Studienlage · Detail
Unklar
GRADE
Moderat
41 Zitate
Stichprobek = 4 Studien
n = 48 Pat.
n = 48 Pat.
Dauergenerally short periods of time
KontrolleKontrollgruppe
EndpunktAnfallsfreiheit
Verblindungunklar
DesignMeta-Analyse
Cannabinoidcbd
Max. Dosis300.0 mg
Applikationoral
Kernaussage
Keine verlässlichen Schlussfolgerungen zur Wirksamkeit von Cannabinoiden bei Epilepsie möglich; nur Nebenwirkungsdaten verfügbar (keine Nebenwirkungen in Behandlungsgruppen berichtet).
Zusammenfassung
Cochrane SR über k=4 RCTs (n=48 Patienten), alle mit Cannabidiol als Add-on zu bestehenden Antiepileptika; alle Studien von niedriger Qualität ohne detaillierte Randomisierungsangaben. Primärer Endpunkt (Anfallsfreiheit nach ≥1 Jahr) wurde nicht berichtet. Sekundärer Endpunkt Nebenwirkungen: keine unerwünschten Ereignisse in den Behandlungsgruppen. Keine verlässlichen Schlussfolgerungen zur Wirksamkeit möglich.
P
PopulationPatienten mit Epilepsie, gepoolt n=48
I
InterventionCannabidiol (200–300 mg/Tag, oral), Cannabinoide allgemein
C
KontrolleKontrollgruppe (Details unklar, keine adäquate Beschreibung der Randomisierung)
O
OutcomeKeine auswertbaren Daten zum primären Endpunkt (Anfallsfreiheit); nur Nebenwirkungsdaten: keine unerwünschten Ereignisse in Behandlungsgruppen
Vertrauen in die Evidenz
Moderat
Dritte von vier GRADE-Stufen, die Effektschätzung ist wahrscheinlich verlässlich.
Herabgestuft wegen
Ungenauigkeit
Qualitätsprofil
Größe
★★★★★
Verblindung
—
Effektstärke
—
Zitate / Jahr
★★★★★
Autoren
Teilen
Abstract
Background: Cannabis appears to have anti-epileptic effects in animals. It is not currently known if it is effective in patients with epilepsy. Some states in the United States of America have explicitly approved its use for epilepsy.
Objectives: To assess the efficacy of Cannabis, or one of Cannabis's constituents in the treatment of people with epilepsy.
Search Methods: We searched the Cochrane Epilepsy Group Specialized Register (May 15, 2012), the Cochrane Central Register of Controlled Trials (CENTRAL issue 4 of 12, The Cochrane Library 2012),MEDLINE (PubMed, searched on May 15, 2012), ISI Web of Knowledge (May 15, 2012), CINAHL (EBSCOhost, May 15, 2012), and ClinicalTrials.gov (May 15, 2012). In addition, we included studies we personally knew about that were not found by the searches, as well as references in the identified studies.
Selection Criteria: Randomized controlled trials (RCTs), whether blinded or not.
Data Collection And Analysis: Two authors independently selected trials for inclusion and extracted data. The primary outcome investigated was seizure freedom at one year or more, or three times the longest interseizure interval. Secondary outcomes included: responder rate at six months or more, objective quality of life data, and adverse events.
Main Results: We found four randomized reports which included a total of 48 patients, each of which used cannabidiol as the treatment agent. One report was an abstract, and another was a letter to the editor. Anti-epileptic drugs were continued in all. Details of randomisation were not included in any study. There was no investigation of whether control and treatment groups were the same or different. All the reports were low quality.The four reports only answered the secondary outcome about adverse effects. None of the patients in the treatment groups suffered adverse effects.
Authors' Conclusions: No reliable conclusions can be drawn at present regarding the efficacy of cannabinoids as a treatment for epilepsy. The dose of 200 to 300 mg daily of cannabidiol was safely administered to small numbers of patients, for generally short periods of time, and so the safety of long term cannabidiol treatment cannot be reliably assessed.
„Was dem Handeln im Weg steht, wird zum Weg.“