Department of Orthopedics, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran.
Department of Clinical Pharmacy, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.
Rev Recent Clin Trials. 2023;18(4):288-299. doi: 10.2174/0115748871250545230919055109.
Available experimental and clinical evidence indicates that N-Acetyl cysteine (NAC) may have an analgesic role in specific pain conditions, particularly neuropathic pain. Thus, we hypothesized that NAC supplementation might be also helpful in decreasing pain and improving pain-related disability in patients with acute radiculopathy. We designed this study to investigate the potential use of NAC-adjunctive treatment to Nonsteroidal Anti- Inflammatory Drugs (NSAIDs) in patients with acute radiculopathy secondary to lumbar intervertebral disc herniation.
Sixty-two patients diagnosed with acute lumbar radiculopathy associated with disc herniation were randomly allocated to the NAC or the placebo groups. Besides naproxen at a dose of 500 mg twice a day, participants based on their allocation group started with NAC or matched placebo at a dose of 600 mg twice a day for eight weeks. The pain severity, measured by the Visual Analog Scale (VAS), and pain-related disability measured by the Oswestry Disability Index (ODI) were measured at baseline and weeks 2, 4, and 8 of treatment. Global improvement of symptoms rated by Patient and Clinical Global Impressions of Change (PGIC and CGIC) was also recorded at the end of week 8. All analyses were conducted on an Intentionto- Treat (ITT) analysis data set.
A comparison of the VAS and ODI scores at weeks 2 and 4 of the treatment between the two groups did not show a significant difference. In contrast, from week 4 to week 8, we noticed a significantly greater reduction in the mean VAS and ODI scores in the NAC group compared to the placebo group (p-value <0.001 for both variables). In parallel with these results, also, more NAC-treated than placebo-treated patients achieved treatment success defined as ''very much'' or ''much improved'' on CGIC and PGIC scales, and these differences reached a significant level (p-value = .011 and p-value = .043).
This study suggested that NAC might be a relevant candidate for adjunct therapy in managing acute lumbar radiculopathy. Additional clinical trials are needed to validate these findings.
现有实验和临床证据表明，N-乙酰半胱氨酸（NAC）在某些特定疼痛病症中可能具有镇痛作用，特别是在神经病理性疼痛中。因此，我们假设 NAC 补充剂可能有助于减轻急性神经根病变患者的疼痛并改善与疼痛相关的残疾。我们设计了这项研究，旨在研究 NAC 辅助治疗与非甾体抗炎药（NSAIDs）联合治疗腰椎间盘突出症引起的急性神经根病变患者的潜在用途。
62 例被诊断为急性腰椎神经根病变合并椎间盘突出症的患者被随机分配到 NAC 或安慰剂组。除了每天两次服用 500 毫克萘普生外，根据分组，患者开始每天两次服用 600 毫克 NAC 或匹配的安慰剂，持续八周。在基线和治疗的第 2、4 和 8 周，使用视觉模拟量表（VAS）测量疼痛严重程度，使用 Oswestry 残疾指数（ODI）测量与疼痛相关的残疾。在第 8 周末，还记录了患者和临床总体印象变化量表（PGIC 和 CGIC）对症状整体改善的评分。所有分析均基于意向治疗（ITT）分析数据集进行。
与安慰剂组相比，在治疗的第 2 和第 4 周，两组之间的 VAS 和 ODI 评分比较没有显著差异。相反，从第 4 周到第 8 周，我们注意到 NAC 组的 VAS 和 ODI 评分均值明显降低，与安慰剂组相比差异有统计学意义（两个变量的 p 值均<0.001）。与这些结果一致的是，在 CGIC 和 PGIC 量表上，更多的 NAC 治疗患者达到了治疗成功的定义，即“非常好”或“明显改善”，这些差异具有统计学意义（p 值=0.011 和 p 值=0.043）。
本研究表明，NAC 可能是治疗急性腰椎神经根病变的一种相关候选辅助治疗药物。需要进一步的临床试验来验证这些发现。
