首页|Efficacy and Safety of Ganyushu Granule in Treatment of Premenstrual Syndrome with Gan(Liver)Depression and Qi Stagnation Syndrome:A Randomized,Double-Blind,Multicenter,Phase-Ⅱ Clinical Trial

Efficacy and Safety of Ganyushu Granule in Treatment of Premenstrual Syndrome with Gan(Liver)Depression and Qi Stagnation Syndrome:A Randomized,Double-Blind,Multicenter,Phase-Ⅱ Clinical Trial

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Objective:To confirm the efficacy and safety of Ganyushu Granule(GYSG)in treating premenstrual syndrome(PMS)in patients with Gan(Liver)depression and qi stagnation syndrome(GDQSS)and determine its effective dosage.Methods:From June 2018 to March 2021,a total of 240 PMS women with GDQSS were included and randomly divided into 3 groups in a 1∶1∶1 ratio using central block randomization:high-dose GYSG group(n=78,GYSG 2 packs/time),low-dose GYSG group(n=82,GYSG and its simulant 1 pack/time),and placebo group(n=80,GYSG simulant 2 packs/time).Treatment with GYSG or placebo was given thrice daily and for up to 3 menstrual cycles.Primary outcomes were PMS diary(PMSD)score and premenstrual tension syndrome self-rating scale(PMTS).Secondary outcomes were Chinese medicine(CM)syndrome efficacy.PMSD,PMTS,and efficacy of CM were evaluated with menstrual cycles during the treatment period.Outcome indicators were analyzed after each menstrual cycle.All analyses were performed using an intention-to-treat method,and clinical safety was assessed.Results:Of the 216 patients included in the effectiveness analysis,70,75,and 71 patients were in the high-,low-dose GYSG,and placebo groups,respectively.From the 2nd treatment cycle,the change in PMSD scores in the high-and low-dose groups was lower than that in the placebo group(P＜0.05).PMTS scores in the high-dose GYSG group after the 1st treatment cycle was lower than that in the placebo group(P＜0.05),while after the 3rd treatment cycle,that in the low-dose group was lower than that in the placebo group(P＜0.05).After the 2nd treatment cycle,the high-dose GYSG group had the best CM syndrome efficacy(P＜0.05).No serious adverse reactions were reported.Conclusions:GYSG was safe and well-tolerated at both doses for treating PMS patients with GDQSS.High-dose GYSG might be the optimal dose for a phase Ⅲ trial.(Registration No.ChiCTR1 800016595)

premenstrual syndromeChinese medicineGanyushu Granulerandomized controlled trial

TENG Xiu-xiang、XU Lian-wei、LIN Jie、ZHANG Jin-feng、ZHANG Qin、SUN Yun、YANG De-feng、LI Hong-mei、ZHAO Pei、LIU Jun

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Department of Gynecology,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing(100700),China

Department of Gynecology,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai(200032),China

Department of Gynecology,The First Hospital of Hunan University of Chinese Medicine,Changsha(410021),China

Department of Gynecology,Shanxi Traditional Chinese Medicine Hospital,Taiyuan(030024),China

Department of Gynecology,Hangzhou Hospital of Traditional Chinese Medicine,Hangzhou(310005),China

Department of Gynecology,Wenzhou Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine,Wenzhou,Zhejiang Province(325000),China

Department of Gynecology,Luoyang First People's Hospital,Luoyang,Henan Province(471000),China

Department of Gynecology,The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine,Harbin(150001),China

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Capital Health Development Research Special Project

2022-2-2233

2024

10.1007/s11655-024-3755-z

中国结合医学杂志(英文版)
中国中西医结合学会 中国中医研究院

中国结合医学杂志(英文版)

CSTPCD
影响因子：1.056
ISSN：1672-0415
年,卷(期)：2024.30(9)