Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy.
Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy.
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用于评估互补药物和替代药物的基于Internet的随机对照试验：脊椎关节炎中的益生菌。
DOI：
10.1186/1471-2474-9-4
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发表时间：
2008-01-11
影响因子：
2.3
通讯作者：
Allen SJ
中科院分区：
文献类型：
--
作者：
Brophy S;Burrows CL;Brooks C;Gravenor MB;Siebert S;Allen SJ
由于缺乏临床试验，补充和替代药物（CAM）的临床有效性受到广泛争议。互联网可以为开展低风险干预措施的随机对照试验（RCT）提供一种有效且经济的方法。我们调查了互联网是否可以用于执行基于互联网的CAM RCT，以满足修订后的CONSORT（报告试验的统一标准）声明RCT报告质量检查表。第二个目的是检查益生菌与安慰剂相比在12周内的幸福感方面的效果。年龄≥18岁的确诊脊柱关节病患者，居住在英国，可以上网，被邀请参加一项基于互联网的益生菌RCT，与安慰剂相比，改善健康和肠道症状。干预措施是每天口服含有4株活细菌的益生菌或相同的安慰剂，持续3个月。根据修订后的CONSORT声明，主要结局指标是试验的性能。147人被随机分配到试验中。CAM的基于互联网的试验符合修订后的CONSORT声明，如有效设盲、分配隐藏、意向治疗分析和参与者通过试验的流程。在19个月内完成了所需人数参与者的招募工作。65%（96/147）完成了整个3个月的试验。该试验成本低，并表明在意向治疗分析中，益生菌并没有改善健康或肠道症状。基于互联网的随机对照试验被证明是一种成功和经济的方法来检查这种CAM干预。招募、依从性和完成率均与传统RCT报告的相似，但成本仅为一小部分。基于互联网的随机对照试验可以满足修订后的CONSORT声明的所有标准，并且是研究低风险干预措施的适当方法。ISRCTN36133252
The clinical effectiveness of complementary and alternative medicines (CAMs) is widely debated because of a lack of clinical trials. The internet may provide an effective and economical approach for undertaking randomised controlled trials (RCTs) of low-risk interventions. We investigated whether the internet could be used to perform an internet-based RCT of a CAM fulfilling the revised CONSORT (Consolidated Standards of Reporting Trials) statement quality checklist for reporting of RCTs. A secondary aim was to examine the effect of probiotics compared to placebo in terms of well-being over 12 weeks. People aged ≥18 years with confirmed spondyloarthropathy living in the United Kingdom with internet access were invited to participate in an internet-based RCT of probiotic compared to placebo for improving well-being and bowel symptoms. The intervention was a probiotic containing 4 strains of live bacteria or identical placebo taken by mouth daily for 3 months. The primary outcome measure was the performance of the trial according to the revised CONSORT statement. 147 people were randomised into the trial. The internet-based trial of the CAM fulfilled the revised CONSORT statement such as efficient blinding, allocation concealment, intention to treat analysis and flow of participants through the trial. Recruitment of the required number of participants was completed in 19 months. Sixty-five percent (96/147) completed the entire 3 months of the trial. The trial was low cost and demonstrated that in an intention to treat analysis, probiotics did not improve well-being or bowel symptoms. The internet-based RCT proved to be a successful and economical method for examining this CAM intervention. Recruitment, adherence and completion rate were all similar to those reported with conventional RCTs but at a fraction of the cost. Internet-based RCTs can fulfil all the criteria of the revised CONSORT statement and are an appropriate method for studying low-risk interventions. ISRCTN36133252
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影响因子：
29.4
作者：
Gionchetti, P;Rizzello, F;Campieri, M
通讯作者：
Campieri, M
影响因子：
1.6
作者：
Jacobs, BP;Bent, S;Cummings, SR
通讯作者：
Cummings, SR
影响因子：
105.7
作者：
Hammerman, Cathy;Bin-Nun, Alona;Kaplan, Michael
通讯作者：
Kaplan, Michael
影响因子：
105.7
作者：
McAlindon, T;Formica, M;Lehmer, M
通讯作者：
Lehmer, M
影响因子：
5.2
作者：
Baeten, D;De Keyser, F;Veys, EM
通讯作者：
Veys, EM