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Updated: Aug 25, 2025

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
Published on: February 17, 2023
Unclear Insomnia Concept in Randomized Controlled Trials and Systematic Reviews: A Meta-Epidemiological Study
Masahiro Banno1,2,3, Yasushi Tsujimoto3,4,5, Kunihiro Kohmura1
1Department of Psychiatry, Seichiryo Hospital, Tsurumai 4-16-27, Showa-ku, Nagoya 466-0064, Japan.
Abstract:
There are two possible ways to conceptualize the term "insomnia": insomnia disorder and insomnia symptoms, which are often poorly reported. The purpose of this study was to examine the proportion of randomized controlled trials (RCTs) and systematic reviews (SRs) that mention insomnia in their abstracts and cannot distinguish between insomnia disorder and insomnia symptoms from the abstract. We included RCT and SR articles that included the word "insomnia" in the methods or results sections of their structured abstracts, published after 2010. We searched PubMed using English language restrictions on 10 March 2022. From 1580 PubMed articles, we obtained 100 random samples each for eligible RCTs and SRs. The unclear insomnia concept accounted for 88% of the RCT abstracts and 94% of the SR abstracts. Among the RCT and SR abstracts with unclearness, the concept of insomnia was unclear in 27% of RCTs and 57% of SRs after investigating the full text. The concept of insomnia has been unclear in many RCTs and SRs abstracts. The authors of RCTs and SRs are recommended to state "insomnia disorder" or "insomnia symptoms" in the methods and results sections of their abstracts.
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