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Mathieson S, Maher CG, McLachlan AJ, et al. Trial of Pregabalin for Acute and Chronic Sciatica. N Engl J Med. 2017 Mar 23;376(12):1111-1120. doi: 10.1056/NEJMoa1614292.
Discipline Area Score
Physician 6 / 7
Abstract

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 .).

Comments from MORE raters

Physician rater

Very important study in that the results disagree with what is common practice.

Physician rater

The goal here is to find a way to avoid prescribing narcotics for these patients. Unfortunately, other medications have limited usefulness. Bring on the chiropractors?

Physician rater

Because pregabalin is often prescribed for patients with acute sciatica, this article provides helpful data about the lack of efficacy compared with placebo.

Physician rater

Result not at all surprising.

Physician rater

Excellent study.

Physician rater

This article was practice changing for me. Chronic pain is challenging and I would occasionally recommend pregabalin...no more.

Physician rater

Given the "opiate crisis" in the U.S., there is significant interest in investigating the use of alternate agents for analgesia; pregabalin in one of those agents that seems to have become fashionable to use. This well-designed RCT demonstrates that perhaps some of that enthusiasm should be tempered - at least for chronic pain.

Physician rater

The overuse of lyrica in primary care is a serious problem. It has addiction potential and very little upside. This is further proof of this.
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