L I Xiyu, Yang Yanhong, Sun Jian, Nie Quanfang, Liu Lifen, L I Guifen, Y U Junping, Zhang Zhuangjin, X U Yi, Zou Ting, Shi Yun
{"title":"加味消渴丸治疗经前综合征(肝郁脾虚、血热证)的有效性和安全性:一项多中心、随机、安慰剂对照试验。","authors":"L I Xiyu, Yang Yanhong, Sun Jian, Nie Quanfang, Liu Lifen, L I Guifen, Y U Junping, Zhang Zhuangjin, X U Yi, Zou Ting, Shi Yun","doi":"10.19852/j.cnki.jtcm.20231110.003","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To investigate the effectiveness and safety of Jiawei Xiaoyao pill (,JXP) in the treatment of symptoms associated with premenstrual syndrome (PMS).</p><p><strong>Methods: </strong>A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018, and randomized to receive either a JXP or a matching placebo (12 g/d, 6 g twice a day) for 3 menstrual cycles. The primary indicator was the reduced Daily Record of Severity of Problems (DRSP) scores in the luteal phase after 3 months of treatment. The safety outcomes included clinical adverse events (AEs), adverse reactions (ARs), changes in vital signs, and laboratory tests.</p><p><strong>Results: </strong>JXP surpassed the placebo in reducing DRSP scores (psychological/somatic dysfunction) in the luteal phase over 3 menstrual cycles of treatment (PFAS = 0.002, PPPS = 0.001). Additionally, there were no significant differences in the incidence of AEs, severe AEs, withdrawal due to AEs and ARs between the two groups (all <i>P</i> > 0.05), and no clinically significant adverse medical events related to the test drug observed.</p><p><strong>Conclusions: </strong>JXP was superior to the placebo in relieving the symptoms associated with PMS, which signified that JXP may be effective, safe, and well-tolerated as an alternative therapy.</p>","PeriodicalId":94119,"journal":{"name":"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan","volume":"44 2","pages":"373-380"},"PeriodicalIF":0.0000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10927397/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and safety of Jiawei Xiaoyao pill in the treatment of premenstrual syndrome (liver depression, spleen deficiency, and blood-heat syndrome): a multi-center, randomized, placebo-controlled trial.\",\"authors\":\"L I Xiyu, Yang Yanhong, Sun Jian, Nie Quanfang, Liu Lifen, L I Guifen, Y U Junping, Zhang Zhuangjin, X U Yi, Zou Ting, Shi Yun\",\"doi\":\"10.19852/j.cnki.jtcm.20231110.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To investigate the effectiveness and safety of Jiawei Xiaoyao pill (,JXP) in the treatment of symptoms associated with premenstrual syndrome (PMS).</p><p><strong>Methods: </strong>A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018, and randomized to receive either a JXP or a matching placebo (12 g/d, 6 g twice a day) for 3 menstrual cycles. The primary indicator was the reduced Daily Record of Severity of Problems (DRSP) scores in the luteal phase after 3 months of treatment. The safety outcomes included clinical adverse events (AEs), adverse reactions (ARs), changes in vital signs, and laboratory tests.</p><p><strong>Results: </strong>JXP surpassed the placebo in reducing DRSP scores (psychological/somatic dysfunction) in the luteal phase over 3 menstrual cycles of treatment (PFAS = 0.002, PPPS = 0.001). Additionally, there were no significant differences in the incidence of AEs, severe AEs, withdrawal due to AEs and ARs between the two groups (all <i>P</i> > 0.05), and no clinically significant adverse medical events related to the test drug observed.</p><p><strong>Conclusions: </strong>JXP was superior to the placebo in relieving the symptoms associated with PMS, which signified that JXP may be effective, safe, and well-tolerated as an alternative therapy.</p>\",\"PeriodicalId\":94119,\"journal\":{\"name\":\"Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan\",\"volume\":\"44 2\",\"pages\":\"373-380\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10927397/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.20231110.003\",\"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.20231110.003","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Effectiveness and safety of Jiawei Xiaoyao pill in the treatment of premenstrual syndrome (liver depression, spleen deficiency, and blood-heat syndrome): a multi-center, randomized, placebo-controlled trial.
Objective: To investigate the effectiveness and safety of Jiawei Xiaoyao pill (,JXP) in the treatment of symptoms associated with premenstrual syndrome (PMS).
Methods: A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018, and randomized to receive either a JXP or a matching placebo (12 g/d, 6 g twice a day) for 3 menstrual cycles. The primary indicator was the reduced Daily Record of Severity of Problems (DRSP) scores in the luteal phase after 3 months of treatment. The safety outcomes included clinical adverse events (AEs), adverse reactions (ARs), changes in vital signs, and laboratory tests.
Results: JXP surpassed the placebo in reducing DRSP scores (psychological/somatic dysfunction) in the luteal phase over 3 menstrual cycles of treatment (PFAS = 0.002, PPPS = 0.001). Additionally, there were no significant differences in the incidence of AEs, severe AEs, withdrawal due to AEs and ARs between the two groups (all P > 0.05), and no clinically significant adverse medical events related to the test drug observed.
Conclusions: JXP was superior to the placebo in relieving the symptoms associated with PMS, which signified that JXP may be effective, safe, and well-tolerated as an alternative therapy.