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随机临床试验:瑜伽与溃疡性结肠炎书面自我护理建议的比较。

Randomised clinical trial: yoga vs written self-care advice for ulcerative colitis.

机构信息

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine Essen, University of Duisburg-Essen, Essen, Germany.

Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), University of Technology Sydney, Sydney, NSW, Australia.

出版信息

Aliment Pharmacol Ther. 2017 Jun;45(11):1379-1389. doi: 10.1111/apt.14062. Epub 2017 Apr 5.

Abstract

BACKGROUND

Perceived stress seems to be a risk factor for exacerbation of ulcerative colitis. Yoga has been shown to reduce perceived stress.

AIMS

To assess the efficacy and safety of yoga for improving quality of life in patients with ulcerative colitis.

METHODS

A total of 77 patients (75% women; 45.5 ± 11.9 years) with ulcerative colitis in clinical remission but impaired quality of life were randomly assigned to yoga (12 supervised weekly sessions of 90 min; n = 39) or written self-care advice (n = 38). Primary outcome was disease-specific quality of life (Inflammatory Bowel Disease Questionnaire). Secondary outcomes included disease activity (Rachmilewitz clinical activity index) and safety. Outcomes were assessed at weeks 12 and 24 by blinded outcome assessors.

RESULTS

The yoga group had significantly higher disease-specific quality of life compared to the self-care group after 12 weeks (Δ = 14.6; 95% confidence interval=2.6-26.7; P = 0.018) and after 24 weeks (Δ = 16.4; 95% confidence interval=2.5-30.3; P = 0.022). Twenty-one and 12 patients in the yoga group and in the self-care group, respectively, reached a clinical relevant increase in quality of life at week 12 (P = 0.048); and 27 and 17 patients at week 24 (P = 0.030). Disease activity was lower in the yoga group compared to the self-care group after 24 weeks (Δ = -1.2; 95% confidence interval=-0.1-[-2.3]; P = 0.029). Three and one patient in the yoga group and in the self-care group, respectively, experienced serious adverse events (P = 0.317); and seven and eight patients experienced nonserious adverse events (P = 0.731).

CONCLUSIONS

Yoga can be considered as a safe and effective ancillary intervention for patients with ulcerative colitis and impaired quality of life.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02043600.

摘要

背景

感知压力似乎是溃疡性结肠炎恶化的一个风险因素。瑜伽已被证明可以减轻感知压力。

目的

评估瑜伽改善溃疡性结肠炎患者生活质量的疗效和安全性。

方法

共有 77 例(75%为女性;45.5±11.9 岁)处于临床缓解期但生活质量受损的溃疡性结肠炎患者被随机分配至瑜伽组(12 次每周 90 分钟的监督课程;n=39)或书面自我护理建议组(n=38)。主要结局为疾病特异性生活质量(炎症性肠病问卷)。次要结局包括疾病活动度(Rachmilewitz 临床活动指数)和安全性。盲法结局评估者在 12 周和 24 周时评估结局。

结果

与自我护理组相比,瑜伽组在 12 周时(Δ=14.6;95%置信区间=2.6-26.7;P=0.018)和 24 周时(Δ=16.4;95%置信区间=2.5-30.3;P=0.022)的疾病特异性生活质量显著更高。瑜伽组和自我护理组分别有 21 名和 12 名患者在 12 周时达到临床相关的生活质量改善(P=0.048);27 名和 17 名患者在 24 周时达到临床相关的生活质量改善(P=0.030)。与自我护理组相比,瑜伽组在 24 周时的疾病活动度更低(Δ=-1.2;95%置信区间=-0.1-[-2.3];P=0.029)。瑜伽组和自我护理组分别有 3 名和 1 名患者发生严重不良事件(P=0.317);有 7 名和 8 名患者发生非严重不良事件(P=0.731)。

结论

瑜伽可被视为溃疡性结肠炎伴生活质量受损患者的一种安全有效的辅助干预措施。

试验注册

ClinicalTrials.gov 标识符:NCT02043600。

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