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Lyrica no better than placebo for acute, chronic sciatica pain relief

Patients who received pregabalin experienced the same reduction in pain as those who received a placebo for acute and chronic sciatica, according to research published in The New England Journal of Medicine. 

The findings also suggest that patients who took the pain medication were more likely to have adverse events from taking that drug than patients who took a placebo.

“It seems people associate a drop in pain being due to taking a capsule, rather than something that would happen naturally over time,” C.W. Christine Lin, PhD, of The George Institute for Global Health and Sydney Medical School, Australia, said in a press release. “[General practitioners] who are prescribing pregabalin should take note of these findings, and talk with their patients about other ways of managing and preventing pain.”

In this randomized, double blind, placebo-controlled trial, 207 patients were randomly assigned a placebo at a dose of 150 mg per day that was adjusted to a maximum dose of 600 mg per day (n = 101) or a matching dose of pregabalin (Lyrica, Pfizer) for up to 8 weeks (n = 106). The intensity of a patient’s leg pain at 8 weeks and again at 52 weeks was rated on a scale of 0 to 10 (10 being the worst) as the primary outcomes. Extent of disability, back-pain intensity and quality-of-life measures at prespecified time points for 1 year were the secondary outcomes.

Lin and colleagues reported that, 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% CI, –0.2 to 1.2). At week 52, the mean unadjusted leg-pain intensity score was 3.4 in the pregabalin group and 3 in the placebo group (adjusted mean difference, 0.3; 95% CI, –0.5 to 1). In addition, there were no significant between-group differences in the secondary outcomes at week 8 or week 52.

Researchers also wrote that the most common adverse event was dizziness, but others included dorsalgia, sweating, malaise, and suicidal thoughts as well as hospitalizations for chest pain, dyspnea and nausea, increased back pain or leg pain, psychological distress, and suicide attempts, and that the incidence of adverse events was higher in the pregabalin group.

“Until now, there has been no high-quality evidence to help patients and doctors know whether pregabalin works for treating sciatica. …. There are no drugs proven to work for people with sciatica, and even epidural injections only provide a small benefit in the short term,” Lin said in the release. “What we do know is that most people with sciatica do eventually recover with time.”

In a related editorial, Nadine Attal, MD, PhD, of the Ambroise Paré Hospital, and Michel Barrot, PhD, of the University of Strasbourg, both in France, pointed to that ultimate recovery and the different kinds of pain that patients with sciatica experience for the study’s results.

“Acute sciatica resolves without treatment in one-third of patients within 2 weeks after onset and in three-quarters of patients within 3 months after onset. …. These findings are consistent with spontaneous recovery in both groups,” Attal and Barrot wrote.

They noted, “Given that patients with sciatica presumably have a combination of neuropathic pain and nociceptive pain (ie, pain caused by the activation of nociceptors, such as arthritis pain), another reason that the results of the trial by Mathieson et al may have been negative is that only 22% to 34% of the patients had probable characteristics of neuropathic pain at baseline.” —by Janel Miller

Disclosure: Lin reports no relevant financial disclosures. Attal reports receiving personal fees from Aptinyx, Astellas, Galapagos, Grunenthal, Johnson & Johnson, Mundipharma, Novartis, Pfizer, Sanofi Pasteur MSD and Teva Pharmaceuticals. Barrot reports receiving grant support from Theranexus and SATT Conectus. Please see the full study for a list of all other authors’ relevant financial disclosures.