Primary objective (30% responder rate) not significant; however secondary analyses showed significant improvement in average pain, worst pain and sleep disturbance in the low and medium dose groups compared with placebo, with dose-dependent side effects.
n=360 cancer patients with opioid-refractory tumour pain, nabiximols (Sativex) vs. placebo in three dose levels (low/medium/high); primary endpoint (30% responder rate) not significant (p=0,59); secondary continuous responder analysis significant in favour of nabiximols overall (p=0,035) as well as in the low- (p=0,008) and medium-dose group (p=0,039); mean daily pain (p=0,006), worst pain (p=0,011) and sleep disturbance (p=0,003) significantly improved in the low-dose arm; side effects dose-dependent, high-dose group less favourable compared with placebo.
The highest of four GRADE levels, the effect estimate is very reliable.
The impediment to action advances action.