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一项关于芦荟对肠易激综合征患者影响的随机、交叉、安慰剂对照研究:对患者生活质量的作用

A Randomised, Cross-Over, Placebo-Controlled Study of Aloe vera in Patients with Irritable Bowel Syndrome: Effects on Patient Quality of Life.

作者信息

Hutchings H A, Wareham K, Baxter J N, Atherton P, Kingham J G C, Duane P, Thomas L, Thomas M, Ch'ng C L, Williams J G

机构信息

School of Medicine, University of Wales Swansea, Singleton Park, Swansea SA2 8PP, UK.

出版信息

ISRN Gastroenterol. 2011;2011:206103. doi: 10.5402/2011/206103. Epub 2010 Oct 11.

Abstract

Background. Irritable bowel syndrome (IBS) is a chronic, difficult to treat condition. The efficacy of Aloe vera in treating IBS symptoms is not yet proven. The purpose of this study was to determine if Aloe vera is effective in improving quality of life. Methods. A multicentre, randomised, double-blind, cross-over placebo controlled study design. Patients were randomised to Aloe vera, wash-out, placebo or placebo, washout, Aloe vera. Each preparation (60 mL) was taken orally twice a day. Patient quality of life was measured using the Gastrointestinal Symptoms Rating Score, Irritable Bowel Syndrome Quality of Life, EuroQol and the Short-Form-12 at baseline and treatment periods 1 and 2. Results. A total of 110 patients were randomised, but only 47 completed all questionnaires and both study arms. Statistical analysis showed no difference between the placebo and Aloe vera treatment in quality of life. Discussion. This study was unable to show that Aloe vera was superior to placebo in improving quality of life. Drop outs and other confounding factors may have impacted on the power of the study to detect a clinically important difference. Conclusion. This study failed to find Aloe vera superior to placebo in improving quality of life proven Irritable Bowel Syndrome patients.

摘要

背景。肠易激综合征(IBS)是一种慢性且难以治疗的病症。芦荟治疗IBS症状的疗效尚未得到证实。本研究的目的是确定芦荟是否能有效改善生活质量。方法。采用多中心、随机、双盲、交叉安慰剂对照研究设计。患者被随机分为芦荟组、洗脱期、安慰剂组或安慰剂组、洗脱期、芦荟组。每种制剂(60毫升)每天口服两次。在基线期以及治疗期1和2,使用胃肠道症状评分量表、肠易激综合征生活质量量表、欧洲五维度健康量表和简明健康调查量表12项来测量患者的生活质量。结果。共有110名患者被随机分组,但只有47名患者完成了所有问卷以及两个研究阶段。统计分析表明,安慰剂组和芦荟治疗组在生活质量方面没有差异。讨论。本研究未能表明芦荟在改善生活质量方面优于安慰剂。退出研究的患者和其他混杂因素可能影响了该研究检测出临床显著差异的效能。结论。本研究未能发现芦荟在改善已确诊肠易激综合征患者的生活质量方面优于安慰剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dac/3168391/27ff622547fe/GASTROENTEROLOGY2011-206103.001.jpg

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