Kidney Ning Xinyi Clinical Research By The Pill Treatment Of Premature Ovarian Failure

Introduction: Premature ovarian failure (POF) refers to a state of estrogen deficiency and gonadotropin elevation. POF is most often seen in women between the menarche and 40 years old. With the increasing development of society during the past decades, modern women face higher and higher pressure of life. Therefore, there is a yearly upward trend in the incidence of POF. Some epidemiological investigations revealed that the POF incidence was 1% to 3%. However, POF puts patients into severe sufferings including amenorrhea, infertility, menopause symptoms, and prematurely senile. It thus badly affects the patients' physical and mental health. Even worse, it might bring family instability. It is consider that the pathogenesis of this disease is mainly due to the disharmony between the heart and the kidney, liver stagnation and spleen weakness, Qi and blood asthenia, as well as blood stasis, which further causes heart-kidney-uterine reproductive axis disorders. Consequently, the therapeutic methods should focus on invigorating the kidney and nourishing the heart in addition to the function improvement of liver and spleen. In the present study, we treated patient suffering from POF with the pills named Bu Shen Ning Xin Yi Jing. It is very effective. This clinical observation could help us understand the efficacy and therapeutic mechanisms of the pills on POF.Objectives: The purposes of the present study are to investigate the effects and mechanisms of Bu Shen Ning Xin Yi Jing Pill on premature ovarian failure (POF) through a clinical study.Study Design/Setting: A double-blinded, randomized and controlled interventional study.Methods: Sixty women with POF were administered and randomized into the treatment group and the control group. Every group had thirty cases. There was no significant difference between the two groups regarding age, disease course and severities. Patients in the treatment and control groups were requested to have the Bu Shen Ning Xin Yi Jing Pill a.nd the Liu Wei Di Huang Pill, respectively. Six-month duration was considered as a therapeutic course. Symptoms including period changes, hot flushes, diaphoresis, agitation, emotional lability, vagina dryness and fatigue were evaluated before and after the treatment. The serum levels of follicle stimulating hormone (FSH) and estradiol (E₂) were determined by the chemistry luminescence method. Differences between the treatment and control groups were investigated.Results: Improved menstruation were revealed in both groups and the treatment group showed significant improvement than the control group (p<0.01). Effective rate of menstruation in treatment group was 80% (24 cases), while that in control group was 46.67% (14 cases).In comparison with prior-treatment whose general system score was 22.0±5.8, significant improvements in all symptoms in the treatment group were found (p<0.01), which was manifested by down-regulation of the general symptom score to 11.1±6.8 after the treatment. In control group, there were significant improvements in symptoms such as period changes and vagina dryness compared with prior-treatment, but no improvements in symptoms including hectic fever, diaphoresis, palpitation and fatigue. The treatment group showed significantly better results than the control group, especially in the major symptoms including fidgety irritability and vaginal dryness, as well as in the minor symptoms including fatigue and weakness. The general symptom score in control group dropped from 19.0±6.0 to 14.8±6.9 after having Liu Wei Di Huang Pill. The differences between the two groups was significant (p <0.05). Other symptom scores showed no significant difference between the two groups (p>0.05). The symptoms total score markedly decreased after having the Bu Shen Ning Xin Yi Jing Pill. There was a significantly lower general symptom total score in the treatment group compared with the control group (p <0.05).There was no significant difference in serum levels of FSH and E2 between the treatment and control groups. In the treatment group, serum FSH levels sharply dropped by 25.1±2.8 IU/L (p=0.001) after treatment, while the serum E2 levels significantly elevated by 7.4±2.4 pg /ml (p<0.05) compared with those of prior-treatment. In the control group, there was a marked down-regulation in serum FSH levels by 9.2±2.2 IU/L (p =0.003), but no distinct change in the serum E2 level though there was an elevation of 0.5±0.8 pg /ml (p>0.05) compared with those of prior-treatment.The serum E₂ levels significantly up-regulated in the treatment group at 19.3±15.7 pg /ml compared with the control group at 12.5±7.3 pg /ml (p<0.05), but no significant difference was noted in the serum FSH levels between the two groups (p> 0.05).The total effective rate in the treatment group was 70% (21 cases), whereas 40% in the control group (12 cases). The difference had statistical significance (P<0.01).Conclusion: Due to invigorating the kidney and nourishing the heart in addition to the function improvement of liver and spleen, the Bu Shen Ning Xin Yi Jing Pill could benefit patients suffering from the POF via significant improvements in a series of the perimenopausal symptoms, such as hot flushes, sweating, emotional lability, vaginal dryness, musculoskeletal weakness, insomnia, fatigue, and palpitation. Thereby it improves a patient's life quality. Its overall effects are significantly better than the control group having the Liu Wei Di Huang Pill. Additionally, the pill can balance the endocrine hormones, which lowering the serum FSH level while up-regulating the E₂ level. The effects from the treatment group were much distinguished than that from the control group. The symptoms total score decreased significantly after the treatment and the total effective rate is 70%. In a conclusion, the Bu Shen Ning Xin Yi Jing Pill is effective in the treatment of POF.