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The Placebo Response in Pediatric Abdominal Pain-Related Functional Gastrointestinal Disorders: A Systematic Review
Daniël R Hoekman1, Judith Zeevenhooven1, Faridi S van Etten-Jamaludin2
1Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.
Insights
Approximately 41% of children with functional gastrointestinal disorders experience symptom improvement with placebo treatment. Study design factors, such as dosing frequency and trial duration, significantly influence these placebo response rates in pediatric patients.
Area of Science:
- Pediatric Gastroenterology
- Clinical Trial Methodology
- Psychosomatic Medicine
Background:
- Pediatric functional gastrointestinal disorders (FGIDs) are common, often involving abdominal pain.
- The placebo response is a significant factor in FGID clinical trials, yet its determinants in pediatric populations require further investigation.
- Understanding placebo effects is crucial for designing effective therapeutic strategies and interpreting clinical trial outcomes in children.
Purpose of the Study:
- To quantify the placebo response magnitude in pediatric FGIDs.
- To identify trial characteristics that influence placebo response rates and pain reduction.
- To provide data for optimizing future clinical trial designs in pediatric FGIDs.
Main Methods:
- Systematic review and meta-analysis of randomized placebo-controlled trials in children aged 4-18 with abdominal pain-related FGIDs.
- Searched CENTRAL, MEDLINE, EMBASE, and CINAHL databases.
- Analyzed pooled proportion of placebo responders and used univariate meta-regression to assess trial characteristic effects.
Main Results:
- The pooled improvement rate in children receiving placebo was 41% (95% CI, 34%-49%).
- Seventeen percent of children reported no pain on placebo (95% CI, 8%-32%).
- Factors like lower dosing frequency, longer treatment duration, and higher placebo dropout rates were associated with increased 'no pain' reports. Pain scale improvements were greater in studies from the Middle East and those with more female participants.
Conclusions:
- A substantial proportion of children with FGIDs experience symptom improvement with placebo.
- Specific trial design elements, including dosing, duration, and participant demographics, significantly correlate with placebo response magnitude.
- These findings offer valuable insights for enhancing the design and interpretation of future clinical trials for pediatric FGIDs.
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 < .001), and higher placebo dropout (P < .001) were associated with higher report of no pain. Response on Faces Pain Scales was greater in studies conducted in the Middle East (P = .002), in studies that did not report the randomization schedule (P = .02), and in studies with a higher percentage of females (P = .04).
Conclusions:
Approximately 41% of children with abdominal pain-related functional gastrointestinal disorders improve on placebo. Several trial characteristics are correlated significantly with the proportion of patients with no pain on placebo and with the magnitude of the placebo response on Faces Pain Scales. These data could be valuable for the design of future studies.
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