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Updated: Jan 26, 2026

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
Published on: February 17, 2023
Protocol registration or development may benefit the design, conduct and reporting of dose-response meta-analysis:
Chang Xu1,2, Liang-Liang Cheng3, Yu Liu4
1Center for Evidence-Based Medicine and Clinical Research, Taihe Hospital, Hubei University of Medicine, Shiyan, 442000, China.
Background:
To investigate the prevalence of protocol registration (or development) among published dose-response meta-analyses (DRMAs), and whether DRMAs with a protocol are better than those not.
Methods:
Three databases were searched for eligible DRMAs. The modified AMSTAR (14 items) and PRISMA checklists (26 items) were used to assess the methodological and reporting quality, with each item assigned 1 point if it met the requirement or 0 if not. We matched (1,2) DRMAs with registered or published protocol to those not, by region and publication years. The summarized quality score and compliance rate of each item were compared between the two groups. Multivariable regression was employed to see if protocol registration or development was associated with total quality score.
Results:
We included 529 DRMAs, with 45 (8.51%) completed protocol registration or development. We observed a higher methodological score for DRMAs with protocol than the matched controls (9.47 versus 8.58, P < 0.01); this embodied in 4 out of 14 items of AMSTAR [e.g., Duplicate data extraction (rate difference, RD = 0.17, 95% CI: 0.04, 0.30; P = 0.01). A higher reporting score (cubic transformed) for DRMAs with protocol than the matched controls was also observed (11,875.00 versus 10,229.53, P < 0.01); which embodied in 6 out of 26 items of PRISMA [e.g. Describe methods for publication bias (RD = 0.08, 95% CI: 0.01, 0.14; P = 0.02)]. Regression analysis suggested positive association between protocol registration or development and total reporting score (P = 0.012) while not for methodological score (P = 0.87).
Conclusions:
Only a small proportion of DRMAs completed protocol registration or development, and those with protocol were better reported than those not. Protocol registration or development is highly desirable.
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