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

Objective To investigate the magnitude and determinants of the placebo response in studies with pediatric abdominal pain-related functional gastrointestinal disorders. Study design The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL were searched for systematic...

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Bibliographic Details
Published in:The Journal of pediatrics 2017-03, Vol.182, p.155-163.e7
Main Authors: Hoekman, Daniël R., MD, Zeevenhooven, Judith, BSc, van Etten-Jamaludin, Faridi S., BSc, Douwes Dekker, Iuke, MD, Benninga, Marc A., MD, PhD, Tabbers, Merit M., MD, PhD, Vlieger, Arine M., MD, PhD
Format: Article
Language:English
Subjects:
Abdominal Pain - drug therapy
Abdominal Pain - etiology
Abdominal Pain - physiopathology
Adolescent
Child
Child, Preschool
determinants
Female
Gastrointestinal Diseases - complications
Gastrointestinal Diseases - drug therapy
Gastrointestinal Diseases - physiopathology
Humans
improvement
magnitude
Male
Pain Measurement - drug effects
Pediatrics
Placebo Effect
Placebos - administration & dosage
Randomized Controlled Trials as Topic
Reference Values
Severity of Illness Index
Treatment Outcome
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Summary:Objective To investigate the magnitude and determinants of the placebo response in studies with pediatric abdominal pain-related functional gastrointestinal disorders. Study design The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL were searched for systematic reviews and randomized placebo-controlled trials concerning children 4-18 years of age with an abdominal pain-related functional gastrointestinal disorder. The primary outcome was the pooled proportion of subjects assigned to placebo with improvement as defined by the authors. The effect of trial characteristics on the magnitude of the placebo response was investigated using univariate meta-regression analysis. Results Twenty-one trials were identified. The pooled proportion of subjects with improvement was 41% (95% CI, 34%-49%; 17 studies) and with no pain was 17% (95% CI, 8%-32%; 7 studies). The pooled standardized mean difference on the Faces Pain Scales compared with baseline was −0.73 (95% CI, −1.04 to −0.42; 8 studies). There was significant heterogeneity across studies with respect to both outcomes. Lower dosing frequency ( P  = .04), positive study ( P  = .03), longer duration of treatment ( P  
ISSN:0022-3476
1097-6833
DOI:10.1016/j.jpeds.2016.12.022