| Research objectiveThis study attempted to assess the clinical efficacy and security of the yishen huoxue decoction in treating DOR by observing the changes of the levels of female sex hormone,the clinical symptoms,the scores for the modified kupperman index and the security index.On this basis,the study was expected to explore the possible therapeutic mechanism and eventually to provide the objective clinical basis for treating DOR with traditional chinese medicine.Meanwhile it was also expected to preliminarily evaluate the severity of menopausal symptoms of patients with DOR by the scores for the modified kupperman index and explore the application value in this disease.Research methodThis study intended to include 60 patients who were diagnosed with DOR of kidney deficiency and blood stasis.The 60 patients who met the inclusion criteria were randomly assigned to two groups:treatment group(n=30)and control group(n=30).In the treatment group,the patients received treatment with yishen huoxue decoction.In the control group,the patients received treatment with estrogen-progestin.The patients from two groups all need to be treated for 3 menstrual periods.At last,the levels of female sex hormone,the TCM clinical symptoms,the scores for the modified kupperman index and the security index were observed and compared before and after treatment.ResultsA total of 32 cases were included in the treatment group,but 1 of which was lost and 1 was discharged.while 31 cases were included in the control group and 1 of which was lost.Comparison before and after treatment in both groups:1.the Levels of Serum Hormone:In the treatment group,the levels of FSH and LH were significantly reduced(P<0.05),and there was no significant effect on improving the levels of FSH/LH and E2(P>0.05).The control group had a significant effect on reducing the level of FSH and increasing the level of E2(P<0.01),but no significant effect on improving the levels of LH and FSH/LH(P>0.05).2.the TCM Clinical Symptoms:The treatment group and the control group could significantly improve the clinical symptoms scores of the patients with DOR(P<0.05).3.the Scores for the Modified Kupperman Index:The treatment group had effects on the improvement of tidal fever with sweating,paresthesia,insomnia,mood fluctuations,vertigo,fatigue,joint pain,headache and sexual life(P<0.05),and had significant effect on the improvement of tidal fever with sweating,paresthesia,insomnia,mood fluctuations,fatigue,joint pain,headache and sexual life especially(P<0.01),but had no significant effects on the improvement of depression,suspicion,palpitations,feeling like ants moving on the skin and urinary tract infection(P>0.05).The control group had no obvious effect in improving tidal fever with sweating,paresthesia,fatigue,joint pain and sexual life(P<0.05),and particularly had obvious effect to improve sexual life(P<0.01),but had no effects on improving the insomnia,mood swings,depression,susupicion,dizziness,headache,heart palpitations,feeling like ants moving on the skin and urinary tract infection(P>0.05).4.The Classification of TCM Syndromes:Both the treatment group and the control group could significantly improve the classification of the TCM syndromes(P<0.01).5.The Classification of the Severity of Menopausal Symptoms:Both the treatment group and the control group could significantly improve the classification of the severity of menopausal symptoms(P<0.01).Comparison before and after treatment between groups:1.the Levels of Serum Hormone:The both groups had the similar efficacy in improving the level of FSH(P>0.05).The treatment group had a significant advantage in reducing the level of LH compared with the control group(P<0.01).2.the TCM Clinical Symptoms:The treatment group had more obvious advantage in improving the color of menses,lumbosacral pain and dysmenorrhea than the control group(P<0.01).The control group had a more obvious advantage in improving the menstrual circle than the treatment group.The both groups had the same efficacy in improving light periods,dizziness and tinnitus,sexual hypoactivity and the feeling not wanting to drink water when mouth dry(P>0.05).3.the Scores for the Modified Kupperman Index:The treatment group had more advantage than the control group in improving the tidal fever with sweating,paresthesia,insomnia,mood swings,fatigue,and headache(P<0.05),especially in improving paresthesia,mood swings,fatigue and headache(P<0.01).The both groups had the same efficacy in improving joint pain and sexual life(P>0.05).Nither of the treatment group or the control group could significantly improve groupsin improving depression,suspicion,palpitations,and feeling like ants moving on the skin(P>0.05).4.The Classification of TCM Syndromes:The treatment group had more advantage than the control group in improving the classification of TCM syndromes(P<0.05).5.The Classification of the Severity of Menopausal Symptoms:The treatment group had a significant advantage in improving the classification of the severity of menopausal symptoms(P<0.01).6.the Total Efficacy:There was no significant difference in the total efficacy between the treatment group and the control group.Therefore,the total clinical efficacy of the treatment group was no less than that of the control group(P>0.05).ConclusionThe yishen huoxue decoction can lower the levels of FSH and LH.It can also improve the symptoms during the period and other clinical symptoms and improve the perimenopausal symtoms of tidal fever with sweating,paresthesia,insomnia,mood fluctuations,vertigo,fatigue,joint pain,headache and sexual life.The clinical study demonstrated that the yishen huoxue decoction is eutherapeutic for DOR.It is safe and there is no adverse reaction in the study.So,the yishen huoxue decoction is worthy of wild application to clinic. |
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