Nabiximols Did Not Reduce Spasticity After Stroke but Appeared Safe for Heart Patients
In a double-blind RCT, nabiximols (Sativex) did not reduce spasticity in stroke patients compared to placebo, but importantly showed no cardiovascular safety concerns in this high-risk population.
Quick Facts
What This Study Found
Among 34 stroke patients, nabiximols did not improve spasticity on the primary or secondary endpoints compared to placebo. However, no cardiovascular adverse events occurred, suggesting cannabis-based treatments may be safe in stroke patients despite theoretical cardiovascular risks.
Key Numbers
41 enrolled, 34 completed; 2 serious adverse events (none cardiovascular); no primary or secondary efficacy endpoints met; crossover design with 1-month phases
How They Did This
Double-blind, randomized, placebo-controlled crossover trial. 41 patients entered, 34 completed. Patients received nabiximols oromucosal spray or placebo for 1 month each, with cardiovascular monitoring throughout.
Why This Research Matters
Nabiximols is approved for MS spasticity but not stroke spasticity. While this trial found no efficacy, the cardiovascular safety finding is significant because stroke patients are typically excluded from cannabis studies due to heart risk concerns.
The Bigger Picture
Spasticity mechanisms differ between MS and stroke, which may explain the null finding. The safety data, however, opens the door for further investigation of cannabinoids in stroke patients for other indications.
What This Study Doesn't Tell Us
Small sample size may have been underpowered to detect effects. Patients had relatively low baseline pain and spasticity levels, which may have limited room for improvement.
Questions This Raises
- ?Would nabiximols work for stroke patients with higher baseline spasticity?
- ?Do different spasticity mechanisms between MS and stroke require different cannabinoid approaches?
Trust & Context
- Key Stat:
- No cardiovascular adverse events in stroke patients
- Evidence Grade:
- Well-designed double-blind crossover RCT, but small sample and potentially underpowered.
- Study Age:
- Published in 2022
- Original Title:
- Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study.
- Published In:
- Frontiers in neurology, 13, 892165 (2022)
- Authors:
- Marinelli, Lucio(2), Puce, Luca(2), Mori, Laura(2), Leandri, Massimo, Rosa, Gian Marco, Currà, Antonio, Fattapposta, Francesco, Trompetto, Carlo
- Database ID:
- RTHC-04043
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked Questions
Does nabiximols help with spasticity after stroke?
This RCT found no benefit of nabiximols over placebo for post-stroke spasticity. The authors suggest this may be because spasticity mechanisms differ between stroke and multiple sclerosis, where nabiximols is approved.
Is cannabis safe for stroke patients?
Despite concerns about cardiovascular risks, this study found no cardiovascular adverse events in stroke patients using nabiximols, suggesting it may be safe for this population. This is important because stroke patients are usually excluded from cannabis research.
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Cite This Study
https://rethinkthc.com/research/RTHC-04043APA
Marinelli, Lucio; Puce, Luca; Mori, Laura; Leandri, Massimo; Rosa, Gian Marco; Currà, Antonio; Fattapposta, Francesco; Trompetto, Carlo. (2022). Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study.. Frontiers in neurology, 13, 892165. https://doi.org/10.3389/fneur.2022.892165
MLA
Marinelli, Lucio, et al. "Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study.." Frontiers in neurology, 2022. https://doi.org/10.3389/fneur.2022.892165
RethinkTHC
RethinkTHC Research Database. "Cannabinoid Effect and Safety in Spasticity Following Stroke..." RTHC-04043. Retrieved from https://rethinkthc.com/research/marinelli-2022-cannabinoid-effect-and-safety
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.