| Objective:The objective is to observe the efficacy and safety of Bushen Culuan Recipe in treatment of ovulatory dysfunctional infertility. Verify the contribution degree of reinforcing kidney and resolving stasis TCM, and explore its mechanism, which provides scientific basis for clinical treatment.Methods:A multi-center, randomized, double-blind, double-simulated, controlled trial with superiority test was designed. According to diagnostic, inclusion and exclusion criteria, we observed 349 patients which belonged to 6 kinds of ovulatory disorders. These patients divided into the treatment group (n=177, treated with Bushen Culuan Recipe) and control group (n=172, treated with clomiphene). Both the two groups started taking drugs from 5th day of menstruation, or 5th day of vaginal bleeding after drug withdrawal. The treatment group:①Bushen Culuan Recipe (Chinese Dodder Seed, Chinese Taxillus Herb, Rhizoma dipsacus, Chinese Angelica, Medicinal Cyathula officinalis Root, Dan-shen Root),1 package at a time,3 times daily, for 14 days+ ②Clomiphene Mimetic,1 pill for each time,1 time daily, for 5 days. The control group:①Clomiphene,1 pill for each time,1 time daily, for 5 days+②Bushen Culuan Recipe Mimetic,1 package at a time,3 times daily, for 14 days. A course of treatment included 3 menstrual cycles. All patients should complete at least one course of treatment. Follow-up was scheduled for 12-24 months. Monitor the diameter of follicles and thickness of endometrium by vaginal ultrsonography B. Detect serum reproductive endocrine hormones (included FSH, LH, PRL,E2, P, T) before and after treatment. And record ovulation/pregnancy ending and Case Report Form. Using t test, Chi-square test and non-parametric analysis, comparing total effective rate, ovulatory rate, pregnant rate, diameter of follicles, thickness of endometrium, serum reproductive endocrine hormones and situation of TCM symptoms before and after treatment. Detect safety indices, included blood, urine and stool routine, liver and renal function, and electrocardiogram.Results:Applying Bushen Culuan Recipe in treatment of ovulatory dysfunctional infertility, the results were as follows:(1) 6 related diseases in the total cases of anovulatory infertility. Abnormal uterine bleeding-ovulatory disorders(AUB-O), Polycystic ovary syndrome(PCOS), High prolactin(HPRL), Luteinized unruptured follicle syndrome(LUFS), Luteal phase defect(LPD), Diminished ovarian reserve/Premature ovarian failure(DOR/POF) distributed as follows:Xiyuan hospital 4、59、21、26、27、66 cases, Dongzhimen Hospital 5、51、0、5、9、2 cases, Beijing Obstetrics and Gynecology Hospital 0、 35、1、6、18、14 cases. Excluded exfoliated cases:Xiyuan hospital 3、52、18、16、 20、47 cases, Dongzhimen Hospital 4、40、0、5、7、2 cases, Beijing Obstetrics and Gynecology Hospital 0、26、1、4、13、8 cases.(2) According to 47 TCM symptoms in Case Report Form, respectively calculated the integral mean value in these 6 diseases and draw diagrams. We found that TCM symptoms in 6 kinds of diseases distributed smiliarly, and the degree of same symptom in 6 diseases was different. The high integral mean value symptoms: sore waist and knee, cold pain at lower abdomen, dysmenorrheal with dark blood and clots, little measure cycle, little measure, turkey red menses, red menses, dark menses, extreme coldness, cold pain at lower abdomen, dark eye socket, dark facial plaque or dark lips, breast pain before menstrual, stuffiness in chest and irritable.The low integral mean value symptoms:intermenstrual bleeding, light menstrual color, purplish menses, purlish dark menses, emaciation, diarrhea with undigested food, diarrhea.(3) There were 136 cases in the treatment group, clinical cure rate was 32.35%, markedly rate was 30.15%, effective rate was 27.94%, invalid rate was 9.56%, total effective rate was 90.44%. There were 130 cases in the control group, clinical cure rate was 17.69%, markedly rate was 21.54%, effective rate was 30.77%, invalid rate was 30.00%, total effective rate was 70.00%. There was significant statistical difference in total effective rate between the two groups(P<0.05).(4) There were 504 cycles observed in the treatment group,348 of them were ovulatory cycles, ovulatory rate was 69.05%. There were 507 cycles observed in the control group,359 of them were ovulatory cycles, ovulatory rate was 70.81%. The ovulatroy rate between the two groups showed no statistically significant(P>0.05).(5) There were 57 cases pregnant in the treatment group. The pregnant rate is 41.19%. There were 36 cases pregnant in the control group. The pregnant rate is 27.69%. There was significant statistical difference in pregnant rate between the two groups(P<0.05). There were 49 cases successful pregnant in the treatment group. The successful pregnant rate is 85.96%. There were 28 cases successful pregnant in the control group. The successful pregnant rate is 77.78%. The successful pregnant rate between the two groups showed no statistically significant(P>0.05).(6) There was significant statistical difference in TCM symptoms between before and after treatment in these two groups(P<0.05).Compared the 47 TCM symptoms respectively in treatment and control groups prior-treatment and post-treatment, we found that there were significant differences on all symptoms in the treatment group(P<0.05), and expect purplish menses, purlish dark menses, emaciation, diarrhea with undigested food, diarrhoea in the control group(P<0.05).Compared the 47 TCM symptoms after treatment in the two groups, we found that there were significant differences in some symptoms of treatment group, included sore waist and knee, dizziness and tinnitus, cold pain at lower abdomen before menstruation, dysmenorrhea with dark blood and clots, little measure, light and dark menstrual color, turkey red menses, red menses, dark menses, palpitation, cold pain at lower abdomen, sex apathy, dry throat and thirst, dark facial plaque or dark lips, frequent nocturnal, dry stool, breast pain before menstrual, stuffiness in chest and irritable, black mood, dysmenorrheal, fat body, chest tightness and nausea.(7) The diameter of follicles in treatment group was 18.18±0.96mm, thickness of endometrium was 9.13±1.59mm. The diameter of follicles in control group was 19.29±2.45mm, thickness of endometrium was 7.72±1.25mm. There was significant statistical difference in diameter of follicles and thickness of endometrium between the two groups(P<0.05).(8) After treatment, the hormone of E2 increased and FSH, LH, PRL, P, T decreased in the treatment group. There was significant difference for E2 and PRL in the treatment.(P<0.05).(9) Routine tests of blood, urine and stool, liver and kidney functions and electrocardiogram result remained normal after treatment. No obvious adverse reactions were found in the two groups during the whole observation.Results:TCM symptoms in 6 kinds of ovulatory dysfunctional disorders distribute similarly, and the same symptom in different diseases shows different degree, which highlight the theoretical basis for the different diseases and clarify the concept of combination of disease and syndrome. Bushen Culuan Recipe is safe, and total effectiveness is better than Clomiphene. Bushen Culuan Recipe had significant advantages in pregnant rate, thickness of endometrium, serum reproductive endocrine hormones and TCM symptoms. Besides, Bushen Culuan Recipe can also regulate E2 and PRL, promote the follicular development and endometrium growth, increase ovulatory and pregnant rate. Meanwhile, reinforcing kidney and resolving stasis TCM can comprehensive adjust organism state, promote balance between Yin and Yang, Qi and Blood circulation, viscera function coordination, thus provide the best condition for pregnancy. |
PDF Full Text Request