Studienlage · Detail
Klarer Nutzen
GRADE
Hoch
214 Zitate
Stichproben = 298 Pat. (gepoolt)
Dauerunklar
KontrollePlacebo
EndpunktVAS/11-Punkte-Skala
Verblindungdoppelblind
DesignMeta-Analyse
THC:CBD1:1
Kernaussage
Cannabinoide (insbesondere Cannabidiol/THC-Spray, Cannabidiol und Dronabinol) zeigten eine statistisch signifikante Schmerzreduktion von durchschnittlich 1,6 Punkten (p < 0,001) und waren Placebo um 0,8 Punkte überlegen (p = 0,029), allerdings war die Evidenzbasis klein.
Zusammenfassung
Meta-Analyse über 7 RCTs (n=298; 222 behandelt, 76 Placebo) zu Cannabinoiden bei neuropathischem und MS-bedingtem Schmerz; gepoolte Schmerzreduktion 1,6±0,4 Punkte (p<0,001); Cannabinoide gegenüber Placebo überlegen um 0,8±0,3 Punkte (p=0,029). Sativex (CBD/THC-Spray), Cannabidiol und Dronabinol einzeln alle signifikant wirksam.
P
PopulationErwachsene (≥18 Jahre) mit neuropathischem Schmerz oder MS-bedingtem Schmerz, gepoolt n=298 (222 Behandlung, 76 Placebo)
I
InterventionCannabinoid-basierte Therapien: Cannabidiol/THC-Mundspray (Sativex), Cannabidiol, Dronabinol
C
KontrollePlacebo
O
OutcomeGepoolte Schmerzreduktion aller Cannabinoide: −1,6 ± 0,4 Punkte (p<0,001); Cannabinoide vs. Placebo am Endpunkt: −0,8 ± 0,3 Punkte (p=0,029)
Vertrauen in die Evidenz
Hoch
Höchste von vier GRADE-Stufen, die Effektschätzung ist sehr verlässlich.
Qualitätsprofil
Größe
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Verblindung
Doppelblind
Effektstärke
Klarer Nutzen
Zitate / Jahr
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Abstract
Debilitating pain, occurring in 50-70% of multiple sclerosis (MS) patients, is poorly understood and infrequently studied. We summarized efficacy and safety data of cannabinoid-based drugs for neuropathic pain. Studies were identified from Medline, Embase, and Cochrane databases; Bayer Healthcare provided additional trials. Accepted were randomized, double-blinded placebo-controlled trials of cannabinoid-based treatments for MS-related/neuropathic pain in adults > or = 18 years of age. Two reviewers identified studies and extracted data; a third adjudicated disagreements. Data included baseline and endpoint pain scores on visual analog or 11-point ordinal scales. Of 18 articles and three randomized controlled trial (RCT) reports identified, 12 articles and two reports were rejected (9 = inappropriate disease or outcome, 1 = duplicate, 1 = review, and 1 = abstract); six accepted articles and one RCT-report involved 298 patients (222 treated, 76 placebo); four examined Sativex (a cannabidiol/delta-9-tetrahydrocannabinol (THC) buccal spray) (observations = 196), five cannabidiol (n = 41), and three dronabinol (n = 91). Homogeneity chi(2) values were non-significant, allowing data combination. Analyses focused on baseline-endpoint score differences. The cannabidiol/THC buccal spray decreased pain 1.7 +/- 0.7 points (p = 0.018), cannabidiol 1.5 +/- 0.7 (p = 0.044), dronabinol 1.5 +/- 0.6 (p = 0.013), and all cannabinoids pooled together 1.6 +/- 0.4 (p < 0.001). Placebo baseline-endpoint scores did not differ (0.8 +/- 0.4 points, p = 0.023). At endpoint, cannabinoids were superior to placebo by 0.8 +/- 0.3 points (p = 0.029). Dizziness was the most commonly observed adverse event in the cannabidiol/THC buccal spray arms (39 +/- 16%), across all cannabinoid treatments (32.5 +/- 16%) as well as in the placebo arms (10 +/- 4%). Cannabinoids including the cannabidiol/THC buccal spray are effective in treating neuropathic pain in MS. This review was based on a small number of trials and patients. Pain related to MS was assumed to be similar to neuropathic pain.
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