Study register · detail
Clear benefit
GRADE
Moderate
276 citations
Samplen = 15 Pat.
DurationSingle doses or up to 4,5 months
ControlPlacebo
EndpointSleep duration / seizure…
Blindingdoppelblind
DesignRCT (placebokontrolliert)
Cannabinoidcbd
Max. dose300.0 mg
Routeoral
Key finding
CBD improved sleep duration and reduced dream recall in insomniacs and showed antiepileptic effect in treatment-refractory patients.
Summary
Placebo-controlled trial (n=15 treatment-refractory epilepsy patients) with CBD 200–300 mg/day over up to 4,5 months: 7 of 8 CBD patients showed improvement in disease course compared to only 1 of 8 in the placebo group.
P
PopulationHealthy subjects (insomniacs) and epilepsy patients (secondary generalized epilepsy, treatment-refractory); sleep study n=15, epilepsy study n=15
I
InterventionCBD oral 40/80/160 mg (sleep) or 200–300 mg/day (epilepsy); chronic administration for up to 4,5 months
C
ControlPlacebo (and 5 mg nitrazepam as active control in sleep study)
O
OutcomeSleep study: 160 mg CBD → significantly longer sleep vs. placebo; all CBD doses → significantly less dream recall vs. placebo. Epilepsy study: 7/8 CBD patients improved vs. 1/7 under placebo
Confidence in the evidence
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size
★★★★★
Blinding
Double-blind
Effect size
Clear benefit
Citations / year
★★★★★
Authors
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Abstract
Clinical trials with cannabidiol (CBD) in healthy volunteers, isomniacs, and epileptic patients conducted in the authors' laboratory from 1972 up to the present are reviewed. Acute doses of cannabidiol ranging from 10 to 600 mg and chronic administration of 10 mg for 20 days or 3 mg/kg/day for 30 days did not induce psychologic or physical symptoms suggestive of psychotropic or toxic effects; however, several volunteers complained of somnolence. Complementary laboratory tests (EKG, blood pressure, and blood and urine analysis) revealed no sign of toxicity. Doses of 40, 80, and 160 mg cannabidiol were compared to placebo and 5 mg nitrazepam in 15 insomniac volunteers. Subjects receiving 160 mg cannabidiol reported having slept significantly more than those receiving placebo; the volunteers also reported significantly less dream recall; with the three doses of cannabidiol than with placebo. Fifteen patients suffering from secondary generalized epilepsy refractory to known antiepileptic drugs received either 200 to 300 mg cannabidiol daily or placebo for as long as 4.5 months. Seven out of the eight epileptics receiving cannabidiol had improvement of their disease state, whereas only one placebo patient improved.
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