Developing a core outcome set for infant colic for primary, secondary and tertiary care settings: a prospective study.

OBJECTIVE: Infant colic (IC) is defined as recurrent and prolonged crying without an obvious cause or evidence of failure to thrive or illness. It is a common problem with a prevalence of 5%-25%. The unknown aetiology results in a wide variety in interventions and use of heterogeneous outcome measures across therapeutic trials. Our aim was to develop a core outcome set (COS) for IC to facilitate and improve evidence synthesis. DESIGN AND SETTING: Prospective study design; primary, secondary and tertiary care. METHODS: The COS was developed using a modified Delphi technique. First, healthcare professionals (HCPs) and parents of infants with IC were asked to list up to five outcomes they considered relevant in the treatment of IC. Outcomes mentioned by >10% of participants were forwarded to a shortlist. In the second round, outcomes on this shortlist were rated and prioritised. The final COS was defined in a face-to-face expert meeting of paediatricians. RESULTS: F of invited stakeholders (133 HCPs and 55 parents of infants with IC) completed both Delphi rounds. Duration of crying, family stress, sleeping time of infant, quality of life (of family), discomfort of infant and hospital admission/duration were rated as most important outcomes in IC, framing the final COS. CONCLUSIONS: The use of this COS should serve as a minimum of outcomes to be measured and reported. This will benefit evidence synthesis, by enhancing homogeneity of outcomes, and enable evaluation of success in therapeutic trials on IC. Researchers are strongly encouraged to use this COS when setting up a clinical trial in primary, secondary and/or tertiary care or performing a systematic review on IC.

Yoga Therapy for Abdominal Pain-Related Functional Gastrointestinal Disorders in Children: A Randomized Controlled Trial.

OBJECTIVES: The aim of the present study was to compare effects of 10 weeks of yoga therapy (YT) and standard medical care (SMC) on abdominal pain and quality of life (QoL) in children with abdominal pain-related functional gastrointestinal disorders (AP-FGIDs). METHODS: Sixty-nine patients, ages 8 to 18 years, with AP-FGIDs, were randomized to SMC complemented with YT or SMC alone. YT is a mixture of yoga poses, meditation, and relaxation exercises and was given once a week in group sessions. SMC consisted of education, reassurance, dietary advice, and fibers/mebeverine, if necessary. Pain intensity (pain intensity score [PIS] 0-5) and frequency (pain frequency score [PFS] 0-4) were scored in a pain diary, and QoL was measured with KIDSCREEN-27. Follow-up was 12 months. Treatment response was defined as ≥50% reduction of weekly pain scores. RESULTS: At 1-year follow-up, treatment response was accomplished in 58% of the YT group and in 29% of the control group (P = 0.01); no significant differences for other time points were found. YT, and not SMC, resulted in a significant reduction of PIS (P < 0.01) and PFS (P < 0.01) after 12 months. During the study, however, YT was not significantly superior compared with SMC. Subanalyses for time points demonstrated a significant greater reduction of PIS at 12 months in favor of YT. No differences were found for QoL. YT was more effective in the reduction of reported monthly school absence (P = 0.03). CONCLUSION: At 1-year follow-up, YT in addition to standard care was superior compared with SMC according to treatment success, PIS, and reduction of school absence. YT, however, was not significantly more effective in improving PFS or QoL, compared with SMC.

Epidemiology of pediatric functional abdominal pain disorders: a meta-analysis.

OBJECTIVE: We aimed to review the literature regarding epidemiology of functional abdominal pain disorders in children and to assess its geographic, gender and age distribution including associated risk factors of developing functional abdominal pain. METHODS: The Cochrane Library, MEDLINE, EMBASE, CINAHL and PsychInfo databases were systematically searched up to February 2014. Study selection criteria included: (1) studies of birth cohort, school based or general population samples (2) containing data concerning epidemiology, prevalence or incidence (3) of children aged 4-18 years (4) suffering from functional abdominal pain. Quality of studies was rated by a self-made assessment tool. A random-effect meta-analysis model was used to estimate the prevalence of functional abdominal pain in childhood. RESULTS: A total of 58 articles, including 196,472 children were included. Worldwide pooled prevalence for functional abdominal pain disorders was 13.5% (95% CI 11.8-15.3), of which irritable bowel syndrome was reported most frequently (8.8%, 95% CI 6.2-11.9). The prevalence across studies ranged widely from 1.6% to 41.2%. Higher pooled prevalence rates were reported in South America (16.8%) and Asia (16.5%) compared to Europe (10.5%). And a higher pooled prevalence was reported when using the Rome III criteria (16.4%, 95% CI 13.5-19.4). Functional abdominal pain disorders are shown to occur significantly more in girls (15.9% vs. 11.5%, pooled OR 1.5) and is associated with the presence of anxiety and depressive disorders, stress and traumatic life events. CONCLUSION: Functional abdominal pain disorders are a common problem worldwide with irritable bowel syndrome as most encountered abdominal pain-related functional gastrointestinal disorder. Female gender, psychological disorders, stress and traumatic life events affect prevalence.

Nonpharmacologic treatment of functional abdominal pain disorders: a systematic review.

BACKGROUND AND OBJECTIVE: Various nonpharmacologic treatments are available for pediatric abdominal pain-related functional gastrointestinal disorders (AP-FGIDs). Data on efficacy and safety are scarce. The goal of this study was to summarize the evidence regarding nonpharmacologic interventions for pediatric AP-FGIDs: lifestyle interventions, dietary interventions, behavioral interventions, prebiotics and probiotics, and alternative medicine. METHODS: Searches were conducted of the Medline and Cochrane Library databases. Systematic reviews and randomized controlled trials (RCTs) concerning nonpharmacologic therapies in children (aged 3-18 years) with AP-FGIDs were included, and data were extracted on participants, interventions, and outcomes. The quality of evidence was assessed by using the GRADE approach. RESULTS: Twenty-four RCTs were found that included 1390 children. Significant improvement of abdominal pain was reported after hypnotherapy compared with standard care/wait-list approaches and after cognitive behavioral therapy compared with a variety of control treatments/wait-list approaches. Written self-disclosure improved pain frequency at the 6-month follow-up only. Compared with placebo, Lactobacillus rhamnosus GG (LGG) and VSL#3 were associated with significantly more treatment responders (LGG relative risk: 1.31 [95% confidence interval: 1.08 to 1.59]; VSL#3: P < .05). Guar gum significantly improved irritable bowel syndrome symptom frequency; however, no effect was found for other fiber supplements (relative risk: 1.17 [95% confidence interval: 0.75 to 1.81]) or a lactose-free diet. Functional disability was not significantly decreased after yoga compared with a wait-list approach. No studies were found concerning lifestyle interventions; gluten-, histamine-, or carbonic acid-free diets; fluid intake; or prebiotics. No serious adverse effects were reported. The quality of evidence was found to be very low to moderate. CONCLUSIONS: Although high-quality studies are lacking, some evidence shows efficacy of hypnotherapy, cognitive behavioral therapy, and probiotics (LGG and VSL#3) in pediatric AP-FGIDs. Data on fiber supplements are inconclusive.

Pharmacologic treatment in pediatric functional abdominal pain disorders: a systematic review.

OBJECTIVE: To systematically review literature assessing efficacy and safety of pharmacologic treatments in children with abdominal pain-related functional gastrointestinal disorders (AP-FGIDs). STUDY DESIGN: MEDLINE and Cochrane Database were searched for systematic reviews and randomized controlled trials investigating efficacy and safety of pharmacologic agents in children aged 4-18 years with AP-FGIDs. Quality of evidence was assessed using Grades of Recommendation, Assessment, Development and Evaluation approach. RESULTS: We included 6 studies with 275 children (aged 4.5-18 years) evaluating antispasmodic, antidepressant, antireflux, antihistaminic, and laxative agents. Overall quality of evidence was very low. Compared with placebo, some evidence was found for peppermint oil in improving symptoms (OR 3.3 (95% CI 0.9-12.0) and for cyproheptadine in reducing pain frequency (relative risk [RR] 2.43, 95% CI 1.17-5.04) and pain intensity (RR 3.03, 95% CI 1.29-7.11). Compared with placebo, amitriptyline showed 15% improvement in overall quality of life score (P = .007) and famotidine only provides benefit in global symptom improvement (OR 11.0; 95% CI 1.6-75.5; P = .02). Polyethylene glycol with tegaserod significantly decreased pain intensity compared with polyethylene glycol only (RR 3.60, 95% CI 1.54-8.40). No serious adverse effects were reported. No studies were found concerning antidiarrheal agents, antibiotics, pain medication, anti-emetics, or antimigraine agents. CONCLUSIONS: Because of the lack of high-quality, placebo-controlled trials of pharmacologic treatment for pediatric AP-FGIDs, there is no evidence to support routine use of any pharmacologic therapy. Peppermint oil, cyproheptadine, and famotidine might be potential interventions, but well-designed randomized controlled trials are needed.

Glucose hydrogen breath test for small intestinal bacterial overgrowth in children with abdominal pain-related functional gastrointestinal disorders.

OBJECTIVES: A potential link between small intestinal bacterial overgrowth (SIBO) and abdominal pain-related functional gastrointestinal disorders (AP-FGID) has been suggested by symptom similarities and by the reported prevalence of SIBO in children with irritable bowel syndrome (IBS) and functional AP. The aim of this study is to evaluate the prevalence of SIBO using the glucose hydrogen breath test (GHBT), in a cohort of Dutch children with AP-FGID fulfilling the Rome III criteria, and to identify potential predictors. METHODS: Children ages 6 to 18 years with AP-FGID fulfilling the Rome III criteria were included. All of the children underwent a GHBT. SIBO was diagnosed if the fasting breath hydrogen concentration was ≥20 ppm or an increase in H2 levels of ≥12 ppm above the baseline value was measured after ingestion of glucose. Gastrointestinal symptoms were collected using a standardised AP questionnaire. RESULTS: A total of 161 Dutch children with AP-FGID were enrolled. Twenty-three patients (14.3%) were diagnosed as having SIBO, as assessed by GHBT; 78% of the children diagnosed as having SIBO had fasting hydrogen levels ≥20 ppm. IBS was significantly more found in children with SIBO compared with children without SIBO (P = 0.001). An altered defecation pattern (ie, change in frequency or form of stool) (P = 0.013), loss of appetite (P = 0.007), and belching (P = 0.023) were significantly more found in children with SIBO compared with those without SIBO. CONCLUSIONS: SIBO is present in 14.3% of children presenting with AP-FGID. IBS, altered defecation pattern, loss of appetite, and belching were predictors for SIBO in children with AP-FGID.

Dientamoeba fragilis and chronic abdominal pain in children: a case-control study.

BACKGROUND: The association between Dientamoeba (D.) fragilis and the aetiology of functional gastrointestinal disorders (FGID) in children is unclear. AIM: The aim of this retrospective case-control study is to clarify the clinical relevance of D. fragilis in children with chronic abdominal pain. METHODS: From April 2011 until April 2013, a total of 132 patients with chronic abdominal pain (AP), aged 8-18 years, referred to a non-academic hospital, and 77 control patients, aged 8-18 years without gastrointestinal symptoms referred to a psychiatric hospital, were included in the study. D. fragilis was diagnosed by real-time PCR in faecal samples. Symptomatic children without a D. fragilis infection fulfilled the ROME III criteria for AP-related FGID (AP-FGID). Clinical data were retrospectively analysed by examining patients' hospital records from the Jeroen Bosch Hospital and Herlaarhof in The Netherlands. RESULTS: D. fragilis was detected in 57 patients with chronic AP (43.2%) and in 39 controls (50.6%) (p=0.255). No significant differences in symptomatology were found between D. fragilis-infected children and children fulfilling the criteria for AP-FGID. Parasitological eradication was achieved in 61.7% of patients after treatment with metronidazole or clioquinol, while clinical improvement occurred in only 40.4% of patients (p=0.435). CONCLUSIONS: There were no differences in symptoms comparing children with and without D fragilis infection. Furthermore, no relation was found between clinical and microbiological response after treatment for D. fragilis. This retrospective study suggests that there is no association between chronic AP and D. fragilis infection.

Probiotics for childhood functional gastrointestinal disorders: a systematic review and meta-analysis.

UNLABELLED: A systematic review and meta-analysis were performed to investigate the quantity and quality of the current evidence regarding the effect of different probiotic strains in the treatment of functional gastrointestinal disorders (FGID) in children and adolescents. CONCLUSION: Probiotics are more effective than placebo in the treatment of patients with abdominal pain-related FGID, especially with respect to patients with irritable bowel syndrome. To date, however, probiotics have not proved effective for children with functional constipation.