| ObjectiveIn this study,patients with premature ovarian insufficiency were selected to conduct a comprehensive analysis of the efficacy and safety of the prescription of "Huyang Kunfang"formula according to the principle of randomized double-blind control,with a view to provide new evidence-based evidence for the prevention and treatment of the disease with traditional Chinese medicine.Methods72 patients who met the inclusion criteria were selected as the research objects from the gynecological outpatient department of Guangdong Hospital of Traditional Chinese Medicine,or were recruited through hospital advertisements between September 2017 and May 2019.According to the 2:1 random number table,they were randomly divided into HYYK group and control group,with 48 cases in HYYK group and 24 cases in control group.Among them,the HYYK group was treated with Huyang Kunfang formula granules,the control group received placebo treatment with granules simulating traditional Chinese medicine,and the treatment period was 12 weeks.Finally,3 patients were eliminated,6 patients were dropped,and a total of 63 patients were completed.Observe and record the changes of the numbers of menstrual times during the treatment period,the difference between the number of menstrual cramps before and after treatment,and the effective rate,serum FSH,E2 and AMH levels,menopausal symptom scores.And the safety assessment of the medication.The data were analyzed by SPSS 26.0 software.ResultsThe data of excluded patients were not included in the result analysis.By interpolating the missing data of 6 dropped-out patients,the data of 69 patients were finally analyzed:1.The primary outcome assessment:(1)The number of menstrual cramps during treatment and effectiveness of the difference in the number of menstrual cramps before and after treatment:all 69 patients and those with oligomenorrhea,menopause,and amenorrhea,the average number of menstrual cramps during the treatment period in the HYYK group was higher than the control group,but there was no statistically significant difference between the groups of all 69 patients(P>0.05),and the difference between the groups of 53 patients with oligomenorrhea,menopause and amenorrhea was statistically significant(P<0.05).The effective rate of the difference in the number of menstrual cramps before and after treatment was further analyzed.All 69 patients and 53 patients with oligomenorrhea,menopause,and amenorrhea had a higher effective rate of menstrual cramps before and after treatment in the HYYK group than in the control group.And the difference in effective rate between the two groups was statistically significant(P<0.05).2.The secondary outcome assessment:(1)The level of serum endocrine:The levels of AMH,FSH and E2 in serum of all 69 patients in the two groups before and after treatment and the difference before and after treatment were not statistically significant(P>0.05).(2)The score of the MRS:①Repeated measures analysis of variance was used,with the MRS scale total score,psychological dimension,physical dimension,and urogenital dimension scores as dependent variables,observation time as time factor,and group as independent variable.The results showed that the time point factor in the model significant significance(P<0.05).The interaction between the observation time point and the group was not significant(P>0.05).The total score of the MRS scale,the psychological dimension,and the urogenital dimension scores are not significant between the groups(P>0.05),and the physical dimension had significant significance between the groups(P<0.05).②Repeated measures analysis of variance was used.The scores of items 1-11 of the MRS scale were used as the dependent variables,the time of observation was used as the time factor,and the group was used as the independent variable.The point factor was significant(P<0.05),but the interaction between the observation time point and the group was not significant(P>0.05).The time point factor in the 9th and 11th item models was not significant(P>0.05),and the interaction between the observation time point and the group was not significant(P>0.05).There was significant meaning between groups in the 1-2 item models(P<0.05),and there was no significant meaning between groups in the 3-11 item models(P>0.05).ConclusionFor patients with premature ovarian insufficiency,the HYYK formula can promote the development of follicles,regulate ovarian function,and improve the number of menstrual cramps.For patients with oligomenorrhea,menopause,and amenorrhea,the effect is more significant.Compared with placebo,the HYYK formula was more effective in improving physical-dimension related symptoms of menopause,especially physical-dimension hot flashes and sweating and heart discomfort symptoms. |
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