The Placebo Response in Pediatric Abdominal Pain-Related Functional Gastrointestinal Disorders: A Systematic Review and Meta-Analysis

Hoekman, Daniël R.; Zeevenhooven, Judith; Etten-Jamaludin, Faridi S. van; Dekker, Iuke Douwes; Benninga, Marc A.; Tabbers, Merit M.; Vlieger, Arine M.

doi:10.1016/j.jpeds.2016.12.022

Cited by 42 publications

(32 citation statements)

References 69 publications

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“…A placebo effect may have initiated when the children were informed that during one of the procedures they should be given a treatment which may decrease the pain of venipuncture. We know the placebo effect in children to be high [ 28 ], but we considered it unethical not to inform the child about the expected effect of N2O. However, the effects of expectations in children and adolescents, as well as the mediation by parents, need further investigation.…”

Section: Discussionmentioning

confidence: 99%

Pain and Stress Response during Intravenous Access in Children with Congenital Adrenal Hyperplasia: Effects of EMLA and Nitrous Oxide Treatment

Ekbom

2017

Pain Research and Treatment

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Background Congenital adrenal hyperplasia (CAH) is an endocrine condition that requires regularly blood samples for optimal treatment. The management of CAH in children is complex when intravenous access is one of the most stressful procedures for children. The purpose of this pilot study was to investigate the effects of nitrous oxide inhalation (N2O) in combination with cutaneous application of local anesthetics (EMLA) for improving intravenous access in children with CAH. Method Ten children (7–14 years) were studied. The children received two intravenous procedures: one with EMLA and one with EMLA + N2O. The order of priority was randomized. The outcomes were the children's pain experience (0–10) and an evaluation of satisfaction (1–5) after the procedure. Heart rate, blood pressure, saturation, and analyses of 17-hydroxyprogesterone (17-OHP), norepinephrine, and glucose were analyzed. Results Higher pain scores, heart rate, and glucose levels were reported after EMLA, compared to EMLA + N2O, but 17-OHP levels remained unchanged. The children's satisfaction with the intravenous procedure was more positive for EMLA + N2O. Conclusions EMLA + N2O offers the possibility of improving the intravenous procedure for anxious children with CAH. Although the quality of care was better with N2O treatment, it was not possible to demonstrate that this is a prerequisite for valid 17-OHP measurements.

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Section: Discussionmentioning

confidence: 99%

Pain and Stress Response during Intravenous Access in Children with Congenital Adrenal Hyperplasia: Effects of EMLA and Nitrous Oxide Treatment

Ekbom

2017

Pain Research and Treatment

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“…In published functional dyspepsia (another FGID) trials in adults, placebo response rates vary from 6 to 72% and in large trials, seem to be stable around 45% (45). Approximately 41% of children with abdominal pain-related functional gastrointestinal disorders demonstrate improvement on placebos (46). A meta-analysis determined that spontaneous improvement and placebo-effect are significant contributors to the therapeutic effect observed with medication (47).…”

Section: Cholecystectomy Outcomementioning

confidence: 99%

Biliary Dyskinesia in Children and Adolescents: A Mini Review

et al. 2020

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Introduction: While functional gallbladder disorder is a well-recognized and defined condition in adults, its pediatric analog, biliary dyskinesia, lacks uniformity in diagnosis. Yet, biliary dyskinesia is among the most common conditions resulting in cholecystectomy in youth and its frequency continues to rise. The primary aims of the current review were assess the efficacy of cholecystectomy in children diagnosed with biliary dyskinesia and the utility of cholescintigraphy in predicting outcomes. Results: All previous studies assessing outcomes in youth with biliary dyskinesia have been retrospective and therefore of low quality. There is a lack of uniformity in patient selection. Short term follow-up reveals partial response in 63.4-100% with complete resolution in 44.2-100%. Only 4 studies have reported long-term outcomes with complete symptom resolution in 44-60.7%. The published research generally indicates that the gallbladder ejection fraction (GBEF) as determined by cholescintigraphy lacks utility in predicting cholecystectomy outcome utilizing the commonly used cutoff values. There are data suggesting that more extreme cutoff values may improve the predictive value of GBEF. Conclusion: There is a lack of consensus on the symptom profile defining biliary dyskinesia in youth and current literature does not support the use of cholescintigraphy to select patients for cholecystectomy. There is a substantial portion of pediatric patients diagnosed with biliary dyskinesia who do not experience long-term benefit from cholecystectomy. Well-designed prospective studies of surgical outcomes are lacking. Increasing the uniformity in patient selection, including both symptom profiles and cholescintigraphy results, will be key in understanding the utility of cholecystectomy for this condition.

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“…In the past 15 years, migraine preventive trials in children and adolescents have demonstrated that a substantial proportion of children and adolescents assigned to the placebo arm have a clinically meaningful improvement in headache frequency . Placebo response has a number of potential biological and psychological mechanisms and is an important area of scientific investigation in its own right, and knowledge of its potential magnitude is important in designing clinical efficacy trials. In the case of pediatric and adolescent trials of anti‐CGRP mAbs, it is possible that placebo response rates could be even higher than what has been seen in oral preventive trials as work in adults has demonstrated that placebo response rates to injections are higher than to oral medications .…”

Section: Recommendations Regarding Participant Selection For Anti‐cgrmentioning

confidence: 99%

Recommendations on the Use of Anti‐CGRP Monoclonal Antibodies in Children and Adolescents

et al. 2018

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The Placebo Response in Pediatric Abdominal Pain-Related Functional Gastrointestinal Disorders: A Systematic Review and Meta-Analysis

Cited by 42 publications

References 69 publications

Pain and Stress Response during Intravenous Access in Children with Congenital Adrenal Hyperplasia: Effects of EMLA and Nitrous Oxide Treatment

Pain and Stress Response during Intravenous Access in Children with Congenital Adrenal Hyperplasia: Effects of EMLA and Nitrous Oxide Treatment

Biliary Dyskinesia in Children and Adolescents: A Mini Review

Recommendations on the Use of Anti‐CGRP Monoclonal Antibodies in Children and Adolescents

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