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.
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.
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.
“針刺臨床試驗干預措施報告標準”（Standards，for Reporting Interventions in Clinical Trials of Acupuncture，STRICTA）于2001年和2002年在5種期刊上發表。該指南以對照試驗檢查清單及解釋的形式供作者和期刊編輯使用，旨在提高針刺臨床試驗報告的質量，尤其是對其中干預措施的報告，因而有助于對這些試驗的解釋和重復。隨后對STRICTA的應用及影響的述評都強調了STRICTA的價值，也提出了改進和修訂的建議。 為使修訂過程順利進地，STRICTA工作組、CONSORT工作組和中國Cochrane中心于2008年開始合作，召集成立的包含47名成員的專家小組對清單的修改稿提出了電子版反饋意見。在后來于弗萊堡（Freiburg）召開的見面會上，由21名專家組成的工作組進一步修訂了STRICTA對照檢查清單，并計劃如何對其進行發布。 新的STRICTA對照檢查清單作為CONSORT的正式擴展版，包含6項條目及17條二級條目。這些條目為報告針刺治療的合理性、針刺的細節、治療方案、其他干預措施、治療師的背景以及對照或對照干預提供了指南。而且，作為修訂工作的一部分，對每一條目作了詳盡解釋，并針對每一條目給出了良好報告的實例。此外，STRICTA中的“對照”（controlled）一詞被替換成了“臨床”（clinical），以示STRICTA適用于更廣泛的各類臨床評價設計，包括非對照結局研究和病例報道。修訂的STRICTA對照檢查清單有望與CONSORT聲明及其非藥物治療擴展版一起共同提高針刺臨床試驗的報告質量。