Clinical Research On PCOS Phlegmatic Hygrosis Syndrome Treatment With Kidney-invigoration And Sputum-elimination Method And Liver-clearing And Sputum-elimination Method

ObjectiveThis clinical trial intends to discuss the clinical efficacy and safety of the application of Chinese Medicine in PCOS treatment by comparing the Kidney-invigoration and Sputum-elimination Method, the Liver-clearing and Sputum-elimination Method and the Simple Sputum and Dampness Elimination Method and analyzing the corresponding indexes.MethodsChoose 90 patients of polycystic ovary syndrome and assign them to the Kidney-invigoration and Sputum-elimination Group, the Liver-clearing and Sputum-elimination Group and the Control Group at the rate of 1:1:1. The Kidney-invigoration and Sputum-elimination Group takes Guishen Pill and Erchen Decoction; the Liver-clearing and Sputum-elimination Group takes Dan Zhi Xiao Yao Powder and Erchen Decoction; the Control Group takes Erchen Decoction. The treatment course lasts for 12 weeks. Observe the comprehensive clinical effect, the TCM syndrome curative effect, and the efficacy and safety of sex hormone levels and the F-G hairy scores before and after treatment.ResultsThis clinical trial takes 90 cases, including 30 in the Kidney-invigoration and Sputum-elimination Group,30 in the Liver-clearing and Sputum-elimination Group and 30 in the Control Group. Before treatment, three groups have no statistical difference (P> 0.05) in the baseline material comparison, such as patient's age, disease courses, basic body temperature, menstrual conditions, and Chinese Medicine syndrome distributions which indicate the two groups'baseline are consistent and comparable.After treatment, the comprehensive curative effect of the Kidney-invigoration and Sputum-elimination Group, the Liver-clearing and Sputum-elimination Group and the Control Group are respectively 96.67,93.33% and 70.0%, and the difference was statistically significant (P< 0.05) by rank and sum test. Three groups have good curative effect for the treatment of PCOS, and the effect of the Kidney-invigoration and Sputum-elimination Group and the Liver-clearing and Sputum-elimination Group are much superior to that of the Control Group. After treatment, the Chinese Medicine syndrome comprehensive curative efficacy of the Kidney-invigoration and Sputum-elimination Group, the Liver-clearing and Sputum-elimination Group and the Control Group are 96.67%,86.67% and 63.33%. By rank and sum test, the difference among three groups was statistically significant (P<0.05). Three groups have good curative effect for PCOS, while the Kidney-invigoration and Sputum-elimination Group is slightly higher than the Liver-clearing and Sputum-elimination Group and much higher than the Control Group in curative effect.In improving Chinese Medicine syndromes, the Chinese Medicine Syndrome Total Scores of the Kidney-invigoration and Sputum-elimination Group, the Liver-clearing and Sputum-elimination Group and the Control Group are respectively 4.70±2.03,4.43±2.64 and 4.23±1.76 which decrease to 1.16±0.23,1.34±0.75 and 2.08±0.52 after treatment and the score difference are 3.54±1.17,3.09±0.96 and 2.15±0.83 respectively. After the treatment, the difference of the TCM syndrome curative effect total scores after treatment and the AP D-values of the three groups have statistical significance (P< 0.05). Three groups have no significant difference in the improvement of menstrual cycle after treatment. After treatment, the three groups' menstruation quality and menstrual color recovery rate have no statistical significance in comparison, while the difference of the menstrual volume recovery rates of the three groups have statistical significance (P<0.05). After treatment, three groups'disappearance rates of Chinese Medicine body signs like dry and bitter mouth, feeble and sour waist and knees, etc. have significant difference(P<0.05). Three groups'disappearance rates of Chinese Medicine body signs like mental fatigue, loss of appetite, loose stools, etc. have no statistical significant difference.In endocrine regulation, the FSH levels of the Kidney-invigoration and Sputum-elimination Group, the Liver-clearing and Sputum-elimination Group and the Control Group rise to 8.01±2.92,8.19±2.51 and 7.62±2.32 from the original 6.54±1.76,7.06±2.14 and 6.71±1.60 and there's no significant interclass difference (P> 0.05). The in-class AP difference has statistical significance(P< 0.05). The LH levels of the three groups decrease from 14.89±4.01,14.67±3.89 and 14.86±3.95 before treatment to 9.52±3.52,9.10±3.50和9.62±3.57 after treatment. There's no significant interclass difference (P> 0.05). The in-class AP difference has statistical significance (P< 0.05). The T-levels of the three groups decrease from 6.19±3.36,6.71±2.99 and 6.48±3.86befroe treatment to 3.34±0.40,3.72±0.56 and 3.80±0.60 after treatment. The interclass difference and the in-class AP difference have statistical significance (P< 0.05). The D-values before and after treatment are not statistically significant in comparison. The PRL level of the Kidney-invigoration and Sputum-elimination Group, the Liver-clearing and Sputum-elimination Group and the Control Group decrease respectively from 15.79±5.97,15.74±6.17 and 16.77±5.38 before treatment to 9.36±5.26,11.26±5.66 and 12.23±4.77 after treatment and the interclass difference is not statistically significant (P> 0.05), and the in-class AP difference has statistical significance (P< 0.05). The E2 level of the Kidney-invigoration and Sputum-elimination Group, the Liver-clearing and Sputum-elimination Group and the Control Group rise from 36.62±0.31, 37.68±12.02 and 36.24±11.51 before treatment to 80.92±8.45,79.15±8.35 and 70.75±7.9 after treatment. The interclass and in-class AP differences have statistical significance (P< 0.05). The F-G levels of the three groups decrease from 4.37±0.42,4.23±0.45 and 4.18±0.43 before treatment to 3.71±0.55,3.33±0.39 and 3.32±0.38 respectively after treatment. The interclass and in-class AP differences have statistical significance (P< 0.05).Conclusion1. The clinical comprehensive effect of the Kidney-invigoration and Sputum-elimination Group, the Liver-clearing and Sputum-elimination Group and the Control Group are 96.67%,93.33% and 70.0%respectively. Compared with the Control group, the difference is statistically significant (P< 0.05).2. The TCM syndrome Total Scores of the three groups decrease significantly. The effect of the Kidney-invigoration and Sputum-elimination Group is superior to those of the Liver-clearing and Sputum-elimination Group and the Control Group.3. The F-G Scores of the three groups decrease after treatment and the in-class AP difference is statistically significant (P< 0.05).4. Three groups'FSH and E2 levels rise after treatment, while the LH, T and PRL levels decrease.The Kidney-invigoration and Sputum-elimination Method and the Liver-clearing and Sputum-elimination Group have good curative effect in PCOS treatment with the former slightly superior to the latter. They are safe and effective and worthy of clinical recommendation.