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In recent years， with the change in life style， social environment， and national childbearing policy， the proportion of high-risk pregnant women has increased significantly， triggering the spectrum of obstetric diseases to constantly change， which has brought new challenges to the diagnosis and treatment of obstetrics. Traditional Chinese medicine （TCM） has been proved effective in dealing with a variety of obstetric diseases， and various treatment methods are available， which can serve as alternative means for solving refractory obstetric diseases. However， most obstetric clinicians are currently less aware of the therapeutic effects of TCM， which has significantly hindered its participation in clinical treatment. Therefore， the China Association of Chinese Medicine （CACM） organized the outstanding young obstetricians of TCM and western medicine to discuss 15 obstetric diseases responding specifically to TCM or integrated TCM and western medicine， including hyperemesis gravidarum， threatened abortion， ectopic gestation， cough during pregnancy， pregnancy-induced hypertension syndrome， maternal-fetal ABO incompatibility， postpartum hypogalactia， residual pregnancy tissue in uterine cavity， puerperal infection， pantalgia after childbirth， hematoma/undesirable healing after caesarean section， postpartum urinary retention， ileus after cesarean section， pelvic floor dysfunction， and postnatal depression. The suggestions for their treatment with TCM or integrated TCM and western medicine were also proposed， aiming to provide patients with effective and personalized treatments in clinical practice and improve the diagnosis and treatment effects of obstetric diseases， thus benefiting the public. At the same time， more obstetrical clinicians are expected to understand the therapeutic effects and advantages of TCM and draw on the strengths of both TCM and western， thereby promoting the establishment of an obstetric diagnosis and treatment system with Chinese characteristics.
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OBJECTIVE@#To evaluate the efficacy and safety of Chinese medicine (CM) improving pregnancy outcomes after surgery for endometriosis-associated infertility.@*METHODS@#A multicenter, randomized, double-blind placebo parallel controlled clinical trial was designed. A total of 202 patients who had laparoscopy for endometriosis-associated infertility with qi stagnation and blood stasis syndrome were included and randomly divided into the CM treatment group and placebo control group at a ratio of 1:1 using a central block randomization from May 2014 to September 2017, 101 patients in each group. The two groups received continuous intervention at 1-5 days after surgery, for 6 menstrual cycles. Before ovulation, the CM group was treated Huoxue Xiaoyi Granule (); after ovulation, Bushen Zhuyun Granule ( was involved. The control group was treated with placebo. Transvaginal ultrasonography was performed every menstrual cycle during the treatment, and female hormone levels in the follicular and luteal phases were measured during the 1st, 3rd and 6th menstrual cycles. The analysis was continued until pregnancy. The primary outcomes were clinical pregnancy rate and pregnancy outcome, and the secondary outcomes were follicular development and endometrial receptivity. Safety evaluations were performed before and after treatment.@*RESULTS@#(1) Clinical pregnancy and live birth rates: the clinical pregnancy and live birth rates of the CM group were significantly higher than those of the placebo group [44.6% (45/101) vs. 29.7% (30/101), 34.7% (35/101) vs. 20.8% (21/101), both P0.05).@*CONCLUSION@#Strategies for activating blood circulation-regulating Gan (Liver)-tonifying Shen (Kidney) sequential therapy can effectively improve the clinical pregnancy rate and live birth rate of endometriosis-associated infertility with qi stagnation and blood stasis after laparoscopy, improve follicular development, promote ovulation, improve endometrial receptivity, while being a safe treatment option. (Trial registration No. NCT02676713).
ABSTRACT
Endometriosis (EM) is a major cause of infertility and has a complex pathogenesis, which brings severe challenges in both clinical treatment and scientific research. Current clinical research focuses on the difficult problem of improving the pregnancy rate of EM patients. Our studies found that Chinese medicine has significant advantages in terms of improving the pregnancy rate of EM patients.
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Pelvic inflammatory disease is an infectious disease. At present, Western medicine is mainly treated with antibiotics. However, the situation of antibiotics abuse is so grim that the potential risks such as the imbalance of bacteria, the resistance of bacteria, the production of super bacteria and the increase of adverse reactions are becoming more and more serious. Therefore, it is urgent to find a way to supplement or substitute antibiotics for the treatment of this disease. Traditional Chinese medicine treatment of the disease is effective and has its unique advantages. This paper mainly discusses the advantages and evidences of traditional Chinese medicine (TCM) treatment of pelvic inflammatory disease, to further prove the effectiveness and safety of TCM treatment and to provide medical evidence of reducing antibiotics use.
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<p><b>OBJECTIVE</b>To investigate the effect of Chinese medicine (CM) and Western medicine (WM) on quality of life (QOL) after conservative surgery for endometriosis.</p><p><b>METHODS</b>A total of 320 patients with endometriosis were randomized into two groups by using random block design, CM group (160 cases, activating blood circulation and removing blood stasis treatment based on syndrome differentiation) and WM group (160 cases, gonadotropin-releasing hormone agonist or gestrinone treatment) after conservative surgery. Treatment was given for 3-6 months (according to the revised American Fertility Society scoring system stage), and the World Health Organization QOL-BREF (WHOQOL-BREF) was applied to patients before and after treatment to assess QOL.</p><p><b>RESULTS</b>There were 136 cases in the CM group and 141 cases in the WM group completing therapy. In the CM group, the use of the WHOQOL-BREF showed that the physical, psychological and environmental scores posttreatment were significantly higher than those at pre-treatment (P < 0.05), and for 12 items (pain and discomfort, energy and fatigue, sleep and rest, mobility, activities of daily living, work capacity, negative feelings, health and social care: accessibility and quality, participation in and opportunities for recreation/leisure activities, appetite, QOL score, overall health status and QOL), the difference in scores was significant (P < 0.05). In the WM group, 4 items (pain and discomfort, opportunities for acquiring new information and skills, QOL score, overall health status and QOL) had significantly different scores post-treatment compared with those at pre-treatment (P < 0.05). Before treatment, the QOL in the two groups of patients showed no significant difference (P > 0.05). After treatment, the scores for physical health in the CM group were significantly higher than those of the WM group (P < 0.05) and the scores of 4 items (mobility, activities of daily living, sexual activity, QOL score) in the CM group were significantly higher than those in the WM group (P < 0.05).</p><p><b>CONCLUSIONS</b>CM and WM treatment could improve the QOL of patients with endometriosis after conservative surgery. CM treatment is more effective than WM.</p>
Subject(s)
Adolescent , Adult , Female , Humans , Middle Aged , Young Adult , China , Drugs, Chinese Herbal , Therapeutic Uses , Endometriosis , Diagnosis , General Surgery , Follow-Up Studies , Gonadotropin-Releasing Hormone , Therapeutic Uses , Pain Measurement , Pain, Postoperative , Drug Therapy , Patient Satisfaction , Postoperative Care , Methods , Prospective Studies , Quality of Life , Reference Values , Risk Assessment , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>To compare the clinical effect of Chinese medicine (CM) and Western medicine (WM) for controlling the recurrence of pelvic endometriosis after a conservative operation.</p><p><b>METHODS</b>The study was a multi-center, randomized, parallel controlled and prospective clinical trial. Patients were randomly divided into two groups: CM group (106 cases) and WM group (102 cases). Drugs were given to patients during 1-5 days of the first menstruation after a conservative operation in both groups. Patients with stages I and II (revised American Fertility Society) were treated for 3 months, while the patients with stages III and IV were treated for 6 months. The patients in the CM group were treated using three types of Chinese herbal medicine based on syndrome differentiation. Patients in the WM group were treated using gonadotropin releasing hormone agonist (GnRH-a) or gestrinone. Patients treated with GnRH-a received add-back therapy of Tibolone Tablets once a day after 4 months of treatment. Any cases of dysmenorrheal chronic pelvic pain, menstruation and any adverse reactions of patients were recorded once a month during the preoperative and postoperative periods and once every 3 months during the follow-up period. During the preoperative, postoperative and the follow-up periods, patients underwent type B ultrasonography of the pelvis and measurements of serum CA125 levels, gynecologic examination, routine evaluations of blood, urine, hepatic function (glutamate pyruvate transaminase), renal function (blood urea nitrogen) and electrocardiograms. During the follow-up period they underwent type B pelvic ultrasonography, measurement of serum CA125 levels and further gynecologic examinations. The two treatments were compared for clinical recurrence rates, pregnancy rates and the incidence of adverse reactions.</p><p><b>RESULTS</b>The incidence and timing of recurrence of endometriosis were not significantly different between the two groups. The first pregnancy achieved by the patient in the CM group was significantly earlier than that in the WM group (P <0.05). Moreover, the incidence of adverse reactions in the WM group was significantly higher than in the CM group (P <0.01).</p><p><b>CONCLUSIONS</b>Treatment with Chinese herbal medicines prevented the recurrence of endometriosis after a conservative operation, improved the conception rate and showed fewer and lighter adverse reactions than did treatment with WM therapy. Treatment with Chinese herbal medicine meets the need of patients wishing to have a child following endometriosis and is an appropriate form of clinical treatment.</p>