Quality assessment on randomized sham-acupuncture controlled trials of acupuncture for primary insomnia over the past decade

ZHANG Boyu; GAO Xiyan; GAO Ling; CHU Wenming; LI Yun; DONG Li

doi:10.13703/j.0255-2930.20250310-k0006

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Quality assessment on randomized sham-acupuncture controlled trials of acupuncture for primary insomnia over the past decade

Literature Research | 更新时间：2026-04-16

- Quality assessment on randomized sham-acupuncture controlled trials of acupuncture for primary insomnia over the past decade
- Chinese Acupuncture & Moxibustion Vol. 46, Issue 4, Pages: 644-654(2026)
- 作者机构：
  
  河南中医药大学，郑州　450046
  河南中医药大学第三附属医院，郑州　450003
- 作者简介：
- 基金信息：
- DOI：10.13703/j.0255-2930.20250310-k0006
  CLC：
- Received：10 March 2025，
  
  Online First：29 August 2025，
  
  Published：12 April 2026
- 稿件说明：
移动端阅览
ZHANG Boyu, GAO Xiyan, GAO Ling, et al. Quality assessment on randomized sham-acupuncture controlled trials of acupuncture for primary insomnia over the past decade[J]. Chinese Acupuncture & Moxibustion, 2026, 46(4): 644-654.
DOI：

ZHANG Boyu, GAO Xiyan, GAO Ling, et al. Quality assessment on randomized sham-acupuncture controlled trials of acupuncture for primary insomnia over the past decade[J]. Chinese Acupuncture & Moxibustion, 2026, 46(4): 644-654. DOI： 10.13703/j.0255-2930.20250310-k0006.

摘要

目的：

系统评价针刺治疗原发性失眠（PI）随机假针刺对照试验的报告质量。

方法：

检索中国期刊全文数据库（CNKI）、中国生物医学文献服务系统（SinoMed）、维普中文科技期刊数据库（VIP）、万方数据知识服务平台（Wanfang）及PubMed（医学文献数据库）、CENTRAL（Cochrane临床对照试验中心注册库）、EMbase（生物医学文献库）2014年12月31日至2024年12月31日收录的针刺治疗PI的随机假针刺对照试验的文献。采用随机对照临床试验报告标准（CONSORT声明）、针刺临床试验干预措施报告标准（STRICTA标准）和假针刺对照报告指南与清单（SHARE清单）对纳入的文献进行多维质量评估，计算各条目报告率及质量评分（QS）。

结果：

共纳入文献37篇，其中中文文献31篇、英文文献6篇。涉及假针刺对照的形式有8种，以非刺入型假针刺和非效穴浅刺居多。基于CONSORT声明、STRICTA 标准、SHARE清单的QS中位数分别为16、11、8。基于CONSORT声明，中文文献报告率低于50%的条目占所有条目的62.16%（23/37），9个条目报告率为0%，5个条目报告率为100%；英文文献报告率为0%的条目有7个，13个条目报告率为100%。基于STRICTA标准，中文文献报告率低于50%的条目占所有条目的29.41%（5/17），无条目报告率为0%，2个条目报告率为100%；英文文献报告率为0%的条目有2个，8个条目报告率为100%。基于SHARE清单，中文文献报告率低于50%的条目占68.42%（13/19），3个条目报告率为0%，无条目报告率为100%；英文文献报告率低于50%的条目占36.84%（7/19），3个条目报告率为0%，3个条目报告率为100%。

结论：

针刺治疗PI的随机假针刺对照试验报告质量整体不高，尤其在试验设计透明度、假针刺细节规范性和方法学严谨性方面亟待提升。建议未来研究严格遵循CONSORT声明、STRICTA标准及SHARE清单，强化盲法实施、样本量计算及试验注册，以增强证据可靠性，推动针灸循证实践国际化。

Abstract

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.

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