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 mL 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 (P<0.05). 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 (P<0.01). TCMSS scores after 3-month treatment in the ZQ and COM groups were significantly lower than those in the PG group (P<0.05, P<0.01). Compared with baseline, PBAC scores in the ZQ and COM groups after 3 months of treatment were also significantly higher (both P<0.01). 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 (P<0.05). 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 (P<0.05). Compared with baseline, only the SF-36 scores of COM group were significantly improved after 3 months of treatment (P<0.05). 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.
Female ; Humans ; Progesterone/therapeutic use* ; Qi ; Oligomenorrhea/drug therapy* ; Quality of Life ; Prospective Studies ; Medicine, Chinese Traditional ; Drugs, Chinese Herbal/adverse effects* ; Capsules ; Kidney

OBJECTIVES: Hysteroscopic adhesiolysis (HA) remains the mainstay on treatment for intrauterine adhesions (IUA). The fertility outcome of patients with moderate and severe intrauterine adhesions after HA is still far from satisfactory. Estrogen combined with progesterone is the most common treatment; however, they do not help in improving the fertility rate to the maximum because of the limitations. This retrospective, non-randomized controlled study will assess the effects of traditional Chinese medicine Yangmo decoction after HA in restoration of the endometrium and improvement of the fertility rate. METHODS: A total of 427 patients, who met the inclusion criteria, aged between 20 and 45 years and diagnosed with moderate or severe IUA underwent HA at the Third Xiangya Hospital from January to August 2021, were enrolled for this study. Participants were assigned into 2 groups: A Yangmo decoction group (n=213, patients were given Yangmo decoction consisting of Ginseng flower, Sanchi flower, Daidai flower, Snow lotus, Licorice and so on after HA), and an estrogen and progesterone group (n=214, patients were given estrogen and progesterone after HA). The following basic information was collected retrospectively for both groups, including age, parity, history of abortion, menstrual status, and times of hysteroscopic interventions. American Fertility Society (AFS) score was used by a senior surgeon and the density of opening of endometrial glands was evaluated during HA. The parameters were obtained from three-dimensional transvaginal ultrasound (3D-TVUS) preoperatively and postoperatively, to evaluate the efficacy of Yangmo decoction, estrogen, and progesterone. All patients were followed up on telephone to determine the fertility rate until 6 months from the last HA. RESULTS: Based on the basic information collected preoperatively, there were no significant differences between the groups (all P>0.05). Postoperatively, patients in the Yangmo decoction group had a better surgical success rate with a more significant AFS reduction (P<0.001), better density of opening of endometrial glands in the uterine cavity (P<0.000 1) after HA, and a better fertility rate (40.4%) in the time of 6 months after the last HA than those of the estrogen and progesterone group. CONCLUSIONS Yangmo decoction has better therapeutic efficacy in the treatment of intrauterine adhesion after HA than the combined effect of estrogen and progesterone. Yangmo decoction helps restore the endometrium and improve the fertility rate, therefore, it can be adopted as a routine practice for IUA patients who have fertility requirements.
Humans ; Young Adult ; Adult ; Middle Aged ; Retrospective Studies ; Progesterone/therapeutic use* ; East Asian People ; Medicine, Chinese Traditional ; Estrogens/therapeutic use*

BACKGROUNDMenopausal hormone therapy (MHT) has been proven to have beneficial effects on several components of metabolic syndrome. However, the effects vary according to different regimens, dosages, and duration of MHT. The aim of the study was to evaluate the effect of standard-dose 0.625 mg conjugated equine estrogen (CEE) and half-dose 0.3 mg CEE daily with different progestogens in a continuous sequential regimen on postmenopausal metabolic parameters in generally healthy postmenopausal women.

METHODSA prospective, open-label, randomized controlled clinical trial was conducted between February 2014 and December 2015. Totally 123 Chinese postmenopausal women with climacteric symptoms were included in this study and were randomly assigned to three groups: Group A received CEE 0.3 mg/micronized progesterone (MP) 100 mg daily; Group B received CEE 0.625 mg/MP 100 mg daily; and Group C received CEE 0.625 mg/dydrogesterone 10 mg daily. Drugs were given in a continuous sequential pattern. The duration of treatment was 12 months. Clinical, anthropometrical, and metabolic variables were measured. Data were analyzed according to intention-to-treat analysis, using Student's t-test and analysis of variance.

RESULTSA total of 107 participants completed the 12-month follow-up and were included in the data analysis. At 12 months of treatment, high-density lipoprotein cholesterol and apolipoprotein A significantly increased, and low-density lipoprotein cholesterol, fasting glucose, and glycosylated hemoglobin significantly decreased in Groups B and C, compared with baseline (all P < 0.05). Among the three groups, only Group C showed significantly increased triglycerides compared with baseline (1.61 ± 0.80 mmol/L vs. 1.21 ± 0.52 mmol/L, P = 0.026). Each group showed a neutral effect on total cholesterol, lipoprotein A, apolipoprotein B, and fasting insulin levels. No cardiovascular and venous thromboembolic events occurred in the three groups.

CONCLUSIONSAmong Chinese postmenopausal women, half-dose CEE was not sufficient to induce a favorable lipid and carbohydrate profile compared with standard-dose CEE. Adding natural MP may counterbalance the TG-increasing effect of CEE.

TRIAL REGISTRATIONClinicalTrials.gov, NCT01698164; https://clinicaltrials.gov/ct2/show/NCT01698164?term=NCT01698164&rank=1.

Apolipoproteins B ; blood ; Blood Pressure ; drug effects ; Body Composition ; drug effects ; Dydrogesterone ; administration & dosage ; therapeutic use ; Estrogens, Conjugated (USP) ; administration & dosage ; therapeutic use ; Female ; Humans ; Insulin ; blood ; Lipoprotein(a) ; blood ; Metabolic Syndrome ; blood ; drug therapy ; Middle Aged ; Postmenopause ; Progesterone ; administration & dosage ; therapeutic use ; Triglycerides ; blood

BACKGROUNDPreterm birth (PTB) is the leading cause of perinatal morbidity and mortality worldwide, and its prevention is an important health-care priority. The cervical incompetence is a well-known risk factor for PTB and its incidence is about 0.1-2.0%, while there is no ideal optimum treatment recommended currently. The cervical incompetence causes about 15% of habitual abortion in 16-28 weeks. This study aimed to evaluate the effectiveness and safety of cervical cerclage and vaginal progesterone in the treatment of cervical incompetence with/without PTB history.

METHODSWe retrospectively observed the pregnancy outcome of 198 patients diagnosed with cervical incompetence from January 2010 to October 2015 in Beijing Hospital. Among the 198 women involved, women who had at least one PTB before 32 weeks (including abortion in the second trimester attributed to the cervical competence) were assigned to the PTB history cohort, and others were assigned to the non-PTB history cohort. All women underwent cerclage placement (cervical cerclage group) or administrated with vaginal progesterone (vaginal progesterone group) until delivery. The outcomes of interest were the differences in gestational age at delivery, the rate of premature delivery, neonatal outcome, complications, and route of delivery between the two treatment groups.

RESULTSAmong the 198 patients with cervical incompetence, 116 patients in PTB history cohort and 80 patients in non-PTB history cohort were included in the final analysis. In the PTB history cohort, cervical cerclage group had significantly longer cervical length at 2 weeks after the start of treatment (23.1 ± 4.6 mm vs. 12.4 ± 9.1 mm, P = 0.002), higher proportion of delivery ≥37 weeks' gestation (63.4% vs. 33.3%, P = 0.008), bigger median birth weight (2860 g vs. 2250 g, P = 0.031), and lower proportion of neonates whose 1-min Apgar score <7 (5.9% vs. 33.3%, P = 0.005), compared with vaginal progesterone group. No significant differences were found in other outcome measures between the two treatment groups. In the non-PTB history cohort, there were no significant differences in the maternal outcomes between cervical cerclage and vaginal progesterone groups, such as median gestational age at delivery (37.4 weeks vs. 37.3 weeks, P = 0.346) and proportion of delivery ≥37 weeks' gestation (55.9% vs. 60.9%, P = 0.569). There were also no significant differences in the neonatal outcomes between the cervical cerclage and vaginal progesterone groups including the median birth weight (2750 g vs. 2810 g, P = 0.145), perinatal mortality (5.9% vs. 6.5%, P = 0.908), and 1-min Apgar scores (8.8% vs. 8.7%, P = 0.984).

CONCLUSIONSCervical cerclage showed more benefits in the maternal and neonatal outcomes than vaginal progesterone therapy for women with an asymptomatic short cervix and prior PTB history, while cervical cerclage and vaginal progesterone therapies showed similar effectiveness for women with an asymptomatic short cervix but without a history of PTB.

Adult ; Cerclage, Cervical ; methods ; Female ; Gestational Age ; Humans ; Pregnancy ; Pregnancy Outcome ; Premature Birth ; prevention & control ; Progesterone ; administration & dosage ; therapeutic use ; Retrospective Studies ; Uterine Cervical Incompetence ; drug therapy ; prevention & control ; surgery ; Young Adult

Endometrial hyperplasia (EH) comprises a spectrum of changes in the endometrium ranging from a slightly disordered pattern that exaggerates the alterations seen in the late proliferative phase of the menstrual cycle to irregular, hyperchromatic lesions that are similar to endometrioid adenocarcinoma. Generally, EH is caused by continuous exposure of estrogen unopposed by progesterone, polycystic ovary syndrome, tamoxifen, or hormone replacement therapy. Since it can progress, or often occur coincidentally with endometrial carcinoma, EH is of clinical importance, and the reversion of hyperplasia to normal endometrium represents the key conservative treatment for prevention of the development of adenocarcinoma. Presently, cyclic progestin or hysterectomy constitutes the major treatment option for EH without or with atypia, respectively. However, clinical trials of hormonal therapies and definitive standard treatments remain to be established for the management of EH. Moreover, therapeutic options for EH patients who wish to preserve fertility are challenging and require nonsurgical management. Therefore, future studies should focus on evaluation of new treatment strategies and novel compounds that could simultaneously target pathways involved in the pathogenesis of estradiol-induced EH. Novel therapeutic agents precisely targeting the inhibition of estrogen receptor, growth factor receptors, and signal transduction pathways are likely to constitute an optimal approach for treatment of EH.
Antineoplastic Agents, Hormonal/adverse effects ; Disease Management ; Disease Progression ; Endometrial Hyperplasia/classification/etiology/*therapy ; Female ; Gonadotropin-Releasing Hormone/therapeutic use ; Humans ; Hysterectomy ; Molecular Targeted Therapy/methods ; Progesterone Congeners/therapeutic use ; Risk Factors ; Tamoxifen/adverse effects

OBJECTIVE: To evaluate the relationship between response categories assessed by magnetic resonance imaging (MRI) or pathology and survival outcomes, and to determine whether there are prognostic differences among molecular subtypes. MATERIALS AND METHODS: We evaluated 174 patients with biopsy-confirmed invasive breast cancer who had undergone MRI before and after neoadjuvant chemotherapy, but before surgery. Pathology findings were classified as a pathologic complete response (pCR) or a non-pCR, and MRI findings were designated as a radiologic CR (rCR) or a non-rCR. We evaluated overall and subtype-specific associations between clinicopathological factors including the assessment categories and recurrence, using the Cox proportional hazards model. RESULTS: There were 41 recurrences (9 locoregional and 32 distant recurrences). There were statistically significant differences in recurrence outcomes between patients who achieved a radiologic or a pCR and patients who did not achieve a radiologic or a pCR (recurrence hazard ratio, 11.02; p = 0.018 and recurrence hazard ratio, 3.93; p = 0.022, respectively). Kaplan-Meier curves for recurrence-free survival showed that triple-negative breast cancer was the only subtype that showed significantly better outcomes in patients who achieved a CR compared to patients who did not achieve a CR by both radiologic and pathologic assessments (p = 0.004 and 0.001, respectively). A multivariate analysis found that patients who achieved a rCR and a pCR did not display significantly different recurrence outcomes (recurrence hazard ratio, 2.02; p = 0.505 and recurrence hazard ratio, 1.12; p = 0.869, respectively). CONCLUSION: Outcomes of patients who achieved a rCR were similar to those of patients who achieved a pCR. To evaluate survival difference according to molecular subtypes, a larger study is needed.
Adult ; Aged ; Antineoplastic Agents/therapeutic use ; Breast Neoplasms/drug therapy/mortality/*pathology ; Female ; Humans ; Kaplan-Meier Estimate ; *Magnetic Resonance Imaging ; Middle Aged ; Neoadjuvant Therapy ; Neoplasm Recurrence, Local ; Prognosis ; Proportional Hazards Models ; Receptor, ErbB-2/genetics/metabolism ; Receptors, Estrogen/genetics/metabolism ; Receptors, Progesterone/genetics/metabolism ; Remission Induction

To study the effect of total matrines and extracts from Periplaneta americana on negative endometrial cancer cell JEC of progesterone receptors. After detecting the effect of total matrine, extracts from P. americana and their combination on JEC cells' growth inhibition, cell cycle, P53 and c-erbB-2 gene protein expressions through MTT, flow cytometry instrument and Western blot method, the author found that, (1) MTT: total matrines and extracts from P. americana could inhibit the growth of JEC cell, with significant increase in the inhibitory effect in the combination group. (2) Flow cytometry instrument: the cell cycle at G0/G1 increased after the treatment with total matrines, the cell cycle at G2/M increased after the treatment with extracts from periplaneta americana, and the ratio of G0/G1 cell cycle in the combination group was significantly higher than the other groups, with inhibition in cell growth and statistical difference in inter-group comparison (P < 0.05). (3) Western blot: the expression level of P53 increased and c-erbB-2 decreased after the treatment with total matrines, extracts from P. americana and their combination on JEC cell, with statistical difference in inter-group comparison (P < 0.05). The above results suggested that total matrines, extracts from P. americana and their combination could induce cell cycle arrest and inhibit the growth of JEC cell by up-regulating P53 and down-regulating the c-erbB-2 level.
Alkaloids ; therapeutic use ; Animals ; Cell Line, Tumor ; Endometrial Neoplasms ; chemistry ; drug therapy ; pathology ; Female ; Flow Cytometry ; Humans ; Periplaneta ; Phytotherapy ; Plant Extracts ; therapeutic use ; Quinolizines ; therapeutic use ; Receptors, Progesterone ; analysis ; Tumor Suppressor Protein p53 ; analysis ; physiology

It is to observe the therapeutic action of Guizhi Fuling capsule and the combination of active ingredients on model rats with uterine leiomyoma. The hysteromyoma rats models was established in rats by loading eatrogen, to observe the effect on pathological condition of uterus, uterus wet weight, the content of estradiol and progesterone. Guizhi Fuling capsule and the combination of active ingredients remarkably decreased uterus weight, restrained the excess proliferation of the smooth muscle of uterus, decreased the estraiol and progesterone in blood serum. Guizhi Fuling capsule and the combination of active ingredients can restrain the formation of hysteromyoma in a dose-dependent manner. Perhaps the combination of active ingredients is the material foundation of antihysteromyoma.
Animals ; Capsules ; Drugs, Chinese Herbal ; therapeutic use ; Estradiol ; blood ; Female ; Leiomyoma ; blood ; drug therapy ; pathology ; Progesterone ; blood ; Rats ; Rats, Wistar ; Uterine Neoplasms ; blood ; drug therapy ; pathology

OBJECTIVETo explore the molecular biological mechanism of ZHU's Tiaojing Cuyun Recipe (TCR) for treating anovulatory infertility patients with Shen deficiency syndrome (SDS) by observing its clinical efficacy.

METHODSUsing randomized blocking methods, 80 patients were assigned to the treatment group (40 cases) and the control group (40 cases). Patients with regular menstrual cycle started medication from the 5th day of menstruation. Those with irregular menstrual cycle first took progesterone till withdrawal bleeding ,and then started medication from the 5th day of vaginal bleeding. Patients in the treatment group took ZHU's TCR, one dose per day, while those in the control group took Clomifene Citrate (CC), 50 mg per day. Three menstrual cycles consisted of one therapeutic course, a total of 2 courses. Clinical efficacy such as pregnancy rates and abortion rates were observed. Ovulation indices (the maximal diameter of mature follicles, luteinized follicles, ovulational follicles, and the endometrial thickness on the ovulation day), SDS, and integrals of menstrual symptoms were monitored before and after treatment. Serum levels of follicle stimulating hormone (FSH), luteinizing hormone (LH) , and estradiol (E2) were determined using chemiluminescent immunoassay before treatment and after on therapeutic course. Serum levels of activin A (ACTA), inhibin B (INHB), and follistatin (FS) were detected using double antibody sandwich ELISA.

RESULTSCompared with the control group, the pregnancy rate was obviously elevated and the abortion rate was obviously lowered in the treatment group (P <0. 05). Ovulation rates of mature follicles and luteinizing follicles decreased more in the treatment group (P < 0.05). Compared with before treatment, integrals for SDS were lower, the maximal diameter of pre-ovulational follicles was increased, and integrals for menstrual symptoms in non-pregnant patients of the two groups were obviously lowered. Meanwhile, the endometrial thickness on the ovulation day was increased in the treatment group after treatment, but reduced in the control group (P < 0.05, P < 0.01). Compared with the control group, integrals for SDS were decreased, and the maximal diameter of pre-ovulational follicles was lowered in the treatment group after treatment (P < 0.05, P < 0.01). Integrals for SDS and the difference in the endometrial thickness on the ovulation day were increased, but the difference in the maximal diameter of pre-ovulational follicles were reduced (P < 0.05, P < 0.01). In the treatment group serum levels of E2 and ACTA increased more after one therapeutic course than before treatment (P < 0.01), but serum levels of INHB and FS decreased more after one therapeutic course than before treatment (P < 0.05). In the control group serum levels of FSH and ACTA increased more, and the serum level of FS decreased more after one therapeutic course than before treatment (P < 0.05, P < 0.01). Compared with the control group, serum levels of FSH and ACTA increased more, and serum levels of INHB decreased more in the treatment group after one therapeutic course than before treatment (P < 0.05, P < 0.01).

CONCLUSIONSZHU'sTCR could improve SDS of anovulatory infertility patients, regulate the follicular development, and elevate the pregnancy rate. Its actions might be associated with regulating their sex hormones, expressions of ovary local factors such as INHB, ACTA, and FS.

Activins ; Clomiphene ; Drugs, Chinese Herbal ; therapeutic use ; Estradiol ; Female ; Follicle Stimulating Hormone ; Follistatin ; Humans ; Infertility, Female ; complications ; therapy ; Inhibins ; Luteinizing Hormone ; Medicine, Chinese Traditional ; Ovarian Diseases ; Ovarian Follicle ; Ovulation ; Progesterone

OBJECTIVETo observe the effect of Qingre Yangyin Recipe (QRYYR) on sex hormones and insulin resistance (IR) in polycystic ovary syndrome (PCOS) patients.

METHODSTotally 90 PCOS patients were randomly assigned to the Chinese herbs group,the Western medicine group, the combined group, 30 in each group. Patients in the Chinese herbs group took QRYYR, one dose per day in two portions, once in the morning and once in the evening. Patients in the Western medicine group took Metformin 500 mg, twice per day for 3 consecutive months. Patients in the combined group took QRYYR and Metformin (the same as the former said two groups) in the 1st month, and took QRYYR for the following two months. Fasting blood glucose (FPG) and postprandial 2 h blood glucose (2 h GLU) were determined using hexokinase method before and after treatment. Fasting insulin (FINS), postprandial 2 h insulin (2 h INS), luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol (E2), progesterone (P), prolactin (PRL), and testosterone (T) were detected using chemiluminescent method. Leptin and adiponectin (APN) were determined using ELISA. Homeostasis model assessment of insulin resistance (HOMA-IR) was calculated. Body weight and height were measured once before treatment and once after treatment to calculate body mass index (BMI). The total two-phase basal body temperature (BBT) actually obtained within 3 months was statistically collected to calculate the two-phase BBT rate. Scores for Chinese medical syndromes were compared between the two groups before and after treatment.

RESULTSCompared with before treatment in the same group, BMI, FINS, 2 h INS, HOMA-IR, leptin, LH, PRL, T, and scores for Chinese medical syndromes obviously decreased, and APN levels increased (P < 0.05). FPG and 2 h FPG obviously decreased in the Western medicine group and the combined group (P < 0.05). E2 levels obviously decreased in the combined group with statistical difference (P < 0.05). Compared with the Chinese herbs group, the difference of BMI between pre-treatment and post-treatment was more in the combined group (P < 0.05). The difference of FPG,2 h GLU, 2 h INS, HOMA-IR, and APN between pre-treatment and post-treatment was more in the Chinese herbs group and the combined group (P < 0.05). Compared with the Western medicine group, the difference of PRL, T, and scores for Chinese medical syndromes was more in the Western medicine group and the combined group (P < 0.05); the difference of E2 and LH was even more in the combined group (P < 0.05). Compared with the combined group, the biphasic rate was obviously lowered in the Western medicine group (P < 0.05).

CONCLUSIONSQRYYR could improve IR but with weaker power to that of Metformin. It also could decrease serum levels of LH, T, PRL, and scores for Chinese medical syndromes, with superior effect to that of Metformin. The effect in the combined group was better.

Adiponectin ; Blood Glucose ; Body Mass Index ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Estradiol ; Female ; Follicle Stimulating Hormone ; Gonadal Steroid Hormones ; Humans ; Insulin ; Insulin Resistance ; Leptin ; Luteinizing Hormone ; Metformin ; Polycystic Ovary Syndrome ; drug therapy ; metabolism ; Progesterone ; Prolactin ; Testosterone