■多发性硬化症(MS)是影响年轻人的最常见的非创伤性致残疾病。目前尚无明确的治愈性治疗方法。许多随机对照试验(RCT)报道了中草药(CHM)对MS的疗效。由于这些RCT的质量不确定,常规使用CHM治疗MS的建议尚无定论.对MS的CHM的RCTs质量的综合评价迫在眉睫。
■九个数据库,即,PubMed,Embase,WebofScience,科克伦图书馆,EBSCO,Sinomed,万方数据库,中国国家知识基础设施,和VIP数据库,从成立之初到2023年9月进行了搜索。将CHM与安慰剂或针对MS的药物干预进行比较的RCT被认为是合格的。使用合并报告试验标准(CONSORT)及其对CHM公式(CONSORT-CHM公式)的扩展清单来评估RCT的报告质量。使用Cochrane偏差风险工具评估偏差风险。MS的高频草药的选择标准是在排名靠前的草药中累积频率超过50%的那些。
■共包括25个随机对照试验。在包括的RCT中,报告了33%的CONSORT项目和21%的CONSORT-CHM公式项目。资格标题,样本量计算,分配隐藏,随机实施,只有不到5%的试验报告了CONSORT核心项目中的盲化描述。对于CONSORT-CHM公式,每种CHM成分的来源和认证方法的报告特别少.由于信息不足,大多数研究将偏倚风险归类为“不清楚”。最常用的五种草药是,按顺序,熟地黄,熟地黄,淫羊藿,天蝎座,和Poria.没有严重不良反应的报道。
■CONSORT项目的低报告和不清楚的偏倚风险表明RCT在报告完整性和结果有效性方面的质量不足。CONSORT-CHM公式适当考虑了CHM的独特特性,包括原则,公式,和中药。为了提高MSCHM上RCT的质量,研究人员应更紧密地遵守CONSORT-CHM公式指南,并确保全面披露所有研究设计要素.
UNASSIGNED: Multiple sclerosis (MS) is the most common non-traumatic disabling disease affecting young adults. A definitive curative treatment is currently unavailable. Many randomized controlled trials (RCTs) have reported the efficacy of Chinese herbal medicine (CHM) on MS. Because of the uncertain quality of these RCTs, the recommendations for routine use of CHM for MS remain inconclusive. The comprehensive evaluation of the quality of RCTs of CHM for MS is urgent.
UNASSIGNED: Nine databases, namely, PubMed, Embase, Web of Science, Cochrane Library, EBSCO, Sinomed, Wanfang Database,
China National Knowledge Infrastructure, and VIP Database, were searched from inception to September 2023. RCTs comparing CHM with placebo or pharmacological interventions for MS were considered eligible. The Consolidated Standards of Reporting Trials (CONSORT) and its extension for CHM formulas (CONSORT-CHM Formulas) checklists were used to evaluate the reporting quality of RCTs. The risk of bias was assessed using the Cochrane Risk of Bias tool. The selection criteria of high-frequency herbs for MS were those with cumulative frequency over 50% among the top-ranked herbs.
UNASSIGNED: A total of 25 RCTs were included. In the included RCTs, 33% of the CONSORT items and 21% of the CONSORT-CHM Formulas items were reported. Eligibility title, sample size calculation, allocation concealment, randomized implementation, and blinded description in CONSORT core items were reported by less than 5% of trials. For the CONSORT-CHM Formulas, the source and authentication method of each CHM ingredient was particularly poorly reported. Most studies classified the risk of bias as \"unclear\" due to insufficient information. The top five most frequently used herbs were, in order, Radix Rehmanniae Preparata, Radix Rehmanniae Recens, Herba Epimedii, Scorpio, and Poria. No serious adverse effect had been reported.
UNASSIGNED: The low reporting of CONSORT items and the unclear risk of bias indicate the inadequate quality of RCTs in terms of reporting completeness and result validity. The CONSORT-CHM Formulas appropriately consider the unique characteristics of CHM, including principles, formulas, and Chinese medicinal substances. To improve the quality of RCTs on CHM for MS, researchers should adhere more closely to CONSORT-CHM Formulas guidelines and ensure comprehensive disclosure of all study design elements.