Department of Anesthesiology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
School of Chinese Medicine, The University of Hong Kong, Hong Kong, China.
Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD013814. doi: 10.1002/14651858.CD013814.
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.
背景:慢性非特异性下腰痛(LBP)非常常见;它被定义为没有可识别病因且持续三个月以上的疼痛。一些临床实践指南表明,针灸可以提供有效的替代疗法。本综述是对 Cochrane 早期综述的一项拆分,重点关注慢性 LBP。
目的:评估与假干预、无治疗或常规护理相比,针灸治疗慢性非特异性 LBP 的效果。
检索方法:我们检索了 CENTRAL、MEDLINE、Embase、CINAHL、两个中文数据库和两个试验注册处,截至 2019 年 8 月 29 日,没有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,以确定潜在相关的研究。
选择标准:我们仅纳入了针对成人慢性非特异性 LBP 的针灸随机对照试验(RCT)。我们排除了针对特定病因 LBP 的 RCT。我们纳入了将针灸与假干预、无治疗和常规护理进行比较的试验。主要结局是疼痛、背部特定功能状态和生活质量;次要结局是疼痛相关残疾、总体评估或不良事件。
数据收集和分析:两名综述作者独立筛选研究、评估偏倚风险并提取数据。我们使用随机效应模型对具有临床同质性的数据进行了荟萃分析(Review Manager 5.3)。否则,我们以定性方式报告数据。我们使用 GRADE 方法评估证据的确定性。
主要结果:我们纳入了 33 项研究(37 篇文章),涉及 8270 名参与者。大多数研究在欧洲、亚洲、北美和南美洲进行。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、常规护理或无治疗进行了比较。大多数研究由于针灸师的盲法缺乏而存在高度偏倚风险。少数研究存在检测、失访、报告或选择偏倚的高风险。我们发现低确定性证据(7 项试验,1403 名参与者)表明,与假干预相比,针灸可能在短期内(最多 7 天)缓解疼痛(平均差异(MD)-9.22,95%置信区间(CI)-13.82 至-4.61,视觉模拟量表(VAS)0-100)。差异未达到 15 点或 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,针灸在短期内对改善背部特定功能并不比假干预更有效(标准化平均差异(SMD)-0.16,95%CI-0.38 至 0.06;对应于汉诺威功能能力问卷(HFAQ,0 到 100,更高的值表示更好)的变化(MD 3.33 分;95%CI-1.25 至 7.90))。三项试验(1068 名参与者)产生了低确定性证据,表明针灸在短期内对生活质量可能没有更有效的临床效果(SMD 0.24,95%CI 0.03 至 0.45;对应于身体 12 项简短健康调查问卷(SF-12,0 到 100,更高的值表示更好)的变化(MD 2.33 分;95%CI 0.29 至 4.37))。证据降级为低至极低确定性的原因是偏倚、不一致和不精确。我们发现中度确定性证据表明,针灸在短期内能产生更大且具有临床意义的疼痛缓解(MD-20.32,95%CI-24.50 至-16.14;四项试验,366 名参与者;(VAS,0 到 100),并改善背部功能(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))与无治疗相比。由于偏倚,证据降级为中度确定性。没有研究报告短期生活质量或不良事件。低确定性证据(五项试验,1054 名参与者)表明,针灸可能在治疗后立即减轻疼痛(MD-10.26,95%CI-17.11 至-3.40;VAS 0 到 100 上没有临床意义),并改善背部特定功能(SMD:-0.47;95%CI:-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%CI 3.54 至 16.02))与常规护理相比。来自一项试验(731 名参与者)的中度确定性证据发现,针灸在改善身体生活质量方面更为有效(MD 4.20,95%CI 2.82 至 5.58),但在短期改善心理健康质量方面效果不佳(MD 1.90,95%CI 0.25 至 3.55)。由于偏倚、不一致和不精确,证据的确定性被降级为中度到低度。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)和针灸和常规护理组(一项试验,74 名参与者)(RR 3.34,95%CI 0.36 至 30.68))在治疗后立即发生不良事件的发生率相似。由于偏倚和不精确,证据的确定性被降级。没有试验报告针灸与无治疗相比时的不良事件。在针灸组中最常报告的不良事件是针刺部位疼痛、瘀伤、血肿、出血、LBP 恶化和 LBP 以外的疼痛(腿部和肩部疼痛)。
作者结论:我们发现,与假干预相比,针灸在治疗后立即缓解疼痛或改善短期生活质量方面可能没有更具临床意义的作用,并且针灸在短期内可能不会像假干预那样改善背部功能。然而,针灸在短期内比无治疗更有效地改善疼痛和功能。与常规护理作为对照的试验表明,针灸可能不会在临床上减轻疼痛,但该疗法可能会在治疗后立即改善功能,以及短期的身体但不是心理健康质量。考虑到大多数研究存在高偏倚风险、不一致和小样本量导致不精确,证据被降级为中度至非常低确定性。使用针灸治疗慢性腰痛的决定可能取决于可用性、成本和患者的偏好。
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