study of respiratory failure associated with SARS, addressed topics such as the lack of proven value and need for study of antivirals, the importance of antibiotics in people with suspected SARS, the need for a lung-protective ventilatory strategy in patients with SARS that progresses to acute respiratory distress syndrome, and the need for a placebo-controlled trial of corticosteroids for SARS. The panel also addressed adjuvant treatments, noting the benefits of prophylaxis for deep venous thrombosis and stress ulcers (Am. J. Respir. Crit. Care Med. 2005;171:518-26).

An emergency clinical research infrastructure and development of a SARS patient registry are also needed, as is preparation for collection and storage of biological samples from patients, the panel concluded.

Pleural Infection Treatment

Intrapleural streptokinase was of no benefit in patients with pleural infection in a randomized, placebo-controlled trial.

In 427 patients who received either placebo or 25,000 IU of intrapleural streptokinase twice daily for 3 days, the proportion of patients who died or required drainage surgery at 3 months was similar in the two groups (27% of 221 in the placebo group and 31% of 206 in the streptokinase group). Median length of hospital stay was also similar in the two groups (12 and 13 days in the placebo and streptokinase groups, respectively), reported Nicholas A. Maskell, M.R.C.P., of Oxford Radcliffe Hospital, Headington (England), and his colleagues.

Outcomes, as measured with lung function tests and radiographs, also did not differ between the groups. However, those in the treatment group had significantly more serious adverse events, including chest pain, fever, and allergic reactions; 7% in the streptokinase group and 3% in the placebo group experienced such events, the investigators noted (N. Engl. J. Med. 2005;352:865-74).

Although intrapleural streptokinase is widely used in patients with pleural infection on the basis of small studies that showed some benefit, this larger, randomized trial suggests it should generally be avoided in these patients, the investigators concluded.

Infliximab and TB

Patients with infliximab-induced tuberculosis may be at increased risk of a paradoxical response to anti-tuberculous therapy, Carolina Garcia Videl, M.D, of the University of Barcelona (Spain) and her colleagues reported.

A retrospective analysis of 284 patients treated with infliximab showed that 6 developed tuberculosis during a 42-month observation period, and 4 of these had a paradoxical response to the anti-TB therapy—that is, they experienced otherwise unexplained clinical deterioration after initial improvement during the therapy(Clin. Infect. Dis. 2005;756-9).

Patients who experience this effect should remain on their anti-TB therapy for a prolonged period of 9-12 months, and may respond to early addition of corticosteroids to the treatment regimen, they said.