CBD added to standard medications reduced seizures in 80% of children with drug-resistant epilepsy

In a prospective study of 49 children with drug-resistant epileptic encephalopathies, 80% responded to adjunctive CBD treatment, with a median 66% reduction in monthly seizure frequency.

Caraballo, Roberto et al.·Seizure·2020·Moderate EvidenceProspective Cohort
RTHC-02449Prospective CohortModerate Evidence2020RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
Prospective Cohort
Evidence
Moderate Evidence
Sample
N=50

What This Study Found

Of 49 children followed for 3-12 months, 80% responded to CBD add-on therapy. Seizure reduction of at least 25% occurred in 77.6%, at least 50% in 73.5%, and at least 75% in 49%. Mean monthly seizure frequency dropped from 959 to 381 (median decrease 66%, p < 0.001). The most common adverse effect was drowsiness (32%), often resolved by adjusting clobazam dose.

Key Numbers

49 children analyzed; mean age 10.5 years; median age at first seizure 7 months. 80% responders. 73.5% achieved 50%+ seizure reduction. 49% achieved 75%+ reduction. Median seizure frequency decrease: 66%. Drowsiness in 32%.

How They Did This

Prospective cohort study at a single pediatric hospital in Buenos Aires, Argentina. 50 patients with drug-resistant epileptic encephalopathies enrolled between October 2018 and October 2019. CBD oil added to standard antiseizure medications. Mean follow-up: 8.5 months.

Why This Research Matters

Children with drug-resistant epileptic encephalopathies have few treatment options. Real-world effectiveness data from diverse clinical settings supplements evidence from controlled trials.

The Bigger Picture

This study from Argentina adds to growing real-world evidence supporting CBD as an adjunctive therapy for severe childhood epilepsy, consistent with the randomized trial data that led to FDA approval of Epidiolex.

What This Study Doesn't Tell Us

Open-label, single-center, no control group; relatively small sample; interim analysis with variable follow-up periods; the drowsiness-clobazam interaction suggests some benefit may come from altered clobazam metabolism.

Questions This Raises

  • ?How much of the seizure reduction is from CBD directly vs. its interaction with clobazam?
  • ?Will the benefits persist long-term beyond 12 months?

Trust & Context

Key Stat:
80% of children responded; median seizure reduction was 66%
Evidence Grade:
Prospective single-center cohort without a control group; results are consistent with but less rigorous than randomized controlled trials.
Study Age:
Published in 2020.
Original Title:
Effectiveness of cannabidiol in a prospective cohort of children with drug-resistant epileptic encephalopathy in Argentina.
Published In:
Seizure, 80, 75-80 (2020)
Database ID:
RTHC-02449

Evidence Hierarchy

Meta-Analysis / Systematic Review
Randomized Controlled Trial
Cohort / Case-ControlFollows or compares groups over time
This study
Cross-Sectional / Observational
Case Report / Animal Study

Enrolls participants and follows them forward in time.

What do these levels mean? →

Frequently Asked Questions

What types of epilepsy were treated?

The study included children with various drug-resistant epileptic encephalopathies, which are severe forms of epilepsy that have not responded to standard medications. The mean age was 10.5 years with seizure onset typically in infancy.

Were there serious side effects?

All adverse effects were mild or moderate. The most common was drowsiness (32% of patients), which often resolved when the clobazam dose was adjusted. No patients discontinued due to adverse effects.

Read More on RethinkTHC

Cite This Study

RTHC-02449·https://rethinkthc.com/research/RTHC-02449

APA

Caraballo, Roberto; Demirdjian, Graciela; Reyes, Gabriela; Huaman, Marina; Gutierrez, Robinson. (2020). Effectiveness of cannabidiol in a prospective cohort of children with drug-resistant epileptic encephalopathy in Argentina.. Seizure, 80, 75-80. https://doi.org/10.1016/j.seizure.2020.06.005

MLA

Caraballo, Roberto, et al. "Effectiveness of cannabidiol in a prospective cohort of children with drug-resistant epileptic encephalopathy in Argentina.." Seizure, 2020. https://doi.org/10.1016/j.seizure.2020.06.005

RethinkTHC

RethinkTHC Research Database. "Effectiveness of cannabidiol in a prospective cohort of chil..." RTHC-02449. Retrieved from https://rethinkthc.com/research/caraballo-2020-effectiveness-of-cannabidiol-in

Access the Original Study

Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.

This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.