Effectiveness of Zhenqi Buxue Oral Liquid Combined with Progesterone for Treatment of Oligomenorrhea and Hypomenorrhea with Qi-Blood and Kidney(Shen)Essence Deficiency:A Randomized Controlled Trial
作者机构：National Clinical Research Center for Obstetric&Gynecologic DiseasesDepartment of Obstetrics and GynecologyPeking Union Medical College HospitalChinese Academy of Medical Sciences&Peking Union Medical College Address:Peking Union Medical College Hospital(East)Beijing(100730)China Department of Obstetrics and GynecologyLiuzhou Maternal and Child Health Care HospitalLiuzhouGuangxi Zhuang Autonomous Region(545001)China Department of Obstetrics and GynecologySichuan University West China Second University HospitalChendu(610066)China Department of Obstetrics and GynecologyMaternal and Child Health Hospital of Hubei ProvinceWuhan(430070)China Department of Obstetrics and GynecologySoutheast University Zhongda HospitalNanjing(210009)China Department of Obstetrics and GynecologyGuangzhou Women and Children's Medical CenterGuangzhou(510623)China Department of Obstetrics and Gynecologythe First Hospital of Hebei Medical UniversityShijiazhuang(050000)China
出 版 物：《Chinese Journal of Integrative Medicine》 (中国结合医学杂志(英文版))
年 卷 期：2023年第29卷第11期
页 面：963-970页
核心收录：
学科分类：1002[医学-临床医学] 100211[医学-妇产科学] 10[医学]
基 金：Supported by the Capital’s Funds for Health Improvement and Research(CFH:2020-2-40113) Natural Science Foundation of China(No.82074143) the Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences(No.2020-PT320-003)。
摘 要：Objective:To evaluate the effectiveness and safety of Zhenqi Buxue Oral Liquid(ZQ),progesterone capsules,and their combination in treating oligomenorrhea and hypomenorrhea with qi-blood and Kidney(Shen)essence deficiency.Methods:This was a prospective,randomized,multi-center controlled trial between June 2022 to December 2022.Ninety-six oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency were randomly assigned to receive ZQ(ZQ group,29 cases),progesterone capsules(PG group,32 cases),or the combined Chinese and Western medicine(COM group,31 cases)at a ratio of 1:1:1.Patients in the ZQ or PG group took daily 10 m L twice a day of ZQ or 200 mg once a day of progesterone capsules for 10 consecutive days on day 15 of the menstrual cycle respectively,and patients in the COM group received the same ZQ combined with progesterone capsules.The treatment course lasted for 3 months and follow-up was performed at 1 and 3 months after the end of treatment.Primary endpoint was the menstrual Traditional Chinese Medicine Syndrome Scale(TCMSS)scores.Secondary endpoints included pictorial blood loss assessment chart(PBAC)scores,clinical efficacy rate,36-item Short Form Health Survey(SF-36)scores,sex hormones and thickness of endometrium.Adverse events(AEs)were recorded.Results:TCMSS scores after 1-and 3-month treatment in all groups were significantly lower than those at baseline(P0.05).Only TCMSS scores after 3-month treatment in the ZQ and COM groups continuously decreased compared with those after 1-month treatment in the same group(P0.01).TCMSS scores after 3-month treatment in the ZQ and COM groups were significantly lower than those in the PG group(P0.05,P0.01).Compared with baseline,PBAC scores in the ZQ and COM groups after 3 months of treatment were also significantly higher(both P0.01).The total effective rates of TCM syndrome of 3-month treatment were significantly improved in all groups compared with that after 1 month of treatment(P0.05).The total effective rate of the COM group was the highest in the 3rd month of treatment and significantly higher than that of PG group alone(P0.05).Compared with baseline,only the SF-36 scores of COM group were significantly improved after 3 months of treatment(P0.05).No serious adverse reactions were observed after treatment.Conclusions:The combination of ZQ and PG,or ZQ only had better effects on reducing TCMSS scores compared with PG,and COM showed the higher total effective rate compared with monotherapy.Besides,COM could effectively improve menstrual blood loss and quality of life.ZQ combined with PG may be an effective and safe option for oligomenorrhea and hypomenorrhea patients with qi-blood and Shen essence deficiency.
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