| Objective:Endometriosis is one of the main reasons for infertility, with increasing morbidity, is a complicated gynecological disease. About 30%～58% of infertile women are found to have this disease. For those having endometriosis, the chance of infertility is about 30% to 50%, while the chance of miscarriage is about 40 percent, seriously affecting the health and quality of life of women of reproductive age. At present, there is no systematic study on the rules of syndrome differentiation and treatment in Chinese Medicine on endometriosis and its related infertility. This study aims at systematically collect and reviews the clinical research literatures on endometriosis of the latest 20 years, analyze and summarize those prescriptions and herbs with high frequencies in the treatment of endometriosis and its related infertility as a means to provide data support and thoughts for clinical application.Methods and Results:1. Academic research on endometriosis and its related infertility: Collection and collation of contemporary discussions, pathogenesis, clinical data and research reviews of Chinese Medicine and Western medicine literatures on endometriosis and its related infertility, analysis of the current situation, and exploration of new research approach.2. Evaluation on the efficacy of endometriosis and its related infertility2.1 Methods:2.1.1 Develop search strategies:Collect papers published in the China Journals Full-text Database (CNKI). In order to get more relevant papers, each "endometriosis" related paper is reviewed according to its topic, key words and abstract. Treatment, prescriptions and drugs relating to endometriosis and infertility will be collected and reviewed.2.1.2 Develop inclusion and exclusion criteria:Select only those papers related to "endometriosis" and "infertility". Patients confirmed having endometriosis, among them with request for medical treatment of fertility or infertile (called the "Infertile"). The number of participants of the Chinese medicine trial group≥25 cases, not less than 25% of them infertile). The prescriptions and drugs used were effective. Pregnancy rate is a key measurement. (Required results:The pregnancy rate of the Chinese medicine trial group≥25%, pregnancy rate= number of successful pregnancy of those infertile within three years after treatment/the total number of infertile), the treatment was mainly Chinese Medicine, or combined conservative surgery (mainly laparoscopic surgery) with Chinese Medicine. Some papers were excluded due to one of the following reasons:no infertile patient, the pregnancy rate was not stated specifically, using acupuncture, enema, external application, rectal infusion as the key treatment.2.1.3 Data Analysis:Using Excel software and STATA statistical software, and programming formulae, to conduct frequency analysis and paired herbs analysis. By using frequency analysis, the data can be compared and reviewed so that the medicinal herbs most in use can be identified.2.2 Results:2.2.1 Collection and exclusion of literatures:During the search of literatures,11,298 papers related to Endometriosis were obtained. After the first screening,435 papers were identified as related to the Chinese Medicine treatment or the conservative surgery (mainly laparoscopic surgery) with Chinese Medicine treatment. To ensure that there was no missing of relevant paper, each of them was read and analyzed. By screening out the case reports, repeated reports and those with no pregnancy record,95 papers left. Further screening was conducted with 35 papers being screened out (14 papers with adenomyosis only cases,19 papers with number of infertile patient less that 25% in the Chinese Medicine treatment group,5 papers with the pregnancy rate of the experimental group less that 25%).2.2.2 Included literatures:A total of 60 studies matched the diagnostic, inclusion and exclusion criteria were identified of which 47 were treated with Chinese Medicine,13 with combined conservative surgery (mainly laparoscopic surgery) and Chinese Medicine.A total of 3,686 participants were reported in the 47 Chinese Medicine trials,1,778 (48.2%) of which were infertile. The experimental group consisted of 2,593 participants with 1,264 participants (48.7%) infertile. 13 trials with all 664 participants infertile, of which the experimental group has a total of 518 participants (78%). Less than 10% of the participants were from the Reproductive Center or Specialized Center for Infertility Treatment. In the experimental group,5 trials (11%) with sample size≥100 participants, 18 trials (38%) with sample size between 50-99,24 trials (51%) with sample size between 25-49.A total of 1,144 participants were reported in the 13 combined conservative surgery (mainly laparoscopic surgery) with Chinese Medicine trials, of which 787 participants(68.8%) requested treatment for infertility. The experimental group totaling 613 participants with 398 participants (64.9%) infertile.5 out of the 13 trials with all 440 participants infertile while the experimental group has a total of 213 participants (48.4%). Only 1 trial with 127 cases was from the Reproductive Center or Specialized Center for Infertility Treatment. In the experimental group,1 trial (8%) with sample size^100≥participants,3 trials (23%) with sample size between 50-99, trials (69%) with sample size between 25-49.2.2.3 Evaluation of quality:28 out of 47 with controlled trials. As 1 controlled trial did not measure pregnancy rate, making the number of controlled trials reduced to 27(57.4%). The remaining 20 (42.6%) were self-controlled trials. All 13 combined conservative surgery (mainly laparoscopic surgery) with Chinese Medicine were randomized-controlled trials (100%).2.2.4 Rate of Pregnancy:47 trials (100%) reported pregnancy situation during and after treatment.18 trials reported the pregnancy rate of the experimental group≥50% within 3 years. The others with the pregnancy rate between 25%-49%; 13 trials (100%) reported pregnancy situation during and after treatment.7 trials reported pregnancy rate of the experimental group≥50% within 3 years while others with pregnancy rate between 25%-49%2.2.5 Rule of the use of Chinese medicinal herbs of Endometriosis and its related infertility 2.2.5.1 Chinese Medicine treatmentThe top 3 Chinese medicinal herbs were herbs for activating blood and stasis-dissolving (41.3%), tonics (22.7%) and heat-clearing (13.3%); the cumulative frequency was 77.3%. The cumulative frequency of herbs for activating blood and stasis-dissolving and tonics reached 64%, were the most popular herbs for treatment of endometriosis and its related infertility. Those herbs for activating blood and stasis-dissolving with frequency≥7: rhizoma curcumae, rhizoma curcuma, radax salviae miltiorrhizae, rhizoma corydalis, rhizoma chuanxion, semen persicae, hirudo, pollen typhae, squama manis, sanguis draxonis, radix curcumae, faeces trogopterori, flos carthami. Those herbs for tonics with frequency≥7:radix angelicae sinensi, semen cuscutae, radix glycyrrhizae, herba epimedii, radix astragali, radix dipsaci. The top 3 Chinese medicinal herbs for activating blood and stasis-dissolving were:activating blood to relieve pain:rhizoma corydalis, rhizoma chuanxion, pollen typhae; blood-activating and menstruation-regulating:radax salviae miltiorrhizae, semen persicae, flos carthami;removing blood stasis and eliminating mass:rhizoma curcumae, rhizoma sparganii, hirudo. Removing blood stasis and eliminating mass was the most popular one among the three, accounted for 37% of activating blood and stasis-dissolving herbs.2.2.5.2 Chinese Medicine treatment for endometriosis and its related infertility patientsIn order to reflect more accurately the rules of syndrome differentiation and its related infertility, the 13 trials with all infertile participants were selected for separate study. The top 3 Chinese medicinal herbs were herbs for activating blood and stasis-dissolving (42.93%), tonics (27.6%) and heat-clearing (11.7%); the cumulative frequency was 82.2%. The cumulative frequency of herbs for activating blood and stasis-dissolving and tonics reached 70.6%, were the most popular herbs for treatment of endometriosis and its related infertility. The third one was heat-clearing herbs. Those herbs for activating blood and stasis-dissolving with frequency≥4:radax salviae miltiorrhizae, rhizoma curcumae, rhizoma curcuma, hirudo, rhizoma corydalis, radix curcumae, pollen typhae, faeces trogopterori. Those herbs for tonics with frequency≥4:radix angelicae sinensi, semen cuscutae, herba epimedii, radix dipsaci. The top 3 Chinese medicinal herbs for activating blood and stasis-dissolving were:activating blood to relieve pain:rhizoma corydalis, radix curcumae, faeces trogopterori; blood-activating and menstruation-regulating:radax salviae miltiorrhizae, semen persicae, flos carthami:removing blood stasis and eliminating mass:rhizoma curcumae, rhizoma sparganii, hirudo. Removing blood stasis and eliminating mass was the most popular one among the three, accounted for 40% of activating blood and stasis-dissolving herbs.2.2.5.3 Comparison of the use of herbs based on different infertility rateBy comparing the above 2 groups that containing different ratios of infertile patients, it was found that when the clinical trials with infertile participants reached 100%, there were more use of the tonics herbs (27.6% vs. 22.7%) while the use of heat-clearing was decreased by certain percentage points (11.7% vs.13.3%). Activating blood and stasis-dissolving was still the most popular type (42.9% vs.41.3%).2.2.5.4 Combined conservative surgery (mainly laparoscopic surgery) with Chinese Medicine treatmentThe top 3 Chinese medicinal herbs were herbs for activating blood and stasis-dissolving (45.6%), tonics (25.6%) and qi-regulating medicinal (8.1%); the cumulative frequency was 79.4%. The cumulative frequency of herbs for activating blood and stasis-dissolving and tonics reached 71.6%, remained as the most popular herbs for treatment of endometriosis and its related infertility. The third one was qi-regulating medicinal while the fouth was heat-clearing. Radax salviae miltiorrhizae and radix notoginseng have replaced those insects like hirudo, squama manis and eupolyphaga seu steleophaga that with higher power of removing blood stasis and eliminating mass. Rhizoma sparganii and rhizoma curcumae remained the most popular herbs. Those herbs for activating blood and stasis-dissolving with frequency≥4:radax salviae miltiorrhizae, radix notoginseng, rhizoma curcumae, rhizoma corydalis, rhizoma sparganii, sanguis draxonis, rhizoma chuanxion. Those herbs for tonics with frequency≥4:semen cuscutae, radix angelicae sinensis, radix glycyrrhizae, rhizoma polygonati. The top 3 Chinese medicinal herbs for activating blood and stasis-dissolving were:activating blood to relieve pain:radix notoginseng, rhizoma corydalis, sanguis draxonis.; blood-activating and menstruation-regulating:radax salviae miltiorrhizae, semen persicae, herba leonuri;removing blood stasis and eliminating mass: rhizoma curcumae, rhizoma sparganii, hirudo. Activating blood to relieve pain, accounted for 45% of activating blood and stasis-dissolving drug, has replaced removing blood stasis and eliminating mass to become the most popular herbs in the group.2.2.5.6. The medicinal herbs most in use There were 6 herbs that were commonly and widely used in all the above 3 groups of patients. They were: radix paroniae rubra, radix angelicae sinensis, rhizoma curcumae, rhizoma sparganii, radax salviae miltiorrhizae, rhizoma corydalis. Cumulative frequencies of all the 6 herbs were 171,50 and 49 respectively. Cumulative percentage exceeded 30% in each group.2.2.5.7 Paired herbs①Paired herbs for removing blood stasis and eliminating mass:rhizoma sparganii and rhizoma curcumae;②Paired herbs for blood-activating and menstruation-regulating:radix angelicae sinensis and rhizoma chuanxion;③Paired herbs for activating blood to relieve pain:pollen typhae and faeces trogopterori④Paired herbs for nourishing kidney and regulating thoroughfare and conception vessels:herba epimedii and semen cuscutae.Conclusion1. By application of statistical method to review and analyse the clinical research literatures, a conclusion can be drawn that blood stasis and kidney deficiency are the key pathogenesis of Endometriosis and its related infertility. The key therapeutic methods are treatment with promoting Qi and removing blood-statis, and replenishing kidney and dissolving blood. Followed by regulating Qi, and heat-clearing method. When the blood stasis is serious, the more application of removing blood stasis and eliminating mass,2. Regulating Qi helps to sooth the liver and alleviating depression of the infertile. Rhizoma cyperi is the most commonly used herb.3. Throughout this study, six most commonly used herbs are identified:radix paroniae rubra, radix angelicae sinensis, rhizoma curcumae, rhizoma sparganii, radax salviae miltiorrhizae, rhizoma corydalis are found. Herbs of removing blood stasis and eliminating mass have been used very widely, especially those insects like hirudo. There are 4 popular pared herbs like①Paired herbs for removing blood stasis and eliminating mass:rhizoma sparganii and rhizoma curcumae;②Paired herbs for blood-activating and menstruation-regulating: radix angelicae sinensis and rhizoma chuanxion;③Paired herbs for activating blood to relieve pain:pollen typhae and faeces trogopterori④Paired herbs for nourishing kidney and regulating thoroughfare and conception vessels: herba epimedii and semen cuscutae.
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