基层医疗中肠易激综合征的管理：一项探索性随机对照试验中，比较了美贝维林、甲基纤维素、安慰剂和自我管理网站的结果。
Management of irritable bowel syndrome in primary care: the results of an exploratory randomised controlled trial of mebeverine, methylcellulose, placebo and a self-management website.
出版信息
BMC Gastroenterol. 2013 Apr 21;13:68. doi: 10.1186/1471-230X-13-68.
BACKGROUND
Many patients with IBS suffer on-going symptoms. The evidence base is poor for IBS drugs but they are widely prescribed and advised in Guidelines. Cognitive Behavioural Therapy (CBT) can be helpful, but availability is poor in the NHS. We developed a web-based CBT self-management programme (Regul8) in partnership with patients and trialled it and common IBS medications in an exploratory factorial RCT to test trial procedures and provide information for a larger trial.
METHODS
Patients, 16 to 60 years, with IBS symptoms fulfilling Rome III criteria were recruited via GP practices and randomised to over-encapsulated mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 website conditions: Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website.
RESULTS
135 patients recruited from 26 GP practices. Mean IBS SSS score 241.9 (sd 87.7), IBS-QOL 64 (sd 20) at baseline. 91% follow-up at 12 weeks. Mean IBS SSS decreased by 35 points from baseline to 12 weeks. There was no significant difference in IBS SSS or IBS-QOL score between medication or website groups at 12 weeks, or in medication groups at 6 weeks, or IBS-QOL in website groups at 6 weeks. However, IBS SSS at 6 weeks was lower in the No website group than the website groups (IBS SSS no website =162.8 (95% CI 137.4-188.3), website 197.0 (172.4 - 221.7), Website + telephone support 208.0 (183.1-233.0) p = 0.037).
CONCLUSIONS
This exploratory study demonstrates feasibility and high follow-up rates and provides information for a larger trial. Primary outcomes (IBS SS and IBS QOL) did not reach significance at 6 or 12 weeks, apart from IBS SSS being lower in the no-website group at 6 weeks - this disappeared by 12 weeks. Improved Enablement suggests patients with access to the Regul8 website felt better able to cope with their symptoms than the non-website group. Improved SGA score in the Regul8 groups may indicate some overall improvement not captured on other measures.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier (NCT number): NCT00934973.
背景
许多 IBS 患者持续存在症状。IBS 药物的证据基础薄弱，但在指南中广泛开处方和建议使用。认知行为疗法（CBT）可能会有所帮助，但在 NHS 中可用性很差。我们与患者合作开发了一种基于网络的 CBT 自我管理计划（Regul8），并对其进行了试验，并与常见的 IBS 药物一起进行了探索性因子 RCT，以测试试验程序并为更大规模的试验提供信息。
方法
招募了 16 至 60 岁的符合 Rome III 标准的 IBS 症状患者，通过全科医生实践进行随机分组，接受包裹过的美贝维林、甲基纤维素或安慰剂治疗 6 周，并接受 3 种网站条件之一的治疗：有护士电话会议和电子邮件支持的 Regul8、有最低限度电子邮件支持的 Regul8 或没有网站。
结果
从 26 家全科医生诊所招募了 135 名患者。IBS SSS 评分平均为 241.9（标准差 87.7），IBS-QOL 为 64（标准差 20）。12 周时的随访率为 91%。IBS SSS 从基线到 12 周下降了 35 分。在 12 周时，药物或网站组之间的 IBS SSS 或 IBS-QOL 评分没有差异，在 6 周时的药物组之间也没有差异，在 6 周时的网站组之间的 IBS-QOL 也没有差异。然而，在 6 周时，无网站组的 IBS SSS 低于网站组（IBS SSS 无网站=162.8（95%CI 137.4-188.3），网站 197.0（172.4-221.7），网站+电话支持 208.0（183.1-233.0），p=0.037）。
结论
这项探索性研究证明了可行性和高随访率，并为更大规模的试验提供了信息。主要结局（IBS SS 和 IBS QOL）在 6 周或 12 周时均未达到显著水平，除了 6 周时无网站组的 IBS SSS 较低外-这在 12 周时消失了。改善的赋权表明，能够访问 Regul8 网站的患者比非网站组更能应对他们的症状。Regul8 组的 SGA 评分改善可能表明在其他措施上未捕获到的整体改善。
试验注册
ClinicalTrials.gov 标识符（NCT 编号）：NCT00934973。
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