OBJECTIVE:To evaluate the efficacy and safety of Zhumian Tang formula granules(助眠汤配方颗粒)combined with eszopiclone for treating poor sleep quality.METHODS:This multi-center,dynamic blockrandomized,parallel-group ...OBJECTIVE:To evaluate the efficacy and safety of Zhumian Tang formula granules(助眠汤配方颗粒)combined with eszopiclone for treating poor sleep quality.METHODS:This multi-center,dynamic blockrandomized,parallel-group superiority clinical trial included 130 patients.The combined treatment group received Zhumian Tang formula granules combined with eszopiclone treatment,and the control group received eszopiclone treatment only.The group allocation ratio was 1∶1.The duration of treatment was 2 weeks.Participants were asked to complete questionnaires before treatment,after 1 week of the intervention,after 2 weeks of the intervention,and at the follow-up on week 3.The primary outcomes were the Pittsburgh Sleep Quality Index(PSQI)score and the total effective rate of treatment.The secondary outcome was the rate of adverse effects.RESULTS:Compared with the eszopiclone treatment group,the PSQI score of the combined treatment group was significantly lower after 2 weeks of the intervention(6.98 vs 8.26,P<0.05).However,there was no significant difference in the mean PSQI score after 1 week of the intervention(9.89 vs 9.15,P=0.124).After the follow-up on week 3,the PSQI score of the combined treatment group remained significantly lower than that of the eszopiclone treatment group(6.12 vs 8.31,P<0.001).The total effective rates of treatment of the combined group and the eszopiclone group were 36.92%vs 35.38%(Z=0.033,P=0.855)after 1 week of the intervention,83.08%vs 58.46%(Z=9.519,P<0.05)after 2 weeks of the intervention,and 83.08%vs 61.54%(Z=7.530,P<0.05)and after the follow-up on week 3,respectively.There was no significant difference in the overall rate of adverse reactions between the combined and eszopiclone treatment groups(21.53%vs 31.8%,P=0.318).CONCLUSION:The combination of Zhumian Tang formula granules with eszopiclone was found to be safe and more effective in improving sleep quality than eszopiclone alone.Traditional Chinese medicine can enhance the effectiveness of Western medicine in the treatment of insomnia.展开更多
基金Supported by Sichuan Province Central Guided Local Science and Technology Development Special Project:a Study of the Chinese and Western Medicine Clinical Consensus Program for People with Poor Sleep Quality(No.2021ZYD0109)Natural Science Foundation of Sichuan Province:Study on the Efficacy and Mechanism of Acupuncture in Treating Drug-dependent Insomnia from the Liver based on Multi-modal f MRI Technology(No.2022NSFSC0858)。
文摘OBJECTIVE:To evaluate the efficacy and safety of Zhumian Tang formula granules(助眠汤配方颗粒)combined with eszopiclone for treating poor sleep quality.METHODS:This multi-center,dynamic blockrandomized,parallel-group superiority clinical trial included 130 patients.The combined treatment group received Zhumian Tang formula granules combined with eszopiclone treatment,and the control group received eszopiclone treatment only.The group allocation ratio was 1∶1.The duration of treatment was 2 weeks.Participants were asked to complete questionnaires before treatment,after 1 week of the intervention,after 2 weeks of the intervention,and at the follow-up on week 3.The primary outcomes were the Pittsburgh Sleep Quality Index(PSQI)score and the total effective rate of treatment.The secondary outcome was the rate of adverse effects.RESULTS:Compared with the eszopiclone treatment group,the PSQI score of the combined treatment group was significantly lower after 2 weeks of the intervention(6.98 vs 8.26,P<0.05).However,there was no significant difference in the mean PSQI score after 1 week of the intervention(9.89 vs 9.15,P=0.124).After the follow-up on week 3,the PSQI score of the combined treatment group remained significantly lower than that of the eszopiclone treatment group(6.12 vs 8.31,P<0.001).The total effective rates of treatment of the combined group and the eszopiclone group were 36.92%vs 35.38%(Z=0.033,P=0.855)after 1 week of the intervention,83.08%vs 58.46%(Z=9.519,P<0.05)after 2 weeks of the intervention,and 83.08%vs 61.54%(Z=7.530,P<0.05)and after the follow-up on week 3,respectively.There was no significant difference in the overall rate of adverse reactions between the combined and eszopiclone treatment groups(21.53%vs 31.8%,P=0.318).CONCLUSION:The combination of Zhumian Tang formula granules with eszopiclone was found to be safe and more effective in improving sleep quality than eszopiclone alone.Traditional Chinese medicine can enhance the effectiveness of Western medicine in the treatment of insomnia.
