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针刺治疗慢性椎间盘源性坐骨神经痛的疗效和安全性:一项随机对照 sham 针刺试验。

Efficacy and Safety of Acupuncture for Chronic Discogenic Sciatica, a Randomized Controlled Sham Acupuncture Trial.

机构信息

Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

Beijing University of Chinese Medicine, Beijing, China.

出版信息

Pain Med. 2019 Nov 1;20(11):2303-2310. doi: 10.1093/pm/pnz167.

DOI:10.1093/pm/pnz167
PMID:31369674
Abstract

OBJECTIVE

To evaluate the efficacy and safety of acupuncture for discogenic sciatica.

DESIGN

Single-center, parallel, randomized controlled sham acupuncture trial.

METHODS

Twelve sessions of acupuncture or sham acupuncture at the same traditional acupoints over four weeks. The primary outcome was change from baseline in weekly mean leg pain, measured by the visual analog scale (VAS) over the four-week treatment period. The secondary outcomes were determined by the change from baseline in mean VAS scores for leg pain, VAS scores for low back pain, Oswestry Disability Index (ODI) scores, and 36-Item Short Form Health Survey (SF-36) scores. Patients were followed for 28 weeks.

RESULTS

Forty-six patients were enrolled in this study between June 2017 and January 2018, of which 23 were in the acupuncture group and 23 were in the sham acupuncture group. The between-group difference in weekly mean leg pain measured by the VAS over the four-week treatment period was -7.28 mm (95% confidence interval = -13.76 to -0.80, P = 0.029), which is larger than the minimum clinically important difference of 5 mm. The between-group differences in mean VAS scores for low back pain, ODI scores, and SF-36 scores were not significant in the study period (P > 0.05 for all). The proportion of acupuncture-related adverse events was 4.3%, and all adverse events were mild and transient.

CONCLUSIONS

Twelve sessions of acupuncture showed short-term clinical benefits in relieving the symptoms of leg pain for patients with chronic discogenic sciatica compared with sham acupuncture. Acupuncture is safe in treating chronic discogenic sciatica. Further studies with larger sample sizes, a longer treatment period, and long-term follow-up should be conducted to verify these results.

摘要

目的

评估针刺治疗椎间盘源性坐骨神经痛的疗效和安全性。

设计

单中心、平行、随机对照假针刺试验。

方法

四周内共进行 12 次针刺或假针刺相同的传统穴位。主要结局指标为 4 周治疗期间每周平均腿部疼痛的变化,采用视觉模拟评分法(VAS)进行评估。次要结局指标为腿部疼痛的平均 VAS 评分、腰痛 VAS 评分、Oswestry 残疾指数(ODI)评分和 36 项简明健康调查量表(SF-36)评分的基线变化。患者随访 28 周。

结果

2017 年 6 月至 2018 年 1 月期间,本研究共纳入 46 例患者,其中 23 例患者接受针刺治疗,23 例患者接受假针刺治疗。在 4 周治疗期间,VAS 测量的每周平均腿部疼痛的组间差异为-7.28mm(95%置信区间=-13.76 至-0.80,P=0.029),大于 5mm 的最小临床重要差异。在研究期间,腰痛 VAS 评分、ODI 评分和 SF-36 评分的组间差异均无统计学意义(所有 P 值均>0.05)。与针刺相关的不良事件发生率为 4.3%,所有不良事件均为轻度且短暂。

结论

与假针刺相比,12 次针刺治疗可在缓解慢性椎间盘源性坐骨神经痛患者腿部疼痛症状方面显示短期临床获益。针刺治疗慢性椎间盘源性坐骨神经痛是安全的。应进行更大样本量、更长治疗期和长期随访的进一步研究,以验证这些结果。

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