Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy - A phase 3 randomized, double-blind, placebo-controlled, crossover trial (NOOC3)
Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy - A phase 3 randomized, double-blind, placebo-controlled, crossover trial (NOOC3)
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DOI：
10.1002/cncr.23008
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发表时间：
2007-11-01
期刊：
影响因子：
6.2
通讯作者：
Wong, Gilbert Y.
中科院分区：
文献类型：
--
作者：
Rao, Ravi D.;Michalak, John C.;Wong, Gilbert Y.
背景抗癫痫药加巴喷丁已被证明可以缓解各种病因引起的周围神经病变症状。在此基础上，进行了一项多中心、双盲、安慰剂对照、交叉、随机试验，以评价加巴喷丁对化疗所致周围神经病变（CIPN）症状的影响。有症状的CIPN患者，如果主诉“平均”每日疼痛评分为1）0-10数值评定量表（NRS）>= 4;或2）0-3东部肿瘤协作组（群体神经病变量表（ENS）>= 1，则符合条件（数字越高，表明两种量表中症状的严重程度越高）。患者随机接受加巴喷丁（目标剂量，2700毫克）或安慰剂6周。交叉发生在2周洗脱期后。每周通过问卷调查评估CIPN相关症状。统计方法遵循交叉设计的既定方法，包括学生t检验以比较治疗之间的平均患者内差异和线性模型以调整潜在的伴随协变量。有115名患者被随机分配到治疗组或对照组，两组在研究开始时症状匹配良好。在研究期间，两组之间症状严重程度的变化在统计学上相似，不良事件在两组中均为轻度且相似。这项试验未能证明使用加巴喷丁治疗CIPN引起的症状有任何益处。
BACKGROUND. The antiepileptic agent, gabapentin, has been demonstrated to relieve symptoms of peripheral neuropathy due to various etiologies. On the basis of these data, a multicenter, double-blind, placebo-controlled, crossover, randomized trial was conducted to evaluate the effect of gabapentin on symptoms of chemotherapy-induced peripheral neuropathy (CIPN).METHODS. Patients with symptomatic CIPN who complained of 'average' daily pain scores of either 1) >= 4 on a 0-10 numerical rating scale (NRS); or 2) >= 1 on the 0-3 Eastern Cooperative Oncology (Group neuropathy scale (ENS) were eligible (higher numbers indicate greater severity of symptoms in both scales). Patients were randomized to receive gabapentin (target dose, 2700 mg) or placebo for 6 weeks. Crossover occurred after a 2-week washout period. CIPN-related symptoms were evaluated weekly by questionnaires. Statistical methods followed established methods for crossover designs, including Student t tests to compare average intrapatient differences between treatments and linear models to adjust for potential concomitant covariates.RESULTS. There were 115 patients who were randomly assigned to the treatment or control arm. Both groups were well matched by symptoms at study entry. Changes in symptom severity were statistically similar between the 2 groups during the study Adverse events were mild and similar in both groups.CONCLUSIONS. This trial failed to demonstrate any benefit to using gabapentin to treat symptoms caused by CIPN.