Betsy Bates

LOS ANGELES – Visual disturbances may be far more common among patients with migraines than previously believed, according to a study presented at the annual scientific meeting of the American Headache Society.

Dr. Abouch V. Krymchantowski and Dr. Marcus V. Adriano of the Headache Center of Rio de Janeiro prospectively queried 100 consecutive patients (90 women and 10 men) with migraine headaches about their visual symptoms, whether or not they believed their symptoms constituted an aura. The patients ranged in age from 17 to 73 (mean age, 36).

Migraine without aura was the most common diagnosis, seen in 74 patients. Another 10 had migraine with aura, while 16 had both types of headache.

Of the 100 patients in the study, 44 reported some visual alteration that occurred before or during migraine attacks, far higher than the roughly 10% of migraine patients considered to have visual auras. Symptoms included blurred vision in 31 patients, bright spots in 15, zigzag lines in 7, dark spots in 5, diplopia in 4, transient blindness in 3, and hemianopsia in 2. Some patients reported more than one visual symptom, and 19 said their visual symptoms occurred in conjunction with every migraine.

Although 17 patients said they had sought consultations with ophthalmologists concerning their vision problems, only two ophthalmologists correctly linked the symptoms to migraines, Dr. Krymchantowski reported.

Blurred vision, the most common visual disturbance experienced by patients in the study, may be often overlooked. “We are in doubt that patients would report it if not asked,” he said.

An audience member noted that some of his patients report blurred vision that lasts days or even weeks in conjunction with migraine headaches.

Dr. Krymchantowski called for more research into visual alterations related to migraines and suggested that visual auras may be too narrowly defined in current headache guidelines.

LOS ANGELES – Visual disturbances may be far more common among patients with migraines than previously believed, according to a study presented at the annual scientific meeting of the American Headache Society.

Dr. Abouch V. Krymchantowski and Dr. Marcus V. Adriano of the Headache Center of Rio de Janeiro prospectively queried 100 consecutive patients (90 women and 10 men) with migraine headaches about their visual symptoms, whether or not they believed their symptoms constituted an aura. The patients ranged in age from 17 to 73 (mean age, 36).

Migraine without aura was the most common diagnosis, seen in 74 patients. Another 10 had migraine with aura, while 16 had both types of headache.

Of the 100 patients in the study, 44 reported some visual alteration that occurred before or during migraine attacks, far higher than the roughly 10% of migraine patients considered to have visual auras. Symptoms included blurred vision in 31 patients, bright spots in 15, zigzag lines in 7, dark spots in 5, diplopia in 4, transient blindness in 3, and hemianopsia in 2. Some patients reported more than one visual symptom, and 19 said their visual symptoms occurred in conjunction with every migraine.

Although 17 patients said they had sought consultations with ophthalmologists concerning their vision problems, only two ophthalmologists correctly linked the symptoms to migraines, Dr. Krymchantowski reported.

Blurred vision, the most common visual disturbance experienced by patients in the study, may be often overlooked. “We are in doubt that patients would report it if not asked,” he said.

An audience member noted that some of his patients report blurred vision that lasts days or even weeks in conjunction with migraine headaches.

Dr. Krymchantowski called for more research into visual alterations related to migraines and suggested that visual auras may be too narrowly defined in current headache guidelines.

LOS ANGELES – Visual disturbances may be far more common among patients with migraines than previously believed, according to a study presented at the annual scientific meeting of the American Headache Society.

Dr. Abouch V. Krymchantowski and Dr. Marcus V. Adriano of the Headache Center of Rio de Janeiro prospectively queried 100 consecutive patients (90 women and 10 men) with migraine headaches about their visual symptoms, whether or not they believed their symptoms constituted an aura. The patients ranged in age from 17 to 73 (mean age, 36).

Migraine without aura was the most common diagnosis, seen in 74 patients. Another 10 had migraine with aura, while 16 had both types of headache.

Of the 100 patients in the study, 44 reported some visual alteration that occurred before or during migraine attacks, far higher than the roughly 10% of migraine patients considered to have visual auras. Symptoms included blurred vision in 31 patients, bright spots in 15, zigzag lines in 7, dark spots in 5, diplopia in 4, transient blindness in 3, and hemianopsia in 2. Some patients reported more than one visual symptom, and 19 said their visual symptoms occurred in conjunction with every migraine.

Although 17 patients said they had sought consultations with ophthalmologists concerning their vision problems, only two ophthalmologists correctly linked the symptoms to migraines, Dr. Krymchantowski reported.

Blurred vision, the most common visual disturbance experienced by patients in the study, may be often overlooked. “We are in doubt that patients would report it if not asked,” he said.

An audience member noted that some of his patients report blurred vision that lasts days or even weeks in conjunction with migraine headaches.

Dr. Krymchantowski called for more research into visual alterations related to migraines and suggested that visual auras may be too narrowly defined in current headache guidelines.

LOS ANGELES – A structured sleep modification program significantly reduced the frequency and intensity of headaches in women with transformed migraines, University of North Carolina researchers reported at the annual meeting of the American Headache Society.

The strength of the randomized study was reinforced by the inclusion of a “sham” behavioral modification arm and a crossover design.

Dr. Anne H. Calhoun, who serves on the neurology faculty at UNC in Chapel Hill, said headache researchers have known for 125 years about the association between sleep problems and migraines, “but whether headaches are the cause or the result of disrupted sleep is unknown.”

She and her associates previously found that nearly 84% of subjects with migraine were tired on awakening, and that well over half had poor “sleep hygiene,” watching TV or reading in bed, rising between one to six times a night to urinate, napping during the day, and reporting a difficult time falling asleep.

To see whether improved sleep habits would influence headaches, the investigators recruited 43 women referred to the university for the treatment of transformed migraines: They had a history of episodic migraines that, over time, evolved into daily or near-daily headaches with somewhat decreased severity and fewer typical migraine features, such as photophobia and/or phonophobia.

The women in the cohort were in their early to mid-30s, on average, and had experienced chronic headaches for a mean of 11 years. Three-fourths experienced medication-overuse headaches.

All of the women received usual medical care, which included a tapering of overused headache medications, preventive therapy, and treatment of acute headaches.

The 23 women who were randomly selected to receive sleep behavior modification were instructed to keep a consistent bedtime, spend 8 hours a night in bed, discontinue reading or television watching in bed, and refrain from taking naps. They learned visualization techniques to help them fall asleep, and, to reduce nocturia, they were told to eat dinner at least 4 hours before bedtime and to limit fluid intake within 2 hours of bedtime.

“The sham instructions were selected for their impotence on headache frequency or intensity, but they had to seem plausible to participants,” Dr. Calhoun said. The 20 women assigned to the sham group were instructed to schedule a consistent dinner time, apply acupressure for 2 minutes twice a day, keep a record of liquids consumed during the day, and eat some protein as a part of breakfast.

At 6 weeks' follow-up, headache frequency had declined by 29% and headache intensity had dropped by 40% in the women who received behavioral sleep modification, compared with insignificant changes among those who received sham instructions.

Moreover, 8 of 23 women in the sleep modification group no longer met the definition for transformed migraine patients. Instead, they now experienced episodic headaches.

All study participants were then enrolled in a 6-week, open-label trial of sleep behavior modification.

After 6 weeks, 13 of 23 (58%) of the women in the original sleep modification group had reverted from transformed to episodic headaches and 9 of 20 (43%) of the crossover group had done the same.

Adherence to sleep guidelines was correlated with headache improvement. No subject who still had three to five indicators of poor sleep habits reverted to episodic headaches. In contrast, nearly all of the subjects who had “clean” sleep hygiene at the end of the study reverted to episodic rather than chronic daily or near-daily headaches.

“Quite clearly, further studies are needed to confirm these results and to explore a possible mechanism by which nonrestorative sleep may be involved in headache,” Dr. Calhoun said.

LOS ANGELES – A structured sleep modification program significantly reduced the frequency and intensity of headaches in women with transformed migraines, University of North Carolina researchers reported at the annual meeting of the American Headache Society.

The strength of the randomized study was reinforced by the inclusion of a “sham” behavioral modification arm and a crossover design.

Dr. Anne H. Calhoun, who serves on the neurology faculty at UNC in Chapel Hill, said headache researchers have known for 125 years about the association between sleep problems and migraines, “but whether headaches are the cause or the result of disrupted sleep is unknown.”

She and her associates previously found that nearly 84% of subjects with migraine were tired on awakening, and that well over half had poor “sleep hygiene,” watching TV or reading in bed, rising between one to six times a night to urinate, napping during the day, and reporting a difficult time falling asleep.

To see whether improved sleep habits would influence headaches, the investigators recruited 43 women referred to the university for the treatment of transformed migraines: They had a history of episodic migraines that, over time, evolved into daily or near-daily headaches with somewhat decreased severity and fewer typical migraine features, such as photophobia and/or phonophobia.

The women in the cohort were in their early to mid-30s, on average, and had experienced chronic headaches for a mean of 11 years. Three-fourths experienced medication-overuse headaches.

All of the women received usual medical care, which included a tapering of overused headache medications, preventive therapy, and treatment of acute headaches.

The 23 women who were randomly selected to receive sleep behavior modification were instructed to keep a consistent bedtime, spend 8 hours a night in bed, discontinue reading or television watching in bed, and refrain from taking naps. They learned visualization techniques to help them fall asleep, and, to reduce nocturia, they were told to eat dinner at least 4 hours before bedtime and to limit fluid intake within 2 hours of bedtime.

“The sham instructions were selected for their impotence on headache frequency or intensity, but they had to seem plausible to participants,” Dr. Calhoun said. The 20 women assigned to the sham group were instructed to schedule a consistent dinner time, apply acupressure for 2 minutes twice a day, keep a record of liquids consumed during the day, and eat some protein as a part of breakfast.

At 6 weeks' follow-up, headache frequency had declined by 29% and headache intensity had dropped by 40% in the women who received behavioral sleep modification, compared with insignificant changes among those who received sham instructions.

Moreover, 8 of 23 women in the sleep modification group no longer met the definition for transformed migraine patients. Instead, they now experienced episodic headaches.

All study participants were then enrolled in a 6-week, open-label trial of sleep behavior modification.

After 6 weeks, 13 of 23 (58%) of the women in the original sleep modification group had reverted from transformed to episodic headaches and 9 of 20 (43%) of the crossover group had done the same.

Adherence to sleep guidelines was correlated with headache improvement. No subject who still had three to five indicators of poor sleep habits reverted to episodic headaches. In contrast, nearly all of the subjects who had “clean” sleep hygiene at the end of the study reverted to episodic rather than chronic daily or near-daily headaches.

“Quite clearly, further studies are needed to confirm these results and to explore a possible mechanism by which nonrestorative sleep may be involved in headache,” Dr. Calhoun said.

LOS ANGELES – A structured sleep modification program significantly reduced the frequency and intensity of headaches in women with transformed migraines, University of North Carolina researchers reported at the annual meeting of the American Headache Society.

The strength of the randomized study was reinforced by the inclusion of a “sham” behavioral modification arm and a crossover design.

Dr. Anne H. Calhoun, who serves on the neurology faculty at UNC in Chapel Hill, said headache researchers have known for 125 years about the association between sleep problems and migraines, “but whether headaches are the cause or the result of disrupted sleep is unknown.”

She and her associates previously found that nearly 84% of subjects with migraine were tired on awakening, and that well over half had poor “sleep hygiene,” watching TV or reading in bed, rising between one to six times a night to urinate, napping during the day, and reporting a difficult time falling asleep.

To see whether improved sleep habits would influence headaches, the investigators recruited 43 women referred to the university for the treatment of transformed migraines: They had a history of episodic migraines that, over time, evolved into daily or near-daily headaches with somewhat decreased severity and fewer typical migraine features, such as photophobia and/or phonophobia.

The women in the cohort were in their early to mid-30s, on average, and had experienced chronic headaches for a mean of 11 years. Three-fourths experienced medication-overuse headaches.

All of the women received usual medical care, which included a tapering of overused headache medications, preventive therapy, and treatment of acute headaches.

The 23 women who were randomly selected to receive sleep behavior modification were instructed to keep a consistent bedtime, spend 8 hours a night in bed, discontinue reading or television watching in bed, and refrain from taking naps. They learned visualization techniques to help them fall asleep, and, to reduce nocturia, they were told to eat dinner at least 4 hours before bedtime and to limit fluid intake within 2 hours of bedtime.

“The sham instructions were selected for their impotence on headache frequency or intensity, but they had to seem plausible to participants,” Dr. Calhoun said. The 20 women assigned to the sham group were instructed to schedule a consistent dinner time, apply acupressure for 2 minutes twice a day, keep a record of liquids consumed during the day, and eat some protein as a part of breakfast.

At 6 weeks' follow-up, headache frequency had declined by 29% and headache intensity had dropped by 40% in the women who received behavioral sleep modification, compared with insignificant changes among those who received sham instructions.

Moreover, 8 of 23 women in the sleep modification group no longer met the definition for transformed migraine patients. Instead, they now experienced episodic headaches.

All study participants were then enrolled in a 6-week, open-label trial of sleep behavior modification.

After 6 weeks, 13 of 23 (58%) of the women in the original sleep modification group had reverted from transformed to episodic headaches and 9 of 20 (43%) of the crossover group had done the same.

Adherence to sleep guidelines was correlated with headache improvement. No subject who still had three to five indicators of poor sleep habits reverted to episodic headaches. In contrast, nearly all of the subjects who had “clean” sleep hygiene at the end of the study reverted to episodic rather than chronic daily or near-daily headaches.

“Quite clearly, further studies are needed to confirm these results and to explore a possible mechanism by which nonrestorative sleep may be involved in headache,” Dr. Calhoun said.

LOS ANGELES — Capsule endoscopy is so proficient in diagnosing the source of obscure intestinal bleeding it should be considered the first-line option following negative bidirectional endoscopy, the authors of a German study asserted in a presentation at Digestive Disease Week.

Dr. Jörg G. Albert and associates at Martin-Luther-University Hospitals and Clinics in Halle, Germany, reported on 293 capsule endoscopy results in 285 patients seen at five study centers between 2001 and 2004.

Capsule endoscopy identified a bleeding source in 224 patients (76.5%) who had previously undergone bidirectional endoscopies that produced inconclusive results. The data showed that capsule endoscopy was diagnostic in 177 (79%) of these patients, and a repeat capsule endoscopy or additional testing was diagnostic in another 47 patients (21%). In 142 cases, therapeutic measures were initiated based on capsule endoscopy findings. In these cases, the treatments selected were medical therapy in 46%, an endoscopic procedure in 31%, and surgery in 23%.

Capsules were retained in four patients, three of whom required surgery to remove the device, which is swallowed by the patient and transmits images from within the digestive tract.

The most common diagnosis was angiodysplasia, in 40% of patients. Other relatively common diagnoses included bleeding ulcers in 9%, NSAID enteropathy in 6%, suspected malignant tumors in 3%, and Crohn's disease, Meckel's diverticulum, and bleeding diverticulum in 2% of cases each.

No source of bleeding was found in 24% of patients, and these patients experienced half the rate of bleeding recurrences, compared with the group as a whole.

“We were able to follow-up 84% of patients for at least 12 months and a mean of 20 months,” Dr. Albert said in an interview. “One of the main results was that a negative capsule endoscopy resulted in a low rate of recurrence of bleeding events and hospital admission.” In contrast, angiodysplasia was associated with a 6.6-times elevated rate of relapse.

In all, 27% of patients reported a rebleeding episode, with 18% requiring readmission to the hospital and 15% requiring blood transfusions.

Strong predictors of recurrence included a diagnosis of angiodysplasia, use of anticoagulants, patient age older than 60 years, and prior bleeding events.

The investigators emphasized the usefulness of capsule endoscopy in their poster: “A specific change in management is implemented in about two-thirds of cases in whom capsule endoscopy establishes a diagnosis, and in half of all patients investigated, and it seems to influence outcome,” they stated.

“Capsule endoscopy might therefore be regarded as the first-line diagnostic method in intestinal bleeding following negative bidirectional endoscopy.”

Dr. Albert reported having no conflicts of interest.

LOS ANGELES — Capsule endoscopy is so proficient in diagnosing the source of obscure intestinal bleeding it should be considered the first-line option following negative bidirectional endoscopy, the authors of a German study asserted in a presentation at Digestive Disease Week.

Dr. Jörg G. Albert and associates at Martin-Luther-University Hospitals and Clinics in Halle, Germany, reported on 293 capsule endoscopy results in 285 patients seen at five study centers between 2001 and 2004.

Capsule endoscopy identified a bleeding source in 224 patients (76.5%) who had previously undergone bidirectional endoscopies that produced inconclusive results. The data showed that capsule endoscopy was diagnostic in 177 (79%) of these patients, and a repeat capsule endoscopy or additional testing was diagnostic in another 47 patients (21%). In 142 cases, therapeutic measures were initiated based on capsule endoscopy findings. In these cases, the treatments selected were medical therapy in 46%, an endoscopic procedure in 31%, and surgery in 23%.

Capsules were retained in four patients, three of whom required surgery to remove the device, which is swallowed by the patient and transmits images from within the digestive tract.

The most common diagnosis was angiodysplasia, in 40% of patients. Other relatively common diagnoses included bleeding ulcers in 9%, NSAID enteropathy in 6%, suspected malignant tumors in 3%, and Crohn's disease, Meckel's diverticulum, and bleeding diverticulum in 2% of cases each.

No source of bleeding was found in 24% of patients, and these patients experienced half the rate of bleeding recurrences, compared with the group as a whole.

“We were able to follow-up 84% of patients for at least 12 months and a mean of 20 months,” Dr. Albert said in an interview. “One of the main results was that a negative capsule endoscopy resulted in a low rate of recurrence of bleeding events and hospital admission.” In contrast, angiodysplasia was associated with a 6.6-times elevated rate of relapse.

In all, 27% of patients reported a rebleeding episode, with 18% requiring readmission to the hospital and 15% requiring blood transfusions.

Strong predictors of recurrence included a diagnosis of angiodysplasia, use of anticoagulants, patient age older than 60 years, and prior bleeding events.

The investigators emphasized the usefulness of capsule endoscopy in their poster: “A specific change in management is implemented in about two-thirds of cases in whom capsule endoscopy establishes a diagnosis, and in half of all patients investigated, and it seems to influence outcome,” they stated.

“Capsule endoscopy might therefore be regarded as the first-line diagnostic method in intestinal bleeding following negative bidirectional endoscopy.”

Dr. Albert reported having no conflicts of interest.

LOS ANGELES — Capsule endoscopy is so proficient in diagnosing the source of obscure intestinal bleeding it should be considered the first-line option following negative bidirectional endoscopy, the authors of a German study asserted in a presentation at Digestive Disease Week.

Dr. Jörg G. Albert and associates at Martin-Luther-University Hospitals and Clinics in Halle, Germany, reported on 293 capsule endoscopy results in 285 patients seen at five study centers between 2001 and 2004.

Capsule endoscopy identified a bleeding source in 224 patients (76.5%) who had previously undergone bidirectional endoscopies that produced inconclusive results. The data showed that capsule endoscopy was diagnostic in 177 (79%) of these patients, and a repeat capsule endoscopy or additional testing was diagnostic in another 47 patients (21%). In 142 cases, therapeutic measures were initiated based on capsule endoscopy findings. In these cases, the treatments selected were medical therapy in 46%, an endoscopic procedure in 31%, and surgery in 23%.

Capsules were retained in four patients, three of whom required surgery to remove the device, which is swallowed by the patient and transmits images from within the digestive tract.

The most common diagnosis was angiodysplasia, in 40% of patients. Other relatively common diagnoses included bleeding ulcers in 9%, NSAID enteropathy in 6%, suspected malignant tumors in 3%, and Crohn's disease, Meckel's diverticulum, and bleeding diverticulum in 2% of cases each.

No source of bleeding was found in 24% of patients, and these patients experienced half the rate of bleeding recurrences, compared with the group as a whole.

“We were able to follow-up 84% of patients for at least 12 months and a mean of 20 months,” Dr. Albert said in an interview. “One of the main results was that a negative capsule endoscopy resulted in a low rate of recurrence of bleeding events and hospital admission.” In contrast, angiodysplasia was associated with a 6.6-times elevated rate of relapse.

In all, 27% of patients reported a rebleeding episode, with 18% requiring readmission to the hospital and 15% requiring blood transfusions.

Strong predictors of recurrence included a diagnosis of angiodysplasia, use of anticoagulants, patient age older than 60 years, and prior bleeding events.

The investigators emphasized the usefulness of capsule endoscopy in their poster: “A specific change in management is implemented in about two-thirds of cases in whom capsule endoscopy establishes a diagnosis, and in half of all patients investigated, and it seems to influence outcome,” they stated.

“Capsule endoscopy might therefore be regarded as the first-line diagnostic method in intestinal bleeding following negative bidirectional endoscopy.”

Dr. Albert reported having no conflicts of interest.

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 is: “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 cited impairment as a key determinant in decisions about whether to consider or prescribe preventive agents.

The 2005 American Migraine Prevalence and Prevention Study guidelines recommend preventive agents 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, he said, 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.

The 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,” Dr. Hahn added.

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 is: “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 cited impairment as a key determinant in decisions about whether to consider or prescribe preventive agents.

The 2005 American Migraine Prevalence and Prevention Study guidelines recommend preventive agents 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, he said, 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.

The 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,” Dr. Hahn added.

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 is: “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 cited impairment as a key determinant in decisions about whether to consider or prescribe preventive agents.

The 2005 American Migraine Prevalence and Prevention Study guidelines recommend preventive agents 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, he said, 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.

The 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,” Dr. Hahn added.

LOS ANGELES — A structured sleep modification program significantly reduced the frequency and intensity of headaches in women with transformed migraines, University of North Carolina researchers reported at the annual meeting of the American Headache Society.

The strength of the randomized study was reinforced by the inclusion of a “sham” behavioral modification arm and a crossover design.

Dr. Anne H. Calhoun, who serves on the neurology faculty at UNC in Chapel Hill, said that researchers have known for 125 years about the association between sleep problems and migraines, “but whether headaches are the cause or the result of disrupted sleep is unknown.”

She and her associates previously found that nearly 84% of subjects with migraine were tired on awakening, and that well over half had poor “sleep hygiene,” watching TV or reading in bed, rising between one to six times a night to urinate, napping during the day, and reporting a difficult time falling asleep.

To see whether improved sleep habits would influence headaches, the investigators recruited 43 women referred to the university for the treatment of transformed migraines: They had a history of episodic migraines that, over time, evolved into daily or near-daily headaches with somewhat decreased severity and fewer typical migraine features, such as photophobia and/or phonophobia.

The women in the cohort were in their early to mid-30s, on average, and had experienced chronic headaches for a mean of 11 years. Three-fourths experienced medication-overuse headaches.

All of the women received usual medical care, which included a tapering of overused headache medications, preventive therapy, and treatment of acute headaches.

The 23 women who were randomly selected to receive sleep behavior modification were instructed to keep a consistent bedtime, spend 8 hours a night in bed, discontinue reading or television watching in bed, and refrain from taking naps. They learned visualization techniques to help them fall asleep, and, to reduce nocturia, they were told to eat dinner at least 4 hours before bedtime and to limit fluid intake within 2 hours of bedtime.

“The sham instructions were selected for their impotence on headache frequency or intensity, but they had to seem plausible to participants,” Dr. Calhoun said. The 20 women assigned to the sham group were instructed to schedule a consistent dinner time, apply acupressure for 2 minutes twice a day, keep a record of liquids consumed during the day, and eat some protein as a part of breakfast.

At 6 weeks' follow-up, headache frequency had declined by 29% and headache intensity had dropped by 40% in the women who received behavioral sleep modification, compared with insignificant changes among those who received sham instructions. Moreover, 8 of 23 women in the sleep modification group no longer met the definition for transformed migraine patients. Instead, they now experienced episodic headaches.

All study participants were then enrolled in a 6-week, open-label trial of sleep behavior modification. After 6 weeks, 13 of 23 (58%) of the women in the original sleep modification group had reverted from transformed to episodic headaches and 9 of 20 (43%) of the crossover group had done the same.

Adherence to sleep guidelines was correlated with headache improvement. No subject who still had three to five indicators of poor sleep habits reverted to episodic headaches. In contrast, nearly all of the subjects who had “clean” sleep hygiene at the end of the study reverted to episodic rather than chronic daily or near-daily headaches.

“Quite clearly, further studies are needed to confirm these results and to explore a possible mechanism by which nonrestorative sleep may be involved in headache,” Dr. Calhoun said.

LOS ANGELES — A structured sleep modification program significantly reduced the frequency and intensity of headaches in women with transformed migraines, University of North Carolina researchers reported at the annual meeting of the American Headache Society.

The strength of the randomized study was reinforced by the inclusion of a “sham” behavioral modification arm and a crossover design.

Dr. Anne H. Calhoun, who serves on the neurology faculty at UNC in Chapel Hill, said that researchers have known for 125 years about the association between sleep problems and migraines, “but whether headaches are the cause or the result of disrupted sleep is unknown.”

She and her associates previously found that nearly 84% of subjects with migraine were tired on awakening, and that well over half had poor “sleep hygiene,” watching TV or reading in bed, rising between one to six times a night to urinate, napping during the day, and reporting a difficult time falling asleep.

To see whether improved sleep habits would influence headaches, the investigators recruited 43 women referred to the university for the treatment of transformed migraines: They had a history of episodic migraines that, over time, evolved into daily or near-daily headaches with somewhat decreased severity and fewer typical migraine features, such as photophobia and/or phonophobia.

The women in the cohort were in their early to mid-30s, on average, and had experienced chronic headaches for a mean of 11 years. Three-fourths experienced medication-overuse headaches.

All of the women received usual medical care, which included a tapering of overused headache medications, preventive therapy, and treatment of acute headaches.

The 23 women who were randomly selected to receive sleep behavior modification were instructed to keep a consistent bedtime, spend 8 hours a night in bed, discontinue reading or television watching in bed, and refrain from taking naps. They learned visualization techniques to help them fall asleep, and, to reduce nocturia, they were told to eat dinner at least 4 hours before bedtime and to limit fluid intake within 2 hours of bedtime.

“The sham instructions were selected for their impotence on headache frequency or intensity, but they had to seem plausible to participants,” Dr. Calhoun said. The 20 women assigned to the sham group were instructed to schedule a consistent dinner time, apply acupressure for 2 minutes twice a day, keep a record of liquids consumed during the day, and eat some protein as a part of breakfast.

At 6 weeks' follow-up, headache frequency had declined by 29% and headache intensity had dropped by 40% in the women who received behavioral sleep modification, compared with insignificant changes among those who received sham instructions. Moreover, 8 of 23 women in the sleep modification group no longer met the definition for transformed migraine patients. Instead, they now experienced episodic headaches.

All study participants were then enrolled in a 6-week, open-label trial of sleep behavior modification. After 6 weeks, 13 of 23 (58%) of the women in the original sleep modification group had reverted from transformed to episodic headaches and 9 of 20 (43%) of the crossover group had done the same.

Adherence to sleep guidelines was correlated with headache improvement. No subject who still had three to five indicators of poor sleep habits reverted to episodic headaches. In contrast, nearly all of the subjects who had “clean” sleep hygiene at the end of the study reverted to episodic rather than chronic daily or near-daily headaches.

“Quite clearly, further studies are needed to confirm these results and to explore a possible mechanism by which nonrestorative sleep may be involved in headache,” Dr. Calhoun said.

LOS ANGELES — A structured sleep modification program significantly reduced the frequency and intensity of headaches in women with transformed migraines, University of North Carolina researchers reported at the annual meeting of the American Headache Society.

The strength of the randomized study was reinforced by the inclusion of a “sham” behavioral modification arm and a crossover design.

Dr. Anne H. Calhoun, who serves on the neurology faculty at UNC in Chapel Hill, said that researchers have known for 125 years about the association between sleep problems and migraines, “but whether headaches are the cause or the result of disrupted sleep is unknown.”

She and her associates previously found that nearly 84% of subjects with migraine were tired on awakening, and that well over half had poor “sleep hygiene,” watching TV or reading in bed, rising between one to six times a night to urinate, napping during the day, and reporting a difficult time falling asleep.

To see whether improved sleep habits would influence headaches, the investigators recruited 43 women referred to the university for the treatment of transformed migraines: They had a history of episodic migraines that, over time, evolved into daily or near-daily headaches with somewhat decreased severity and fewer typical migraine features, such as photophobia and/or phonophobia.

The women in the cohort were in their early to mid-30s, on average, and had experienced chronic headaches for a mean of 11 years. Three-fourths experienced medication-overuse headaches.

All of the women received usual medical care, which included a tapering of overused headache medications, preventive therapy, and treatment of acute headaches.

The 23 women who were randomly selected to receive sleep behavior modification were instructed to keep a consistent bedtime, spend 8 hours a night in bed, discontinue reading or television watching in bed, and refrain from taking naps. They learned visualization techniques to help them fall asleep, and, to reduce nocturia, they were told to eat dinner at least 4 hours before bedtime and to limit fluid intake within 2 hours of bedtime.

“The sham instructions were selected for their impotence on headache frequency or intensity, but they had to seem plausible to participants,” Dr. Calhoun said. The 20 women assigned to the sham group were instructed to schedule a consistent dinner time, apply acupressure for 2 minutes twice a day, keep a record of liquids consumed during the day, and eat some protein as a part of breakfast.

At 6 weeks' follow-up, headache frequency had declined by 29% and headache intensity had dropped by 40% in the women who received behavioral sleep modification, compared with insignificant changes among those who received sham instructions. Moreover, 8 of 23 women in the sleep modification group no longer met the definition for transformed migraine patients. Instead, they now experienced episodic headaches.

All study participants were then enrolled in a 6-week, open-label trial of sleep behavior modification. After 6 weeks, 13 of 23 (58%) of the women in the original sleep modification group had reverted from transformed to episodic headaches and 9 of 20 (43%) of the crossover group had done the same.

Adherence to sleep guidelines was correlated with headache improvement. No subject who still had three to five indicators of poor sleep habits reverted to episodic headaches. In contrast, nearly all of the subjects who had “clean” sleep hygiene at the end of the study reverted to episodic rather than chronic daily or near-daily headaches.

“Quite clearly, further studies are needed to confirm these results and to explore a possible mechanism by which nonrestorative sleep may be involved in headache,” Dr. Calhoun said.

LOS ANGELES — Visual disturbances may be far more common among patients with migraines than previously believed, according to a study presented at the annual scientific meeting of the American Headache Society.

Dr. Abouch V. Krymchantowski and Dr. Marcus V. Adriano of the Headache Center of Rio de Janeiro, Brazil, prospectively queried 100 consecutive patients (90 women and 10 men) with migraine headaches about their visual symptoms, whether or not they believed their symptoms constituted an aura. The patients ranged in age from 17 to 73 (mean age, 36).

Migraine without aura was the most common diagnosis, seen in 74 patients. Another 10 had migraine with aura, while 16 had both types of headache. But nearly half—44 of 100 patients—reported some visual alteration that occurred before or during migraine attacks, far higher than the roughly 10% of migraine patients considered to have visual auras. Symptoms included blurred vision in 31 patients, bright spots in 15, zigzag lines in 7, dark spots in 5, diplopia in 4, transient blindness in 3, and hemianopsia in 2.

Blurred vision, the most common visual disturbance reported, may be commonly overlooked. Dr. Krymchantowski called for more research into visual alterations related to migraines and suggested that visual auras may be too narrowly defined in current headache guidelines.

LOS ANGELES — Visual disturbances may be far more common among patients with migraines than previously believed, according to a study presented at the annual scientific meeting of the American Headache Society.

Dr. Abouch V. Krymchantowski and Dr. Marcus V. Adriano of the Headache Center of Rio de Janeiro, Brazil, prospectively queried 100 consecutive patients (90 women and 10 men) with migraine headaches about their visual symptoms, whether or not they believed their symptoms constituted an aura. The patients ranged in age from 17 to 73 (mean age, 36).

Migraine without aura was the most common diagnosis, seen in 74 patients. Another 10 had migraine with aura, while 16 had both types of headache. But nearly half—44 of 100 patients—reported some visual alteration that occurred before or during migraine attacks, far higher than the roughly 10% of migraine patients considered to have visual auras. Symptoms included blurred vision in 31 patients, bright spots in 15, zigzag lines in 7, dark spots in 5, diplopia in 4, transient blindness in 3, and hemianopsia in 2.

Blurred vision, the most common visual disturbance reported, may be commonly overlooked. Dr. Krymchantowski called for more research into visual alterations related to migraines and suggested that visual auras may be too narrowly defined in current headache guidelines.

LOS ANGELES — Visual disturbances may be far more common among patients with migraines than previously believed, according to a study presented at the annual scientific meeting of the American Headache Society.

Dr. Abouch V. Krymchantowski and Dr. Marcus V. Adriano of the Headache Center of Rio de Janeiro, Brazil, prospectively queried 100 consecutive patients (90 women and 10 men) with migraine headaches about their visual symptoms, whether or not they believed their symptoms constituted an aura. The patients ranged in age from 17 to 73 (mean age, 36).

Migraine without aura was the most common diagnosis, seen in 74 patients. Another 10 had migraine with aura, while 16 had both types of headache. But nearly half—44 of 100 patients—reported some visual alteration that occurred before or during migraine attacks, far higher than the roughly 10% of migraine patients considered to have visual auras. Symptoms included blurred vision in 31 patients, bright spots in 15, zigzag lines in 7, dark spots in 5, diplopia in 4, transient blindness in 3, and hemianopsia in 2.

Blurred vision, the most common visual disturbance reported, may be commonly overlooked. Dr. Krymchantowski called for more research into visual alterations related to migraines and suggested that visual auras may be too narrowly defined in current headache guidelines.

LOS ANGELES — Capsule endoscopy is so proficient in diagnosing the source of obscure intestinal bleeding it should be considered the first-line option following negative bidirectional endoscopy, the authors of a German study asserted in a presentation at Digestive Disease Week.

Dr. Jörg G. Albert and associates at Martin-Luther-University Hospitals and Clinics in Halle, Germany, reported on 293 capsule endoscopy results in 285 patients seen at five study centers between 2001 and 2004.

Capsule endoscopy identified a bleeding source in 224 patients (76.5%) who had previously undergone bidirectional endoscopies that produced inconclusive results. The data showed that capsule endoscopy was diagnostic in 177 (79%) of these patients, and a repeat capsule endoscopy or additional testing was diagnostic in another 47 patients (21%).

In 142 cases, therapeutic measures were initiated based on capsule endoscopy findings. In these cases, the treatments selected were medical therapy in 46%, an endoscopic procedure in 31%, and surgery in 23%. Capsules were retained in four patients, three of whom required surgery to remove the device, which is swallowed by the patient and transmits images from within the digestive tract.

The most common diagnosis was angiodysplasia, in 40% of patients. Other relatively common diagnoses included bleeding ulcers in 9%, NSAID enteropathy in 6%, suspected malignant tumors in 3%, and Crohn's disease, Meckel's diverticulum, and bleeding diverticulum in 2% of cases each.

No source of bleeding was found in 24% of patients, and these patients experienced half the rate of bleeding recurrences, compared with the group as a whole.

Dr. Albert reported no conflicts of interest.

LOS ANGELES — Capsule endoscopy is so proficient in diagnosing the source of obscure intestinal bleeding it should be considered the first-line option following negative bidirectional endoscopy, the authors of a German study asserted in a presentation at Digestive Disease Week.

Dr. Jörg G. Albert and associates at Martin-Luther-University Hospitals and Clinics in Halle, Germany, reported on 293 capsule endoscopy results in 285 patients seen at five study centers between 2001 and 2004.

Capsule endoscopy identified a bleeding source in 224 patients (76.5%) who had previously undergone bidirectional endoscopies that produced inconclusive results. The data showed that capsule endoscopy was diagnostic in 177 (79%) of these patients, and a repeat capsule endoscopy or additional testing was diagnostic in another 47 patients (21%).

In 142 cases, therapeutic measures were initiated based on capsule endoscopy findings. In these cases, the treatments selected were medical therapy in 46%, an endoscopic procedure in 31%, and surgery in 23%. Capsules were retained in four patients, three of whom required surgery to remove the device, which is swallowed by the patient and transmits images from within the digestive tract.

The most common diagnosis was angiodysplasia, in 40% of patients. Other relatively common diagnoses included bleeding ulcers in 9%, NSAID enteropathy in 6%, suspected malignant tumors in 3%, and Crohn's disease, Meckel's diverticulum, and bleeding diverticulum in 2% of cases each.

No source of bleeding was found in 24% of patients, and these patients experienced half the rate of bleeding recurrences, compared with the group as a whole.

Dr. Albert reported no conflicts of interest.

LOS ANGELES — Capsule endoscopy is so proficient in diagnosing the source of obscure intestinal bleeding it should be considered the first-line option following negative bidirectional endoscopy, the authors of a German study asserted in a presentation at Digestive Disease Week.

Dr. Jörg G. Albert and associates at Martin-Luther-University Hospitals and Clinics in Halle, Germany, reported on 293 capsule endoscopy results in 285 patients seen at five study centers between 2001 and 2004.

Capsule endoscopy identified a bleeding source in 224 patients (76.5%) who had previously undergone bidirectional endoscopies that produced inconclusive results. The data showed that capsule endoscopy was diagnostic in 177 (79%) of these patients, and a repeat capsule endoscopy or additional testing was diagnostic in another 47 patients (21%).

In 142 cases, therapeutic measures were initiated based on capsule endoscopy findings. In these cases, the treatments selected were medical therapy in 46%, an endoscopic procedure in 31%, and surgery in 23%. Capsules were retained in four patients, three of whom required surgery to remove the device, which is swallowed by the patient and transmits images from within the digestive tract.

The most common diagnosis was angiodysplasia, in 40% of patients. Other relatively common diagnoses included bleeding ulcers in 9%, NSAID enteropathy in 6%, suspected malignant tumors in 3%, and Crohn's disease, Meckel's diverticulum, and bleeding diverticulum in 2% of cases each.

No source of bleeding was found in 24% of patients, and these patients experienced half the rate of bleeding recurrences, compared with the group as a whole.

Dr. Albert reported no conflicts of interest.

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, said Dr. Spiegel.

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.

“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, said Dr. Spiegel.

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, said Dr. Spiegel.

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.

“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, said Dr. Spiegel.

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, said Dr. Spiegel.

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.

“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, said Dr. Spiegel.

LOS ANGELES — Even the experts disagree about what tests should be ordered to rule out organic disease in patients presenting with symptoms of irritable bowel syndrome, according to survey results presented at the annual Digestive Disease Week.

Dr. Brennan M. Spiegel and associates at the University of California, Los Angeles, surveyed 27 recognized experts in irritable bowel syndrome (IBS), 53 randomly chosen gastroenterologists from the American Gastroenterological Association, 89 primary care physicians, and 102 nurse-practitioners to determine whether various health care professionals consider IBS to be a diagnosis of exclusion.

Their results suggest that many physicians and other health care professionals are not following practice guidelines issued in 2002 by the American College of Gastroenterology (ACG), which emphasize the importance of assessing IBS symptoms and discourage extensive work-ups for patients who do not have alarming symptoms or findings on physical examination.

Survey respondents were presented with a fictitious patient scenario and asked what tests they would order to establish a diagnosis of IBS. In the vignette, the patient was a 42-year-old woman with a history of loose stools for many years and up to six bowel movements a day. She described crampy, left lower quadrant pain that improved with stool passage. Neither her history nor her physical exam revealed any alarming symptoms.

On that description alone, two-thirds of IBS experts were willing to endorse a diagnosis of IBS, compared with 34% of primary care physicians, 43% of gastroenterologists, and 41% of nurse-practitioners.

IBS experts were in strong agreement that two tests would be warranted to rule out organic disease: a complete blood count and a test for antibodies to celiac sprue. They also agreed on one inappropriate test: a breath test for small-intestine bacterial overgrowth.

“Everything else was uncertain, even among experts, about what to do,” Dr. Spiegel said. Respondents showed “extreme variation” in the additional tests they said they would order, with some advocating a chemistry panel, erythrocyte sedimentation rate, thyroid stimulating hormone, stool white blood cell count, and other tests.

On average, the IBS experts said they would order a total of 2 tests, while gastroenterologists would order 3.9; primary care physicians, 4.1; and nurse-practitioners, 4.3.

The experts, chosen on the basis of their publications and selection for guidelines committees, were also far less likely than other health professionals to say they believed IBS was a diagnosis of exclusion; the rate was 8% of experts, compared with 42% of gastroenterologists and 72% of both primary care physicians and nurse-practitioners.

After adjustment was made for type of health professional, practice type, age, gender, and experience treating IBS patients, the belief that IBS is a diagnosis of exclusion predicted the desire to order 1.6 more tests and spend $364 more on diagnostic testing of the patient in the vignette.

“In general, this disconnect indicates that these guidelines, [which] have been much ballyhooed by the ACG and other groups, either are not being disseminated correctly or simply are not being followed or believed,” Dr. Spiegel said.

An audience member praised the study, saying the findings were “dead on.”

“I think we all realize that the diagnosis of IBS is probably imperfect and fraught with error,” Dr. Spiegel responded.

Interim results of an unrelated study presented at the meeting suggest that if one test is going to be ordered for patients meeting Rome II criteria for diarrhea-predominant or mixed IBS, a celiac disease panel is probably a good choice.

A study from the National Naval Medical Center in Bethesda, Md., Walter Reed Army Medical Center in Washington, and the University of Maryland, Baltimore, attempted to identify organic gastrointestinal findings among 323 patients with IBS who received an extensive array of tests: complete blood count, comprehensive metabolic panel, thyroid function test, erythrocyte sedimentation rate, C-reactive protein panel, inflammatory bowel disease panel, hypolactasia (lactase deficiency) genetic assay, celiac disease panel, and colonoscopy with rectosigmoid biopsies.

A total of 9 of 323 patients, or 2.8%, were diagnosed with organic gastrointestinal disease based on the exhaustive testing. These included four, or 1.2%, with celiac disease; three with inflammatory bowel disease; one with malignancy; and one with sigmoid volvulus.

The only test that identified significantly more disease in IBS patients than in 241 controls was the celiac sprue test, reported Dr. Brooks D. Cash, director of clinical research and a gastroenterologist at the National Naval Medical Center.

LOS ANGELES — Even the experts disagree about what tests should be ordered to rule out organic disease in patients presenting with symptoms of irritable bowel syndrome, according to survey results presented at the annual Digestive Disease Week.

Dr. Brennan M. Spiegel and associates at the University of California, Los Angeles, surveyed 27 recognized experts in irritable bowel syndrome (IBS), 53 randomly chosen gastroenterologists from the American Gastroenterological Association, 89 primary care physicians, and 102 nurse-practitioners to determine whether various health care professionals consider IBS to be a diagnosis of exclusion.

Their results suggest that many physicians and other health care professionals are not following practice guidelines issued in 2002 by the American College of Gastroenterology (ACG), which emphasize the importance of assessing IBS symptoms and discourage extensive work-ups for patients who do not have alarming symptoms or findings on physical examination.

Survey respondents were presented with a fictitious patient scenario and asked what tests they would order to establish a diagnosis of IBS. In the vignette, the patient was a 42-year-old woman with a history of loose stools for many years and up to six bowel movements a day. She described crampy, left lower quadrant pain that improved with stool passage. Neither her history nor her physical exam revealed any alarming symptoms.

On that description alone, two-thirds of IBS experts were willing to endorse a diagnosis of IBS, compared with 34% of primary care physicians, 43% of gastroenterologists, and 41% of nurse-practitioners.

IBS experts were in strong agreement that two tests would be warranted to rule out organic disease: a complete blood count and a test for antibodies to celiac sprue. They also agreed on one inappropriate test: a breath test for small-intestine bacterial overgrowth.

“Everything else was uncertain, even among experts, about what to do,” Dr. Spiegel said. Respondents showed “extreme variation” in the additional tests they said they would order, with some advocating a chemistry panel, erythrocyte sedimentation rate, thyroid stimulating hormone, stool white blood cell count, and other tests.

On average, the IBS experts said they would order a total of 2 tests, while gastroenterologists would order 3.9; primary care physicians, 4.1; and nurse-practitioners, 4.3.

The experts, chosen on the basis of their publications and selection for guidelines committees, were also far less likely than other health professionals to say they believed IBS was a diagnosis of exclusion; the rate was 8% of experts, compared with 42% of gastroenterologists and 72% of both primary care physicians and nurse-practitioners.

After adjustment was made for type of health professional, practice type, age, gender, and experience treating IBS patients, the belief that IBS is a diagnosis of exclusion predicted the desire to order 1.6 more tests and spend $364 more on diagnostic testing of the patient in the vignette.

“In general, this disconnect indicates that these guidelines, [which] have been much ballyhooed by the ACG and other groups, either are not being disseminated correctly or simply are not being followed or believed,” Dr. Spiegel said.

An audience member praised the study, saying the findings were “dead on.”

“I think we all realize that the diagnosis of IBS is probably imperfect and fraught with error,” Dr. Spiegel responded.

Interim results of an unrelated study presented at the meeting suggest that if one test is going to be ordered for patients meeting Rome II criteria for diarrhea-predominant or mixed IBS, a celiac disease panel is probably a good choice.

A study from the National Naval Medical Center in Bethesda, Md., Walter Reed Army Medical Center in Washington, and the University of Maryland, Baltimore, attempted to identify organic gastrointestinal findings among 323 patients with IBS who received an extensive array of tests: complete blood count, comprehensive metabolic panel, thyroid function test, erythrocyte sedimentation rate, C-reactive protein panel, inflammatory bowel disease panel, hypolactasia (lactase deficiency) genetic assay, celiac disease panel, and colonoscopy with rectosigmoid biopsies.

A total of 9 of 323 patients, or 2.8%, were diagnosed with organic gastrointestinal disease based on the exhaustive testing. These included four, or 1.2%, with celiac disease; three with inflammatory bowel disease; one with malignancy; and one with sigmoid volvulus.

The only test that identified significantly more disease in IBS patients than in 241 controls was the celiac sprue test, reported Dr. Brooks D. Cash, director of clinical research and a gastroenterologist at the National Naval Medical Center.

LOS ANGELES — Even the experts disagree about what tests should be ordered to rule out organic disease in patients presenting with symptoms of irritable bowel syndrome, according to survey results presented at the annual Digestive Disease Week.

Dr. Brennan M. Spiegel and associates at the University of California, Los Angeles, surveyed 27 recognized experts in irritable bowel syndrome (IBS), 53 randomly chosen gastroenterologists from the American Gastroenterological Association, 89 primary care physicians, and 102 nurse-practitioners to determine whether various health care professionals consider IBS to be a diagnosis of exclusion.

Their results suggest that many physicians and other health care professionals are not following practice guidelines issued in 2002 by the American College of Gastroenterology (ACG), which emphasize the importance of assessing IBS symptoms and discourage extensive work-ups for patients who do not have alarming symptoms or findings on physical examination.

Survey respondents were presented with a fictitious patient scenario and asked what tests they would order to establish a diagnosis of IBS. In the vignette, the patient was a 42-year-old woman with a history of loose stools for many years and up to six bowel movements a day. She described crampy, left lower quadrant pain that improved with stool passage. Neither her history nor her physical exam revealed any alarming symptoms.

On that description alone, two-thirds of IBS experts were willing to endorse a diagnosis of IBS, compared with 34% of primary care physicians, 43% of gastroenterologists, and 41% of nurse-practitioners.

IBS experts were in strong agreement that two tests would be warranted to rule out organic disease: a complete blood count and a test for antibodies to celiac sprue. They also agreed on one inappropriate test: a breath test for small-intestine bacterial overgrowth.

“Everything else was uncertain, even among experts, about what to do,” Dr. Spiegel said. Respondents showed “extreme variation” in the additional tests they said they would order, with some advocating a chemistry panel, erythrocyte sedimentation rate, thyroid stimulating hormone, stool white blood cell count, and other tests.

On average, the IBS experts said they would order a total of 2 tests, while gastroenterologists would order 3.9; primary care physicians, 4.1; and nurse-practitioners, 4.3.

The experts, chosen on the basis of their publications and selection for guidelines committees, were also far less likely than other health professionals to say they believed IBS was a diagnosis of exclusion; the rate was 8% of experts, compared with 42% of gastroenterologists and 72% of both primary care physicians and nurse-practitioners.

After adjustment was made for type of health professional, practice type, age, gender, and experience treating IBS patients, the belief that IBS is a diagnosis of exclusion predicted the desire to order 1.6 more tests and spend $364 more on diagnostic testing of the patient in the vignette.

“In general, this disconnect indicates that these guidelines, [which] have been much ballyhooed by the ACG and other groups, either are not being disseminated correctly or simply are not being followed or believed,” Dr. Spiegel said.

An audience member praised the study, saying the findings were “dead on.”

“I think we all realize that the diagnosis of IBS is probably imperfect and fraught with error,” Dr. Spiegel responded.

Interim results of an unrelated study presented at the meeting suggest that if one test is going to be ordered for patients meeting Rome II criteria for diarrhea-predominant or mixed IBS, a celiac disease panel is probably a good choice.

A study from the National Naval Medical Center in Bethesda, Md., Walter Reed Army Medical Center in Washington, and the University of Maryland, Baltimore, attempted to identify organic gastrointestinal findings among 323 patients with IBS who received an extensive array of tests: complete blood count, comprehensive metabolic panel, thyroid function test, erythrocyte sedimentation rate, C-reactive protein panel, inflammatory bowel disease panel, hypolactasia (lactase deficiency) genetic assay, celiac disease panel, and colonoscopy with rectosigmoid biopsies.

A total of 9 of 323 patients, or 2.8%, were diagnosed with organic gastrointestinal disease based on the exhaustive testing. These included four, or 1.2%, with celiac disease; three with inflammatory bowel disease; one with malignancy; and one with sigmoid volvulus.

The only test that identified significantly more disease in IBS patients than in 241 controls was the celiac sprue test, reported Dr. Brooks D. Cash, director of clinical research and a gastroenterologist at the National Naval Medical Center.

LOS ANGELES — A combination of rifaximin and loperamide, taken at the first sign of traveler's diarrhea, is the optimal way to treat an illness that affects 10 million American tourists a year, Dr. Herbert L. DuPont said at the annual Digestive Disease Week.

Rifaximin, a gut-selective antibiotic, and loperamide, an antimotility agent, were tested alone and in combination in a randomized trial of 315 U.S. college students who developed acute diarrhea and at least one symptom of an enteric infection while studying in Mexico.

“The Imodium [loperamide] immediately stopped the diarrhea and the antibiotic cured the disease,” Dr. DuPont said in an interview during the meeting.

“If they took Imodium alone, they got immediate improvement, but then they continued to be sick. Rifaximin by itself was slow to get going, but it cured the disease after 24–30 hours,” he said.

“The combination zapped the thing rapidly and cured it, so we think it's probably the optimal way to manage traveler's diarrhea,” said Dr. DuPont, professor of medicine and epidemiology at the University of Texas, Houston, and chief of internal medicine at St. Luke's Episcopal Hospital, also in Houston.

The participants were assigned to receive either 200 mg of rifaximin three times daily for 3 days; 4 mg of loperamide initially, followed by 2 mg after each unformed stool, not to exceed 8 mg/day for 48 hours; or both of these regimens simultaneously.

During the 5-day study period, more than 75% of the students receiving rifaximin or the drug combination achieved a clinical cure, compared with 58% of those receiving loperamide alone.

The time from initiation of treatment to the passage of the last unformed stool was also shorter in patients taking the drug combination (27.3 hours) or rifaximin alone (32.5 hours) than with loperamide alone (69 hours), he reported.

Loperamide and the drug combination resulted in significantly fewer stools passed in the first 24 hours, but in the case of loperamide alone, the effect was transient. Abdominal cramps were less frequent in patients taking the rifaximin-loperamide combination.

Finally, the participants' assessment of “complete wellness” was higher with rifaximin and the rifaximin-loperamide combination.

All of the treatments were well tolerated.

In the poster presentation, Dr. DuPont concluded that the drug combination “provides clinically relevant benefits vs. either agent alone, providing more rapid symptom relief and clinical cure … [possibly representing] a new standard of care.”

Although both drugs are available in many foreign countries, including Mexico, Dr. DuPont recommended that physicians prescribe the drugs to patients before they embark on journeys to developing countries, with instructions to take both medications according to the study schedule if they become ill.

Loperamide is available over the counter, and rifaximin is FDA approved for traveler's diarrhea.

Salix Pharmaceuticals Inc., maker of rifaximin, provided funding for the study.

LOS ANGELES — A combination of rifaximin and loperamide, taken at the first sign of traveler's diarrhea, is the optimal way to treat an illness that affects 10 million American tourists a year, Dr. Herbert L. DuPont said at the annual Digestive Disease Week.

Rifaximin, a gut-selective antibiotic, and loperamide, an antimotility agent, were tested alone and in combination in a randomized trial of 315 U.S. college students who developed acute diarrhea and at least one symptom of an enteric infection while studying in Mexico.

“The Imodium [loperamide] immediately stopped the diarrhea and the antibiotic cured the disease,” Dr. DuPont said in an interview during the meeting.

“If they took Imodium alone, they got immediate improvement, but then they continued to be sick. Rifaximin by itself was slow to get going, but it cured the disease after 24–30 hours,” he said.

“The combination zapped the thing rapidly and cured it, so we think it's probably the optimal way to manage traveler's diarrhea,” said Dr. DuPont, professor of medicine and epidemiology at the University of Texas, Houston, and chief of internal medicine at St. Luke's Episcopal Hospital, also in Houston.

The participants were assigned to receive either 200 mg of rifaximin three times daily for 3 days; 4 mg of loperamide initially, followed by 2 mg after each unformed stool, not to exceed 8 mg/day for 48 hours; or both of these regimens simultaneously.

During the 5-day study period, more than 75% of the students receiving rifaximin or the drug combination achieved a clinical cure, compared with 58% of those receiving loperamide alone.

The time from initiation of treatment to the passage of the last unformed stool was also shorter in patients taking the drug combination (27.3 hours) or rifaximin alone (32.5 hours) than with loperamide alone (69 hours), he reported.

Loperamide and the drug combination resulted in significantly fewer stools passed in the first 24 hours, but in the case of loperamide alone, the effect was transient. Abdominal cramps were less frequent in patients taking the rifaximin-loperamide combination.

Finally, the participants' assessment of “complete wellness” was higher with rifaximin and the rifaximin-loperamide combination.

All of the treatments were well tolerated.

In the poster presentation, Dr. DuPont concluded that the drug combination “provides clinically relevant benefits vs. either agent alone, providing more rapid symptom relief and clinical cure … [possibly representing] a new standard of care.”

Although both drugs are available in many foreign countries, including Mexico, Dr. DuPont recommended that physicians prescribe the drugs to patients before they embark on journeys to developing countries, with instructions to take both medications according to the study schedule if they become ill.

Loperamide is available over the counter, and rifaximin is FDA approved for traveler's diarrhea.

Salix Pharmaceuticals Inc., maker of rifaximin, provided funding for the study.

LOS ANGELES — A combination of rifaximin and loperamide, taken at the first sign of traveler's diarrhea, is the optimal way to treat an illness that affects 10 million American tourists a year, Dr. Herbert L. DuPont said at the annual Digestive Disease Week.

Rifaximin, a gut-selective antibiotic, and loperamide, an antimotility agent, were tested alone and in combination in a randomized trial of 315 U.S. college students who developed acute diarrhea and at least one symptom of an enteric infection while studying in Mexico.

“The Imodium [loperamide] immediately stopped the diarrhea and the antibiotic cured the disease,” Dr. DuPont said in an interview during the meeting.

“If they took Imodium alone, they got immediate improvement, but then they continued to be sick. Rifaximin by itself was slow to get going, but it cured the disease after 24–30 hours,” he said.

“The combination zapped the thing rapidly and cured it, so we think it's probably the optimal way to manage traveler's diarrhea,” said Dr. DuPont, professor of medicine and epidemiology at the University of Texas, Houston, and chief of internal medicine at St. Luke's Episcopal Hospital, also in Houston.

The participants were assigned to receive either 200 mg of rifaximin three times daily for 3 days; 4 mg of loperamide initially, followed by 2 mg after each unformed stool, not to exceed 8 mg/day for 48 hours; or both of these regimens simultaneously.

During the 5-day study period, more than 75% of the students receiving rifaximin or the drug combination achieved a clinical cure, compared with 58% of those receiving loperamide alone.

The time from initiation of treatment to the passage of the last unformed stool was also shorter in patients taking the drug combination (27.3 hours) or rifaximin alone (32.5 hours) than with loperamide alone (69 hours), he reported.

Loperamide and the drug combination resulted in significantly fewer stools passed in the first 24 hours, but in the case of loperamide alone, the effect was transient. Abdominal cramps were less frequent in patients taking the rifaximin-loperamide combination.

Finally, the participants' assessment of “complete wellness” was higher with rifaximin and the rifaximin-loperamide combination.

All of the treatments were well tolerated.

In the poster presentation, Dr. DuPont concluded that the drug combination “provides clinically relevant benefits vs. either agent alone, providing more rapid symptom relief and clinical cure … [possibly representing] a new standard of care.”

Although both drugs are available in many foreign countries, including Mexico, Dr. DuPont recommended that physicians prescribe the drugs to patients before they embark on journeys to developing countries, with instructions to take both medications according to the study schedule if they become ill.

Loperamide is available over the counter, and rifaximin is FDA approved for traveler's diarrhea.

Salix Pharmaceuticals Inc., maker of rifaximin, provided funding for the study.