Study register · detail
Clear benefit
GRADE
Moderate
264 citations
Samplen = 24 Pat.
Duration6 weeks
ControlPlacebo
EndpointTS-CGI
Blindingdoppelblind
DesignRandomized Controlled Trial
Cannabinoidthc
Max. dose10.0 mg
Routeoral
Key finding
THC showed significant or trend-significant improvements in tics on several rating scales (TS-CGI, STSSS, YGTSS, video rating) compared with placebo with good safety.
Summary
RCT (n=24, double-blind, placebo-controlled, 6 weeks): THC up to 10 mg/day significantly reduced tics in Tourette syndrome versus placebo (TS-CGI, YGTSS, STSSS, video rating: p<0,05; ANOVA p=0,037). No serious adverse events. First controlled long-term study with THC in TS.
P
PopulationAdults with Tourette syndrome (DSM-III-R), n=24
I
InterventionDelta-9-tetrahydrocannabinol (THC) oral up to 10 mg/day
C
ControlPlacebo
O
OutcomeSignificant tic reduction (p<0,05) or trend (p<0,10) on TS-CGI, STSSS, YGTSS and video rating; TSSL significant (p<0,05); ANOVA p=0,037
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
Preliminary studies suggested that delta-9-tetrahydrocannabinol (THC), the major psychoactive ingredient of Cannabis sativa L., might be effective in the treatment of Tourette syndrome (TS). This study was performed to investigate for the first time under controlled conditions, over a longer-term treatment period, whether THC is effective and safe in reducing tics in TS. In this randomized, double-blind, placebo-controlled study, 24 patients with TS, according to DSM-III-R criteria, were treated over a 6-week period with up to 10 mg/day of THC. Tics were rated at 6 visits (visit 1, baseline; visits 2-4, during treatment period; visits 5-6, after withdrawal of medication) using the Tourette Syndrome Clinical Global Impressions scale (TS-CGI), the Shapiro Tourette-Syndrome Severity Scale (STSSS), the Yale Global Tic Severity Scale (YGTSS), the self-rated Tourette Syndrome Symptom List (TSSL), and a videotape-based rating scale. Seven patients dropped out of the study or had to be excluded, but only 1 due to side effects. Using the TS-CGI, STSSS, YGTSS, and video rating scale, we found a significant difference (p <.05) or a trend toward a significant difference (p <.10) between THC and placebo groups at visits 2, 3, and/or 4. Using the TSSL at 10 treatment days (between days 16 and 41) there was a significant difference (p <.05) between both groups. ANOVA as well demonstrated a significant difference (p =.037). No serious adverse effects occurred. Our results provide more evidence that THC is effective and safe in the treatment of tics. It, therefore, can be hypothesized that the central cannabinoid receptor system might play a role in TS pathology.
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