Hongjin Xiaojie Capsule,a Chinese patent medicine,for treating moderate to severe cyclical breast pain:A single-blind randomized controlled trial

Background Moderate to severe breast pain has major effects on the quality of life for patients.Patent Chinese medicines are widely used in the treatment of breast pain due to their stable dosage form and good efficacy.Objective To evaluate the beneficial effects and safety of Hongjin Xiaojie Capsule(HJXJC),a Chinese patent medicine,for the treatment of cyclical breast pain.Design,setting,participants and intervention This is a multicenter,single-blind randomized controlled trial conducted in 3 medical centers in China from 2019 to 2021.Patients with moderate to severe cyclic breast pain were randomly divided into the intervention group(who took HJXJC,four capsules per dose,three times a day for 12 weeks)and the control group(waiting for the treatment)in a 1:1 ratio.Main outcome measures The primary outcome was pain duration,and the patients recorded measurements at baseline and at the end of weeks 4,8,12 and 16 on a patient log card.Results The full analysis set(FAS)population included 298 participants(intervention group,n=150;control group,n=148),while the per-protocol analysis set(PPS)included 274 participants.After 12 weeks,the duration of breast pain was significantly shorter in the intervention group(FAS:mean difference,–6.69;95%CI,–7.58 to–5.80;P<0.01,vs control.PPS:mean difference,–7.09;95%CI,–8.01 to–6.16;P<0.01,vs control).The Short-form McGill Pain Questionnaire(SF-MPQ)scores were significantly lower in the intervention group(FAS:mean difference,–12.55;95%CI,–13.90 to–11.21;P<0.01,vs control.PPS:mean difference,–13.07;95%CI,–14.48 to–11.66;P<0.01,vs control).The above indicators continued to be significantly different through week 16.Moreover,in the intervention group,breast lumps shrank after 12 weeks and the size of breast lumps was statistically smaller than that in the control group(P<0.05),whereas the sizes of breast nodules and uterine fibroid showed no statistically significant difference compared with the control group(P>0.05).At weeks 8 and 12,the dysmenorrhea scores in the intervention group were lower than those in the control group(P<0.05).No obvious adverse reactions were observed in any group.Conclusion HJXJC can significantly shorten the duration of breast pain,reduce breast pain,reduce the size of breast lumps,and relieve dysmenorrhea.However,it has no significant effect on the size of breast nodules or uterine fibroid.

Menopausal Symptoms and Sleep Quality During Menopausal Transition and Postmenopause

Background： Menopausal symptoms and sleep difficulty were physiological processes that were affected by genetic and other factors. This study was to investigate the prevalence of menopausal symptoms and sleep quality in menopausal transition （MT） and postmenopause （PM） women in Taiyuan, Shanxi. Methods： A community-based survey of women＇s menopausal symptoms and sleep quality was conducted between July 2012 and May 2013 at six municipal districts of Taiyuan, Shanxi. A sample of 2429 women aged 40-59 years was divided into four groups： early MT, late MT, early PM, and late PM. Sleep quality in the past 2 weeks before the interview was recorded. The data were analyzed using SPSS 16.0. Results： The prevalence of menopausal symptoms was 49.8%. Mild, moderate, and severe symptoms were observed in 28.9%, 18.5%, and 2.5% of participants, respectively. The highest prevalence of menopausal symptoms occurred in the early postmenopausal stage; the subsequences were the late postmenopausal stage and the early MT stage. Interestingly, among the 13 items of modified Kupperman index, the five most common symptoms were fatigue, arthralgia and myalgia, decreased libido, insomnia, and nervousness. Meanwhile, 55% perimenopausal women had poor sleep. Conclusions： Menopausal symptoms are common but mild among women in Taiyuan, Shanxi during MT and PM. In these stages, the prevalence of poor sleep is high.

Effect of Long Protocol on the Outcome of In Vitro Fertilization-embryo Transfer in Patients with Endometriosis Compared with Prolonged Protocol

Objective To investigate the effect of different down-regulation protocol on the in vitro fertilization-embryo transfer （IVF-ET） outcomes in infertile patients with endometriosis （EMs）.Methods A retrospective case control study was performed. Totally 294 infertile patients with EMs were enrolled. And 109 patients （116 cycles） received prolongedprotocol as the control, 185 patients （193 cycles） received long protocol as case group, all followed by standard controlled ovarian hyperstimulation （COH）. Response to gonadotropins, the fertilization rate, the cleavage rate, the implantation rate, the clinical pregnancy rate and the miscarriage rate were measured and analyzed between the two groups. Results A trend toward better ovarian response was observed in long protocol group. Higher fertilization rate, lower total dose of rFSH, shorter duration of stimulation and more endometrial thickness on the day of hCG injection were observed in long protocol group compared with those of prolonged protocol group, and the difference was significant （P〈0.05）. In addition, the clinical pregnancy rate, the cleavage rate and the implantation rate also had an increase trend in long protocol group compared with those of prolonged protocol group, but without significant differences. Conclusion Long protocol regimen before IVF-ET in patients with EMs resulted in a trend toward better ovarian response and higher clinical pregnancy rates than prolonged protocol regimen did.

Expression of centromere protein-C(CENP-C) in villus tissue of the first-trimester spontaneous abortion and its correlation with chromosome segregation

Objective To investigate the expression of centromere protein-C （CENP-C） in villus tissue of the first-trimester spontaneous abortion （SA） and the correlation study of CENP-C expression with chromosome segregation. Methods Fluorescence in situ hybridization （FISH） and G-banded karyotype analysis were used to detect the numerical chromosome abnormality in 94 villus tissues of women with SA. The participants were separated into case group （n=30） and control group （n--30） according to the results with FISH. The qRT-PCR and Western blotting analysis were used to assess the expression level of CENP-C. Results Forty-eight （51.06%） cases had observed the numerical chromosome abnormality, including 30positive cases and the positive rate was 31.91%. The main types of variation included trisomy 16, 21, 22, X monosomy and triploid. The expression levels of CENP-C mRNA and protein in case group were statistically higher than that in control group （P〈0.05）. Conclusion Expression of CENP-C in the villus tissues of women might be related to SA induced by chromosomal aneuploid.