采用CONSORT和STRICTA评价针刺治疗糖尿病胃轻瘫随机对照试验报告质量

Assessing the reporting quality of randomized controlled trials on acupuncture for diabetic gastroparesis using the CONSORT statement and STRICTA

关键词:  糖尿病胃轻瘫  针刺  试验报告统一标准  报告针刺临床试验中干预措施

Key words:  diabetic gastropaersis  acupuncture  CONSORT  STRICTA

摘要:

[目的] 采用试验报告统一标准(CONSORT)和报告针刺临床试验中干预措施(STRICTA)标准评价针刺治疗糖尿病胃轻瘫随机对照试验的报告质量。 [方法] 计算机检索Cochrane 图书馆临床对照试验数据库、PubMed、中国知识基础设施工程、维普等数据库。文种限制为中英文。纳入针刺治疗糖尿病胃轻瘫的随机对照试验, 并采用CONSORT声明和STRICTA标准进行报告质量评价。[结果] 共纳入针刺治疗糖尿病胃轻瘫随机对照研究28篇文献。根据CONSORT声明和STRICTA标准对纳入文献进行分析, 无文献提及随机分配方案的隐藏、样本量的计算方法和治疗师资历。大部分研究对随机方法描述不清、盲法使用率低、未使用流程图、不良反应报道少、针刺细节报道不充分等问题。[结论] 目前针刺治疗糖尿病胃轻瘫的研究报告质量普遍较低。今后应采用国际公认的CONSORT声明和STRICTA标准对针刺疗法进行规范报告。

Abstract:

[Objective] To evaluate the reporting quality of randomized controlled trials (RCTs) on acupuncture for diabetic gastroparesis. [Methods] Four databases including The Cochrane Central Register of Controlled Trials, PubMed, China National Knowledge Infrastructure (CNKI), VIP were searched systematically. Language was limited to Chinese and English. We identified RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). [Results] A total of 28 RCTs were included. In regard to the items in the CONSORT statement and STRICTA, None RCT reported described mechanism used to implement the random allocation sequence, described how sample size was determined and the practitioner background. Most of the RCTs described randomized and blinding methods unclearly, and did not use screening flow, and did not report adverse effect and Needling details. [Conclusion] The reporting quality of RCTs of acupuncture for diabetic gastroparesis was low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture.