德国慢性下腰痛针灸试验（GERAC）：一项三臂随机、多中心、双盲、平行组试验。

German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups.

作者信息

Haake Michael, Müller Hans-Helge, Schade-Brittinger Carmen, Basler Heinz D, Schäfer Helmut, Maier Christoph, Endres Heinz G, Trampisch Hans J, Molsberger Albrecht

机构信息

Orthopaedic Department, University of Regensburg, Bad Abbach, Germany.

出版信息

Arch Intern Med. 2007 Sep 24;167(17):1892-8. doi: 10.1001/archinte.167.17.1892.

DOI:10.1001/archinte.167.17.1892

PMID:17893311

Abstract

BACKGROUND

To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain.

METHODS

A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean +/- SD age, 50 +/- 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement.

RESULTS

At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, -3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P < .001); and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P < .001.

CONCLUSIONS

Low back pain improved after acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy.

摘要

背景

据我们所知，在慢性腰痛患者中，尚未将真针灸与假针灸以及基于指南的传统疗法进行直接比较。

方法

在德国进行了一项患者和观察者双盲的随机对照试验，涉及340个门诊机构，纳入1162例年龄在18至86岁（平均±标准差年龄，50±15岁）、有慢性腰痛病史且平均病程8年的患者。患者接受十次30分钟的治疗，通常每周2次，真针灸组（n = 387）按照中医原则进行治疗；假针灸组（n = 387）在非穴位处浅刺；或传统疗法组，采用药物、物理治疗和运动相结合的方式（n = 388）。对治疗有部分反应（疼痛强度降低10%-50%）的患者可额外接受五次治疗。主要结局指标是6个月后的反应，定义为在冯·科尔夫慢性疼痛分级量表问卷的3个疼痛相关项目上改善33%或更好，或在背部特异性汉诺威功能能力问卷上改善12%或更好。在随访期间被揭盲或采用了允许的伴随疗法以外的其他疗法的患者，无论症状是否改善，均被归类为无反应者。

结果

6个月时，真针灸组的反应率为47.6%，假针灸组为44.2%，传统疗法组为27.4%。组间差异如下：真针灸组与假针灸组相比，为3.4%（95%置信区间，-3.7%至10.3%；P = 0.39）；真针灸组与传统疗法组相比，为20.2%（95%置信区间，13.4%至26.7%；P < 0.001）；假针灸组与传统疗法组相比，为16.8%（95%置信区间，10.1%至23.4%；P < 0.001）。