Issue: November 2017
November 21, 2017
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Guideline Adherence Required to Address Pediatric Constipation

Issue: November 2017
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Pediatric constipation is one of the most frequently treated chronic conditions worldwide, according to a review by Nurko and colleagues in the American Family Physician. Researchers noted that the condition is the catalyst for 3% of all primary care visits, as well as 10% to 25% of all pediatric gastroenterology visits.

Children with this condition also cost the American health care system three times more than children without constipation. In many instances, the negative effects of constipation persist into adulthood, according to the review.

Despite the burden that this condition creates for both patients and the health care infrastructure, it is difficult to determine the prevalence of pediatric constipation. A review of pediatric constipation studies worldwide conducted by Van den Berg and colleagues in the American Journal of Gastroenterology determined that the global prevalence lies somewhere between 1% and 30% for all children.

“Constipation is very common, but it is difficult to get epidemiologic data because there is significant variation,” Barrett H. Barnes, MD, associate professor of pediatrics at the University of Virginia, said in an interview. “There is often a referral bias for those with more severe symptoms, and the children with mild or unrecognized symptoms may not be treated.”

Guidelines created by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) state that these symptoms typically observed in the pediatric population include infrequent and/or painful defecation, fecal incontinence and abdominal pain.

Barrett H. Barnes

Although the organization has provided a set of guidelines to manage the symptoms of pediatric functional constipation, a study published in the Journal of Pediatric Gastroenterology and Nutrition found that 84.3% of pediatricians were unfamiliar or only slightly familiar with these recommendations.

Thomas Ciecierega, MD, pediatric gastroenterologist, director of the pediatric endoscopy unit and pediatric motility at Weill Cornell Medicine and New York-Presbyterian, claims that both pediatricians and pediatric gastroenterologists fail to follow NASPGHAN guidelines. To address recent diagnostic and treatment changes and determine how best to incorporate the NASPGHAN guidelines into daily practice, Healio Gastroenterology and Liver Disease spoke with pediatricians, pediatric gastroenterologists and NASPGHAN leadership about what can be done to counsel parents and patients regarding childhood constipation.

Patient Assessment is Crucial in Diagnosis

Age must be considered to adequately examine a pediatric patient who may be experiencing constipation. Rome III definitions for functional constipation are divided into two groups: the first includes infants aged less than 6 months and the second encompasses children 6 months or older. Children aged less than 4 years must exhibit at least two constipation criteria for a minimum of 1 month, and those older than 4 years need to display symptoms for 2 or more months.

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“We see constipation in different subsets, especially in functional cases,” Kristin Fiorino, MD, pediatric gastroenterologist in the division of gastroenterology, hepatology and nutrition at Children’s Hospital of Philadelphia and associate director of the Suzi and Scott Lustgarten Center for GI Motility, said in an interview. “We usually see constipation occur during the introduction of whole milk around 1 year, during toilet training and in school-aged children who withhold stool during school hours.”

Once the patient’s age is considered, NASPGHAN suggests collecting a thorough history from either the parent or child if they are 8 years or older. Factors considered should include the age at onset of symptoms, success or failure of toilet training, frequency and consistency of stools using a Bristol or Lane scale and the Amsterdam infant stool scale, pain and/or bleeding during the passing of stool, abdominal pain or fecal incontinence, withholding behavior, dietary history, changes in appetite, nausea and/or vomiting and weight loss.

The factors considered when taking a patient’s history not only assist in making a diagnosis of functional constipation, but also rule out or rule in organic causes of constipation. James E. Heubi, MD, professor of pediatrics and associate dean for clinical and translational research at the University of Cincinnati and president of NASPGHAN, said that organic causes are unusual to find.

“Of the patients we see in pediatric gastroenterology, 90% to 95% are functional cases,” he told Healio Gastroenterology and Liver Disease.

Organic causes of constipation have their own set of ‘red flags’ that must be considered before making a diagnosis. Failure of an infant to pass meconium within the first 48 hours has been standard in assessing for intestinal obstruction associated with Hirschsprung’s disease; however, Fiorino notes that more cases of this condition are presenting in which the infant has passed within the first few days of life. Other organic causes of constipation that may be considered include celiac disease, hyperthyroidism, cystic fibrosis or anal stenosis.

Stephen Freedman

While the diagnosis of constipation can vary depending on symptoms presented and possible concerns for organic causes, one diagnostic strategy that NASPGHAN does not support is the use of abdominal imaging due to the lack of evidence supporting its benefits.

Despite this recommendation, a study published in The Journal of Pediatrics found that 65.7% of children who visited an ED for constipation had an abdominal X-ray performed. This practice may become problematic, as those who receive abdominal X-rays are more likely to revisit the hospital within 3 days with an alternate diagnosis, according to a study published in Hospital Pediatrics.

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“There is a dramatic and unnecessary overuse of abdominal X-rays in children, given that you are exposing them to radiation, poor diagnostic assessment and potential misdiagnosis when a constipation diagnosis could be reached through solid history and physical examination,” Stephen Freedman, MDCM, MSc, associate professor of pediatrics at the University of Calgary and the Alberta Children’s Hospital Foundation professor of child health and wellness, said in an interview.

“When you look at the diagnostic test characteristics of abdominal X-rays, they are exceedingly poor, they are unable to rule out pathology and they do not rule in constipation regardless of whether stool is seen or not seen,” he continued.

Although the use of abdominal X-rays is relatively controversial in pediatric gastroenterology, the use of imaging is not the only area in which pediatricians and gastroenterologists alike do not adhere to recommendations outlined in the NASPGHAN guidelines.

On-again, Off-again Guideline Adherence

In a study published in the Journal of Pediatric Gastroenterology and Nutrition, Yang and Punati observed that most health care providers do not use medication to manage constipation without fecal incontinence until other methods of treatment have failed; this practice contradicts category I evidence that demonstrates that the combination of medication and behavioral modifications decreases the amount of time spent constipated.

In the study, researchers also observed that treatment varied for cases of functional constipation with fecal incontinence, with only 73.4% of practitioners implementing bowel cleanout. NASPGHAN guidelines suggest that bowel cleanout should resolve impaction concerns prior to the use of maintenance therapy.

Kristin Fiorino

Although these guidelines are not regularly followed by pediatricians and pediatric gastroenterologists, Barnes noted that these recommendations are helpful if used.

“I think that any time a governing body of subspecialists can give general guidelines for colleagues in general pediatrics and family medicine, it is a good thing,” Barnes said. “Having access to those consensus statements is only beneficial, and I see no downside to pediatricians following them.”

NASPGHAN offers guidelines, resources and professional education on a multitude of gastrointestinal conditions that may cause constipation, including celiac disease and inflammatory bowel disease, as well as training and career development for those in the fields of gastroenterology, hepatology and nutrition. However, these guidelines and educational opportunities are sometimes missed by those in general pediatrics who encounter gastrointestinal problems.

“We try to disseminate the guidelines, and many programs around the country have educational programs designed to educate the primary care provider,” Heubi said. “It is our belief that many situations in which you find children referred to specialists for constipation should be manageable by a primary care pediatrician.”

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In fact, Yang and Punati determined that while 68.6% of specialist referrals were made after 3 months of management, close follow-up was used for only 53.4% of patients without fecal incontinence and for 57.8% of patients who experienced fecal incontinence. The researchers note that it may be possible that these pediatricians may not be carefully monitoring the child’s constipation in follow-up because well-child visits typically occur every 6 to 12 months.

The NASPGHAN guidelines also suggest that pediatricians may be able to assist constipated patients through the prescription of laxatives, which make stools easier to pass. However, the question of whether these products are safe to use in children has become an increasingly popular topic in the pediatric office, leaving pediatricians with the task of counseling parents through the misinformation.

Addressing Laxatives and Parental Concerns

According to NASPGHAN guidelines, proper management of functional constipation in children includes educational measures for parents, behavioral interventions, steps to guarantee regularly-timed bowel movements that are evacuated well, and close follow-up. Additionally, medication may be prescribed and adjusted throughout this process to promote stooling and to encourage disimpaction in children with fecal impaction.

Laxatives, which can be administered orally or through the rectum, are divided into two categories: stimulant or osmotic. Stimulant laxatives, such as Senokot (senna concentrate, Purdue Pharma LP) and Dulcolax (bisacodyl, Sanofi), increase the secretion of water and electrolytes as well as the initiation of peristalsis — a constriction of the gastrointestinal tract that aides in removing stool.

Osmotic laxatives are not efficiently absorbed by the gut, causing water content to increase in the stool, which makes the stool easier to pass. These are most commonly suggested by pediatricians, and are considered the “first line of defense” for many doctors, according to NASPGHAN guidelines. Popular osmotic laxatives include MiraLAX (polyethylene glycol 3350, Bayer), GoLYTELY (plyethelyne glycol solution, Braintree Laboratories Inc.) and magnesium citrate.

“MiraLAX is probably the most commonly-used laxative in the world,” Ciecierega said. “[This laxative] has been a life-saver for us in the pediatric GI world for a very long time, and we have been using this medication in children as young as 6 months for a prolonged period of time.”

Although many doctors have prescribed the use of MiraLAX in children, it is not approved by the FDA for use in this population. Off-label use has recently raised concerns among parents, as some have observed neuropsychiatric issues — anger and aggression, mood swings and paranoia — in their children after prolonged use.

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James E. Heubi

In response to a citizen’s petition from parent groups in 2014, the FDA noted there was insufficient evidence to implement a boxed warning for MiraLAX; however, citing the lack of safety and efficacy data available for this product, the FDA has funded an ongoing study at the Children’s Hospital of Philadelphia analyzing the long-term effects of PEG 3350.

“MiraLAX and products like MiraLAX are the most common agents used for cleanout for colonoscopy. We have found the drug to be very effective,” Heubi said. “We believe as a community that there may have been a limited number of children who have had changes in their behavior or neurologic status during the course of MiraLAX therapy, but it is difficult to prove that the drug was responsible.”

According to the FDA, most drugs prescribed to children have not been approved for this age group; in fact, the organization notes that only approximately 20% of FDA-approved drugs used in the pediatric population are specifically labeled for use in children. Although the FDA cites various reasons for this statistic, the most common reasons for inadequate data include the low financial benefits associated with pediatric pharmaceuticals and ethical considerations. Despite the lack of data for MiraLAX, many doctors do not have significant concerns regarding its safety and efficacy.

“The unfortunate reality is that the vast majority of drugs used in children are off-label, although that is improving through current Health Canada and FDA regulations that require pharmaceutical companies to perform testing and trials in children,” Freedman said. “I do not have a concern with using these medications as long as their risk-benefit profile is very favorable. For MiraLAX, the profile is exceedingly favorable, and the safety has been excellent.”

For parents concerned about the treatment of functional constipation with MiraLAX and other laxatives, alternative treatments are available and condoned by pediatricians.

Small Changes Before Larger Problems

According to Ciecierega, multiple natural options are available for children, including prune, pear, pineapple and apple juice, all of which contain a high sorbitol content. Additionally, he claims that increasing the amount of fruits and vegetables in diets to increase fiber intake can assist in preventing constipation.

“Fiber has been prescribed to patients for decades,” he said. “The only problem is that for children who are constipated, additional fiber can cause a lot of bloating and have an undesirable effect. This treatment usually works much better in children who went through the process of cleanout and then [have] received adequate fluid.”

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Other remedies include senna tea, a homeopathic remedy and a main ingredient in many stimulant laxatives. However, Barnes notes that homeopathic remedies may be risky, as the other ingredients in the mixture are not regulated, and suggests trying an alternate and child-friendly solution instead.

“There have been several posts about people accidentally eating too many sugar-free gummy bears,” he said. “There is a sugar alcohol in those gummies that can cause diarrhea, so parents could give children these candies knowing that it could potentially loosen their stool.”

While dietary changes can assist in the prevention of constipation, the inclusion of pre- or probiotics has not been supported by NASPGHAN. According to the organization, current evidence does not corroborate the use of these bacteria in children to prevent or treat constipation, and pediatricians should not recommend these as a treatment.

Apart from dietary changes, one significant way in which pediatricians can help their patients is through education on proper toilet habits. Fiorino encourages a combination of strategies, including keeping the knees elevated while stooling, removing all distractions and attempting to stool for an age-appropriate amount of time.

“Parents should also be sure that their child is using pubic bathrooms when they are available, including at school,” she said. “Children may be more comfortable using a nurse’s bathroom than a public bathroom, so parents might want to consider this and eliminate some of the fears that a child may have.”

In addition to promoting these behaviors, parents can also encourage their child to stool at a certain time daily.

“Children should have a bowel routine at a set time in the day,” Freedman said. “It does not matter whether this time is in the morning or the night. The routine helps them stool more regularly and promotes healthy stooling and bowel habits.”

These habits, if sustained, can make a significant and positive impact on the life of those with functional constipation, producing healthier and happier children. – by Katherine Bortz

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Disclosures: Barnes, Ciecierega, Fiorino, Freedman and Heubi report no relevant financial disclosures.