Wang Yichen, W U Shiyi, Wang Zhengyan, Chang Wenling, Xie Zhihao, Tang Xing, Zhao Songmei, Zhou Jing, Chen Zehong, Wang Chao, Yang Chunxia
{"title":"竹绵汤配方颗粒联合艾司佐匹克隆治疗睡眠质量差的疗效:一项多中心、随机对照、优效性试验。","authors":"Wang Yichen, W U Shiyi, Wang Zhengyan, Chang Wenling, Xie Zhihao, Tang Xing, Zhao Songmei, Zhou Jing, Chen Zehong, Wang Chao, Yang Chunxia","doi":"10.19852/j.cnki.jtcm.2024.01.002","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the efficacy and safety of Zhumian Tang formula granules combined with eszopiclone for treating poor sleep quality.</p><p><strong>Methods: </strong>This multi-center, dynamic block-randomized, 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.</p><p><strong>Results: </strong>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 <i>vs</i> 8.26, <i>P <</i> 0.05). However, there was no significant difference in the mean PSQI score after 1 week of the intervention (9.89 <i>vs</i> 9.15, <i>P =</i> 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 <i>vs</i> 8.31, <i>P <</i> 0.001). The total effective rates of treatment of the combined group and the eszopiclone group were 36.92% <i>vs</i> 35.38% (<i>Z =</i> 0.033, <i>P =</i> 0.855) after 1 week of the intervention, 83.08% <i>vs</i> 58.46% (<i>Z =</i> 9.519, <i>P <</i> 0.05) after 2 weeks of the intervention, and 83.08% <i>vs</i> 61.54% (<i>Z =</i> 7.530, <i>P <</i> 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% <i>vs</i> 31.8%, <i>P =</i> 0.318).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":94119,"journal":{"name":"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10774717/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy of Zhumian Tang formula granules combined with eszopiclone for the treatment of poor sleep quality: a multi-center, randomized controlled, superiority trial.\",\"authors\":\"Wang Yichen, W U Shiyi, Wang Zhengyan, Chang Wenling, Xie Zhihao, Tang Xing, Zhao Songmei, Zhou Jing, Chen Zehong, Wang Chao, Yang Chunxia\",\"doi\":\"10.19852/j.cnki.jtcm.2024.01.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the efficacy and safety of Zhumian Tang formula granules combined with eszopiclone for treating poor sleep quality.</p><p><strong>Methods: </strong>This multi-center, dynamic block-randomized, 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.</p><p><strong>Results: </strong>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 <i>vs</i> 8.26, <i>P <</i> 0.05). However, there was no significant difference in the mean PSQI score after 1 week of the intervention (9.89 <i>vs</i> 9.15, <i>P =</i> 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 <i>vs</i> 8.31, <i>P <</i> 0.001). The total effective rates of treatment of the combined group and the eszopiclone group were 36.92% <i>vs</i> 35.38% (<i>Z =</i> 0.033, <i>P =</i> 0.855) after 1 week of the intervention, 83.08% <i>vs</i> 58.46% (<i>Z =</i> 9.519, <i>P <</i> 0.05) after 2 weeks of the intervention, and 83.08% <i>vs</i> 61.54% (<i>Z =</i> 7.530, <i>P <</i> 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% <i>vs</i> 31.8%, <i>P =</i> 0.318).</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":94119,\"journal\":{\"name\":\"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-02-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10774717/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.19852/j.cnki.jtcm.2024.01.002\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.19852/j.cnki.jtcm.2024.01.002","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
目的:评估竹绵汤配方颗粒联合艾司佐匹克隆治疗睡眠质量差的有效性和安全性:评估竹绵汤配方颗粒联合艾司佐匹克隆治疗睡眠质量差的疗效和安全性:这项多中心、动态整群随机、平行分组的优效临床试验包括 130 名患者。联合治疗组接受竹绵汤配方颗粒联合艾佐匹克隆治疗,对照组仅接受艾佐匹克隆治疗。组间分配比例为 1∶1。疗程为 2 周。受试者需在治疗前、干预一周后、干预两周后和第三周的随访中填写问卷。主要结果是匹兹堡睡眠质量指数(PSQI)得分和治疗总有效率。次要结果是不良反应率:与艾司佐匹克隆治疗组相比,联合治疗组的 PSQI 评分在干预 2 周后显著降低(6.98 vs 8.26,P 0.05)。然而,干预 1 周后,PSQI 平均得分没有明显差异(9.89 vs 9.15,P = 0.124)。第 3 周随访后,联合治疗组的 PSQI 得分仍明显低于艾佐匹克隆治疗组(6.12 vs 8.31,P 0.001)。干预1周后,联合治疗组和艾司佐匹克隆治疗组的治疗总有效率分别为36.92% vs 35.38% (Z = 0.033, P = 0.855);干预2周后,联合治疗组和艾司佐匹克隆治疗组的治疗总有效率分别为83.08% vs 58.46% (Z = 9.519, P 0.05);第3周随访后,联合治疗组和艾司佐匹克隆治疗组的治疗总有效率分别为83.08% vs 61.54% (Z = 7.530, P 0.05)。联合治疗组和艾司佐匹克隆治疗组的不良反应总发生率无明显差异(21.53% vs 31.8%,P = 0.318):结论:与单独使用埃佐匹克隆相比,竹绵汤配方颗粒与埃佐匹克隆联合用药在改善睡眠质量方面安全有效。中药可提高西药治疗失眠症的疗效。
Efficacy of Zhumian Tang formula granules combined with eszopiclone for the treatment of poor sleep quality: a multi-center, randomized controlled, superiority trial.
Objective: To evaluate the efficacy and safety of Zhumian Tang formula granules combined with eszopiclone for treating poor sleep quality.
Methods: This multi-center, dynamic block-randomized, 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.