Objective:This study focused on the clinical efficacy and safety of the improved Zishui Qinggan decoction for syndrome before and after menopause(deficiency syndrome of both liver and kidney yin).Methods:1.A total of 72 patients with pre-menopausal and post-menopausal syndromes exhibiting the liver-kidney yin-deficiency syndrome were included in the study and divided into treatment and control groups according to the grouping method in the random number table,with 36 patients in each group.2.In the processing group,Zishui Qinggan decoction(granules)is taken orally,1 sachet each time,twice daily,half an hour before breakfast and half an hour after dinner with boiling water and then taken warm,stop taking the medicine for 8 weeks and do not stop taking it during menstruation.In the control group,Kunbao Pills(concentrated pills)is taken orally,50 pills each time,twice a day,half an hour before breakfast and half an hour after dinner with warm water,the course of treatment and precautions are the same as in the treatment group.3.To observe the clinical efficacy,changes in TCM syndrome scores,and changes in serum FSH and LH values before and after treatment in the two groups.4.The security of the drugs in both groups was observed.Results:A total of 7 cases were shed during the treatment period due to the patients’personal reasons for failure to continue treatment,and the clinical observation was finally completed with 32 cases in the processing group and 33 cases in the control group.Overall efficacy:Out of 32 cases in the processing group,12 improved,9 efficient,7 effective,4 ineffective and 87.50%overall efficacy rate,compared to 33 cases in the control group,5 improved,7 efficient,14 effective,7 ineffective and 78.8%overall efficacy rate,a statistically significant difference at P<0.05 level,indicating that the overall efficacy rate was superior to the control group.The results showed that the overall success rate was higher compared to the control group.In terms of TCM symptoms,the processing group was better than the control group in terms of menstrual disorders,hot flashes and sweating,insomnia and dreaminess,chest distension,palpitations and forgetfulness,impatience and irritability or mental depression and emotional instability,and P<0.05.In terms of back and knee pain and weakness,dizziness and tinnitus,dry mouth and sore throat,and urinary frequency and urgency,the efficacy of modified Zishui Qinggan decoction and Kunbao Pills were comparable and P>0.05.Observation indexes:When comparing the two groups,serum FSH and LH levels decreased significantly in the treatment group,P<0.05,indicating that the treatment group was superior to the control group.In terms of safety,no significant adverse reactions and liver and kidney damage were observed during the treatment period in both groups,indicating that the treatment of syndrome before and after menopause(deficiency syndrome of both liver and kidney yin)with Zishui Qinggan decoction or Kunbao Pills has a certain degree of safety.Conclusion:1.Both groups achieved better clinical efficacy in the treatment of syndrome before and after menopause(deficiency syndrome of both liver and kidney yin)with the processing group has better overall results than the control group;2.Both groups were able to improve clinical symptoms in pre-and post-menopausal patients with the syndrome(deficiency syndrome of both liver and kidney yin),but the processing group group was better than the control group in improving menstrual disorders,hot flushes and sweating,insomnia and drowsiness,swelling and chest pain,palpitations and forgetfulness,impatience and irritability,or depression and emotional instability;3.Both modified Zishui Qinggan decoction and Kunbao Pills could effectively regulate serum FSH and LH levels,but the treatment group was better than the control group;4.Neither modified Zishui Qinggan decoction nor Kunbao Pills showed significant adverse effects and liver and kidney damage,both of which are safe and reliable and worthy of further clinical application. |