Bianconi Alessandro, Fiore Matteo, Rosso Annalisa, Acuti Martellucci Cecilia, Calò Giovanna Letizia, Cioni Giovanni, Imperiali Gianmarco, Orazi Vittorio, Tiseo Marco, Troia Anastasia, Zauli Enrico
School of Public Health, Department of Medical and Surgical Sciences, University of Bologna, Via San Giacomo 12, 40138 Bologna, Italy.
Department of Environmental and Prevention Sciences, University of Ferrara, 44121 Ferrara, Italy.
J Clin Med. 2024 Oct 15;13(20):6133. doi: 10.3390/jcm13206133.
: Despite the fact that thiocolchicoside has been widely used in the treatment of musculoskeletal pain, its efficacy has never been systematically evaluated. We carried out a systematic review and meta-analysis of randomized clinical trials (RCTs) to appraise the existing evidence on the efficacy of thiocolchicoside for musculoskeletal pain management. : The literature search was performed on multiple databases, extracting reports of RCTs evaluating the efficacy of thiocolchicoside compared to placebo or no exposure. The reduction in pain intensity was evaluated through between-groups mean differences (MDs) in Visual Analogue Scale (VAS) scores after the intervention. The pooled effect estimates were compared to a minimally important difference (MID) of 1 point on a scale from 0 to 10. : We retrieved eight RCTs, including a total of 1397 patients. All the included studies were determined as being at high risk of bias. Seven trials evaluated patients with acute low back pain. After 2-3 days of treatment, the pooled MD in VAS score was -0.49 (95%CI = -0.90; -0.09) compared to controls. After 5-7 days of treatment, the summary MD was -0.82 (95%CI = -1.46; -0.18). : Although thiocolchicoside was found to significantly reduce patient-reported low back pain, the clinical impact was very small, as the pooled effect estimates were below the MID, and the overall certainty of evidence was very low. In light of the safety concerns raised by the European Medicine Agency, an in-depth analysis on the risk-benefit balance of thiocolchicoside is required.
尽管硫代秋水仙苷已被广泛用于治疗肌肉骨骼疼痛，但其疗效从未得到系统评估。我们对随机临床试验（RCT）进行了系统评价和荟萃分析，以评估关于硫代秋水仙苷治疗肌肉骨骼疼痛疗效的现有证据。
在多个数据库中进行文献检索，提取评估硫代秋水仙苷与安慰剂或无暴露相比疗效的RCT报告。通过干预后视觉模拟量表（VAS）评分的组间平均差异（MD）来评估疼痛强度的降低。将合并效应估计值与0至10分制中1分的最小重要差异（MID）进行比较。
我们检索到八项RCT，共纳入1397例患者。所有纳入研究均被确定为存在高偏倚风险。七项试验评估了急性下腰痛患者。治疗2至3天后，与对照组相比，VAS评分的合并MD为-0.49（95%CI = -0.90；-0.09）。治疗5至7天后，汇总MD为-0.82（95%CI = -1.46；-0.18）。
尽管发现硫代秋水仙苷能显著减轻患者报告的下腰痛，但临床影响非常小，因为合并效应估计值低于MID，且证据的总体确定性非常低。鉴于欧洲药品管理局提出的安全担忧，需要对硫代秋水仙苷的风险效益平衡进行深入分析。
