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Epilepsy and Placebo: A Literature Review.
David A Klodowski1, Shira R Goldenholz1, Daniel M Goldenholz1
1Department of Neurology, Beth Israel Deaconess Medical Center, Baker 5. 330 Brookline Avenue, Boston, MA 02215, USA.
Neurologic Clinics
|November 13, 2025
Summary
Epilepsy treatments require sensitive trials. New research suggests the placebo effect in epilepsy may be minimal, potentially due to natural disease fluctuations rather than a true placebo response.
Area of Science:
- Neurology
- Clinical Trials
- Neuroscience
Background:
- Epilepsy is a common neurological disorder with significant morbidity.
- Effective treatments are crucial to mitigate ongoing neurological damage.
- Current research relies on randomized controlled trials (RCTs) comparing treatments to placebo to assess efficacy.
Purpose of the Study:
- To evaluate the impact of placebo response on the sensitivity of epilepsy treatment trials.
- To explore the potential contribution of natural disease fluctuation versus a true placebo effect in epilepsy.
- To inform the design and interpretation of future clinical trials for epilepsy therapies.
Main Methods:
- Review of existing literature on placebo response in epilepsy clinical trials.
- Analysis of recent modeling studies investigating placebo effects.
- Consideration of factors influencing placebo and nocebo effects in neurological conditions.
Main Results:
- High placebo response rates can reduce the sensitivity of RCTs, masking the true effect of new epilepsy drugs.
- Emerging evidence from modeling suggests the actual placebo effect in epilepsy may be negligible.
- Natural fluctuations in seizure frequency could account for observed placebo responses.
Conclusions:
- The significant placebo response observed in epilepsy trials may not represent a true pharmacological or psychological effect.
- Re-evaluating the role of natural fluctuations is essential for accurate assessment of novel epilepsy treatments.
- Further research is needed to confirm the minimal role of placebo effect and optimize trial methodologies.
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