Verhagen A P, Bierma-Zeinstra S M A, Cardoso J R, de Bie R A, Boers M, de Vet H C W
Department of General Practice, Erasmus MC, P.O. Box 1738, 3000 DR Rotterdam, Netherlands.
Cochrane Database Syst Rev. 2003(4):CD000518. doi: 10.1002/14651858.CD000518.
Balneotherapy (spa therapy) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain, improve joint motion and as a consequence to relieve people' suffering and make them feel well.
To perform a systematic review on the effectiveness of balneotherapy for rheumatoid arthritis.
Using the Cochrane search strategy, studies were found by screening: 1) The MEDLINE CD-ROM database from 1966 to June 2002 and 2) the database from the Cochrane 'Rehabilitation and Related Therapies' Field, the Pedro database up to June 2002. Also, 3) reference checking and 4) personal communications with authors was carried out to retrieve eligible studies. Date of the most recent literature search: June, 2002
Studies were eligible if they were randomised controlled trials (RCTs) comparing balneotherapy with any other intervention or with no intervention. Included participants all suffered from definite or classical rheumatoid arthritis (RA) as defined by the American Rheumatism Association Criteria (ARA) or by the criteria of Steinbrocker. At least one of the WHO/ILAR core set of endpoints for RA clinical trials had to be among the main outcome measures.
The Delphi list was the criteria list used to assess the components of methodological quality. Two reviewers carried out quality assessment and data extraction of the studies. Disagreements were solved by consensus.
Six trials, representing 355 people, were included in this review. Most trials reported positive findings (the absolute improvement in measured outcomes ranged from 0 to 44%), but were methodologically flawed to some extent. A 'quality of life' outcome was reported by two trials. None of the trials performed an intention-to-treat analysis and only two performed a comparison of effects between groups. Pooling of the data was not performed; because of heterogeneity of the studies, multiple outcome measurements, and the overall data presentation was too scarce.
REVIEWER'S CONCLUSIONS: One cannot ignore the positive findings reported in most trials. However the scientific evidence is insufficient because of the poor methodological quality, the absence of an adequate statistical analysis, and the absence, for the patient, of most essential outcome measures (pain, self assessed function, quality of life). Therefore, the noted "positive findings" should be viewed with caution. Because of the methodological flaws an answer about the apparent effectiveness of balneotherapy cannot be provided at this moment. A large, methodological sound trial is needed.
对关节炎患者进行浴疗法(温泉疗法)是最古老的治疗形式之一。浴疗法的目标之一是缓解疼痛、改善关节活动,从而减轻患者痛苦并使其感觉良好。
对浴疗法治疗类风湿关节炎的有效性进行系统评价。
采用Cochrane检索策略,通过筛选以下资源找到相关研究:1)1966年至2002年6月的MEDLINE光盘数据库;2)Cochrane“康复及相关疗法”领域数据库、截至2002年6月的Pedro数据库。此外,还通过3)参考文献核对和4)与作者的个人交流来检索符合条件的研究。最近一次文献检索日期:2002年6月
如果研究是将浴疗法与其他任何干预措施或不进行干预进行比较的随机对照试验(RCT),则符合入选标准。纳入的参与者均患有根据美国风湿病协会标准(ARA)或斯坦布罗克标准定义的明确或典型类风湿关节炎(RA)。类风湿关节炎临床试验的WHO/ILAR核心结局指标集中至少有一项必须作为主要结局指标。
采用德尔菲清单作为评估方法学质量组成部分的标准清单。两名评价员对研究进行质量评估和数据提取。分歧通过协商解决。
本评价纳入了6项试验,共355人。大多数试验报告了阳性结果(测量结局的绝对改善范围为0至44%),但在方法学上存在一定缺陷。两项试验报告了“生活质量”结局。没有一项试验进行意向性分析,只有两项试验对组间效应进行了比较。未进行数据合并;由于研究的异质性、多种结局测量以及总体数据呈现过于稀少。
不能忽视大多数试验报告的阳性结果。然而,由于方法学质量差、缺乏充分的统计分析以及对于患者而言缺乏大多数关键结局指标(疼痛、自我评估功能、生活质量),科学证据不足。因此,对于所指出的“阳性结果”应谨慎看待。由于方法学缺陷,目前无法就浴疗法的明显有效性给出答案。需要进行一项方法学严谨的大型试验。