Rutjes Anne Ws, Nüesch Eveline, Reichenbach Stephan, Jüni Peter
Division of Clinical Epidemiology and Biostatistics, Institute of Social and Preventive Medicine, University of Bern, Finkenhubelweg 11, Bern, Switzerland, 3012.
Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD007321. doi: 10.1002/14651858.CD007321.pub2.
Osteoarthritis is the most common form of joint disease and the leading cause of pain and disability in the elderly. S-Adenosylmethionine may be a viable treatment option but the evidence about its effectiveness and safety is equivocal.
We set out to compare S-Adenosylmethionine (SAMe) with placebo or no specific intervention in terms of effects on pain and function and safety outcomes in patients with knee or hip osteoarthritis.
We searched CENTRAL, MEDLINE, EMBASE, CINAHL and PEDro up to 5 August 2008, checked conference proceedings and reference lists, and contacted authors.
Randomised or quasi-randomised controlled trials that compared SAMe at any dosage and in any formulation with placebo or no intervention in patients with osteoarthritis of the knee or hip.
Two independent authors extracted data using standardised forms. We contacted investigators to obtain missing outcome information. We calculated standardised mean differences (SMDs) for pain and function, and relative risks for safety outcomes. We combined trials using inverse-variance random-effects meta-analysis.
Four trials including 656 patients were included in the systematic review, all compared SAMe with placebo. The methodological quality and the quality of reporting were poor. For pain, the analysis indicated a small SMD of -0.17 (95% CI -0.34 to 0.01), corresponding to a difference in pain scores between SAMe and placebo of 0.4 cm on a 10 cm VAS, with no between trial heterogeneity (I(2) = 0). For function, the analysis suggested a SMD of 0.02 (95% CI -0.68 to 0.71) with a moderate degree of between-trial heterogeneity (I2 = 54%). The meta-analyses of the number of patients experiencing any adverse event, and withdrawals or drop-outs due to adverse events, resulted in relative risks of 1.27 (95% CI 0.94 to 1.71) and 0.94 (95% CI 0.48 to 1.86), respectively, but confidence intervals were wide and tests for overall effect were not significant. No trial provided information concerning the occurrence of serious adverse events.
AUTHORS' CONCLUSIONS: The current systematic review is inconclusive, hampered by the inclusion of mainly small trials of questionable quality. The effects of SAMe on both pain and function may be potentially clinically relevant and, although effects are expected to be small, deserve further clinical evaluation in adequately sized randomised, parallel-group trials in patients with knee or hip osteoarthritis. Meanwhile, routine use of SAMe should not be advised.
骨关节炎是最常见的关节疾病形式，也是老年人疼痛和残疾的主要原因。S-腺苷甲硫氨酸可能是一种可行的治疗选择，但其有效性和安全性的证据并不明确。
我们旨在比较S-腺苷甲硫氨酸（SAMe）与安慰剂或无特定干预措施对膝或髋骨关节炎患者疼痛、功能及安全性结局的影响。
我们检索了截至2008年8月5日的Cochrane系统评价数据库、医学期刊数据库、荷兰医学文摘数据库、护理学与健康领域数据库及循证医学数据库，检查了会议论文集和参考文献列表，并联系了作者。
随机或半随机对照试验，比较了任何剂量和剂型的SAMe与安慰剂或对膝或髋骨关节炎患者不进行干预的情况。
两名独立作者使用标准化表格提取数据。我们联系研究者以获取缺失的结局信息。我们计算了疼痛和功能的标准化均数差（SMD）以及安全性结局的相对风险。我们使用逆方差随机效应荟萃分析合并试验。
系统评价纳入了四项试验，共656例患者，所有试验均比较了SAMe与安慰剂。方法学质量和报告质量较差。对于疼痛，分析显示SMD为-0.17（95%CI -0.34至0.01），相当于SAMe与安慰剂之间的疼痛评分在10 cm视觉模拟量表上相差0.4 cm，试验间无异质性（I² = 0）。对于功能，分析显示SMD为0.02（95%CI -0.68至0.71），试验间异质性程度中等（I² = 54%）。对发生任何不良事件的患者数量以及因不良事件而退出或脱落的患者数量进行的荟萃分析，得出相对风险分别为1.27（95%CI 0.94至1.71）和0.94（95%CI 0.48至1.86），但置信区间较宽，总体效应检验不显著。没有试验提供关于严重不良事件发生情况的信息。
当前的系统评价尚无定论，主要是因为纳入的大多是质量存疑的小型试验。SAMe对疼痛和功能的影响可能具有潜在临床相关性，尽管预期影响较小，但值得在膝或髋骨关节炎患者中进行足够样本量的随机平行组试验进行进一步临床评估。同时，不建议常规使用SAMe。
