Trial of Pregabalin for Acute and Chronic Sciatica

被引：152

作者：

Mathieson, Stephanie ^{[1
,2
]}

Maher, Christopher G. ^{[1
,2
]}

McLachlan, Andrew J. ^{[3
,4
]}

Latimer, Jane ^{[1
,2
]}

Koes, Bart W. ^{[9
]}

Hancock, Mark J. ^{[5
]}

Harris, Ian ^{[6
]}

Day, Richard O. ^{[7
]}

Billot, Laurent ^{[1
,2
]}

Pik, Justin ^{[8
]}

Jan, Stephen ^{[1
,2
]}

Lin, C. -W. Christine ^{[1
,2
]}

机构：

[1] George Inst Global Hlth, Sydney, NSW, Australia

[2] Univ Sydney, Sydney Med Sch, Sydney, NSW, Australia

[3] Univ Sydney, Fac Pharm, Sydney, NSW, Australia

[4] Univ Sydney, Ctr Educ & Res Ageing, Sydney, NSW, Australia

[5] Macquarie Univ, Fac Med & Hlth Sci, Sydney, NSW, Australia

[6] Univ New South Wales, Ingham Inst Appl Med Res, South Western Sydney Clin Sch, Fac Med, Sydney, NSW, Australia

[7] Univ New South Wales, St Vincents Clin Sch, Fac Med, Sydney, NSW, Australia

[8] Australian Capital Terr NeuroSpine Clin, Deakin, ACT, Australia

[9] Erasmus Univ, Med Ctr, Dept Gen Practice, Rotterdam, Netherlands

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2017年 / 376卷 / 12期

基金：

英国医学研究理事会;

关键词：

LOW-BACK-PAIN; NEUROPATHIC PAIN; USUAL CARE; GABAPENTIN; GUIDELINES; EFFICACY; PRECISE; HEALTH; MISUSE;

D O I：

10.1056/NEJMoa1614292

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

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.

引用

页码：1111 / 1120

页数：10

共 32 条

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