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* Department of Pediatrics, University Federico II, Naples, Italy
Associazione Culturale Pediatri, Campania, Naples, Italy
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ABSTRACT |
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 TOP ABSTRACT METHODSRESULTSDISCUSSIONREFERENCES |
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Methods. Thirteen primary care pediatricians were randomly selected from the Campania region of the Italian National Health Service. Each pediatrician completed a detailed FGID questionnaire on consecutive patients seen during a 3-month period. A total of 9660 patients aged birth to 12 years were enrolled prospectively during this 3-month period. Follow-up was performed at 1-, 3-, and 12-month intervals.
Results. A total of 194 children initially met strict criteria for at least 1 FGID. A total of 72 (37.1%) children had infant regurgitation, 26 (13.4%) had functional dyspepsia, 27 (13.9%) had irritable bowel syndrome, and 66 (34.1%) had functional constipation or other defecation disorders. All children who had a diagnosis of FGIDs were reevaluated at 1, 3, and 12 months to study the natural history of the illnesses. Additional evaluation revealed 5 children who had developed an organic diagnosis. Therefore, 5 (2.5%) of 194 children who had a diagnosis of FGIDs by the Rome criteria had a change in diagnosis to an organic disease during the study period, none of whom experienced permanent sequelae.
Conclusions. Of 194 children who received a prospective diagnosis of FGIDs using the Rome criteria, 97.5% continued to satisfy the diagnostic criteria or were improved at follow-up. The low prevalence of functional dyspepsia and irritable bowel syndrome in our population is most likely explained by the lack of adolescents in our sample.
Key Words: regurgitation • dyspepsia • irritable bowel syndrome • abdominal pain • constipation
Abbreviations: FGID, functional gastrointestinal disorder • NHS, National Health Service • IBS, irritable bowel syndrome
Childhood functional gastrointestinal disorders (FGIDs) include a variable combination of age-dependent, chronic, or recurrent gastrointestinal symptoms not otherwise explained by structural or biochemical abnormalities. Until recently, the diagnosis of FGIDs in children was based on the exclusion of organic disease, and physicians felt obliged to order a large battery of tests, many invasive, to confirm or rule out an organic cause. In 1989, a group of investigators met in Rome and developed a consensus opinion to assist in the positive diagnosis of FGIDs, hereafter known as the Rome criteria. These criteria have been widely accepted in adults and have been used in clinical research in recent years.1,2 Criteria for pediatric FGIDs were discussed at a consensus conference in 1997 and published in 1999 (Table 1). 3 Validation of the Rome criteria in both adults and children has been hampered by the lack of a gold standard diagnostic test for the presence of FGIDs.
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METHODS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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Questionnaires were scored for diagnoses by each study pediatrician using previously published criteria for the following disorders: infant regurgitation, cyclic vomiting syndrome, functional diarrhea, functional dyspepsia, irritable bowel syndrome (IBS), and disorders of defecation including functional constipation.3 These criteria are summarized in Table 1. Each child with a diagnosis of FGID was then reevaluated by the same pediatrician after 1, 3, and 12 months to determine whether there had been a change in diagnosis.
After diagnosis, additional investigation and treatment were left to the discretion of the primary care pediatrician. For ensuring relative uniformity in diagnostic and therapeutic decisions, all 13 pediatricians participated in seminars with the research gastroenterology group before, during, and at the conclusion of the study period. Laboratory investigation was determined by the primary care pediatrician and was usually limited to stool studies for bacterial and parasitic infections, complete blood count, and erythrocyte sedimentation rate. Some patients were evaluated with esophagogastroduodenoscopy or anorectal manometry at the principal research center, based on referral and clinical presentation. All children with a suspected diagnosis of IBS or functional dyspepsia were evaluated for the presence of celiac disease by antiendomysial and antigliadin (immunoglobulin G and immunoglobulin A) antibodies, as well as antitransglutaminase antibodies. Tests for Helicobacter pylori antibodies or fecal antigen were performed in most patients with a diagnosis of either IBS or functional dyspepsia.5,6 Treatment options included education and reassurance (all disorders); formula thickening or prokinetic agents (infant regurgitation); histamine-2 receptor antagonists and/or prokinetic agents (functional dyspepsia); dietary modification and, for persistent pain, anticholinergic medication (IBS); and evacuation followed by stool softeners and/or laxatives (functional constipation).
Statistical Analysis
Parametric statistics were adopted for normally distributed variables. Analysis of variance was used to compare multiple means. Cross-tabulations were evaluated by using the 
2 method, setting first grade error at a level of P = .05. Informed consent was obtained from all patients who required evaluation or treatment for FGIDs. The university's investigative review board approved the study.
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RESULTS |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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A total of 194 children satisfied the Rome criteria for the various FGIDs (Table 2). The most common diagnoses were infant regurgitation (72 of 1020 infants) and functional constipation (66 of 9660 children). The low prevalence of functional dyspepsia and IBS is most likely explained by the absence of adolescents in the study population. Only 3 patients were affected by cyclic vomiting syndrome; their mean age was 4.3 ± 1.6 years, with 1 boy and 2 girls. Two patients also complained of migraine headaches, and both had a positive family history. In all 3 patients, the most frequent organic causes of vomiting were excluded. Intravenous ondansetron successfully interrupted the crisis, whereas erythromycin prophylaxis did not reduce the frequency episodes. Because of the small number of cases of cyclic vomiting syndrome, this diagnosis is be discussed here. Furthermore, the 7 patients who satisfied the criteria for functional diarrhea are analyzed along with the 20 patients who satisfied the criteria for IBS.
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Infant Regurgitation
A total of 72 of 194 children with FGID received a diagnosis of infant regurgitation. None of these infants initially had any evidence of failure to thrive, aspiration, chronic asthma, abnormal posturing, hematemesis, or apnea. The mean age of affected infants was 3.8 ± 3.3 months, and the male:female ratio was 39:33. At the 1-month follow-up, 1 infant had developed hematemesis; he underwent upper endoscopy and received a final diagnosis of reflux esophagitis, which improved after therapy with omeprazole. Another infant developed failure to thrive and received a final diagnosis of cow milk protein allergy; his symptoms improved after elimination of cow milk protein from his diet. The remaining 70 patients all had improved by the 3-month follow-up evaluation, and 59 (84.2%) of 70 still satisfied the pediatric Rome criteria (Table 3). They had been treated with reassurance (56%), thickened feeds (33%), and prokinetic agents (11%) such as cisapride 0.2 mg/kg/dose 4 times a day for 4 to 8 weeks. Fifty-one (73%) infants were available for the 12-month follow-up evaluation, and none had significant episodes of reflux or other signs or symptoms of organic disease.
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At diagnosis, 25 of 66 patients with defecation disorders were 4 years old and had been toilet trained. Fourteen of these patients had encopresis at diagnosis, which decreased to 5 at 3 months and 3 to at 12 months.
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DISCUSSION |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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Although the choice of treatment and the decision whether to consult the gastroenterologist for individual patients was left to the discretion of the primary care pediatrician, our use of the restrictive FGID criteria provided each of the study pediatricians with relatively uniform guidelines for treatment and referral. The primary care pediatricians also received general information and feedback about the purposes of the study and the Rome criteria for FGID diagnosis during meetings held with the gastroenterologists before and during the study period.
For infant regurgitation, 7% of the 1020 infants in our study population satisfied the diagnostic criteria. Other authors have reported prevalence rates for infant regurgitation of from 20% to 67%.7,8,11 Our stricter definition of infant regurgitation based on both frequency (2 or more episodes per day) and duration (3 or more weeks) of symptoms may account for our lower prevalence.
Cyclic vomiting syndrome was rare in our population; only 3 patients satisfied the Rome criteria for this diagnosis. In contrast, a previous study estimated the prevalence of cyclic vomiting syndrome to be as high as 2% in the general pediatric population.12 Again, we suspect that our much lower prevalence is attributable to more stringent diagnostic criteria, as well as to the fact that pediatricians completed our questionnaire, whereas patients and their parents completed the questionnaire in the previous study.
Estimates of the prevalence of functional constipation in the pediatric population have varied from a low of 0.3% to a high of 8%, and, again, our prevalence falls toward the lower end of this range. One half of our patients also complained of abdominal pain, not a criterion for the diagnosis of disorders of defecation. Abdominal pain in patients with disorders of defecation was localized to the periumbilical region, in contrast to patients with functional dyspepsia or IBS, in whom the pain was localized to the subxiphoid area or the left upper quadrant. Also, 56% of school-age patients with disorders of defecation presented with encopresis. The prevalence rates of abdominal pain and encopresis in this subgroup of FGID patients are consistent with a previous study from our group.13
Could our prevalence rates be inaccurate? The study is limited by the fact that pediatricians completed the questionnaires, not patients and parents, which may have introduced bias into the data collection: ie, physicians are more likely to report improvement, and parents are less likely to report symptoms. Because of the nature of the Italian NHS, for which patients are encouraged to see their doctor for even minimal complaints, we doubt that we missed many patients with FGIDs. That older, school-aged children and adolescents were underrepresented in our sample is a clear limitation in calculating prevalence rates for IBS and functional dyspepsia, 2 disorders that are much more highly prevalent in those age groups.
Another observation in this general pediatric sample is that children with FGIDs have increased health care utilization and school absenteeism. Especially in patients with functional dyspepsia or IBS, bouts of abdominal pain were responsible for missed school days as well as frequent emergency department evaluations (6.2% of all FGID patients had been seen in the emergency department). We suspect that the phenomenon of school absenteeism would have been much more obvious if our sample had included adolescents.
Could our younger patients who satisfied criteria for IBS and functional dyspepsia have had other pathology that contributed to their pain? We ruled out H pylori infection in 43 of 53 patients in these categories. The prevalence of H pylori infection in children in southern Italy has been reported to be 23%,14 which means that, at most, we missed 2 or 3 cases of H pylori infection in the 10 patients who were not screened. Contrary to the criteria for functional dyspepsia, we did not require a normal endoscopy before assigning the diagnosis, because of the invasive nature of the test. Rather, we made a presumptive diagnosis and followed the patients: the 4 who had not improved by 3 months did undergo endoscopy, and all were normal.
Tables 3, 5, and 6 show that most of our patients with infant regurgitation, functional dyspepsia, and IBS were improved at the 3-month follow-up visit, regardless of therapy. Disorders of defecation are an exception in that most patients required chronic laxative therapy, but they, too, had mostly improved at the 3- and 12-month follow-up visits. These results confirm that the constellation of childhood FGIDs is generally benign.
Many patients were improved at the 3-month follow-up visit. Could these patients have had other diagnoses, such as postinfectious syndromes, that mimicked FGIDs? We believe that the question misses the point; whatever the cause of the conditions documented, at study entry, all 194 patients satisfied stringent diagnostic criteria for FGIDs, criteria designed to exclude organic, structural, and metabolic disease. Therefore, they had the given FGIDs by definition. In adults, the natural history of FGIDs includes waxing and waning of symptoms, and our experience confirms that this is true in children as well.
Most important, our study shows that of the 194 patients in a general pediatric population who initially satisfied the Rome criteria for the diagnosis of FGID, only 5 later turned out to have organic disease. The other 189 either maintained their functional diagnoses or were improved at the 3-month follow-up evaluation. Although we achieved only 71% follow-up at 12 months, none of these FGID patients demonstrated any signs or symptoms of organic disease. Treatment was left to the discretion of the primary care pediatricians and consisted of reassurance and education in all patients, dietary modifications in some, and medications (prokinetics in 6%, antispasmodics in 6%, and laxatives in 34%) in even fewer.
This is the first study to examine the prevalence of the various FGIDs in a general pediatric population by using the Rome criteria for diagnosis. Because only 5 of 194 patients who received a diagnosis of FGIDs later developed organic disease, we believe that the criteria provide the clinician with positive data on which to base the diagnosis of FGID in childhood, thus minimizing what can otherwise become an exhaustive "rule-out" workup in the patient with a suspected functional disorder. Even though children who satisfy the FGID criteria rarely go on to develop organic disease, they nevertheless should be followed regularly.
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ACKNOWLEDGMENTS |
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FOOTNOTES |
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Reprint requests to (A.S.) Department of Pediatrics, University Federico II, Via S. Pansini, 5, 80131 Napoli, Italy. E-mail: staiano{at}unina.it
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REFERENCES |
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TOPABSTRACTMETHODSRESULTSDISCUSSIONREFERENCES |
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S. Osatakul The Natural Course of Infantile Reflux Regurgitation: A Non-Western Perspective Pediatrics, April 1, 2005; 115(4): 1110 - 1111. [Full Text] [PDF]
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