Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (L.Z., Y.S., J.L., W.P., W.W., J.Z., R.J., B.S., Y.Y., Z.L.).
The Key Laboratory of Chinese Internal Medicine of the Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (J.K., Y.L.).
Ann Intern Med. 2024 Aug;177(8):1048-1057. doi: 10.7326/M23-2749. Epub 2024 Jul 2.
Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient.
To investigate the effect of acupuncture for DLSS.
Multicenter randomized clinical trial. (ClinicalTrials.gov: NCT03784729).
5 hospitals in China.
Patients with DLSS and predominantly neurogenic claudication pain symptoms.
18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment.
The primary outcome was change from baseline in the modified Roland-Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ.
A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of -1.3 (CI, -2.6 to -0.03; = 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, -1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient.
The SA could produce physiologic effects.
Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment.
2019 National Administration of Traditional Chinese Medicine "Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM" (NO. 2019XZZX-ZJ).
针灸可能改善退行性腰椎管狭窄症（DLSS），但证据不足。
研究针灸治疗 DLSS 的效果。
多中心随机临床试验。（ClinicalTrials.gov：NCT03784729）。
中国 5 家医院。
以神经源性跛行疼痛为主的 DLSS 患者。
18 次针灸或假针灸（SA）治疗，共 6 周，治疗后随访 24 周。
主要结局是改良 Roland-Morris 残疾问卷（[RMDQ]评分范围为 0 至 24；最小临床重要差异 [MCID]为 2 至 3）从基线的变化。次要结局是根据改良 RMDQ 达到最小（基线降低 30%）和显著（基线降低 50%）临床有意义改善的参与者比例。
共纳入 196 名参与者（每组 98 名）。针灸组基线时改良 RMDQ 评分平均为 12.6（95%CI，11.8 至 13.4），SA 组为 12.7（CI，12.0 至 13.3），6 周时分别降至 8.1（CI，7.1 至 9.1）和 9.5（CI，8.6 至 10.4），平均变化差值为-1.3（CI，-2.6 至 -0.03；=0.044），表明与 SA 相比，改善程度提高了 43.3%。6 周时，针灸组达到最小和显著临床有意义改善的参与者比例差异为 16.0%（CI，1.6%至 30.4%）和 12.6%（CI，-1.0%至 26.2%）。针灸组报告了 3 例与治疗相关的不良事件，SA 组报告了 3 例。所有事件均为轻度和一过性。
SA 可能会产生生理效应。
针灸可能缓解以神经源性跛行疼痛为主的 DLSS 患者的疼痛特异性残疾，尽管与 SA 的差异未达到 MCID。在 6 周治疗后，这种效果可能持续 24 周。
2019 年国家中医药管理局“中医药证据实践能力建设项目——中医药 BEBPC 项目”（NO.2019XZZX-ZJ）。
