Is pregabalin an effective treatment for the pain of acute or chronic sciatica?

Pregabalin does not relieve pain in patients with sciatica. (LOE = 1b)

Mathieson S, Maher CG, McLachlan A, et al. Trial of pregabalin for acute and chronic sciatica. N Engl J Med 2017;376(12):1111-1120.  [PMID:28328324]

Randomized controlled trial (double-blinded)

Government

Concealed

Outpatient (any)

The closely related drugs gabapentin and pregabalin are widely used for the treatment of neuropathic pain, including sciatica. This Australian trial recruited patients with moderate to severe sciatica, defined as pain radiating below the knee and accompanied by evidence of nerve root or spinal nerve involvement such as sensory deficits, diminished reflexes, or weakness. The pain had to have been present for between 1 week and 1 year. The average age of the 207 participants was 54 years, 85% had dermatomal pain, 37% had a neurologic deficit, and 30% had a motor deficit. The patients were randomly assigned to receive either pregabalin in a dose of 75 mg twice daily, increasing to a final target dose of 300 mg twice daily at 8 weeks, or matching placebo. The primary outcome was pain on a 10-point scale, with a difference of 1.5 points considered to be the minimal clinically important difference. Patients were followed up for up to 1 year, and a variety of secondary outcomes were measured, as well. Groups were balanced at the start of the study, and analysis was by intention to treat. At both 8 weeks and 52 weeks, there was no significant difference in the primary outcome, and no difference in secondary outcomes including disability, back pain intensity, global perception of the effect, and quality of life.