Ju Zi Yong, Wang Ke, Cui Hua Shun, Yao Yibo, Liu Shi Min, Zhou Jia, Chen Tong Yu, Xia Jun
College of Acumox and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Cochrane Database Syst Rev. 2017 Dec 2;12(12):CD012057. doi: 10.1002/14651858.CD012057.pub2.
BACKGROUND: Neuropathic pain may be caused by nerve damage, and is often followed by changes to the central nervous system. Uncertainty remains regarding the effectiveness and safety of acupuncture treatments for neuropathic pain, despite a number of clinical trials being undertaken. OBJECTIVES: To assess the analgesic efficacy and adverse events of acupuncture treatments for chronic neuropathic pain in adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, four Chinese databases, ClinicalTrials.gov and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 14 February 2017. We also cross checked the reference lists of included studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) with treatment duration of eight weeks or longer comparing acupuncture (either given alone or in combination with other therapies) with sham acupuncture, other active therapies, or treatment as usual, for neuropathic pain in adults. We searched for studies of acupuncture based on needle insertion and stimulation of somatic tissues for therapeutic purposes, and we excluded other methods of stimulating acupuncture points without needle insertion. We searched for studies of manual acupuncture, electroacupuncture or other acupuncture techniques used in clinical practice (such as warm needling, fire needling, etc). DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcomes were pain intensity and pain relief. The secondary outcomes were any pain-related outcome indicating some improvement, withdrawals, participants experiencing any adverse event, serious adverse events and quality of life. For dichotomous outcomes, we calculated risk ratio (RR) with 95% confidence intervals (CI), and for continuous outcomes we calculated the mean difference (MD) with 95% CI. We also calculated number needed to treat for an additional beneficial outcome (NNTB) where possible. We combined all data using a random-effects model and assessed the quality of evidence using GRADE to generate 'Summary of findings' tables. MAIN RESULTS: We included six studies involving 462 participants with chronic peripheral neuropathic pain (442 completers (251 male), mean ages 52 to 63 years). The included studies recruited 403 participants from China and 59 from the UK. Most studies included a small sample size (fewer than 50 participants per treatment arm) and all studies were at high risk of bias for blinding of participants and personnel. Most studies had unclear risk of bias for sequence generation (four out of six studies), allocation concealment (five out of six) and selective reporting (all included studies). All studies investigated manual acupuncture, and we did not identify any study comparing acupuncture with treatment as usual, nor any study investigating other acupuncture techniques (such as electroacupuncture, warm needling, fire needling).One study compared acupuncture with sham acupuncture. We are uncertain if there is any difference between the two interventions on reducing pain intensity (n = 45; MD -0.4, 95% CI -1.83 to 1.03, very low-quality evidence), and neither group achieved 'no worse than mild pain' (visual analogue scale (VAS, 0-10) average score was 5.8 and 6.2 respectively in the acupuncture and sham acupuncture groups, where 0 = no pain). There was limited data on quality of life, which showed no clear difference between groups. Evidence was not available on pain relief, adverse events or other pre-defined secondary outcomes for this comparison.Three studies compared acupuncture alone versus other therapies (mecobalamin combined with nimodipine, and inositol). Acupuncture may reduce the risk of 'no clinical response' to pain than other therapies (n = 209; RR 0.25, 95% CI 0.12 to 0.51), however, evidence was not available for pain intensity, pain relief, adverse events or any of the other secondary outcomes.Two studies compared acupuncture combined with other active therapies (mecobalamin, and Xiaoke bitong capsule) versus other active therapies used alone. We found that the acupuncture combination group had a lower VAS score for pain intensity (n = 104; MD -1.02, 95% CI -1.09 to -0.95) and improved quality of life (n = 104; MD -2.19, 95% CI -2.39 to -1.99), than those receiving other therapy alone. However, the average VAS score of the acupuncture and control groups was 3.23 and 4.25 respectively, indicating neither group achieved 'no worse than mild pain'. Furthermore, this evidence was from a single study with high risk of bias and a very small sample size. There was no evidence on pain relief and we identified no clear differences between groups on other parameters, including 'no clinical response' to pain and withdrawals. There was no evidence on adverse events.The overall quality of evidence is very low due to study limitations (high risk of performance, detection, and attrition bias, and high risk of bias confounded by small study size) or imprecision. We have limited confidence in the effect estimate and the true effect is likely to be substantially different from the estimated effect. AUTHORS' CONCLUSIONS: Due to the limited data available, there is insufficient evidence to support or refute the use of acupuncture for neuropathic pain in general, or for any specific neuropathic pain condition when compared with sham acupuncture or other active therapies. Five studies are still ongoing and seven studies are awaiting classification due to the unclear treatment duration, and the results of these studies may influence the current findings.
背景:神经性疼痛可能由神经损伤引起,且常伴有中枢神经系统的变化。尽管已经开展了多项临床试验,但针灸治疗神经性疼痛的有效性和安全性仍不确定。 目的:评估针灸治疗成人慢性神经性疼痛的镇痛效果及不良事件。 检索方法:我们于2017年2月14日检索了Cochrane中心对照试验注册库(CENTRAL)、医学期刊数据库(MEDLINE)、荷兰医学文摘数据库(Embase)、四个中文数据库、美国国立医学图书馆临床试验注册平台(ClinicalTrials.gov)和世界卫生组织(WHO)国际临床试验注册平台(ICTRP)。我们还交叉核对了纳入研究的参考文献列表。 选择标准:随机对照试验(RCT),治疗持续时间为八周或更长时间,比较针灸(单独使用或与其他疗法联合使用)与假针灸、其他积极疗法或常规治疗对成人神经性疼痛的疗效。我们检索基于针刺和刺激躯体组织以达到治疗目的的针灸研究,排除不针刺而采用其他方法刺激穴位的研究。我们检索了临床实践中使用的手动针灸、电针或其他针灸技术(如温针、火针等)的研究。 数据收集与分析:我们采用Cochrane期望的标准方法程序。主要结局为疼痛强度和疼痛缓解情况。次要结局为任何表明有一定改善的与疼痛相关的结局、退出研究的情况、经历任何不良事件的参与者、严重不良事件和生活质量。对于二分法结局,我们计算风险比(RR)及95%置信区间(CI),对于连续型结局,我们计算平均差(MD)及95%CI。我们还尽可能计算了获得额外有益结局所需的治疗人数(NNTB)。我们使用随机效应模型合并所有数据,并使用GRADE评估证据质量以生成“结果总结”表。 主要结果:我们纳入了六项研究,涉及462例慢性周围神经性疼痛患者(442例完成研究,其中男性251例,平均年龄52至63岁)。纳入的研究中,403例参与者来自中国,59例来自英国。大多数研究样本量较小(每个治疗组少于50例参与者),且所有研究在参与者和研究人员的盲法方面存在高偏倚风险。大多数研究在序列产生(六项研究中的四项)、分配隐藏(六项研究中的五项)和选择性报告(所有纳入研究)方面的偏倚风险不明确。所有研究均调查了手动针灸,我们未发现任何将针灸与常规治疗进行比较的研究,也未发现任何调查其他针灸技术(如电针、温针、火针)的研究。一项研究将针灸与假针灸进行了比较。我们不确定两种干预措施在减轻疼痛强度方面是否存在差异(n = 45;MD -0.4,95%CI -1.83至1.03,极低质量证据),且两组均未达到“不超过轻度疼痛”(视觉模拟量表(VAS,0 - 10),针灸组和假针灸组的平均得分分别为5.8和6.2,其中0表示无疼痛)。关于生活质量的数据有限,显示两组之间无明显差异。对于该比较,在疼痛缓解、不良事件或其他预先定义的次要结局方面缺乏证据。三项研究比较了单独针灸与其他疗法(甲钴胺联合尼莫地平以及肌醇)。针灸可能比其他疗法降低对疼痛“无临床反应”的风险(n = 209;RR 0.25,95%CI 0.12至0.51),然而,在疼痛强度、疼痛缓解、不良事件或任何其他次要结局方面缺乏证据。两项研究比较了针灸联合其他积极疗法(甲钴胺和消渴痹痛胶囊)与单独使用其他积极疗法。我们发现,与单独接受其他疗法的患者相比,针灸联合治疗组的疼痛强度VAS得分更低(n = 104;MD -1.02,95%CI -1.09至 -0.95),生活质量有所改善(n = 104;MD -2.19,95%CI -2.39至 -1.99)。然而,针灸组和对照组的平均VAS得分分别为3.23和4.25,表明两组均未达到“不超过轻度疼痛”。此外,该证据来自一项存在高偏倚风险且样本量非常小的单一研究。在疼痛缓解方面缺乏证据,并且我们未发现两组在其他参数上存在明显差异,包括对疼痛的“无临床反应”和退出研究的情况。在不良事件方面缺乏证据。由于研究局限性(实施、检测和失访偏倚风险高,且因研究规模小导致偏倚风险混淆)或不精确性,证据的总体质量非常低。我们对效应估计值的信心有限,并认为真实效应可能与估计效应有很大差异。 作者结论:由于现有数据有限,没有足够的证据支持或反驳一般情况下使用针灸治疗神经性疼痛,或者与假针灸或其他积极疗法相比,针灸对任何特定神经性疼痛状况的疗效。五项研究仍在进行中,七项研究因治疗持续时间不明确而有待分类,这些研究的结果可能会影响当前的研究发现。
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