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New treatments, diagnoses for women and children with gastrointestinal disorders

May 3, 2010
Digestive Disease Week
Undiagnosed and untreated pediatric hepatitis C is a grave concern, antibiotic use in the first year of life triples the risk of inflammatory bowel disease (IBD), drugs used to treat IBD in pregnant women are beginning to show that children at nine months are slightly developmentally delayed compared to non-use of this medication during pregnancy, and drugs commonly used to treat reflux in pregnant women may be associated with cardiac birth defects, according to data being presented at Digestive Disease Week.

Undiagnosed and untreated pediatric hepatitis C is a grave concern, antibiotic use in the first year of life triples the risk of inflammatory bowel disease (IBD), drugs used to treat IBD in pregnant women are beginning to show that children at nine months are slightly developmentally delayed compared to non-use of this medication during pregnancy, and drugs commonly used to treat reflux in pregnant women may be associated with cardiac birth defects, according to data being presented at Digestive Disease Week® (DDW®). DDW is the largest international gathering of physicians and researchers in the field of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"There is still much to be learned about the unique health needs of women and children," said Deborah Proctor, MD, AGAF, professor of medicine, Yale University School of Medicine. "Not only do women and children metabolize drugs differently, these populations have special needs to be taken into account. Gastroenterologists need to consider a number of factors in managing female patients, including pregnancy status, state of mind and physical fitness. As children develop, we need to monitor the potential effects of drugs in utero as well as the effects of drugs and disease on their developing bodies."

The Underdiagnosis of Pediatric Hepatitis C: An Emerging Health Care Issue in Florida (Abstract # 232)

A study of pediatric hepatitis C virus (HCV) from the University of Miami Miller School of Medicine found a much lower than expected number of reported cases of HCV in the state of Florida, pointing to a severe lack of adequate identification of such cases in the state. Researchers further estimate that the percentage of children receiving appropriate care for the condition was even lower than would be expected from the anticipated number of cases of HCV.

Based on information from the Third National Health and Nutrition Examination survey (NHANES), approximately 0.2 percent to 0.4 percent of the pediatric population is infected with HCV. Based on this figure, Aymin Delgado-Borrego, MD, MPH, pediatric gastroenterologist and assistant professor of pediatrics at the University of Miami Miller School of Medicine, determined that in the U.S., the expected number of cases of pediatric HCV in Florida would be 12,155. She then compared that number to the cases registered in Florida's Merlin database, which collects reported cases of HCV in that state, and found that 1,755 cases of pediatric HCV, which is only 14.4 percent of the expected number of cases. Dr. Delgado-Borrego and colleagues further estimated that no more than 1.2 percent of expected cases were being treated by a pediatric hepatologist.

HCV is the most common chronic liver disease and the leading indication for liver transplantation. Current treatment for HCV may be associated with some side effects, although it is generally well tolerated in children. The appropriate time to initiate therapy should be individualized. According to Dr. Delgado-Borrego, identification and appropriate referral to subspecialists is important regardless of when treatment will be initiated so that patients may be adequately monitored for the significant morbidity and mortality associated with the infection, including gradual and chronic damage to the liver affecting liver function or the development of liver cancer.

"There is a frightening lack of awareness among both the public and clinicians about hepatitis C virus infection in pediatric patients," said Dr. Delgado-Borrego. "Because HCV patients are typically asymptomatic, it is crucial for at-risk pediatric populations to be screened for the virus and referred to subspecialists for adequate medical assessment and follow-up."

Dr. Delgado-Borrego will present these data on Sunday, May 2 at 4 p.m. CT in 352, Ernest N. Morial Convention Center.

Antibiotic Prescriptions in the First Year of Life Increases the Risk of Pediatric Inflammatory Bowel Disease: A Population-Based Analysis (Abstract #95)

By comparing cases of pediatric IBD and antibiotic use, researchers from the University of Manitoba have discovered that infants who are prescribed antibiotics in the first year of life may be three times more likely to develop lifelong IBD than children not exposed to antibiotics.

Researchers believe that antibiotic use in infants can cause irrevocable impact to developing bowel flora, or bacteria, in the human bowel. Changes or irregularities in bowel flora are thought to be a potential cause of IBD. Bowel flora is established and remains relatively unchanged after one year of age. Taking antibiotics can temporarily change bowel flora, but after, use flora revert back.

Using the University of Manitoba IBD Epidemiological Database (UMIBDED), a database of all Manitobans diagnosed with IBD, researchers identified all children (age 11 and younger) diagnosed with IBD between 1996 and 2008 and cross referenced these records with the Drug Program Information Network, a database of all prescriptions. They compared the prescription records of the children with IBD to a matched cohort database of children without IBD. The control cohort of 360 children was matched to the 36 children diagnosed with IBD on the basis of age, gender and region of residence during diagnosis. Sixty percent of the children with IBD had received one or more prescription antibiotic in the first year of life compared with 39 percent of the control group.

"Our findings suggest that antibiotic use in the first year of life is associated with developing IBD in childhood. It is also possible that children who require antibiotics may for other reasons be predisposed to developing IBD. However, if the use of antibiotics is associated with triggering IBD, it may be by impacting upon bowel flora at a vulnerable point in development," said Charles Bernstein, MD, professor of medicine, head of the section of gastroenterology and director of the University of Manitoba IBD Clinical and Research Center.

He added, "This association may give us cause to think about the overuse of antibiotics in young children, especially those who may be at risk for developing IBD, such as children with siblings who have IBD." Bernstein noted that antibiotic use should not be eliminated in newborns, but should be prescribed more vigilantly.

To confirm this study's findings, more research with another population and larger sample sizes is necessary.

Souradet Y. Shaw, MD, will present these data on Sunday, May 2 at 10:30 a.m. CT in 295-296, Ernest N. Morial Convention Center.

One-Year Newborn Outcomes Among Offspring of Women with Inflammatory Bowel Disease: the PIANO Registry (Abstract #764)

Women with IBD who take medication for the disease have good pregnancy outcomes, according to a new study led by researchers at the University of California, San Francisco (UCSF). IBD includes Crohn's disease and ulcerative colitis.

Lead investigator Uma Mahadevan-Velayos, MD, associate professor of medicine, director of clinical research at the UCSF Center for Colitis and Crohn's disease, said researchers sought to determine the impact of IBD medication exposure in utero on newborn development in the first year of life. The study, part of a larger six-year study titled the PIANO registry (Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes), sought to look at adverse pregnancy outcomes which include low birth weight, stillbirths, complications with labor and delivery, as well as birth defects.

Researchers will follow children for four years from birth. Dr. Mahadevan-Velayos said this is important and novel because prior studies in IBD look at birth defects around the time of birth even though "many birth defects are picked up later in the first year," she said, adding that those studies do not account for issues with developmental delay and problems with height and weight that are unknown until later in life. Furthermore, this study already has nearly 600 women enrolled and hopes to ultimately have 1,000. Many previous studies have looked at a small group of patients at only one hospital, which is not large enough to provide statistical significance. Also, because researchers are following patients prospectively, they can gather specific valuable data for every patient throughout pregnancy and then for the next four years.

The women in the study have been divided into three groups: group A consists of women taking 6MP/Azathioprine; group B includes women taking infliximab, adalimumab or certolizumab; and a third control group includes women who are not taking any medications from group A or B.

Researchers looked at childhood developmental stages at months four, nine and 12 after birth and found there was no consistent association with drug exposure and rate of pregnancy complications or birth defects. Out of 600 live births, five birth defects were noted at birth, but 17 were noted after one year, which suggests a large number of missed birth defects in children who are not monitored for longer periods. The entire cohort of women have not yet delivered or reached one year of age so the data is only a preliminary analysis.

Dr. Mahadevan-Velayos said that at its completion, the study could have significant implications for treatment. "It's important to remember that as recently as 15 years ago, doctors counseled women with Crohn's disease and ulcerative colitis not to have children at all," she said.

Dr. Mahadevan-Velayos will present these data on Tuesday, May 4, at 3:15 p.m. CT in 295-296, Ernest N. Morial Convention Center.

Maternal Use of Proton Pump Inhibitors (PPI) During Pregnancy is Associated with an Increased Risk for Cardiac Birth Defects (Abstract #475b)

The use of common anti-reflux medications during pregnancy may be associated with cardiac birth defects, according to a new study from the University of Pennsylvania School of Medicine.

More than half of all women who become pregnant suffer from gastroesophageal reflux (GERD), better known as heartburn, which can be hard to control during pregnancy. Often symptoms start early in pregnancy when the fetus is most vulnerable to the effects of medications, which can lead to birth defects. Because of the prevalence of GERD during pregnancy, investigators sought to determine the safety of a popular class of anti-reflux medications, proton pump inhibitors (PPIs), on the developing fetus.

Usually, physicians treat pregnancy-related GERD with conservative measures such as advising patients to eat smaller meals, but frequently, these methods are ineffective, which is why physicians are increasingly prescribing PPIs. Since PPIs are relatively new to the market, not much is known about their safety during pregnancy. For example, omeprazole, the most commonly used PPI, is designated as a class C by FDA, which means that animal studies show adverse effects to the fetus, yet there are no adequate studies in humans since those that have been conducted had too small a sample to draw any definitive conclusions.

Researchers performed a nested case-control study within The Health Improvement Network database and looked at medical records from pregnant women in the U.K. from 2000 to 2008. They identified which pregnancies resulted in birth defects and compared the maternal PPI use of these cases with matched pregnancies that did not result in a birth defect.

"We found that PPI use during pregnancy was associated with a doubling in the risk of cardiac birth defects in the newborn," said lead researcher Andrew D. Rhim, MD, the Sir William Osler MD Fellow in Gastroenterology at the University of Pennsylvania School of Medicine. "The lack of association between maternal PPI use and other types of birth defects makes it less likely that our findings are due to confounding."

Dr. Rhim cautioned that cardiac birth defects associated with PPI use, such as ventricular septal defect and Tetralogy of Fallot, are relatively rare. Thus, a pregnant woman taking PPIs should not necessarily assume this will automatically cause birth defects in her baby. He added that patients and physicians need to weigh the possible risks and benefits of anti-reflux treatment on a case-by-case basis, since many women will develop heartburn in pregnancy that can be severe and result in poor quality of life. Of all of the PPIs that researchers looked at, omeprazole was associated with the greatest increase in the risk for having a baby with a cardiac birth defect.

He said the data from the study suggest that H2 receptor antagonists (H2RA), another anti-reflux medication that has been proven to be effective and are considered safe in pregnancy, could be tried before PPIs to minimize potential risks. Then, if symptoms are not controlled by H2RAs, PPIs could be considered next.

Dr. Rhim will present these data on Monday, May 3 at 4:15 p.m. CT in 291, Ernest N. Morial Convention Center.

Impact of High-Level Sport Practice on the Prevalence of Anal Incontinence in a Young Healthy Female Population (Abstract #903)

Young, healthy women who engage in athletics appear to be at increased risk for anal incontinence, according to a new study from the Université de la Méditerranée, Marseille, France. Researchers sought to determine the extent to which high-level sports (consisting of at least eight hours per week of practice) may induce anal incontinence in young females. Women aged 18 to 40 were divided into two groups: those in the intensive sport group who practiced at least eight hours a week and the non-intensive sport group, who practiced less.

Of the 393 women enrolled, 169 were in the intensive sport group and 224 were in the non-intensive sport group. The prevalence of anal incontinence was statistically higher in the intensive sport group (14.8 percent versus 4.9 percent), as was urinary incontinence (33.1 percent versus 18.3 percent) and dyspareunia [painful sexual intercourse] (20.1 percent versus 9.4 percent). Statistically, intensive sport practice was significantly linked to anal incontinence; daily leakage was observed in 20 percent of the cases, weekly in 36 percent and monthly in 44 percent.

Veronique Vitton, MD, PhD, associate professor at Université de la Méditerranée, Marseille, France, says the study is important because in demonstrating a higher prevalence of anal incontinence in a group of young women who do not have any of the conventional risk factors for incontinence, such as childbirth injuries, advanced age or post-menopausal status, researchers have identified a new at-risk population. The idea that sport may influence anal incontinence was suggested by the National Institute of Health in 2008, but had not yet been demonstrated.

"Diagnosis and treatment of pelvic floor dysfunction in physically active females is particularly important because these lesions may compromise the future quality of life of these young females," said Jean-Charles Grimaud, MD, co-author and presenter during DDW.

Dr. Vitton cautioned that women should not be discouraged from exercising, but that women who engage in long-term high-impact sports should be informed of possible consequences of exercise on pelvic floor function. In light of the findings of the current study, preventive measures such as pelvic floor muscle training could be developed. She added that primary prevention in young high-level female athletes, such as education about methods for preventing incontinence, should take precedent over secondary prevention measures of detecting anal incontinence symptoms at an early stage.

While urinary incontinence was previously documented, few data were available about anal incontinence in female athletes; this study is the first to demonstrate a significant difference in prevalence of anal incontinence in active young females.

Dr. Jean-Charles Grimaud will present these data on Wednesday, May 5 at 8:30 a.m. CT in 255-/257, Ernest N. Morial Convention Center.

Irritable Bowel Syndrome (IBS) Among Caregivers of Chronically Ill Patients: Prevalence, Quality of Life (QoL) and Association with Psychological Stress (Abstract #M1337)

Caregivers of chronically ill patients have a relatively high prevalence of irritable bowel syndrome (IBS), which is highly associated with depression, anxiety and poor quality of life (QoL), according to a new study from the Medical-Biological Research Institute in Veracruz, Mexico.

Recent studies have shown that caregiving over long periods can have a negative mental and physical impact on caregivers. Though significant associations have been reported between IBS and psychological distress, including sexual abuse and post-traumatic stress disorder, it is not well known if caregiving is associated with IBS.

Researchers sought to determine the prevalence of IBS and its association with anxiety, depression and QoL among a group of caregivers of chronically ill patients. They evaluated 96 caregivers (parents, spouses and non-relatives) who had been providing care for at least six months to patients who suffer from chronic kidney failure, end-stage cancer and terminal neurological disease, among other conditions. They were evaluated using the Zarit Caregiver Burden Interview (ZBI), which assesses the burden experienced by caregivers using 22 questions that are then graded; any score greater than 47 represents significant caregiver burden.

Results showed that 69 subjects, or 72 percent, had caregiver burden, but the most relevant finding was that 47 (49 percent) had IBS according to Rome II criteria. The group with IBS reported higher scores in the ZBI (69 percent versus 40 percent), higher scores for anxiety (12 percent versus 7.5 percent) and depression (9.5 percent versus 7.2 percent), when compared to non-IBS caregivers. In addition, the authors found that caregivers with IBS had lower IBS-QoL scores compared to the non-IBS caregiver group (70 percent versus 93 percent).

"This tells us there is definitely a link between people who care for chronically ill individuals and their own health," said Jose M. Remes, MD, Medical-Biological Research Institute, Veracruz, Mexico. "Further study is needed to determine the physical and mental effects of caring for a chronically ill patient."

Dr. Remes will present these data on Monday, May 3 at 8 a.m. CT in Hall F, Ernest N. Morial Convention Center.

Patients with IBS Commonly Use Narcotics (Abstract #W1378)

Doctors often unnecessarily treat irritable bowel syndrome (IBS) with narcotics. A course of treatment is generally inadvisable because it does not improve functional status and may have adverse long term effects, according to a new study. Women are about twice as likely as men to suffer from IBS.

Researchers, led by Spencer D. Dorn, MD, assistant professor of medicine, University of North Carolina (UNC), surveyed nearly 1,800 patients who had seen a physician for Rome III criteria defined IBS. They looked at demographic characteristics, clinical features including subtype, duration, severity, most troublesome symptom, quality of life, psychological factors such as anxiety and depression, overall satisfaction with care, and medications currently used.

The study, conducted by researchers at the UNC Center for Functional GI disorders and the International Foundation for Functional GI Disorders, found that 325 patients, or 18 percent, reported currently using narcotics. These patients reported more abdominal pain, poorer health quality, more IBS-related limitations, more hospitalizations and surgeries, and that they were more likely to use antidepressants and antacid medications.

"Although narcotics are commonly used, they may have deleterious long term effects, including narcotic bowel syndrome and sometimes drug dependency," said Dr. Dorn. Instead, Dr. Dorn and his UNC colleagues recommend an integrative approach that emphasizes patient education, self management over time, non-narcotic symptom-based therapies, and sometimes antidepressants and/or psychotherapy.

"In the current U.S. health-care system, clinicians often lack the time, infrastructure and incentives needed to provide integrative care to patients with chronic conditions, including IBS," said Dr. Dorn. "Instead, very often physicians take the path of least resistance. Narcotic prescriptions are a quick and easy way to get patients out of their office, even though the long term effects can be harmful." He added that physicians have to resolve to finding better training and incentives to treat patients who would otherwise benefit from more integrative treatments.

Dr. Dorn said the findings are especially important since the U.S. accounts for just 4 percent of the world's population and more than 80 percent of the narcotics prescribed worldwide.

Dr. Dorn will present these data on Monday, May 5 at 8 a.m. CT in Hall F, Ernest N. Morial Convention Center.

Digestive Disease Week® 2010 (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the AGA Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 1 -- May 5, 2010 in New Orleans, LA. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

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