Objective

2

To systematically evaluate the reporting quality of randomized sham-acupuncture controlled trials of acupuncture for primary insomnia (PI).

Methods

2

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

2

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

2

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.