期刊
PAIN MEDICINE
卷 22, 期 4, 页码 861-874出版社
OXFORD UNIV PRESS
DOI: 10.1093/pm/pnab050
关键词
Nabiximols; Neuropathic Pain; Systematic Review; Meta-Analysis; Chronic Non-Cancer Pain; Pain Management
资金
- Almirall Hermal GmbH (Reinbek, Germany)
The pooled analysis of nine RCTs demonstrated that nabiximols was superior to placebo in reducing chronic neuropathic pain with a small effect size. Larger RCTs are needed to further evaluate the efficacy of nabiximols in neuropathic pain.
Objective. Pooled analysis of nabiximols and placebo in randomized controlled studies (RCTs) of chronic neuropathic pain. Design. Systematic review and meta-analysis. Methods. A systematic literature search was conducted to identify double-blind placebo-controlled RCTs of nabiximols for chronic neuropathic pain. The clinical endpoint of interest was change from baseline in mean pain score on 11-point numerical rating scales. Mean difference (MD) and standardized mean difference (SMD, Hedges' g) were calculated using fixed effect (FE) and random effects (RE) models. Strength of evidence was assessed using the Cochrane Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. Risk of bias was assessed using the revised Cochrane risk-of-bias tool (RoB 2). Results. Nine RCTs with 1289 participants were included. Quality of evidence (GRADE) was moderate. One study had a high risk of bias (RoB 2) and five had some concerns. For the pooled endpoint of change from baseline in mean pain score, nabiximols was superior to placebo, with a MD of -0.40 (95% confidence interval [CI]: -.59 to -.21; FE, P<.0001) or -0.44 (95% CI: -.70 to -.19; RE, P = .0006). A SMD of -0.21 (95% CI: -.32 to -.10; FE) or -0.26 (95% CI: -.42 to -.10; RE) indicated an incremental benefit over background analgesia. Results in favor of nabiximols were maintained in sensitivity analyses. Conclusions. Nabiximols was superior to placebo for reduction of chronic neuropathic pain, with a small effect size. Larger RCTs designed to assess the effect of nabiximols in neuropathic pain are required to reach more definitive conclusions.
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