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Risk of Ischemic Colitis Increases With Irritable Bowel, Constipation
LOS ANGELES — Patients with irritable bowel syndrome are eight times as likely as other patients to develop ischemic colitis, according to a database study presented in poster form at the annual Digestive Disease Week.
Constipation is another risk factor, conferring a 2.6-fold increased risk of ischemic colitis, reported Mark Cziraky, Pharm.D., vice president of HealthCore Inc., a Wilmington, Del.-based research firm.
The study was funded and conducted on behalf of Novartis Pharmaceuticals Corp., manufacturer of several drugs for irritable bowel syndrome (IBS) and constipation.
Dr. Cziraky and his associates identified 100,143 patients with newly diagnosed IBS in the HealthCore Managed Care Database, which contains medical records for 12 million people. They matched these patients by age and gender to 100,143 controls who saw a physician for a reason other than IBS during the study period from January 2000 to February 2005. The same database also was used to identify 81,399 patients with newly diagnosed constipation and age- and gender-matched controls.
During a median follow-up time of about 18 months, there were 167 cases of ischemic colitis among the IBS patients, compared with 77 among the matched controls (90.37 cases per 100,000 patient-years, vs. 41.47 cases per 100,000 patient-years). In a multivariate model, the relative risk of ischemic colitis was 8.16 for the IBS patients, compared with the controls.
In the constipation group, there were 199 cases of ischemic colitis, compared with 64 cases in matched controls (80.44 cases per 100,000 patient-years, vs. 43.03 cases per 100,000 patient-years). In the multivariate model, the relative risk of ischemic colitis was 2.6 for the constipation patients, compared with the controls.
When researchers examined 1-year follow-up data, the data supported “an even stronger relationship” between IBS or constipation and ischemic colitis, the poster concluded.
LOS ANGELES — Patients with irritable bowel syndrome are eight times as likely as other patients to develop ischemic colitis, according to a database study presented in poster form at the annual Digestive Disease Week.
Constipation is another risk factor, conferring a 2.6-fold increased risk of ischemic colitis, reported Mark Cziraky, Pharm.D., vice president of HealthCore Inc., a Wilmington, Del.-based research firm.
The study was funded and conducted on behalf of Novartis Pharmaceuticals Corp., manufacturer of several drugs for irritable bowel syndrome (IBS) and constipation.
Dr. Cziraky and his associates identified 100,143 patients with newly diagnosed IBS in the HealthCore Managed Care Database, which contains medical records for 12 million people. They matched these patients by age and gender to 100,143 controls who saw a physician for a reason other than IBS during the study period from January 2000 to February 2005. The same database also was used to identify 81,399 patients with newly diagnosed constipation and age- and gender-matched controls.
During a median follow-up time of about 18 months, there were 167 cases of ischemic colitis among the IBS patients, compared with 77 among the matched controls (90.37 cases per 100,000 patient-years, vs. 41.47 cases per 100,000 patient-years). In a multivariate model, the relative risk of ischemic colitis was 8.16 for the IBS patients, compared with the controls.
In the constipation group, there were 199 cases of ischemic colitis, compared with 64 cases in matched controls (80.44 cases per 100,000 patient-years, vs. 43.03 cases per 100,000 patient-years). In the multivariate model, the relative risk of ischemic colitis was 2.6 for the constipation patients, compared with the controls.
When researchers examined 1-year follow-up data, the data supported “an even stronger relationship” between IBS or constipation and ischemic colitis, the poster concluded.
LOS ANGELES — Patients with irritable bowel syndrome are eight times as likely as other patients to develop ischemic colitis, according to a database study presented in poster form at the annual Digestive Disease Week.
Constipation is another risk factor, conferring a 2.6-fold increased risk of ischemic colitis, reported Mark Cziraky, Pharm.D., vice president of HealthCore Inc., a Wilmington, Del.-based research firm.
The study was funded and conducted on behalf of Novartis Pharmaceuticals Corp., manufacturer of several drugs for irritable bowel syndrome (IBS) and constipation.
Dr. Cziraky and his associates identified 100,143 patients with newly diagnosed IBS in the HealthCore Managed Care Database, which contains medical records for 12 million people. They matched these patients by age and gender to 100,143 controls who saw a physician for a reason other than IBS during the study period from January 2000 to February 2005. The same database also was used to identify 81,399 patients with newly diagnosed constipation and age- and gender-matched controls.
During a median follow-up time of about 18 months, there were 167 cases of ischemic colitis among the IBS patients, compared with 77 among the matched controls (90.37 cases per 100,000 patient-years, vs. 41.47 cases per 100,000 patient-years). In a multivariate model, the relative risk of ischemic colitis was 8.16 for the IBS patients, compared with the controls.
In the constipation group, there were 199 cases of ischemic colitis, compared with 64 cases in matched controls (80.44 cases per 100,000 patient-years, vs. 43.03 cases per 100,000 patient-years). In the multivariate model, the relative risk of ischemic colitis was 2.6 for the constipation patients, compared with the controls.
When researchers examined 1-year follow-up data, the data supported “an even stronger relationship” between IBS or constipation and ischemic colitis, the poster concluded.
Doctor-Patient Dialogue Helps Patients With IBS : Educational strategy offers a low-cost, effective intervention that can reduce global symptoms.
LOS ANGELES — An educational tool kit designed to improve patient-physician interactions during visits for irritable bowel syndrome had a greater impact on global symptom relief than did any medication ever studied for the enigmatic disorder.
Dr. Brennan M. Spiegel and associates at the University of California, Los Angeles, tested the tool kit in a randomized study of 73 patients with irritable bowel syndrome (IBS) symptoms who attended the gastrointestinal disease catchment clinic for the VA Greater Los Angeles Health Care System.
Follow-up surveys 3 months later found that patients assigned to the physician-patient intervention group were far more likely than were those who received standard care to say they had achieved relief of their global symptoms (20 of 36 patients, or 56%, compared with 5 of 34 patients, or 15%.)
The intervention effect size of 0.75 “exceeds the largest effect size demonstrated in pharmaceutical studies for IBS,” Dr. Spiegel said at the annual Digestive Disease Week.
For example, studies of alosetron using similar outcome measures had effect sizes between 0.2 and 0.5, he said.
“This does not mean by any means that these agents are not effective. It does suggest that medical therapy alone may be suboptimal if it is not delivered in the context of a supportive and informative physician-patient interaction,” he said.
The multifactorial intervention consisted of a five-part tool kit that included:
▸ A waiting room questionnaire to document the patient's primary concerns, fears, and opinions about what might be causing IBS symptoms.
▸ A laminated flash card for the physician that includes key components of an effective discussion of IBS, including reminders to ask about psychosocial elements of the disease, descriptions of IBS in lay language, and the fact that IBS is not a life-threatening disease.
▸ A worksheet and diagram of the brain and gut that the physician could use to depict a simple explanation of the complex neural circuitry linking the two.
▸ A multimedia patient educational kit, including a self-empowerment video, an explanation of the brain-gut axis in lay language, information about support groups, a dietary card, and educational materials about IBS from the National Institutes of Health.
▸ A letter, sent 1 month following the office visit, asking the patient, “How are you doing?” and providing information about how to contact the physician if symptoms had not improved. This correspondence also included more educational information about IBS.
Physicians were free to use or ignore the patient's questionnaire, the flash card, and worksheet during the office visit; however, most found that it actually “streamlined” the visit, Dr. Spiegel said.
Similarly, patients could read or dispose of the educational materials provided. Some told investigators that they found the worksheet very important, while others primarily relied on the diet cards they found in the take-home educational kit.
Whatever elements did the trick, the intervention clearly had an impact on patients, with significant differences seen in global IBS symptoms, satisfaction, and perceptions of physicians' interpersonal skills.
Ironically, the same physicians saw IBS patients assigned to the intervention group or to usual care.
When independent observers assessed physicians' notes from the visits, they found “very large differences” between the intervention and standard care groups in terms of observations concerning patients' quality of life and extraintestinal symptoms such as anxiety or depression. None of the physician notes documenting visits with control group patients mentioned patients' fears and concerns or disease education efforts, while these elements appeared in their notes regarding 23% and 54% of intervention patient visits, respectively.
Dr. Spiegel prefaced the report on his findings by acknowledging the deep frustration many physicians feel in dealing with patients with IBS, since the disease is common and expensive, symptom expression is heterogeneous, the disease model is incomplete, and highly effective treatment options are scarce.
This frustration can spill over into office visits that leave neither party satisfied.
“Unfortunately, data from our group and others demonstrate that there is a disconnect, oftentimes, between physicians and patients,” he said. “Patients often feel uninformed after they have left the office and physicians often do a poor job of predicting patients' severity when patients and physicians fill out the same questionnaire.”
The low-cost intervention, which will now be further tested, may help to bridge gaps in communication, fostering the physician/patient relationship as a cornerstone of treatment of IBS, Dr. Spiegel said.
LOS ANGELES — An educational tool kit designed to improve patient-physician interactions during visits for irritable bowel syndrome had a greater impact on global symptom relief than did any medication ever studied for the enigmatic disorder.
Dr. Brennan M. Spiegel and associates at the University of California, Los Angeles, tested the tool kit in a randomized study of 73 patients with irritable bowel syndrome (IBS) symptoms who attended the gastrointestinal disease catchment clinic for the VA Greater Los Angeles Health Care System.
Follow-up surveys 3 months later found that patients assigned to the physician-patient intervention group were far more likely than were those who received standard care to say they had achieved relief of their global symptoms (20 of 36 patients, or 56%, compared with 5 of 34 patients, or 15%.)
The intervention effect size of 0.75 “exceeds the largest effect size demonstrated in pharmaceutical studies for IBS,” Dr. Spiegel said at the annual Digestive Disease Week.
For example, studies of alosetron using similar outcome measures had effect sizes between 0.2 and 0.5, he said.
“This does not mean by any means that these agents are not effective. It does suggest that medical therapy alone may be suboptimal if it is not delivered in the context of a supportive and informative physician-patient interaction,” he said.
The multifactorial intervention consisted of a five-part tool kit that included:
▸ A waiting room questionnaire to document the patient's primary concerns, fears, and opinions about what might be causing IBS symptoms.
▸ A laminated flash card for the physician that includes key components of an effective discussion of IBS, including reminders to ask about psychosocial elements of the disease, descriptions of IBS in lay language, and the fact that IBS is not a life-threatening disease.
▸ A worksheet and diagram of the brain and gut that the physician could use to depict a simple explanation of the complex neural circuitry linking the two.
▸ A multimedia patient educational kit, including a self-empowerment video, an explanation of the brain-gut axis in lay language, information about support groups, a dietary card, and educational materials about IBS from the National Institutes of Health.
▸ A letter, sent 1 month following the office visit, asking the patient, “How are you doing?” and providing information about how to contact the physician if symptoms had not improved. This correspondence also included more educational information about IBS.
Physicians were free to use or ignore the patient's questionnaire, the flash card, and worksheet during the office visit; however, most found that it actually “streamlined” the visit, Dr. Spiegel said.
Similarly, patients could read or dispose of the educational materials provided. Some told investigators that they found the worksheet very important, while others primarily relied on the diet cards they found in the take-home educational kit.
Whatever elements did the trick, the intervention clearly had an impact on patients, with significant differences seen in global IBS symptoms, satisfaction, and perceptions of physicians' interpersonal skills.
Ironically, the same physicians saw IBS patients assigned to the intervention group or to usual care.
When independent observers assessed physicians' notes from the visits, they found “very large differences” between the intervention and standard care groups in terms of observations concerning patients' quality of life and extraintestinal symptoms such as anxiety or depression. None of the physician notes documenting visits with control group patients mentioned patients' fears and concerns or disease education efforts, while these elements appeared in their notes regarding 23% and 54% of intervention patient visits, respectively.
Dr. Spiegel prefaced the report on his findings by acknowledging the deep frustration many physicians feel in dealing with patients with IBS, since the disease is common and expensive, symptom expression is heterogeneous, the disease model is incomplete, and highly effective treatment options are scarce.
This frustration can spill over into office visits that leave neither party satisfied.
“Unfortunately, data from our group and others demonstrate that there is a disconnect, oftentimes, between physicians and patients,” he said. “Patients often feel uninformed after they have left the office and physicians often do a poor job of predicting patients' severity when patients and physicians fill out the same questionnaire.”
The low-cost intervention, which will now be further tested, may help to bridge gaps in communication, fostering the physician/patient relationship as a cornerstone of treatment of IBS, Dr. Spiegel said.
LOS ANGELES — An educational tool kit designed to improve patient-physician interactions during visits for irritable bowel syndrome had a greater impact on global symptom relief than did any medication ever studied for the enigmatic disorder.
Dr. Brennan M. Spiegel and associates at the University of California, Los Angeles, tested the tool kit in a randomized study of 73 patients with irritable bowel syndrome (IBS) symptoms who attended the gastrointestinal disease catchment clinic for the VA Greater Los Angeles Health Care System.
Follow-up surveys 3 months later found that patients assigned to the physician-patient intervention group were far more likely than were those who received standard care to say they had achieved relief of their global symptoms (20 of 36 patients, or 56%, compared with 5 of 34 patients, or 15%.)
The intervention effect size of 0.75 “exceeds the largest effect size demonstrated in pharmaceutical studies for IBS,” Dr. Spiegel said at the annual Digestive Disease Week.
For example, studies of alosetron using similar outcome measures had effect sizes between 0.2 and 0.5, he said.
“This does not mean by any means that these agents are not effective. It does suggest that medical therapy alone may be suboptimal if it is not delivered in the context of a supportive and informative physician-patient interaction,” he said.
The multifactorial intervention consisted of a five-part tool kit that included:
▸ A waiting room questionnaire to document the patient's primary concerns, fears, and opinions about what might be causing IBS symptoms.
▸ A laminated flash card for the physician that includes key components of an effective discussion of IBS, including reminders to ask about psychosocial elements of the disease, descriptions of IBS in lay language, and the fact that IBS is not a life-threatening disease.
▸ A worksheet and diagram of the brain and gut that the physician could use to depict a simple explanation of the complex neural circuitry linking the two.
▸ A multimedia patient educational kit, including a self-empowerment video, an explanation of the brain-gut axis in lay language, information about support groups, a dietary card, and educational materials about IBS from the National Institutes of Health.
▸ A letter, sent 1 month following the office visit, asking the patient, “How are you doing?” and providing information about how to contact the physician if symptoms had not improved. This correspondence also included more educational information about IBS.
Physicians were free to use or ignore the patient's questionnaire, the flash card, and worksheet during the office visit; however, most found that it actually “streamlined” the visit, Dr. Spiegel said.
Similarly, patients could read or dispose of the educational materials provided. Some told investigators that they found the worksheet very important, while others primarily relied on the diet cards they found in the take-home educational kit.
Whatever elements did the trick, the intervention clearly had an impact on patients, with significant differences seen in global IBS symptoms, satisfaction, and perceptions of physicians' interpersonal skills.
Ironically, the same physicians saw IBS patients assigned to the intervention group or to usual care.
When independent observers assessed physicians' notes from the visits, they found “very large differences” between the intervention and standard care groups in terms of observations concerning patients' quality of life and extraintestinal symptoms such as anxiety or depression. None of the physician notes documenting visits with control group patients mentioned patients' fears and concerns or disease education efforts, while these elements appeared in their notes regarding 23% and 54% of intervention patient visits, respectively.
Dr. Spiegel prefaced the report on his findings by acknowledging the deep frustration many physicians feel in dealing with patients with IBS, since the disease is common and expensive, symptom expression is heterogeneous, the disease model is incomplete, and highly effective treatment options are scarce.
This frustration can spill over into office visits that leave neither party satisfied.
“Unfortunately, data from our group and others demonstrate that there is a disconnect, oftentimes, between physicians and patients,” he said. “Patients often feel uninformed after they have left the office and physicians often do a poor job of predicting patients' severity when patients and physicians fill out the same questionnaire.”
The low-cost intervention, which will now be further tested, may help to bridge gaps in communication, fostering the physician/patient relationship as a cornerstone of treatment of IBS, Dr. Spiegel said.
Upper Endoscopy for NCCP Produces Surprising Results
LOS ANGELES — Nearly 30% of patients with noncardiac chest pain had a diagnosis of hiatal hernia and almost 20% had esophageal erosions when they underwent upper endoscopy as part of their work-ups at 76 community, university, and Veterans Affairs and military hospitals.
“Unlike what is commonly accepted, esophageal findings are relatively common in patients with noncardiac chest pain,” Dr. Ram Dickman said at the annual Digestive Disease Week.
Previous thinking about the prevalence of esophageal findings in patients with noncardiac chest pain (NCCP) was guided by one study representing a single center's experience. In that study, fewer than 10% of NCCP patients had esophageal findings on upper endoscopy, said Dr. Dickman of the Neuro-Enteric Clinical Research Group in the gastroenterology section at the Southern Arizona VA Health Care System and University of Arizona Health Sciences Center, Tucson.
To offer a more representative analysis, Dr. Dickman and his associates retrospectively compared the endoscopic results of 3,688 consecutive patients undergoing upper endoscopy for NCCP with the records of 32,981 consecutive patients who underwent the same examination for reflux symptoms.
The NCCP group included more female patients, nonwhites, and patients aged 60 or older.
As expected, patients with reflux symptoms were significantly more likely to have esophageal findings on endoscopy. Barrett's esophagus was more than twice as prevalent in reflux patients and esophageal erosion was 1.5 times as common, compared with patients with NCCP.
Indeed, the most common finding on endoscopy reports for NCCP patients was “normal,” seen in 44%.
Nonetheless, among patients with NCCP, hiatal hernia was found in 28.6%, esophageal erosion in 19.4%, Barrett's esophagus in 4.4%, and stricture or stenosis in 3.6%. Upper gastrointestinal tract tumors were found in just 0.2% of the NCCP patients, with a similarly low rate found in patients with reflux symptoms.
The decision to scope a patient with NCCP may be guided by predictive risk factors, and whether a certain findings would alter management of the patient, Dr. Dickman said.
For example, males and VA or military hospital patients with NCCP had an increased likelihood of having Barrett's esophagus, and male gender was also a risk factor for esophageal erosions. Older patients and those seen in a VA or military hospital were more likely to have a peptic stricture.
LOS ANGELES — Nearly 30% of patients with noncardiac chest pain had a diagnosis of hiatal hernia and almost 20% had esophageal erosions when they underwent upper endoscopy as part of their work-ups at 76 community, university, and Veterans Affairs and military hospitals.
“Unlike what is commonly accepted, esophageal findings are relatively common in patients with noncardiac chest pain,” Dr. Ram Dickman said at the annual Digestive Disease Week.
Previous thinking about the prevalence of esophageal findings in patients with noncardiac chest pain (NCCP) was guided by one study representing a single center's experience. In that study, fewer than 10% of NCCP patients had esophageal findings on upper endoscopy, said Dr. Dickman of the Neuro-Enteric Clinical Research Group in the gastroenterology section at the Southern Arizona VA Health Care System and University of Arizona Health Sciences Center, Tucson.
To offer a more representative analysis, Dr. Dickman and his associates retrospectively compared the endoscopic results of 3,688 consecutive patients undergoing upper endoscopy for NCCP with the records of 32,981 consecutive patients who underwent the same examination for reflux symptoms.
The NCCP group included more female patients, nonwhites, and patients aged 60 or older.
As expected, patients with reflux symptoms were significantly more likely to have esophageal findings on endoscopy. Barrett's esophagus was more than twice as prevalent in reflux patients and esophageal erosion was 1.5 times as common, compared with patients with NCCP.
Indeed, the most common finding on endoscopy reports for NCCP patients was “normal,” seen in 44%.
Nonetheless, among patients with NCCP, hiatal hernia was found in 28.6%, esophageal erosion in 19.4%, Barrett's esophagus in 4.4%, and stricture or stenosis in 3.6%. Upper gastrointestinal tract tumors were found in just 0.2% of the NCCP patients, with a similarly low rate found in patients with reflux symptoms.
The decision to scope a patient with NCCP may be guided by predictive risk factors, and whether a certain findings would alter management of the patient, Dr. Dickman said.
For example, males and VA or military hospital patients with NCCP had an increased likelihood of having Barrett's esophagus, and male gender was also a risk factor for esophageal erosions. Older patients and those seen in a VA or military hospital were more likely to have a peptic stricture.
LOS ANGELES — Nearly 30% of patients with noncardiac chest pain had a diagnosis of hiatal hernia and almost 20% had esophageal erosions when they underwent upper endoscopy as part of their work-ups at 76 community, university, and Veterans Affairs and military hospitals.
“Unlike what is commonly accepted, esophageal findings are relatively common in patients with noncardiac chest pain,” Dr. Ram Dickman said at the annual Digestive Disease Week.
Previous thinking about the prevalence of esophageal findings in patients with noncardiac chest pain (NCCP) was guided by one study representing a single center's experience. In that study, fewer than 10% of NCCP patients had esophageal findings on upper endoscopy, said Dr. Dickman of the Neuro-Enteric Clinical Research Group in the gastroenterology section at the Southern Arizona VA Health Care System and University of Arizona Health Sciences Center, Tucson.
To offer a more representative analysis, Dr. Dickman and his associates retrospectively compared the endoscopic results of 3,688 consecutive patients undergoing upper endoscopy for NCCP with the records of 32,981 consecutive patients who underwent the same examination for reflux symptoms.
The NCCP group included more female patients, nonwhites, and patients aged 60 or older.
As expected, patients with reflux symptoms were significantly more likely to have esophageal findings on endoscopy. Barrett's esophagus was more than twice as prevalent in reflux patients and esophageal erosion was 1.5 times as common, compared with patients with NCCP.
Indeed, the most common finding on endoscopy reports for NCCP patients was “normal,” seen in 44%.
Nonetheless, among patients with NCCP, hiatal hernia was found in 28.6%, esophageal erosion in 19.4%, Barrett's esophagus in 4.4%, and stricture or stenosis in 3.6%. Upper gastrointestinal tract tumors were found in just 0.2% of the NCCP patients, with a similarly low rate found in patients with reflux symptoms.
The decision to scope a patient with NCCP may be guided by predictive risk factors, and whether a certain findings would alter management of the patient, Dr. Dickman said.
For example, males and VA or military hospital patients with NCCP had an increased likelihood of having Barrett's esophagus, and male gender was also a risk factor for esophageal erosions. Older patients and those seen in a VA or military hospital were more likely to have a peptic stricture.
Eosinophilic Esophagitis Remains Enigma in Adults : Dysphagia, the most dominant symptom in adults, may be intermittent—or catastrophic in some cases.
LOS ANGELES — Eosinophilic esophagitis appears to be a different disease in adults than it is in children, sharing similar pathophysiologic features and perhaps an allergic etiology, but displaying a different pattern of symptoms, Dr. David A. Katzka said at the annual Digestive Disease Week.
“Certainly this is a new kid on the block, with many of us feeling this is a totally new disease,” said Dr. Katzka, director of the swallowing program at the University of Pennsylvania in Philadelphia.
It is generally agreed that eosinophilia is on the rise, paralleling patterns seen with asthma, atopic dermatitis, and other allergy-driven diseases.
Children with eosinophilic esophagitis complain of a “plethora” of symptoms, including nausea and vomiting, epigastric pain, heartburn, and dysphagia.
“In adults, by far and away, the most dominant symptom is dysphagia,” Dr. Katzka stressed. “It may be intermittent. It may be catastrophic,” he said, noting that it has become a highly prevalent cause of food impaction, despite the fact the disease was only described in 1993.
At first believed to be a variant of gastroesophageal reflux disease (GERD), the disease is clearly a distinct entity with a genetic component in some families. On the other hand, many adults with the disease have GERD symptoms and some respond to aggressive acid suppression with proton pump inhibitors, making the connection between the two entities vexing.
In both children and adults, the diagnosis is pathologic and based on an ill-defined elevated rate of eosinophils found in a patchy pattern in the esophageal mucosa.
Most pathologists now consider 20 eosinophils per high-powered field to be diagnostic, “but clearly there's a spectrum here,” Dr. Katzka said.
He emphasized the importance of taking multiple biopsies, since there may be 5 eosinophils per high-powered field in one spot, and “50 in another.”
Longitudinal furrows are very common findings on endoscopy in all age groups.
In addition, rings throughout the esophagus and strictures are commonly seen in adults (and less often, in children) even on radiographic films.
A small caliber esophagus and extreme mucosal fragility may also be present.
Eosinophilic abscesses, visualized as white specks, are seen in 17%–20% of children with the disease and are “almost pathopneumonic” in adults.
Finally, the esophagus may have a “firm, woody feel,” Dr. Katzka said.
Debate rages as to whether a person with a normal-appearing esophagus can have the disease. Dr. Katzka said he believes it is possible.
The peripheral eosinophil count is normal in about 90% of patients.
Although studies have not been done in adults to direct management, Dr. Katzka recommends RAST testing, patch testing, and skin testing to try to identify an allergen or combination of allergens that may be responsible. However, he warned of an “imprecise correlation between skin, blood, and esophageal findings” and said some adult patients do not respond to avoidance of known allergens.
The biggest problem is convincing patients to avoid foods that may be contributing to the condition.
“It is very hard to convince teens and adults to go on an elemental diet and avoid pizza and beer and all of these things they like to eat on a regular basis,” he said.
In children, treatment with steroids, leukotriene inhibitors, and mast cell stabilizers have been shown effective.
In adults, “we're flying by the seat of our pants” in regard to treatment, he said.
He recommends a 2-month course of fluticasone propionate and possibly, maintenance with montelukast, noting that some specialists also suggest a 1–2 month course of proton pump inhibitors prior to performing a second endoscopy.
Dilation of the esophagus may be indicated, but should be attempted with caution. Adults may experience severe chest pain, tearing, or perforation, and endoscopists may encounter diffuse wall fibrosis.
“We will treat these patients very aggressively for 2 months before thinking about dilation,” he said.
In children, eosinophilic esophagitis seems to stabilize and improve over time, while in adults, limited studies suggest it persists or worsens.
“One of our fears is that in adults, this is a progressive or static disease that has to be recognized and treated early.”
But there are so many unanswered questions about the disease in adults that easy recognition is difficult and the best course of treatment uncertain, for now.
Clearly, some patients accommodate dysphagia for years by chewing their food carefully and avoiding difficult-to-swallow foods such as meats and bread. Others, however, seem to have suffered no symptoms during childhood or young adulthood.
“It's striking to look at individual patients diagnosed at 62 years old or 53 years old. Was this person born with the disease and didn't feel it until he was 62 years old? Do we have a silent, slowly progressive disease that [begins in childhood but] doesn't become apparent until later in life, or is this really a different disease in some patients? We don't know,” he said.
LOS ANGELES — Eosinophilic esophagitis appears to be a different disease in adults than it is in children, sharing similar pathophysiologic features and perhaps an allergic etiology, but displaying a different pattern of symptoms, Dr. David A. Katzka said at the annual Digestive Disease Week.
“Certainly this is a new kid on the block, with many of us feeling this is a totally new disease,” said Dr. Katzka, director of the swallowing program at the University of Pennsylvania in Philadelphia.
It is generally agreed that eosinophilia is on the rise, paralleling patterns seen with asthma, atopic dermatitis, and other allergy-driven diseases.
Children with eosinophilic esophagitis complain of a “plethora” of symptoms, including nausea and vomiting, epigastric pain, heartburn, and dysphagia.
“In adults, by far and away, the most dominant symptom is dysphagia,” Dr. Katzka stressed. “It may be intermittent. It may be catastrophic,” he said, noting that it has become a highly prevalent cause of food impaction, despite the fact the disease was only described in 1993.
At first believed to be a variant of gastroesophageal reflux disease (GERD), the disease is clearly a distinct entity with a genetic component in some families. On the other hand, many adults with the disease have GERD symptoms and some respond to aggressive acid suppression with proton pump inhibitors, making the connection between the two entities vexing.
In both children and adults, the diagnosis is pathologic and based on an ill-defined elevated rate of eosinophils found in a patchy pattern in the esophageal mucosa.
Most pathologists now consider 20 eosinophils per high-powered field to be diagnostic, “but clearly there's a spectrum here,” Dr. Katzka said.
He emphasized the importance of taking multiple biopsies, since there may be 5 eosinophils per high-powered field in one spot, and “50 in another.”
Longitudinal furrows are very common findings on endoscopy in all age groups.
In addition, rings throughout the esophagus and strictures are commonly seen in adults (and less often, in children) even on radiographic films.
A small caliber esophagus and extreme mucosal fragility may also be present.
Eosinophilic abscesses, visualized as white specks, are seen in 17%–20% of children with the disease and are “almost pathopneumonic” in adults.
Finally, the esophagus may have a “firm, woody feel,” Dr. Katzka said.
Debate rages as to whether a person with a normal-appearing esophagus can have the disease. Dr. Katzka said he believes it is possible.
The peripheral eosinophil count is normal in about 90% of patients.
Although studies have not been done in adults to direct management, Dr. Katzka recommends RAST testing, patch testing, and skin testing to try to identify an allergen or combination of allergens that may be responsible. However, he warned of an “imprecise correlation between skin, blood, and esophageal findings” and said some adult patients do not respond to avoidance of known allergens.
The biggest problem is convincing patients to avoid foods that may be contributing to the condition.
“It is very hard to convince teens and adults to go on an elemental diet and avoid pizza and beer and all of these things they like to eat on a regular basis,” he said.
In children, treatment with steroids, leukotriene inhibitors, and mast cell stabilizers have been shown effective.
In adults, “we're flying by the seat of our pants” in regard to treatment, he said.
He recommends a 2-month course of fluticasone propionate and possibly, maintenance with montelukast, noting that some specialists also suggest a 1–2 month course of proton pump inhibitors prior to performing a second endoscopy.
Dilation of the esophagus may be indicated, but should be attempted with caution. Adults may experience severe chest pain, tearing, or perforation, and endoscopists may encounter diffuse wall fibrosis.
“We will treat these patients very aggressively for 2 months before thinking about dilation,” he said.
In children, eosinophilic esophagitis seems to stabilize and improve over time, while in adults, limited studies suggest it persists or worsens.
“One of our fears is that in adults, this is a progressive or static disease that has to be recognized and treated early.”
But there are so many unanswered questions about the disease in adults that easy recognition is difficult and the best course of treatment uncertain, for now.
Clearly, some patients accommodate dysphagia for years by chewing their food carefully and avoiding difficult-to-swallow foods such as meats and bread. Others, however, seem to have suffered no symptoms during childhood or young adulthood.
“It's striking to look at individual patients diagnosed at 62 years old or 53 years old. Was this person born with the disease and didn't feel it until he was 62 years old? Do we have a silent, slowly progressive disease that [begins in childhood but] doesn't become apparent until later in life, or is this really a different disease in some patients? We don't know,” he said.
LOS ANGELES — Eosinophilic esophagitis appears to be a different disease in adults than it is in children, sharing similar pathophysiologic features and perhaps an allergic etiology, but displaying a different pattern of symptoms, Dr. David A. Katzka said at the annual Digestive Disease Week.
“Certainly this is a new kid on the block, with many of us feeling this is a totally new disease,” said Dr. Katzka, director of the swallowing program at the University of Pennsylvania in Philadelphia.
It is generally agreed that eosinophilia is on the rise, paralleling patterns seen with asthma, atopic dermatitis, and other allergy-driven diseases.
Children with eosinophilic esophagitis complain of a “plethora” of symptoms, including nausea and vomiting, epigastric pain, heartburn, and dysphagia.
“In adults, by far and away, the most dominant symptom is dysphagia,” Dr. Katzka stressed. “It may be intermittent. It may be catastrophic,” he said, noting that it has become a highly prevalent cause of food impaction, despite the fact the disease was only described in 1993.
At first believed to be a variant of gastroesophageal reflux disease (GERD), the disease is clearly a distinct entity with a genetic component in some families. On the other hand, many adults with the disease have GERD symptoms and some respond to aggressive acid suppression with proton pump inhibitors, making the connection between the two entities vexing.
In both children and adults, the diagnosis is pathologic and based on an ill-defined elevated rate of eosinophils found in a patchy pattern in the esophageal mucosa.
Most pathologists now consider 20 eosinophils per high-powered field to be diagnostic, “but clearly there's a spectrum here,” Dr. Katzka said.
He emphasized the importance of taking multiple biopsies, since there may be 5 eosinophils per high-powered field in one spot, and “50 in another.”
Longitudinal furrows are very common findings on endoscopy in all age groups.
In addition, rings throughout the esophagus and strictures are commonly seen in adults (and less often, in children) even on radiographic films.
A small caliber esophagus and extreme mucosal fragility may also be present.
Eosinophilic abscesses, visualized as white specks, are seen in 17%–20% of children with the disease and are “almost pathopneumonic” in adults.
Finally, the esophagus may have a “firm, woody feel,” Dr. Katzka said.
Debate rages as to whether a person with a normal-appearing esophagus can have the disease. Dr. Katzka said he believes it is possible.
The peripheral eosinophil count is normal in about 90% of patients.
Although studies have not been done in adults to direct management, Dr. Katzka recommends RAST testing, patch testing, and skin testing to try to identify an allergen or combination of allergens that may be responsible. However, he warned of an “imprecise correlation between skin, blood, and esophageal findings” and said some adult patients do not respond to avoidance of known allergens.
The biggest problem is convincing patients to avoid foods that may be contributing to the condition.
“It is very hard to convince teens and adults to go on an elemental diet and avoid pizza and beer and all of these things they like to eat on a regular basis,” he said.
In children, treatment with steroids, leukotriene inhibitors, and mast cell stabilizers have been shown effective.
In adults, “we're flying by the seat of our pants” in regard to treatment, he said.
He recommends a 2-month course of fluticasone propionate and possibly, maintenance with montelukast, noting that some specialists also suggest a 1–2 month course of proton pump inhibitors prior to performing a second endoscopy.
Dilation of the esophagus may be indicated, but should be attempted with caution. Adults may experience severe chest pain, tearing, or perforation, and endoscopists may encounter diffuse wall fibrosis.
“We will treat these patients very aggressively for 2 months before thinking about dilation,” he said.
In children, eosinophilic esophagitis seems to stabilize and improve over time, while in adults, limited studies suggest it persists or worsens.
“One of our fears is that in adults, this is a progressive or static disease that has to be recognized and treated early.”
But there are so many unanswered questions about the disease in adults that easy recognition is difficult and the best course of treatment uncertain, for now.
Clearly, some patients accommodate dysphagia for years by chewing their food carefully and avoiding difficult-to-swallow foods such as meats and bread. Others, however, seem to have suffered no symptoms during childhood or young adulthood.
“It's striking to look at individual patients diagnosed at 62 years old or 53 years old. Was this person born with the disease and didn't feel it until he was 62 years old? Do we have a silent, slowly progressive disease that [begins in childhood but] doesn't become apparent until later in life, or is this really a different disease in some patients? We don't know,” he said.
Brakes Put on SURx System for Stress Incontinence
TUCSON, ARIZ. — The SURx radiofrequency system for treating stress urinary incontinence is no longer being marketed, following recognition by CooperSurgical Inc. that “the product is much more technique-dependent than we had hoped it would be,” a company official revealed in a telephone interview.
“It turns out this is a very technique-dependent procedure that requires [application of energy at] just the right depth, just the right exposure, and just the right amount of endopelvic fascia [to be successful],” said Loren Smith, vice president of marketing for the Trumbull, Conn.-based surgical device company.
“There are a few dozen really strong supporters of the product, and for them, we make the product available. They are highly trained, very skilled surgeons and have gotten excellent results. They want to continue to use it, and more power to them,” Mr. Smith said.
After CooperSurgical purchased the SURx company in late 2003, it launched a number of intensive, hands-on training sessions for surgeons. It soon became evident that incorrect placement or application of energy was a common problem, he added.
“It became too time-consuming and costly to really do the—not literal, but figurative—hand-holding required for surgeons to become comfortable enough to have consistent results, patient after patient.”
A few small studies presented at recent urogynecology meetings began to hint at inconsistent success rates with radiofrequency bladder neck suspension for the treatment of stress urinary incontinence (SUI) or mixed urinary incontinence, prompting an investigation into the current status of SURx radiofrequency devices that could be used transvaginally or laparoscopically for minimally invasive SUI treatment.
For example, more than half of patients were considered treatment failures within 6 weeks of undergoing laparoscopic application of radiofrequency energy to the pubocervical fascia at the level of the urethrovesical junction in a study reported at the annual meeting of the Society of Gynecologic Surgeons.
Among 24 women who had failed conservative treatment for stress incontinence, 14 demonstrated objective and/or subjective incontinence by 6 weeks and 9 opted to undergo additional procedures. Just six patients were subjectively cured and four subjectively “improved,” defined as “rare SUI,” at 6 weeks.
Dr. Michael D. Vardy and Dr. Vincent Lucente independently stopped offering the SURx procedure after evaluating results at their respective institutions, Mount Sinai School of Medicine in New York and the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, Pa.
In addition to serving as fellowship director in the division of female pelvic medicine and reconstructive surgery at Mount Sinai, Dr. Vardy directs female pelvic medicine and reconstructive surgery at Englewood (N.J.) Hospital and Medical Center.
The Vardy/Lucente study referenced a prior report from the University of Rochester (N.Y.) of poor success rates after using a transvaginal approach to SURx radiofrequency ablation for SUI.
Presented at the 2005 American Urogynecologic Society meeting in Atlanta, the Rochester study noted that among 15 patients, 1 was continent, 4 obtained greater than 50% improvement, and 10 were unimproved postoperatively.
The results of both studies are at odds with previous reports of 70%–81% success rates with radiofrequency bladder neck suspension. For example, a 2002 study from the Geisinger Medical Center in Danville, Pa., found that 76 of 94 (81%) of women were “continent or improved” 12 months after radiofrequency bladder neck suspension (J. Urol. 2002;167:141–5).
In a review article, Dr. Roger Dmochowski and Dr. Rodney A. Appell of Vanderbilt University Medical Center, Nashville, Tenn., reported “treatment success”—defined as cured or improved—in 70 of 96 patients (73%) who completed a 12-month follow-up examination after transvaginal radiofrequency therapy (Curr. Urol. Rep. 2003;4:350–5).
The same article cited the Geisinger study as further evidence for its conclusion that radiofrequency application “results in reproducible tissue effects, which have provided substantial improvement for women with genuine stress urinary incontinence, with minimal short-term and essentially no long-term complications.”
Dr. Vardy, contacted by e-mail, said he believes the uneven history of SURx radiofrequency treatment of SUI is “typical of industry-sponsored research.” Inconsistent outcome measures make it difficult to interpret data from such studies, he said.
TUCSON, ARIZ. — The SURx radiofrequency system for treating stress urinary incontinence is no longer being marketed, following recognition by CooperSurgical Inc. that “the product is much more technique-dependent than we had hoped it would be,” a company official revealed in a telephone interview.
“It turns out this is a very technique-dependent procedure that requires [application of energy at] just the right depth, just the right exposure, and just the right amount of endopelvic fascia [to be successful],” said Loren Smith, vice president of marketing for the Trumbull, Conn.-based surgical device company.
“There are a few dozen really strong supporters of the product, and for them, we make the product available. They are highly trained, very skilled surgeons and have gotten excellent results. They want to continue to use it, and more power to them,” Mr. Smith said.
After CooperSurgical purchased the SURx company in late 2003, it launched a number of intensive, hands-on training sessions for surgeons. It soon became evident that incorrect placement or application of energy was a common problem, he added.
“It became too time-consuming and costly to really do the—not literal, but figurative—hand-holding required for surgeons to become comfortable enough to have consistent results, patient after patient.”
A few small studies presented at recent urogynecology meetings began to hint at inconsistent success rates with radiofrequency bladder neck suspension for the treatment of stress urinary incontinence (SUI) or mixed urinary incontinence, prompting an investigation into the current status of SURx radiofrequency devices that could be used transvaginally or laparoscopically for minimally invasive SUI treatment.
For example, more than half of patients were considered treatment failures within 6 weeks of undergoing laparoscopic application of radiofrequency energy to the pubocervical fascia at the level of the urethrovesical junction in a study reported at the annual meeting of the Society of Gynecologic Surgeons.
Among 24 women who had failed conservative treatment for stress incontinence, 14 demonstrated objective and/or subjective incontinence by 6 weeks and 9 opted to undergo additional procedures. Just six patients were subjectively cured and four subjectively “improved,” defined as “rare SUI,” at 6 weeks.
Dr. Michael D. Vardy and Dr. Vincent Lucente independently stopped offering the SURx procedure after evaluating results at their respective institutions, Mount Sinai School of Medicine in New York and the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, Pa.
In addition to serving as fellowship director in the division of female pelvic medicine and reconstructive surgery at Mount Sinai, Dr. Vardy directs female pelvic medicine and reconstructive surgery at Englewood (N.J.) Hospital and Medical Center.
The Vardy/Lucente study referenced a prior report from the University of Rochester (N.Y.) of poor success rates after using a transvaginal approach to SURx radiofrequency ablation for SUI.
Presented at the 2005 American Urogynecologic Society meeting in Atlanta, the Rochester study noted that among 15 patients, 1 was continent, 4 obtained greater than 50% improvement, and 10 were unimproved postoperatively.
The results of both studies are at odds with previous reports of 70%–81% success rates with radiofrequency bladder neck suspension. For example, a 2002 study from the Geisinger Medical Center in Danville, Pa., found that 76 of 94 (81%) of women were “continent or improved” 12 months after radiofrequency bladder neck suspension (J. Urol. 2002;167:141–5).
In a review article, Dr. Roger Dmochowski and Dr. Rodney A. Appell of Vanderbilt University Medical Center, Nashville, Tenn., reported “treatment success”—defined as cured or improved—in 70 of 96 patients (73%) who completed a 12-month follow-up examination after transvaginal radiofrequency therapy (Curr. Urol. Rep. 2003;4:350–5).
The same article cited the Geisinger study as further evidence for its conclusion that radiofrequency application “results in reproducible tissue effects, which have provided substantial improvement for women with genuine stress urinary incontinence, with minimal short-term and essentially no long-term complications.”
Dr. Vardy, contacted by e-mail, said he believes the uneven history of SURx radiofrequency treatment of SUI is “typical of industry-sponsored research.” Inconsistent outcome measures make it difficult to interpret data from such studies, he said.
TUCSON, ARIZ. — The SURx radiofrequency system for treating stress urinary incontinence is no longer being marketed, following recognition by CooperSurgical Inc. that “the product is much more technique-dependent than we had hoped it would be,” a company official revealed in a telephone interview.
“It turns out this is a very technique-dependent procedure that requires [application of energy at] just the right depth, just the right exposure, and just the right amount of endopelvic fascia [to be successful],” said Loren Smith, vice president of marketing for the Trumbull, Conn.-based surgical device company.
“There are a few dozen really strong supporters of the product, and for them, we make the product available. They are highly trained, very skilled surgeons and have gotten excellent results. They want to continue to use it, and more power to them,” Mr. Smith said.
After CooperSurgical purchased the SURx company in late 2003, it launched a number of intensive, hands-on training sessions for surgeons. It soon became evident that incorrect placement or application of energy was a common problem, he added.
“It became too time-consuming and costly to really do the—not literal, but figurative—hand-holding required for surgeons to become comfortable enough to have consistent results, patient after patient.”
A few small studies presented at recent urogynecology meetings began to hint at inconsistent success rates with radiofrequency bladder neck suspension for the treatment of stress urinary incontinence (SUI) or mixed urinary incontinence, prompting an investigation into the current status of SURx radiofrequency devices that could be used transvaginally or laparoscopically for minimally invasive SUI treatment.
For example, more than half of patients were considered treatment failures within 6 weeks of undergoing laparoscopic application of radiofrequency energy to the pubocervical fascia at the level of the urethrovesical junction in a study reported at the annual meeting of the Society of Gynecologic Surgeons.
Among 24 women who had failed conservative treatment for stress incontinence, 14 demonstrated objective and/or subjective incontinence by 6 weeks and 9 opted to undergo additional procedures. Just six patients were subjectively cured and four subjectively “improved,” defined as “rare SUI,” at 6 weeks.
Dr. Michael D. Vardy and Dr. Vincent Lucente independently stopped offering the SURx procedure after evaluating results at their respective institutions, Mount Sinai School of Medicine in New York and the Institute for Female Pelvic Medicine and Reconstructive Surgery in Allentown, Pa.
In addition to serving as fellowship director in the division of female pelvic medicine and reconstructive surgery at Mount Sinai, Dr. Vardy directs female pelvic medicine and reconstructive surgery at Englewood (N.J.) Hospital and Medical Center.
The Vardy/Lucente study referenced a prior report from the University of Rochester (N.Y.) of poor success rates after using a transvaginal approach to SURx radiofrequency ablation for SUI.
Presented at the 2005 American Urogynecologic Society meeting in Atlanta, the Rochester study noted that among 15 patients, 1 was continent, 4 obtained greater than 50% improvement, and 10 were unimproved postoperatively.
The results of both studies are at odds with previous reports of 70%–81% success rates with radiofrequency bladder neck suspension. For example, a 2002 study from the Geisinger Medical Center in Danville, Pa., found that 76 of 94 (81%) of women were “continent or improved” 12 months after radiofrequency bladder neck suspension (J. Urol. 2002;167:141–5).
In a review article, Dr. Roger Dmochowski and Dr. Rodney A. Appell of Vanderbilt University Medical Center, Nashville, Tenn., reported “treatment success”—defined as cured or improved—in 70 of 96 patients (73%) who completed a 12-month follow-up examination after transvaginal radiofrequency therapy (Curr. Urol. Rep. 2003;4:350–5).
The same article cited the Geisinger study as further evidence for its conclusion that radiofrequency application “results in reproducible tissue effects, which have provided substantial improvement for women with genuine stress urinary incontinence, with minimal short-term and essentially no long-term complications.”
Dr. Vardy, contacted by e-mail, said he believes the uneven history of SURx radiofrequency treatment of SUI is “typical of industry-sponsored research.” Inconsistent outcome measures make it difficult to interpret data from such studies, he said.
Home Remedies: Many Are Tried, Some Are True
VANCOUVER, B.C. — Home remedies are often inexpensive, readily available, and highly appealing to parents seeking “natural” cures for common conditions, Dr. Heidi Budden said at a conference sponsored by the North Pacific Pediatric Society.
Some work very well, with efficacy rivaling prescription drugs in well-designed studies.
But there are pitfalls.
To be effective, some home remedies require unrealistic dosages or wind up costing more than prescription or over-the-counter medications.
Others are downright dangerous. Candle waxing for otitis externa, for example, frequently caused wax burns in the children or caught their hair on fire.
Dr. Budden, of the department of pediatrics at the University of British Columbia, Vancouver, reviewed the literature and her own clinical experience and offered perspective on a variety of home remedies for children, including:
▸ Cranberry juice for urinary tract infections. Popular belief holds that this tangy berry works to combat UTIs by altering the acidity of the urine. In fact, a review article in the journal Clinical Infectious Diseases found that the average person would have to eat 3/4 of a pound of cranberries or drink more than 3 cups of straight cranberry juice (not the watered-down juice mixes palatable to kids) on a daily basis to accomplish this aim.
“Really, in practical terms, the acidity of the urine is probably not what's helping us,” she said.
There appears to be scientific merit in attributing benefit to other characteristics of cranberries, however, including their possession of properties that interfere with the ability of Escherichia coli bacteria to adhere to uroepithelial cells.
This would not cure a UTI, but it does appear to contribute to a reduction in infections if used as a prophylactic measure over the course of many months. More study is needed, said Dr. Budden.
In adult women with a history of UTIs, several trials have demonstrated that regular use of cranberry extract tablets or concentrated juice can significantly reduce the incidence of UTIs.
The many ounces of prevention do not come cheap, however. According to an article in the Canadian Journal of Urology, two daily tablets of cranberry extract would have cost more than $400 (U.S. dollars) over the course of a year in 2002. The price of juice cited in trials was even higher, at nearly $1,000 a year at 2002 prices in Canada.
The evidence in children is far less clear, and studies have generally focused on patients with renal disease rather than simple, recurrent UTIs in otherwise healthy children.
On the other hand, daily consumption of cranberry juice was found to do no harm to children in a placebo-controlled study in a day care center (Clin. Nutr. 2005;24:1065–72).
Drinking excessive cranberry juice does have implications for overall caloric intake of children, particularly in the context of obesity, commented Dr. Budden.
▸ Probiotics for the treatment or prevention of diarrhea. Many parents give their children probiotics, especially lactobacilli, in the hopes they will prevent antibiotic-associated diarrhea or will shorten the course of rotavirus or nonrotavirus diarrheal illnesses. Although more studies would certainly be helpful in clarifying the issue, some evidence suggests certain strains of lactic acid-fermenting bacteria may indeed be beneficial in children.
An Israeli study found that probiotics in combination with zinc shortened acute gastroenteritis by 12 hours (J. Am. Coll. Nutr. 2005;24:370–5). “That may not seem like a lot, but … the parents were quite grateful,” said Dr. Budden.
A study of children in Bangladesh found probiotics taken within 2 days of onset of nonrotavirus diarrhea reduced stool frequency and amount and reduced the amount of oral rehydration required (Pediatrics 2005; 116:e221–8).
No studies have examined prophylactic use of probiotics concurrent with antibiotic use; however, the practice proved useful in a Japanese study of elderly patients, she said.
▸ Home remedies for tinea pedis. Ketoconazole is highly effective for tinea pedis, but when patients don't like to use it or their families are seeking natural alternatives, a number of home remedies may be good alternatives, said Dr. Budden.
Tea tree oil, derived from an Australian plant, achieved a mycologic cure in about 60% of patients in a placebo-controlled study—less than the 90% cure expected from ketoconazole, but not insignificant (Australas. J. Dermatol. 2002;43:175–8).
Even better efficacy was reported for an extract of Solanum chrysotrichum, a Mexican plant (Planta Med. 2003;69:390–5). Clinical effectiveness with the plant extract was seen in 96% of 101 patients, compared with 92% of those using ketoconazole. Mycologic cure and tolerability were virtually equal in the two groups.
“My personal favorite [tinea pedis remedy] is vinegar,” said Dr. Budden, who recalled its effectiveness during her military training. Anecdotally, vinegar mixed equally with water is effective as an antifungal agent when used as a soak or applied directly to the affected areas of the feet. It also is said to counteract the odor associated with tinea pedis.
Cranberries may have properties that interfere with the ability of bacteria to adhere to uroepithelial cells. Elsevier Global Medical News
VANCOUVER, B.C. — Home remedies are often inexpensive, readily available, and highly appealing to parents seeking “natural” cures for common conditions, Dr. Heidi Budden said at a conference sponsored by the North Pacific Pediatric Society.
Some work very well, with efficacy rivaling prescription drugs in well-designed studies.
But there are pitfalls.
To be effective, some home remedies require unrealistic dosages or wind up costing more than prescription or over-the-counter medications.
Others are downright dangerous. Candle waxing for otitis externa, for example, frequently caused wax burns in the children or caught their hair on fire.
Dr. Budden, of the department of pediatrics at the University of British Columbia, Vancouver, reviewed the literature and her own clinical experience and offered perspective on a variety of home remedies for children, including:
▸ Cranberry juice for urinary tract infections. Popular belief holds that this tangy berry works to combat UTIs by altering the acidity of the urine. In fact, a review article in the journal Clinical Infectious Diseases found that the average person would have to eat 3/4 of a pound of cranberries or drink more than 3 cups of straight cranberry juice (not the watered-down juice mixes palatable to kids) on a daily basis to accomplish this aim.
“Really, in practical terms, the acidity of the urine is probably not what's helping us,” she said.
There appears to be scientific merit in attributing benefit to other characteristics of cranberries, however, including their possession of properties that interfere with the ability of Escherichia coli bacteria to adhere to uroepithelial cells.
This would not cure a UTI, but it does appear to contribute to a reduction in infections if used as a prophylactic measure over the course of many months. More study is needed, said Dr. Budden.
In adult women with a history of UTIs, several trials have demonstrated that regular use of cranberry extract tablets or concentrated juice can significantly reduce the incidence of UTIs.
The many ounces of prevention do not come cheap, however. According to an article in the Canadian Journal of Urology, two daily tablets of cranberry extract would have cost more than $400 (U.S. dollars) over the course of a year in 2002. The price of juice cited in trials was even higher, at nearly $1,000 a year at 2002 prices in Canada.
The evidence in children is far less clear, and studies have generally focused on patients with renal disease rather than simple, recurrent UTIs in otherwise healthy children.
On the other hand, daily consumption of cranberry juice was found to do no harm to children in a placebo-controlled study in a day care center (Clin. Nutr. 2005;24:1065–72).
Drinking excessive cranberry juice does have implications for overall caloric intake of children, particularly in the context of obesity, commented Dr. Budden.
▸ Probiotics for the treatment or prevention of diarrhea. Many parents give their children probiotics, especially lactobacilli, in the hopes they will prevent antibiotic-associated diarrhea or will shorten the course of rotavirus or nonrotavirus diarrheal illnesses. Although more studies would certainly be helpful in clarifying the issue, some evidence suggests certain strains of lactic acid-fermenting bacteria may indeed be beneficial in children.
An Israeli study found that probiotics in combination with zinc shortened acute gastroenteritis by 12 hours (J. Am. Coll. Nutr. 2005;24:370–5). “That may not seem like a lot, but … the parents were quite grateful,” said Dr. Budden.
A study of children in Bangladesh found probiotics taken within 2 days of onset of nonrotavirus diarrhea reduced stool frequency and amount and reduced the amount of oral rehydration required (Pediatrics 2005; 116:e221–8).
No studies have examined prophylactic use of probiotics concurrent with antibiotic use; however, the practice proved useful in a Japanese study of elderly patients, she said.
▸ Home remedies for tinea pedis. Ketoconazole is highly effective for tinea pedis, but when patients don't like to use it or their families are seeking natural alternatives, a number of home remedies may be good alternatives, said Dr. Budden.
Tea tree oil, derived from an Australian plant, achieved a mycologic cure in about 60% of patients in a placebo-controlled study—less than the 90% cure expected from ketoconazole, but not insignificant (Australas. J. Dermatol. 2002;43:175–8).
Even better efficacy was reported for an extract of Solanum chrysotrichum, a Mexican plant (Planta Med. 2003;69:390–5). Clinical effectiveness with the plant extract was seen in 96% of 101 patients, compared with 92% of those using ketoconazole. Mycologic cure and tolerability were virtually equal in the two groups.
“My personal favorite [tinea pedis remedy] is vinegar,” said Dr. Budden, who recalled its effectiveness during her military training. Anecdotally, vinegar mixed equally with water is effective as an antifungal agent when used as a soak or applied directly to the affected areas of the feet. It also is said to counteract the odor associated with tinea pedis.
Cranberries may have properties that interfere with the ability of bacteria to adhere to uroepithelial cells. Elsevier Global Medical News
VANCOUVER, B.C. — Home remedies are often inexpensive, readily available, and highly appealing to parents seeking “natural” cures for common conditions, Dr. Heidi Budden said at a conference sponsored by the North Pacific Pediatric Society.
Some work very well, with efficacy rivaling prescription drugs in well-designed studies.
But there are pitfalls.
To be effective, some home remedies require unrealistic dosages or wind up costing more than prescription or over-the-counter medications.
Others are downright dangerous. Candle waxing for otitis externa, for example, frequently caused wax burns in the children or caught their hair on fire.
Dr. Budden, of the department of pediatrics at the University of British Columbia, Vancouver, reviewed the literature and her own clinical experience and offered perspective on a variety of home remedies for children, including:
▸ Cranberry juice for urinary tract infections. Popular belief holds that this tangy berry works to combat UTIs by altering the acidity of the urine. In fact, a review article in the journal Clinical Infectious Diseases found that the average person would have to eat 3/4 of a pound of cranberries or drink more than 3 cups of straight cranberry juice (not the watered-down juice mixes palatable to kids) on a daily basis to accomplish this aim.
“Really, in practical terms, the acidity of the urine is probably not what's helping us,” she said.
There appears to be scientific merit in attributing benefit to other characteristics of cranberries, however, including their possession of properties that interfere with the ability of Escherichia coli bacteria to adhere to uroepithelial cells.
This would not cure a UTI, but it does appear to contribute to a reduction in infections if used as a prophylactic measure over the course of many months. More study is needed, said Dr. Budden.
In adult women with a history of UTIs, several trials have demonstrated that regular use of cranberry extract tablets or concentrated juice can significantly reduce the incidence of UTIs.
The many ounces of prevention do not come cheap, however. According to an article in the Canadian Journal of Urology, two daily tablets of cranberry extract would have cost more than $400 (U.S. dollars) over the course of a year in 2002. The price of juice cited in trials was even higher, at nearly $1,000 a year at 2002 prices in Canada.
The evidence in children is far less clear, and studies have generally focused on patients with renal disease rather than simple, recurrent UTIs in otherwise healthy children.
On the other hand, daily consumption of cranberry juice was found to do no harm to children in a placebo-controlled study in a day care center (Clin. Nutr. 2005;24:1065–72).
Drinking excessive cranberry juice does have implications for overall caloric intake of children, particularly in the context of obesity, commented Dr. Budden.
▸ Probiotics for the treatment or prevention of diarrhea. Many parents give their children probiotics, especially lactobacilli, in the hopes they will prevent antibiotic-associated diarrhea or will shorten the course of rotavirus or nonrotavirus diarrheal illnesses. Although more studies would certainly be helpful in clarifying the issue, some evidence suggests certain strains of lactic acid-fermenting bacteria may indeed be beneficial in children.
An Israeli study found that probiotics in combination with zinc shortened acute gastroenteritis by 12 hours (J. Am. Coll. Nutr. 2005;24:370–5). “That may not seem like a lot, but … the parents were quite grateful,” said Dr. Budden.
A study of children in Bangladesh found probiotics taken within 2 days of onset of nonrotavirus diarrhea reduced stool frequency and amount and reduced the amount of oral rehydration required (Pediatrics 2005; 116:e221–8).
No studies have examined prophylactic use of probiotics concurrent with antibiotic use; however, the practice proved useful in a Japanese study of elderly patients, she said.
▸ Home remedies for tinea pedis. Ketoconazole is highly effective for tinea pedis, but when patients don't like to use it or their families are seeking natural alternatives, a number of home remedies may be good alternatives, said Dr. Budden.
Tea tree oil, derived from an Australian plant, achieved a mycologic cure in about 60% of patients in a placebo-controlled study—less than the 90% cure expected from ketoconazole, but not insignificant (Australas. J. Dermatol. 2002;43:175–8).
Even better efficacy was reported for an extract of Solanum chrysotrichum, a Mexican plant (Planta Med. 2003;69:390–5). Clinical effectiveness with the plant extract was seen in 96% of 101 patients, compared with 92% of those using ketoconazole. Mycologic cure and tolerability were virtually equal in the two groups.
“My personal favorite [tinea pedis remedy] is vinegar,” said Dr. Budden, who recalled its effectiveness during her military training. Anecdotally, vinegar mixed equally with water is effective as an antifungal agent when used as a soak or applied directly to the affected areas of the feet. It also is said to counteract the odor associated with tinea pedis.
Cranberries may have properties that interfere with the ability of bacteria to adhere to uroepithelial cells. Elsevier Global Medical News
Patient Selection, Patience Key to Pessary Success
TUCSON, ARIZ. — A randomized crossover trial suggests that symptom relief and satisfaction can be obtained by either of two commonly used pessary types, but that patient selection and patience are both key to success.
The multicenter study enrolled 134 women ages 30–89 (mean age 61) with symptomatic pelvic organ prolapse. They were randomized to be fitted with one of two types of pessary and to wear it, if possible, for 3 months before being switched to the other pessary design for 3 months.
Subjects could discontinue the use of either pessary at any time.
Indeed, only 62 of 134 subjects stayed in the study long enough to complete satisfaction scores on both types of pessaries and of those, just 22 were highly satisfied with both.
“Some could not be fitted. Some didn't like pessaries. Some had had enough of pessaries after one trial.
“The message I got was that pessaries aren't really for everyone. They really are for a subset of patients,” said Dr. Geoffrey W. Cundiff, professor of obstetrics and gynecology at Johns Hopkins School of Medicine in Baltimore.
Surprisingly, younger women were far less likely than their older counterparts to complete the trial comparing a ring pessary with support and a gellhorn pessary, reported Dr. Cundiff at the annual meeting of the Society of Gynecologic Surgeons.
Satisfaction rates were similar for the two pessary types, but there was a clear difference in the types of patients who preferred each design.
The 36 women who reported high satisfaction with the ring pessary were older and had weaker pelvic floor muscles. They were more likely to be nonwhite and to be more parous than those who preferred the gellhorn pessary.
Meanwhile, the 39 women who strongly preferred the gellhorn pessary were more likely to have anterior wall prolapse and less likely to have had a hysterectomy or prior prolapse surgery.
Refusal to wear a pessary for 3 months was significantly more common among younger women (mean age 57, compared with 66) and nonwhite women. The nine subjects who wore the pessaries but were dissatisfied with both were more likely to be white, have a history of prior prolapse surgery, and have stage II prolapse.
A subanalysis of the data demonstrated that patients who wore either pessary for 3 months experienced a significant reduction in lower urinary tract symptoms, particularly obstructive symptoms.
Among 97 patients who completed the Pelvic Floor Distress Inventory, no differences were seen in symptomatic relief offered by the ring or gellhorn pessaries, reported Dr. Joseph I. Schaffer, chief of gynecology at the University of Texas Southwestern Medical Center in Dallas.
Scores on the Obstructive/Discomfort subscale declined from a mean 20.32 at baseline to 8.61. Irritative subscale scores declined from a baseline mean of 15.85 to 10, and Stress subscale scores declined from 15.55 at baseline to 12.24.
On another measure, the Urinary Distress Inventory, scores improved from a baseline mean of 51.31 to 31.45.
“This study challenges commonly held beliefs regarding pessaries,” said Dr. Cundiff, and audience members agreed.
One attendee, Dr. Marc Toglia of Philadelphia, admitted the results “challenge my belief system.”
Both physicians acknowledged their surprise that so many women would find the gellhorn pessary preferable to a ring pessary, particularly if they had anterior wall prolapse.
A formal discussant on the study, Dr. Deborah Myers of Brown University School of Medicine in Providence, R.I., took note of the fact that a third of the patients required refitting of a pessary.
“This is important information for patients and physicians,” she said. “Don't give up on the first try.”
TUCSON, ARIZ. — A randomized crossover trial suggests that symptom relief and satisfaction can be obtained by either of two commonly used pessary types, but that patient selection and patience are both key to success.
The multicenter study enrolled 134 women ages 30–89 (mean age 61) with symptomatic pelvic organ prolapse. They were randomized to be fitted with one of two types of pessary and to wear it, if possible, for 3 months before being switched to the other pessary design for 3 months.
Subjects could discontinue the use of either pessary at any time.
Indeed, only 62 of 134 subjects stayed in the study long enough to complete satisfaction scores on both types of pessaries and of those, just 22 were highly satisfied with both.
“Some could not be fitted. Some didn't like pessaries. Some had had enough of pessaries after one trial.
“The message I got was that pessaries aren't really for everyone. They really are for a subset of patients,” said Dr. Geoffrey W. Cundiff, professor of obstetrics and gynecology at Johns Hopkins School of Medicine in Baltimore.
Surprisingly, younger women were far less likely than their older counterparts to complete the trial comparing a ring pessary with support and a gellhorn pessary, reported Dr. Cundiff at the annual meeting of the Society of Gynecologic Surgeons.
Satisfaction rates were similar for the two pessary types, but there was a clear difference in the types of patients who preferred each design.
The 36 women who reported high satisfaction with the ring pessary were older and had weaker pelvic floor muscles. They were more likely to be nonwhite and to be more parous than those who preferred the gellhorn pessary.
Meanwhile, the 39 women who strongly preferred the gellhorn pessary were more likely to have anterior wall prolapse and less likely to have had a hysterectomy or prior prolapse surgery.
Refusal to wear a pessary for 3 months was significantly more common among younger women (mean age 57, compared with 66) and nonwhite women. The nine subjects who wore the pessaries but were dissatisfied with both were more likely to be white, have a history of prior prolapse surgery, and have stage II prolapse.
A subanalysis of the data demonstrated that patients who wore either pessary for 3 months experienced a significant reduction in lower urinary tract symptoms, particularly obstructive symptoms.
Among 97 patients who completed the Pelvic Floor Distress Inventory, no differences were seen in symptomatic relief offered by the ring or gellhorn pessaries, reported Dr. Joseph I. Schaffer, chief of gynecology at the University of Texas Southwestern Medical Center in Dallas.
Scores on the Obstructive/Discomfort subscale declined from a mean 20.32 at baseline to 8.61. Irritative subscale scores declined from a baseline mean of 15.85 to 10, and Stress subscale scores declined from 15.55 at baseline to 12.24.
On another measure, the Urinary Distress Inventory, scores improved from a baseline mean of 51.31 to 31.45.
“This study challenges commonly held beliefs regarding pessaries,” said Dr. Cundiff, and audience members agreed.
One attendee, Dr. Marc Toglia of Philadelphia, admitted the results “challenge my belief system.”
Both physicians acknowledged their surprise that so many women would find the gellhorn pessary preferable to a ring pessary, particularly if they had anterior wall prolapse.
A formal discussant on the study, Dr. Deborah Myers of Brown University School of Medicine in Providence, R.I., took note of the fact that a third of the patients required refitting of a pessary.
“This is important information for patients and physicians,” she said. “Don't give up on the first try.”
TUCSON, ARIZ. — A randomized crossover trial suggests that symptom relief and satisfaction can be obtained by either of two commonly used pessary types, but that patient selection and patience are both key to success.
The multicenter study enrolled 134 women ages 30–89 (mean age 61) with symptomatic pelvic organ prolapse. They were randomized to be fitted with one of two types of pessary and to wear it, if possible, for 3 months before being switched to the other pessary design for 3 months.
Subjects could discontinue the use of either pessary at any time.
Indeed, only 62 of 134 subjects stayed in the study long enough to complete satisfaction scores on both types of pessaries and of those, just 22 were highly satisfied with both.
“Some could not be fitted. Some didn't like pessaries. Some had had enough of pessaries after one trial.
“The message I got was that pessaries aren't really for everyone. They really are for a subset of patients,” said Dr. Geoffrey W. Cundiff, professor of obstetrics and gynecology at Johns Hopkins School of Medicine in Baltimore.
Surprisingly, younger women were far less likely than their older counterparts to complete the trial comparing a ring pessary with support and a gellhorn pessary, reported Dr. Cundiff at the annual meeting of the Society of Gynecologic Surgeons.
Satisfaction rates were similar for the two pessary types, but there was a clear difference in the types of patients who preferred each design.
The 36 women who reported high satisfaction with the ring pessary were older and had weaker pelvic floor muscles. They were more likely to be nonwhite and to be more parous than those who preferred the gellhorn pessary.
Meanwhile, the 39 women who strongly preferred the gellhorn pessary were more likely to have anterior wall prolapse and less likely to have had a hysterectomy or prior prolapse surgery.
Refusal to wear a pessary for 3 months was significantly more common among younger women (mean age 57, compared with 66) and nonwhite women. The nine subjects who wore the pessaries but were dissatisfied with both were more likely to be white, have a history of prior prolapse surgery, and have stage II prolapse.
A subanalysis of the data demonstrated that patients who wore either pessary for 3 months experienced a significant reduction in lower urinary tract symptoms, particularly obstructive symptoms.
Among 97 patients who completed the Pelvic Floor Distress Inventory, no differences were seen in symptomatic relief offered by the ring or gellhorn pessaries, reported Dr. Joseph I. Schaffer, chief of gynecology at the University of Texas Southwestern Medical Center in Dallas.
Scores on the Obstructive/Discomfort subscale declined from a mean 20.32 at baseline to 8.61. Irritative subscale scores declined from a baseline mean of 15.85 to 10, and Stress subscale scores declined from 15.55 at baseline to 12.24.
On another measure, the Urinary Distress Inventory, scores improved from a baseline mean of 51.31 to 31.45.
“This study challenges commonly held beliefs regarding pessaries,” said Dr. Cundiff, and audience members agreed.
One attendee, Dr. Marc Toglia of Philadelphia, admitted the results “challenge my belief system.”
Both physicians acknowledged their surprise that so many women would find the gellhorn pessary preferable to a ring pessary, particularly if they had anterior wall prolapse.
A formal discussant on the study, Dr. Deborah Myers of Brown University School of Medicine in Providence, R.I., took note of the fact that a third of the patients required refitting of a pessary.
“This is important information for patients and physicians,” she said. “Don't give up on the first try.”
Tool Kit Beats Rx for Irritable Bowel Syndrome
LOS ANGELES – An educational tool kit designed to improve patient-physician interactions during visits for irritable bowel syndrome had a greater impact on global symptom relief than did any medication ever studied for the enigmatic disorder.
Dr. Brennan M. Spiegel and associates at the University of California, Los Angeles, tested the tool kit in a randomized study of 73 patients with irritable bowel syndrome (IBS) symptoms who attended the gastrointestinal disease catchment clinic for the VA Greater Los Angeles Health Care System.
Follow-up surveys 3 months later found that patients assigned to the physician-patient intervention group were far more likely than were those who received standard care to say they had achieved relief of their global symptoms (20 of 36 patients, or 56%, compared with 5 of 34 patients, or 15%.)
The intervention effect size of 0.75 “exceeds the largest effect size demonstrated in pharmaceutical studies for IBS,” Dr. Spiegel said at the annual Digestive Disease Week.
Although studies of alosetron using similar outcome measures had effect sizes between 0.2 and 0.5, “this does not mean … that these agents are not effective. It does suggest that medical therapy alone may be suboptimal if it is not delivered in the context of a supportive and informative physician/patient interaction,” he said.
The multifactorial intervention consisted of a five-part tool kit that included:
▸ A waiting room questionnaire to document the patient's primary concerns, fears, and opinions about what might be causing IBS symptoms.
▸ A laminated flash card for the physician that includes key components of an effective discussion of IBS, including reminders to ask about psychosocial elements of the disease, descriptions of IBS in lay language, and the fact that IBS is not a life-threatening disease.
▸ A worksheet and diagram of the brain and gut that the physician could use to depict a simple explanation of the complex neural circuitry linking the two.
▸ A multimedia patient educational kit, including a self-empowerment video, an explanation of the brain-gut axis in lay language, information about support groups, a dietary card, and educational materials about IBS from the National Institutes of Health.
▸ A letter, sent 1 month following the office visit, asking the patient, “How are you doing?” and providing information about how to contact the physician if symptoms had not improved. This correspondence also included more educational information about IBS.
Physicians were free to use or ignore the patient's questionnaire, the flash card, and worksheet during the office visit; however most found that it actually “streamlined” the visit, Dr. Spiegel said.
Similarly, patients could read or dispose of the educational materials provided. Some told study investigators that they found the worksheet very important, while others primarily relied on the diet cards they found in the take-home educational kit.
Whatever elements did the trick, the intervention clearly had an impact on patients, with significant differences seen in global IBS symptoms, satisfaction, and perceptions of their physicians' interpersonal skills.
Ironically, the same physicians saw IBS patients assigned to the intervention group or to usual care.
When independent observers assessed physicians' notes from the visits, they found “very large differences” between the intervention and standard care groups in terms of observations concerning patients' quality of life and extraintestinal symptoms such as anxiety or depression. None of the physician notes documenting visits with control group patients mentioned patients' fears and concerns or disease education efforts, while these elements appeared in their notes regarding 23% and 54% of intervention patient visits, respectively.
Dr. Spiegel prefaced the report on his findings by acknowledging the deep frustration many physicians feel in dealing with patients with IBS, since the disease is common and expensive, symptom expression is heterogeneous, the disease model is incomplete, and highly effective treatment options are scarce.
This frustration can spill over into office visits that leave neither party satisfied.
“Patients often feel uninformed after they have left the office and physicians often do a poor job of predicting patients' severity when patients and physicians fill out the same questionnaire,” he said.
LOS ANGELES – An educational tool kit designed to improve patient-physician interactions during visits for irritable bowel syndrome had a greater impact on global symptom relief than did any medication ever studied for the enigmatic disorder.
Dr. Brennan M. Spiegel and associates at the University of California, Los Angeles, tested the tool kit in a randomized study of 73 patients with irritable bowel syndrome (IBS) symptoms who attended the gastrointestinal disease catchment clinic for the VA Greater Los Angeles Health Care System.
Follow-up surveys 3 months later found that patients assigned to the physician-patient intervention group were far more likely than were those who received standard care to say they had achieved relief of their global symptoms (20 of 36 patients, or 56%, compared with 5 of 34 patients, or 15%.)
The intervention effect size of 0.75 “exceeds the largest effect size demonstrated in pharmaceutical studies for IBS,” Dr. Spiegel said at the annual Digestive Disease Week.
Although studies of alosetron using similar outcome measures had effect sizes between 0.2 and 0.5, “this does not mean … that these agents are not effective. It does suggest that medical therapy alone may be suboptimal if it is not delivered in the context of a supportive and informative physician/patient interaction,” he said.
The multifactorial intervention consisted of a five-part tool kit that included:
▸ A waiting room questionnaire to document the patient's primary concerns, fears, and opinions about what might be causing IBS symptoms.
▸ A laminated flash card for the physician that includes key components of an effective discussion of IBS, including reminders to ask about psychosocial elements of the disease, descriptions of IBS in lay language, and the fact that IBS is not a life-threatening disease.
▸ A worksheet and diagram of the brain and gut that the physician could use to depict a simple explanation of the complex neural circuitry linking the two.
▸ A multimedia patient educational kit, including a self-empowerment video, an explanation of the brain-gut axis in lay language, information about support groups, a dietary card, and educational materials about IBS from the National Institutes of Health.
▸ A letter, sent 1 month following the office visit, asking the patient, “How are you doing?” and providing information about how to contact the physician if symptoms had not improved. This correspondence also included more educational information about IBS.
Physicians were free to use or ignore the patient's questionnaire, the flash card, and worksheet during the office visit; however most found that it actually “streamlined” the visit, Dr. Spiegel said.
Similarly, patients could read or dispose of the educational materials provided. Some told study investigators that they found the worksheet very important, while others primarily relied on the diet cards they found in the take-home educational kit.
Whatever elements did the trick, the intervention clearly had an impact on patients, with significant differences seen in global IBS symptoms, satisfaction, and perceptions of their physicians' interpersonal skills.
Ironically, the same physicians saw IBS patients assigned to the intervention group or to usual care.
When independent observers assessed physicians' notes from the visits, they found “very large differences” between the intervention and standard care groups in terms of observations concerning patients' quality of life and extraintestinal symptoms such as anxiety or depression. None of the physician notes documenting visits with control group patients mentioned patients' fears and concerns or disease education efforts, while these elements appeared in their notes regarding 23% and 54% of intervention patient visits, respectively.
Dr. Spiegel prefaced the report on his findings by acknowledging the deep frustration many physicians feel in dealing with patients with IBS, since the disease is common and expensive, symptom expression is heterogeneous, the disease model is incomplete, and highly effective treatment options are scarce.
This frustration can spill over into office visits that leave neither party satisfied.
“Patients often feel uninformed after they have left the office and physicians often do a poor job of predicting patients' severity when patients and physicians fill out the same questionnaire,” he said.
LOS ANGELES – An educational tool kit designed to improve patient-physician interactions during visits for irritable bowel syndrome had a greater impact on global symptom relief than did any medication ever studied for the enigmatic disorder.
Dr. Brennan M. Spiegel and associates at the University of California, Los Angeles, tested the tool kit in a randomized study of 73 patients with irritable bowel syndrome (IBS) symptoms who attended the gastrointestinal disease catchment clinic for the VA Greater Los Angeles Health Care System.
Follow-up surveys 3 months later found that patients assigned to the physician-patient intervention group were far more likely than were those who received standard care to say they had achieved relief of their global symptoms (20 of 36 patients, or 56%, compared with 5 of 34 patients, or 15%.)
The intervention effect size of 0.75 “exceeds the largest effect size demonstrated in pharmaceutical studies for IBS,” Dr. Spiegel said at the annual Digestive Disease Week.
Although studies of alosetron using similar outcome measures had effect sizes between 0.2 and 0.5, “this does not mean … that these agents are not effective. It does suggest that medical therapy alone may be suboptimal if it is not delivered in the context of a supportive and informative physician/patient interaction,” he said.
The multifactorial intervention consisted of a five-part tool kit that included:
▸ A waiting room questionnaire to document the patient's primary concerns, fears, and opinions about what might be causing IBS symptoms.
▸ A laminated flash card for the physician that includes key components of an effective discussion of IBS, including reminders to ask about psychosocial elements of the disease, descriptions of IBS in lay language, and the fact that IBS is not a life-threatening disease.
▸ A worksheet and diagram of the brain and gut that the physician could use to depict a simple explanation of the complex neural circuitry linking the two.
▸ A multimedia patient educational kit, including a self-empowerment video, an explanation of the brain-gut axis in lay language, information about support groups, a dietary card, and educational materials about IBS from the National Institutes of Health.
▸ A letter, sent 1 month following the office visit, asking the patient, “How are you doing?” and providing information about how to contact the physician if symptoms had not improved. This correspondence also included more educational information about IBS.
Physicians were free to use or ignore the patient's questionnaire, the flash card, and worksheet during the office visit; however most found that it actually “streamlined” the visit, Dr. Spiegel said.
Similarly, patients could read or dispose of the educational materials provided. Some told study investigators that they found the worksheet very important, while others primarily relied on the diet cards they found in the take-home educational kit.
Whatever elements did the trick, the intervention clearly had an impact on patients, with significant differences seen in global IBS symptoms, satisfaction, and perceptions of their physicians' interpersonal skills.
Ironically, the same physicians saw IBS patients assigned to the intervention group or to usual care.
When independent observers assessed physicians' notes from the visits, they found “very large differences” between the intervention and standard care groups in terms of observations concerning patients' quality of life and extraintestinal symptoms such as anxiety or depression. None of the physician notes documenting visits with control group patients mentioned patients' fears and concerns or disease education efforts, while these elements appeared in their notes regarding 23% and 54% of intervention patient visits, respectively.
Dr. Spiegel prefaced the report on his findings by acknowledging the deep frustration many physicians feel in dealing with patients with IBS, since the disease is common and expensive, symptom expression is heterogeneous, the disease model is incomplete, and highly effective treatment options are scarce.
This frustration can spill over into office visits that leave neither party satisfied.
“Patients often feel uninformed after they have left the office and physicians often do a poor job of predicting patients' severity when patients and physicians fill out the same questionnaire,” he said.
Open-Ended Question Can Reveal Impact of Migraine
LOS ANGELES – Health care providers asked lots of questions during videotaped, real-life office visits by patients with migraines, but almost always failed to ask the one question that would indicate whether they should prescribe a preventive medication.
That question: “Can you tell me how your headaches impact your daily life?”
The American Migraine Communication Study, presented at the annual meeting of the American Headache Society, found that providers asked an average of 13 questions in the average 12-minute office visit with a patient seeking care for migraine headaches.
Of those questions, 91% were closed-ended or short-answer questions that patients could respond to with one or two words.
An example of a closed-ended question would be: “Is your headache pain one-sided?” as opposed to, “Can you tell me about your headache pain?”
In more than three-fourths of 60 videotaped office visits, not a single open-ended question was asked, reported Dr. Steven R. Hahn, professor of clinical medicine at the Albert Einstein College of Medicine, New York.
Both providers and patients knew they were being videotaped in the observational linguistic study conducted in community-based private practices. Separate postvisit interviews were conducted with patients and the 14 primary care providers, 8 neurologists, and 6 nurse practitioners or physician assistants who agreed to participate.
Most of the questions posed by providers addressed headache frequency; yet, more than half the time their understanding of their patients' headache frequency was not aligned with patients' own reports once the visits concluded.
Similarly, their understanding of their patients' headache severity was misaligned with their patients' perspective following 34% of visits.
Just 10% of office visits touched upon the degree of impairment experienced by migraine patients, even though an expert consensus panel in 2005 pointed to impairment as a key determinant in the decision about whether to consider or prescribe preventive medications.
The 2005 American Migraine Prevalence and Prevention Study guidelines recommend preventive medications for patients with frequent headaches that severely affect their lives, defined by at least one of the following: migraines on more than 6 days/month; more than 4 days/month of missed school/work due to migraine; or more than 3 days/month of severe impairment or bed rest due to headache.
The guidelines call for consideration of preventive medication for patients with less severe impairment, such as 3 days/month of migraine with some impact on daily function.
Preventive medications might include anticonvulsants, blood pressure medications, antidepressants, serotonin antagonists, or unconventional treatments such as magnesium salts or vitamins.
Among 60 patients in the communication study, 20 met the criteria for preventive therapy but were not receiving preventive medication. In office visits with 10 of these patients, prevention was never discussed. In the remaining visits, prevention was discussed and medication prescribed in two and was discussed but no medication was prescribed in three.
Dr. Hahn agreed with audience members who deplored the brevity of office visits addressing a topic as complex as migraines. However, time constraints are a reality. “I can tell you from this study that one question very quickly reveals the information that was missing from these encounters,” he said.
That open-ended question, “Can you tell me how your headaches impact your daily life?” would often be enough to elicit a succinct description of impairment that could guide decision making about preventive therapy, he said.
“It is actually a time-efficient approach,” he said.
LOS ANGELES – Health care providers asked lots of questions during videotaped, real-life office visits by patients with migraines, but almost always failed to ask the one question that would indicate whether they should prescribe a preventive medication.
That question: “Can you tell me how your headaches impact your daily life?”
The American Migraine Communication Study, presented at the annual meeting of the American Headache Society, found that providers asked an average of 13 questions in the average 12-minute office visit with a patient seeking care for migraine headaches.
Of those questions, 91% were closed-ended or short-answer questions that patients could respond to with one or two words.
An example of a closed-ended question would be: “Is your headache pain one-sided?” as opposed to, “Can you tell me about your headache pain?”
In more than three-fourths of 60 videotaped office visits, not a single open-ended question was asked, reported Dr. Steven R. Hahn, professor of clinical medicine at the Albert Einstein College of Medicine, New York.
Both providers and patients knew they were being videotaped in the observational linguistic study conducted in community-based private practices. Separate postvisit interviews were conducted with patients and the 14 primary care providers, 8 neurologists, and 6 nurse practitioners or physician assistants who agreed to participate.
Most of the questions posed by providers addressed headache frequency; yet, more than half the time their understanding of their patients' headache frequency was not aligned with patients' own reports once the visits concluded.
Similarly, their understanding of their patients' headache severity was misaligned with their patients' perspective following 34% of visits.
Just 10% of office visits touched upon the degree of impairment experienced by migraine patients, even though an expert consensus panel in 2005 pointed to impairment as a key determinant in the decision about whether to consider or prescribe preventive medications.
The 2005 American Migraine Prevalence and Prevention Study guidelines recommend preventive medications for patients with frequent headaches that severely affect their lives, defined by at least one of the following: migraines on more than 6 days/month; more than 4 days/month of missed school/work due to migraine; or more than 3 days/month of severe impairment or bed rest due to headache.
The guidelines call for consideration of preventive medication for patients with less severe impairment, such as 3 days/month of migraine with some impact on daily function.
Preventive medications might include anticonvulsants, blood pressure medications, antidepressants, serotonin antagonists, or unconventional treatments such as magnesium salts or vitamins.
Among 60 patients in the communication study, 20 met the criteria for preventive therapy but were not receiving preventive medication. In office visits with 10 of these patients, prevention was never discussed. In the remaining visits, prevention was discussed and medication prescribed in two and was discussed but no medication was prescribed in three.
Dr. Hahn agreed with audience members who deplored the brevity of office visits addressing a topic as complex as migraines. However, time constraints are a reality. “I can tell you from this study that one question very quickly reveals the information that was missing from these encounters,” he said.
That open-ended question, “Can you tell me how your headaches impact your daily life?” would often be enough to elicit a succinct description of impairment that could guide decision making about preventive therapy, he said.
“It is actually a time-efficient approach,” he said.
LOS ANGELES – Health care providers asked lots of questions during videotaped, real-life office visits by patients with migraines, but almost always failed to ask the one question that would indicate whether they should prescribe a preventive medication.
That question: “Can you tell me how your headaches impact your daily life?”
The American Migraine Communication Study, presented at the annual meeting of the American Headache Society, found that providers asked an average of 13 questions in the average 12-minute office visit with a patient seeking care for migraine headaches.
Of those questions, 91% were closed-ended or short-answer questions that patients could respond to with one or two words.
An example of a closed-ended question would be: “Is your headache pain one-sided?” as opposed to, “Can you tell me about your headache pain?”
In more than three-fourths of 60 videotaped office visits, not a single open-ended question was asked, reported Dr. Steven R. Hahn, professor of clinical medicine at the Albert Einstein College of Medicine, New York.
Both providers and patients knew they were being videotaped in the observational linguistic study conducted in community-based private practices. Separate postvisit interviews were conducted with patients and the 14 primary care providers, 8 neurologists, and 6 nurse practitioners or physician assistants who agreed to participate.
Most of the questions posed by providers addressed headache frequency; yet, more than half the time their understanding of their patients' headache frequency was not aligned with patients' own reports once the visits concluded.
Similarly, their understanding of their patients' headache severity was misaligned with their patients' perspective following 34% of visits.
Just 10% of office visits touched upon the degree of impairment experienced by migraine patients, even though an expert consensus panel in 2005 pointed to impairment as a key determinant in the decision about whether to consider or prescribe preventive medications.
The 2005 American Migraine Prevalence and Prevention Study guidelines recommend preventive medications for patients with frequent headaches that severely affect their lives, defined by at least one of the following: migraines on more than 6 days/month; more than 4 days/month of missed school/work due to migraine; or more than 3 days/month of severe impairment or bed rest due to headache.
The guidelines call for consideration of preventive medication for patients with less severe impairment, such as 3 days/month of migraine with some impact on daily function.
Preventive medications might include anticonvulsants, blood pressure medications, antidepressants, serotonin antagonists, or unconventional treatments such as magnesium salts or vitamins.
Among 60 patients in the communication study, 20 met the criteria for preventive therapy but were not receiving preventive medication. In office visits with 10 of these patients, prevention was never discussed. In the remaining visits, prevention was discussed and medication prescribed in two and was discussed but no medication was prescribed in three.
Dr. Hahn agreed with audience members who deplored the brevity of office visits addressing a topic as complex as migraines. However, time constraints are a reality. “I can tell you from this study that one question very quickly reveals the information that was missing from these encounters,” he said.
That open-ended question, “Can you tell me how your headaches impact your daily life?” would often be enough to elicit a succinct description of impairment that could guide decision making about preventive therapy, he said.
“It is actually a time-efficient approach,” he said.
Topiramate Reduces Chronic Headache Days
LOS ANGELES – The anticonvulsant drug topiramate significantly eased chronic daily headaches, one of the most intractable forms of headache to treat, in a randomized, placebo-controlled trial conducted at 46 U.S. centers.
Although subjects continued to experience headaches on about half of the days in a given month, the relief they obtained had a significant impact on their daily functioning, reported Dr. Stephen D. Silberstein at the annual meeting of the American Headache Society.
With this multicenter study, topiramate has demonstrated “the best efficacy of any drug [used in the treatment of] chronic daily headache,” he said in an interview following the meeting.
At baseline, patients enrolled in the trial experienced headaches about 20–21 days a month, including 17 days in which their headaches were migraines or had migraine features, including unilateral pain, pulsatility, worsening of pain with movement, and nausea and/or vomiting.
The group of 328 patients included mostly women. On average, they had suffered chronic, near-daily headaches for more than 9 years.
The mean number of days per month patients had migraine or “migrainous” headaches declined by 6.41 days in patients randomized to topiramate, compared with 4.67 days in those on placebo, said Dr. Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia.
Patients who took 100 mg/day of topiramate for 3 months after a washout period and a 4-week titration phase had strictly defined migraines less often than did those on placebo: 4.1 days versus 5.6 days, he reported.
Although total average headache severity was not significantly improved by topiramate, peak severity decreased substantially, suggesting that topiramate reduces the migrainous component of headaches, Dr. Silberstein said.
Topiramate, marketed as Topamax, is Food and Drug Administration approved for the prevention of episodic migraine headaches, defined as those occurring less than 15 days/month.
In addition to this pivotal U.S. study, it was the subject of a companion study conducted in Europe that produced similar results in patients with chronic daily headaches, even when those patients suffered from medication overuse headaches.
Dr. Silberstein acknowledged the suggestion by one audience member that the results were “significant but not overly dramatic,” but he noted the limitations of any clinical trial with regard to its clinical application.
“I think it's extremely important to point out that in real life … we'll increase the dose to get significantly higher levels,” he said.
In his clinic, it is not uncommon for patients with severe, long-standing chronic daily headaches to receive 800 mg to 1 g of topiramate per day.
The most common side effect seen in both the U.S. and European trials was paresthesia, seen in about 30% of topiramate patients, especially during titration. Adverse events leading to withdrawal from the trial occurred in 11.3% of the topiramate patients and 6.2% of those receiving placebo. Mental confusion was an uncommon adverse effect. There were no serious adverse events in either group.
Dr. Silberstein disclosed that he receives grant support and serves on the advisory board and as a speaker for Ortho-McNeil Neurologics Inc., the manufacturer of topiramate.
In real life, physicians tend to increase the doses to higher levels than those used in the study. DR. SILBERSTEIN
LOS ANGELES – The anticonvulsant drug topiramate significantly eased chronic daily headaches, one of the most intractable forms of headache to treat, in a randomized, placebo-controlled trial conducted at 46 U.S. centers.
Although subjects continued to experience headaches on about half of the days in a given month, the relief they obtained had a significant impact on their daily functioning, reported Dr. Stephen D. Silberstein at the annual meeting of the American Headache Society.
With this multicenter study, topiramate has demonstrated “the best efficacy of any drug [used in the treatment of] chronic daily headache,” he said in an interview following the meeting.
At baseline, patients enrolled in the trial experienced headaches about 20–21 days a month, including 17 days in which their headaches were migraines or had migraine features, including unilateral pain, pulsatility, worsening of pain with movement, and nausea and/or vomiting.
The group of 328 patients included mostly women. On average, they had suffered chronic, near-daily headaches for more than 9 years.
The mean number of days per month patients had migraine or “migrainous” headaches declined by 6.41 days in patients randomized to topiramate, compared with 4.67 days in those on placebo, said Dr. Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia.
Patients who took 100 mg/day of topiramate for 3 months after a washout period and a 4-week titration phase had strictly defined migraines less often than did those on placebo: 4.1 days versus 5.6 days, he reported.
Although total average headache severity was not significantly improved by topiramate, peak severity decreased substantially, suggesting that topiramate reduces the migrainous component of headaches, Dr. Silberstein said.
Topiramate, marketed as Topamax, is Food and Drug Administration approved for the prevention of episodic migraine headaches, defined as those occurring less than 15 days/month.
In addition to this pivotal U.S. study, it was the subject of a companion study conducted in Europe that produced similar results in patients with chronic daily headaches, even when those patients suffered from medication overuse headaches.
Dr. Silberstein acknowledged the suggestion by one audience member that the results were “significant but not overly dramatic,” but he noted the limitations of any clinical trial with regard to its clinical application.
“I think it's extremely important to point out that in real life … we'll increase the dose to get significantly higher levels,” he said.
In his clinic, it is not uncommon for patients with severe, long-standing chronic daily headaches to receive 800 mg to 1 g of topiramate per day.
The most common side effect seen in both the U.S. and European trials was paresthesia, seen in about 30% of topiramate patients, especially during titration. Adverse events leading to withdrawal from the trial occurred in 11.3% of the topiramate patients and 6.2% of those receiving placebo. Mental confusion was an uncommon adverse effect. There were no serious adverse events in either group.
Dr. Silberstein disclosed that he receives grant support and serves on the advisory board and as a speaker for Ortho-McNeil Neurologics Inc., the manufacturer of topiramate.
In real life, physicians tend to increase the doses to higher levels than those used in the study. DR. SILBERSTEIN
LOS ANGELES – The anticonvulsant drug topiramate significantly eased chronic daily headaches, one of the most intractable forms of headache to treat, in a randomized, placebo-controlled trial conducted at 46 U.S. centers.
Although subjects continued to experience headaches on about half of the days in a given month, the relief they obtained had a significant impact on their daily functioning, reported Dr. Stephen D. Silberstein at the annual meeting of the American Headache Society.
With this multicenter study, topiramate has demonstrated “the best efficacy of any drug [used in the treatment of] chronic daily headache,” he said in an interview following the meeting.
At baseline, patients enrolled in the trial experienced headaches about 20–21 days a month, including 17 days in which their headaches were migraines or had migraine features, including unilateral pain, pulsatility, worsening of pain with movement, and nausea and/or vomiting.
The group of 328 patients included mostly women. On average, they had suffered chronic, near-daily headaches for more than 9 years.
The mean number of days per month patients had migraine or “migrainous” headaches declined by 6.41 days in patients randomized to topiramate, compared with 4.67 days in those on placebo, said Dr. Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia.
Patients who took 100 mg/day of topiramate for 3 months after a washout period and a 4-week titration phase had strictly defined migraines less often than did those on placebo: 4.1 days versus 5.6 days, he reported.
Although total average headache severity was not significantly improved by topiramate, peak severity decreased substantially, suggesting that topiramate reduces the migrainous component of headaches, Dr. Silberstein said.
Topiramate, marketed as Topamax, is Food and Drug Administration approved for the prevention of episodic migraine headaches, defined as those occurring less than 15 days/month.
In addition to this pivotal U.S. study, it was the subject of a companion study conducted in Europe that produced similar results in patients with chronic daily headaches, even when those patients suffered from medication overuse headaches.
Dr. Silberstein acknowledged the suggestion by one audience member that the results were “significant but not overly dramatic,” but he noted the limitations of any clinical trial with regard to its clinical application.
“I think it's extremely important to point out that in real life … we'll increase the dose to get significantly higher levels,” he said.
In his clinic, it is not uncommon for patients with severe, long-standing chronic daily headaches to receive 800 mg to 1 g of topiramate per day.
The most common side effect seen in both the U.S. and European trials was paresthesia, seen in about 30% of topiramate patients, especially during titration. Adverse events leading to withdrawal from the trial occurred in 11.3% of the topiramate patients and 6.2% of those receiving placebo. Mental confusion was an uncommon adverse effect. There were no serious adverse events in either group.
Dr. Silberstein disclosed that he receives grant support and serves on the advisory board and as a speaker for Ortho-McNeil Neurologics Inc., the manufacturer of topiramate.
In real life, physicians tend to increase the doses to higher levels than those used in the study. DR. SILBERSTEIN