Pharmacological treatments for functional nausea and functional dyspepsia in children: a systematic review

References

• Hyams JS, Di Lorenzo C, Saps M, et al. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2016;150:1456–1468.
   Web of Science ®Google Scholar
• Robin SG, Keller C, Zwiener R, et al. Prevalence of pediatric functional gastrointestinal disorders utilizing the Rome IV criteria. J Pediatr. 2017;195:134–139.
   Web of Science ®Google Scholar
• Kovacic K, Williams S, Li BUK, et al. High prevalence of nausea in children with pain-associated functional gastrointestinal disorders: are Rome criteria applicable? J Pediatr Gastroenterol Nutr. 2013;57:311–315.
   PubMed Web of Science ®Google Scholar
• Perez ME, Youssef NN. Dyspepsia in childhood and adolescence: insights and treatment considerations. Curr Gastroenterol Rep. 2007;9:447–455.
   PubMedGoogle Scholar
• Russell A, Sherman AL, Walker LS. Nausea complicating recurrent abdominal pain in childhood predicts functional GI disorders, disability, depression and anxiety in young adulthood: results of a prospective cohort study. Gastroenterology. 2015;148:122.
   Web of Science ®Google Scholar
• Du L, Chen B, Kim JJ, et al. Micro‐inflammation in functional dyspepsia: a systematic review and meta‐analysis. Neurogastroenterol Motil. 2018;30(4):e13304.
   PubMed Web of Science ®Google Scholar
• Koloski NA, Jones M, Kalantar J, et al. The brain–gut pathway in functional gastrointestinal disorders is bidirectional: a 12-year prospective population-based study. Gut. 2012;61:1284–1290.
   PubMed Web of Science ®Google Scholar
• Korterink JJ, Ockeloen L, Benninga MA, et al. Probiotics for childhood functional gastrointestinal disorders: a systematic review and meta-analysis. Acta Paediatr. 2014;103:365–372.
   PubMed Web of Science ®Google Scholar
• Rosen JM, Cocjin JT, Schurman JV, et al. Visceral hypersensitivity and electromechanical dysfunction as therapeutic targets in pediatric functional dyspepsia. World J Gastrointest Pharmacol Ther. 2014;5:122–138.
   PubMedGoogle Scholar
• Russell AC, Stone AL, Walker LS. Functional nausea in children: a review of the literature and need for diagnostic criteria. Children. 2016;3(1):5.
   Google Scholar
• Singh P, Yoon SS, Kuo B. Nausea: a review of pathophysiology and therapeutics. Therap Adv Gastroenterol. 2016;9(1):98–112.
   PubMed Web of Science ®Google Scholar
• Wu CY, Chou LT, Chen HP, et al. Effect of fluoxetine on symptoms and gastric dysrhythmia in patients with functional dyspepsia. Hepatogastroenterology. 2003;50(49):278–283.
   PubMedGoogle Scholar
• Mak ADP, Northoff G, Yeung DK et al. Increased glutamate in somatosensory cortex in functional dyspepsia. Sci Rep. 2017;7(1):3926.
   PubMedGoogle Scholar
• Van Oudenhove L, Vandenberghe J, Geeraerts B, et al. Relationship between anxiety and gastric sensorimotor function in functional dyspepsia. Psychosom Med. 2007;69(5):455–463.
   PubMed Web of Science ®Google Scholar
• Van Oudenhove L, Vandenberghe J, Geeraerts B, et al. Determinants of symptoms in functional dyspepsia: gastric sensorimotor function, psychosocial factors or somatisation? Determinants of symptoms in functional dyspepsia: gastric sensorimotor function, psychosocial factors or somatization? Gut. 2008;57:1666–1673.
   PubMed Web of Science ®Google Scholar
• Tack J, Caenepeel P, Fischler B, et al. Symptoms associated with hypersensitivity to gastric distention in functional dyspepsia. Gastroenterology. 2001;121:526–535.
   PubMed Web of Science ®Google Scholar
• Jung H, Talley NJ. Role of the duodenum in the pathogenesis of functional dyspepsia: a paradigm shift. J Neurogastroenterol Motil. 2018;24:345–354.
   PubMed Web of Science ®Google Scholar
• Li X, Chen H, Lu H, et al. The study on the role of inflammatory cells and mediators in post-infectious functional dyspepsia. Scand J Gastroenterol. 2010;45(5):573–581.
   PubMed Web of Science ®Google Scholar
• Oshima T, Toyoshima F, Nakajima S, et al. Genetic factors for functional dyspepsia. J Gastroenterol Hepatol. 2011;26:83–87.
   PubMed Web of Science ®Google Scholar
• Tahara T, Shibata T, Nakamura M, et al. Homozygous TRPV1 315C influences the susceptibility to functional dyspepsia. J Clin Gastroenterol. 2010;44(1):e1–e7.
   PubMedGoogle Scholar
• Asgarshirazi M, Shariat M, Dalili H. Comparison of the effects of pH-dependent peppermint oil and synbiotic lactol (bacillus coagulans + fructooligosaccharides) on childhood functional abdominal pain: a randomized placebo-controlled study. Iran Red Crescent Med J. 2015;17:e23844.
   PubMed Web of Science ®Google Scholar
• Choi M-G, Rhee PL, Park H, et al. Randomized, controlled, multi-center trial: comparing the safety and efficacy of DA-9701 and itopride hydrochloride in patients with functional dyspepsia. J Neurogastroenterol Motil. 2015;21:414–422.
   PubMed Web of Science ®Google Scholar
• Chumpitazi BP, Kearns GL, Shulman RJ. Review article: the physiological effects and safety of peppermint oil and its efficacy in irritable bowel syndrome and other functional disorders. Aliment Pharmacol Ther. 2018;47:738–752.
   PubMed Web of Science ®Google Scholar
• Drossman DA, Tack J, Ford AC, et al. Neuromodulators for functional gastrointestinal disorders (disorders of gut-brain interaction): a rome foundation working team report. Gastroenterology. 2018;154(4):1140–1171.
   PubMed Web of Science ®Google Scholar
• Enck P. Functional dyspepsia. Nat Rev Dis Primers. 2017;3:17081.
   PubMed Web of Science ®Google Scholar
• Ford AC, Luthra P, Tack J, et al. Efficacy of psychotropic drugs in functional dyspepsia: systematic review and meta-analysis. Gut. 2017;66:411–420.
   PubMed Web of Science ®Google Scholar
• Fortunato JE, Wagoner AL, Harbinson RL, et al. Effect of fludrocortisone acetate on chronic unexplained nausea and abdominal pain in children with orthostatic intolerance. J Pediatr Gastroenterol Nutr. 2014;59(1):39–43.
   PubMed Web of Science ®Google Scholar
• Grover M, Camilleri M. Effects on gastrointestinal functions and symptoms of serotonergic psychoactive agents used in functional gastrointestinal diseases. J Gastroenterol. 2013;48:177–181.
   PubMed Web of Science ®Google Scholar
• Harer KN, Pasricha PJ. Chronic unexplained nausea and vomiting or Gastric Neuromuscular Dysfunction (GND)? An update on nomenclature, pathophysiology and treatment, and relationship to gastroparesis. Curr Treat Options Gastroenterol. 2016;14:410–419.
   PubMedGoogle Scholar
• Hojo M, Nagahara A, Asaoka D, et al. A systematic review of the effectiveness of antianxiety and antidepressive agents for functional dyspepsia. Intern MedIntern Med. 2017;56:3127–3133.
   PubMed Web of Science ®Google Scholar
• Huang X, Lv B, Zhang S, et al. Itopride therapy for functional dyspepsia: a meta-analysis. World J Gastroenterol. 2012;18:7371–7377.
   PubMed Web of Science ®Google Scholar
• Igarashi M, Nakae H, Matsuoka T, et al. Alteration in the gastric microbiota and its restoration by probiotics in patients with functional dyspepsia. BMJ Open Gastroenterol. 2017;4(1):e000144.
   PubMed Web of Science ®Google Scholar
• Jung H-K, Lee KJ, Choi MG, et al. Efficacy of DA-9701 (motilitone) in functional dyspepsia compared to pantoprazole: a multicenter, randomized, double-blind, non-inferiority study. J Neurogastroenterol Motil. 2016;22:254–263.
   PubMed Web of Science ®Google Scholar
• Kaminski A, Kamper A, Thaler K, et al. Antidepressants for the treatment of abdominal pain-related functional gastrointestinal disorders in children and adolescents. Cochrane Database Syst Rev. 2011;7(3):1015–1038.
   Google Scholar
• Lu Y, Chen M, Huang Z, et al. Antidepressants in the treatment of functional dyspepsia: a systematic review and meta-analysis. PLoS One. 2016;11(6):e0157798.
   PubMed Web of Science ®Google Scholar
• Malfertheiner P. STW 5 (iberogast) therapy in gastrointestinal functional disorders. Dig Dis. 2017;35:25–29.
   PubMed Web of Science ®Google Scholar
• Melzer J, Iten F, Reichling J, et al. Iberis amara L. and iberogast®—results of a systematic review concerning functional dyspepsia. J Herb Pharmacother. 2004;4:51–59.
   PubMedGoogle Scholar
• Rodriguez L, Diaz J, Nurko S. Safety and efficacy of cyproheptadine for treating dyspeptic symptoms in children. J Pediatr. 2013;163:261–267.
   PubMed Web of Science ®Google Scholar
• Sanger GJ, Broad J, Andrews PLR. The relationship between gastric motility and nausea: gastric prokinetic agents as treatments. Eur J Pharmacol. 2013;715:10–14.
   PubMed Web of Science ®Google Scholar
• Sarna SK, Soergel KH, Koch TR, et al. Gastrointestinal motor effects of erythromycin in humans. Gastroenterology. 1991;101:1488–1496.
   PubMed Web of Science ®Google Scholar
• Suzuki H, Matsuzaki J, Fukushima Y, et al. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study. Neurogastroenterol Motil. 2014;26:950–961.
   PubMed Web of Science ®Google Scholar
• Tack J, Masclee A, Heading R, et al. A dose-ranging, placebo-controlled, pilot trial of acotiamide in patients with functional dyspepsia. Neurogastroenterol Motil. 2009;21:272–280.
   PubMed Web of Science ®Google Scholar
• Talley NJ, Goodsall T, Potter M. Functional dyspepsia. Aust Prescr. 2017;40:209–213.
   PubMed Web of Science ®Google Scholar
• Thiwan SIM, Drossman DA. Treatment of functional GI disorders with psychotropic medicines: a review of evidence with a practical approach. Gastroenterol Hepatol (N Y). 2006;2:678–688.
   PubMedGoogle Scholar
• Zala AV, Walker MM, Talley NJ. Emerging drugs for functional dyspepsia. Expert Opin Emerg Drugs. 2015;20:221–233.
   PubMed Web of Science ®Google Scholar
• Korterink JJ, Rutten JMTM, Venmans L, et al. Pharmacologic treatment in pediatric functional abdominal pain disorders: a systematic review. J Pediatr. 2015;166:424–431.
   PubMed Web of Science ®Google Scholar
• Klassen TP, Hartling L, Craig JC, et al. Children are not just small adults: the urgent need for high-quality trial evidence in children. PLoS Med. 2008;5:e172.
   PubMed Web of Science ®Google Scholar
• Dehghani SM, Imanieh MH, Oboodi R, et al. The comparative study of the effectiveness of cimetidine, ranitidine, famotidine, and omeprazole in treatment of children with dyspepsia. ISRN Pediatr. 2011;2011:1–5.
   Google Scholar
• See MC, Birnbaum AH, Schechter CB, et al. Double-blind, placebo-controlled trial of famotidine in children with abdominal pain and dyspepsia: global and quantitative assessment. Dig Dis Sci. 2001;46:985–992.
   PubMed Web of Science ®Google Scholar
• Yang C-Y, Huang H-B, Peng D-G. Efficacy of mosapride and pantoprazole in treatment of children with functional dyspepsia. World Chinese J Dig. 2015;23:1989–1993.
   Google Scholar
• Wang WH, Huang JQ, Zheng GF, et al. Effects of proton-pump inhibitors on functional dyspepsia: a meta-analysis of randomized placebo-controlled trials. Clin Gastroenterol Hepatol. 2007;5:178–185.
   PubMed Web of Science ®Google Scholar
• Laine L, Nagar A. Long-term PPI use: balancing potential harms and documented benefits. Am J Gastroenterol. 2016;111(7):913.
   PubMed Web of Science ®Google Scholar
• Moayyedi P, Shelly S, Deeks JJ, et al. Pharmacological interventions for non‐ulcer dyspepsia. Cochrane Database Syst Rev. 2006;4:CD001960.
   Google Scholar
• Ruigómez A, Johansson S, Nagy P, et al. Utilization and safety of proton-pump inhibitors and histamine-2 receptor antagonists in children and adolescents: an observational cohort study. Curr Med Res Opin. 2017;33(12):2201–2209.
   PubMed Web of Science ®Google Scholar
• Sachs G, Shin JM, Howden CW. The clinical pharmacology of proton pump inhibitors. Aliment Pharmacol Ther. 2006;23:2–8.
   PubMed Web of Science ®Google Scholar
• Tolia V, Boyer K. Long-term proton pump inhibitor use in children: a retrospective review of safety. Dig Dis Sci. 2008;53:385–393.
   PubMed Web of Science ®Google Scholar
• Cares K, Al-Ansari N, Macha S, et al. Short article: risk of small intestinal bacterial overgrowth with chronic use of proton pump inhibitors in children. Eur J Gastroenterol Hepatol. 2017;29(4):396–399.
   PubMed Web of Science ®Google Scholar
• Hegar B, Hutapea EI, Advani N, et al. A double-blind placebo-controlled randomized trial on probiotics in small bowel bacterial overgrowth in children treated with omeprazole. J Pediatr (Rio J). 2013;89:381–387.
   PubMed Web of Science ®Google Scholar
• Sieczkowska A, Landowski P, Zagozdzon P, et al. Small bowel bacterial overgrowth associated with persistence of abdominal symptoms in children treated with a proton pump inhibitor. J Pediatr. 2015;166:1310–1312.
   PubMed Web of Science ®Google Scholar
• Canani RB, Cirillo P, Roggero P, et al. Therapy with gastric acidity inhibitors increases the risk of acute gastroenteritis and community-acquired pneumonia in children. Pediatrics. 2006;117:e817–20.
   PubMed Web of Science ®Google Scholar
• Freedberg DE, Lamousé-Smith ES, Lightdale JR, et al. Use of acid suppression medication is associated with risk for C. difficile infection in infants and children: a population-based study. Clin Infect Dis. 2015;61:912–917.
   PubMed Web of Science ®Google Scholar
• Turco R, Martinelli M, Miele E, et al. Proton pump inhibitors as a risk factor for paediatric clostridium difficile infection. Aliment Pharmacol Ther. 2010;31:754–759.
   PubMed Web of Science ®Google Scholar
• Holbrook JT, Wise RA, Gold BD, et al. Lansoprazole for children with poorly controlled asthma: a randomized controlled trial. JAMA. 2012;307(4):373–381.
   PubMed Web of Science ®Google Scholar
• Orenstein SR, Hassall E, Furmaga-Jablonska W, et al. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease. J Pediatr. 2009;154:514–520.
   PubMed Web of Science ®Google Scholar
• Costa MBG, Azeredo IL, Marciano RD, et al. Evaluation of small intestine bacterial overgrowth in patients with functional dyspepsia through H2 breath test. Arq Gastroenterol. 2012;49:279–283.
   PubMedGoogle Scholar
• De Bruyne P, Ito S. Toxicity of long-term use of proton pump inhibitors in children. Arch Dis Child. 2018;103:78–82.
   PubMed Web of Science ®Google Scholar
• Mt-Isa S, Tomlin S, Sutcliffe A, et al. Prokinetics prescribing in paediatrics. J Pediatr Gastroenterol Nutr. 2015;60:508–514.
   PubMed Web of Science ®Google Scholar
• Blonski W, Vela MF, Freeman J, et al. The effect of oral buspirone, pyridostigmine, and bethanechol on esophageal function evaluated with combined multichannel esophageal impedance-manometry in healthy volunteers. J Clin Gastroenterol. 2009;43:253–260.
   PubMed Web of Science ®Google Scholar
• Qin F, Huang X, Ren P. Chinese herbal medicine modified xiaoyao san for functional dyspepsia: meta-analysis of randomized controlled trials. J Gastroenterol Hepatol. 2009;24:1320–1325.
   PubMed Web of Science ®Google Scholar
• van der Pol R, Langendam M, Benninga M, et al. Efficacy and safety of histamine-2 receptor antagonists. JAMA Pediatr. 2014;168:947.
   PubMed Web of Science ®Google Scholar
• Orenstein SR, Shalaby TM, Devandry SN, et al. Famotidine for infant gastro-oesophageal reflux: a multi-centre, randomized, placebo-controlled, withdrawal trial. Aliment Pharmacol Ther. 2003;17:1097–1107.
   PubMed Web of Science ®Google Scholar
• Van Wering HM, Benninga MA. Histamine-2 receptor antagonist in the treatment of gastroesophageal reflux disease. In: Holger Till, Mike Thomson, John E. Foker, George W. Holcomb III, Khalid M. Khan, editors. Esophageal and gastric disorders in infancy and childhood. Berlin, Heidelberg: Springer; 2017. p. 987–994.
   Google Scholar
• Tighe MP, Afzal NA, Bevan A, et al. Current pharmacological management of gastro-esophageal reflux in children. Pediatr Drugs. 2009;11:185–202.
   PubMedGoogle Scholar
• Rosen R. Pediatric gastroesophageal reflux clinical practice guidelines. J Pediatr Gastroenterol Nutr. 2018;66:516–554.
   PubMed Web of Science ®Google Scholar
• Yang YJ, Bang CS, Baik GH, et al. Prokinetics for the treatment of functional dyspepsia: Bayesian network meta-analysis. BMC Gastroenterol. 2017;17:83.
   PubMed Web of Science ®Google Scholar
• Bang CS, Kim JH, Baik GH, et al. Mosapride treatment for functional dyspepsia: A meta-analysis. J Gastroenterol Hepatol. 2015;30:28–42.
   PubMed Web of Science ®Google Scholar
• Friesen CA, Lin Z, Hyman PE, et al. Electrogastrography in pediatric functional dyspepsia. J Pediatr Gastroenterol Nutr. 2006;42:265–269.
   PubMed Web of Science ®Google Scholar
• Asrani VM, Yoon HD, Megill RD, et al. Interventions that affect gastrointestinal motility in hospitalized adult patients: a systematic review and meta-analysis of double-blind placebo-controlled randomized trials. Medicine. 2016;95:e2463.
   PubMed Web of Science ®Google Scholar
• Patole S, Rao S, Doherty D. Erythromycin as a prokinetic agent in preterm neonates: a systematic review. Arch Dis Child Fetal Neonatal Ed. 2005;90(4):F301–6.
   PubMed Web of Science ®Google Scholar
• Varni JW, Shulman RJ, Self MM, et al. Gastrointestinal symptoms predictors of health-related quality of life in pediatric patients with functional gastrointestinal disorders. Qual Life Res. 2017;26:1015–1025.
   PubMed Web of Science ®Google Scholar
• Hoekman DR, Zeevenhooven J, van Etten-Jamaludin FS, et al. The placebo response in pediatric abdominal pain-related functional gastrointestinal disorders: a systematic review and meta-analysis. J Pediatr. 2017;182:155–163.
   PubMed Web of Science ®Google Scholar
• Di Pietro ML, Cutrera R, Teleman AA, et al. Placebo-controlled trials in pediatrics and the child’s best interest. Ital J Pediatr. 2015;41:11.
   PubMed Web of Science ®Google Scholar
• Shelby GD, Shirkey KC, Sherman AL, et al. Functional abdominal pain in childhood and long-term vulnerability to anxiety disorders. Pediatrics. 2013;132:475–482.
   PubMed Web of Science ®Google Scholar
• Joseph PD, Craig JC, Caldwell PHY. Clinical trials in children. Br J Clin Pharmacol. 2015;79:357–369.
   PubMed Web of Science ®Google Scholar
• Hyams JS, Davis P, Sylvester FA, et al. Dyspepsia in children and adolescents: a prospective study. J Pediatr Gastroenterol Nutr. 2000;30:413–418.
   PubMed Web of Science ®Google Scholar
• Irvine EJ, Tack J, Crowell MD, et al. Design of treatment trials for functional gastrointestinal disorders. Gastroenterology. 2006;130:1538–1551.
   PubMed Web of Science ®Google Scholar
• Smeets FGM, Masclee AAM, Conchillo JM, et al. Systematic review: disease‐specific instruments to assess gastrointestinal symptoms in functional dyspepsia. Neurogastroenterol Motil. 2018;30:e13327.
   Web of Science ®Google Scholar
• Hasler WL, Li BU, Koch KL, et al. Methodologic considerations for studies of chronic nausea and vomiting in adults and children. Auton Neurosci. 2017;202:28–39.
   PubMed Web of Science ®Google Scholar
• Rashid AN-S, Taminiau JA, Benninga MA, et al. Definitions and outcome measures in pediatric functional upper gastrointestinal tract disorders. J Pediatr Gastroenterol Nutr. 2016;62:581–587.
   PubMed Web of Science ®Google Scholar
• Baxter AL, Watcha MF, Baxter WV, et al. Development and validation of a pictorial nausea rating scale for children. Pediatrics. 2011;127:e1542–9.
   PubMed Web of Science ®Google Scholar
• Tack J, Carbone F, Holvoet L, et al. The use of pictograms improves symptom evaluation by patients with functional dyspepsia. Aliment Pharmacol Ther. 2014;40(5):523–530.
   PubMed Web of Science ®Google Scholar
• Xiao Y, Liu YY, Yu KQ, et al. Chinese herbal medicine liu jun zi tang and xiang sha liu jun zi tang for functional dyspepsia: meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med. 2012;2012:1–7.
   Google Scholar
• Guo Y, Zhu J, Su X, et al. Efficacy of Chinese herbal medicine in functional dyspepsia: A meta-analysis of randomized, double-blind, placebo-controlled trials. J Tradit Chinese Med Sci. 2016;3:147–156.
   Google Scholar
• Saps M, Youssef N, Miranda A, et al. Multicenter, randomized, placebo-controlled trial of amitriptyline in children with functional gastrointestinal disorders. Gastroenterology. 2009;137:1261–1269.
   PubMed Web of Science ®Google Scholar
• Patel SM, Stason WB, Legedza A, et al. The placebo effect in irritable bowel syndrome trials: a meta-analysis. Neurogastroenterol Motil. 2005;17(3):332–340.
   PubMed Web of Science ®Google Scholar
• Duncanson KR, Talley NJ, Walker MM, et al. Food and functional dyspepsia: a systematic review. J Hum Nutr Diet. 2018;31:390–407.
   PubMed Web of Science ®Google Scholar
• Carbone F, Tack J, Hoffman I. The intragastric pressure measurement. J Pediatr Gastroenterol Nutr. 2017;64:918–924.
   PubMed Web of Science ®Google Scholar
• Potter MDE, Walker MM, Jones MP, et al. Wheat intolerance and chronic gastrointestinal symptoms in an australian population-based study: association between wheat sensitivity, celiac disease and functional gastrointestinal disorders. Am J Gastroenterol. 2018;113:1036–1044.
   PubMed Web of Science ®Google Scholar
• Calvert EL, Houghton LA, Cooper P, et al. Long-term improvement in functional dyspepsia using hypnotherapy. Gastroenterology. 2002;123:1778–1785.
   PubMed Web of Science ®Google Scholar
• Ho RS, Chung VC, Wong CH, et al. Acupuncture and related therapies used as add-on or alternative to prokinetics for functional dyspepsia: overview of systematic reviews and network meta-analysis. Sci Rep. 2017;7(1):10320.
   Google Scholar
• Richardson J, Smith JE, McCall G, et al. Hypnosis for nausea and vomiting in cancer chemotherapy: a systematic review of the research evidence. Eur J Cancer Care. 2007;16(5):402–412.
   PubMed Web of Science ®Google Scholar
• Schurman JV, Wu YP, Grayson P, et al. A pilot study to assess the efficacy of biofeedback-assisted relaxation training as an adjunct treatment for pediatric functional dyspepsia associated with duodenal eosinophilia. J Pediatr Psychol. 2010;35:837–847.
   PubMed Web of Science ®Google Scholar
• Teich S, Mousa HM, Punati J, et al. Efficacy of permanent gastric electrical stimulation for the treatment of gastroparesis and functional dyspepsia in children and adolescents. J Pediatr Surg. 2013;48:178–183.
   PubMed Web of Science ®Google Scholar
• Glasziou P, Altman DG, Bossuyt P, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383:267–276.
   PubMed Web of Science ®Google Scholar
• Mathieu S, Boutron I, Moher D, et al. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA. 2009;302:977.
   PubMed Web of Science ®Google Scholar
• Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726.
   PubMed Web of Science ®Google Scholar
• Engel GL. The need for a new medical model: a challenge for biomedicine. Science. 1977;196:129–136.
   PubMed Web of Science ®Google Scholar
• Drossman DA. Functional gastrointestinal disorders: history, pathophysiology, clinical features, and Rome IV. Gastroenterology. 2016;150:1262–1279.
   Web of Science ®Google Scholar
• Lindau ST, Laumann EO, Levinson W, et al. Synthesis of scientific disciplines in pursuit of health: the interactive biopsychosocial model. Perspect Biol Med. 2003;46:S74–86.
   PubMed Web of Science ®Google Scholar
• Prinsen CAC, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a ‘Core Outcome Set’ – a practical guideline. Trials. 2016;17:449.
   PubMed Web of Science ®Google Scholar
• Williamson P, Altman D, Blazeby J, et al. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy. 2012;17:1–2.
   PubMed Web of Science ®Google Scholar
• Greenberg RG, Gamel B, Bloom D, et al. Parents’ perceived obstacles to pediatric clinical trial participation: findings from the clinical trials transformation initiative. Contemp Clin Trials Commun. 2018;9:33–39.
   PubMed Web of Science ®Google Scholar
• Suvarna V. Phase IV of drug development. Perspect Clin Res. 2010;1:57–60.
   PubMedGoogle Scholar
• Haque A, Daniel S, Maxwell T, et al. Postmarketing surveillance studies-an industry perspective on changing global requirements and implications. Clin Ther. 2017;39:675–685.
   PubMed Web of Science ®Google Scholar
• Klein DF. The flawed basis for FDA post-marketing safety decisions: the example of anti-depressants and children. Neuropsychopharmacology. 2006;31:689–699.
   PubMed Web of Science ®Google Scholar
• Steutel NF, Langendam MW, Benninga MA, et al. A multifaceted intervention to reduce pediatric acid-suppressant prescriptions for GER: what have we learned? J Pediatr Gastroenterol Nutr. 2018;67:605–609.
   PubMed Web of Science ®Google Scholar
• Zeitoun J-D, Ross JS, Atal I, et al. Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study. BMJ Open. 2017;7:e018587.
   PubMed Web of Science ®Google Scholar