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针刺与假针刺治疗椎间盘突出所致慢性坐骨神经痛的随机临床试验

Acupuncture vs Sham Acupuncture for Chronic Sciatica From Herniated Disk: A Randomized Clinical Trial.

作者信息

Tu Jian-Feng, Shi Guang-Xia, Yan Shi-Yan, Ni Guang-Xia, Yu Fang-Ting, Cai Guo-Wei, Liu Zhi-Shun, Ma Chao-Yang, Wang Li-Qiong, Yang Jing-Wen, Zhou Xiao-Qing, Meng Xiu-Li, Fu Hai-Yang, Li Jing, Wan Wen-Jun, Sun Tian-Heng, Wang Xue-Zhou, Liu Cun-Zhi

机构信息

International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.

Department of Acupuncture, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.

出版信息

JAMA Intern Med. 2024 Dec 1;184(12):1417-1424. doi: 10.1001/jamainternmed.2024.5463.

Abstract

IMPORTANCE

Sciatica is commonly caused by herniated lumbar disc and contributes to severe pain and prolonged disability. Although acupuncture is widely used by patients with chronic sciatica, the evidence of its efficacy is scarce.

OBJECTIVE

To investigate the efficacy and safety of acupuncture compared with sham acupuncture in patients with chronic sciatica from herniated disk.

DESIGN, SETTINGS, AND PARTICIPANTS: This was a multicenter 2-arm randomized clinical trial conducted in 6 tertiary-level hospitals in China of patients with chronic sciatica from herniated disk. Participants were recruited from March 25, 2021, to September 23, 2021, with a final follow-up through September 22, 2022. Data analyses were performed from December 2022 to March 2023.

INTERVENTIONS

Participants were randomly assigned to receive 10 sessions of acupuncture (n = 110) or sham acupuncture (n = 110) over 4 weeks. Participants, outcome assessors, and statisticians were blinded.

MAIN OUTCOMES AND MEASURES

The 2 coprimary outcomes were changes in visual analog scale (VAS) for leg pain and Oswestry Disability Index (ODI) from baseline to week 4. Secondary outcomes were adverse events.

RESULTS

A total of 216 patients (mean [SD] age, 51.3 [15.2] years; 147 females [68.1%] and 69 males [31.9%]) were included in the analyses. The VAS for leg pain decreased 30.8 mm in the acupuncture group and 14.9 mm in the sham acupuncture group at week 4 (mean difference, -16.0; 95% CI, -21.3 to -10.6; P < .001). The ODI decreased 13.0 points in the acupuncture group and 4.9 points in the sham acupuncture group at week 4 (mean difference, -8.1; 95% CI, -11.1 to -5.1; P < .001). For both VAS and ODI, the between-group difference became apparent starting in week 2 (mean difference, -7.8; 95% CI, -13.0 to -2.5; P = .004 and -5.3; 95% CI, -8.4 to -2.3; P = .001, respectively) and persisted through week 52 (mean difference, -10.8; [95% CI, -16.3 to -5.2; P < .001; and -4.8; 95% CI, -7.8 to -1.7; P = .003, respectively). No serious adverse events occurred.

CONCLUSIONS AND RELEVANCE

This randomized clinical trial found that in patients with chronic sciatica from herniated disk, acupuncture resulted in less pain and better function compared with sham acupuncture at week 4, and these benefits persisted through week 52. Acupuncture should be considered as a potential treatment option for patients with chronic sciatica from a herniated disk.

TRIAL REGISTRATION

Chictr.org Identifier: ChiCTR2100044585.

摘要

重要性

坐骨神经痛通常由腰椎间盘突出引起,会导致严重疼痛和长期残疾。尽管针灸被慢性坐骨神经痛患者广泛使用,但其疗效证据却很稀少。

目的

研究与假针灸相比,针灸治疗椎间盘突出所致慢性坐骨神经痛患者的疗效和安全性。

设计、设置和参与者:这是一项在中国6家三级医院进行的多中心双臂随机临床试验,研究对象为椎间盘突出所致慢性坐骨神经痛患者。参与者于2021年3月25日至2021年9月23日招募,最终随访至2022年9月22日。数据分析于2022年12月至2023年3月进行。

干预措施

参与者被随机分配在4周内接受10次针灸治疗(n = 110)或假针灸治疗(n = 110)。参与者、结果评估者和统计人员均处于盲态。

主要结局和指标

两个共同主要结局是从基线到第4周时腿部疼痛视觉模拟量表(VAS)和Oswestry功能障碍指数(ODI)的变化。次要结局是不良事件。

结果

共有216名患者(平均[标准差]年龄,51.3[15.2]岁;147名女性[68.1%]和69名男性[31.9%])纳入分析。在第4周时,针灸组腿部疼痛VAS下降30.8 mm,假针灸组下降14.9 mm(平均差值,-16.0;95%置信区间,-21.3至-10.6;P <.001)。第4周时,针灸组ODI下降13.0分,假针灸组下降4.9分(平均差值,-8.1;95%置信区间,-11.1至-5.1;P <.001)。对于VAS和ODI,组间差异从第2周开始变得明显(平均差值,-7.8;95%置信区间,-13.0至-2.5;P = 0.004和-5.3;95%置信区间,-8.4至-2.3;P = 0.001),并持续至第52周(平均差值,-10.8;[95%置信区间,-16.3至-5.2;P <.001;以及-4.8;95%置信区间,-7.8至-1.7;P = 0.003)。未发生严重不良事件。

结论和意义

这项随机临床试验发现,对于椎间盘突出所致慢性坐骨神经痛患者,与假针灸相比,针灸在第4周时能减轻疼痛并改善功能,且这些益处持续至第52周。针灸应被视为椎间盘突出所致慢性坐骨神经痛患者的一种潜在治疗选择。

试验注册

中国临床试验注册中心标识符:ChiCTR2100044585。

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