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The placebo effect in the treatment of children with epilepsy: A systematic review
Enduena Begolli1, Camille Højer Winther1, Maria J Miranda2
1Deptartment of Pediatrics, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Insights
In pediatric epilepsy, placebo showed no significant seizure reduction versus levetiracetam or perampanel, but did versus low-dose pregabalin. Placebo also improved behavior scores compared to levetiracetam.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
- Evidence-Based Medicine
Background:
- The placebo effect is a complex phenomenon in clinical practice.
- Understanding its role in treating pediatric epilepsy is crucial for optimizing anti-seizure medication (ASM) protocols.
- Systematic reviews are essential for synthesizing evidence on placebo responses in specific pediatric populations.
Purpose of the Study:
- To systematically review and analyze the placebo effect in children and adolescents with epilepsy.
- To compare placebo efficacy against various anti-seizure medications (ASMs).
- To evaluate behavioral outcomes and adverse event rates in placebo-treated pediatric epilepsy patients.
Main Methods:
- A systematic literature review was conducted using PubMed, adhering to PRISMA guidelines.
- 1173 articles were screened, with 17 studies meeting inclusion criteria for analysis.
- Studies compared ASMs to placebo in pediatric epilepsy populations.
Main Results:
- Placebo did not significantly reduce seizures compared to levetiracetam (LEV) and perampanel (PER).
- A significant placebo effect was observed in reducing seizures compared to pregabalin (PGB), particularly at lower doses.
- Placebo groups showed lower Child Behavior Checklist (CBCL) problem scores than LEV groups, but adverse event rates varied widely (14%–91.8%).
Conclusions:
- Placebo effectiveness varied significantly depending on the comparator ASM in pediatric epilepsy.
- The placebo effect demonstrated potential benefits in behavioral outcomes compared to certain ASMs.
- Further research is needed to understand long-term effects and optimize ASM use by considering the placebo response.
Purpose:
To investigate the placebo effect in the treatment of children and adolescents with epilepsy.
Methods:
We conducted a systematic review of studies comparing anti-seizure medication (ASM) to placebo in children and adolescents with epilepsy. Eligible studies were identified through the database PubMed following PRISMA guidelines resulting in the identification of 1173 articles. Screening and inclusion were assessed by two independent reviewers and 17 studies met inclusion criteria.
Results:
Seventeen studies involving children and adolescents with epilepsy were included in this review. Compared to levetiracetam (LEV) and perampanel (PER), the placebo did not show a significant reduction in seizures. However, compared to pregabalin (PGB) the placebo was significant in reducing seizures at lower doses. Results for eslicarbazepine (ESL) were contradictory. Placebo-treated patients generally had lower Child Behavior checklist (CBCL) problem scores than those on LEV, which was associated with higher Total Problem Scores and worse Aggressive Behavior scores. Adverse event (AE) rates in the placebo groups varied widely, from 14 % to 91.8 %.
Conclusion:
This systematic review examined the effect of placebo treatment compared to ASMs in childhood epilepsy across 17 studies. The effectiveness of placebos was not significant compared to LEV and PER. However, there was a significant placebo effect compared to PGB, which was higher compared to low PGB doses than compared to high PGB doses. AE rates varied widely. Assessing long-term cognitive and behavioral outcomes was challenging due to short study durations and potential biases. Future research could play a critical role in preventing AEs in children undergoing ASM treatment by providing a deeper understanding of the placebo effect associated with these medications.
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