There was an increased risk of non-serious AEs with cannabinoids compared with placebo .
Conclusions There was moderate evidence to support cannabinoids in treating chronic , non-cancer pain at 2 weeks .
Similar results were observed at later time points , but the confidence in effect is low .
There is little evidence that cannabinoids increase the risk of experiencing serious AEs , although non-serious AEs may be common in the short-term period following use
Background For patients with chronic , non-cancer pain , traditional pain-relieving medications include opioids , which have shown benefits but are associated with increased risks of addiction and adverse effects .
Medical cannabis has emerged as a treatment alternative for managing these patients and there has been a rise in the number of r and omized clinical trials in recent years ; therefore , a systematic review of the evidence was warranted .
Objective To analyze the evidence surrounding the benefits and harms of medical cannabinoids in the treatment of chronic , non-cancer-related pain .
A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex(®) ), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis.
BACKGROUND Spasticity is a disabling complication of multiple sclerosis , affecting many patients with the condition . We report the first Phase 3 placebo-controlled study of an oral antispasticity agent to use an enriched study design . METHODS A 19-week follow-up , multicentre , double-blind , r and omized , placebo-controlled , parallel-group study in subjects with multiple sclerosis spasticity not fully relieved with current antispasticity therapy . Subjects were treated with nabiximols , as add-on therapy , in a single-blind manner for 4weeks , after which those achieving an improvement in spasticity of ≥20 % progressed to a 12-week r and omized , placebo-controlled phase . RESULTS Of the 572 subjects enrolled , 272 achieved a ≥20 % improvement after 4weeks of single-blind treatment , and 241 were r and omized . The primary end-point was the difference between treatments in the mean spasticity Numeric Rating Scale ( NRS ) in the r and omized , controlled phase of the study . Intention-to-treat ( ITT ) analysis showed a highly significant difference in favour of nabiximols ( P=0.0002 ) . Secondary end-points of responder analysis , Spasm Frequency Score , Sleep Disturbance NRS Patient , Carer and Clinician Global Impression of Change were all significant in favour of nabiximols . CONCLUSIONS The enriched study design provides a method of determining the efficacy and safety of nabiximols in a way that more closely reflects proposed clinical practice , by limiting exposure to those patients who are likely to benefit from it . Hence , the difference between active and placebo should be a reflection of efficacy and safety in the population intended for treatment
There was an increased risk of non-serious AEs with cannabinoids compared with placebo .
Conclusions There was moderate evidence to support cannabinoids in treating chronic , non-cancer pain at 2 weeks .
Similar results were observed at later time points , but the confidence in effect is low .
There is little evidence that cannabinoids increase the risk of experiencing serious AEs , although non-serious AEs may be common in the short-term period following use
Background For patients with chronic , non-cancer pain , traditional pain-relieving medications include opioids , which have shown benefits but are associated with increased risks of addiction and adverse effects .
Medical cannabis has emerged as a treatment alternative for managing these patients and there has been a rise in the number of r and omized clinical trials in recent years ; therefore , a systematic review of the evidence was warranted .
Objective To analyze the evidence surrounding the benefits and harms of medical cannabinoids in the treatment of chronic , non-cancer-related pain .