Cohen Steven P, Hanling Steven, Bicket Mark C, White Ronald L, Veizi Elias, Kurihara Connie, Zhao Zirong, Hayek Salim, Guthmiller Kevin B, Griffith Scott R, Gordin Vitaly, White Mirinda Anderson, Vorobeychik Yakov, Pasquina Paul F
Blaustein Pain Treatment Center, Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA Walter Reed National Military Medical Center, Bethesda, MD, USA Blaustein Pain Treatment Center, Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA
Pain Medicine Division, Department of Anesthesiology, Naval Medical Center-San Diego, USA.
BMJ. 2015 Apr 16;350:h1748. doi: 10.1136/bmj.h1748.
To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy.
A multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes.
Eight military, Veterans Administration, and civilian hospitals.
145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain.
Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin.
Average leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥ 2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit.
There were no significant differences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted difference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments.
Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier: NCT01495923.
评估硬膜外类固醇注射或加巴喷丁对腰骶神经根病是否为更好的治疗方法。
2011年至2014年进行的一项多中心随机研究。计算机生成随机分组，按地点分层。患者和评估医生对治疗结果不知情。
八家军队医院、退伍军人管理局医院和民营医院。
145例因椎间盘突出或椎管狭窄继发腰骶部放射性疼痛且病程少于四年、腿痛与背痛同样严重或更严重的患者。
参与者接受硬膜外类固醇注射加安慰剂药丸或假注射加巴喷丁。
注射后1个月和3个月时，采用0至10分数字评分量表评估的平均腿痛程度。阳性结局定义为腿痛减轻≥2分且总体感觉效果为阳性。所有患者均进行1个月的随访；病情改善的患者在3个月随访时仍对治疗不知情。
1个月时主要结局指标无显著差异（硬膜外类固醇注射组平均疼痛评分3.3（标准差2.6），与基线相比平均变化-2.2（标准差2.4）；加巴喷丁组分别为3.7（标准差2.6）和-1.7（标准差2.6）；校正差异0.4，95%置信区间-0.3至1.2；P=0.25），3个月时也无显著差异（平均疼痛评分分别为3.4（标准差2.7）和与基线相比平均变化-2.0（标准差2.6），加巴喷丁组分别为3.7（标准差2.8）和-1.6（标准差2.7）；校正差异0.3，-0.5至1.2；P=0.43）。在次要结局中，治疗后1个月，接受硬膜外类固醇注射的患者最严重腿痛的减轻幅度（-3.0，标准差2.8）大于接受加巴喷丁治疗的患者（-2.0，标准差2.9；P=0.04），且更有可能获得阳性成功结局（66%对46%；需治疗人数=5.0，95%置信区间2.8至27.0；P=0.02）。3个月时，治疗组之间无显著差异。
尽管硬膜外类固醇注射在某些结局指标上可能比加巴喷丁更有益，但差异不大，且对大多数人来说是短暂的。试验注册ClinicalTrials.gov标识符：NCT01495923。
