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Updated: Apr 17, 2026
Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
Published on: February 17, 2023
[Quality assessment on randomized sham-acupuncture controlled trials of acupuncture for primary insomnia over the
Boyu Zhang1, Xiyan Gao1, Ling Gao1
1Henan University of CM, Zhengzhou 450046, China; Third Affiliated Hospital of Henan University of CM, Zhengzhou 450003.
Objective:
To systematically evaluate the reporting quality of randomized sham-acupuncture controlled trials of acupuncture for primary insomnia (PI).
Methods:
From China Journal Full-text Database (CNKI), China Biomedical Literature Service System (SinoMed), VIP Chinese Science and Technology Journal Database (VIP), and Wanfang Data Knowledge Service Platform (Wanfang), and PubMed, CENTRAL, and EMbase, dated from December 31, 2014, to December 31, 2024, the articles of randomized sham-acupuncture controlled trials of acupuncture for PI were searched. Using the CONSORT statement, STRICTA guidelines, and SHARE checklist, the multidimensional assessment was performed for the quality of included articles, and the reporting rate of each item and the quality score (QS) were calculated.
Results:
A total of 37 articles were included, of which 31 were in Chinese and 6 in English. There were 8 forms of sham-acupuncture control design, most of which referred to sham-acupuncture without penetrating into points or shallow acupuncture by inserting into non-effective points. Based on CONSORT statement, STRICTA guidelines, and SHARE checklist, the median of QS was 16, 11 and 8, respectively. According to CONSORT statement, for the RCTs published in Chinese, 62.16% (23/37) of items were below the reporting rate of 50%, the reporting rate of 9 items was 0%, and that of 5 items was 100%; and for those published in English, the reporting rate of 7 items was 0% and that of 13 items was 100%. Regarding STRICTA guidelines, for the RCTs published in Chinese, 29.41% (5/17) of items were below the reporting rate of 50%, the reporting rate of 0 item was 0%, and that of 2 items was 100%; and for those published in English, the reporting rate of 0 item was 0% and that of 8 items was 100%. In view of SHARE checklist, for the RCTs published in Chinese, 68.42% (13/19) of items were below the reporting rate of 50%, the reporting rate of 3 items was 0%, and that of 0 item was 100%; and for those published in English, 36.84% (7/19) of items were below the reporting rate of 50%, the reporting rate of 3 items was 0% and that of 3 items was 100%.
Conclusion:
The reporting quality of randomized sham-acupuncture controlled trials of acupuncture for PI shows overall non-completion, especially in trial design transparency, standardization of the details in sham-acupuncture, and methodological rigor. Future studies should strictly adhere to the CONSORT statement, STRICTA guidelines and SHARE checklist, strengthen the implementation of blinding, calculation of sample size, and trial registration, so as to enhance evidence reliability and promote the global practice of evidence-based acupuncture.
