针灸与假针灸治疗椎间盘突出引起的慢性坐骨神经痛:随机临床试验

IF 22.5 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL JAMA Internal Medicine Pub Date : 2024-10-14 DOI:10.1001/jamainternmed.2024.5463
Jian-Feng Tu, Guang-Xia Shi, Shi-Yan Yan, Guang-Xia Ni, Fang-Ting Yu, Guo-Wei Cai, Zhi-Shun Liu, Chao-Yang Ma, Li-Qiong Wang, Jing-Wen Yang, Xiao-Qing Zhou, Xiu-Li Meng, Hai-Yang Fu, Jing Li, Wen-Jun Wan, Tian-Heng Sun, Xue-Zhou Wang, Cun-Zhi Liu
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引用次数: 0

摘要

重要性:坐骨神经痛通常由腰椎间盘突出症引起,会导致剧烈疼痛和长期残疾。虽然针灸被慢性坐骨神经痛患者广泛使用,但其疗效的证据却很少:研究针灸与假针灸对腰椎间盘突出症引起的慢性坐骨神经痛患者的疗效和安全性:这是一项多中心双臂随机临床试验,在中国 6 家三级甲等医院进行,对象为腰椎间盘突出症引起的慢性坐骨神经痛患者。参与者招募时间为 2021 年 3 月 25 日至 2021 年 9 月 23 日,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:随机分配参与者在 4 周内接受 10 次针灸(n = 110)或假针灸(n = 110)。参与者、结果评估者和统计人员均为盲人:两个主要结果是腿痛视觉模拟量表(VAS)和Oswestry残疾指数(ODI)从基线到第4周的变化。次要结果为不良事件:共有 216 名患者(平均 [SD] 年龄 51.3 [15.2] 岁;147 名女性 [68.1%] 和 69 名男性 [31.9%])参与了分析。第4周时,针灸组腿部疼痛的VAS值下降了30.8毫米,假针灸组下降了14.9毫米(平均差异,-16.0;95% CI,-21.3至-10.6;P 结论及意义:这项随机临床试验发现,与假针灸相比,针灸治疗腰椎间盘突出症引起的慢性坐骨神经痛患者在第 4 周时疼痛更轻、功能更好,而且这些益处一直持续到第 52 周。对于椎间盘突出引起的慢性坐骨神经痛患者,针灸应被视为一种潜在的治疗方法:试验注册:Chictr.org Identifier:ChiCTR2100044585。
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Acupuncture vs Sham Acupuncture for Chronic Sciatica From Herniated Disk: A Randomized Clinical Trial.

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.

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来源期刊
JAMA Internal Medicine
JAMA Internal Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
43.50
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1.30%
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371
期刊介绍: JAMA Internal Medicine is an international, peer-reviewed journal committed to advancing the field of internal medicine worldwide. With a focus on four core priorities—clinical relevance, clinical practice change, credibility, and effective communication—the journal aims to provide indispensable and trustworthy peer-reviewed evidence. Catering to academics, clinicians, educators, researchers, and trainees across the entire spectrum of internal medicine, including general internal medicine and subspecialties, JAMA Internal Medicine publishes innovative and clinically relevant research. The journal strives to deliver stimulating articles that educate and inform readers with the latest research findings, driving positive change in healthcare systems and patient care delivery. As a member of the JAMA Network, a consortium of peer-reviewed medical publications, JAMA Internal Medicine plays a pivotal role in shaping the discourse and advancing patient care in internal medicine.
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