Objective To evaluate the reporting quality of randomized controlled trials (RCTs) on acupuncture for acute ischemic stroke. Methods Six databases including The Cochrane Central Register of Controlled Trials (CENTRAL, Issue 4, 2005), MEDLINE (1966 to December 2005), EMbase (1984 to December 2005), China National Knowledge Infrastructure (CNKI, 1994 to December 2005), China Biomedicine Database disc (CBMdisc, 1980 to December 2005), VIP (a full text issues database of China, 1989 to December 2005) were searched systematically. Handsearch for further references was conducted. Language was limited to Chinese and English. We identified 74 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 In regard to the items in the CONSORT statement, 54 (73%) RCTs described baseline demographic and clinical characteristics in each group. Twenty-six (35%) mentioned the method of generating the random sequence, with 4 (5%) using a computer allocation. Only 6 (8%) RCTs had adequate allocation concealment, with 5 RCTs using sealed opaque envelopes and 1 RCT using centralized computer allocation. Only 8 (11%) RCTs used blinding, including 5 described as double-blind. Four (5%) RCTs reported the sample size calculation and 5 (7%) RCTs reported that an intention-to-treat (ITT) analysis. In regard to the items in STRICTA , only 4 (5%) RCTs reported the numbers of needles inserted. In 35 (47%) RCTs the needle type was reported, but only 26 (35%) mentioned the depths of insertion. Only 1 (1%) RCT mentioned the length of clinical experience and 6 (8%) RCTs reported the background of the acupuncture practitioners, but none stated the duration of their training.Conclusion The reporting quality of RCTs of acupuncture for acute ischemic stroke was low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture.
ObjectiveTo evaluate the reporting quality of randomized controlled trials (RCTs) on acupuncture for neck disorder. MethodsThree databases including CENTRAL (Issue 3, 2010), MEDLINE and EMbase from January 2006 to December 2010 were searched electronically, and only English articles were included. A manual search for further references was conducted from those references initially identified. We identified 14 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). ResultsFinally 14 RCTs were included. Regarding the CONSORT statement, 9 (64.3%) RCTs described the baseline demographic and clinical characteristics in each group. Only 7 (50.0%) studies mentioned how the random sequence was generated. Only 6 (42.9%) RCTs had adequate allocation concealment, with 4 RCTs which described the concealment in detail. Only 8 (57.1%) RCTs used blinding, including 2 described as double-blind. Only two (14.3%) RCTs reported how the sample size was calculated. Corresponding to the items in STRICTA, 5 (35.7%) RCTs reported the numbers of needles inserted. The others just indicated the acu-points. The needle type, model and the thickness of needles were reported in 12 (85.7%) RCTs, but only 4 (28.6%) mentioned the depths of insertion. There were only 4 RCTs (28.6%) that reported the background of the acupuncture practitioners and the duration of their training. ConclusionThe RCTs of acupuncture for neck disorder meeting the criteria for the CONSORT statement and STRICTA still have room for improvement. Promoting the use of the CONSORT statement and STRICTA should help to improve the reporting quality of acupuncture related research, and hence to elucidate the scientific understanding of acupuncture.
ObjectivesTo evaluate the reporting quality of domestic and foreign randomized controlled trials (RCTs) on acupuncture for dry eye based on Consolidated Standards of Reporting Trials Expand Statement 2010 (CONSORT 2010) and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).MethodsCNKI, VIP, CBM, WanFang Data, PubMed, EMbase and The Cochrane Library databases were electronically searched to collect RCTs of acupuncture for dry eye at home and abroad from inception to February 2020. The reporting quality of the selected literature was evaluated with the items in the CONSORT and STRICTA, respectively.ResultsA total of 69 Chinese literatures and 8 English literatures were included. The average reporting rate of all items of CONSORT in Chinese and English literatures was 41.4% and 56.4%, respectively. The missing items of Chinese literature report primarily focused on the sections of “methodology”, “results”, and “other information”. The Chinese and English literature report rate was relatively close in terms of the literature report rate of STRICTA, and both were relatively complete in the description of acupuncture intervention.ConclusionsThe reporting quality of RCTs of acupuncture treatment for dry eye in China and abroad is generally low. Further improving the relevant reporting quality according to the CONSORT statement 2010 and STRICTA 2010 is urgent.
“针刺临床试验干预措施报告标准”（Standards，for Reporting Interventions in Clinical Trials of Acupuncture，STRICTA）于2001年和2002年在5种期刊上发表。该指南以对照试验检查清单及解释的形式供作者和期刊编辑使用，旨在提高针刺临床试验报告的质量，尤其是对其中干预措施的报告，因而有助于对这些试验的解释和重复。随后对STRICTA的应用及影响的述评都强调了STRICTA的价值，也提出了改进和修订的建议。 为使修订过程顺利进地，STRICTA工作组、CONSORT工作组和中国Cochrane中心于2008年开始合作，召集成立的包含47名成员的专家小组对清单的修改稿提出了电子版反馈意见。在后来于弗莱堡（Freiburg）召开的见面会上，由21名专家组成的工作组进一步修订了STRICTA对照检查清单，并计划如何对其进行发布。 新的STRICTA对照检查清单作为CONSORT的正式扩展版，包含6项条目及17条二级条目。这些条目为报告针刺治疗的合理性、针刺的细节、治疗方案、其他干预措施、治疗师的背景以及对照或对照干预提供了指南。而且，作为修订工作的一部分，对每一条目作了详尽解释，并针对每一条目给出了良好报告的实例。此外，STRICTA中的“对照”（controlled）一词被替换成了“临床”（clinical），以示STRICTA适用于更广泛的各类临床评价设计，包括非对照结局研究和病例报道。修订的STRICTA对照检查清单有望与CONSORT声明及其非药物治疗扩展版一起共同提高针刺临床试验的报告质量。