| ObjectiveThis clinical study is to investigate the effect and advance of the Professor Lai’s Tongyuan Therapy of the combination of acupuncture and medicine to treat the delayed menstruation caused by Polycystic Ovary Syndrome, compared with the western medicine Diane-35. So it cans be the practically clinical basis of the efficiency of the new therapy, Professor Lai’s Tongyuan Therapy of the combination of acupuncture and chinese medicine.MethodsThis study adopts the method of prospective randomized controlled trial. It has be collected 60 cases of the delayed menstruation patients of PCOS, those are confirmed in accordance with the diagnostic and inclusion criteria of this study, and those are visitors in acupuncture and gynecological department of the First Affiliated Hospital of Guangzhou University of TCM from December 2014 to December 2015. Through the simple randomization method, those patients are divided into test group (Lai’s Tongyuan Therapy of the combination of acupuncture and chinese medicine) and control group (Diane-35 group) with 30 cases in each group. The test group were treated with Lai’s Tongyuan Therapy of the combination of acupuncture and traditional Chinese medicines "Tiaojing Effective Prescription",which were treated by main acupoints of Baihui, Xinshu, Geshu, Qihai, Guanyuan, Tianshu, Guilai, Sanyinjiao, Hegu and Taichong in 30 minutes after the arrival of Qi for twice a week, and the "Tiaojing Effective Prescription" were basically composed of Herba Rehmannia Root, prepared Rehmannia Root, Cistanche, Epimedii, Morinda officinalis, Leonuri, Rhizoma Cyperi,and took daily. The control group was treated with Diane-35, one tablet, once a day, continuously 21 days, began with the seventh day after the menstrual withdrawal bleeding. Both groups were continuously treated for 3 months, and followed up for 3 months. Before and after treatment and follow-up period, the Changes in menstrual cycle, menstrual volume, TCM syndrome, body mass index, etc. were observed and recorded. And then these collected data were analyzed by SPSS 22.0 in order to compare the clinical effect between the Lai’s Tongyuan Therapy of the combination of acupuncture and chinese medicine and the western medicine Diane-35.Result1. Baseline databefore treatment, the two groups in age, course of disease, BMI, sex hormone levels (LH, FSH, LH/FSH, T), menstrual cycle, menstrual volume, TCM syndrome scores had no significant difference(P>0.05), the two groups were comparable.2. Effect of syndrome and menstruation regulatingafter 3 months of treatment, the test group were off in 1 case, and the syndrome curative efficacy was totally 89.66%; Followed up for 3 months,2 cases were pregnant, which the pregnancy rate was 7%, and the menstruation regulating efficacy of the long-term was totally 93.10%. The control group after 3 months of treatment had 2 cases in loss, syndrome curative efficacy was totally 50%, and during 3 months of follow-up, had no pregnancy and the menstruation regulating efficacy of the long-term was totally 64.26%. So it confirms that the effect of syndrome and menstruation regulating of Lai’s Tongyuan Therapy of the combination of acupuncture and chinese medicine surpasses the effect of Diane-35.3. Effect of menstrual cycleafter treatment, both groups’menstrual cycle were regular compared with (28 cases) had regular menstrual cycle, which were below 35 days. However, during the follow-up period, most of the patients (26 cases)in the control group had delayed menstruation again, causing the recurrence rate was 92.85%, while the test group contained the curative effect during the follow-up period (P=0.001<0.01). It tells that during the treatment the improvement of menstrual cycle in Lai’s Tongyuan Therapy group is not better than the Diane-35 group,but during the follow-up period the Lai’s Tongyuan Therapy group is obviously superior to the Diane-35 group because of its distinct and stable curative efficacy of the long-term4. Effect of menstrual volumeThe menstrual volume distribution of the test group during treatment and follow-up period were better than those before treatment, and differences were statistically significant(P<0.05), while the control group had no statistically significant differences. After the treatment and during the follow-up period, differences between two groups were statistically significant (P<0.05), and the test group was better than the control group on the improvement of menstrual volume distribution. It suggests that Lai’s Tongyuan Therapy can effectively improve patients’menstrual volume distribution.while the Diane-35 can’t make it.5. Effect of TCM symptom scoresAfter treatment, the TCM symptom scores in both groups have decreased significantly (P< 0.01), and during the follow-up period occured the same changes. Besides, the decrease of the TCM symptom scores in the test group was more obvious than in the control group not only after treatment but also during the the follow-up period.It shows that both two methods can improve the TCM symptoms and reduce the score, but Lai’s Tongyuan Therapy is obviously better than Diane-35.ConclusionLai’s Tongyuan Therapy of the combination of acupuncture and chinese medicine can effectively regulate the menstrual cycle and improve the TCM symptoms of PCOS, and when it comes to the improvement or efficacy of TCM syndrome, TCM syndrome scores, menstrual volume, body mass index, the Lai’s Tongyuan Therapy is superior to the Diane-35. About the effect of menstrual cycle, Diane-35 can regulate the menstrual cycle below 35 days during the treatment, which is significantly better than Lai’s Tongyuan Therapy. However, during the follow-up period,most of the patients treated by Diane-35 would have delayed menstruation again with the high recurrence rate,while the Lai’s Tongyuan Therapy contained the distinct and stable curative efficacy of the long-term,which is obviously superior to the Diane-35In general, as a new therapy of the combination of acupuncture and chinese medicine which is found by Professor Lai, it has the characteristics of efficiency, safety, less side effect, easy acceptance by patients and is worthy to be popularized in clinic treatment of PCOS. |
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