Derry Sheena, Moore R Andrew
Pain Research and Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD010111. doi: 10.1002/14651858.CD010111.
Topical creams with capsaicin are used to treat pain from a wide range of chronic conditions including neuropathic pain. Following application to the skin capsaicin causes enhanced sensitivity to noxious stimuli, followed by a period with reduced sensitivity and, after repeated applications, persistent desensitisation. There is uncertainty about the efficacy and tolerability of capsaicin for treating painful chronic neuropathies. This is an update of an earlier review of topical capsaicin for chronic neuropathic pain in adults that looked at all doses and formulations of capsaicin. The original review has now been split: here we consider only formulations using a low concentration of capsaicin (< 1%) applied several times daily over several weeks, while another review will consider a single application of capsaicin at a high concentration.
To review the evidence from controlled trials on the efficacy and tolerability of topically applied low-concentration (< 1%) capsaicin in chronic neuropathic pain in adults.
Cochrane CENTRAL, MEDLINE, EMBASE and Oxford Pain Relief Database, searched to July 2012.
Randomised, double-blind, placebo-controlled studies of at least six weeks' duration, using low-concentration (< 1%) topical capsaicin to treat neuropathic pain.
Two review authors independently assessed study quality and validity, and extracted data. Information was extracted on numbers of participants with pain relief (clinical improvement) after at least six weeks, and with local skin reactions, and used to calculate relative risk (or risk ratio, RR) and numbers needed to treat to benefit (NNT) and harm (NNH). Details of definition of pain relief and specific adverse events were sought.
No additional studies were identified for this update of low concentration capsaicin. Included studies were published before 1996. Six studies (389 participants in total) compared regular application of low dose (0.075%) capsaicin cream with placebo cream. There was substantial heterogeneity in results, probably as a result of the small number of studies each with small numbers of participants, as well as the different pain conditions studied and different definitions of "clinical success" reported. Only two studies reported data for the preferred primary outcome of at least 50% pain relief, and there were too few data for pooled analysis. Local skin reactions were more common with capsaicin, usually tolerable, and attenuated with time; the NNH for repeated low-dose application was 2.5 (95% confidence interval (CI) 2.1 to 3.1). All studies satisfied minimum criteria for quality and validity, but maintenance of blinding remains a potential problem.
AUTHORS' CONCLUSIONS: There were insufficient data to draw any conclusions about the efficacy of low-concentration capsaicin cream in the treatment of neuropathic pain. The information we have suggests that low-concentration topical capsaicin is without meaningful effect beyond that found in placebo creams; given the potential for bias from small study size, this makes it unlikely that low-concentration topical capsaicin has any meaningful use in clinical practice. Local skin irritation, which was often mild and transient but may lead to withdrawal, was common. Systemic adverse effects were rare.
含辣椒素的外用乳膏用于治疗多种慢性疾病引起的疼痛,包括神经性疼痛。将辣椒素涂抹于皮肤后,会导致对有害刺激的敏感性增强,随后是一段敏感性降低的时期,反复涂抹后会出现持续的脱敏现象。辣椒素治疗慢性疼痛性神经病变的疗效和耐受性尚不确定。这是对早期关于成人慢性神经性疼痛外用辣椒素的综述的更新,该综述研究了辣椒素的所有剂量和剂型。原来的综述现在已被拆分:在此我们仅考虑使用低浓度(<1%)辣椒素、在数周内每日多次涂抹的剂型,而另一篇综述将考虑高浓度辣椒素的单次应用。
综述关于外用低浓度(<1%)辣椒素治疗成人慢性神经性疼痛的疗效和耐受性的对照试验证据。
检索至2012年7月的考克兰中央对照试验注册库、医学期刊数据库、荷兰医学文摘数据库和牛津疼痛缓解数据库。
随机、双盲、安慰剂对照研究,持续时间至少六周,使用低浓度(<1%)外用辣椒素治疗神经性疼痛。
两位综述作者独立评估研究质量和有效性,并提取数据。提取关于至少六周后疼痛缓解(临床改善)的参与者人数以及局部皮肤反应的数据,并用于计算相对危险度(或风险比,RR)以及治疗获益所需人数(NNT)和伤害所需人数(NNH)。寻求疼痛缓解的定义和特定不良事件的详细信息。
本次低浓度辣椒素更新未识别出其他研究。纳入的研究发表于1996年之前。六项研究(共389名参与者)比较了定期涂抹低剂量(0.075%)辣椒素乳膏与安慰剂乳膏。结果存在很大异质性,可能是由于研究数量少且每个研究的参与者人数少,以及所研究的疼痛状况不同和报告的“临床成功”定义不同。只有两项研究报告了至少50%疼痛缓解这一首选主要结局的数据,且数据太少无法进行汇总分析。辣椒素引起的局部皮肤反应更常见,通常可耐受,且会随时间减轻;重复低剂量应用的NNH为2.5(95%置信区间(CI)2.1至3.1)。所有研究均满足质量和有效性的最低标准,但维持盲法仍然是一个潜在问题。
没有足够的数据就低浓度辣椒素乳膏治疗神经性疼痛的疗效得出任何结论。我们所掌握的信息表明,低浓度外用辣椒素除了安慰剂乳膏所具有的效果外没有有意义的效果;鉴于研究规模小可能存在偏倚,这使得低浓度外用辣椒素在临床实践中不太可能有任何有意义的用途。局部皮肤刺激很常见,通常轻微且短暂,但可能导致停药。全身不良反应很少见。