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Review Pegs Anal Incontinence Rate in Women at 4.5%; Age Key Factor
MONTREAL — Anal incontinence is four times more prevalent than previously thought, and it affects older men and women almost equally, according to what British researchers describe as the first systematic review of the prevalence of this disorder.
“Age, not gender, is the most important factor, and obstetric trauma does not have a major effect,” Philip Toozs-Hobson, M.D., reported at the annual meeting of the International Continence Society.
The review of 29 studies with a total of 69,152 participants found an overall rate of anal incontinence of 3.5% in men and 4.5% in women across all age groups. “It suggests that the 1% rate presumed by government agencies is an underestimate,” said Dr. Toozs-Hobson, a consultant gynecologist at Birmingham (England) Women's Hospital.
Moreover, the effects of obstetric trauma could not be seen in this data, he said.
“It has long been thought that the incidence of anal incontinence is higher in women because trauma occurs to the anal sphincter during childbirth,” Dr. Toozs-Hobson said during the meeting.
“However, this study does not provide evidence that women under 60 years have significantly higher rates of incontinence, when compared with men of similar age.”
When data were broken down according to age, the prevalences for men and women under age 60 years were 0.8% and 1.6%, respectively.
Although the rates were much higher in people over age 60 years, they remained similar across the genders, at 5.1% for men and 6.2% for women, Dr. Toozs-Hobson said.
“Many experts believe that the effects of obstetric trauma may only appear in older age, but we did not find significant interaction between age and gender,” he said.
Inasmuch as anal incontinence is increasingly becoming recognized as a significant cause of physical and psychological morbidity, these data may well have implications for community health care providers, Dr. Toozs-Hobson said.
MONTREAL — Anal incontinence is four times more prevalent than previously thought, and it affects older men and women almost equally, according to what British researchers describe as the first systematic review of the prevalence of this disorder.
“Age, not gender, is the most important factor, and obstetric trauma does not have a major effect,” Philip Toozs-Hobson, M.D., reported at the annual meeting of the International Continence Society.
The review of 29 studies with a total of 69,152 participants found an overall rate of anal incontinence of 3.5% in men and 4.5% in women across all age groups. “It suggests that the 1% rate presumed by government agencies is an underestimate,” said Dr. Toozs-Hobson, a consultant gynecologist at Birmingham (England) Women's Hospital.
Moreover, the effects of obstetric trauma could not be seen in this data, he said.
“It has long been thought that the incidence of anal incontinence is higher in women because trauma occurs to the anal sphincter during childbirth,” Dr. Toozs-Hobson said during the meeting.
“However, this study does not provide evidence that women under 60 years have significantly higher rates of incontinence, when compared with men of similar age.”
When data were broken down according to age, the prevalences for men and women under age 60 years were 0.8% and 1.6%, respectively.
Although the rates were much higher in people over age 60 years, they remained similar across the genders, at 5.1% for men and 6.2% for women, Dr. Toozs-Hobson said.
“Many experts believe that the effects of obstetric trauma may only appear in older age, but we did not find significant interaction between age and gender,” he said.
Inasmuch as anal incontinence is increasingly becoming recognized as a significant cause of physical and psychological morbidity, these data may well have implications for community health care providers, Dr. Toozs-Hobson said.
MONTREAL — Anal incontinence is four times more prevalent than previously thought, and it affects older men and women almost equally, according to what British researchers describe as the first systematic review of the prevalence of this disorder.
“Age, not gender, is the most important factor, and obstetric trauma does not have a major effect,” Philip Toozs-Hobson, M.D., reported at the annual meeting of the International Continence Society.
The review of 29 studies with a total of 69,152 participants found an overall rate of anal incontinence of 3.5% in men and 4.5% in women across all age groups. “It suggests that the 1% rate presumed by government agencies is an underestimate,” said Dr. Toozs-Hobson, a consultant gynecologist at Birmingham (England) Women's Hospital.
Moreover, the effects of obstetric trauma could not be seen in this data, he said.
“It has long been thought that the incidence of anal incontinence is higher in women because trauma occurs to the anal sphincter during childbirth,” Dr. Toozs-Hobson said during the meeting.
“However, this study does not provide evidence that women under 60 years have significantly higher rates of incontinence, when compared with men of similar age.”
When data were broken down according to age, the prevalences for men and women under age 60 years were 0.8% and 1.6%, respectively.
Although the rates were much higher in people over age 60 years, they remained similar across the genders, at 5.1% for men and 6.2% for women, Dr. Toozs-Hobson said.
“Many experts believe that the effects of obstetric trauma may only appear in older age, but we did not find significant interaction between age and gender,” he said.
Inasmuch as anal incontinence is increasingly becoming recognized as a significant cause of physical and psychological morbidity, these data may well have implications for community health care providers, Dr. Toozs-Hobson said.
Unexpected Complications With TOT Reported
MONTREAL — Although the complication rate remains low with the use of transobturator tape to treat stress urinary incontinence, unexpected complications are beginning to emerge as this treatment becomes more widely used, according to Sarah Hamilton Boyles, M.D., an instructor and fellow in obstetrics and gynecology at Oregon Health and Science University's Center for Women's Health in Portland.
“There are documented cases of complications that the companies had said could not occur, and it's important that we are all aware of these complications,” Dr. Hamilton Boyles said in an interview.
In a study she presented at the annual meeting of the International Continence Society, Dr. Hamilton Boyles searched the Manufacturer and User Facility Device Experience (MAUDE) database to identify all complications reported with the use of three transobturator tape (TOT) techniques available in the United States. These included ObTape (manufactured by Mentor, Minneapolis), Monarc (American Medical Systems, Minnetonka, Minn.), and the TVT Obturator System (Gynecare, Somerville, N.J.).
MAUDE, maintained by the Food and Drug Administration, collects voluntary physician reports and mandatory reports from manufacturers, distributors, and user facilities. A review of published literature revealed that documented complications with TOT are low, and include bladder, urethra, and vaginal perforation; vaginal and urethral erosion; thigh pain; infection; urinary retention; and bleeding of 200–300 cc, she said. In addition, many of these problems were associated with a different TOT (UraTape), which is no longer on the market.
However, her search of MAUDE revealed some other unexpected complications. “Unique complications that are only easily discovered when searching a large surgical database such as MAUDE were found in the categories of infection, neuropathy, and bleeding,” she reported.
The study revealed 173 reports of complications in 140 patients from January 2004 to January 2005. Among the complications were 25 cases of infection, 4 cases of neuropathy, and 5 cases of bleeding. A total of 18 of the infection cases were associated with erosion, including one vaginal abscess just below the mucosa and 2 ischiorectal fossa abscesses occurring remote from placement at about 2 months post procedure—both of which required surgical drainage.
There were two other abscesses not associated with erosion. Both of these occurred by the adductor muscle and also required surgical drainage. And five other infections were not specified.
Among the neuropathy cases, two involved gait difficulty, one of these with a confirmed obturator injury. In addition, there was a case of peripheral numbness, and one other case which was not specified.
Among the bleeding cases, the procedure was aborted in one case after an estimated blood loss of 600 cc during urethral dissection.
Another case involved an estimated blood loss of 650 cc during the pass of the right trocar. In addition, there was one injury to the iliac vessel that required embolization, another case involving a hemoglobin drop to 4 g/dL during the procedure, and another case of an unspecified hematoma, Dr. Hamilton Boyles said.
She cautioned that a comparison of complications according to technique is impossible since the MAUDE database records only reported complications and did not record what percentage they represent of the total number of procedures performed.
However, among the 25 infection cases and 105 erosion cases reported to the database, 22 and 99, respectively, occurred with the ObTape. In addition, all three of the urethral injuries, three of the four cases of neuropathy, and eight of the nine reports of pain occurred with the TVT Obturator System.
“Even though the overall rate of complications is low, because so many of these procedures are done, it is societally important to know about them,” she said.
A recent survey of members of the International Urogynecology Association revealed that although tension-free vaginal tape is the most popular treatment for stress urinary incontinence, 13% of respondents preferred TOT, she said (Eur Urol. 2005;47:648–52).
MONTREAL — Although the complication rate remains low with the use of transobturator tape to treat stress urinary incontinence, unexpected complications are beginning to emerge as this treatment becomes more widely used, according to Sarah Hamilton Boyles, M.D., an instructor and fellow in obstetrics and gynecology at Oregon Health and Science University's Center for Women's Health in Portland.
“There are documented cases of complications that the companies had said could not occur, and it's important that we are all aware of these complications,” Dr. Hamilton Boyles said in an interview.
In a study she presented at the annual meeting of the International Continence Society, Dr. Hamilton Boyles searched the Manufacturer and User Facility Device Experience (MAUDE) database to identify all complications reported with the use of three transobturator tape (TOT) techniques available in the United States. These included ObTape (manufactured by Mentor, Minneapolis), Monarc (American Medical Systems, Minnetonka, Minn.), and the TVT Obturator System (Gynecare, Somerville, N.J.).
MAUDE, maintained by the Food and Drug Administration, collects voluntary physician reports and mandatory reports from manufacturers, distributors, and user facilities. A review of published literature revealed that documented complications with TOT are low, and include bladder, urethra, and vaginal perforation; vaginal and urethral erosion; thigh pain; infection; urinary retention; and bleeding of 200–300 cc, she said. In addition, many of these problems were associated with a different TOT (UraTape), which is no longer on the market.
However, her search of MAUDE revealed some other unexpected complications. “Unique complications that are only easily discovered when searching a large surgical database such as MAUDE were found in the categories of infection, neuropathy, and bleeding,” she reported.
The study revealed 173 reports of complications in 140 patients from January 2004 to January 2005. Among the complications were 25 cases of infection, 4 cases of neuropathy, and 5 cases of bleeding. A total of 18 of the infection cases were associated with erosion, including one vaginal abscess just below the mucosa and 2 ischiorectal fossa abscesses occurring remote from placement at about 2 months post procedure—both of which required surgical drainage.
There were two other abscesses not associated with erosion. Both of these occurred by the adductor muscle and also required surgical drainage. And five other infections were not specified.
Among the neuropathy cases, two involved gait difficulty, one of these with a confirmed obturator injury. In addition, there was a case of peripheral numbness, and one other case which was not specified.
Among the bleeding cases, the procedure was aborted in one case after an estimated blood loss of 600 cc during urethral dissection.
Another case involved an estimated blood loss of 650 cc during the pass of the right trocar. In addition, there was one injury to the iliac vessel that required embolization, another case involving a hemoglobin drop to 4 g/dL during the procedure, and another case of an unspecified hematoma, Dr. Hamilton Boyles said.
She cautioned that a comparison of complications according to technique is impossible since the MAUDE database records only reported complications and did not record what percentage they represent of the total number of procedures performed.
However, among the 25 infection cases and 105 erosion cases reported to the database, 22 and 99, respectively, occurred with the ObTape. In addition, all three of the urethral injuries, three of the four cases of neuropathy, and eight of the nine reports of pain occurred with the TVT Obturator System.
“Even though the overall rate of complications is low, because so many of these procedures are done, it is societally important to know about them,” she said.
A recent survey of members of the International Urogynecology Association revealed that although tension-free vaginal tape is the most popular treatment for stress urinary incontinence, 13% of respondents preferred TOT, she said (Eur Urol. 2005;47:648–52).
MONTREAL — Although the complication rate remains low with the use of transobturator tape to treat stress urinary incontinence, unexpected complications are beginning to emerge as this treatment becomes more widely used, according to Sarah Hamilton Boyles, M.D., an instructor and fellow in obstetrics and gynecology at Oregon Health and Science University's Center for Women's Health in Portland.
“There are documented cases of complications that the companies had said could not occur, and it's important that we are all aware of these complications,” Dr. Hamilton Boyles said in an interview.
In a study she presented at the annual meeting of the International Continence Society, Dr. Hamilton Boyles searched the Manufacturer and User Facility Device Experience (MAUDE) database to identify all complications reported with the use of three transobturator tape (TOT) techniques available in the United States. These included ObTape (manufactured by Mentor, Minneapolis), Monarc (American Medical Systems, Minnetonka, Minn.), and the TVT Obturator System (Gynecare, Somerville, N.J.).
MAUDE, maintained by the Food and Drug Administration, collects voluntary physician reports and mandatory reports from manufacturers, distributors, and user facilities. A review of published literature revealed that documented complications with TOT are low, and include bladder, urethra, and vaginal perforation; vaginal and urethral erosion; thigh pain; infection; urinary retention; and bleeding of 200–300 cc, she said. In addition, many of these problems were associated with a different TOT (UraTape), which is no longer on the market.
However, her search of MAUDE revealed some other unexpected complications. “Unique complications that are only easily discovered when searching a large surgical database such as MAUDE were found in the categories of infection, neuropathy, and bleeding,” she reported.
The study revealed 173 reports of complications in 140 patients from January 2004 to January 2005. Among the complications were 25 cases of infection, 4 cases of neuropathy, and 5 cases of bleeding. A total of 18 of the infection cases were associated with erosion, including one vaginal abscess just below the mucosa and 2 ischiorectal fossa abscesses occurring remote from placement at about 2 months post procedure—both of which required surgical drainage.
There were two other abscesses not associated with erosion. Both of these occurred by the adductor muscle and also required surgical drainage. And five other infections were not specified.
Among the neuropathy cases, two involved gait difficulty, one of these with a confirmed obturator injury. In addition, there was a case of peripheral numbness, and one other case which was not specified.
Among the bleeding cases, the procedure was aborted in one case after an estimated blood loss of 600 cc during urethral dissection.
Another case involved an estimated blood loss of 650 cc during the pass of the right trocar. In addition, there was one injury to the iliac vessel that required embolization, another case involving a hemoglobin drop to 4 g/dL during the procedure, and another case of an unspecified hematoma, Dr. Hamilton Boyles said.
She cautioned that a comparison of complications according to technique is impossible since the MAUDE database records only reported complications and did not record what percentage they represent of the total number of procedures performed.
However, among the 25 infection cases and 105 erosion cases reported to the database, 22 and 99, respectively, occurred with the ObTape. In addition, all three of the urethral injuries, three of the four cases of neuropathy, and eight of the nine reports of pain occurred with the TVT Obturator System.
“Even though the overall rate of complications is low, because so many of these procedures are done, it is societally important to know about them,” she said.
A recent survey of members of the International Urogynecology Association revealed that although tension-free vaginal tape is the most popular treatment for stress urinary incontinence, 13% of respondents preferred TOT, she said (Eur Urol. 2005;47:648–52).
Oocyte Freezing Protocol Said To Boost Pregnancy Rates
MONTREAL — Preliminary results from an ongoing study of oocyte cryopreservation show “the highest pregnancy rates so far reported,” making egg freezing “a viable clinical option,” according to John K. Jain, M.D., the principal investigator.
“Egg freezing has turned a corner—it's arrived,” said Dr. Jain, of USC Fertility, which is the nonprofit fertility practice of the University of Southern California's Keck School of Medicine, Los Angeles.
A total of 20 women (mean age 31 years) with tubal factor infertility have been enrolled in the study, which provides them with in vitro fertilization at no charge. To date, five of eight women have become pregnant after having their eggs removed and frozen for 1 month, then thawed and fertilized by intracytoplasmic sperm injection, followed by subsequent embryo transfer.
He reported the findings in a poster presentation during the joint annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.
The pregnancy rate per transfer of 55.6% is “the highest I've seen reported,” Dr. Jain said in an interview.
A recent metaanalysis of all published frozen-egg pregnancies (118) suggests a worldwide live birth rate of 21.6% per transfer in women with a mean age of 33 years, reported Kutluk Oktay, M.D., in a separate presentation at the meeting (see accompanying story). Unpublished data from this year's World Congress on Human Oocyte Cryopreservation suggest that the highest U.S. success rate until now has been a 34% pregnancy rate per transfer at Assisted Fertility Services of the Community Health Network in Indianapolis.
Dr. Jain attributes the success of his egg freezing protocol to a combination of culture medium and freezing method. The center uses a slow-freeze protocol in sodium-depleted, choline-substituted medium—an approach favored by many other leading centers in the world.
Two of the five women have delivered singletons, with the other pregnancies (including a set of triplets) well into their second or third trimesters, he said.
Each transfer procedure in the study included an average of 3.2 embryos, compared with an average of 2.7 embryos per transfer reported in the egg freezing metaanalysis.
The American Society for Reproductive Medicine currently recommends that in women younger than 35, to reduce the risks of multiple pregnancy, no more than two embryos should be transferred; it also recommends that consideration be given to single embryo transfer in patients with the best prognosis.
The optimal number of embryos to transfer following oocyte cryopreservation is still undetermined, Dr. Jain said.
MONTREAL — Preliminary results from an ongoing study of oocyte cryopreservation show “the highest pregnancy rates so far reported,” making egg freezing “a viable clinical option,” according to John K. Jain, M.D., the principal investigator.
“Egg freezing has turned a corner—it's arrived,” said Dr. Jain, of USC Fertility, which is the nonprofit fertility practice of the University of Southern California's Keck School of Medicine, Los Angeles.
A total of 20 women (mean age 31 years) with tubal factor infertility have been enrolled in the study, which provides them with in vitro fertilization at no charge. To date, five of eight women have become pregnant after having their eggs removed and frozen for 1 month, then thawed and fertilized by intracytoplasmic sperm injection, followed by subsequent embryo transfer.
He reported the findings in a poster presentation during the joint annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.
The pregnancy rate per transfer of 55.6% is “the highest I've seen reported,” Dr. Jain said in an interview.
A recent metaanalysis of all published frozen-egg pregnancies (118) suggests a worldwide live birth rate of 21.6% per transfer in women with a mean age of 33 years, reported Kutluk Oktay, M.D., in a separate presentation at the meeting (see accompanying story). Unpublished data from this year's World Congress on Human Oocyte Cryopreservation suggest that the highest U.S. success rate until now has been a 34% pregnancy rate per transfer at Assisted Fertility Services of the Community Health Network in Indianapolis.
Dr. Jain attributes the success of his egg freezing protocol to a combination of culture medium and freezing method. The center uses a slow-freeze protocol in sodium-depleted, choline-substituted medium—an approach favored by many other leading centers in the world.
Two of the five women have delivered singletons, with the other pregnancies (including a set of triplets) well into their second or third trimesters, he said.
Each transfer procedure in the study included an average of 3.2 embryos, compared with an average of 2.7 embryos per transfer reported in the egg freezing metaanalysis.
The American Society for Reproductive Medicine currently recommends that in women younger than 35, to reduce the risks of multiple pregnancy, no more than two embryos should be transferred; it also recommends that consideration be given to single embryo transfer in patients with the best prognosis.
The optimal number of embryos to transfer following oocyte cryopreservation is still undetermined, Dr. Jain said.
MONTREAL — Preliminary results from an ongoing study of oocyte cryopreservation show “the highest pregnancy rates so far reported,” making egg freezing “a viable clinical option,” according to John K. Jain, M.D., the principal investigator.
“Egg freezing has turned a corner—it's arrived,” said Dr. Jain, of USC Fertility, which is the nonprofit fertility practice of the University of Southern California's Keck School of Medicine, Los Angeles.
A total of 20 women (mean age 31 years) with tubal factor infertility have been enrolled in the study, which provides them with in vitro fertilization at no charge. To date, five of eight women have become pregnant after having their eggs removed and frozen for 1 month, then thawed and fertilized by intracytoplasmic sperm injection, followed by subsequent embryo transfer.
He reported the findings in a poster presentation during the joint annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.
The pregnancy rate per transfer of 55.6% is “the highest I've seen reported,” Dr. Jain said in an interview.
A recent metaanalysis of all published frozen-egg pregnancies (118) suggests a worldwide live birth rate of 21.6% per transfer in women with a mean age of 33 years, reported Kutluk Oktay, M.D., in a separate presentation at the meeting (see accompanying story). Unpublished data from this year's World Congress on Human Oocyte Cryopreservation suggest that the highest U.S. success rate until now has been a 34% pregnancy rate per transfer at Assisted Fertility Services of the Community Health Network in Indianapolis.
Dr. Jain attributes the success of his egg freezing protocol to a combination of culture medium and freezing method. The center uses a slow-freeze protocol in sodium-depleted, choline-substituted medium—an approach favored by many other leading centers in the world.
Two of the five women have delivered singletons, with the other pregnancies (including a set of triplets) well into their second or third trimesters, he said.
Each transfer procedure in the study included an average of 3.2 embryos, compared with an average of 2.7 embryos per transfer reported in the egg freezing metaanalysis.
The American Society for Reproductive Medicine currently recommends that in women younger than 35, to reduce the risks of multiple pregnancy, no more than two embryos should be transferred; it also recommends that consideration be given to single embryo transfer in patients with the best prognosis.
The optimal number of embryos to transfer following oocyte cryopreservation is still undetermined, Dr. Jain said.
Empiric Antiviral Therapy Worthwhile During Flu Outbreaks
Empiric therapy with antiviral medication during an influenza epidemic is superior to both rapid diagnostic test-based therapy and no therapy in symptomatic pediatric patients, according to an analysis based on hypothetical scenarios.
“We found no role for rapid diagnostic testing during local outbreaks, because clinical diagnosis is highly predictive, whereas rapid testing leads to frequent false-negative results,” said Michael B. Rothberg, M.D., and colleagues at Baystate Medical Center in Springfield, Mass. (Arch. Pediatr. Adolesc. Med. 2005;159:1055–62).
The analysis included hypothetical patients, 2, 7, and 15 years old, presenting to a primary care physician with fever and cough or coryza within 48 hours of symptom onset in a local influenza outbreak.
The costs and benefits of empiric antiviral therapy, test-guided antiviral therapy, or no antiviral therapy were examined using evidence from all trials of the medications in children. Two treatment choices were included in the analysis: amantadine hydrochloride and oseltamivir phosphate (the only drugs currently licensed for the treatment of influenza in children younger than 7 years), and two rapid diagnostic tests were considered: QuickVue (Quidel Corp., San Diego) and ZstatFlu (ZymeTx Inc., Oklahoma City).
The analysis considered vaccinated and unvaccinated patients separately. Consideration was given to outbreaks that were predominantly influenza A (90%) or a mixture of influenza A (55%) and B.
Compared with no treatment, empiric therapy with antiviral medication improved quality-adjusted life expectancy in all scenarios by both shortening the duration of illness and preventing otitis media.
The choice of which medication and whether it saved money depended on the age of the child and which type of influenza was predominant. “When influenza A predominates, both drugs appear equally effective, but amantadine may be better tolerated and is less expensive,” said the authors. “Because amantadine is not active against influenza B, however, oseltamivir will be more effective when influenza B is prevalent.”
In a scenario where influenza A predominated, empiric amantadine improved quality-adjusted life expectancy for all age groups. It was the least expensive strategy in children under 15 years old, saving $121 per child, compared with no treatment, because of the savings it gave parents who could return to work faster. However, this treatment resulted in no savings if the child was old enough to stay home alone.
During seasons in which influenza B was common, empiric oseltamivir improved quality-adjusted life expectancy in all age groups and was the least expensive option for 2-year-olds. But the cost increased with weight. And vaccinated children had lower costs and better outcomes in all cases.
Rapid testing was useful only in influenza B (or mixed) outbreaks when a patient's likelihood of infection was low. In such cases, a negative test could avoid the higher cost and side effects of oseltamivir.
Otherwise, “because the rate of adverse effects from oseltamivir and the false-negative rate for QuickVue are identical, a child is more likely to be helped than harmed by empirical oseltamivir whenever the probability of influenza is greater than 50%,” the researchers said.
They noted some obstacles to the implementation of their model in clinical practice. First, some practitioners may be uncomfortable with prescribing empiric therapy, although “such caution avoids unnecessary adverse effects, but leads to undertreatment.” Second, parents paying out-of-pocket may be unwilling to purchase the more expensive oseltamivir—especially if a child's illness will not result in loss of parental income. And, despite years of evidence supporting antiviral use, many physicians are unfamiliar with them and many pharmacies may not stock them.
Some potential benefits were not considered in the model, including antivirals' potential to decrease hospitalizations in high-risk children, such as asthma patients.
There also is some suggestion that antiviral therapy can decrease transmission of influenza. The researchers point out that in order to prescribe antivirals in a cost-effective manner, clinicians must be aware of which type of influenza is prevalent. This information is available at state health departments and from the Centers for Disease Control and Prevention (www.cdc.gov
Empiric therapy with antiviral medication during an influenza epidemic is superior to both rapid diagnostic test-based therapy and no therapy in symptomatic pediatric patients, according to an analysis based on hypothetical scenarios.
“We found no role for rapid diagnostic testing during local outbreaks, because clinical diagnosis is highly predictive, whereas rapid testing leads to frequent false-negative results,” said Michael B. Rothberg, M.D., and colleagues at Baystate Medical Center in Springfield, Mass. (Arch. Pediatr. Adolesc. Med. 2005;159:1055–62).
The analysis included hypothetical patients, 2, 7, and 15 years old, presenting to a primary care physician with fever and cough or coryza within 48 hours of symptom onset in a local influenza outbreak.
The costs and benefits of empiric antiviral therapy, test-guided antiviral therapy, or no antiviral therapy were examined using evidence from all trials of the medications in children. Two treatment choices were included in the analysis: amantadine hydrochloride and oseltamivir phosphate (the only drugs currently licensed for the treatment of influenza in children younger than 7 years), and two rapid diagnostic tests were considered: QuickVue (Quidel Corp., San Diego) and ZstatFlu (ZymeTx Inc., Oklahoma City).
The analysis considered vaccinated and unvaccinated patients separately. Consideration was given to outbreaks that were predominantly influenza A (90%) or a mixture of influenza A (55%) and B.
Compared with no treatment, empiric therapy with antiviral medication improved quality-adjusted life expectancy in all scenarios by both shortening the duration of illness and preventing otitis media.
The choice of which medication and whether it saved money depended on the age of the child and which type of influenza was predominant. “When influenza A predominates, both drugs appear equally effective, but amantadine may be better tolerated and is less expensive,” said the authors. “Because amantadine is not active against influenza B, however, oseltamivir will be more effective when influenza B is prevalent.”
In a scenario where influenza A predominated, empiric amantadine improved quality-adjusted life expectancy for all age groups. It was the least expensive strategy in children under 15 years old, saving $121 per child, compared with no treatment, because of the savings it gave parents who could return to work faster. However, this treatment resulted in no savings if the child was old enough to stay home alone.
During seasons in which influenza B was common, empiric oseltamivir improved quality-adjusted life expectancy in all age groups and was the least expensive option for 2-year-olds. But the cost increased with weight. And vaccinated children had lower costs and better outcomes in all cases.
Rapid testing was useful only in influenza B (or mixed) outbreaks when a patient's likelihood of infection was low. In such cases, a negative test could avoid the higher cost and side effects of oseltamivir.
Otherwise, “because the rate of adverse effects from oseltamivir and the false-negative rate for QuickVue are identical, a child is more likely to be helped than harmed by empirical oseltamivir whenever the probability of influenza is greater than 50%,” the researchers said.
They noted some obstacles to the implementation of their model in clinical practice. First, some practitioners may be uncomfortable with prescribing empiric therapy, although “such caution avoids unnecessary adverse effects, but leads to undertreatment.” Second, parents paying out-of-pocket may be unwilling to purchase the more expensive oseltamivir—especially if a child's illness will not result in loss of parental income. And, despite years of evidence supporting antiviral use, many physicians are unfamiliar with them and many pharmacies may not stock them.
Some potential benefits were not considered in the model, including antivirals' potential to decrease hospitalizations in high-risk children, such as asthma patients.
There also is some suggestion that antiviral therapy can decrease transmission of influenza. The researchers point out that in order to prescribe antivirals in a cost-effective manner, clinicians must be aware of which type of influenza is prevalent. This information is available at state health departments and from the Centers for Disease Control and Prevention (www.cdc.gov
Empiric therapy with antiviral medication during an influenza epidemic is superior to both rapid diagnostic test-based therapy and no therapy in symptomatic pediatric patients, according to an analysis based on hypothetical scenarios.
“We found no role for rapid diagnostic testing during local outbreaks, because clinical diagnosis is highly predictive, whereas rapid testing leads to frequent false-negative results,” said Michael B. Rothberg, M.D., and colleagues at Baystate Medical Center in Springfield, Mass. (Arch. Pediatr. Adolesc. Med. 2005;159:1055–62).
The analysis included hypothetical patients, 2, 7, and 15 years old, presenting to a primary care physician with fever and cough or coryza within 48 hours of symptom onset in a local influenza outbreak.
The costs and benefits of empiric antiviral therapy, test-guided antiviral therapy, or no antiviral therapy were examined using evidence from all trials of the medications in children. Two treatment choices were included in the analysis: amantadine hydrochloride and oseltamivir phosphate (the only drugs currently licensed for the treatment of influenza in children younger than 7 years), and two rapid diagnostic tests were considered: QuickVue (Quidel Corp., San Diego) and ZstatFlu (ZymeTx Inc., Oklahoma City).
The analysis considered vaccinated and unvaccinated patients separately. Consideration was given to outbreaks that were predominantly influenza A (90%) or a mixture of influenza A (55%) and B.
Compared with no treatment, empiric therapy with antiviral medication improved quality-adjusted life expectancy in all scenarios by both shortening the duration of illness and preventing otitis media.
The choice of which medication and whether it saved money depended on the age of the child and which type of influenza was predominant. “When influenza A predominates, both drugs appear equally effective, but amantadine may be better tolerated and is less expensive,” said the authors. “Because amantadine is not active against influenza B, however, oseltamivir will be more effective when influenza B is prevalent.”
In a scenario where influenza A predominated, empiric amantadine improved quality-adjusted life expectancy for all age groups. It was the least expensive strategy in children under 15 years old, saving $121 per child, compared with no treatment, because of the savings it gave parents who could return to work faster. However, this treatment resulted in no savings if the child was old enough to stay home alone.
During seasons in which influenza B was common, empiric oseltamivir improved quality-adjusted life expectancy in all age groups and was the least expensive option for 2-year-olds. But the cost increased with weight. And vaccinated children had lower costs and better outcomes in all cases.
Rapid testing was useful only in influenza B (or mixed) outbreaks when a patient's likelihood of infection was low. In such cases, a negative test could avoid the higher cost and side effects of oseltamivir.
Otherwise, “because the rate of adverse effects from oseltamivir and the false-negative rate for QuickVue are identical, a child is more likely to be helped than harmed by empirical oseltamivir whenever the probability of influenza is greater than 50%,” the researchers said.
They noted some obstacles to the implementation of their model in clinical practice. First, some practitioners may be uncomfortable with prescribing empiric therapy, although “such caution avoids unnecessary adverse effects, but leads to undertreatment.” Second, parents paying out-of-pocket may be unwilling to purchase the more expensive oseltamivir—especially if a child's illness will not result in loss of parental income. And, despite years of evidence supporting antiviral use, many physicians are unfamiliar with them and many pharmacies may not stock them.
Some potential benefits were not considered in the model, including antivirals' potential to decrease hospitalizations in high-risk children, such as asthma patients.
There also is some suggestion that antiviral therapy can decrease transmission of influenza. The researchers point out that in order to prescribe antivirals in a cost-effective manner, clinicians must be aware of which type of influenza is prevalent. This information is available at state health departments and from the Centers for Disease Control and Prevention (www.cdc.gov
Probiotic Significantly Improves Irritable Bowel Symptoms
MONTREAL — Daily ingestion of a probiotic preparation containing a bifidobacterium strain can significantly reduce symptoms and normalize the immune response in patients with irritable bowel syndrome, according to two studies presented as posters at the 13th World Congress of Gastroenterology.
A multicenter study which randomized 362 women with irritable bowel syndrome (IBS) to one of three strengths of an investigational probiotic Bifidobacterium infantis 35624 or placebo daily for 4 weeks showed significant improvement in abdominal pain and discomfort, as well as all other measured symptoms in those taking the medium-strength probiotic formulation.
“The very high dose didn't have an effect because it didn't disperse out of the capsule,” said lead investigator Peter Whorwell, M.D., professor of medicine and gastroenterology at the University of Manchester (England).
He explained that the effective delivery of probiotic formulations remains a challenge.
“A lot of probiotic preparations are not necessarily bioavailable because they may not be alive, or they may be in a medium where they are not dispersing well. So it raises a whole issue about quality. If you just go into a supermarket you don't know what you're getting,” he said in an interview.
In another pilot study, 13 IBS patients and 10 healthy controls received milk containing B. infantis 35624 every day for 3 weeks.
Peripheral blood mononuclear cells collected at baseline and after each feeding were cultured for 3 days, either alone or with a stimulant, and cytokine levels were analyzed.
The study found that at baseline spontaneous production of cytokines from the IBS subjects was no different from healthy subjects, while in vitro stimulation of their peripheral blood mononuclear cells produced a significantly higher level of proinflammatory cytokines and a lower level of anti-inflammatory cytokines.
However, probiotic feeding normalized this proinflammatory immune response in the IBS subjects.
Similar work by the same group comparing treatment with B. infantis 35624 or lactobacillus demonstrated symptom relief and a similar normalization of the proinflammatory response with bifidobacterium but not lactobacillus (Gastroenterology 2005;128:541–51).
This response is suggestive of “an immune-modulating role for this organism, in this disorder,” concluded Liam O'Mahony, Ph.D., lead author, of University College Cork (Ireland).
Both studies were sponsored by Procter & Gamble, which is investigating B. infantis 35624.
MONTREAL — Daily ingestion of a probiotic preparation containing a bifidobacterium strain can significantly reduce symptoms and normalize the immune response in patients with irritable bowel syndrome, according to two studies presented as posters at the 13th World Congress of Gastroenterology.
A multicenter study which randomized 362 women with irritable bowel syndrome (IBS) to one of three strengths of an investigational probiotic Bifidobacterium infantis 35624 or placebo daily for 4 weeks showed significant improvement in abdominal pain and discomfort, as well as all other measured symptoms in those taking the medium-strength probiotic formulation.
“The very high dose didn't have an effect because it didn't disperse out of the capsule,” said lead investigator Peter Whorwell, M.D., professor of medicine and gastroenterology at the University of Manchester (England).
He explained that the effective delivery of probiotic formulations remains a challenge.
“A lot of probiotic preparations are not necessarily bioavailable because they may not be alive, or they may be in a medium where they are not dispersing well. So it raises a whole issue about quality. If you just go into a supermarket you don't know what you're getting,” he said in an interview.
In another pilot study, 13 IBS patients and 10 healthy controls received milk containing B. infantis 35624 every day for 3 weeks.
Peripheral blood mononuclear cells collected at baseline and after each feeding were cultured for 3 days, either alone or with a stimulant, and cytokine levels were analyzed.
The study found that at baseline spontaneous production of cytokines from the IBS subjects was no different from healthy subjects, while in vitro stimulation of their peripheral blood mononuclear cells produced a significantly higher level of proinflammatory cytokines and a lower level of anti-inflammatory cytokines.
However, probiotic feeding normalized this proinflammatory immune response in the IBS subjects.
Similar work by the same group comparing treatment with B. infantis 35624 or lactobacillus demonstrated symptom relief and a similar normalization of the proinflammatory response with bifidobacterium but not lactobacillus (Gastroenterology 2005;128:541–51).
This response is suggestive of “an immune-modulating role for this organism, in this disorder,” concluded Liam O'Mahony, Ph.D., lead author, of University College Cork (Ireland).
Both studies were sponsored by Procter & Gamble, which is investigating B. infantis 35624.
MONTREAL — Daily ingestion of a probiotic preparation containing a bifidobacterium strain can significantly reduce symptoms and normalize the immune response in patients with irritable bowel syndrome, according to two studies presented as posters at the 13th World Congress of Gastroenterology.
A multicenter study which randomized 362 women with irritable bowel syndrome (IBS) to one of three strengths of an investigational probiotic Bifidobacterium infantis 35624 or placebo daily for 4 weeks showed significant improvement in abdominal pain and discomfort, as well as all other measured symptoms in those taking the medium-strength probiotic formulation.
“The very high dose didn't have an effect because it didn't disperse out of the capsule,” said lead investigator Peter Whorwell, M.D., professor of medicine and gastroenterology at the University of Manchester (England).
He explained that the effective delivery of probiotic formulations remains a challenge.
“A lot of probiotic preparations are not necessarily bioavailable because they may not be alive, or they may be in a medium where they are not dispersing well. So it raises a whole issue about quality. If you just go into a supermarket you don't know what you're getting,” he said in an interview.
In another pilot study, 13 IBS patients and 10 healthy controls received milk containing B. infantis 35624 every day for 3 weeks.
Peripheral blood mononuclear cells collected at baseline and after each feeding were cultured for 3 days, either alone or with a stimulant, and cytokine levels were analyzed.
The study found that at baseline spontaneous production of cytokines from the IBS subjects was no different from healthy subjects, while in vitro stimulation of their peripheral blood mononuclear cells produced a significantly higher level of proinflammatory cytokines and a lower level of anti-inflammatory cytokines.
However, probiotic feeding normalized this proinflammatory immune response in the IBS subjects.
Similar work by the same group comparing treatment with B. infantis 35624 or lactobacillus demonstrated symptom relief and a similar normalization of the proinflammatory response with bifidobacterium but not lactobacillus (Gastroenterology 2005;128:541–51).
This response is suggestive of “an immune-modulating role for this organism, in this disorder,” concluded Liam O'Mahony, Ph.D., lead author, of University College Cork (Ireland).
Both studies were sponsored by Procter & Gamble, which is investigating B. infantis 35624.
In Vitro Fertilization May Increase Breast Cancer Risk in Predisposed
MONTREAL — Ovulation induction for in vitro fertilization may promote the growth of breast cancer in patients who are predisposed to the disease, results of a case series of seven IVF patients later diagnosed with the disease suggest.
“A breast cancer family history should be included in the pre-IVF work-up, and women with a positive history should be considered candidates for an alternate IVF stimulation protocol,” recommended Kutluk Oktay, M.D., who reported the findings in a poster at the joint annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.
In a case series of seven breast cancer patients who had undergone ovarian stimulation for in vitro fertilization (IVF), Dr. Oktay's team found more than half (57%) had a family history of breast cancer. It is normally expected that only about 10% of breast cancer patients will have a family history of the disease.
All women had estrogen- and progesterone-receptor-positive breast cancer, when normally it is expected that about 40% of breast cancer patients will have this type of disease, said Dr. Oktay, of Cornell University in New York.
Ovulation induction exposes women to supraphysiologic levels of estrogen, which may be problematic in women with a family history of breast cancer, Dr. Oktay suggested. “Not that IVF necessarily causes their cancer, but it may promote it,” he said. “Counseling should include the fact that if you have a family history of breast cancer, this may increase your risk—but it may simply facilitate the appearance of the disease and so patients should be closely examined before IVF and followed after.”
The mean age of the patients was 40, and the mean duration from the time of their IVF treatment until their breast cancer diagnosis was 8.5 months.
One patient had a breast lesion biopsied before undergoing IVF, and it was initially negative for malignancy. However, after her IVF treatment, the mass grew, and a second biopsy revealed stage I invasive ductal carcinoma.
One other patient had stage I invasive ductal carcinoma, three had stage IIA disease, and two had carcinoma in situ. Tumor size was less than or equal to 1.5 cm in all except one patient.
Dr. Oktay, also of the Center for Reproductive Medicine and Infertility of New York-Presbyterian Hospital/Weill Cornell Medical Center, recommends that IVF patients who face an elevated risk of breast cancer based on their family history should undergo ovulation induction with a letrozole/FSH protocol instead of standard ovulation induction, which exposes patients to high levels of estrogen.
Letrozole, an aromatase inhibitor that also is used to treat breast cancer, can stimulate oocyte production without raising estrogen levels, making it ideal for this patient population. “Obviously, if they conceive, they are going to be exposed to high levels of estrogen anyway … and the studies so far don't suggest that pregnancy necessarily increases the risk of cancer.”
MONTREAL — Ovulation induction for in vitro fertilization may promote the growth of breast cancer in patients who are predisposed to the disease, results of a case series of seven IVF patients later diagnosed with the disease suggest.
“A breast cancer family history should be included in the pre-IVF work-up, and women with a positive history should be considered candidates for an alternate IVF stimulation protocol,” recommended Kutluk Oktay, M.D., who reported the findings in a poster at the joint annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.
In a case series of seven breast cancer patients who had undergone ovarian stimulation for in vitro fertilization (IVF), Dr. Oktay's team found more than half (57%) had a family history of breast cancer. It is normally expected that only about 10% of breast cancer patients will have a family history of the disease.
All women had estrogen- and progesterone-receptor-positive breast cancer, when normally it is expected that about 40% of breast cancer patients will have this type of disease, said Dr. Oktay, of Cornell University in New York.
Ovulation induction exposes women to supraphysiologic levels of estrogen, which may be problematic in women with a family history of breast cancer, Dr. Oktay suggested. “Not that IVF necessarily causes their cancer, but it may promote it,” he said. “Counseling should include the fact that if you have a family history of breast cancer, this may increase your risk—but it may simply facilitate the appearance of the disease and so patients should be closely examined before IVF and followed after.”
The mean age of the patients was 40, and the mean duration from the time of their IVF treatment until their breast cancer diagnosis was 8.5 months.
One patient had a breast lesion biopsied before undergoing IVF, and it was initially negative for malignancy. However, after her IVF treatment, the mass grew, and a second biopsy revealed stage I invasive ductal carcinoma.
One other patient had stage I invasive ductal carcinoma, three had stage IIA disease, and two had carcinoma in situ. Tumor size was less than or equal to 1.5 cm in all except one patient.
Dr. Oktay, also of the Center for Reproductive Medicine and Infertility of New York-Presbyterian Hospital/Weill Cornell Medical Center, recommends that IVF patients who face an elevated risk of breast cancer based on their family history should undergo ovulation induction with a letrozole/FSH protocol instead of standard ovulation induction, which exposes patients to high levels of estrogen.
Letrozole, an aromatase inhibitor that also is used to treat breast cancer, can stimulate oocyte production without raising estrogen levels, making it ideal for this patient population. “Obviously, if they conceive, they are going to be exposed to high levels of estrogen anyway … and the studies so far don't suggest that pregnancy necessarily increases the risk of cancer.”
MONTREAL — Ovulation induction for in vitro fertilization may promote the growth of breast cancer in patients who are predisposed to the disease, results of a case series of seven IVF patients later diagnosed with the disease suggest.
“A breast cancer family history should be included in the pre-IVF work-up, and women with a positive history should be considered candidates for an alternate IVF stimulation protocol,” recommended Kutluk Oktay, M.D., who reported the findings in a poster at the joint annual meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society.
In a case series of seven breast cancer patients who had undergone ovarian stimulation for in vitro fertilization (IVF), Dr. Oktay's team found more than half (57%) had a family history of breast cancer. It is normally expected that only about 10% of breast cancer patients will have a family history of the disease.
All women had estrogen- and progesterone-receptor-positive breast cancer, when normally it is expected that about 40% of breast cancer patients will have this type of disease, said Dr. Oktay, of Cornell University in New York.
Ovulation induction exposes women to supraphysiologic levels of estrogen, which may be problematic in women with a family history of breast cancer, Dr. Oktay suggested. “Not that IVF necessarily causes their cancer, but it may promote it,” he said. “Counseling should include the fact that if you have a family history of breast cancer, this may increase your risk—but it may simply facilitate the appearance of the disease and so patients should be closely examined before IVF and followed after.”
The mean age of the patients was 40, and the mean duration from the time of their IVF treatment until their breast cancer diagnosis was 8.5 months.
One patient had a breast lesion biopsied before undergoing IVF, and it was initially negative for malignancy. However, after her IVF treatment, the mass grew, and a second biopsy revealed stage I invasive ductal carcinoma.
One other patient had stage I invasive ductal carcinoma, three had stage IIA disease, and two had carcinoma in situ. Tumor size was less than or equal to 1.5 cm in all except one patient.
Dr. Oktay, also of the Center for Reproductive Medicine and Infertility of New York-Presbyterian Hospital/Weill Cornell Medical Center, recommends that IVF patients who face an elevated risk of breast cancer based on their family history should undergo ovulation induction with a letrozole/FSH protocol instead of standard ovulation induction, which exposes patients to high levels of estrogen.
Letrozole, an aromatase inhibitor that also is used to treat breast cancer, can stimulate oocyte production without raising estrogen levels, making it ideal for this patient population. “Obviously, if they conceive, they are going to be exposed to high levels of estrogen anyway … and the studies so far don't suggest that pregnancy necessarily increases the risk of cancer.”
Refeeding Syndrome Looms for Patients With Eating Disorders
MONTREAL – Refeeding syndrome is a potential problem for all eating-disordered patients who are reintroducing fluids and food, but it is difficult to predict which patients are at greatest risk, Ovidio Bermudez, M.D., said at an international conference sponsored by the Academy for Eating Disorders.
“There is something about the reintroduction of nutrients to someone who has suffered a significant nutritional insult that can cause severe metabolic imbalances, resulting in cardiovascular, pulmonary, neurological, hepatic, and even bone marrow dysfunction,” he said in an interview.
Once the body has adjusted to a state of malnourishment, refeeding will signal the body to switch off its compensatory mechanisms, thus unmasking many nutritional deficiencies, said Dr. Bermudez, medical director of the eating disorders program at Laureate Psychiatric Clinic and Hospital in Tulsa, Okla. The result is electrolyte and fluid imbalances, glucose intolerance, liver dysfunction, and thiamine deficiency.
“All patients who are refed will develop some degree of refeeding syndrome, but there is great variability in terms of the severity of the readjustment. Most patients fare well without any apparent clinical challenges, some patients have a moderate challenge, and a few patients have very severe or even fatal consequences,” he said.
Although there are few predictive factors to identify patients most at risk for refeeding syndrome, they tend to be those who are the most underweight (less than 70% of their ideal body weight) and have low prealbumin levels. But these predictors should not be relied on too heavily, Dr. Bermudez warned. “The idea that a person who has had only a moderate metabolic insult is not going to develop some of these problems would be a false reassurance. The best approach we should have as physicians is to know the literature and know the group of patients at highest risk,” but to be alert for any trouble, he said.
By screening for problems prior to refeeding and then monitoring patients carefully during the refeeding, Dr. Bermudez noted, most serious consequences can be avoided.
He recommended that a comprehensive metabolic panel (including liver and renal function tests), calcium, phosphorous and magnesium levels, CBC, and a prealbumin test should be performed prior to refeeding. Any vitamin and trace mineral deficiencies, as well as electrolyte and glucose imbalances, should also be corrected at that time. During refeeding, fluids and caloric intake should be increased gradually by 200–250 kcal every 2–3 days, and weight gain should not exceed 2–3 pounds per week, Dr. Bermudez said. Initially, patients should have their vital signs, weight, and fluid intake and output monitored daily, with weekly assessments of CBC, electrolytes and glucose, calcium, phosphorus, magnesium, and liver and renal function, he said.
“How long to do this is not quite clear. In our setting, it is usually 2–3 weeks, but in others it can be up to 6 weeks,” he said. “Sometimes patients are ambulatory, but I think the sicker patients should be refed in the hospital. Then you can relax the surveillance and be more guided by symptoms.”
MONTREAL – Refeeding syndrome is a potential problem for all eating-disordered patients who are reintroducing fluids and food, but it is difficult to predict which patients are at greatest risk, Ovidio Bermudez, M.D., said at an international conference sponsored by the Academy for Eating Disorders.
“There is something about the reintroduction of nutrients to someone who has suffered a significant nutritional insult that can cause severe metabolic imbalances, resulting in cardiovascular, pulmonary, neurological, hepatic, and even bone marrow dysfunction,” he said in an interview.
Once the body has adjusted to a state of malnourishment, refeeding will signal the body to switch off its compensatory mechanisms, thus unmasking many nutritional deficiencies, said Dr. Bermudez, medical director of the eating disorders program at Laureate Psychiatric Clinic and Hospital in Tulsa, Okla. The result is electrolyte and fluid imbalances, glucose intolerance, liver dysfunction, and thiamine deficiency.
“All patients who are refed will develop some degree of refeeding syndrome, but there is great variability in terms of the severity of the readjustment. Most patients fare well without any apparent clinical challenges, some patients have a moderate challenge, and a few patients have very severe or even fatal consequences,” he said.
Although there are few predictive factors to identify patients most at risk for refeeding syndrome, they tend to be those who are the most underweight (less than 70% of their ideal body weight) and have low prealbumin levels. But these predictors should not be relied on too heavily, Dr. Bermudez warned. “The idea that a person who has had only a moderate metabolic insult is not going to develop some of these problems would be a false reassurance. The best approach we should have as physicians is to know the literature and know the group of patients at highest risk,” but to be alert for any trouble, he said.
By screening for problems prior to refeeding and then monitoring patients carefully during the refeeding, Dr. Bermudez noted, most serious consequences can be avoided.
He recommended that a comprehensive metabolic panel (including liver and renal function tests), calcium, phosphorous and magnesium levels, CBC, and a prealbumin test should be performed prior to refeeding. Any vitamin and trace mineral deficiencies, as well as electrolyte and glucose imbalances, should also be corrected at that time. During refeeding, fluids and caloric intake should be increased gradually by 200–250 kcal every 2–3 days, and weight gain should not exceed 2–3 pounds per week, Dr. Bermudez said. Initially, patients should have their vital signs, weight, and fluid intake and output monitored daily, with weekly assessments of CBC, electrolytes and glucose, calcium, phosphorus, magnesium, and liver and renal function, he said.
“How long to do this is not quite clear. In our setting, it is usually 2–3 weeks, but in others it can be up to 6 weeks,” he said. “Sometimes patients are ambulatory, but I think the sicker patients should be refed in the hospital. Then you can relax the surveillance and be more guided by symptoms.”
MONTREAL – Refeeding syndrome is a potential problem for all eating-disordered patients who are reintroducing fluids and food, but it is difficult to predict which patients are at greatest risk, Ovidio Bermudez, M.D., said at an international conference sponsored by the Academy for Eating Disorders.
“There is something about the reintroduction of nutrients to someone who has suffered a significant nutritional insult that can cause severe metabolic imbalances, resulting in cardiovascular, pulmonary, neurological, hepatic, and even bone marrow dysfunction,” he said in an interview.
Once the body has adjusted to a state of malnourishment, refeeding will signal the body to switch off its compensatory mechanisms, thus unmasking many nutritional deficiencies, said Dr. Bermudez, medical director of the eating disorders program at Laureate Psychiatric Clinic and Hospital in Tulsa, Okla. The result is electrolyte and fluid imbalances, glucose intolerance, liver dysfunction, and thiamine deficiency.
“All patients who are refed will develop some degree of refeeding syndrome, but there is great variability in terms of the severity of the readjustment. Most patients fare well without any apparent clinical challenges, some patients have a moderate challenge, and a few patients have very severe or even fatal consequences,” he said.
Although there are few predictive factors to identify patients most at risk for refeeding syndrome, they tend to be those who are the most underweight (less than 70% of their ideal body weight) and have low prealbumin levels. But these predictors should not be relied on too heavily, Dr. Bermudez warned. “The idea that a person who has had only a moderate metabolic insult is not going to develop some of these problems would be a false reassurance. The best approach we should have as physicians is to know the literature and know the group of patients at highest risk,” but to be alert for any trouble, he said.
By screening for problems prior to refeeding and then monitoring patients carefully during the refeeding, Dr. Bermudez noted, most serious consequences can be avoided.
He recommended that a comprehensive metabolic panel (including liver and renal function tests), calcium, phosphorous and magnesium levels, CBC, and a prealbumin test should be performed prior to refeeding. Any vitamin and trace mineral deficiencies, as well as electrolyte and glucose imbalances, should also be corrected at that time. During refeeding, fluids and caloric intake should be increased gradually by 200–250 kcal every 2–3 days, and weight gain should not exceed 2–3 pounds per week, Dr. Bermudez said. Initially, patients should have their vital signs, weight, and fluid intake and output monitored daily, with weekly assessments of CBC, electrolytes and glucose, calcium, phosphorus, magnesium, and liver and renal function, he said.
“How long to do this is not quite clear. In our setting, it is usually 2–3 weeks, but in others it can be up to 6 weeks,” he said. “Sometimes patients are ambulatory, but I think the sicker patients should be refed in the hospital. Then you can relax the surveillance and be more guided by symptoms.”
Eating Disorders a Challenge As Patients Become Adults
MONTREAL – When young patients with eating disorders transfer from the pediatric to the adult care setting, they literally take their lives into their own hands–which sometimes leaves their families and health care professionals empty handed.
Parents and the health care team play a central decision-making role in the pediatric setting, but the adult system transfers full responsibility to the patient. Some adolescents are ready for this new empowerment. For others, the freedom to refuse treatment or to exclude family members can create many bumps along the road, noted experts at an international conference sponsored by the Academy for Eating Disorders.
“Everyone's fear is that the child will enter the adult system, get less attention, and eventually die,” said D. Blake Woodside, M.D., director of the inpatient eating disorders program at Toronto General Hospital. Indeed, the harsh reality is that, unlike pediatric programs, most adult eating disorder programs have no resources and often no legal jurisdiction to treat involuntary patients, he said.
But although many patients drift away from treatment at this time, the natural course of anorexia nervosa (AN), is such that the risk of death during this middle phase of the illness tends to be low, he said.
“There is a period of instability and risk of death in the early phase of the disease [around puberty] and the late phase after fifteen or more years, but through the middle phase it stabilizes and there are few deaths,” he said. “We have had hundreds of patients who have had a Body Mass Index of 14 for years. Sure, they are very sick, but they probably will not die.”
Many adolescents with eating disorders do not recognize or acknowledge their need to continue treatment as adults, said Debra K. Katzman, M.D., of the department of pediatrics at the University of Toronto's Hospital for Sick Children. In a recent survey of adolescents under age 18 with AN, only 14% anticipated that they would need treatment in the adult system and only 33% said they would participate in such a transfer.
She said it is useful for parents and pediatric caregivers to remember that aggressive treatment early in the course of the illness can have a positive outcome on child and adolescent growth and development and eventual long-term outcome.
“What we struggle with as pediatricians is the worry, knowing that we can make a significant impact on the patient's growth and development if we intervene. But once these patients are adults, intervention is less likely to make significant change.”
Dr. Katzman recommends that the transition from pediatric to adult care should be an extended and gradual one, starting as early as age 10. “The transition may take years. It's a process through which patients and their families are empowered to become active participants in their own care.”
The first step is actually a step back on the part of parents, said Leora Pinhas, M.D., psychiatric director of the eating disorders program at the University of Toronto's Hospital for Sick Children. Although the adolescent may be 18 years old, many teens with eating disorders are developmentally delayed–which makes this process particularly difficult. “We try to encourage them to accept help from those who have their best interests at heart,” she said.
But family dynamics can be very fragile, added Dr. Woodside. “If parents are sufficiently anxious and can't back off, the patient can cut off contact with them completely,” he explained.
MONTREAL – When young patients with eating disorders transfer from the pediatric to the adult care setting, they literally take their lives into their own hands–which sometimes leaves their families and health care professionals empty handed.
Parents and the health care team play a central decision-making role in the pediatric setting, but the adult system transfers full responsibility to the patient. Some adolescents are ready for this new empowerment. For others, the freedom to refuse treatment or to exclude family members can create many bumps along the road, noted experts at an international conference sponsored by the Academy for Eating Disorders.
“Everyone's fear is that the child will enter the adult system, get less attention, and eventually die,” said D. Blake Woodside, M.D., director of the inpatient eating disorders program at Toronto General Hospital. Indeed, the harsh reality is that, unlike pediatric programs, most adult eating disorder programs have no resources and often no legal jurisdiction to treat involuntary patients, he said.
But although many patients drift away from treatment at this time, the natural course of anorexia nervosa (AN), is such that the risk of death during this middle phase of the illness tends to be low, he said.
“There is a period of instability and risk of death in the early phase of the disease [around puberty] and the late phase after fifteen or more years, but through the middle phase it stabilizes and there are few deaths,” he said. “We have had hundreds of patients who have had a Body Mass Index of 14 for years. Sure, they are very sick, but they probably will not die.”
Many adolescents with eating disorders do not recognize or acknowledge their need to continue treatment as adults, said Debra K. Katzman, M.D., of the department of pediatrics at the University of Toronto's Hospital for Sick Children. In a recent survey of adolescents under age 18 with AN, only 14% anticipated that they would need treatment in the adult system and only 33% said they would participate in such a transfer.
She said it is useful for parents and pediatric caregivers to remember that aggressive treatment early in the course of the illness can have a positive outcome on child and adolescent growth and development and eventual long-term outcome.
“What we struggle with as pediatricians is the worry, knowing that we can make a significant impact on the patient's growth and development if we intervene. But once these patients are adults, intervention is less likely to make significant change.”
Dr. Katzman recommends that the transition from pediatric to adult care should be an extended and gradual one, starting as early as age 10. “The transition may take years. It's a process through which patients and their families are empowered to become active participants in their own care.”
The first step is actually a step back on the part of parents, said Leora Pinhas, M.D., psychiatric director of the eating disorders program at the University of Toronto's Hospital for Sick Children. Although the adolescent may be 18 years old, many teens with eating disorders are developmentally delayed–which makes this process particularly difficult. “We try to encourage them to accept help from those who have their best interests at heart,” she said.
But family dynamics can be very fragile, added Dr. Woodside. “If parents are sufficiently anxious and can't back off, the patient can cut off contact with them completely,” he explained.
MONTREAL – When young patients with eating disorders transfer from the pediatric to the adult care setting, they literally take their lives into their own hands–which sometimes leaves their families and health care professionals empty handed.
Parents and the health care team play a central decision-making role in the pediatric setting, but the adult system transfers full responsibility to the patient. Some adolescents are ready for this new empowerment. For others, the freedom to refuse treatment or to exclude family members can create many bumps along the road, noted experts at an international conference sponsored by the Academy for Eating Disorders.
“Everyone's fear is that the child will enter the adult system, get less attention, and eventually die,” said D. Blake Woodside, M.D., director of the inpatient eating disorders program at Toronto General Hospital. Indeed, the harsh reality is that, unlike pediatric programs, most adult eating disorder programs have no resources and often no legal jurisdiction to treat involuntary patients, he said.
But although many patients drift away from treatment at this time, the natural course of anorexia nervosa (AN), is such that the risk of death during this middle phase of the illness tends to be low, he said.
“There is a period of instability and risk of death in the early phase of the disease [around puberty] and the late phase after fifteen or more years, but through the middle phase it stabilizes and there are few deaths,” he said. “We have had hundreds of patients who have had a Body Mass Index of 14 for years. Sure, they are very sick, but they probably will not die.”
Many adolescents with eating disorders do not recognize or acknowledge their need to continue treatment as adults, said Debra K. Katzman, M.D., of the department of pediatrics at the University of Toronto's Hospital for Sick Children. In a recent survey of adolescents under age 18 with AN, only 14% anticipated that they would need treatment in the adult system and only 33% said they would participate in such a transfer.
She said it is useful for parents and pediatric caregivers to remember that aggressive treatment early in the course of the illness can have a positive outcome on child and adolescent growth and development and eventual long-term outcome.
“What we struggle with as pediatricians is the worry, knowing that we can make a significant impact on the patient's growth and development if we intervene. But once these patients are adults, intervention is less likely to make significant change.”
Dr. Katzman recommends that the transition from pediatric to adult care should be an extended and gradual one, starting as early as age 10. “The transition may take years. It's a process through which patients and their families are empowered to become active participants in their own care.”
The first step is actually a step back on the part of parents, said Leora Pinhas, M.D., psychiatric director of the eating disorders program at the University of Toronto's Hospital for Sick Children. Although the adolescent may be 18 years old, many teens with eating disorders are developmentally delayed–which makes this process particularly difficult. “We try to encourage them to accept help from those who have their best interests at heart,” she said.
But family dynamics can be very fragile, added Dr. Woodside. “If parents are sufficiently anxious and can't back off, the patient can cut off contact with them completely,” he explained.
Expert Sees Possible Link Between Strep Throat and Anorexia Nervosa
MONTREAL – Streptococcal pharyngitis may be a very occasional trigger for anorexia nervosa and other neuropsychiatric conditions and should be investigated in patients with sudden onset of psychiatric symptoms, Mae S. Sokol, M.D., said at an international conference sponsored by the Academy for Eating Disorders.
Identification of this cause of anorexia nervosa would not change treatment of the condition (although this possibility is being investigated), but it would alert patients and physicians to the need for more aggressive prevention and treatment of future strep infections, said Dr. Sokol of Creighton University in Omaha, Neb.
She said group A beta hemolytic streptococci (GABHS) have been linked with several illnesses known collectively as PANDAS (pediatric autoimmune neuropsychiatric disorder associated with streptococcus). The PANDAS classification also includes obsessive-compulsive disorder (OCD) and tic disorders such as Tourette's syndrome.
It is well recognized that rheumatic fever and Sydenham's chorea are streptococcus-triggered autoimmune attacks on cardiac cells and cerebral neurons, respectively. It also is believed that PANDAS might be caused by similar attacks on basal ganglia cells, noted Dr. Sokol, who is also director of the eating disorders program at Children's Hospital in Omaha.
“We hypothesize that the immune system may look at the basal ganglia cells in the brain and mistakenly attack those cells, which may cause patients to have abnormal thoughts about food and weight,” she said in an interview at the conference.
Why this damage to basal ganglia cells manifests sometimes as anorexia and other times as OCD, Tourette's, or infantile autism is not known, she said.
“Since the basal ganglia are also involved with emotion, we think this area of the brain may be affected slightly differently with each condition. Another theory is that maybe we are seeing the same thing in children with PANDAS anorexia and children with PANDAS OCD–only in the PANDAS anorexia, the obsessions are about food and weight, whereas in PANDAS OCD they are about other things. What's common in all these patients is a sense of perfectionism after they become ill,” Dr. Sokol explained.
She presented her study of 21 children and adolescents with possible PANDAS anorexia. The subjects met some or all of the following criteria:
▸ Presence of anorexia meeting DSM-IV criteria.
▸ Prepubertal onset of anorexia. This was present in 10 of the 21 participants. Participants ranged in age from 10.5 to 18 years at enrollment, with symptom onset at 9.7–16 years.
▸ Acute onset/exacerbation of their anorexia symptoms. This occurred in 19 of the 21 participants.
▸ Association with GABHS infection: anorexia onset or exacerbation within 1 day to 6 months of strep infection. This occurred in all participants.
▸ Increased psychiatric symptoms, not exclusively during the strep illness. Present in all participants.
▸ Concomitant neurologic abnormalities, such as choreiform movements, motor hyperactivity, or adventitious movements. This occurred in only two participants but has been reported more frequently in PANDAS OCD.
Dr. Sokol said physicians who suspect PANDAS anorexia should try to confirm laboratory strep tests, although at this stage treatment recommendations would be no different for this group.
However, identification of an infection-triggered anorexia could alert physicians and patients to the need for more aggressive prevention strategies such as the use of prophylactic antibiotics (which is still under investigation) and to the importance of influenza vaccination, which can decrease vulnerability to strep, she said.
MONTREAL – Streptococcal pharyngitis may be a very occasional trigger for anorexia nervosa and other neuropsychiatric conditions and should be investigated in patients with sudden onset of psychiatric symptoms, Mae S. Sokol, M.D., said at an international conference sponsored by the Academy for Eating Disorders.
Identification of this cause of anorexia nervosa would not change treatment of the condition (although this possibility is being investigated), but it would alert patients and physicians to the need for more aggressive prevention and treatment of future strep infections, said Dr. Sokol of Creighton University in Omaha, Neb.
She said group A beta hemolytic streptococci (GABHS) have been linked with several illnesses known collectively as PANDAS (pediatric autoimmune neuropsychiatric disorder associated with streptococcus). The PANDAS classification also includes obsessive-compulsive disorder (OCD) and tic disorders such as Tourette's syndrome.
It is well recognized that rheumatic fever and Sydenham's chorea are streptococcus-triggered autoimmune attacks on cardiac cells and cerebral neurons, respectively. It also is believed that PANDAS might be caused by similar attacks on basal ganglia cells, noted Dr. Sokol, who is also director of the eating disorders program at Children's Hospital in Omaha.
“We hypothesize that the immune system may look at the basal ganglia cells in the brain and mistakenly attack those cells, which may cause patients to have abnormal thoughts about food and weight,” she said in an interview at the conference.
Why this damage to basal ganglia cells manifests sometimes as anorexia and other times as OCD, Tourette's, or infantile autism is not known, she said.
“Since the basal ganglia are also involved with emotion, we think this area of the brain may be affected slightly differently with each condition. Another theory is that maybe we are seeing the same thing in children with PANDAS anorexia and children with PANDAS OCD–only in the PANDAS anorexia, the obsessions are about food and weight, whereas in PANDAS OCD they are about other things. What's common in all these patients is a sense of perfectionism after they become ill,” Dr. Sokol explained.
She presented her study of 21 children and adolescents with possible PANDAS anorexia. The subjects met some or all of the following criteria:
▸ Presence of anorexia meeting DSM-IV criteria.
▸ Prepubertal onset of anorexia. This was present in 10 of the 21 participants. Participants ranged in age from 10.5 to 18 years at enrollment, with symptom onset at 9.7–16 years.
▸ Acute onset/exacerbation of their anorexia symptoms. This occurred in 19 of the 21 participants.
▸ Association with GABHS infection: anorexia onset or exacerbation within 1 day to 6 months of strep infection. This occurred in all participants.
▸ Increased psychiatric symptoms, not exclusively during the strep illness. Present in all participants.
▸ Concomitant neurologic abnormalities, such as choreiform movements, motor hyperactivity, or adventitious movements. This occurred in only two participants but has been reported more frequently in PANDAS OCD.
Dr. Sokol said physicians who suspect PANDAS anorexia should try to confirm laboratory strep tests, although at this stage treatment recommendations would be no different for this group.
However, identification of an infection-triggered anorexia could alert physicians and patients to the need for more aggressive prevention strategies such as the use of prophylactic antibiotics (which is still under investigation) and to the importance of influenza vaccination, which can decrease vulnerability to strep, she said.
MONTREAL – Streptococcal pharyngitis may be a very occasional trigger for anorexia nervosa and other neuropsychiatric conditions and should be investigated in patients with sudden onset of psychiatric symptoms, Mae S. Sokol, M.D., said at an international conference sponsored by the Academy for Eating Disorders.
Identification of this cause of anorexia nervosa would not change treatment of the condition (although this possibility is being investigated), but it would alert patients and physicians to the need for more aggressive prevention and treatment of future strep infections, said Dr. Sokol of Creighton University in Omaha, Neb.
She said group A beta hemolytic streptococci (GABHS) have been linked with several illnesses known collectively as PANDAS (pediatric autoimmune neuropsychiatric disorder associated with streptococcus). The PANDAS classification also includes obsessive-compulsive disorder (OCD) and tic disorders such as Tourette's syndrome.
It is well recognized that rheumatic fever and Sydenham's chorea are streptococcus-triggered autoimmune attacks on cardiac cells and cerebral neurons, respectively. It also is believed that PANDAS might be caused by similar attacks on basal ganglia cells, noted Dr. Sokol, who is also director of the eating disorders program at Children's Hospital in Omaha.
“We hypothesize that the immune system may look at the basal ganglia cells in the brain and mistakenly attack those cells, which may cause patients to have abnormal thoughts about food and weight,” she said in an interview at the conference.
Why this damage to basal ganglia cells manifests sometimes as anorexia and other times as OCD, Tourette's, or infantile autism is not known, she said.
“Since the basal ganglia are also involved with emotion, we think this area of the brain may be affected slightly differently with each condition. Another theory is that maybe we are seeing the same thing in children with PANDAS anorexia and children with PANDAS OCD–only in the PANDAS anorexia, the obsessions are about food and weight, whereas in PANDAS OCD they are about other things. What's common in all these patients is a sense of perfectionism after they become ill,” Dr. Sokol explained.
She presented her study of 21 children and adolescents with possible PANDAS anorexia. The subjects met some or all of the following criteria:
▸ Presence of anorexia meeting DSM-IV criteria.
▸ Prepubertal onset of anorexia. This was present in 10 of the 21 participants. Participants ranged in age from 10.5 to 18 years at enrollment, with symptom onset at 9.7–16 years.
▸ Acute onset/exacerbation of their anorexia symptoms. This occurred in 19 of the 21 participants.
▸ Association with GABHS infection: anorexia onset or exacerbation within 1 day to 6 months of strep infection. This occurred in all participants.
▸ Increased psychiatric symptoms, not exclusively during the strep illness. Present in all participants.
▸ Concomitant neurologic abnormalities, such as choreiform movements, motor hyperactivity, or adventitious movements. This occurred in only two participants but has been reported more frequently in PANDAS OCD.
Dr. Sokol said physicians who suspect PANDAS anorexia should try to confirm laboratory strep tests, although at this stage treatment recommendations would be no different for this group.
However, identification of an infection-triggered anorexia could alert physicians and patients to the need for more aggressive prevention strategies such as the use of prophylactic antibiotics (which is still under investigation) and to the importance of influenza vaccination, which can decrease vulnerability to strep, she said.
Probiotic May Reduce Irritable Bowel Symptoms
MONTREAL — Daily ingestion of a probiotic preparation containing a bifidobacterium strain can significantly reduce symptoms and normalize the immune response in patients with irritable bowel syndrome, according to two studies presented as posters at the 13th World Congress of Gastroenterology.
A multicenter study which randomized 362 women with irritable bowel syndrome (IBS) to one of three strengths of an investigational probiotic Bifidobacterium infantis 35624 or placebo daily for 4 weeks showed significant improvement in abdominal pain and discomfort, as well as all other measured symptoms in those taking the medium-strength probiotic formulation.
“The very high dose didn't have an effect because it didn't disperse out of the capsule,” commented lead investigator Peter Whorwell, M.D., a professor of medicine and gastroenterology at the University of Manchester (England). He went on to explain that the effective delivery of probiotic formulations remains a challenge.
“A lot of probiotic preparations are not necessarily bioavailable because they may not be alive, or they may be in a media where they are not dispersing well. So it raises a whole issue about quality. If you just go into a supermarket you don't know what you're getting,” he said in an interview.
In another pilot study, 13 IBS patients and 10 healthy controls received milk containing B. infantis 35624 every day for 3 weeks. Peripheral blood mononuclear cells collected at baseline and after each feeding were cultured for 3 days, either alone or with a stimulant, and cytokine levels were analyzed.
The study found that at baseline, spontaneous production of cytokines from the IBS subjects was no different from healthy subjects, while in vitro stimulation of their peripheral blood mononuclear cells produced a significantly higher level of proinflammatory cytokines and a lower level of anti-inflammatory cytokines.
However, probiotic feeding normalized this proinflammatory immune response in the IBS subjects.
Similar work by the same group comparing treatment with B. infantis 35624 or lactobacillus demonstrated symptom relief and a similar normalization of the proinflammatory response with bifidobacterium but not lactobacillus (Gastroenterology 2005;128:541–51).
This response is suggestive of “an immune-modulating role for this organism, in this disorder,” concluded Liam O'Mahony, Ph.D., lead author, of University College Cork (Ireland).
Both studies were sponsored by Procter & Gamble, which is investigating B. infantis 35624.
MONTREAL — Daily ingestion of a probiotic preparation containing a bifidobacterium strain can significantly reduce symptoms and normalize the immune response in patients with irritable bowel syndrome, according to two studies presented as posters at the 13th World Congress of Gastroenterology.
A multicenter study which randomized 362 women with irritable bowel syndrome (IBS) to one of three strengths of an investigational probiotic Bifidobacterium infantis 35624 or placebo daily for 4 weeks showed significant improvement in abdominal pain and discomfort, as well as all other measured symptoms in those taking the medium-strength probiotic formulation.
“The very high dose didn't have an effect because it didn't disperse out of the capsule,” commented lead investigator Peter Whorwell, M.D., a professor of medicine and gastroenterology at the University of Manchester (England). He went on to explain that the effective delivery of probiotic formulations remains a challenge.
“A lot of probiotic preparations are not necessarily bioavailable because they may not be alive, or they may be in a media where they are not dispersing well. So it raises a whole issue about quality. If you just go into a supermarket you don't know what you're getting,” he said in an interview.
In another pilot study, 13 IBS patients and 10 healthy controls received milk containing B. infantis 35624 every day for 3 weeks. Peripheral blood mononuclear cells collected at baseline and after each feeding were cultured for 3 days, either alone or with a stimulant, and cytokine levels were analyzed.
The study found that at baseline, spontaneous production of cytokines from the IBS subjects was no different from healthy subjects, while in vitro stimulation of their peripheral blood mononuclear cells produced a significantly higher level of proinflammatory cytokines and a lower level of anti-inflammatory cytokines.
However, probiotic feeding normalized this proinflammatory immune response in the IBS subjects.
Similar work by the same group comparing treatment with B. infantis 35624 or lactobacillus demonstrated symptom relief and a similar normalization of the proinflammatory response with bifidobacterium but not lactobacillus (Gastroenterology 2005;128:541–51).
This response is suggestive of “an immune-modulating role for this organism, in this disorder,” concluded Liam O'Mahony, Ph.D., lead author, of University College Cork (Ireland).
Both studies were sponsored by Procter & Gamble, which is investigating B. infantis 35624.
MONTREAL — Daily ingestion of a probiotic preparation containing a bifidobacterium strain can significantly reduce symptoms and normalize the immune response in patients with irritable bowel syndrome, according to two studies presented as posters at the 13th World Congress of Gastroenterology.
A multicenter study which randomized 362 women with irritable bowel syndrome (IBS) to one of three strengths of an investigational probiotic Bifidobacterium infantis 35624 or placebo daily for 4 weeks showed significant improvement in abdominal pain and discomfort, as well as all other measured symptoms in those taking the medium-strength probiotic formulation.
“The very high dose didn't have an effect because it didn't disperse out of the capsule,” commented lead investigator Peter Whorwell, M.D., a professor of medicine and gastroenterology at the University of Manchester (England). He went on to explain that the effective delivery of probiotic formulations remains a challenge.
“A lot of probiotic preparations are not necessarily bioavailable because they may not be alive, or they may be in a media where they are not dispersing well. So it raises a whole issue about quality. If you just go into a supermarket you don't know what you're getting,” he said in an interview.
In another pilot study, 13 IBS patients and 10 healthy controls received milk containing B. infantis 35624 every day for 3 weeks. Peripheral blood mononuclear cells collected at baseline and after each feeding were cultured for 3 days, either alone or with a stimulant, and cytokine levels were analyzed.
The study found that at baseline, spontaneous production of cytokines from the IBS subjects was no different from healthy subjects, while in vitro stimulation of their peripheral blood mononuclear cells produced a significantly higher level of proinflammatory cytokines and a lower level of anti-inflammatory cytokines.
However, probiotic feeding normalized this proinflammatory immune response in the IBS subjects.
Similar work by the same group comparing treatment with B. infantis 35624 or lactobacillus demonstrated symptom relief and a similar normalization of the proinflammatory response with bifidobacterium but not lactobacillus (Gastroenterology 2005;128:541–51).
This response is suggestive of “an immune-modulating role for this organism, in this disorder,” concluded Liam O'Mahony, Ph.D., lead author, of University College Cork (Ireland).
Both studies were sponsored by Procter & Gamble, which is investigating B. infantis 35624.