Moi John H Y, Sriranganathan Melonie K, Edwards Christopher J, Buchbinder Rachelle
Department of Rheumatology, The Royal Melbourne Hospital, Parkville, Australia.
Cochrane Database Syst Rev. 2013 May 31;2013(5):CD010039. doi: 10.1002/14651858.CD010039.pub2.
Although lifestyle interventions are commonly recommended in the management of patients with chronic gout, the evidence from trial data for their benefits and safety has not been previously examined in a systematic review.
The objective of this systematic review was to evaluate the benefits and safety of lifestyle interventions for the treatment of people with chronic gout.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE for studies on 5 April 2013. We also searched the 2010 to 2011 American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) abstracts and performed a handsearch of the reference lists of included articles.
Studies were included if they were randomised or quasi-randomised controlled trials (RCTs or CCTs) which compared lifestyle interventions to another therapy (active or placebo) in patients with chronic gout. Outcomes of interest were changes in gout attack frequency, joint pain, serum urate levels, tophus size, function, quality of life and adverse effects.
Two review authors independently applied methods recommended by The Cochrane Collaboration for the selection, appraisal, data collection and synthesis of studies. We assessed the quality of the body of evidence for each outcome using the GRADE approach.
Only one study (120 participants), at moderate risk of bias, was included in the review. Patients were randomised to one of three interventions: either skim milk powder (SMP) enriched with glycomacropeptide (GMP) and G600, non-enriched SMP or lactose powder, over a three-month period. The frequency of acute gout attacks, measured as the number of flares per month, decreased in all three groups over the three-month study period. Low quality evidence indicated that there was no difference between the SMP/GMP/G600 group and combined control groups (SMP and lactose powder) at three months (mean difference (MD) -0.21, 95% confidence interval (CI) -0.76 to 0.34). There were no significant between-group differences in terms of withdrawals due to adverse effects (risk ratio (RR) 1.27, 95% CI 0.53 to 3.03), and serious adverse events resulting in hospitalisation (2/40 SMP/GMP/G600 group versus 3/80 controls; RR 1.33, 95% CI 0.23 to 7.66). Gastrointestinal adverse effects were the most commonly reported. Pain from self reported gout flares, measured on a 10-point Likert scale, improved more in the SMP/GMP/G600 group compared to controls (MD -1.03, 95% CI -1.96 to -0.10), an absolute difference of 10% (absolute risk difference -0.10, 95% CI -0.20 to -0.01). This is unlikely to be of clinical significance. Physical function, tophus regression and serum urate normalisation were not reported in this study.
AUTHORS' CONCLUSIONS: While there is good evidence from observational studies of an association between various lifestyle risk factors and gout development, there is a paucity of high-quality evidence from randomised controlled trials to either support or refute the use of lifestyle modifications for improving outcomes in people with chronic gout.
尽管生活方式干预在慢性痛风患者的管理中普遍被推荐,但此前尚未有系统评价对试验数据中其益处和安全性的证据进行审查。
本系统评价的目的是评估生活方式干预对慢性痛风患者治疗的益处和安全性。
我们于2013年4月5日检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE和EMBASE以查找相关研究。我们还检索了2010至2011年美国风湿病学会(ACR)和欧洲抗风湿病联盟(EULAR)的摘要,并对纳入文章的参考文献列表进行了手工检索。
如果研究为随机或半随机对照试验(RCT或CCT),比较了慢性痛风患者生活方式干预与另一种治疗(活性或安慰剂),则纳入研究。感兴趣的结局包括痛风发作频率、关节疼痛、血清尿酸水平、痛风石大小、功能、生活质量和不良反应的变化。
两位综述作者独立应用Cochrane协作网推荐的方法进行研究的选择、评估、数据收集和综合分析。我们使用GRADE方法评估每个结局的证据质量。
本综述仅纳入了一项研究(120名参与者),该研究存在中度偏倚风险。患者被随机分配到三种干预措施之一:富含糖巨肽(GMP)和G600的脱脂奶粉(SMP)、未富集的SMP或乳糖粉,为期三个月。在三个月的研究期间,所有三组中以每月发作次数衡量的急性痛风发作频率均有所下降。低质量证据表明,三个月时SMP/GMP/G600组与联合对照组(SMP和乳糖粉)之间无差异(平均差(MD)-0.21,95%置信区间(CI)-0.76至0.34)。在因不良反应而退出方面,组间无显著差异(风险比(RR)1.27,95%CI 0.53至3.03),以及导致住院的严重不良事件(SMP/GMP/G600组2/40,对照组3/80;RR 1.33,95%CI 0.23至7.66)。胃肠道不良反应是最常报告的。以10分制李克特量表衡量的自我报告痛风发作疼痛,SMP/GMP/G600组相比对照组改善更明显(MD -1.03,95%CI -1.96至-0.10),绝对差异为10%(绝对风险差-0.10,95%CI -0.20至-0.01)。这可能不具有临床意义。本研究未报告身体功能、痛风石消退和血清尿酸正常化情况。
虽然观察性研究有充分证据表明各种生活方式风险因素与痛风发展之间存在关联,但随机对照试验中缺乏高质量证据来支持或反驳使用生活方式改变来改善慢性痛风患者的结局。