溃疡性结肠炎中安慰剂反应的荟萃分析。
Meta-analysis of the placebo response in ulcerative colitis.
作者信息
Garud Sagar, Brown Alphonso, Cheifetz Adam, Levitan Emily B, Kelly Ciaran P
机构信息
Department of Medicine, Beth Israel Deaconess Medical Center, 300 Deaconess Building, 1 Deaconess Road, Boston, MA 02215, USA.
出版信息
Dig Dis Sci. 2008 Apr;53(4):875-91. doi: 10.1007/s10620-007-9954-6. Epub 2007 Oct 13.
PURPOSE
The placebo response rate in randomized controlled trials (RCTs) in ulcerative colitis (UC) varies from 0 to 76%. The aims of this study were to quantify the pooled placebo response rate and identify the factors affecting it.
METHODS
We performed a meta-analysis of 110 RCTs carried out between 1955 and 2005 and published in English. Regression analysis was used to identify factors significantly modifying placebo response.
RESULTS
The pooled placebo remission rate was 23% (95%CI: 18.4-28%) and the pooled placebo improvement rate was 32.1% (95%CI: 28.1-36.3%). Multivariate analysis showed that the country where the study was performed (P = 0.025 for placebo remission and P = 0.0083 for placebo response rates) significantly influenced the placebo remission and response rates.
CONCLUSION
Placebo remission and response rates in RCTs of UC are highly variable and are significantly influenced by the country in which the RCT is performed.
目的
在溃疡性结肠炎（UC）的随机对照试验（RCT）中，安慰剂反应率在0%至76%之间变化。本研究的目的是量化汇总安慰剂反应率并确定影响它的因素。
方法
我们对1955年至2005年间开展并以英文发表的110项随机对照试验进行了荟萃分析。采用回归分析来确定显著改变安慰剂反应的因素。
结果
汇总安慰剂缓解率为23%（95%置信区间：18.4 - 28%），汇总安慰剂改善率为32.1%（95%置信区间：28.1 - 36.3%）。多变量分析表明，开展研究的国家（安慰剂缓解的P值为0.025，安慰剂反应率的P值为0.0083）对安慰剂缓解率和反应率有显著影响。
结论
UC随机对照试验中的安慰剂缓解率和反应率高度可变，且受开展随机对照试验所在国家的显著影响。
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