Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, 2/F, Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, Hong Kong.
Accident & Emergency Department, Prince of Wales Hospital, 2/F, Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, Hong Kong.
Postgrad Med J. 2024 Sep 22;100(1188):741-750. doi: 10.1093/postmj/qgae052.
Low back pain (LBP) is a leading cause of disability worldwide and has posed numerous health and socioeconomic challenges. This study compared whether nonsteroidal anti-inflammatory drugs (NSAIDs) in combination with tramadol, tizanidine or placebo would be the best treatment regime to improve the Roland Morris Disability Questionnaire (RMDQ) scores at 1 week.
This was a multi-center, double-blind, randomized, and placebo-controlled trial including adult patients with acute LBP and sciatica in three emergency departments in Hong Kong. Patients were randomized to the receive tramadol 50 mg, tizanidine 2 mg, or placebo every 6 hours for 2 weeks in a 1:1:1 ratio. The RMDQ and other secondary outcomes were measured at baseline, Day 2, 7, 14, 21, and 28. Data were analyzed on an intention to treat basis. Crude and adjusted mean differences in the changes of RMDQ and NRS scores from baseline to Day 7 between tizanidine/tramadol and placebo were determined with 95% confidence intervals.
Two hundred and ninety-one patients were analyzed with the mean age of 47.4 years and 57.7% were male. The primary outcome of mean difference in RMDQs on Day 7 (compared with baseline) was non-significant for tizanidine compared with placebo (adjusted mean difference - 0.56, 95% CI -2.48 to 1.37) and tramadol compared with placebo (adjusted mean difference - 0.85, 95% CI -2.80 to 1.10). Only 23.7% were fully compliant to the treatment allocated. Complier Average Causal Effect analysis also showed no difference in the primary outcome for the tizanidine and tramadol versus placebo.
Among patients with acute LBP and sciatica presenting to the ED, adding tramadol or tizanidine to diclofenac did not improve functional recovery.
下腰痛（LBP）是全球范围内导致残疾的主要原因，给健康和社会经济带来了诸多挑战。本研究旨在比较非甾体抗炎药（NSAIDs）联合曲马多、替扎尼定或安慰剂是否能成为改善 Roland Morris 残疾问卷（RMDQ）评分的最佳治疗方案，评估时间为 1 周。
这是一项多中心、双盲、随机、安慰剂对照试验，纳入了香港 3 家急诊科的急性 LBP 和坐骨神经痛的成年患者。患者按 1:1:1 的比例随机接受曲马多 50mg、替扎尼定 2mg 或安慰剂，每 6 小时 1 次，持续 2 周。RMDQ 和其他次要结局在基线、第 2、7、14、21 和 28 天进行测量。采用意向治疗进行数据分析。采用置信区间确定替扎尼定/曲马多与安慰剂相比，从基线到第 7 天 RMDQ 和 NRS 评分变化的粗均值差异和调整均值差异。
共分析了 291 例患者，平均年龄为 47.4 岁，57.7%为男性。第 7 天 RMDQ 的主要结局（与基线相比），替扎尼定与安慰剂相比差异无统计学意义（调整后的平均差异-0.56，95%CI-2.48 至 1.37），曲马多与安慰剂相比差异也无统计学意义（调整后的平均差异-0.85，95%CI-2.80 至 1.10）。只有 23.7%的患者完全遵守了分配的治疗方案。遵从平均因果效应分析也表明，替扎尼定和曲马多与安慰剂相比，主要结局无差异。
在急诊科就诊的急性 LBP 和坐骨神经痛患者中，与双氯芬酸联合使用曲马多或替扎尼定并不能改善功能恢复。
