Mijnhout G S, Alkhalaf A, Kleefstra N, Bilo H J G
Department of Internal Medicine, Isala Clinics, Zwolle, the Netherlands.
Neth J Med. 2010 Apr;68(4):158-62.
Neuropathic pain is difficult to treat. We identified those studies in the literature in which the effectiveness of alpha lipoic acid as a treatment for neuropathic pain was evaluated.
Systematic literature review. The databases MEDLINE and EMBASE were searched using the keywords 'lipoic acid', 'thioctic acid', 'diabet*', and the medical subject headings (MeSH ) 'thioctic acid' and 'diabetes mellitus'. Randomised placebo-controlled trials (RCTs) and meta-analyses were selected and assessed for their methodological quality.
Five RCTs and one meta-analysis were found. The Total Symptom Score (TSS) was used as the primary outcome measure. A significant improvement in the TSS was reported in four of the RCTs. An oral or intravenous alpha lipoic dose of at least 600 mg per day resulted in a 50% reduction in the TSS. However, compared with the control group, the TSS reduction in most groups was less than 30%, which is the threshold presumed to be clinically relevant. Four RCTs were of good quality (level of evidence 1b), one RCT had methodological limitations (level 2b), and the methodological quality of the meta-analysis was insufficient for the purposes of this review.
Based on the currently available evidence, when given intravenously at a dosage of 600 mg once daily over a period of three weeks, alpha lipoic acid leads to a significant and clinically relevant reduction in neuropathic pain (grade of recommendation A). It is unclear if the significant improvements seen after three to five weeks of oral administration at a dosage of >or= 600 mg daily are clinically relevant.
神经性疼痛难以治疗。我们在文献中查找了评估α硫辛酸治疗神经性疼痛有效性的研究。
系统文献综述。使用关键词“硫辛酸”“硫辛酸”“糖尿病*”以及医学主题词(MeSH)“硫辛酸”和“糖尿病”检索MEDLINE和EMBASE数据库。选取随机安慰剂对照试验(RCT)和荟萃分析并评估其方法学质量。
找到5项RCT和1项荟萃分析。总症状评分(TSS)用作主要结局指标。4项RCT报告TSS有显著改善。每日口服或静脉注射至少600mgα硫辛酸可使TSS降低50%。然而,与对照组相比,大多数组的TSS降低幅度小于30%,这是假定具有临床相关性的阈值。4项RCT质量良好(证据级别1b),1项RCT存在方法学局限性(级别2b),荟萃分析的方法学质量对于本综述而言不足。
基于现有证据,当以每日600mg的剂量静脉注射3周时,α硫辛酸可使神经性疼痛显著且在临床上有意义地减轻(推荐等级A)。每日口服≥600mg,3至5周后出现的显著改善是否具有临床相关性尚不清楚。