Wiffen Philip J, Derry Sheena, Moore R Andrew
UK Cochrane Centre, National Institute for Health Research, Summertown Pavilion, Middle Way, Oxford, UK, OX2 7LG.
Cochrane Database Syst Rev. 2011 Feb 16(2):CD006044. doi: 10.1002/14651858.CD006044.pub3.
This is an update of the original Cochrane review published in Issue 2, 2007. Some antiepileptic medicines have a place in the treatment of neuropathic pain (pain due to nerve damage). This updated review adds five new additional studies looking at evidence for Lamotrigine as an effective treatment for acute and chronic pain.
To assess analgesic efficacy and adverse effects of the antiepileptic drug lamotrigine in acute and chronic pain.
Randomised controlled trials (RCTs) of lamotrigine in acute, and chronic pain (including cancer pain) were identified from MEDLINE, EMBASE and CENTRAL up to January 2011. Additional studies were sought from the reference list of the retrieved papers.
RCTs investigating the use of lamotrigine (any dose, by any route, and for any study duration) for the treatment of acute or chronic pain. Assessment of pain intensity or pain relief, or both, using validated scales. Participants were adults aged 18 and over. Only full journal publication articles were included.
Dichotomous data (ideally for the outcome of at least 50% pain relief) were used to calculate relative risk with 95% confidence intervals. Meta-analysis was undertaken using a fixed-effect model. Numbers needed to treat to benefit (NNTs) were calculated as the reciprocal of the absolute risk reduction. For unwanted effects, the NNT becomes the number needed to harm (NNH) and was calculated.
Twelve included studies in 11 publications (1511 participants), all with chronic neuropathic pain: central post stroke pain (1), chemotherapy induced neuropathic pain (1), diabetic neuropathy (4), HIV related neuropathy (2), mixed neuropathic pain (2), spinal cord injury related pain (1), and trigeminal neuralgia (1); none investigated lamotrigine in acute pain. The update had five additional studies (1111 additional participants). Participants were aged between 26 and 77 years. Study duration was 2 weeks in one study and at least 6 weeks in the remainder; eight were of eight week duration or longer. There is no convincing evidence that lamotrigine is effective in treating acute or chronic pain at doses of about 200-400 mg daily. Almost 10% of participants taking lamotrigine reported a skin rash.
AUTHORS' CONCLUSIONS: The additional studies tripled participant numbers providing data for analysis, and new, more stringent criteria for outcomes and analysis were used; conclusions about lamotrigine's lack of efficacy in chronic pain did not change. Given availability of more effective treatments including antiepileptics and antidepressant medicines, lamotrigine does not have a significant place in therapy based on available evidence.
这是对2007年第2期发表的原始Cochrane系统评价的更新。一些抗癫痫药物在治疗神经性疼痛(由神经损伤引起的疼痛)方面具有一定作用。本次更新的系统评价增加了五项新的研究,旨在探究拉莫三嗪作为急性和慢性疼痛有效治疗方法的证据。
评估抗癫痫药物拉莫三嗪在急性和慢性疼痛中的镇痛效果及不良反应。
从MEDLINE、EMBASE和CENTRAL数据库中检索截至2011年1月的拉莫三嗪治疗急性和慢性疼痛(包括癌痛)的随机对照试验(RCT)。从检索到的论文参考文献列表中查找其他研究。
研究拉莫三嗪(任何剂量、任何给药途径、任何研究持续时间)用于治疗急性或慢性疼痛的RCT。使用经过验证的量表评估疼痛强度或疼痛缓解情况,或两者皆评估。参与者为18岁及以上的成年人。仅纳入完整发表在期刊上的文章。
使用二分数据(理想情况下为至少50%疼痛缓解的结果)计算相对风险及95%置信区间。采用固定效应模型进行荟萃分析。计算治疗获益所需的人数(NNT),即绝对风险降低的倒数。对于不良反应,计算伤害所需的人数(NNH)。
11篇出版物中的12项纳入研究(1511名参与者),均为慢性神经性疼痛:中风后中枢性疼痛(1项)、化疗引起的神经性疼痛(1项)、糖尿病性神经病变(4项)、HIV相关神经病变(2项)、混合性神经病变性疼痛(2项)、脊髓损伤相关疼痛(1项)和三叉神经痛(1项);无研究调查拉莫三嗪在急性疼痛中的应用。本次更新增加了五项研究(额外1111名参与者)。参与者年龄在26至77岁之间。一项研究的持续时间为2周,其余研究至少为6周;八项研究的持续时间为8周或更长。没有令人信服的证据表明拉莫三嗪在每日剂量约200 - 400毫克时对治疗急性或慢性疼痛有效。服用拉莫三嗪的参与者中近10%报告出现皮疹。
额外的研究使参与者数量增加了两倍,为分析提供了数据,并且采用了新的、更严格的结果和分析标准;关于拉莫三嗪在慢性疼痛中缺乏疗效的结论没有改变。鉴于有包括抗癫痫药物和抗抑郁药物在内的更有效治疗方法,基于现有证据,拉莫三嗪在治疗中没有显著地位。