| Objective:To observe the clinical efficacy of different doses of Cordyceps sinensis combined with Yishen Tiaojing paste in treating premature ovarian insufficiency(POI),and to evaluate the efficacy of Cordyceps sinensis in the treatment of patients with POI.Method:Patients diagnosed as POI with syndrome of kidney deficiency and liver stagnation were collected from gynecology and reproductive department of Jiangsu Province Hospital of TCM from Autumnal Equinox to Vernal Equinox during November 2018 to October 2020.There were totally 76 patients included and divided into three groups,which were trial group(high dosage CS group,low dosage CS group)and control group.The grouping was produced by the third party with random number table and a double-blind,randomized prospective study was adopted.At the same term,the superiority test was compared to active drug as control.The trial group was given Yishen Tiaojing paste combine with cordyceps sinensis orally,while the control group was given Yishen Tiaojing paste orally.The prescription was twice a day,30 grams each time,3 months for a course of treatment during Autumnal Equinox to Vernal Equinox,taken with warm water on an empty stomach in the morning and before bedtime,stop taking it during regular menses.TCM syndrome scores,sex hormone levels(E2,LH,FSH),AMH,three-dimensional(3D)ultrasound markers of ovarian reserve(OV,AFC,PSV),indicators of cellular immunity(CD3+,CD4+/CD8+),routine blood test,and assessment of hepatic and renal functions(ALT,AST,Cr,BUN)were observed at the initial diagnosis and after a course of treatment.The spontaneous pregnancy rate was observed at 3 months follow-up after the treatment.Results:(1)TCM syndrome scores:After the treatment,the trial group(high dosage CS group,low dosage CS group)showed statistically significant improvement(P<0.05)in main symptoms(menstrual cycle,menstrual volume and color,painful distension in chest and rib side,lumbosacral pain)and secondary symptoms(inhibited menstruation with clot,depression and irritability,insomnia,discomfort in lower abdomen).Besides the low dosage CS group showed better results in rectifying menstrual cycle and relieving discomfort in lower abdomen,and the differences were statistically significant(P<0.05).However,there were no significant differences among three groups.(2)The changes of sex hormone and AMH level in three groups after the treatment:①In the group of high dose Cordyceps,the level of LH decreased from(20.36±17.87)mIU/ml to(16.21±14.06);the level of FSH decreased from(33.51±21.94)mIU/ml to(26.96±18.49)mIU/mL;the level of E2 increased from(48.33±27.87)ng/L to(62.61±35.91)ng/L;the level of AMH increased from(0.15±0.26)ng/ml to(0.26 ± 0.46)ng/mL.②In the group of low dose Cordyceps,the level of LH decreased from(23.82± 18.53)mIU/ml to(16.82±12.48);the level of FSH decreased from(36.85±34.14)mIU/ml to(26.22±21.84)mIU/mL;the level of E2 increased from(43.00±22.53)ng/L to(92.68±66.20)ng/L;the level of AMH increased from(0.78±1.27)ng/ml to(1.25± 1.83)ng/mL.③In the control group,the level of LH decreased from(19.83±23.06)mIU/ml to(17.71±15.53);the level of FSH decreased from(38.17±37.61)mIU/ml to(27.51±24.15)mIU/mL;the level of E2 increased from(48.21±24.52)ng/L to(78.72±75.57)ng/L;the level of AMH slightly decreased from(1.02±1.94)ng/ml to(0.88±1.51)ng/mL.(3)The changes of cellular immunity after the treatment:①In the group of high dose Cordyceps,the level of CD3+ slightly increased from(0.72±0.06)%to(0.73± 10.05)%;CD4+/CD8+level increased from(1.11±0.36)to(1.30±0.27).②In the group of low dose Cordyceps,the level of CD3+increased from(0.74±0.07)%to(0.80±0.05)%;CD4+/CD8+level increased from(1.40±0.56)to(1.51±0.48).③In the control group,the level of CD3+increased from(0.71±0.09)%to(0.73±0.06)%;CD4+/CD8+level decreased from(1.49±0.62)to(1.42±0.64).According to the LSD test,it showed that the low dosage CS group was better in increasing the level of CD3+than the others,but there were no significant differences among three groups in improving the level of CD4+/CD8+.(4)The changes of three-dimensional(3D)ultrasound markers of ovarian reserve after the treatment:①n the group of high dose Cordyceps group,the OV improved from(2.79±1.73)cm3 to(3.28±1.57)cm3;the AFC increased from(1.83± 1.68)to(2.44±2.35);the PSV increased from(6.52±4.85)cm/s to(8.31±7.91)cm/s.②In the group of low dose Cordyceps group,the OV improved from(2.75± 1.28)cm3 to(3.36±2.02)cm3;the AFC increased from(2.31±3.36)to(3.10±4.09);the PSV increased from(6.72±5.03)cm/s to(7.65±8.24)cm/s.③In the control group:the OV improved from(2.75±0.99)cm3 to(3.08±1.03)cm3;the AFC increased from(1.67±2.17)to(2.56±3.61);the PSV slightly increased from(7.20±5.12)cm/s to(7.79±3.54)cm/s.There were no significant differences among three groups in the OV,AFC and PSV.(5)Clinical efficacy and spontaneous pregnancy rate:There were no significant differences among three groups in clinical efficacy,and the spontaneous pregnancy rate(P>0.05),which the high dosage CS was 0%(0/6),the low dosage CS group was 11.1%(1/9)and the control group was 5.2%(1/19)(there were 34 had recent fertility needs among the 74 patients).Conclusion:(1)The clinical effects in treating premature ovarian insufficiency(POI)with syndrome of kidney deficiency and liver stagnation was equivalent among Yishen Tiaojing paste with different doses of CS and Yishen Tiaojing paste only.However,the results had shown that the low dosage CS has more advantage in rectifying menstrual cycle,improving the level of E2 and AMH than the others groups.Both trial and control groups could improve the clinical symptoms and sex hormone levels,develop ovarian volume and antral follicle count,with slightly gastrointestinal reactions.These treatments were safe and manageable also did not have significant side effects.(2)The low dosage CS group had increased the level of CD3+significantly while the high dosage CS group had increased the level of CD4+/CD8+significantly.It showed that the Yishen Tiaojing paste with different doses of CS both have immunomodulatory effects in different ways.(3)The estrogen effect and immunomodulatory effect of Cordyceps sinensis may enhance the function of Yishen Tiaojing paste in regulating female reproductive endocrine system through multi-link and multi-target action mode.However,the specific optimal benefit dose of Cordyceps sinensis in the treatment of POI remains to be further studied. |
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