Neuropathie
Studienlage · Detail Randomized Controlled Trial (double-blind, crossover, multicenter) · Neuropathie · 2008

Comparison of analgesic effects and patient tolerability of nabilone and dihydrocodeine for chronic neuropathic pain: randomised, crossover, double blind study

Kein Nutzen nachgewiesen GRADE Moderat 203 Zitate
Stichproben = 96 Pat.
Dauer14 Wochen
KontrolleDihydrocodein, max. 240 mg/Tag, 6 Wochen…
EndpunktVAS
Verblindungdoppelblind
DesignRandomized Controlled Trial (double-blind, crossover, multicenter)
Cannabinoidthc
Max. Dosis2.0 mg
Applikationoral
Kernaussage

Nabilone war Dihydrocodein unterlegen: der Schmerz-Score war unter Nabilone um 6,0 mm höher (schlechtere Schmerzlinderung), und Nabilone verursachte mehr Nebenwirkungen.

Zusammenfassung

n=96, doppelblinde Crossover-RCT (14 Wochen, 3 UK-Zentren); Nabilon (max. 2 mg/d) vs. Dihydrocodein (max. 240 mg/d) bei chronischem neuropathischem Schmerz; mittlerer VAS-Score unter Nabilon um 6,0 mm höher (95%-KI 1,4–10,5 mm; n=73 Available-Case); Per-Protocol-Analyse (n=64): 5,6 mm (95%-KI 0,8–10,3 mm) — Dihydrocodein überlegen; Nebenwirkungen unter Nabilon häufiger.

P
PopulationErwachsene mit chronischem neuropathischem Schmerz, n=96, Alter 23–84 Jahre
I
InterventionNabilon (synthetisches Cannabinoid), max. 2 mg/Tag, 6 Wochen eskalierende Dosierung
C
KontrolleDihydrocodein (schwaches Opioid), max. 240 mg/Tag, 6 Wochen eskalierende Dosierung
O
OutcomeMittlerer VAS-Score um 6,0 mm schlechter unter Nabilon vs. Dihydrocodein (95%-KI 1,4–10,5 mm) in der Available-Case-Analyse; Dihydrocodein zeigte bessere Schmerzlinderung
Vertrauen in die Evidenz
Moderat

Dritte von vier GRADE-Stufen, die Effektschätzung ist wahrscheinlich verlässlich.

Herabgestuft wegen
Ungenauigkeit
Qualitätsprofil
Größe
Verblindung Doppelblind
Effektstärke Kein Nutzen
Zitate / Jahr
Autoren
Frank B, Serpell M G, Hughes J et al.
DOI 10.1136/bmj.39429.619653.80
Design: Randomized Controlled Trial (double-blind, crossover, multicenter)
Teilen
Abstract
To compare the analgesic efficacy and side effects of the synthetic cannabinoid nabilone with those of the weak opioid dihydrocodeine for chronic neuropathic pain. Randomised, double blind, crossover trial of 14 weeks' duration comparing dihydrocodeine and nabilone. Outpatient units of three hospitals in the United Kingdom. 96 patients with chronic neuropathic pain, aged 23-84 years. The primary outcome was difference between nabilone and dihydrocodeine in pain, as measured by the mean visual analogue score computed over the last 2 weeks of each treatment period. Secondary outcomes were changes in mood, quality of life, sleep, and psychometric function. Side effects were measured by a questionnaire. Patients received a maximum daily dose of 240 mg dihydrocodeine or 2 mg nabilone at the end of each escalating treatment period of 6 weeks. Treatment periods were separated by a 2 week washout period. Results Mean baseline visual analogue score was 69.6 mm (range 29.4-95.2) on a 0-100 mm scale. 73 patients were included in the available case analysis and 64 patients in the per protocol analysis. The mean score was 6.0 mm longer for nabilone than for dihydrocodeine (95% confidence interval 1.4 to 10.5) in the available case analysis and 5.6 mm (10.3 to 0.8) in the per protocol analysis. Side effects were more frequent with nabilone. Dihydrocodeine provided better pain relief than the synthetic cannabinoid nabilone and had slightly fewer side effects, although no major adverse events occurred for either drug.

„Was dem Handeln im Weg steht, wird zum Weg.“ — Marc Aurel