Yang Jinsong, Yu Fanjun, Lin Keyi, Qu Haotian, He Yihan, Zhao Jing, Feng Fen, Pan Litao, Kui Yu
Guangzhou University of Chinese Medicine, Guangzhou, China.
Guangdong Provincial Academy of Chinese Medical, Guangzhou, China.
Evid Based Complement Alternat Med. 2022 Feb 17;2022:5157870. doi: 10.1155/2022/5157870. eCollection 2022.
To assess the reporting quality of randomized controlled trials (RCTs) on acupuncture for primary insomnia (PI).
Seven Chinese and English databases were searched for publication reporting RCTs on acupuncture for PI from the inception of the databases to August 6, 2021. The internationally recognized Consolidated Standards of Reporting Trials (CONSORT) statement and the International Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines were used to evaluate the reporting quality. The agreement between two researchers was calculated by Cohen's kappa.
A total of 102 eligible RCTs were assessed. According to the CONSORT statement (2017), the positive reporting rates of items such as "abstract," "background," "participants," and "numbers analyzed" were above 80%. However, the positive reporting rates of items such as "sample size," "randomization implementation," "Outcomes and estimation," "Ancillary analyses," and "Registration" were below 20%. According to STRICTA guidelines, the positive reporting rates of items such as "style of acupuncture," "reasons for acupuncture treatment," "Number of needles inserted," "Needle retention time," "Treatment regimen," and "precise description of the control intervention" were above 80%. However, the positive reporting rates of items such as "setting and context of treatment" and "practitioner background" were below 20%.
It is essential to advocate the endorsement of the CONSORT statement and STRICTA guidelines to improve the quality of acupuncture RCT reports.
评估针刺治疗原发性失眠（PI）的随机对照试验（RCT）的报告质量。
检索7个中英文数据库，以查找从数据库建库至2021年8月6日发表的关于针刺治疗PI的RCT。采用国际认可的《报告试验的统一标准》（CONSORT）声明和《针刺对照试验干预措施报告国际标准》（STRICTA）指南来评估报告质量。两位研究者之间的一致性采用Cohen's kappa计算。
共评估了102项符合条件的RCT。根据CONSORT声明（2017年），“摘要”“背景”“参与者”和“分析的数量”等条目的阳性报告率高于80%。然而，“样本量”“随机化实施”“结果与估计”“辅助分析”和“注册”等条目的阳性报告率低于20%。根据STRICTA指南，“针刺方式”“针刺治疗的原因”“针刺针数”“留针时间”“治疗方案”和“对照干预的精确描述”等条目的阳性报告率高于80%。然而，“治疗的设置和背景”和“从业者背景”等条目的阳性报告率低于20%。
倡导认可CONSORT声明和STRICTA指南对于提高针刺RCT报告的质量至关重要。
