{"paper_id":"6f57ce2f-cda7-456e-912e-5bcfc4dbfa64","body_text":"Mechanism Study on the Treatment of Pelvic Pain in \nEndometriosis by Qu Yu Jie Du Xiao Zheng Decotion in \nCombination with Dextroprogesterone \nChen Wanga, Mengjie Chenb,* \nXi'an Hospital of Traditional Chinese Medicine, Xi'an 710021, Shaanxi, China \na1360057098@qq.com, bmengjie8369@163.com \n*Corresponding author \nKeywords Endometriosis, Qu Yu Jie Du Xiao Zheng Decotion, Deferiprone, Tumor \nNecrosis Factor, Prostaglandins, Nerve Growth Factor \nAbstract: This study aimed to evaluate the clinical efficacy and effect on serum levels of \nPGE2, NGF and TNF -α of the combination of Qu Yu Jie Du Xiao Zheng Decotion  and \nDydrogesterone in treating pelvic pain in patients with endometriosis . Sixty patients were \nrandomly divided into three groups: Chinese medicine group, Western medicine group, and \ncombination group. After treatment,  the combination group showed significant relief of \npain, and the apparent efficacy of menstrual pain, pelvic pressure pain, and  palpable \nnodules was 70%, 83.33%, and 61.54%, respectively, which was significantly higher than \nthat of the other two groups. There were significant differences in serum TNF-α, NGF and \nPGE2 levels among the three groups after treatment. The conclusion was that the \ncombination of Qu Yu Jie Du Xiao Zheng Decotion  and Dydrogesterone could \nsignificantly improve the immune function  of patients with endometriosis , regulate levels \nof nerve growth factor, tumor necrosis factor, and prostaglandin E2, thereby relieving pain. \n1. Introduction \nEndometriosis (EMs) is a gynecological disease caused by endometrial growth in the uterus and \nother extra-uterine parts, which mostly occurs in women aged 20-45 years old, and the incidence of \nthis disease has been on the rise in recent years [1].EMs can infiltrate other organs in the patient's \npelvic cavity, and has the characteristics of proliferation, hyperplasia, and metastasis, with clinical \nmanifestations such as pelvic pain and infertility, which seriously affect the patient's health and \nquality of life [2].For the treatment of EMs, Western medicine mainly adopts sex hormone therapies \nsuch as progesterone, contraceptive pills, and mifepristone to achieve the purpose of relieving pain \nby inhibiting ovulation, which has a better effect on symptomatic improvement in the short term, \nbut is prone to drug resistance, and the symptoms are easy to recur after discontinuing the drug \n[3].In Chinese medicine, this disease belongs to the category of \"dysmenorrhea\" and \"symptoms\". \nIn recent years, many scholars believe that the pathogenesis of EMs is stasis of blood, evil blood \ncongestion in the uterus and veins of the uterus, which becomes toxic over time and is transformed \ninto stasis of toxins, and advocate that this disease should be treated with the method of eliminating \nMEDS Basic Medicine (2023) \nClausius Scientific Press, Canada\nDOI: 10.23977/medbm.2023.010214 \nISSN 2616-2091 Vol. 1 Num. 2\n89\n\nstasis of blood and removing toxins [4]. In the present study, in order to enhance the efficacy of \nEMs, the treatment of Qu Yu Jie Du Xiao Zheng decotion was added on the basis of conventional \nwestern medicine treatment, which is now reported as follows. \n2. Information and Methods \nIn this study, a total of sixty patients diagnosed with EMs were selected from the gynecology \noutpatient clinic of Xi'an Hospital of Traditional Chinese Medicine between January 2022 and \nDecember 2022. The random assignment of patients to different treatment groups, namely A: \nTraditional Chinese medicine group, B: Western medicine group, and C: Combination of Chinese \nand Western medicine group, was conducted using  the random number generation algorithm in \nSPSS22.0 statistical software. The age range of the traditional Chinese medicine group was between \n25 and 44 years, with an average age of 33.95± 4.23 years. The duration of the disease varied from \n0.4 to 5 years, with an average duration of 2.07± 1.15 years. The body mass index ranged from 19.8 \nto 26, with a mean body mass index of 22.28± 1.34. In the western medicine group, the age range \nwas between 22 and 25 years, with a mean age of 32.55± 6.75 years. The disease d uration varied \nfrom 0.5 to 4 years, with an average duration of 1.85± 1.18 years. The body mass index ranged from \n18.9 to 27, with a mean body mass index of 22.72± 1.95. In the group combining Chinese and \nWestern medicines, the age range was between 25 and 45 years, with a mean age of 33.5± 5.63 years. \nThe disease duration varied from 1 to 6 years, with an average duration of 2.35± 1.31 years. The \nbody mass index ranged from 19 to 26, with a mean body mass index of 22.32± 1.49. After \nconducting a χ2 test, the di fference between the baseline data of the three groups was not \nstatistically significant (P>0.05), and was considered comparable. \nThe inclusion criteria for this study were as follows: ①\n Patients with endometriosis who met \nboth the clinical diagnostic crit eria of Western medicine [5] and the Chinese medicine diagnosis of \n\"stasis, toxicity, dampness and turbidity\" [6]; ② Patients who did not have plans for pregnancy \nwithin the next year; ③ Patients who voluntarily agreed to participate in the study and signe d the \ninformed consent form; ④ Patients who had previously undergone treatment with hormonal drugs \nor conservative surgical treatments, and had ceased usage for a minimum of three months; or \npatients who had received traditional Chinese medicine (TCM) trea tment for at least three months; \nor patients who had previously received TCM treatment, but had stopped using the medicine for at \nleast one month and still met the aforementioned diagnostic criteria. \nThe exclusion criteria for this study encompass various medical conditions, which include severe \nuterine fibroids, cardiovascular and cerebrovascular diseases, hepatic and renal diseases, as well as \nhematopoietic system diseases. Additionally, patients with psychiatric disorders and those who have \ndemonstrated allergies to the drug being tested, as well as the control drug, are also excluded. \nFurthermore, individuals who fail to meet the inclusion criteria, fail to adhere to the drug usage \ncriteria, or have incomplete data that may hinder the assessment of thera peutic efficacy and safety \nare also excluded. \nTreatment ①\n The oral Qu Yu Jie Du Xiao Zheng decoction in the Traditional Chinese medicine \ngroup consists of various herbal ingredients. These include 30g of Sargentgloryvine Stem , 30g of \nHedyotis diffusa, 30g of Coix seed, 30g of Astragalus membranaceus, 15g of Corrugated wood, 15g \nof Litchi seed (broken), 10g of  Pseudobulbus Cremastrae seu Pleiones  (broken), 9g of  Agastache \nrugosus (after the lower part of the head), 2 Centipede (with head and feet removed), 6g of Resina \ndraconis, 6g of Eupolyphaga, 6g of Olibanum, 6g of  Myrrha, and 6g of  Radix Glycyrrhizae \nPreparata[7]. The Xi'an Hospital of Traditional Chinese Medicine's Pharmacy Center prepared a \ndecoction, while the Traditional Chinese Medicine Decoction R oom provided the broth, in the \namount of 200mL per bag. The recommended dosage is one bag, two times a day, in the morning \n90\n\nand evening. It is important to note that no other medications should be taken for this condition \nduring the treatment period. Additi onally, the consumption of cold drinks, oily foods, and \nstimulating foods should be minimized while taking this medication. If a cold is contracted, the \nmedication should be immediately discontinued. In the event of pregnancy during treatment, the \nmedication should also be stopped immediately. Individuals with allergies to Chinese medicine are \nprohibited from using this medication, and those who are allergic should exercise caution. ②\nWestern medicine group: Daflon (Diflucan tablets Abbott Biologicals B.V . (Netherlands)) should be \nadministered at a dosage of 10mg per intake, twice daily, starting from the fifth day of the menstrual \ncycle and continuing for a duration of 20 days. It is necessary to undergo a consecutive treatment \nregimen for three menstrual cy cles. It is important to note that the concomitant use of other \nmedications with similar effects is strictly contraindicated during the treatment period. ③ \nCombination of Chinese and Western medicines group: the administration method of oral Chinese \nmedicine is similar to that of the Chinese medicine group. Additionally, dydrogesterone tablets are \norally administered starting on the 5th day of menstruation, following the dosage and administration \nmethod of the Western medicine group. There is no combined me dication involved.Observation \nindicators  \nPelvic pain scores: The \"Pelvic Pain Assessment Scale\" [8] was utilized by patients to document \nvarious aspects of their pain. These included menstrual pain, encompassing abdominal and breast \npain, as well as lumba r pain before and after menstruation, and symptoms of anal irritation during \nmenstruation. Additionally, scores were assigned to other pelvic pain symptoms, such as \nnon\n-menstrual pelvic pain, pain during intercourse, and anal cramps. The severity of menstr ual pain \nand non-menstrual pelvic pain was measured using the Visual Analog Scale (V AS) before and after \ntreatment for all three patient groups. \nSerum factor levels: ELISA was used to detect the levels of nerve growth factor (NGF), \nprostaglandin E2 (PGE2) and tumor necrosis factor -alpha (TNF-α) in the peripheral blood in the \nserum before and after treatment, and the experimental process was carried out in strict accordance \nwith the instructions. \nIn this experiment, percent efficacy was used to assess the tr eatment effect. The formula for \ncalculating the percentage of efficacy was (pre -treatment points - post-treatment \npoints)/pre-treatment points)× 100%. According to the calculated percentage of efficacy, the efficacy \nwas categorized into four grades: cured, obvious, effective and ineffective. The specific efficacy \nevaluation criteria are as follows: \n① Cured: after drug intervention, various clinical symptoms disappeared, such as pelvic masses, \ntender nodules and other local signs basically disappeared. The percentage of efficacy (N) is greater \nthan or equal to 95% [9]. \n② Significant effect: clinical symptoms basically disappeared and pelvic mass was reduced \n(compared with gynecological examination and pelvic ultrasound examination at the same time of \nmenstrual cycle). The percentage \nof efficacy is 95% greater than N greater than or equal to 70%. \n③ Effective: Symptoms are relieved and pelvic lesions are not significantly enlarged or slightly \nreduced. The percentage of efficacy is 70% greater than N greater than or equal to 30%. \nIneffective: no change or aggravation of the main symptoms, local lesions have a tendency to \naggravate. The percentage of efficacy (N) is less than 30%. \nAccording to the above criteria, patients can be categorized into different levels a ccording to the \nefficacy percentage to assess the effectiveness of treatment. \nStatistical methods In this experiment, SPSS 22.0 statistical software was used to process the \nobtained data. For the general data of the three groups of patients, the chi -square test was used to \nanalyze the count data, while for the measurement data, the variance chi -square test was performed \nfirst, and then the independent samples t -test was used to compare the differences between the \n91\n\ngroups, while the paired samples t -test was used to compare the differences between the groups. \nWhen the p-value is less than 0.05, it means that the difference is statistically significant. \n3. Results \n3.1 Comparison of VAS Scores among the 3 Groups See Table 1. \nTable 1\n. Comparison of VAS scores in 3 groups (x± s, points) \nGroup Number of cases Before treatment After treatment Before and after difference \n(D value) \nChinese medicine group 20 5.83± 1.95 2.8± 1.05 3.03± 1.55 \nWestern medicine group  20 5.60± 2.14 3.05± 1.36 2.55± 1.75 \nChinese and Western medicine \nCombined group 20 6.10± 1.80 1.95± 1.05 4.15± 1.43 \nAs can be seen from Table 1, the V AS scores of the three groups had different decreases after \ntreatment. After t -test, the difference between the points of the combined Chinese and Western \nmedicine group compared with the Chinese medicine group and the Western medicine group was \nextremely significant (p < 0.01), and the difference of the combined Chinese and Western medicine \ngroup > the difference of the Chinese medicine group > the difference of the Western medicine \ngroup, which indicated that in terms of the effect of pain relief, the combined Chinese and Western \nmedicine group had a better effect than the other two groups. \n3\n.2 Comparison of Pelvic Pain Efficacy after Treatment in the 3 Gr oups See Table 2. \nTable 2. Comparison of the effective rate of pelvic pain treatment among 3 groups of patients \nSymptoms Group Number of cases Disappearance rate \nMenstrual abdominal \npain \nChinese medicine group 19 9 (47.36%) \nWestern medicine group 17 7 (41.11%) \nChinese and Western medicine \nCombined group 20 14(70.00%) \nLumbosacral pain \nChinese medicine group 15 7 (46.67%) \nWestern medicine group 18 8 (44.44%) \nChinese and Western medicine \nCombined group 15 10(66.67%) \nPelvic pressure pain  \nChinese medicine group 18 10(55.56%) \nWestern medicine group 19 9(47.37%) \nChinese and Western medicine \nCombined group 18 15(83.33%) \nSexual intercourse \npain \nChinese medicine group 11 7(63.64%) \nWestern medicine group 14 8(57.14%) \nChinese and Western medicine \nCombined group 12 10(83.30%) \nAnal pain  \nChinese medicine group 13 8(61.54%) \nWestern medicine group 11 6(54.55%) \nChinese and Western medicine \nCombined group 14 11(78.57%) \nTender nodules \nChinese medicine group 12 5(41.67%) \nWestern medicine group 15 7(46.67%) \nChinese and Western medicine \nCombined group 13 8(61.54%) \n92\n\nAs can be seen from Table 2, after treatment, the apparent efficacy rates of menstrual abdominal \npain, pelvic pressure pain, and tender nodules of the patients in the combination of Chinese and \nWestern medicines group were 70%, 83.33%, and 61.54%, respectively, which were higher than \nthose of the rest of the two groups, and the difference between the apparent efficacy rates of pelvic \npain of the combination of Chinese and Western medicines treatment group compared with the \nChinese medicine treatment group and the Western medicine treatment group was extremely \nsignificant after the χ2 test (p<0.01); after treatment,  the apparent efficacy rates of intercourse pain, \nlumbosacral pain, anal pain of patients in the After the treatment, the apparent efficiency of sexual \nintercourse pain, lumbosacral cramps and anal cramps of the patients in the combined group was \nalso higher than that of the remaining two groups, but the difference was not statistically significant, \nwhich indicated that the combination of traditional Chinese and Western medicines group could \nachieve effective relief of pelvic pain. \n3.3\n Comparison of Serum TNF-α, NGF and PGE2 Levels before and after Treatment in the 3 \nGroups See Table 3. \nTable 3. Comparison of serum TNF-α, NG F and PGE2 levels before and after treatment in 3 groups \nof patients \nAs shown in the above table, the difference in serum TNF- α, NGF and PGE2 levels between the \nthree groups before and after treatment was statistically significant (p < 0.05 or p < 0.01), in \naddition, the difference in TNF- α, NGF and PGE2 levels after treatment between the weste rn \nmedicine group and the combination of western and traditional Chinese medicines group was \nstatistically significant (p < 0.05), and the difference between the Chinese and western medicine \ngroup after treatment TNF- α, NGF and PGE2 levels after treatment in the Chinese medicine group \nand the combination of Chinese and Western medicines group, the difference was statistically \nsignificant (P < 0.05), while the difference was not statistically significant in the comparison of \nTNF-α, NGF and PGE2 levels after treatment in the Chinese medicine group and the combination \nof Chinese and Western medicines group (P > 0.05). \nItem  Chinese medicine \ngroup (n=20) \nWestern medicine \ngroup (n=20) \nChinese and Western \nmedicine \nCombined group(n=20) \n F value   P value \nTNF-α      \nBefore \ntreatment  11.94± 1.33 11.86± 2.54 11.52± 1.96 0.268 0.767 \nPost-treat\nment  10.54± 1.75 9.15± 3.58 7.87± 3.30 3.416 0.038 \nNGF      \nBefore \ntreatment  89.97± 9.39 80.81± 17.31 90.62± 10.60 2.140 0.134 \nPost-treat\nment  72.15± 12.56 66.23± 14.06 64.07± 26.40 4.901 0.014 \nPGE2      \nBefore \ntreatment  95.318± 8.790 95.01± 12.77 98.04± 9.43 0.307 0.738 \nPost-treat\nment  81.620± 15.33 79.87± 18.07 63.51± 26.68 6.453 0.004 \n93\n\n4. Discussion \nEffect of Qu Yu Jie Du Xiao Zheng decotion in Combination with Dydrogesterone Tablets on \nPelvic Pain The results of this study showed that after the intervention of Qu Yu Jie Du Xiao Zheng \ndecotion in Combination with Dydrogesterone Tablets, the patients' pelvic pain was significantly \nimproved, and the significant scores of dysmenorrhea, pelvic tenderness and palpable nodules were \nhigher than those of dysmenorrhea, pelvic pain, and palpable nodules of the rest of the two groups \nwith a statistically significant difference (P<0.05), which confirms that Qu Yu Jie Du X iao Zheng \ndecotion can also effectively relieve other symptoms such as pain during sexual intercourse and \nanal pain. \nEffects of Qu Yu Jie Du Xiao Zheng decotion in combination with Difluprednate Tablets on the \nlevels of TNF -α, NGF and PGE2 in the serum of the patients Modern medicine believes that \nendometriosis is a kind of intractable disease, and the mechanism of its pathogenesis is extremely \ncomplex, which has not been completely clarified, and is currently dominated by the retrograde \nflow of menstrual blood and the implantation theory [10], that is, the fragments of the endometrium \nretrograde flow of menstrual blood and enter the pelvic cavity via the fallopian tubes, and then are \nplanted in the ovary or other parts of the pelvic cavity [11]. or other pa rts of the pelvis [11]. Pelvic \npain is one of the main symptoms of endometriosis, and the mechanism by which it arises is a \ncomplex process. Studies have shown that immunoinflammatory factors, estrogen levels, nerve \ngrowth factors, and serum prostaglandins  are closely related to the occurrence of \nendometriosis-related pain. It has been found that ectopic endothelial tissue can secrete nerve \ngrowth factor (NGF) [12], and activated macrophages can produce a large amount of tumor necrosis \nfactor (TNF-) and increase the level of cyclooxygenase-2 (COX2), which in turn increases the level \nof prostaglandins, which in turn increases the level of prostaglandins. The activated mast cells can \ndegranulate and secrete TNF - and PGs [13]. Therefore, the serum levels of TNF -, NGF and PGE2 \nare higher in patients with endografts. According to the results of this experiment, the levels of \nTNF-α, NGF and PGE2 in the serum of patients in the combined Chinese and Western medicine \ngroup were significantly lower after treatment comp ared with those before treatment, and the \ndifference was statistically significant (P < 0.01). Meanwhile, there were significant differences \nbetween the Western medicine group and the combined Chinese and Western medicine group in the \nlevels of TNF -α, NGF and PGE2 after treatment (P < 0.05). Significant differences also existed \nbetween the TCM group and the combined TCM and Western medicine group in the levels of \nTNF-α, NGF and PGE2 after treatment (P < 0.05), however, the differences between the TCM \ngroup and the Western medicine group in the levels of TNF-α, NGF and PGE2 after treatment were \nnot statistically significant (P > 0.05). This suggests that the combination of Qu Yu Jie Du Xiao \nZheng decotion and Difenocoumarol Tablets was able to regulate the le vels of TNF -α, NGF and \nPGE2 in the serum of the patients, which significantly alleviated the pain of pelvic pain in patients \nwith endogamy. \nLegislative basis for the treatment of endometriosis byQu Yu Jie Du Xiao Zheng decotion in \ncombination with dextroprogesterone tablets Endometriosis is an estrogen -dependent disease, for \nwhich Western medicine drug therapy is mainly given as hormonal thera pies (progestins, birth \ncontrol pills, sex hormones such as mifepristone). Deferiprogesterone is a progestin, which can \ninhibit endometrial hyperplasia, shrink the ectopic endometrium, and further inhibit the \ndevelopment of ectopic foci [14]. Endometriosis  belongs to the category of \"dysmenorrhea\" and \n\"obstruction in the abdomen\" in traditional Chinese medicine (TCM). TCM believes that the core of \nthis disease is \"blood stasis\", so the treatment is based on activating blood circulation and \neliminating blood stasis. In recent years, some scholars believe that the basic pathology of EMs is \nnot only \"blood stasis\", but also \"turbid fluid\", and that both of them can not only be brewed into \n94\n\nstasis toxin and dampness toxin for a long period of time, but also fumigate with each other and turn \ninto heat toxin. In the previous project, we have formulated  Qu Yu Jie Du Xiao Zheng decotion, \nwhich has the function of dispelling blood stasis, resolving toxins and removing turbidities, and \neliminating crushing and dispersin g lumps and knots, to treat dysmenorrhea and obstruction in the \nabdomen of internal heterotaxy, and it has achieved good therapeutic effect. In this experiment, in \norder to improve the efficacy of EMS, the formula of Qu Yu Jie Du Xiao Zheng decotion was added \non the basis of oral administration of dydrogesterone tablets, in which all the medicines in the \nformula were combined together to eliminate and remit the evil toxins in an all -rounded way and at \nvarious levels, such as clearing away heat and detoxific ation, dispelling blood stasis, removing \ndampness and resolving turbidities and toxins, clearing up the channels of the worms and \neliminating the toxicity and alleviating the toxicity by benefiting the qi to support the toxins and \nrelieving toxicity throug h the glycytes and the toxins, so as to eliminate blood stasis and clear up \nchannels of the worms and resolving turbidities and eliminating symptoms and alleviating pain [15]. \nThe results of this study also proved that the difference in V AS scores before a nd after treatment \nbetween Qu Yu Jie Du Xiao Zheng decotion in combination with dydrogesterone tablets was more \nobvious compared with the traditional Chinese medicine group and the western medicine group \n(P<0.05), and the improvement of pelvic pain in the combination of traditional Chinese medicine \nand western medicine group was more significant than that in the rest of the two groups, which \nsuggests that the addition of Qu Yu Jie Du Xiao Zheng decotion in combination with \ndydrogesterone tablets can enhance  the effect of improving pelvic pain. The difference in serum \nTNF-α, NGF and PGE2 levels between the Chinese and Western medicine combination group \nbefore and after treatment was statistically significant (P < 0.01), confirming that the combination \nof Qu Yu Jie Du Xiao Zheng decotion and dydrogesterone tablets could regulate the serum levels of \nTNF-α, NGF and PGE2 in patients with endogenous syndrome. \nIn conclusion, the combination of Qu Yu Jie Du Xiao Zheng decotion with dydrogesterone \ntablets can regulate the serum levels of TNF-α, NGF and PGE2 in patients, effectively improve the \nsymptoms of pelvic pain in patients with endometriosis, and the effect is remarkable, which \nprovides a new way of thinking for the treatment of endometriosis pain. \nFunding \nHealth \nResearch Talent Program of Xi'an Municipal Health Planning Commission (2022yb02) \nReferences \n[1] Sun A’ mei, Liu Changyun, Liu Hanrong, Wang Zhengfang. 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