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| Efficacy and safety of Guipi Pills for insomnia：a systematic review and Meta-analysis |
| Hits 13 Download times 1 Received:October 30, 2024 |
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| DOI
10.11656/j.issn.1672-1519.2024.12.12 |
| Key Words
Guipi Pills;insomnia;efficacy;safety;system review;Meta-analysis |
| Author Name | Affiliation | E-mail | | ZHANG Hengrui | The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100029, China | | | JI Zhaochen | Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | robin_johnson@foxmail.com | | LUO Bin | The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100029, China | 13901387438@163.com |
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| Abstract
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| [Objective] To systematically evaluate the efficacy and safety of Guipi Pills in treating insomnia. [Methods] CNKI，Wanfang，SinoMed，PubMed，Web of Science，and Artificial Intelligence-enhanced Clinical Evidence Database for Chinese Patent Medicine（AICED-CPM） under the traditional Chinese medicine（TCM） Clinical Evidence Database were searched for randomized controlled trials of Guipi Pills for the treatment of insomnia，and the search time range was all from the establishment of the database to October 2024. The Cochrane Systematic Reviewer’s Handbook Risk of Risk of Bias（RoB） was used to evaluate methodological quality from 7 aspects，and meta-analyses were performed using the R language built into AICED-CPM. [Results] Five studies with a total of 382 patients were included，including 192 in the experimental group and 190 in the control group. The results of Meta-analysis showed that in terms of clinical efficacy，Guipi Pills had obvious efficacy，which was comparable to that of Western medicine，but inferior to traditional Chinese medicine decoction，and the combination of Guipi Pills and Western medicine could improve the efficacy[RR=1.17，95%CI （1.00，1.36），P<0.05]. In terms of SQ sleep indicators，Guipi Pills has obvious curative effect and can significantly improve the efficacy when combined with Western medicine. In terms of sleep process parameters，sleep cycles，SDS and SAS self-rating scales，Guipi Pills had obvious curative effect，but the effect was not as good as that of traditional Chinese medicine decoction. In terms of SRSS score，the combination of Guipi Pills and Western medicine could significantly improve the efficacy，and the above results were statistically significant（P<0.05）. In terms of safety，only one study reported adverse events with no serious adverse effects，and the overall safety profile was good. [Conclusion] Guipi Pills has efficacy in the treatment of insomnia，and can enhance the efficacy when combined with Western medicine，and the safety is well. There are still some limitations in this study. In the current application scenario of Guipi Pills，patients buy and use it by themselves，but few clinical studies have been carried out，and there is a lack of data reporting on TCM syndrome types and patient baselines，so it is necessary to promote more high-quality clinical studies to verify them. |
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