Karjalainen Teemu V, Jain Nitin B, Page Cristina M, Lähdeoja Tuomas A, Johnston Renea V, Salamh Paul, Kavaja Lauri, Ardern Clare L, Agarwal Arnav, Vandvik Per O, Buchbinder Rachelle
Monash Department of Clinical Epidemiology, Cabrini Institute and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia, 3144.
Cochrane Database Syst Rev. 2019 Jan 17;1(1):CD005619. doi: 10.1002/14651858.CD005619.pub3.
Surgery for rotator cuff disease is usually used after non-operative interventions have failed, although our Cochrane Review, first published in 2007, found that there was uncertain clinical benefit following subacromial decompression surgery.
To synthesise the available evidence of the benefits and harms of subacromial decompression surgery compared with placebo, no intervention or non-surgical interventions in people with rotator cuff disease (excluding full thickness rotator cuff tears).
We searched CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICRTP registry from 2006 until 22 October 2018, unrestricted by language.
We included randomised and quasi-randomised controlled trials (RCTs) of adults with rotator cuff disease (excluding full-thickness tears), that compared subacromial decompression surgery with placebo, no treatment, or any other non-surgical interventions. As it is least prone to bias, subacromial decompression compared with placebo was the primary comparison. Other comparisons were subacromial decompression versus exercises or non-operative treatment. Major outcomes were mean pain scores, shoulder function, quality of life, participant global assessment of success, adverse events and serious adverse events. The primary endpoint for this review was one year. For serious adverse events, we also included data from prospective cohort studies designed to record harms that evaluated subacromial decompression surgery or shoulder arthroscopy.
We used standard methodologic procedures expected by Cochrane.
We included eight trials, with a total of 1062 randomised participants with rotator cuff disease, all with subacromial impingement. Two trials (506 participants) compared arthroscopic subacromial decompression with arthroscopy only (placebo surgery), with all groups receiving postoperative exercises. These trials included a third treatment group: no treatment (active monitoring) in one and exercises in the other. Six trials (556 participants) compared arthroscopic subacromial decompression followed by exercises with exercises alone. Two of these trials included a third arm: sham laser in one and open subacromial decompression in the other.Trial size varied from 42 to 313 participants. Participant mean age ranged between 42 and 65 years. Only two trials reported mean symptom duration (18 to 22 months in one trial and 30 to 31 months in the other), two did not report duration and four reported it categorically.Both placebo-controlled trials were at low risk of bias for the comparison of surgery versus placebo surgery. The other trials were at high risk of bias for several criteria, most notably at risk of performance or detection bias due to lack of participant and personnel blinding. We have restricted the reporting of results of benefits in the Abstract to the placebo-controlled trials.Compared with placebo, high-certainty evidence indicates that subacromial decompression provides no improvement in pain, shoulder function, or health-related quality of life up to one year, and probably no improvement in global success (moderate-certainty evidence, downgraded due to imprecision).At one year, mean pain (on a scale zero to 10, higher scores indicate more pain), was 2.9 points after placebo surgery and 0.26 better (0.84 better to 0.33 worse), after subacromial decompression (284 participants), an absolute difference of 3% (8% better to 3% worse), and relative difference of 4% (12% better to 5% worse). At one year, mean function (on a scale 0 to 100, higher score indicating better outcome), was 69 points after placebo surgery and 2.8 better (1.4 worse to 6.9 better), after surgery (274 participants), an absolute difference of 3% (7% better to 1% worse), and relative difference of 9% (22% better to 4% worse). Global success rate was 97/148 (or 655 per 1000), after placebo and 101/142 (or 708 per 1000) after surgery corresponding to RR 1.08 (95% CI 0.93 to 1.27). Health-related quality of life was 0.73 units (European Quality of Life EQ-5D, -0.59 to 1, higher score indicating better quality of life), after placebo and 0.03 units worse (0.011 units worse to 0.06 units better), after subacromial decompression (285 participants), an absolute difference of 1.3% (5% worse to 2.5% better), and relative difference of 4% (15% worse to 7% better).Adverse events including frozen shoulder or transient minor complications of surgery were reported in approximately 3% of participants across treatment groups in two randomised controlled trials, but due to low event rates we are uncertain if the risks differ between groups: 5/165 (37 per 1000) reported adverse events with subacromial decompression and 9/241 (34 per 1000) with placebo or non-operative treatment, RR 0.91 (95% CI 0.31 to 2.65) (moderate-certainty evidence, downgraded due to imprecision). The trials did not report serious adverse events.Based upon moderate-certainty evidence from two observational trials from the same prospective surgery registry, which also included other shoulder arthroscopic procedures (downgraded for indirectness), the incidence proportion of serious adverse events within 30 days following surgery was 0.5% (0.4% to 0.7%; data collected 2006 to 2011), or 0.6% (0.5 % to 0.7%; data collected 2011 to 2013). Serious adverse events such as deep infection, pulmonary embolism, nerve injury, and death have been observed in participants following shoulder surgery.
AUTHORS' CONCLUSIONS: The data in this review do not support the use of subacromial decompression in the treatment of rotator cuff disease manifest as painful shoulder impingement. High-certainty evidence shows that subacromial decompression does not provide clinically important benefits over placebo in pain, function or health-related quality of life. Including results from open-label trials (with high risk of bias) did not change the estimates considerably. Due to imprecision, we downgraded the certainty of the evidence to moderate for global assessment of treatment success; there was probably no clinically important benefit in this outcome either compared with placebo, exercises or non-operative treatment.Adverse event rates were low, 3% or less across treatment groups in the trials, which is consistent with adverse event rates reported in the two observational studies. Although precise estimates are unknown, the risk of serious adverse events is likely less than 1%.
肩袖疾病的手术治疗通常在非手术干预失败后使用，尽管我们于2007年首次发表的Cochrane综述发现，肩峰下减压手术的临床益处尚不确定。
综合现有证据，比较肩峰下减压手术与安慰剂、不干预或非手术干预对肩袖疾病（不包括全层肩袖撕裂）患者的利弊。
我们检索了CENTRAL、MEDLINE、Embase、Clinicaltrials.gov和WHO ICRTP注册库，时间跨度从2006年至2018年10月22日，不受语言限制。
我们纳入了成年肩袖疾病患者（不包括全层撕裂）的随机和半随机对照试验（RCT），这些试验比较了肩峰下减压手术与安慰剂、不治疗或任何其他非手术干预措施。由于最不易产生偏倚，肩峰下减压与安慰剂的比较是主要比较。其他比较包括肩峰下减压与运动或非手术治疗。主要结局包括平均疼痛评分、肩部功能、生活质量、参与者对成功的总体评估、不良事件和严重不良事件。本综述的主要终点是一年。对于严重不良事件，我们还纳入了旨在记录危害的前瞻性队列研究的数据，这些研究评估了肩峰下减压手术或肩关节镜检查。
我们采用了Cochrane预期的标准方法程序。
我们纳入了八项试验，共有1062名随机分配的肩袖疾病参与者，均患有肩峰下撞击症。两项试验（506名参与者）比较了关节镜下肩峰下减压与仅行关节镜检查（安慰剂手术），所有组均接受术后运动。这些试验包括第三个治疗组：一组为不治疗（主动监测），另一组为运动。六项试验（556名参与者）比较了关节镜下肩峰下减压加运动与单纯运动。其中两项试验包括第三个组：一组为假激光治疗，另一组为开放性肩峰下减压。试验规模从42名至313名参与者不等。参与者的平均年龄在42岁至65岁之间。只有两项试验报告了平均症状持续时间（一项试验为18至22个月，另一项试验为30至31个月），两项未报告持续时间，四项进行了分类报告。两项安慰剂对照试验在手术与安慰剂手术比较中偏倚风险较低。其他试验在几个标准上存在高偏倚风险，最明显的是由于缺乏参与者和人员盲法而存在实施或检测偏倚风险。我们在摘要中对益处结果的报告仅限于安慰剂对照试验。与安慰剂相比，高确定性证据表明，肩峰下减压在长达一年的时间里在疼痛、肩部功能或健康相关生活质量方面没有改善，在总体成功率方面可能也没有改善（中等确定性证据，因不精确性而降级）。一年时，安慰剂手术后的平均疼痛（0至10分，分数越高疼痛越严重）为2.9分，肩峰下减压后改善了0.26分（改善0.84分至恶化0.33分）（284名参与者），绝对差异为3%（改善8%至恶化3%），相对差异为4%（改善12%至恶化5%）。一年时，安慰剂手术后的平均功能（0至100分，分数越高结局越好）为69分，手术后改善了2.8分（恶化1.4分至改善6.9分）（274名参与者），绝对差异为3%（改善7%至恶化1%），相对差异为9%（改善22%至恶化4%）。总体成功率在安慰剂组为97/148（或每1000人中有655人），手术后为101/142（或每1000人中有708人），相对危险度为1.08（95%CI 0.93至1.27）。健康相关生活质量在安慰剂组为0.73单位（欧洲生活质量EQ-5D，-0.59至1，分数越高生活质量越好），肩峰下减压后恶化了0.03单位（恶化0.011单位至改善0.06单位）（285名参与者），绝对差异为1.3%（恶化5%至改善2.5%），相对差异为4%（恶化15%至改善7%）。两项随机对照试验中，各治疗组约3%的参与者报告了不良事件，包括肩周炎或手术短暂轻微并发症，但由于事件发生率较低，我们不确定各组风险是否不同：肩峰下减压组5/165（每1000人中有37人）报告了不良事件，安慰剂或非手术治疗组9/241（每1000人中有34人），相对危险度为0.91（95%CI 0.31至2.65）（中等确定性证据，因不精确性而降级）。试验未报告严重不良事件。基于来自同一前瞻性手术注册库的两项观察性试验的中等确定性证据（也包括其他肩关节镜手术，因间接性而降级），手术后30天内严重不良事件的发生率为0.5%（0.4%至0.7%；2006年至2011年收集的数据），或0.6%（0.5%至0.7%；2011年至2013年收集的数据）。肩部手术后的参与者中观察到了严重不良事件，如深部感染、肺栓塞、神经损伤和死亡。
本综述中的数据不支持使用肩峰下减压治疗表现为疼痛性肩部撞击症的肩袖疾病。高确定性证据表明，肩峰下减压在疼痛、功能或健康相关生活质量方面相对于安慰剂没有提供临床上重要的益处。纳入开放标签试验（偏倚风险高）的结果并没有显著改变估计值。由于不精确性，我们将治疗成功总体评估的证据确定性降至中等；与安慰剂、运动或非手术治疗相比，该结局可能也没有临床上重要的益处。不良事件发生率较低，试验中各治疗组均为3%或更低，这与两项观察性研究报告的不良事件发生率一致。尽管精确估计值未知，但严重不良事件的风险可能低于1%。
