Artisanal cannabis extracts helped only 24% of children with epilepsy, matching placebo rates from pharmaceutical trials

Only 5 of 21 children with refractory epilepsy responded to oral cannabis extracts, a rate similar to placebo in randomized trials of pharmaceutical-grade CBD products.

Knupp, Kelly G et al.·Seizure·2019·Preliminary EvidenceObservational
RTHC-02114ObservationalPreliminary Evidence2019RETHINKTHC RESEARCH DATABASErethinkthc.com/research

Quick Facts

Study Type
Observational
Evidence
Preliminary Evidence
Sample
N=32

What This Study Found

The 24% responder rate (50%+ seizure reduction) matched placebo rates from formal clinical trials. Three children (14%) stopped the extract early due to perceived worsening of seizures. CBD blood levels showed no significant association with response.

Key Numbers

32 enrolled, 21 analyzed; median age 10.3 years; median seizure frequency 2.7/day at baseline; 5/21 (24%) responded; median high CBD dose 0.9 mg/kg/day (vs. 10-20 mg/kg/day in pharmaceutical trials); 3/21 (14%) withdrew due to perceived seizure increase.

How They Did This

Prospective observational study enrolling 32 children; 21 completed the protocol with 4-week baseline and 12-week treatment periods. Seizure frequency, CBD, and THC-COOH blood levels assessed every 4 weeks.

Why This Research Matters

Many families turn to artisanal cannabis products for their children's epilepsy. This prospective study suggests these products may perform no better than placebo, possibly due to lower CBD doses than those used in pharmaceutical trials.

The Bigger Picture

The gap between artisanal and pharmaceutical CBD products is not just about purity. The doses families typically give their children may be far below the therapeutic threshold identified in clinical trials.

What This Study Doesn't Tell Us

Small sample (21), no control group, observational design. CBD doses used were much lower than in RCTs of pharmaceutical-grade products. Product variability among artisanal preparations likely.

Questions This Raises

  • ?Would higher doses of artisanal products improve response rates?
  • ?Are families underdosing because of cost, availability, or fear of side effects?

Trust & Context

Key Stat:
24% responder rate
Evidence Grade:
Preliminary: small observational study without controls.
Study Age:
Published in 2019.
Original Title:
Prospective evaluation of oral cannabis extracts in children with epilepsy.
Published In:
Seizure, 72, 23-27 (2019)
Database ID:
RTHC-02114

Evidence Hierarchy

Meta-Analysis / Systematic Review
Randomized Controlled Trial
Cohort / Case-Control
Cross-Sectional / ObservationalSnapshot without intervening
This study
Case Report / Animal Study

Watches what happens naturally without intervening.

What do these levels mean? →

Frequently Asked Questions

Why did artisanal cannabis extracts perform so poorly?

The median CBD dose (0.9 mg/kg/day) was far below the 10-20 mg/kg/day used in pharmaceutical trials, suggesting underdosing as a likely factor.

Did blood CBD levels predict who would respond?

No, CBD and THC-COOH blood levels were not significantly associated with response status in this study.

Read More on RethinkTHC

Cite This Study

RTHC-02114·https://rethinkthc.com/research/RTHC-02114

APA

Knupp, Kelly G; Rice, John D; Helmkamp, Laura J; Galinkin, Jeffrey; Sempio, Cristina; Jost, Klawitter; Chapman, Kevin E. (2019). Prospective evaluation of oral cannabis extracts in children with epilepsy.. Seizure, 72, 23-27. https://doi.org/10.1016/j.seizure.2019.09.007

MLA

Knupp, Kelly G, et al. "Prospective evaluation of oral cannabis extracts in children with epilepsy.." Seizure, 2019. https://doi.org/10.1016/j.seizure.2019.09.007

RethinkTHC

RethinkTHC Research Database. "Prospective evaluation of oral cannabis extracts in children..." RTHC-02114. Retrieved from https://rethinkthc.com/research/knupp-2019-prospective-evaluation-of-oral

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.