Table 1.
Study | Treatments (subjects per group) |
Duration | Outcome | Toxicity | Limitations |
---|---|---|---|---|---|
Mechoulam & Carlini, (1978) | TRE – CBD 200 mg/day (4) TRE – Placebo (5) |
3 months | CBD: 2 seizure free; 1 partial improvement; 1 no change |
None | No baseline seizure frequency, no definition of improvement; unclear if AEDs were changed; small N/limited power; not truly randomized-blinded; unknown if groups were matched |
Cunha et al (1980) | TRE-TLE CBD (7) * TRE-TLE Placebo (8)*,** |
200–300 mg/day for 3- 18 wks |
Last visit: 4 CBD, 1 placebo |
Somnolence | Not clearly blinded since one patient transferred groups and doses were adjusted in CBD but no mention of this in placebo group and CBD group received had longer average treatment |
Ames et al (1986) | IDD- TRE CBD (?6)$ IDD- TRE Placebo (?6)$ x 4 wks |
CBD 300/day x1 wk; 200/dy x 3 wks |
No difference between CBD v. Placebo |
Somnolence | This was a letter to the editor and details are lacking. |
Trembly et al (1990) | TRE (?10 or 12)$$ | 3 mos baseline; 6 mos placebo: Randomized to either 6 mos placebo v. CBD 100 tid; then crossover for 6 mos on alternative treatment. |
no change in seizure frequency or cognitive/behavioral tests |
None | Only truly double blind study. Unclear why sample size differed in two reports. Data reported is incomplete |
TRE: treatment-resistant epilepsy, TLE: temporal lobe epilepsy, IDD: intellectual/developmental disability
Frequent convulsions for > = 1year; – 1 GTCSz per week
One patient transferred from placebo to treatment after 1 month
12 subjects were divided into two groups, but distribution uncertain
Abstract and subsequent book chapter have different N’s (10 and 12)