Few clinical guidelines for the treatment of sciatica exist and evidence regarding effective medical treatments is limited. One medicine that is prescribed for the management of sciatica is pregabalin (also known as Lyrica®). Pregabalin is a neuropathic pain medicine, effective in reducing neuropathic pain in conditions such as post-herpetic neuralgia and diabetic peripheral neuropathy. Pregabalin was once thought to be a useful treatment for sciatica because of the coexisting neuropathic pain component with nociceptive pain. However, despite increasing prescription rates of pregabalin for back and neck pain, for example, a six-fold increase in Australian primary care between 2003/4 and 2013/4, there was no robust evidence for its efficacy and safety in patients with sciatica.
Our group at The George Institute for Global Health, Sydney Medical School, The University of Sydney conducted a prospectively registered, randomised, double-blind, placebo-controlled trial of pregabalin in patients with acute or chronic sciatica, called PRECISE. In summary, patients seeking care for their sciatica were recruited. Sciatica was defined as radiating pain into one leg below the knee, accompanied by the presence of at least one of the following clinical features: dermatomal leg pain, myotomal weakness, sensory deficits, or diminished reflex, as determined by the study doctor (i.e. general practitioner). We randomised 209 patients of which 82% had chronic sciatica, to receive either pregabalin (maximum dose of 600 mg/day) or matching placebo for up to eight weeks. The primary outcome was leg pain intensity at the end of the course of treatment. Secondary outcomes included disability, back pain intensity and quality-of-life measures. Our results clearly found that there was no significant difference between groups in leg pain intensity or any secondary outcome at week 8 or over one year. However, the number of adverse events in the pregabalin group was significantly higher than the placebo group (P = 0.002). The most common side effect in both groups was dizziness, with 70 events reported by 42 participants in the pregabalin group and 19 events reported by 13 participants in the placebo group.
The take home message is that pregabalin is no more effective than placebo for reducing leg pain intensity in patients with sciatica, but will likely give patients more side effects. Based on that, we do not recommend the use of pregabalin in patients with sciatica. We want doctors, clinicians and patients to be aware of our findings to ensure that patients are being managed by best evidence practice. For anyone taking pregabalin for their sciatica it is best to speak to your doctor who can advise what to do next. More research is certainly needed to find effective medical treatments for these patients.
About Stephanie Mathieson
Stephanie is a Research Fellow at School of Public Health, Sydney Medical School, University of Sydney. The PRECISE study was part of her recently completed PhD at The George Institute for Global Health that investigated medicines for back pain and sciatica. Her post-doctoral research continues this theme within the WISER Health Care group, a research collaboration that aims to conduct research that will reduce overdiagnosis and overtreatment in Australia and around the world.
Stephanie Mathieson, Christopher G. Maher, Andrew J. McLachlan, Jane Latimer, Bart W. Koes, Mark J. Hancock, Ian Harris, Richard O. Day, Laurent Billot, Justin Pik, Stephen Jan, and C.-W. Christine Lin (2017) Trial of Pregabalin for Acute and Chronic Sciatica. N Engl J Med 376:1111-1120 DOI: 10.1056/NEJMoa1614292
Commissioning Editor: Ben Wand; Associate Editor Hopin Lee