Zhang Xiao-Jie, Wang Yi-Jing, Lu Xiao, Ying Peng-Jie, Qian Shi-Yan, Liang Jie, Zheng Guo-Qing
Department of Neurology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China.
Department of Neurology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, China.
Front Pharmacol. 2023 Jan 10;13:1106957. doi: 10.3389/fphar.2022.1106957. eCollection 2022.
HuatuoZaizao pill (HZP), a Chinese patent medicine, is often used in the treatment of stroke. However, there is still a lack of enough evidence to recommend the routine use of HZP for stroke. This study is aimed at evaluating the quality of reporting of randomized controlled trials (RCTs) on HZP for stroke. RCTs on HuatuoZaizao pill for stroke were evaluated by using Consolidated Standards of Reporting Trials (CONSORT) guidelines and CONSORT extension criteria on reporting herbal interventions (CONSORT-CHM) guidelines. Microsoft Excel 2007 and SPSS20.0 was used for statistics analyses. Seventeen studies involving 1801 stroke patients were identified. CONSORT-CHM has expanded 24.3% (9/37) items in CONSORT and added a small item. The average scores of CONSORT evaluation is 14.6, while the average scores of the CONSORT-CHM evaluation is 11.6. The central items in CONSORT as eligibility criterion, sample size calculation, primary outcome, method of randomization sequence generation, allocation concealment, implementation of randomization, description of blinding, and detailed statistical methods were reported in 77%, 6%, 100%, 47%, 6%, 6%, 6%, and 94% of trials, respectively. In terms of the CONSORT-CHM, none of the articles reported in detail the dosage form, origin, formula basis and so on of HZP, and only half of studies reported the outcome indicators related to Traditional Chinese Medicine syndromes. The overall report quality of RCT related to HZP is low. HZP still needs to report higher quality RCTs to prove its effectiveness and safety.
华佗再造丸(HZP)是一种中成药,常用于治疗中风。然而,目前仍缺乏足够证据推荐将HZP常规用于中风治疗。本研究旨在评估关于HZP治疗中风的随机对照试验(RCT)的报告质量。采用《报告试验的统一标准》(CONSORT)指南以及关于草药干预报告的CONSORT扩展标准(CONSORT-CHM)指南对关于华佗再造丸治疗中风的RCT进行评估。使用Microsoft Excel 2007和SPSS20.0进行统计分析。共纳入17项研究,涉及1801例中风患者。CONSORT-CHM在CONSORT中扩展了24.3%(9/37)的条目并新增了一个小条目。CONSORT评估的平均得分是14.6,而CONSORT-CHM评估的平均得分是11.6。CONSORT中的核心条目,如纳入标准、样本量计算、主要结局、随机序列生成方法、分配隐藏、随机化实施、盲法描述以及详细的统计方法,分别在77%、6%、100%、47%、6%、6%、6%和94%的试验中有所报告。就CONSORT-CHM而言,没有文章详细报告HZP的剂型、来源、配方依据等,仅有一半的研究报告了与中医证候相关的结局指标。与HZP相关的RCT的总体报告质量较低。HZP仍需要开展更高质量的RCT来证明其有效性和安全性。