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针刺疗法与安慰剂治疗慢性机械性颈部疼痛的随机对照试验

Acupuncture versus placebo for the treatment of chronic mechanical neck pain: a randomized, controlled trial.

作者信息

White Peter, Lewith George, Prescott Phil, Conway Joy

机构信息

Complementary Medicine Research Unit, Mail Primary Medical Care, University of Southampton, Aldermoor Health Centre, Southampton, United Kingdom.

出版信息

Ann Intern Med. 2004 Dec 21;141(12):911-9. doi: 10.7326/0003-4819-141-12-200412210-00007.

DOI:10.7326/0003-4819-141-12-200412210-00007
PMID:15611488
Abstract

BACKGROUND

Despite substantial increases in its popularity and use, the efficacy of acupuncture for chronic mechanical neck pain remains unproved.

OBJECTIVE

To compare acupuncture and placebo for neck pain.

DESIGN

A randomized, single-blind, placebo-controlled, parallel-arm trial with 1-year follow-up.

SETTING

The outpatient departments of 2 major hospitals in the United Kingdom, 1999 to 2001.

PATIENTS

135 patients 18 to 80 years of age who had chronic mechanical neck pain. Eleven patients withdrew from treatment, and 124 completed the primary end point.

MEASUREMENTS

The primary outcome was pain 1 week after treatment, according to a visual analogue scale. Secondary outcomes were pain at other time points, score on the Neck Disability Index and the Short Form-36, and use of analgesic medications.

INTERVENTIONS

Patients were randomly assigned to receive, over 4 weeks, 8 treatments with acupuncture or with mock transcutaneous electrical stimulation of acupuncture points using a decommissioned electroacupuncture stimulation unit.

RESULTS

Both groups improved statistically from baseline, and acupuncture and placebo had similar credibility. For the primary outcome (weeks 1 to 5), a statistically significant difference in visual analogue scale score in favor of acupuncture (6.3 mm [95% CI, 1.4 to 11.3 mm]; P = 0.01) was observed between the 2 study groups, after adjustment for baseline pain and other covariates. However, this difference was not clinically significant because it demonstrated only a 12% (CI, 3% to 21%) difference between acupuncture and placebo. Secondary outcomes showed a similar pattern.

LIMITATIONS

All treatments were provided by 1 practitioner. Although the control was credible, it did not mimic the process of needling. A nonintervention group was not present to control for regression to the mean.

CONCLUSIONS

Acupuncture reduced neck pain and produced a statistically, but not clinically, significant effect compared with placebo. The beneficial effects of acupuncture for pain may be due to both nonspecific and specific effects.

摘要

背景

尽管针灸的普及程度和使用量大幅增加,但其对慢性机械性颈部疼痛的疗效仍未得到证实。

目的

比较针灸与安慰剂治疗颈部疼痛的效果。

设计

一项随机、单盲、安慰剂对照、平行组试验,随访1年。

地点

1999年至2001年英国2家大型医院的门诊部。

患者

135例年龄在18至80岁之间的慢性机械性颈部疼痛患者。11例患者退出治疗,124例完成主要终点指标。

测量指标

主要结局为治疗1周后的疼痛程度,采用视觉模拟评分法。次要结局包括其他时间点的疼痛程度、颈部功能障碍指数和简明健康状况调查量表(Short Form-36)评分以及止痛药物的使用情况。

干预措施

患者被随机分配接受为期4周的8次针灸治疗或使用退役的电针刺激仪对穴位进行模拟经皮电刺激治疗。

结果

两组患者均较基线有统计学意义的改善,针灸组和安慰剂组的可信度相似。对于主要结局(第1至5周),在调整基线疼痛和其他协变量后,两组间视觉模拟评分存在统计学意义的差异,针灸组更优(6.3 mm [95% CI,1.4至11.3 mm];P = 0.01)。然而,这种差异在临床上并不显著,因为针灸组与安慰剂组之间仅显示出12%(CI,3%至21%)的差异。次要结局呈现相似模式。

局限性

所有治疗均由1名医生提供。尽管对照可信,但未模拟针刺过程。未设置非干预组以控制均值回归。

结论

与安慰剂相比,针灸可减轻颈部疼痛,且在统计学上有显著效果,但在临床上并不显著。针灸治疗疼痛的有益效果可能归因于非特异性和特异性效应。

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