基于CONSORT和STRICTA评价针灸治疗肠易激综合征临床随机对照试验报告质量

Assessment of the Reporting Quality of Randomized Controlled Trials on Acupuncture for Irritable Bowel Syndrome with the CONSORT Statement and STRICTA

目的:采用CONSORT声明和STRICTA标准评价国内针灸治疗肠易激综合征临床随机对照试验质量。方法:利用计算机检索与手工检索。检索CNKI、CBM、VIP和万方4个数据库,结合手工检索相关期刊,筛选出符合研究标准的文献,采用CONSORT声明和STRICTA标准进行质量评价。结果:共纳入合格文献42篇。大部分文献存在随机方法描述不清和无随机隐藏、盲法使用率低、无样本量计算、无意向治疗分析、针刺细节报道不充分、无针刺治疗医生的资历等问题。结论:目前针灸治疗肠易激综合征的临床随机对照试验质量普遍较低,影响报道的可靠性和同质可比性。为提高针灸临床随机试验可靠性和质量,应该将CONSORT声明和STRICTA标准引入针灸临床随机试验设计并严格执行。

Objective ： To assess the quality of clinical randomized controlled trials of acupuncture treatment of irritable bowel syndrome with CONSORT （ Consolidated Standards for Reporting of Trials ） statement and STRICTA （ Standards for Reporting Interventions in Controlled Trials of acupuncture ） as criteria. Methods：Computer and hand searches were used. Databases including CNKI （China National Knowledge Infrastrue-ture ）, CBM （ China Biomedicine Database disc ）, VIP （ a full text issues database of China ） and WANFANG （ another full text is-sues database of China ） were searched in combination with hand searching for relevant journals to sift out the study criteria. CONSORT statement and STRICTA were used to assess the quality of the included literatm~. Results ： A total of 42 pieces of literature were included. A large part of those had no clear description of random methods, random conceahnent, use of blind methods, sample size calculation, intention-to-treat analysis, full report of acupuncture details and mention of practitioners＇ background. Conclusion ： The quality of clinical randomized controlled trials of acupuncture treatment of irritable bowel syndrome is generally low, which affects the reliability and homogeneous comparability of the reports. To improve the reliability and quality of clinical randomized controlled trials of acupuncture treatment, CONSORT statement and STRICTA should be introduced into the trial design and strictly performed.