Functional gastrointestinal disorders, quality of life, and behaviour in adolescents with history of infant colic.

AIM: To assess the prevalence of functional gastrointestinal disorders (FGIDs), health-related quality of life (HRQOL), and behavioural problems in a cohort of adolescents with a history of infant colic (IC), as defined by Wessel's criteria. METHODS: 388 adolescents, aged 15-18 years, who participated in a randomised controlled trial for infants with colic, were invited for our observational follow-up study. Prevalence of FGIDs was assessed with the Rome IV Questionnaire on Paediatric Gastrointestinal Disorders (RIV-QPGD), HRQOL through self-report of the Paediatric Quality of Life Inventory (PedsQL), and behavioural problems through parent-report of the child behaviour checklist (CBCL). Multivariable models were used to compare prevalence rates of FGIDs and HRQOL scores. RESULTS: 190 (49%) adolescents with a history of IC (cases) and 381 controls were included (median age 17.0 [IQR 16.0-17.0] and 16.0 [15.0-17.0] years, respectively). Cases had a significantly higher risk for postprandial distress syndrome compared to controls (aOR 2.49 (95%CI 1.18-5.25), p = 0.002). After multivariable regression, total, physical and school HRQOL scores were significantly lower in cases compared to controls (p = 0.003, 0.001, and 0.009). CONCLUSION: Adolescents with a history of IC demonstrate higher prevalence rates of postprandial distress syndrome compared to controls. However, conclusions should be made with caution due to attrition and information bias.

ESPGHAN and NASPGHAN 2023 protocol for paediatric FAPD treatment guidelines (standard operating procedure).

INTRODUCTION: To date, no international guidelines have been published for the treatment of paediatric functional abdominal pain disorders (FAPDs), subcategorised into functional abdominal pain-not otherwise specified (FAP-NOS), irritable bowel syndrome (IBS), functional dyspepsia and abdominal migraine (AM). We aim for a treatment guideline, focusing on FAP-NOS, IBS and AM, that appreciates the extensive array of available therapies in this field. We present the prospective operating procedure and technical summary protocol in this manuscript. METHODS: Grading of Recommendations, Assessment, Development and Evaluation (GRADE) will be followed in the development of the guideline, following the approach as laid out in the GRADE handbook, supported by the WHO. The Guideline Development Group (GDG) is formed by paediatric gastroenterologists from both the European Society for Pediatric Gastroenterology, Hepatology and Nutrition, as well as the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Also, one clinical psychologist with expertise in FAPDs is a voting member in the GDG. A final consensus list of treatment options is translated into 'patient, intervention, comparison, outcome' format options. Prospective agreement on the magnitude of health benefits or harms categories was reached through a Delphi process among the GDG to support grading of the literature.There will be a detailed technical evidence review with randomised controlled trial data that will be judged for risk of bias with the Cochrane tool. Recommendations are preferably based on GRADE but could also be best practice statements following the available evidence. A full Delphi process will be used to make recommendations using online response systems. This set of procedures has been approved by all members of the GDG.

Do Polymorphisms Predict Hypnotherapy Response in Children With Functional Abdominal Pain Disorders: An Explorative Study.

Genetic variations, in specific COMT , OPRM1 , and MAO-A polymorphisms, have been associated with hypnotizability in adults. The aim of this exploratory study was to investigate whether these polymorphisms are also associated with response to hypnotherapy (HT) in children. Patients (8-18 years, n = 260) diagnosed with a functional abdominal pain disorder (FAPD) from a previous trial assessing HT efficacy were approached for participation and 144 agreed to collect a buccal sample. Primary aim was to explore the association between COMT , OPRM1 , and MAO-A polymorphisms with treatment success (TS) after 3-month HT. Additionally, associations between these polymorphisms and adequate relief, anxiety, depression, quality of life, somatization, hypnotic susceptibility, expectations, pain beliefs, and coping strategies were evaluated. Participants with different variations of COMT , MAO-A , and OPRM1 achieved similar TS levels ( P > 0.05). No associations were found between these polymorphisms and secondary outcomes. This suggest that in pediatric patients with FAPDs, COMT , OPRM1 , and MAO-A polymorphisms do not predict HT response.

Home-based guided hypnotherapy for children with functional abdominal pain and irritable bowel syndrome in primary care: study protocol for a randomised controlled trial.

INTRODUCTION: Children often present to primary care with functional abdominal pain (FAP) or irritable bowel syndrome (IBS), and around half still have abdominal complaints 1 year later. Hypnotherapy is an evidence-based treatment that is used in specialist care, but it lacks evidence in primary care. This study will investigate the (cost) effectiveness of home-based guided hypnotherapy for children with FAP or IBS in primary care. METHODS AND ANALYSIS: We report the design of a pragmatic randomised controlled trial among children aged 7-17 years, diagnosed with FAP or IBS by their general practitioner (GP), with assessments over 12 months. The control group will receive care as usual (CAU) by their GP (eg, communication, education and reassurance), while the intervention group will receive CAU plus 3 months of home-based guided hypnotherapy via a website. The primary outcome will be the proportion of children with adequate relief from abdominal pain/discomfort at 12 months, analysed on an intention-to-treat basis. Secondary outcomes will include the adequacy of pain relief at 3 and 6 months, pain/discomfort severity, pain frequency and intensity, daily functioning and impact on function, anxiety and depression, pain beliefs, sleep disturbances, school absence, somatisation, and healthcare use and costs. We must include 200 children to determine a 20% difference in those with adequate relief (55% control vs 75% intervention). ETHICS AND DISSEMINATION: The Medical Ethics Review Committee of the University Medical Center Groningen, the Netherlands, approved this study (METc2020/237). The results will be disseminated to patients, GPs and other stakeholders via email, a dedicated website, peer-reviewed publications and presentations at national and international conferences. We plan to collaborate with the Dutch Society of GPs to implement the results in clinical practice. TRIAL REGISTRATION NUMBER: NCT05636358.

Children with functional gastrointestinal disorders with and without co-existing nausea: A comparison of clinical and psychological characteristics.

BACKGROUND: Nausea co-existing with functional gastrointestinal disorders (FGIDs) has been suggested to negatively impact physical and psychological factors in children. This study aims to compare clinical and psychological characteristics of a large cohort of pediatric patients with an FGID with and without nausea. METHODS: Patients of two previous randomized controlled trials were included, the first assessing the effect of hypnotherapy (HT) in 260 children fulfilling Rome criteria of irritable bowel syndrome (IBS) or functional abdominal pain (FAP), the second examining the effect of HT in 100 children with nausea in children with either functional nausea (FN) or functional dyspepsia (FD). At inclusion, demographics, clinical features, including the presence of nausea, depression and anxiety, somatization, and health-related quality of life (QoL) were assessed in patients. KEY RESULTS: In total, 355 patients with IBS (n = 131), FAP (n = 127), FN (n = 62), and FD (n = 35) were included, of which 255 (72%) patients experienced nausea versus 100 (28%) without nausea. Age at onset of symptoms was higher in children experiencing nausea (12.0y vs. 9.0y, p = 0.000). Significantly higher somatization, anxiety and depression scores, and lower health-related QoL were reported for children with nausea. There were no significant differences between children with only nausea and children with nausea and abdominal pain. CONCLUSIONS AND INFERENCES: Children with nausea, either with or without abdominal pain, report higher somatization scores, increased anxiety and depression, and lower overall QoL, compared to children with pain-related FGIDs without accompanying nausea. Addressing the presence of nausea in children with FGIDs seems essential to customize their treatment and improve overall quality of life.

Teenagers' and parental attitudes towards the use of placebo pills.

The placebo response a significant therapeutic improvement after a placebo intervention - can be high in children. The question arises of how optimal advantages of placebo treatment in pediatric clinical care be achieved. In this era of shared-decision making, it is important to be aware of patients' and parental attitudes. Therefore, the aim of the current study was to assess teenagers' and parental views on the use of placebo pills in pediatric clinical care. All patients (aged 12-18 years) and parents of children (aged 0-18 years), visiting the pediatric outpatient clinic between March 2020 through December 2020, were invited to participate in this study multicenter survey study. Of 1644 distributed questionnaires: 200/478 (47%) teenagers and 456/1166 (45%) parents filled out the complete survey. More parents were positive towards prescribing placebo medication than teenagers (80% vs. 71%, p = .019), especially when the clinician disclosed the use of a placebo to parents and teenagers, respectively (76% vs. 55%, p = .019). Increasing age of teenagers was positively associated with the willingness for placebo interventions (OR 0.803, 95%CI 0.659-0.979), as was a higher level of parental education (OR 0.706, 95%CI 0.526-0.949).  Conclusion: This study emphasizes the willingness of teenagers and parents to receive placebo medication. Placebo medication becoming more acceptable and integrated into daily care may contribute to a decrease in medication use. What is Known: • A placebo is a treatment without inherent power to produce any therapeutic effect, but can result in significant therapeutic improvement, the so-called placebo response. • Treatment response rates after placebo interventions in children can be high, ranging from 41 to 46% in pediatric trials. What is New: • Most teenagers (71%) and parents (80%) find it appropriate for healthcare professionals to prescribe placebo medication. • Compared to adult care, pediatrics has a unique feature to disclose placebo treatment to parents while concealing it for the young patient: the majority of teenagers (85%) and parents (91%) agree to disclose placebo treatment to parents exclusively.

Hypnotherapy in Pediatric Gastroenterology.

In several countries, gut-directed hypnotherapy is becoming an established and evidence-based treatment in pediatric gastroenterology. This article describes what hypnotherapy is, offers an overview of its effect in gut-brain disorders and explains its potential mode of action. Moreover, the use of hypnotherapy in other areas of pediatric gastroenterology, as a supportive tool to reduce pain, stress, depression, and anxiety and improve quality of life, will be also discussed. Guidance toward implementing hypnotherapy in clinical practice is provided, including examples of how you can explain hypnosis to patients with gastroenterological symptoms.

Teenagers' and parental individual needs for side effects information and the influence of nocebo effect education.

OBJECTIVES: When developing a policy on how information about medication and its side effects (SE) should be provided in pediatrics, it is crucial to know individual needs. This paper investigates teenagers' and parental attitudes on information on SE, before and after education on the nocebo effect (NE). METHODS: This multicenter survey study included 226 teenagers (12-18 years) and 525 parents of patients (0-18 years). Questions assessed demographics, clinical characteristics and attitudes towards the amount of SE information before and after the explanation of NE. RESULTS: Before NE education, 679 (93 %) participants preferred to receive SE information: 337 (45 %) about all possible SE and 360 (48 %) desired specific information (i.e., severe, common, visible, or long-term SE). After NE explanation, significantly more participants (58 %) wished to receive information about all possible SE (p < .001). When explaining SE, teenagers preferred positive framing more than parents (64 % vs. 54 %, p = .043). CONCLUSIONS: Most teenagers and parents wish to receive extensive SE information, even after explaining the NE, but variances in individual needs exist. PRACTICE IMPLICATIONS: This study emphasizes the importance of tailor-made communication strategies for providing information on medications to parents and their children.

The association between exposure to antibiotics in the first week of life and later otitis media: The INCA study.

Otitis media (OM) is one of the most common diagnoses in preschool-age children. Its pathophysiology is poorly understood, but is associated with changes in the nasopharyngeal microbiome, immune system, and presence of allergies. These, in turn, can be affected by early-life antibiotic exposure. Therefore, this study aimed to determine if antibiotic treatment in the first week of life in children born at term was associated with acute otitis media (AOM) and otitis media with effusion (OME) in the first 4-6 years of life. METHODS: A prospective birth cohort of 436 term-born infants was followed up at 4-6 years of age. Parents reported (recurrent) AOM and OME through online questionnaires, sent to parents of 418 eligible children. Doctors' diagnoses of AOM and OME were collected after additional informed consent. Multivariate logistic regression analyses were used to study the association between antibiotic exposure and AOM and OME. RESULTS: Of the 436 infants, 151 infants received antibiotics in the first week of life. In total, 341 (82%) questionnaires were collected. The parental-reported prevalence was 45% (155/341) for AOM. Of these 155 children, 33 children also had OME (10% of the total cohort). Doctor's diagnoses were obtained from 308 (74%) children, of which 30% (91/308) had AOM. Of these 91 children, 12 children also had OME and 8 children had OME without a diagnosis of AOM (6% of the total obtained diagnoses). Antibiotic treatment in the first week of life was not significantly associated with parent-reported nor doctor-diagnosed (recurrent) AOM and OME in the first 4-6 years of life in the regression models. CONCLUSION: Antibiotic treatment in the first week of life was not associated with AOM and OME in the first 4-6 years of life in this prospective cohort of Dutch infants. More insight into the pathophysiology of OM is warranted to determine whether antibiotic-induced microbiome changes play a role in the susceptibility to OM.

Microbial effects of prebiotics, probiotics and synbiotics after Caesarean section or exposure to antibiotics in the first week of life: A systematic review.

BACKGROUND AND AIMS: Disruption of the developing microbiota by Caesarean birth or early exposure to antibiotics may impact long-term health outcomes, which can potentially be prevented by nutritional supplements. This systematic review aimed to summarise the evidence regarding the effects of prebiotics, probiotics and synbiotics on the intestinal microbiota composition of term infants born by Caesarean section or exposed to antibiotics in the first week of life. METHODS: A systematic search was performed from inception to August 2022 in Medline and Embase. Two researchers independently performed title and abstract screening (n = 12,230), full-text screening (n = 46) and critical appraisal. We included randomised controlled trials which included term-born infants who were born following Caesarean section or who were exposed to postpartum antibiotics in the first week of life, pre-, pro- or synbiotics were administered <6 weeks after birth and outcome(s) consisted of microbiota analyses. RESULTS: Twelve randomised controlled trials investigating Caesarean born infants and one randomised controlled trial including infants exposed to antibiotics were included. Group sizes varied from 11 to 230 with 1193 infants in total. Probiotic (n = 7) or synbiotic (n = 3) supplementation significantly increased the abundance of the supplemented bacterial species (of the Bifidobacterium and Lactobacillus genus), and there was a decrease in Enterobacteriaceae, especially <4 weeks of age. At phylum level, Actinobacteria (two studies), Proteobacteria (one study) and Firmicutes (one study) increased after probiotic supplementation. In three studies on prebiotics, two studies reported a significant increase in Bifidobacteria and one study found a significant increase in Enterobacteriaceae. DISCUSSION: Prebiotic, probiotic and synbiotic supplements seem to restore dysbiosis after Caesarean section towards a microbial signature of vaginally born infants by increasing the abundance of beneficial bacteria. However, given the variety in study products and study procedures, it is yet too early to advocate specific products in clinical settings.

Clinical outcomes following pre-, pro- and synbiotic supplementation after caesarean birth or antibiotic exposure in the first week of life in term born infants: A systematic review of the literature.

Background: Caesarean section and early exposure to antibiotics disrupt the developing gastrointestinal microbiome, which is associated with long-term health effects. Objective: The aim of this systematic review was to summarise the impact of prebiotics, probiotics, or synbiotics supplementation on clinical health outcomes of term infants born by caesarean section or exposed to antibiotics in the first week of life. Design: A systematic search was performed in Medline and Embase from inception to August 2021. Title and abstract screening (n = 11,248), full text screening (n = 48), and quality assessment were performed independently by two researchers. Results: Six RCTs studying caesarean born infants were included, group sizes varied between 32-193 with in total 752 children. No studies regarding supplementation after neonatal antibiotic exposure were found. Three studies administered a probiotic, one a prebiotic, one a synbiotic, and one study investigated a prebiotic and synbiotic. Several significant effects were reported at follow-up varying between 10 days and 13 years: a decrease in atopic diseases (n = 2 studies), higher immune response to tetanus and polio vaccinations (n = 2), lower response to influenza vaccination (n = 1), fewer infectious diseases (n = 2), and less infantile colic (n = 1), although results were inconsistent. Conclusions: Supplementation of caesarean-born infants with prebiotics, probiotics, or synbiotics resulted in significant improvements in some health outcomes as well as vaccination responses. Due to the variety of studied products and the paucity of studies, no recommendations can be given yet on the routine application of prebiotics, probiotics, or synbiotics to improve health outcomes after caesarean section or neonatal antibiotic exposure.

Impact of the COVID-19 pandemic on mental health in parents of infants with colic and on healthcare use.

AIM: To examine the impact of the COVID-19 pandemic on the mental health of parents of infants with colic and on healthcare use. METHODS: Retrospective cohort study. Data of 64 parents of infants with colic prepandemic and 43 parents of infants with colic during the pandemic were analysed using validated questionnaires on parental stress, depression and anxiety. Additionally, we evaluated the number of outpatient clinic visits and admission rates pre- and during the pandemic by collecting data on the diagnosis treatment combination 'excessive crying' from electronic patient files in three secondary hospitals in the Netherlands. RESULTS: Mothers in the pandemic group reported significantly higher levels of depression than mothers in the prepandemic group (12.3 ± 7.0 and 8.8 ± 5.2; p = 0.04). Moreover, mothers showed a trend towards higher stress levels during the pandemic (29.6 ± 9.6 and 25.2 ± 8.1; p = 0.06). During the pandemic, admission numbers of infants with colic compared to prepandemic data increased with 34% (146 vs. 196). CONCLUSION: Mothers of infants with colic reported significantly more feelings of depression during the COVID-19 pandemic. Furthermore, the pandemic was associated with increased healthcare use amongst infants with colic. With the continuing pandemic, we recommend active perinatal support for this vulnerable population.

Follow-up of infants with colic into childhood: Do they develop behavioural problems?

AIM: To assess whether infants with colic (IC) demonstrate persisting developmental dysregulation into childhood, manifested as behavioural problems, and to determine if these behavioural problems are associated with parenting factors. METHODS: Preschool children with a history of IC at the age of 0-3 months, as defined by the Wessel criteria, were invited to participate in an observational follow-up study, in which their caregivers completed the Child Behaviour Checklist (CBCL). Raw scores and clinical-range scores on the internalising, externalising and total behavioural problems scales were compared with a Dutch normative sample using independent t-tests and Chi-square tests. For the clinical-range scores, multivariable logistic regressions (odds ratios [99% confidence interval, CI]) were used to adjust for confounders and to identify variables associated with behavioural problems. RESULTS: Two hundred and fifty-eight children with a history of IC (median age 5.1 (interquartile range, IQR 4.6-5.5) years, 51.9% boys) were included. The cases had a significantly higher adjusted risk (adjusted odds ratios (aORs) [99% CI]) of scoring in the clinical range of the emotionally reactive, internalising and total problems scale (2.96 [1.24-7.06]; 2.50 [1.35-4.62]; 2.98 [1.46-6.07], respectively). Internalising (P < 0.001), externalising (P < 0.001) and total (P < 0.001) behavioural problems in children with a history of IC were associated with higher parenting stress scores. CONCLUSIONS: Children with a history of IC demonstrated significantly more internalising behavioural problems at preschool age compared to the norm sample. Specific advice and support need to be available for parents to understand and regulate the behaviour of their child, from infancy to childhood.

Long-Term Follow-up of Individual Therapist Delivered and Standardized Hypnotherapy Recordings in Pediatric Irritable Bowel Syndrome or Functional Abdominal Pain.

OBJECTIVES: We previously showed that standardized home-based gut-directed hypnosis exercises with compact disc (CD) is non-inferior to individual hypnotherapy (iHT) by a therapist in the treatment of children with irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)). Aim of this follow-up study was to investigate the long-term effects of standardized-hypnosis-recordings at home in comparison to iHT. METHODS: All participants from our previous randomized controlled trial were invited to complete: 1) an online standardized abdominal pain dairy, on which pain frequency and intensity were scored, and 2) an online questionnaire including adequate relief (AR), anxiety/depression scores, somatization, quality of life (QOL), pain beliefs, school and/or work absenteeism and health care utilization. RESULTS: 227 out of 250 (91%) participants completed this study. After a median duration of 6 years follow-up (5.8-6.2), 80.0% in the CD group vs 86.6% in the iHT group reported AR of their abdominal complaints (P=.22). Compared to the 1-year follow-up, AR percentages were stable. Treatment success was seen in 67.6% in the CD group vs 71.3% in the iHT group (P=.66). Anxiety and depression scores, somatization, pain beliefs, health care utilization and school/work absenteeism also improved significantly in both study groups compared with baseline. No differences were found in QOL-scores. CONCLUSIONS: Both home-based treatment with standardized-hypnosis-recordings and iHT given by a therapist show persisting positive results in more than 80% of children with IBS and FAP(S) after 6 years of follow-up. These results support the rationale for implementation of this easy-to-use, widely available and cost-effective home-treatment in daily practice.

Effect of antibiotics in the first week of life on faecal microbiota development.

BACKGROUND: Infants are frequently exposed to antibiotics (AB) in the first week of life for suspected bacterial infections. Little is known about the effect of AB on the developing intestinal microbiota. Therefore, we studied intestinal microbiota development with and without AB exposure in the first week of life in term born infants. METHODS: We analysed the faecal microbiota from birth until 2.5 years of age by 16S rRNA gene amplicon sequencing in a cohort with 56 term born infants, exposed to AB in the first week of life (AB+) (AB for 2-3 days (AB2, n=20), AB for 7 days (AB7, n=36)), compared with 126 healthy controls (AB-). The effects of AB and duration were examined in relation to delivery and feeding mode. RESULTS: AB+ was associated with significantly increased relative abundance of Enterobacteriaceae at 3 weeks and 1 year and a decrease of Bifidobacteriaceae, from 1 week until 3 months of age only in vaginally delivered, but not in C-section born infants. Similar deviations were noted in AB7, but not in AB2. After AB, breastfed infants had lower relative abundance of potentially pathogenic Enterobacteriaceae compared with formula fed infants and recovered 2 weeks faster towards controls. CONCLUSIONS: AB exposure in the first week of life alters faecal microbiota development with deviations in the relative abundance of individual taxa until 1 year of age. These alterations can have long-term health consequences, which emphasises the need for future studies aiming at restoring intestinal microbiota after AB administration.

Neonatal Antibiotics and Food Allergy Are Associated With FGIDs at 4-6 Years of Age.

OBJECTIVES: Antibiotics may contribute to the development of functional gastrointestinal disorders (FGIDs). This study aimed to determine whether antibiotics during the first week of life, infantile colic in the first year of life, gut-associated immune markers at 1 year of age, and allergies at 4-6 years of age in term-born children were associated with a higher prevalence of FGIDs at 4-6 years of age. METHODS: A prospective observational cohort of 436 term-born infants was followed up at the age of 4-6 years; 151 received broad-spectrum antibiotics (AB+), and 285 healthy controls (AB-). Validated Questionnaire On Pediatric Gastrointestinal Symptoms-Rome III and International Study of Asthma and Allergy in Childhood questionnaires were sent to parents of 418 available children. The independent t-test, chi-squared test or non-parametric test and logistic multivariate regression analyses were used. RESULTS: In total, 340 of 418 (81%) questionnaires were completed. Only the presence of functional abdominal pain was significantly higher in AB+ than AB- (4% vs 0.4%, respectively, P  = 0.045). Children with food allergy fulfilled significantly more often the criteria for irritable bowel syndrome (IBS) and abdominal migraine (26% vs 9%, P  = 0.002 and 7% vs 1%, P  = 0.043, respectively) compared to non-allergic children. No differences in FGIDs existed at the age of 4-6 years between children with and without a history of infantile colic. There were significant differences in gut-associated immune markers between children with and without FGIDs. CONCLUSION: Antibiotics during the first week of life resulted in a higher risk for functional abdominal pain at 4-6 years. Furthermore, food allergy was associated with IBS and abdominal migraine at 4-6years.

A therapeutic guide on pediatric irritable bowel syndrome and functional abdominal pain-not otherwise specified.

Disorders of the gut-brain interaction negatively impact quality of life and carry a substantial socioeconomic burden. Irritable bowel syndrome (IBS) and functional abdominal pain-not otherwise specified (FAP-NOS) are common functional abdominal pain disorders in childhood. The pathophysiology is not fully understood, and high-quality intervention trials and international guidelines are missing. Therefore, the management of these disorders remains challenging. This review aims to provide an up-to-date overview of therapeutic possibilities for pediatric IBS or FAP-NOS and recommends management strategies. To prevent unnecessary referrals and extensive costs, it is fundamental to make a positive diagnosis of IBS or FAP-NOS in children with chronic abdominal pain with only minimal investigations. A tailor-made approach for each patient, based on the accompanying physical and psychological symptoms, is proposed to date. CONCLUSION: Shared decision-making including non-pharmacological and pharmacological interventions should be considered and discussed with the family. WHAT IS KNOWN: • Irritable bowel syndrome and functional abdominal pain-not otherwise specified are common in childhood. • Although the number of treatment options has grown recently, managing these disorders can be challenging and unsatisfactory, and no evidence-based international management guidelines are available. WHAT IS NEW: • We suggest using a stepwise individualized approach to management, where after first-line management, both non-pharmacological and pharmacological interventions should be discussed.

Skills or Pills: Randomized Trial Comparing Hypnotherapy to Medical Treatment in Children With Functional Nausea.

BACKGROUND & AIMS: The potential effectiveness of gut-directed hypnotherapy (HT) is unknown for pediatric chronic nausea. This randomized controlled trial compared HT with standard medical treatment (SMT). METHODS: One hundred children (ages, 8-18 y) with chronic nausea and fulfilling functional nausea (FN) or functional dyspepsia (FD) criteria were allocated randomly (1:1) to HT or SMT, with a 3-month intervention period. Outcomes were assessed at baseline, at the halfway point, after treatment, and at the 6- and 12-month follow-up evaluation. Children scored nausea symptoms in a 7-day diary. The primary outcome was treatment success, defined as a reduction in nausea of 50% or more, at the 12-month follow-up evaluation. Secondary outcomes included adequate relief of nausea. RESULTS: After treatment and at the 6-month follow-up evaluation, there was a trend toward higher treatment success in the HT group compared with the SMT group (45% vs 26%, P = .052; and 57% vs 40%, P = .099, respectively). At 12 months, treatment success was similar in both groups (60% in the HT group and 55% in the SMT group; P = .667). In the FN group, significantly higher success rates were found for HT, but no differences were found in patients with FD. Adequate relief was significantly higher in the HT group than in the SMT group at the 6-month follow-up evaluation (children: 81% vs 55%, P = .014; parents: 79% vs 53%; P = .016), but not at the 12-month follow-up evaluation. CONCLUSIONS: HT and SMT were effective in reducing nausea symptoms in children with FN and FD. In children with FN, HT was more effective than SMT during and after the first 6 months of treatment. Therefore, HT and SMT, applied separately or in combination, should be offered to children with FN as a treatment option (Clinical trials registration number: NTR5814).

[No harm, no foul? Adverse events in pediatric complementary and alternative medicine use]. / Baat het niet, het kan wel schaden.

In the Netherlands, children are frequently using complementary and alternative medicine (CAM), but data on adverse events are scarce. A three-year registration amongst Dutch pediatricians found 32 cases of adverse events associated with pediatric CAM use. Twenty-two children experienced adverse events that were indirectly related to the CAM treatment, such as delaying or stopping a regular treatment or diagnosis or using an unnecessary (deficient) diet. These indirect effects involved many different therapies. Nine children experienced direct adverse events such as toxicity of an ingested substance or harm due to body manipulation. Direct effects occurred after using herbal medicine, high dose vitamins or supplements, and manual-based manipulation. The authors advise physicians to be aware of potential side-effects of CAM treatment in children and inform parents regarding its use. A list of ten recommendations for parents considering the use of CAM for their children is presented.