Translational Medicine II. (Poster discussion will take place in the Aula during the Coffee Break)
Introduction:
About 2.8 million people live with multiple sclerosis worldwide, and more than a quarter suffer from spasticity refractory to standard treatment. Nabiximols, a well characterized Cannabis sativa extract as an add-on agent may alleviate spasticity in these cases.
Aims:
The aim of our study was to investigate the efficacy of nabiximols in the alleviation of multiple sclerosis-associated spasticity in the meta-analysis of randomized clinical trials.
Method:
We followed the recommendation of Cochrane collaborations, and the protocol was preregistered to PROSPERO (CRD42021282177). The systematic search was performed on 2021.10.15. in 5 medical databases. The primary outcome was responder rate by spasticity numerical rating scale. The evaluated intervention consisted of nabiximols besides standard treatment in patients with refractory spasticity. The comparator was standard treatment alone and placebo. Spasticity-related other parameters were measured as secondary outcomes. We estimated pooled mean differences or odds ratios and associated 95% confidence intervals (95%CI).
Results:
We identified 9 eligible randomized controlled trials comprising 1451 patients in double-blind studies. With our primary outcome, we confirmed that at least two times more people will respond well to nabiximols than placebo (OR = 2.41, 95% CI = 1.39; 4.18, p < 0.01). On the other hand, heterogeneity was high, as only 5 studies could have been included to this estimation with an I2 of 68% (p = 0.01). The secondary outcomes were also in accordance with the primary outcome.
Conclusion:
Our present meta-analysis confirms the utility of nabiximols in therapy-resistant spasticity of multiple sclerosis. While several limitations (eg. the lack of comparison with other agents, relatively high heterogeneity) can influence the weight of our results and side effects can have negative effect on the cost-benefit ratio, the agent’s presence in the general therapy of this symptom can be underlined.