Acupuncture for chronic nonspecific low back pain

WTW

Abstract

Background: Chronic nonspecific low back pain (LBP) is very common; it is defined as pain without a recognizable etiology that lasts for more than three months. Some clinical practice guidelines suggest that acupuncture can offer an effective alternative therapy. This review is a split from an earlier Cochrane review and it focuses on chronic LBP.

Objectives: To assess the effects of acupuncture compared to sham intervention, no treatment, or usual care for chronic nonspecific LBP.

Search methods: We searched CENTRAL, MEDLINE, Embase, CINAHL, two Chinese databases, and two trial registers to 29 August 2019 without restrictions on language or publication status. We also screened reference lists and LBP guidelines to identify potentially relevant studies.

Selection criteria: We included only randomized controlled trials (RCTs) of acupuncture for chronic nonspecific LBP in adults. We excluded RCTs that investigated LBP with a specific etiology. We included trials comparing acupuncture with sham intervention, no treatment, and usual care. The primary outcomes were pain, back-specific functional status, and quality of life; the secondary outcomes were pain-related disability, global assessment, or adverse events.

Data collection and analysis: Two review authors independently screened the studies, assessed the risk of bias and extracted the data. We meta-analyzed data that were clinically homogeneous using a random-effects model in Review Manager 5.3. Otherwise, we reported the data qualitatively. We used the GRADE approach to assess the certainty of the evidence.

Main results: We included 33 studies (37 articles) with 8270 participants. The majority of studies were carried out in Europe, Asia, North and South America. Seven studies (5572 participants) conducted in Germany accounted for 67% of the participants. Sixteen trials compared acupuncture with sham intervention, usual care, or no treatment. Most studies had high risk of performance bias due to lack of blinding of the acupuncturist. A few studies were found to have high risk of detection, attrition, reporting or selection bias. We found low-certainty evidence (seven trials, 1403 participants) that acupuncture may relieve pain in the immediate term (up to seven days) compared to sham intervention (mean difference (MD) -9.22, 95% confidence interval (CI) -13.82 to -4.61, visual analogue scale (VAS) 0-100). The difference did not meet the clinically important threshold of 15 points or 30% relative change. Very low-certainty evidence from five trials (1481 participants) showed that acupuncture was not more effective than sham in improving back-specific function in the immediate term (standardized mean difference (SMD) -0.16, 95% CI -0.38 to 0.06; corresponding to the Hannover Function Ability Questionnaire (HFAQ, 0 to 100, higher values better) change (MD 3.33 points; 95% CI -1.25 to 7.90)). Three trials (1068 participants) yielded low-certainty evidence that acupuncture seemed not to be more effective clinically in the short term for quality of life (SMD 0.24, 95% CI 0.03 to 0.45; corresponding to the physical 12-item Short Form Health Survey (SF-12, 0-100, higher values better) change (MD 2.33 points; 95% CI 0.29 to 4.37)). The reasons for downgrading the certainty of the evidence to either low to very low were risk of bias, inconsistency, and imprecision. We found moderate-certainty evidence that acupuncture produced greater and clinically important pain relief (MD -20.32, 95% CI -24.50 to -16.14; four trials, 366 participants; (VAS, 0 to 100), and improved back function (SMD -0.53, 95% CI -0.73 to -0.34; five trials, 2960 participants; corresponding to the HFAQ change (MD 11.50 points; 95% CI 7.38 to 15.84)) in the immediate term compared to no treatment. The evidence was downgraded to moderate certainty due to risk of bias. No studies reported on quality of life in the short term or adverse events. Low-certainty evidence (five trials, 1054 participants) suggested that acupuncture may reduce pain (MD -10.26, 95% CI -17.11 to -3.40; not clinically important on 0 to 100 VAS), and improve back-specific function immediately after treatment (SMD: -0.47; 95% CI: -0.77 to -0.17; five trials, 1381 participants; corresponding to the HFAQ change (MD 9.78 points, 95% CI 3.54 to 16.02)) compared to usual care. Moderate-certainty evidence from one trial (731 participants) found that acupuncture was more effective in improving physical quality of life (MD 4.20, 95% CI 2.82 to 5.58) but not mental quality of life in the short term (MD 1.90, 95% CI 0.25 to 3.55). The certainty of evidence was downgraded to moderate to low because of risk of bias, inconsistency, and imprecision. Low-certainty evidence suggested a similar incidence of adverse events immediately after treatment in the acupuncture and sham intervention groups (four trials, 465 participants) (RR 0.68 95% CI 0.46 to 1.01), and the acupuncture and usual care groups (one trial, 74 participants) (RR 3.34, 95% CI 0.36 to 30.68). The certainty of the evidence was downgraded due to risk of bias and imprecision. No trial reported adverse events for acupuncture when compared to no treatment. The most commonly reported adverse events in the acupuncture groups were insertion point pain, bruising, hematoma, bleeding, worsening of LBP, and pain other than LBP (pain in leg and shoulder).

Authors' conclusions: We found that acupuncture may not play a more clinically meaningful role than sham in relieving pain immediately after treatment or in improving quality of life in the short term, and acupuncture possibly did not improve back function compared to sham in the immediate term. However, acupuncture was more effective than no treatment in improving pain and function in the immediate term. Trials with usual care as the control showed acupuncture may not reduce pain clinically, but the therapy may improve function immediately after sessions as well as physical but not mental quality of life in the short term. The evidence was downgraded to moderate to very low-certainty considering most of studies had high risk of bias, inconsistency, and small sample size introducing imprecision. The decision to use acupuncture to treat chronic low back pain might depend on the availability, cost and patient's preferences.

摘要背景：慢性非特异性腰痛（LBP）非常常见；它被定义为没有可识别病因的疼痛，持续时间超过三个月。一些临床实践指南表明，针灸可以提供一种有效的替代疗法。这篇综述是从早期的Cochrane综述中分离出来的，它专注于慢性LBP。目的：评估针灸与假干预、不治疗或常规护理治疗慢性非特异性LBP的效果。搜索方法：截至2019年8月29日，我们搜索了CENTRAL、MEDLINE、Embase、CINAHL、两个中文数据库和两个试验注册，不受语言或出版状态的限制。我们还筛选了参考文献列表和LBP指南，以确定潜在的相关研究。选择标准：我们只纳入了针灸治疗成人慢性非特异性LBP的随机对照试验。我们排除了研究具有特定病因的LBP的随机对照试验。我们纳入了将针灸与假干预、不治疗和常规护理进行比较的试验。主要结果是疼痛、背部特定功能状态和生活质量；次要结果是与疼痛相关的残疾、整体评估或不良事件。数据收集和分析：两位综述作者独立筛选研究，评估偏倚风险并提取数据。我们使用Review Manager 5.3中的随机效应模型对临床上同质的数据进行了荟萃分析。除此之外，我们对数据进行了定性报告。我们使用GRADE方法来评估证据的确定性。主要结果：我们纳入了33项研究（37篇文章），8270名参与者。大多数研究在欧洲、亚洲、北美和南美进行。在德国进行的七项研究（5572名参与者）占参与者的67%。16项试验将针灸与假干预、常规护理或不治疗进行了比较。由于缺乏针灸师的盲目性，大多数研究都有很高的表现偏差风险。一些研究被发现具有高风险的检测、流失、报告或选择偏差。我们发现，与假干预相比，针灸可以在短期内（最多七天）缓解疼痛的低确定性证据（七项试验，1403名参与者）（平均差（MD）-9.22，95%置信区间（CI）-13.82至-4.61，视觉模拟评分（VAS）0-100）。差异未达到15分或30%相对变化的临床重要阈值。来自五项试验（1481名参与者）的极低确定性证据表明，针灸在短期内改善背部特异性功能方面并不比假手术更有效（标准化平均差（SMD）-0.16，95%CI-0.38至0.06；与Hannover功能能力问卷（HFAQ，0-100，数值越高越好）的变化相对应（MD 3.33分；95%CI-1.25-7.90）（SMD 0.24，95%置信区间0.03至0.45；对应于身体12项简式健康调查（SF-12，0-100，数值越高越好）的变化（MD 2.33分；95%置信区间0.29至4.37）。将证据的确定性降级为低至极低的原因是偏倚、不一致和不精确的风险。我们发现适度确定的证据表明，针灸能产生更大的临床重要疼痛缓解（MD-20.32，95%CI-24.50至-16.14；四项试验，366名参与者；（VAS，0-100），与不治疗相比，近期背部功能改善（SMD-0.53，95%CI-0.73至-0.34；五项试验，2960名参与者；对应于HFAQ变化（MD 11.50分；95%CI 7.38至15.84））。由于存在偏见的风险，证据被降级为中等确定性。没有关于短期生活质量或不良事件的研究报告。低确定性证据（五项试验，1054名参与者）表明，针灸可以减轻疼痛（MD-10.26，95%CI-17.11至-3.40；对0至100 VAS没有临床重要性），并在治疗后立即改善背部特异性功能（SMD:-0.47；95%置信区间：-0.77至-0.17；五项试验，1381名参与者；对应于HFAQ变化（MD 9.78分，95%置信区间3.54至16.02））。来自一项试验（731名参与者）的中等确定性证据发现，针灸在改善身体生活质量方面更有效（MD 4.20，95%CI 2.82至5.58），但在短期内不能改善心理生活质量（MD 1.90，95%CI 0.25至3.55）。由于存在偏倚、不一致和不精确的风险，证据的确定性被降级为中等至较低。低确定性证据表明，针灸和假干预组（四项试验，465名参与者）（RR 0.68，95%CI 0.46至1.01）以及针灸和常规护理组（一项试验，74名参与者）在治疗后立即发生类似的不良事件（RR