A randomized controlled trial of gabapentin for chronic low back pain with and without a radiating component.

A randomized controlled trial of gabapentin for chronic low back pain with and without a radiating component.
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DOI:
10.1097/j.pain.0000000000000554
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发表时间:
2016-07
期刊:
影响因子:
7.4
通讯作者:
Garfin SR
Garfin SR
中科院分区:
医学1区
文献类型:
--
作者:
Atkinson JH;Slater MA;Capparelli EV;Patel SM;Wolfson T;Gamst A;Abramson IS;Wallace MS;Funk SD;Rutledge TR;Wetherell JL;Matthews SC;Zisook S;Garfin SR

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加巴喷丁是用于慢性下腰痛的止痛药,但没有支持这种做法的对照试验。这项随机、双臂、为期12周的平行小组研究将加巴喷丁(强制滴定每天最多3600毫克)与惰性安慰剂进行了比较。主要的疗效衡量标准是从基线到治疗最后一周的疼痛强度的变化,由描述符差异量表衡量;次要结果是残疾(奥斯威斯蒂残疾指数)。意向治疗分析包括108名随机的慢性背痛患者(每天疼痛6个月,≥),他们的疼痛已经或没有辐射到下肢(43%)。不计算缺失分数的随机效应回归模型被用于分析结果数据。疼痛强度随着时间的推移显著降低(p<.0001),服用加巴喷丁或安慰剂的受试者报告的疼痛强度比基线减少了约30%,但组之间没有显著差异(p=.423)。同样的结果也适用于残疾分数。在完成12周(N=72)的应答者分析中,报告疼痛强度至少减少30%或50%,或至少对医生临床总体变化印象有“最小改善”的比例在不同组之间没有显著差异。在有辐射性疼痛(n=46)和非辐射性疼痛(n=62)的参与者之间,无论是在治疗臂内还是在治疗臂之间,其止痛效果都没有显著差异。加巴喷丁血药浓度与疼痛强度无明显相关性。加巴喷丁对有或没有辐射成分的慢性下腰痛的止痛似乎无效。
Gabapentin is prescribed for analgesia in chronic low back pain, yet there are no controlled trials supporting this practice. This randomized, two-arm, 12-week, parallel group study compared gabapentin (forced titration up to 3600 mg daily) to inert placebo. The primary efficacy measure was change in pain intensity from baseline to the last week on treatment measured by the Descriptor Differential Scale; the secondary outcome was disability (Oswestry Disability Index). The intention-to-treat analysis comprised 108 randomized chronic back pain patients (daily pain for ≥ 6 months) whose pain did (43%) or did not radiate into the lower extremity. Random effects regression models which did not impute missing scores were used to analyze outcome data. Pain intensity decreased significantly over time (p < .0001) with subjects on gabapentin or placebo reporting reductions of about 30% from baseline, but did not differ significantly between groups (p = .423). The same results pertained for disability scores. In responder analyses of those who completed 12 weeks (N=72), the proportion reporting at least 30% or 50% reduction in pain intensity, or at least “Minimal Improvement” on the Physician Clinical Global Impression of Change did not differ significantly between groups. There were no significant differences in analgesia between participants with radiating (n = 46) and non-radiating (n = 62) pain either within or between treatment arms. There was no significant correlation between gabapentin plasma concentration and pain intensity. Gabapentin appears to be ineffective for analgesia in chronic low back pain with or without a radiating component.
DOI: 10.1016/0304-3959(88)90138-8
发表时间: 1988-12-01
期刊: PAIN
影响因子: 7.4
作者:
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DOI: 10.1038/clpt.1987.26
发表时间: 1987-03-01
影响因子: 6.7
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DOI: 10.1016/0304-3959(94)00180-m
发表时间: 1995-05-01
期刊: PAIN
影响因子: 7.4
作者:
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