In a recent trial, researchers investigated the safety and efficacy of pregabalin for the treatment of acute and chronic sciatica.
Recommendations on the most effective way to treat sciatica (a shooting nerve pain in the back of the legs) vary. The drug pregabalin has been shown to ease certain types of nerve pain and oversensitivity, but research on its ability to safely and effectively treat sciatica is limited. If pregabalin therapy were found to be safe, highly effective, and fairly inexpensive it could serve as a standard treatment for the condition, improving the lives of many patients with chronic sciatica.
In a recent Australian trial published in the New England Journal of Medicine, researchers assessed the safety and the effectiveness of pregabalin in the treatment of sciatica patients. Adult patients who had been experiencing moderate to severe sciatica symptoms for one week to one year were recruited for the study. Patients were considered as having sciatica if they experienced shooting pain below one knee, plus muscle weakness, numbness, surface pain in specific parts of the leg, or reduced reflexes. Patients were excluded if they were pregnant or planning to conceive, breastfeeding, planning to undergo sciatica-related surgery during the first eight weeks of the trial, had mental health issues, or were on medications which should not be taken alongside pregabalin, or that would interfere with results. Assessments took place after weeks two, four, eight, 12, 26, and 52.
Patients were randomly assigned to receive 150 mg/day of either pregabalin or a placebo. The dose was raised from 150 to 300 mg/day after the first week, 300 to 450 mg/day after the second week, and from 450 to 600 mg/day after the third week. Over the course of the eighth week, the dose dropped from 600 mg/day to zero. Doses could be adjusted and additional care provided based on an individual patient’s progress and their doctor’s discretion.
In total, 209 patients were recruited for the study, 108 of whom received pregabalin and 101 of whom received a placebo. Roughly seventy-four percent followed the regimen to which they were assigned. Patients taking pregabalin saw no greater improvements in symptoms at eight and 52 weeks than their placebo-taking counterparts. There were 351 adverse events: 227 events among 68 pregabalin patients and 124 events among 43 placebo patients. Dizziness was by far the most common, with 70 episodes among 42 pregabalin patients and 19 episodes among 13 placebo patients. The upper back pain was twice as common among pregabalin patients as placebo patients, general discomfort was more common in pregabalin patients, and sweating was slightly more common in placebo patients. Life-threatening adverse events, including physical pain or psychological distress requiring hospitalization, were rare and not significantly different between the two groups.
Although previous research has found pregabalin to be effective against some types of neuropathic pain, this study suggests that pregabalin is not appropriate for the treatment of sciatica. In fact, pregabalin did not reduce pain or disability or improve quality of life any more than the placebo. Further, patients on pregabalin were more likely to experience moderate adverse events than those on the placebo.
Written by Raishard Haynes, MBS
Reference: Mathieson, S. et al. (2017). Trial of Pregabalin for Acute and Chronic Sciatica. N Engl J Med 2017; 376:1111-20. DOI: 10.1056/NEJMoa1614292