BACKGROUND: Sciatica can be disabling, and evidence regarding medical treatments 
is limited. Pregabalin is effective in the treatment of some types of 
neuropathic pain. This study examined whether pregabalin may reduce the 
intensity of sciatica.
METHODS: We conducted a randomized, double-blind, placebo-controlled trial of 
pregabalin in patients with sciatica. Patients were randomly assigned to receive 
either pregabalin at a dose of 150 mg per day that was adjusted to a maximum 
dose of 600 mg per day or matching placebo for up to 8 weeks. The primary 
outcome was the leg-pain intensity score on a 10-point scale (with 0 indicating 
no pain and 10 the worst possible pain) at week 8; the leg-pain intensity score 
was also evaluated at week 52, a secondary time point for the primary outcome. 
Secondary outcomes included the extent of disability, back-pain intensity, and 
quality-of-life measures at prespecified time points over the course of 1 year.
RESULTS: A total of 209 patients underwent randomization, of whom 108 received 
pregabalin and 101 received placebo; after randomization, 2 patients in the 
pregabalin group were determined to be ineligible and were excluded from the 
analyses. At week 8, the mean unadjusted leg-pain intensity score was 3.7 in the 
pregabalin group and 3.1 in the placebo group (adjusted mean difference, 0.5; 
95% confidence interval [CI], -0.2 to 1.2; P=0.19). At week 52, the mean 
unadjusted leg-pain intensity score was 3.4 in the pregabalin group and 3.0 in 
the placebo group (adjusted mean difference, 0.3; 95% CI, -0.5 to 1.0; P=0.46). 
No significant between-group differences were observed with respect to any 
secondary outcome at either week 8 or week 52. A total of 227 adverse events 
were reported in the pregabalin group and 124 in the placebo group. Dizziness 
was more common in the pregabalin group than in the placebo group.
CONCLUSIONS: Treatment with pregabalin did not significantly reduce the 
intensity of leg pain associated with sciatica and did not significantly improve 
other outcomes, as compared with placebo, over the course of 8 weeks. The 
incidence of adverse events was significantly higher in the pregabalin group 
than in the placebo group. (Funded by the National Health and Medical Research 
Council of Australia; PRECISE Australian and New Zealand Clinical Trials 
Registry number, ACTRN12613000530729 .).