PDF(Pubmed)
Abstract：
UNASSIGNED: Chronic lower back pain (LBP) is a major global health concern. Pharmacopuncture has been widely used to treat LBP in Korea; however, randomized clinical trials (RCT) or active control have not been conducted to evaluate its effectiveness. Therefore, this RCT aimed to compare the effectiveness of pharmacopuncture and physical therapy (PT) for the treatment of chronic LBP.
UNASSIGNED: A two-arm, parallel, and multicenter RCT was conducted at four hospitals of Korean medicine. Participants with chronic LBP were randomly assigned at a 1:1 ratio using block randomization to undergo 10 sessions of pharmacopuncture or PT over 5 weeks and followed up for 25 weeks. The numerical rating scale (NRS) and visual analog scale scores of LBP and radiating leg pain and the Oswestry disability index (ODI), 5-level EuroQol-5 dimension (EQ-5D-5L), and the patient global impression of change were recorded at baseline and at 6, 13, and 25 weeks. An intention-to-treat analysis was conducted as the primary analysis using a linear mixed model.
UNASSIGNED: One-hundred patients (mean age, 49.27 years; 58 women) were recruited. At 6 weeks after randomization, pharmacopuncture showed statistically superior results compared with PT in LBP (difference in NRS, 1.54; 95% CI, 0.94-2.13), function (difference in ODI, 4.52%; 95% CI, 0.93-8.11%), and quality of life (difference in EQ-5D-5L) scores (-0.05; 95% CI, -0.08 to -0.01). This effect persisted for 25 weeks. In the survival analysis for participants with at least a 50% reduction in the NRS scores of LBP during the 182-day follow-up, the pharmacopuncture group showed significantly faster recovery than the PT group (P<0.001, Log rank test).
UNASSIGNED: Pharmacopuncture significantly reduced pain and improved functional outcomes and quality of life in patients with low back pain compared with physical therapy. Based on the findings of this study, pharmacopuncture could be recommended as a treatment for patients with chronic low back pain.
UNASSIGNED: A two-arm, parallel, and multicenter RCT was conducted at four hospitals of Korean medicine. Participants with chronic LBP were randomly assigned at a 1:1 ratio using block randomization to undergo 10 sessions of pharmacopuncture or PT over 5 weeks and followed up for 25 weeks. The numerical rating scale (NRS) and visual analog scale scores of LBP and radiating leg pain and the Oswestry disability index (ODI), 5-level EuroQol-5 dimension (EQ-5D-5L), and the patient global impression of change were recorded at baseline and at 6, 13, and 25 weeks. An intention-to-treat analysis was conducted as the primary analysis using a linear mixed model.
UNASSIGNED: One-hundred patients (mean age, 49.27 years; 58 women) were recruited. At 6 weeks after randomization, pharmacopuncture showed statistically superior results compared with PT in LBP (difference in NRS, 1.54; 95% CI, 0.94-2.13), function (difference in ODI, 4.52%; 95% CI, 0.93-8.11%), and quality of life (difference in EQ-5D-5L) scores (-0.05; 95% CI, -0.08 to -0.01). This effect persisted for 25 weeks. In the survival analysis for participants with at least a 50% reduction in the NRS scores of LBP during the 182-day follow-up, the pharmacopuncture group showed significantly faster recovery than the PT group (P<0.001, Log rank test).
UNASSIGNED: Pharmacopuncture significantly reduced pain and improved functional outcomes and quality of life in patients with low back pain compared with physical therapy. Based on the findings of this study, pharmacopuncture could be recommended as a treatment for patients with chronic low back pain.
摘要：
慢性下背痛（LBP）是全球主要的健康问题。在韩国，药物穿刺已被广泛用于治疗LBP；然而，尚未进行随机临床试验(RCT)或主动对照以评估其有效性.因此,本RCT旨在比较药物穿刺和物理治疗(PT)治疗慢性LBP的有效性.
■双臂，平行,在韩国的四家医院进行了多中心RCT。患有慢性LBP的参与者使用区组随机化以1：1的比例随机分配，在5周内接受10次药物穿刺或PT治疗，并随访25周。LBP和放射性腿部疼痛的数字评定量表（NRS）和视觉模拟量表评分以及Oswestry残疾指数（ODI），5级EuroQol-5尺寸（EQ-5D-5L），在基线和第6,13和25周记录患者的总体变化印象.使用线性混合模型进行意向治疗分析作为主要分析。
■100名患者(平均年龄，49.27岁；58名妇女）被招募。随机化后6周，与LBP中的PT相比，药物穿刺显示出统计学上更好的结果（NRS的差异，1.54；95%CI，0.94-2.13），函数(ODI差异，4.52%；95%CI，0.93-8.11%），和生活质量（EQ-5D-5L差异）评分（-0.05；95％CI，-0.08至-0.01）。这种效果持续25周。在182天随访期间，LBP的NRS评分降低至少50%的参与者的生存分析中，药物穿刺组恢复速度明显快于PT组(P<0.001,Logrank检验)。
■与物理治疗相比，药物穿刺可显著减轻腰背痛患者的疼痛，改善患者的功能预后和生活质量。根据这项研究的结果，药物穿刺可推荐作为慢性下腰痛患者的治疗方法.
■双臂，平行,在韩国的四家医院进行了多中心RCT。患有慢性LBP的参与者使用区组随机化以1：1的比例随机分配，在5周内接受10次药物穿刺或PT治疗，并随访25周。LBP和放射性腿部疼痛的数字评定量表（NRS）和视觉模拟量表评分以及Oswestry残疾指数（ODI），5级EuroQol-5尺寸（EQ-5D-5L），在基线和第6,13和25周记录患者的总体变化印象.使用线性混合模型进行意向治疗分析作为主要分析。
■100名患者(平均年龄，49.27岁；58名妇女）被招募。随机化后6周，与LBP中的PT相比，药物穿刺显示出统计学上更好的结果（NRS的差异，1.54；95%CI，0.94-2.13），函数(ODI差异，4.52%；95%CI，0.93-8.11%），和生活质量（EQ-5D-5L差异）评分（-0.05；95％CI，-0.08至-0.01）。这种效果持续25周。在182天随访期间，LBP的NRS评分降低至少50%的参与者的生存分析中，药物穿刺组恢复速度明显快于PT组(P<0.001,Logrank检验)。
■与物理治疗相比，药物穿刺可显著减轻腰背痛患者的疼痛，改善患者的功能预后和生活质量。根据这项研究的结果，药物穿刺可推荐作为慢性下腰痛患者的治疗方法.
