Clinical Observation On Treatment Of Liver - Kidney Yin Deficiency Type Menopause Syndrome With Shaoyao Yikun Granule

Objective:To observe the curative effect and to discuss the mechanism of drug effect in the treatment of menopausal syndrome due to Yin deficiency of the liver and kidney with Shao Qi Yi Kun Granule, in order to provide prescription that is more effective and convenient for clinical treatment.Methods:48 patients who were in accordance with the inclusion criteria of menopausal syndrome due to Yin deficiency of the liver and kidney were allocated randomly with the ratio of 2:1 into the treatment group and the control group. Each patient in the treatment group was given 2 packets of Shao Qi Yi Kun Granule (8g per packet) and was instructed to take it orally three times a day, while the patients in the control group were given Shao Qi Yi Kun Granule simulation agent. Both groups have to join three courses of treatment and the duration of each course is 4 weeks. The changes were observed and evaluated by using TCM symptoms scoring criteria, modified Kupperman Index score during each course of treatment. Plasma FSH and E2 were measured before the treatment starts and the end of the last course of treatment.Result:(1) The total effective rate after 3 courses of treatment in the treatment group was 100.00%, while the control group was 25.00%.(2) Significant differences were observed in TCM symptoms scoring before and after 4 weeks of treatment in the treatment group (p=0.000). The TCM symptom scoring in the treatment group decreased gradually with prolonged drug administration. The differences in the TCM symptoms scoring before (17.25 ± 4.171) and after (15.38 ± 4.161) the treatment was statistically significant,p=0.000.(3) Shao Qi Yi Kun Granule can improve the major symptoms of the menopausal syndrome due to Yin deficiency of the liver and kidney effectively. The effective rate was over 90.00% in improving the symptoms such as hot flushes, sweating, dizziness, tinnitus, itchy skin, heel pain and dryness in vaginal. Meanwhile, the effective rate was 73.00%-87.00% in improving the symptoms such as sleeping disorders, dry stool, soreness and weakness of the lower back and knee.(4) The modified Kupperman Index before and after the treatment had no differences in the control group (p>0.05), while the treatment group had statistically significant (p<0.05). Both groups had significant differences, p=0.000 after treatment in the modified Kupperman Index score.(5) The modified Kupperman Index score had showed significant differences after treatment in the treatment group compared to the control group, p<0.05, by showing improvements of the symptoms such as hot flushes, sweating, depression, dizziness, fatigue, joint and muscle pain, headache, palpitation, sexual activity, etc.(6) According to the modified Kupperman Index score, the conditions of the patients in the treatment group were improved. None of the patients’ conditions has worsened nor deteriorated. Meanwhile, no obvious changes were showed in the control group.(7) The level of plasma E2 in the treatment group has increased after the treatment, but there was no significant differences (p=0.061) before and after the treatment. In the other hand, the level of plasma FSH in the treatment group has decreased after the treatment, but no significant differences (p=0.135) were showed before and after the treatment. The level of plasma E2 has no significant differences (p=0.717) in the control group before and after the treatment. Although the level of plasma FSH were increased, no significant differences (p=0.621) were showed before and after the treatment.(8) None of the patients in the series had showed any side effects nor feeling uncomfortable during the courses of treatment.Conclusion:By tonifying the liver and kidney, and subduing hyperactivity of liver Yang to calm the mind, Shao Qi Yi Kun Granule can treat and relieve the major symptoms of menopausal syndrome due to Yin deficiency of the liver and kidney effectively and also decreased the modified Kupperman Index score, improving the quality of life of the patients. In addition, Shao Qi Yi Kun Granule can increase the plasma E2, decreasing the plasma FSH, thus, it gives a preliminary presumption that the Shao Qi Yi Kun Granule may have regulating function to the endocrine system.