The "tonifying the kidneys, resolving blood stasis and clearing collaterals" method in polycystic ovary syndrome (PCOS) research: study protocol for a multicentre cohort study nested randomised controlled trials

The "tonifying the kidneys, resolving blood stasis and clearing collaterals" method in polycystic ovary syndrome (PCOS) research: study protocol for a multicentre cohort study nested randomised controlled trials | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol The "tonifying the kidneys, resolving blood stasis and clearing collaterals" method in polycystic ovary syndrome (PCOS) research: study protocol for a multicentre cohort study nested randomised controlled trials Rui Song, yonghui liu, Dongyan Yang, Na Li, Hua Xu, Kailin Jiao, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3896980/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction : Polycystic ovary syndrome (PCOS) presents as a multi-complicated syndrome and increases the risk of other diseases. Life management is clinically ineffective as a first-line basic treatment for polycystic ovary syndrome. Acupuncture and Chinese herbal medicine (CHM) have excellent clinical efficacy for PCOS. however,there is currently a dearth of high-quality data demonstrating its efficacy.The purpose of this experiment is to assess the safety and efficacy, especially the long-term efficacy,of individualized life management、CHM, acupoint thread-embedding therapy for treating PCOS. Methods and analysis : We present a multicentre, prospective, combined randomised clinical trial and observational cohort study design, with a target sample size of 316 patients with PCOS of the kidney deficiency and blood stasis type aged between 18-45years. Patients were divided into an observational cohort with a renal supplementation and blood-stasis-restoration cohort based on whether or not they were exposed to the tonifying-kidney, resolving-blood stasis-and-tongue method. Based on the examination results, the observation cohort received individualised life management and appropriate pharmacological interventions and was followed up for 6 months. The kidney tonifying and resolving stasis through the channels cohort was randomly divided into A) Kidney tonifying and resolving stasis traditional Chinese medicine group, B) Kidney tonifying and resolving stasis buried under ultrasound in the musculoskeletal bone group, and C) Kidney tonifying and resolving stasis traditional Chinese medicine combined with burying group by the method of randomised numerical table based on the above. The kidney tonifying and resolving stasis through the channels cohort treatment cycle was 3 months, and the follow-up period was 3 months. Main results: (1) the change of menstrual of PCOS patients before and after treatment ; (2) the efficacy of traditional Chinese medicine symptoms. Secondary results: Sex hormones, AMH, ultrasound;changes in scores such as polycystic cognition,PCOSQ-50 score,menstruation,hirsutism,Ffq168,IPAQ-SFHADS etc.All assessments were followed up with redcap questionnaires at baseline at weeks 4, 8, and 12 after the start of the intervention and at weeks 16, 20, and 24 after the end of the intervention. Trial registration number : (2023) Lun Shen No.41; Pre-results.The trial was launched on July 2023 through https://www.chictr.org.cn/ Registrationnumber:ChiCTR2300073832. Polycystic ovary syndrome Embedding Chinese herbal formula Protocol Cohort study Figures Figure 1 Article Summary Strengths And Limitations Of This Study In this study, the current problems of first-line life management of patients with polycystic ovary syndrome were optimised, and individualised life management was implemented. The advantages and favourable factors of implementing individualised life management in patients with polycystic ovary syndrome were observed through the redcap data base system for regular management of patients, recording of results and follow-up, providing high-quality evidence for assessing the safety, efficacy, and long-term efficacy of individualised life management, CHM, and acupoint acupuncture for the treatment of polycystic ovary syndrome. Added advantages include high-quality information about the efficacy of acupuncture under ultrasound, the compounding of Chinese herbs, and the effect of combining the two combinations for the treatment of PCOS. However,the rationale for the action of acupoint burrowing therapy in polycystic ovary syndrome is unclear. Background Patients with polycystic ovary syndrome (PCOS) present with phenotypes such as irregular menstruation, ovulation disorders, hyperandrogenism, and polycystic changes in the ovaries. It also increases the risk of type 2 diabetes mellitus[1], cardiovascular disease[2], metabolic syndrome[2], estrogen-related malignancies[1], multiple disorders of pregnancy[1], fetal growth restriction[1], preterm labour[1], and the development of many related disorders during pregnancy and childbirth[1].First-line guidelines for PCOS recommend life management, which is currently ineffective and requires multidisciplinary collaboration to implement individualised life management and enhance shared decision-making and implementation[2][3][4][5]. Individualised life management for patients with PCOS can be targeted, multidisciplinary, and collaborative guidance to improve the current poor implementation of polycystic life management. Acupuncture and Chinese herb medicines (CHMs) have significant efficacy in improving menstruation[7], ovulation[6][8], pregnancy[7][8][9][21], body weight[9], insulin resistance[9][10][11][24], sex hormones[7][23][24] regulation of intestinal flora[9][20], mood[12], and sleep in patients with PCOS. Therefore, Chinese medicine treatments have a wide range of positive significance for patients with polycystic ovary syndrome. Currently, basic studies and META analyses exist on applying TCM in PCOS. However, fewer high-quality clinical observation protocols and no published articles compare the advantages of the two treatments of TCM and buried threads and the efficacy of their combined treatments. Thus, this study will look at the advantages of implementing individualised life management for patients with PCOS through a combination of randomised clinical trials and observational cohort studies. It will also study the safety, efficacy, and long-term efficacy of herbal medicine and buried threads in PCOS. Trial procedure The entire trial consists of a screening/baseline period (weeks -2 and 0), a 3-month treatment period (weeks 4 - 12) and a 3-month follow-up period (weeks 16 - 24) (Figure 1). Assessments will be performed at baseline, weeks 4, 8 and 12 of treatment and weeks 16, 20 and 24 of follow-up. Sex hormone and ultrasound examinations will be performed at baseline, week 12 of treatment and week 24 of follow-up. The flow chart and study design schedule are shown in Figure 1 and Table 1, respectively. Potential participants will be invited to participate in an initial assessment (first visit), including screening for inclusion and exclusion criteria. If eligible, participants will sign informed consent, record sex hormone and ultrasound results , and will be assessed with the Polycystic Awareness 20, Practice Scale, PCOSQ-50 Polycystic Quality of Life Score, SF-36 Health Status, Menstruation, Hirsutism, and Acne Scale, Dietary Ffq168, EAT-26 scales, IPAQ-SF Exercise Scale, the Sleep Assessment Pittsburgh Sleep Scale, Anxiety and Depression Assessment HADS Scale, and other assessments (the above scales are professionally translated by English Level 6, and are all internationally accepted scales). It was divided into an observational control cohort and a renal-supplementation and blood-stasis-restoration cohort based on whether or not they were exposed to the treatment of tonifying the kidneys, resolving blood stasis, and promoting collaterals. The observational cohort consisted of individualised life management and basic western medical treatment, and was followed up for 6 months. The renal-supplementation and blood-stasis-restoration cohort was included was randomly divided by the method of randomised numerical table and was divided into A group Kidney tonifying and stasis removing herbal medicine group,B group Burying threads under ultrasound for tonifying the kidney and resolving stasis in the muscles and bones, and C group Kidney tonifying and blood stasis removing traditional Chinese medicine combined with burying the thread group. Group A:the traditional Chinese medicine for tonifying the kidney and resolving blood stasis was decocted with water, 200ml of the medicine was taken warm in the morning and evening, the medicine was taken for 3 consecutive courses of treatment (1 course of treatment for 1 menstrual cycle), and the medicine was discontinued during the menstruation period, and the follow-up period was 3 months. Group B:group tonifying the kidney and resolving blood stasis in the muscle and bones under ultrasound buried thread group 14 days 1 time, treatment for 3 months,and the follow-up period was 3 months. Group C:Group A+Group B: the time of taking medicine and burying thread is the same as the above two groups. The treatment period of the treatment cohort was 3 months, and the follow-up period was 3 months. Main results: (1)Pre- and post-treatment improvement of menstruation in PCOS patients;(2)Determination of the efficacy of Chinese medicine symptoms;Secondary results:Sex hormones, AMH(anti-Müllerianhormone), ultrasound; changes in scores on the remaining scales such as polycystic cognition, PCOSQ-50 score, menstruation, hirsutism, Ffq168, IPAQ-SFHADS, etc., were reviewed at week 12 after discontinuation of medication and week 24 of follow up.Fasting insulin, glycaemia, lipids, liver and renal function were reviewed for the presence of metabolic problems, and follow up on the pregnancy rate and the incidence of spontaneous abortions was carried out. The medication (basic western medicine, traditional Chinese medicine), ultrasound acupuncture points and depth、safety observations will be recorded throughout the treatment process. All assessments（assessed with the Polycystic Awareness 20, Practice Scale, PCOSQ-50 Polycystic Quality of Life Score, SF-36 Health Status, Menstruation, Hirsutism, and Acne Scale, Dietary Ffq168, and EAT-26 scales,t IPAQ-SF Exercise Scale,Pittsburgh Sleep Scale, HADS Scale and other assessments）will be followed up and evaluated at baseline and at weeks 4, 8 and 12 after the start of the intervention and at weeks 16, 20 and 24 after the end of the intervention through questionnaires distributed by redcap.sex hormone and ultrasound results recorded on the baseline, weeks12 of treatment and weeks 24 of follow-up. Table 1. Participant schedule Stage Screening/baseline period Treatment period follow-up period Visits One two three four Five six seven Time (weeks) Based on the practice of accomplishing the goals set by the patient Week -2~0 Week4± 7days Week8± 7days Week12± 7days Week16± 7days Week20± 7days Week24± 7days Sign the informed consent form X Inclusion/exclusion criteria X Demographic information (family,menstruation,maternity, travel) X Multicapsular cognition, practice scales, goal setting and completion X X X X X X X Current problem scale assessment: menstrual scale, hirsutism, acne, etc. This part of the scale is based on whether the patient has problems and the need to solve them X X X X X X X Diet (category/EAT26/168 frequency) X X X X X X X Exercise (International Scale of Exercise) X X X X X X X Sleep (Pittsburgh Sleepiness Scale) X X X X X X X Emotion (Anxiety Depression Scale) X X X X X X X Sex hormones X X X Ultrasound X X X Adverse events, safety evaluation This part of the scale is completed based on whether the patient has problems X X X X X X Research Completion X X Researcher Review X X Review by the person in charge X X Note: In this table, "X" represents the items that must be completed; "X" represents the items that need to be completed for individualized patient requirements [insert Table 1] Participants Participants recruit from outpatient gynaecology, endocrinology, and TCM clinics at Shaanxi Provincial Hospital of Traditional Chinese Medicine and the First Affiliated Hospital of Xi'an Jiaotong University. In addition, posters, newspapers, and online advertisements were used for recruitment. Diagnostic indicators 1. Adopt the diagnostic criteria in the Chinese Diagnostic and Treatment Guidelines for PCOS formulated by the Endocrinology Group of the Obstetrics and Gynaecology Section of the Chinese Medical Association and guideline experts in 2018[13]: (1) Scarce menstruation, amenorrhea, or irregular uterine bleeding; (2) Clinical manifestations of hyperandrogenism or hyperandrogenemia; (3) Polycystic ovaries on ultrasound (≥12 follicles with a diameter of 2-9 mm and/or an ovarian volume of ≥10 ml in one or both ovaries on ultrasound). Of the above 3 conditions, (1) is necessary, (2) and (3) have 1 or more. Other diseases that may cause hyperandrogenism and ovulation abnormalities are ruled out one by one before the diagnosis of PCOS is made. 1.1 Judgment criteria for scanty menstruation, amenorrhoea, and irregular bleeding: Regarding the relevant contents of the 9th edition of the textbook Obstetrics and Gynaecology, edited by Xie Xing, Kong Beihua, and Duan Tao, the criteria are formulated as follows[14]: (1) Scarcity of menstruation: the menstrual cycle is 35 days-6 months; (2) Secondary amenorrhoea: cessation of menstruation for more than 6 months after the establishment of normal menstruation or for more than 3 cycles according to one's original menstrual cycle. 1.2 Refer to the guidelines of integrated Chinese and Western medicine for the diagnosis and treatment of abnormal uterine bleeding with ovulatory disorders[15]: Irregular bleeding: irregular menstruation, menstrual cycle, menstrual period, frequency, and amount of menstruation can be abnormal. Determination of ovulation disorder: basal body temperature (BBT), monophasic suggests anovulation, biphasic suggests ovulation; or blood test for progesterone 5-7 days before menstruation, less than 15μg/L suggests ovulation disorder. 2. Chinese medicine diagnosis and identification criteria: (1) Formulate the Chinese evidence score with reference to the Quantitative Table of Symptom Grading of the Guiding Principles for Clinical Research of New Chinese Medicines for Malefactors; (2) China Traditional Chinese Medicine Press, Chinese Medicine and Gynaecology, 6th edition textbook, Zhang Yuzhen, Science of Traditional Chinese Medicine. Beijing: China Press of Traditional Chinese Medicine, 2002.9 The identification criteria of kidney deficiency and blood stasis in PCOS, primary symptoms: disorders of the menstrual cycle (menstruation at the beginning, at the end, or irregular intervals), menstruation stopping and shutting down. Secondary symptoms: (1) lumbosacral pain; (2) cold pain in the abdomen, especially during menstruation; (3) distension and pain in the lesser abdomen; (4) lack of warmth in the hands and feet; (5) dull tongue or petechiae; (6) fine stringy pulse. Inclusion criteria (1) Compliance with the above Western medical diagnostic criteria: the diagnostic criteria in the Chinese Diagnostic and Treatment Guidelines for Polycystic Ovary Syndrome[13] developed by the Endocrinology Group of the Obstetrics and Gynaecology Section of the Chinese Medical Association and the Guidelines Expert Group in 2018 were adopted: (2) Complying with the diagnostic criteria of TCM, identifying the type of kidney deficiency and blood stasis, primary symptoms: menstrual cycle disorders (menstrual cycle at the beginning, at the end, or irregular intervals), menstrual shutdown. Secondary symptoms: (1) lumbosacral pain; (2) cold pain in the abdomen, especially during menstruation; (3) distension and pain in the abdomen; (4) lack of warmth in the hands and feet; (5) dull tongue or petechiae; (6) fine stringy pulse. (3) Be 18-45 years old. (4) Understand the nature and purpose of the study, be willing to participate, cooperate with follow-up, examination, and treatment, and sign the informed consent form. Exclusion criteria (1) Those with menstrual irregularities caused by congenital or acquired organic lesions of the reproductive organs; (2) The presence of endocrine diseases similar to PCOS, such as hyperprolactinaemia, thyroid disease, Cushing's syndrome, atypical congenital adrenal hyperplasia, tumours of the ovaries or adrenal glands that release testosterone, functional hypothalamic amenorrhea, and early-onset ovarian insufficiency; (3) Excluding patients with uterine bleeding caused by pregnancy, coagulation disorders, endometrial polyps and local anomalies, adenomyosis, fibroids, endometrial malignancy and atypical hyperplasia; (4) Patients with combined serious heart, liver, kidney, blood, oncological system, and other primary diseases; patients with severe anaemia requiring blood transfusion; and patients with mental illness; (5) Those who have taken hormone drugs or drugs affecting sex hormones, blood sugar, insulin, lipid metabolism, etc. in the past 3 months. (6) Those who are allergic to proteins and those who have broken or ulcerated skin at the site of the proposed buried thread to affect the operation; (7) Those who participate in other clinical studies simultaneously affect the results of this study. Intervention Kidney tonifying and stasis removing cohort A: Kidney tonifying and stasis removing herbal medicine group: herbal medicine provided by the herbal pharmacy of Shaanxi Provincial Hospital of Traditional Chinese Medicine and the First Affiliated Hospital of Xi'an Jiaotong University Formula for tonifying the kidneys and eliminating stasis: Rehmanniae radix praeparata (Shoudihuang)15g, Angelicae sinensis radix(Danggui)15g, Paeoniae Radix Alba (Baishao)15g, Poria(Fuling)15g, Cortex Moutan(Mudanpi)15g, Epimedium brevicornu（Yinyanghuo）15g, Salvia miltiorrhiza(Danshen)15g, Achyranthis bidentatae radix (Niuxi)15g, Leonurus japonicus (Yimucao)15g, Rhizoma Cyperi(Xiangfu)15g. Dosage: 400ml of Chinese herbal medicines in water, 1 dose daily, 200ml in the morning and 200ml in the evening, warm, 3 consecutive courses of treatment (1 menstrual cycle is 1 course of treatment), stop the medicine during menstruation. B: Burying threads under ultrasound for tonifying the kidney and resolving stasis in the muscles and bones: Preparatory equipment: absorbable surgical suture, collagen material, specification 4-0-2cm (Shandong Boda Medical Supplies Co.Ltd.), needle with sterile disposable injection needle, specification: 0.7*30TWLB (Jiangsu Suyun Medical Instrument Co.Ltd.), aseptic medication change kit (Zhende Medical), medical infusion bottle mouth sticker specification: 28mm*16mm (Yangzhou Fleury Biotechnology Co.Ltd.). Medical Infusion Vial Paste Specification: 28mm*16mm (Yangzhou Fleury Biotechnology Co. Ltd.) Selection of acupuncture points (tonifying the kidney, eliminating blood stasis, and promoting circulation): BL23 (bilateral), EX-CA1 (bilateral), uterus(bilateral), RN4, SP10 (bilateral), ST36 (bilateral), SP6 (bilateral), ST25 (bilateral). After the patient emptied the bladder, according to the location of the acupoints, the patient was placed in the position (supine/post-prone) to perform the acupoint burrowing. Specific operation process: open the single-use sterile dressing change bag, disinfect both hands with sterile gloves, local disinfection of acupoints, ultrasonographers using Neusoft N7 ultrasound equipment, select C2-5 ultrasound probe, set the frequency of 1.5Hz, respectively, aligned with the selected acupoints, acupuncturist use cotton swabs to wipe off excess coupling agent on the skin surface at the acupoints and disinfect the skin with iodine povidone, iodine swabs to disinfect the acupoints from the inside to the outside twice, hold the disposable No.5 buried needle in the left hand, hold sterile tweezers with the right hand to clip and put absorbable surgical suture into the buried sterile injecting needles, and then send the collagen threads into the acupoints and leave it behind under the ultrasound guidance of the acupuncturist with at least 5 years of experience, and then withdraw the sterile injecting needles. This procedure was done 1 time per 14 days, with an overall treatment for 3 months. The needle was withdrawn, and the acupuncture point was fixed with a disposable infusion bottle mouth sticker.14 Treatment was once a day for 3 months. C : Kidney tonifying and blood stasis removing traditional Chinese medicine combined with burying the thread group: the above two groups of programmes were combined, taking medication and burying the thread time treatment and operation as the above two groups. Control group Individualised life management: according to the patient's polycystic treatment goal, multidisciplinary doctors made a joint decision to formulate a plan based on the patient's current problems and needs, self-set goals, acceptable plan, willingness to accept feedback and communication frequency, combined with the patient's previous examination, combined with the guidelines, and high-quality meta-analysis for the correction of the plan. Communicate and develop a detailed individualised management plan with the patient. Necessary basic western medicine includes: 1. adjustment of menstrual cycle, 2. treatment of hyperandrogenism, 3. metabolic adjustment, 4. induction of ovulation, 5. in vitro fertilisation-embryo transfer, etc. Sample size In this study, previous studies[18], and our observational study, we chose the changes in menstrual evidence points of the three treatment groups of buried threads, traditional Chinese medicine, and buried threads combined with traditional Chinese medicine, with a test level of α=0.05 (bilateral) and a test efficacy of 1-β=0.9. The sample size of the three groups was calculated to require a total sample size of 93 cases by the PASS 15 software. The randomised controlled sample size was about 117 cases, considering a lapse rate of 20%. According to the sample size estimation formula of the cohort study, taking into account the dropout rate of 20%, the total sample size of this study is about 316 cases. Outcomes Main outcome indicators (1)Pre- and post-treatment improvement of menstruation in PCOS patients,Referring to the Guiding Principles for Clinical Research of New Chinese Medicines in the evidence ratings.Evaluation in terms of menstrual cycle, menstrual flow, menstrual period with a maximum score of 18 points; the more severe the symptoms, the higher the score ; (2) Determination of the efficacy of Chinese medicine symptoms: Referring to the Guiding Principles for the Clinical Research of New Chinese Medicines issued by the State Drug Administration in 2002 (trial version), the efficacy index was calculated according to the points of Chinese medicine symptoms before and after the treatment (evaluating in terms of the menstrual cycle, menstrual volume, the colour of menstruation, dark red tongue, and dull and astringent pulse, with a maximum score of 56 points; the more severe the symptoms, the higher the score), and the formula (Nimodipine method) was as follows: efficacy index (n) = (treatment period). The formula (Nimodipine method) is efficacy index (n) = (pre-treatment symptom score - post-treatment symptom score) / pre-treatment symptom score X 100%. Symptoms basically disappeared, n > 95%; apparent effect: Symptoms are significantly reduced after treatment, 95% > n > 70%; Effective: reduction of symptoms after treatment, 70% > n > 30%; Ineffective: no reduction or aggravation of symptoms after treatment, n < 30%. Secondary outcome indicators Sex hormones, AMH(anti-Müllerianhormone), ultrasound; changes in scores on the remaining scales such as polycystic cognition, PCOSQ-50 score, menstruation, hirsutism, Ffq168, IPAQ-SFHADS, etc., were reviewed at week 12 after discontinuation of medication and week 24 of follow up. Fasting insulin, glycaemia, lipids, liver, and renal function were reviewed for the presence of metabolic problems, and follow-up on the pregnancy rate and the incidence of spontaneous abortions was carried out. Safety Observations Subjects were analysed once a month during the trial for the occurrence of the primary target endpoint event completion during the treatment period. Attention was paid to the presence or absence of adverse reactions, such as allergy, needle sickness, fever, haemorrhage, infection, etc. Detailed records were kept of the time of occurrence and disappearance, clinical symptoms, duration, treatment measures of the adverse reactions to evaluate their safety further and determine whether to continue the treatment. grade degree of safety adverse reaction Security Indicators process Grade Ⅰ safe none none No treatment required. Continue treatment Grade Ⅱ comparatively safe Light none No treatment required, can be treated Grade Ⅲ have a security problem Medium mild abnormality Can continue treatment after symptomatic treatment Grade Ⅳ A serious security problem Heavy significant abnormality End of study Withdrawal/discontinuation of test indicator Sudden onset of heavy uterine or vaginal bleeding requiring urgent surgical or transfusion treatment; Immediate termination of the trial if pregnancy, sudden onset of other serious illness, or accident is established; Record details of serious adverse events/reactions in subjects where the investigator deems it necessary to terminate the trial; Subjects should try to complete the following items when withdrawing from the study during the follow-up phase of treatment: safety items such as the three major routine, liver and kidney function, and electrocardiogram; and perform efficacy index scores; Record the occurrence of adverse endpoint events: spontaneous abortion, haemorrhage, etc. Data management and quality control The trial protocol discussed by gynaecology, endocrinology, acupuncture, Chinese medicine, ultrasound nutrition and reproductive medicine specialists. All staff were aware of the specifics study protocol, study procedures before starting this study. Data will be stored and managed following Chinese ethical guidelines. REDCap will be used for questionnaire distribution, communication with experts, and outcome data collection. Chinese medicines were prescribed by Chinese medicine practitioners with at least 5 years of clinical experience.The acupuncture therapists with more than 5 years of qualification in acupuncture and moxibustion at the First Affiliated Hospital of Xi'an Jiaotong University carried the burying threads under the guidance of ultrasound. Confidentiality of participants' data,and it will not be possible to identify specific individuals in the published results. Statistical analyses SPSS 20.0 (SPSS Inc. China) was used for statistical analysis. (1) Measurement data: Mean earth standard deviation was used for statistical description, and a normality test was conducted first. If it conformed to a normal distribution, a paired samples t-test was used. If it did not conform to normal distribution, a non-parametric test was used, and hypothesis tests were all based on the criterion of P<0.05 as statistically significant; (2) Counting data: Statistical descriptions using frequencies, percentages, and composition ratios. Reasons for poor life management outcomes will be analysed using linear, logistic, Cox proportional risk, etc., to assess individualized life management's advantages and favourable factors. Discussion This is a clinical study of the advantages and favourable factors of individualised life management of PCOS, the safety, efficacy, and long-term efficacy of CHM and acupuncture point burrowing treatment. Currently, the efficacy of life management of PCOS is poor, and multidisciplinary (gynaecological, psychological, nutritional, etc.) studies[ 3 ][ 4 ]have found that there is a lack of individualized protocols and guidance for polycystic patients. At the same time, both the patient and the physician advocate for the achievement of individualized management[ 3 ][ 4 ][ 5 ]. The present study provides high-quality support for the advantages and factors conducive to the individualized life management of PCOS. Compared with previous studies, there are fewer high-quality clinical studies on TCM, and this study will provide information on the efficacy of ultrasound-under-embedded threads, TCM compounding, and the combination of the two. The efficacy of kidney tonifying and blood-activating herbs[ 6 ][ 7 ][ 8 ][ 17 ][ 18 ][ 19 ][ 20 ] and buried thread treatment[ 16 ][ 21 ][ 22 ] in improving PCOS is certain, feasible and safe. The PI3K/AKT/mTOR signaling pathway was activated in PCOS-IR rats,by Chinese medicine with blood activation Gui Zhi Fu Ling Wan[ 17 ]relieved ovulation dysfunction. Natural remedy for kidney tonicity in a mouse model of chronic stress PCOS disease[ 18 ]decreased granulosa cell apoptosis through the PERK-ATF4-CHOP signaling pathway. The herbal kidney tonic BSTJF[ 19 ]effectively reduced the pathophysiology of PCOS by enhancing glucose metabolism and oxidative stress via mitochondrial SIRT3 and the insulin signaling system.The kidney tonifying and resolving formula[ 20 ]was associated with reduced serum LPS and TLR4 expression levels, which inhibited the activation of NF-κB signalling-mediated inflammatory response in ovarian tissues and improved PCOS. A meta-analysis also found that acupuncture medication was more effective than Western medication in terms of ovulation rate and pregnancy rate, with ovulation rate of acupoint burrowing combined with medication (93.3%) and pregnancy rate of acupuncture burrowing treatment and medication ( 69.4%)[ 21 ]. Moreover, Furthermore, the necessary acupoints of Sanyinjiao (SP6), Guanyuan (CV4), Zusanli (ST36), Pishu (BL20), Shenshu (BL23), Zigong (EX-CA1) and other locations have an effect similar to that of estrogen, which may be significant and influence the p38MAPK signaling pathway[ 22 ]. In rats treated with DHEA to simulate PCOS, acupuncture may enhance ovarian shape and function[ 23 ]. The mutant sex hormone receptor genes are improved by electroacupuncture at the acupoints of Zusanli (ST36), Sanyinjiao (SP6), and Neiguan (PC6).Furthermore, it improves glucose intolerance and insulin intolerance[ 24 ]. Pharmacognosy: "Radix Rehmanniae has the properties of tranquillising the five viscera, harmonising the blood vessels, nourishing the true yin, and sealing and filling the bone marrow[ 25 ]. It also has multiple pharmacological actions, such as hemostasis, antioxidation, anti-osteoporosis, lowering blood sugar, anti-inflammation, antidepression, and anti-anxiety[ 26 ]. Jingyue quanquan - Ben cao zheng: "Angelica sinensis has a sweet and heavy flavour that can tonify blood and light and pungent qi that can move blood[ 27 ].” Danggui contains β-magnetene, α-pinene, camphene, and other components, which have the effect of excitation of uterine smooth muscle and improvement of immune blood flow[ 28 ]. Danggui (Angelicae Sinensis Radix) had a beneficial effect on a rat with PCOS, and the underlying mechanism was partly related to the JAK2/STAT3 signaling pathway mediated by interleukin-6[ 29 ]. Moreover, poria enters the kidney meridian and can be used as a meridian-inducing agent or combined with kidney tonic drugs to help the kidneys generate yin. The active ingredients in Poria are mainly Poria triterpenes and Poria polysaccharides[ 30 ]. Fuling formulae plus hypoglycaemic agents can further reduce FGB, 2hPG, HbA1c, TG, LDL, FINs, and IR levels and have a potential effect on the improvement of the inflammatory response of PCOS, combined with pancreatic island resistance, hyperlipidaemia, and other conditions[ 31 ] Mudanpi has the function of clearing heat and cooling blood, activating blood circulation, and removing blood stasis, and modern pharmacological studies have concluded that it has antibacterial and anti-inflammatory, immunomodulatory, hypoglycemic, antithrombotic, and antioxidant damage effects[ 32 ] White peony has the efficacy of nourishing blood and regulating menstruation. The chemical composition of white peony has glycosides, triterpenoids, flavonoids, etc, which have the efficacy of improving metabolism and immunity[ 33 ]. Szechuan hyssop enters the blood division and is good at descending; it can activate blood circulation, dispel blood stasis, and regulate menstruation. It is used for women with menstrual closure and irregular menstruation. Hyssop contains triterpenoids, steroids, and polysaccharides, and it has the effect of excitation of the uterus and improvement of fertility[ 34 ]. Xiangsui can disperse gas and depression, gas sparse depression dispersal, then the new blood and the body and carry on." The "Compendium of Materia Medica" said it "is the gas disease of the General Secretary, the female section of the commander-in-chief also." Chongqing Hall Essentials: "Salvia divinorum, descending and line blood, blood heat and stagnation of the appropriate, so for the regulation of menstruation and postpartum to be medicine[ 35 ]." Modern studies have shown that Salvia miltiorrhiza has an important effect on polycystic reproduction and metabolism[ 36 ]. Yinyanghuo, warm in nature, pungent, and sweet in flavour, is good at tonifying the kidney and strengthening the yuan-yang[ 37 ].Yinyanghuo plays immune inflammation regulatory and sex hormone regulatory roles in infertility treatment[ 38 ]. The Materia Medica Seeking Truth, Yun Yi Mu Cao, "promotes blood circulation, dispels blood stasis and generates new blood, regulates menstruation and removes toxins, and is an important agent for the prenatal and postpartum periods[ 39 ]." The chemical composition mainly contains motherwort alkaloids, which have the effects of uterine excitation, improving immunity, anticoagulation, and lipid regulation[ 40 ]. Modern pharmacology of the above drugs has shown that they improve uterine and ovarian function, immunity, and metabolism. The Chinese medicine compound selected for this study can tonify kidney essence[ 25 ][ 36 ], regulate yin and yang, qi and blood[ 27 ] and the function of each organ, and expel disease and stasis[ 39 ], thus improving the imbalance of yin and yang and dysfunction of internal organs, so that the metabolism of qi, blood, and fluids is normal. Furthermore, menstruation is restored[ 26 ][ 28 ], and the polycystic symptom[ 31 ][ 32 ][ 34 ][ 38 ]is improved. Problems faced by the acupuncture point buried thread treatment: 1. lack of accuracy of the buried thread points, buried thread depth is too shallow fat liquefaction, 2. touching blood vessels when burying the thread, there may be subcutaneous bleeding, and so on. Therefore, the programme will be under the ultrasonic positioning of muscle and bone-buried wire treatment. With this technique, you can see the acupoints buried wire level, observe the buried wire needle position, depth, and adjacent activities of the tissue structure, and accurately show the needle and blood vessels, nerves, tissues, and the interrelationship between the timely adjustment of the direction and angle, and avoid damage to the important internal organs and tissues. To achieve the visualization of the needle and implantation of the wire body material, a clear gas, and the needle level relationship are needed to improve the accuracy of minimally invasive buried wire implantation. Minimally invasive buried thread implantation level of accuracy and enhanced clinical efficacy[ 41 ][ 42 ][ 43 ]. Acupuncture point buried thread procedures are easy to use, safe, and can shorten patient visits while increasing patient compliance.[ 42 ][ 43 ]. Therefore, based on previous work and literature[ 22 ][ 44 ][ 45 ][ 46 ][ 47 ][ 48 ][ 49 ][ 50 ], the above acupoints were selected for the buried thread treatment. REDCap is the largest online trial database system for clinica research. In addition to all the advantages of EDC, REDCap also has the advantages and features of being free of charge, secure with restricted user access, easy to follow up with regular emails or SMS, the ability to design electronic case report forms, data entry, external data import, and electronic signatures for informed consent to satisfy the requirements of data management and quality assurance. This trial was a multicentre, prospective, cohort study, and the use of Redcap in the management of polycystic patients provides high-quality evidence to evaluate the safety, efficacy, and long-term efficacy of individualised life management, CHM, and acupoint acupuncture for the treatment of polycystic ovary syndrome. Abbreviations polycystic ovary syndrome (PCOS) ,Chinese herbal medicine(CHM),AMH (anti-Müllerianhormone);basal body temperature (BBT) ; Declarations Ethics and Dissemination: Neither the full paper nor parts of it have been submitted or published elsewhere. Papers will not be submitted elsewhere until the journal's editorial process is complete. The study protocol was reviewed and approved by the Ethics Committee of Shaanxi Provincial Hospital of Traditional Chinese Medicine and complied with the ethical standards for medical research involving human subjects as set out in the 1964 Declaration of Helsinki and its subsequent amendments. Participants submitted informed consent before taking part in the study. Ethics approval and consent to participate A statement to confirm that all methods were carried out in accordance with relevant guidelines and regulations.This study was conducted in accordance with the requirements of the Declaration of Helsinki and approved by the Chinese Clinical Trial Institution Review Committee (registration number：ChiCTR2300073832)，All participant have signed informed consent. Consent for publication Not applicable Availability of data and materials Connect author RS, [email protected] Competing interests The authors declare no competing interests. Funding This project was supported by the Shaanxi Provincial Science and Technology Council Fund (Project No. 2023-YBSF-043). Author contributions YHL conceived the study, initiated the design and revised the manuscript,RS is responsible for drafted the Manuscript and writing,Participant recruitment and data entry is provided byYHL,DYY,NL,KLJ, YX, HHZ, LQS, RS,Acupuncture treatments is administered by RS,Ultrasound observation is administered by HX;RW,RS is responsible for inform consent and finished trail registration procedures and measures, LQS, YHL is responsible for outcome assessment and manuscript revision. All authors commented on and approved the final manuscript. Acknowledgements Thank you to each of the physicians for their contribution to patient inclusion and patient cooperation. The authors thank AiMi Academic Services (www.aimieditor.com) for English language editing and review services. Authors' information The authors of this manuscript are RS,DYY,NL,HX,YX, HHZ, who, are affiliated with Shaanxi Provincial Hospital of Traditional Chinese Medicine,KLJ, who are affiliated with The Second Affiliated Hospital, Air Force Medical University,YHL,LQS,RWis affiliated with the First Affiliated Hospital of Xi'an Jiaotong University. References Choudhury AA, Rajeswari VD. Polycystic ovary syndrome (PCOS) increases the risk of subsequent gestational diabetes mellitus (GDM): A novel therapeutic perspective. Life Sci. 2022;310:121069. 10.1016/j.lfs.2022.121069 . Epub 2022 Oct 13. PMID: 36243118. Guan C, Zahid S, Minhas AS, et al. Polycystic ovary syndrome: a risk-enhancing factor for cardiovascular disease. Fertil Steril. 2022;117(5):924–35. 10.1016/j.fertnstert.2022.03.009.PMID . Moran LJ, Tan ZQ, Bayer S, et al. Perspectives of Allied Health Professionals on Implementation of the Lifestyle Polycystic Ovary Syndrome Guidelines: A Qualitative Study. J Acad Nutr Diet. 2022;122(7):1305–16. Epub 2021 Nov 18. PMID: 34800697. Chhour I, Blackshaw L, Moran LJ, et al. Barriers and facilitators to the implementation of lifestyle management in polycystic ovary syndrome: Endocrinologists' and obstetricians and gynaecologists' perspectives. Patient Educ Couns. 2022;105(7):2292–8. Epub 2021 Dec 23. PMID: 34980547. Teede HJ, Tay CT, Laven J, et al. International PCOS Network. Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. Fertil Steril. 2023;120(4):767–93. Epub 2023 Aug 14. PMID: 37589624. Ji, Lin. Meta-analysis and prescription characteristics of tonifying the kidney and activating blood in the treatment of polycystic ovary syndrome [D]. Guangzhou University of Traditional Chinese Medicine(China); 2019. Dong, Yufang. Meta-analysis of traditional Chinese medicine in the treatment of polycystic ovary syndrome[D]. Gansu University of Traditional Chinese Medicine(China); 2020. Song Y-J, Liang F-X, Wu S. Network meta-analysis on the effects of the acupuncture-related therapy on ovulation rate and pregnancy rate in patients with polycystic ovary syndrome[J]Zhongguo Zhen Jiu(China). 2019;39(7):792–8. Zhang F, Ma T, Tong X, et al. Electroacupuncture improves metabolic and ovarian function in a rat model of polycystic ovary syndrome by decreasing white adipose tissue, increasing brown adipose tissue, and modulating the gut microbiota. Acupunct Med. 2022;40(4):347–59. Epub 2021 Dec 10. PMID: 34892981. Li J, Wu W. Elisabet Stener-Victorin,et al,A prospective pilot study of the effect of acupuncture on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance[J]. Acupunct Med. 2020;38(5):310–8. Zheng R, Qing P, Han M et al. The Effect of Acupuncture on Glucose Metabolism and Lipid Profiles in Patients with PCOS: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.[J]Evid Based Complement Alternat Med. 2021; 2021:5555028. Zhang HL, Huo ZJ, Wang HN, et al. Acupuncture ameliorates negative emotion in PCOS patients: a randomized controlled trial[. J] Zhongguo Zhen Jiu. 2020;40(4):385–90. Song Y, Li R. Interpretation of Chinese diagnosis and treatment guidelines for polycystic ovary syndrome[J]. J practical Obstet gynaecology(China) 2018,34(10).737–41. Xie Xing K, Beihua D, Tao C, Hongbo, associate, editors. Obstetrics and gynaecology 9th edition [M]. Beijing: People's Health Publishing House(China), 2018.07. Obstetrics and Gynaecology Committee of the Chinese Society of Integrative Medicine. Guidelines for combined Chinese and Western medicine diagnosis and treatment of abnormal uterine bleeding in ovulatory disorders[J],Chinese. J Integr Medicine(China). 2020;40(04):391–400. Chao-chao YU, Chao-yang MA,Yuan XIONG, et al. Effectiveness of acupoint catgut embedding therapy for polycystic ovary syndrome: a systematic review and meta-analysis,[J]World. J Acupuncture-Moxibustion. 2017;27(04):41–51. Liu M, Zhu H, Zhu Y, Hu X. Guizhi Fuling Wan reduces autophagy of granulosa cell in rats with polycystic ovary syndrome via restoring the PI3K/AKT/mTOR signaling pathway. J Ethnopharmacol. 2021;270:113821. 10.1016/j.jep.2021.113821 . Pan X, Liu Y, Liu L, et al. Bushen Jieyu Tiaochong Formula reduces apoptosis of granulosa cells via the PERK-ATF4-CHOP signaling pathway in a rat model of polycystic ovary syndrome with chronic stress. J Ethnopharmacol. 2022;292:114923. 10.1016/j.jep.2021.114923 . Zhang Q, Ren J, Wang F, et al. Chinese herbal medicine alleviates the pathogenesis of polycystic ovary syndrome by improving oxidative stress and glucose metabolism via mitochondrial Sirtuin 3 signaling. Phytomedicine. 2023;109:154556. 10.1016/j.phymed.2022.154556 . Wang Y, Xiao H, Liu Y, et al. Effects of Bu Shen Hua Zhuo formula on the LPS/TLR4 pathway and gut microbiota in rats with letrozole-induced polycystic ovary syndrome. Front Endocrinol (Lausanne). 2022;13:891297. 10.3389/fendo.2022.891297 . Published 2022 Aug 9. Song YJ, Liang FX, Wu S et al. [Network meta-analysis on the effects of the acupuncture-related therapy on ovulation rate and pregnancy rate in patients with polycystic ovary syndrome]. Zhongguo Zhen Jiu. 2019;39(7):792-8. Chinese. 10.13703/j.0255-2930.2019.07.029 . PMID: 31286745. Wang SC, Jiang YM, Qiu LR, Su M. Efficacy of needling acupoints of Guanyuan (CV4), Sanyinjiao (SP6), Zusanli (ST36), Pishu (BL20), Shenshu (BL23), Zigong (EX-CA1) on expression of p38 mitogen-activated protein kinase in ovarian tissue in rats with premature ovarian failure induced by cyclophosphamide. J Tradit Chin Med. 2021;41(6):953–8. 10.19852/j.cnki.jtcm.2021.06.012 . Li D, Bai P, Wu JY, et al. Effect of Acupuncture on Ovary Morphology and Function in DHEA-Induced Polycystic Ovary Syndrome Model Rats. Chin J Integr Med. 2021;27(3):220–4. 10.1007/s11655-021-3290-0 . Ji C, Xu W, Zhang Z, Cui S, Yi W. Effect of Electroacupuncture on Reproductive Disorders and Insulin Resistance in a Murine Polycystic Ovary Syndrome Model. Evid Based Complement Alternat Med. 2021;2021:9968463. 10.1155/2021/9968463 . Published 2021 Dec 26. Ming. Jia Shoxue; (Qing) Li Yanhua; Yang Jinping and others. Drugs chemical meaning [M]. Beijing: China Traditional Chinese Medicine; 2015. p. 01. Li M, Jiang H, Hao Y, et al. A systematic review on botany, processing, application, phytochemistry and pharmacological action of Radix Rehmnniae. J Ethnopharmacol. 2022;285:114820. 10.1016/j.jep.2021.114820 . Epub 2021 Nov 10. PMID: 34767834. Ming. Zhang Jingyue. Jingyue encyclopaedia series Materia Medica Zheng [M]. Beijing: China Medical Science and Technology; 2017. p. 09. Yanchun M, Jianhui H, Wenxuan W, et al. Progress in the study of chemical composition and pharmacological effects of Angelica sinensis[J]. J Traditional Chin Medicine(China). 2022;50(01):111–4. Gao Y, Lian YY, Huang XY. Protective effect of aqueous extract from angelica Sinensis on rats with polycystic ovary syndrome. Pharmacol Clin Chin Materia Med. 2021;37(02):69–74. Xinyu ZHANG, Wei LIN, Shuyue LEI et al. Progress of pharmacological effects of Poria cocos polysaccharides and triterpenoids[J]. Shandong Chem Ind 2023,52(11):82–5. 10.19319/j.cnki.issn.1008-021x.2023.11.003 . Yang Peishu Z, Na. Poria pharmacological effects and research progress[J]. Inner Mongolia Traditional Chin Medicine(China). 2021;40(11):155–6. Zhai Chunmei M, Xiangying F, Jingju et al. Progress of modern pharmacological research on peony bark[J]. Chin Med information(China) 2020,37(01):109–14. Jiang H, Li J, Wang L, et al. Total glucosides of paeony: A review of its phytochemistry, role in autoimmune diseases, and mechanisms of action. J Ethnopharmacol. 2020;258:112913. 10.1016/j.jep.2020.112913 . Vanadium LY, Wen O. Progress of research on the material basis and pharmacological activity of saponins and steroid ketones in Cow's Knee[J]. Chin Mod Traditional Chin Medicine(China). 2020;22(12):2122–36. (Qing Dynasty). Wang Xuequan; Shi Renchao, Cai Dingfang. The Essays of Chongqing Hall [M]. Nanjing: Jiangsu Science and Technology; 1986. p. 12. Shen W, Jin B, Han Y, et al. The Effects of Salvia miltiorrhiza on Reproduction and Metabolism in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2021;2021:9971403. 10.1155/2021/9971403 . Published 2021 May 15. Li LIL, Jiarui,WANG WANG, Jing et al. Progress of research on the main chemical constituents, pharmacological effects and predictive analysis of quality markers of Epimedium[J]. Chin J Traditional Chin Med 2023,41(11):143–51. 10.13193/j.issn.1673-7717.2023.11.030 . Xie L, Zhao S, Zhang X et al. Wenshenyang recipe treats infertility through hormonal regulation and inflammatory responses revealed by transcriptome analysis and network pharmacology. Front Pharmacol 2022 Aug 8;13:917544. 10.3389/fphar.2022.917544 . PMID: 36003498; PMCID: PMC9393626. (qing) Huang Gongxiu; Wang Shumin. Materia Medica [M]. Beijing: China Press of Traditional Chinese Medicine, 1997.03. Wang, Bin. Research on the pharmacological effects of motherwort and its clinical application progress in obstetrics and gynaecology diseases[J]. Hebei Traditional Chin Medicine(China). 2021;43(11):1933–6. Jingjing Q, Guizhen C, Xueyu W. Application and consideration of musculoskeletal ultrasound in acupoint embedding therapy[J]. Shanghai J Acupunct Moxibustion(China). 2020;39(10):1330–4. Han Z, Li X, Liu Z et al. The study on the clinical effectiveness and safety of traditional Chinese medicine acupoint catgut embedding guided by musculoskeletal ultrasound in the treatment of nerve root sciatica: A protocol for systematic review and meta-analysis of randomized controlled trials.[J].Medicine (Baltimore). 2021,100(13):e25387. Yu B, Xuan L, Jin Y et al. Efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial.[J]Trials. 2021;22(1):755. Huang Shouqiang X, Haiyan X, Jun. A systematic evaluation of the effectiveness of acupuncture in the treatment of infertility in polycystic ovary syndrome[J]. Chin J Evidence-Based Medicine(China). 2021;21(04):431–7. Cui SRi-liangL, Nan Y. Research progress of acupuncture treatment of polycystic ovary syndrome[J].Henan Traditional Chinese Medicine(China),2022,42(07), 1114–8. Jin XI, Hao CHEN. CHENG Jie,Quality evaluation of systematic evaluation of acupuncture for polycystic ovary syndrome[J]Chinese. J Evidence-Based Med (China) 2019,19(02)205–11. Hongli ZHU, Xiaoyun ZHAO. RAO Long,Acupoint spectrum of acupuncture for polycystic ovary syndrome based on data mining[J]Western Traditional Chinese Medicine(China). 2020,33(05),123–6. Huang M, Liu M, Gao SQ. Based on data mining to explore the selection law of acupoint embedding in the treatment of polycystic ovary syndrome,[J]World Chinese Medicine(China). 2020,15(17),2579–83. Chaochao YU, Guojin YAO. ZHOU Yilun,A study on the clinical selection pattern of acupuncture points for polycystic ovary syndrome[J],Acupuncture and Moxibustion Clinical Journal(China). 2016,32(11).73–6. Zhou X, Fu QH, Pei J. Clinical efficacy of acupuncture point embedded thread in the treatment of polycystic ovary syndrome and quality evaluation of RCT report[J]. Chin Electron J Acupunct Moxibustion(China). 2020;9(04):159–64. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3896980","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":270893405,"identity":"441c7d59-7191-4158-914a-7f3366fad342","order_by":0,"name":"Rui Song","email":"","orcid":"","institution":"Shaanxi Provincial Hospital of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Rui","middleName":"","lastName":"Song","suffix":""},{"id":270893406,"identity":"4422aa5e-21c9-45cc-9457-76204836ec25","order_by":1,"name":"yonghui 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design.\u003c/p\u003e","description":"","filename":"OnlineFigure.png","url":"https://assets-eu.researchsquare.com/files/rs-3896980/v1/e26e67427cef75d945a54bde.png"},{"id":53473987,"identity":"f0f6fddd-dc5d-41a8-beaa-85f48994d281","added_by":"auto","created_at":"2024-03-26 12:11:57","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":458684,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3896980/v1/84da9414-0a80-4e20-a19c-946fc1568318.pdf"},{"id":50747670,"identity":"8f338c63-8218-4075-a01b-ff02efb34be6","added_by":"auto","created_at":"2024-02-06 17:13:14","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":182962,"visible":true,"origin":"","legend":"","description":"","filename":"completedCONSORTchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-3896980/v1/839b3c587a1a08b4aeb2be6e.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"The \"tonifying the kidneys, resolving blood stasis and clearing collaterals\" method in polycystic ovary syndrome (PCOS) research: study protocol for a multicentre cohort study nested randomised controlled trials","fulltext":[{"header":"Article Summary","content":"\u003cp\u003e\u003cstrong\u003eStrengths And Limitations Of This Study\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this study, the current problems of first-line life management of patients with polycystic ovary syndrome were optimised, and individualised life management was implemented.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe advantages and favourable factors of implementing individualised life management in patients with polycystic ovary syndrome were observed through the redcap data base system for regular management of patients, recording of \u0026nbsp;results and follow-up, providing high-quality evidence for assessing the safety, efficacy, and long-term efficacy of individualised life management, CHM, and acupoint acupuncture for the treatment of polycystic ovary syndrome.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAdded advantages include high-quality information about the efficacy of acupuncture under ultrasound, the compounding of Chinese herbs, and the effect of combining the two combinations for the treatment of \u0026nbsp; PCOS.\u003c/p\u003e\n\u003cp\u003eHowever,the rationale for the action of acupoint burrowing therapy in polycystic ovary syndrome is unclear.\u003c/p\u003e"},{"header":"Background","content":"\u003cp\u003ePatients with polycystic ovary syndrome (PCOS) present with phenotypes such as irregular menstruation, ovulation disorders, hyperandrogenism, and polycystic changes in the ovaries. It also increases the risk of type 2 diabetes mellitus[1], cardiovascular disease[2], metabolic syndrome[2], estrogen-related malignancies[1], multiple disorders of pregnancy[1], fetal growth restriction[1], preterm labour[1], and the development of many related disorders during pregnancy and childbirth[1].First-line guidelines for PCOS recommend life management, which is currently ineffective and requires multidisciplinary collaboration to implement individualised life management and enhance shared decision-making and implementation[2][3][4][5]. Individualised life management for patients with PCOS can be targeted, multidisciplinary, and collaborative guidance to improve the current poor implementation of polycystic life management.\u003c/p\u003e\n\u003cp\u003eAcupuncture and Chinese herb medicines (CHMs) have significant efficacy in improving menstruation[7], ovulation[6][8], pregnancy[7][8][9][21], body weight[9], insulin resistance[9][10][11][24], sex hormones[7][23][24]\u0026nbsp;regulation of intestinal flora[9][20], mood[12], and sleep in patients with PCOS. Therefore, Chinese medicine treatments have a wide range of positive significance for patients with polycystic ovary syndrome.\u003c/p\u003e\n\u003cp\u003eCurrently, basic studies and META analyses exist on applying TCM in PCOS. However, fewer high-quality clinical observation protocols and no published articles compare the advantages of the two treatments of TCM and buried threads and the efficacy of their combined treatments. Thus, this study will look at the advantages of implementing individualised life management for patients with PCOS through a combination of randomised clinical trials and observational cohort studies. It will also study the safety, efficacy, and long-term efficacy of herbal medicine and buried threads in PCOS.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial procedure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe entire trial consists of a screening/baseline period (weeks -2 and 0), a 3-month treatment period (weeks 4 - 12) and a 3-month follow-up period (weeks 16 - 24) (Figure 1). Assessments will be performed at baseline, weeks 4, 8 and 12 of treatment and weeks 16, 20 and 24 of follow-up. Sex hormone and ultrasound examinations will be performed at baseline, week 12 of treatment and week 24 of follow-up. The flow chart and study design schedule are shown in Figure 1 and Table 1, respectively.\u003c/p\u003e\n\u003cp\u003ePotential participants will be invited to participate in an initial assessment (first visit), including screening for inclusion and exclusion criteria. If eligible, participants will sign informed consent, record sex hormone and ultrasound results , and will be assessed with the Polycystic Awareness 20, Practice Scale, PCOSQ-50 Polycystic Quality of Life Score, SF-36 Health Status, Menstruation, Hirsutism, and Acne Scale, Dietary Ffq168, EAT-26 scales, \u0026nbsp;IPAQ-SF Exercise Scale, the Sleep Assessment Pittsburgh Sleep Scale, Anxiety and Depression Assessment HADS Scale, and other assessments (the above scales are professionally translated by English Level 6, and are all internationally accepted scales).\u003c/p\u003e\n\u003cp\u003eIt was divided into an observational control cohort and a renal-supplementation and blood-stasis-restoration cohort based on whether or not they were exposed to the treatment of tonifying the kidneys, resolving blood stasis, and promoting collaterals.\u003c/p\u003e\n\u003cp\u003eThe observational cohort consisted of individualised life management and basic western medical treatment, and was followed up for 6 months.\u003c/p\u003e\n\u003cp\u003eThe renal-supplementation and blood-stasis-restoration cohort was included was randomly divided by the method of randomised numerical table and was divided into A group\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKidney tonifying and stasis removing herbal medicine group,B group Burying threads under ultrasound for tonifying the kidney and resolving stasis in the muscles and bones, and C group Kidney tonifying and blood stasis removing traditional Chinese medicine combined with burying the thread group.\u003c/p\u003e\n\u003cp\u003eGroup A:the traditional Chinese medicine for tonifying the kidney and resolving blood stasis was decocted with water, 200ml of the medicine was taken warm in the morning and evening, the medicine was taken for 3 consecutive courses of treatment (1 course of treatment for 1 menstrual cycle), and the medicine was discontinued during the menstruation period, and the follow-up period was 3 months.\u003c/p\u003e\n\u003cp\u003eGroup B:group tonifying the kidney and resolving blood stasis in the muscle and bones under ultrasound buried thread group 14 days 1 time, treatment for 3 months,and the follow-up period was 3 months.\u003c/p\u003e\n\u003cp\u003eGroup C:Group A+Group B: the time of taking medicine and burying thread is the same as the above two groups. The treatment period of the treatment cohort was 3 months, and the follow-up period was 3 months.\u003c/p\u003e\n\u003cp\u003eMain results: (1)Pre- and post-treatment improvement of menstruation in PCOS patients;(2)Determination of the efficacy of Chinese medicine symptoms;Secondary results:Sex hormones, AMH(anti-M\u0026uuml;llerianhormone), ultrasound; changes in scores on the remaining scales such as polycystic cognition, PCOSQ-50 score, menstruation, hirsutism, Ffq168, IPAQ-SFHADS, etc., were reviewed at week 12 after discontinuation of medication and week 24 of follow up.Fasting insulin, glycaemia, lipids, liver and renal function were reviewed for the presence of metabolic problems, and follow up on the pregnancy rate and the incidence of spontaneous abortions was carried out.\u003c/p\u003e\n\u003cp\u003eThe medication (basic western medicine, traditional Chinese medicine), ultrasound acupuncture points and depth、safety observations will be recorded throughout the treatment process. All assessments（assessed with the Polycystic Awareness 20, Practice Scale, PCOSQ-50 Polycystic Quality of Life Score, SF-36 Health Status, Menstruation, Hirsutism, and Acne Scale, Dietary Ffq168, and EAT-26 scales,t IPAQ-SF Exercise Scale,Pittsburgh Sleep Scale, HADS Scale and other assessments）will be followed up and evaluated at baseline and at weeks 4, 8 and 12 after the start of the intervention and at weeks 16, 20 and 24 after the end of the intervention through questionnaires distributed by redcap.sex hormone and ultrasound results recorded on the baseline, weeks12 of treatment and weeks 24 of follow-up.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1. Participant schedule\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"602\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.58139534883721%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eStage\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.119601328903654%\" valign=\"top\"\u003e\n \u003cp\u003eScreening/baseline period\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"29.235880398671096%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eTreatment period\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"31.06312292358804%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003efollow-up period\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eVisits\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003eOne\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003etwo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003ethree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003efour\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003eFive\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003esix\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003eseven\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.833333333333334%\" valign=\"top\"\u003e\n \u003cp\u003eTime (weeks)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"15.833333333333334%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eBased on the practice of accomplishing the goals set by the patient\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003eWeek -2~0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003eWeek4\u0026plusmn; 7days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003eWeek8\u0026plusmn; 7days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003eWeek12\u0026plusmn; 7days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003eWeek16\u0026plusmn; 7days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003eWeek20\u0026plusmn; 7days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003eWeek24\u0026plusmn; 7days\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eSign the informed consent form\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eInclusion/exclusion criteria\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eDemographic information (family,menstruation,maternity, travel)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eMulticapsular cognition, practice scales, goal setting and completion\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"13.810316139767055%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eCurrent problem scale assessment: menstrual scale, hirsutism, acne, etc.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.980033277870216%\" rowspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003eThis part of the scale is based on whether the patient has\u003c/p\u003e\n \u003cp\u003eproblems and the need to solve them\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.143094841930116%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.98169717138103%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.316139767054908%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.820299500831947%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.480865224625624%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.484193011647255%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.983361064891847%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"15.689981096408317%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eDiet (category/EAT26/168 frequency)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.068052930056712%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.476370510396976%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.720226843100189%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.88468809073724%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.043478260869565%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.775047258979207%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.342155009451796%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"15.689981096408317%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eExercise (International Scale of Exercise)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.068052930056712%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.476370510396976%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.720226843100189%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.88468809073724%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.043478260869565%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.775047258979207%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.342155009451796%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"15.689981096408317%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eSleep (Pittsburgh Sleepiness Scale)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.068052930056712%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.476370510396976%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.720226843100189%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.88468809073724%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.043478260869565%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.775047258979207%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.342155009451796%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"15.689981096408317%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eEmotion (Anxiety Depression Scale)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.068052930056712%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.476370510396976%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.720226843100189%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.88468809073724%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.043478260869565%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.775047258979207%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.342155009451796%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eSex hormones\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eUltrasound\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"10%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003eAdverse events, safety evaluation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"15.666666666666666%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003eThis part of the scale is completed based on whether the patient has\u003c/p\u003e\n \u003cp\u003eproblems\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eResearch Completion\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eResearcher Review\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.666666666666668%\" colspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eReview by the person in charge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.166666666666666%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.333333333333334%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.833333333333333%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.5%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10%\" valign=\"top\"\u003e\n \u003cp\u003eX\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eNote: In this table, \u0026quot;X\u0026quot; represents the items that must be completed; \u0026quot;X\u0026quot; represents the items that need to be completed for individualized patient requirements\u003c/p\u003e\n\u003cp\u003e[insert Table 1]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants recruit from outpatient gynaecology, endocrinology, and TCM clinics at Shaanxi Provincial Hospital of Traditional Chinese Medicine and the First Affiliated Hospital of Xi\u0026apos;an Jiaotong University. In addition, posters, newspapers, and online advertisements were used for recruitment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiagnostic indicators\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. Adopt the diagnostic criteria in the Chinese Diagnostic and Treatment Guidelines for PCOS formulated by the Endocrinology Group of the Obstetrics and Gynaecology Section of the Chinese Medical Association and guideline experts in 2018[13]:\u003c/p\u003e\n\u003cp\u003e(1) Scarce menstruation, amenorrhea, or irregular uterine bleeding;\u003c/p\u003e\n\u003cp\u003e(2) Clinical manifestations of hyperandrogenism or hyperandrogenemia;\u003c/p\u003e\n\u003cp\u003e(3) Polycystic ovaries on ultrasound (\u0026ge;12 follicles with a diameter of 2-9 mm and/or an ovarian volume of \u0026ge;10 ml in one or both ovaries on ultrasound).\u003c/p\u003e\n\u003cp\u003eOf the above 3 conditions, (1) is necessary, (2) and (3) have 1 or more. Other diseases that may cause hyperandrogenism and ovulation abnormalities are ruled out one by one before the diagnosis of PCOS is made.\u003c/p\u003e\n\u003cp\u003e1.1 Judgment criteria for scanty menstruation, amenorrhoea, and irregular bleeding:\u003c/p\u003e\n\u003cp\u003eRegarding the relevant contents of the 9th edition of the textbook Obstetrics and Gynaecology, edited by Xie Xing, Kong Beihua, and Duan Tao, the criteria are formulated as follows[14]:\u003c/p\u003e\n\u003cp\u003e(1) Scarcity of menstruation: the menstrual cycle is 35 days-6 months;\u003c/p\u003e\n\u003cp\u003e(2) Secondary amenorrhoea: cessation of menstruation for more than 6 months after the\u003c/p\u003e\n\u003cp\u003eestablishment of normal menstruation or for more than 3 cycles according to one\u0026apos;s original menstrual cycle.\u003c/p\u003e\n\u003cp\u003e1.2 Refer to the guidelines of integrated Chinese and Western medicine for the diagnosis and treatment of abnormal uterine bleeding with ovulatory disorders[15]: Irregular bleeding: irregular menstruation, menstrual cycle, menstrual period, frequency, and amount of menstruation can be abnormal. Determination of ovulation disorder: basal body temperature (BBT), monophasic suggests anovulation, biphasic suggests ovulation; or blood test for progesterone 5-7 days before menstruation, less than 15\u0026mu;g/L suggests ovulation disorder.\u003c/p\u003e\n\u003cp\u003e2. Chinese medicine diagnosis and identification criteria:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(1) Formulate the Chinese evidence score with reference to the Quantitative Table of Symptom Grading of the Guiding Principles for Clinical Research of New Chinese Medicines for Malefactors;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(2) China Traditional Chinese Medicine Press, Chinese Medicine and Gynaecology, 6th edition textbook, Zhang Yuzhen, Science of Traditional Chinese Medicine. Beijing: China Press of Traditional Chinese Medicine, 2002.9 The identification criteria of kidney deficiency and blood stasis in PCOS, primary symptoms: disorders of the menstrual cycle (menstruation at the beginning, at the end, or irregular intervals), menstruation stopping and shutting down. Secondary symptoms: (1) lumbosacral pain; (2) cold pain in the abdomen, especially during menstruation; (3) distension and pain in the lesser abdomen; (4) lack of warmth in the hands and feet; (5) dull tongue or petechiae; (6) fine stringy pulse.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(1) Compliance with the above Western medical diagnostic criteria: the diagnostic criteria in the Chinese Diagnostic and Treatment Guidelines for Polycystic Ovary Syndrome[13]\u0026nbsp;developed by the Endocrinology Group of the Obstetrics and Gynaecology Section of the Chinese Medical Association and the Guidelines Expert Group in 2018 were adopted:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(2) Complying with the diagnostic criteria of TCM, identifying the type of kidney deficiency and blood stasis, primary symptoms: menstrual cycle disorders (menstrual cycle at the beginning, at the end, or irregular intervals), menstrual shutdown. Secondary symptoms: (1) lumbosacral pain; (2) cold pain in the abdomen, especially during menstruation; (3) distension and pain in the abdomen; (4) lack of warmth in the hands and feet; (5) dull tongue or petechiae; (6) fine stringy pulse.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(3) Be 18-45 years old.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(4) Understand the nature and purpose of the study, be willing to participate, cooperate with follow-up, examination, and treatment, and sign the informed consent form.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(1) Those with menstrual irregularities caused by congenital or acquired organic lesions of the reproductive organs;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(2) The presence of endocrine diseases similar to PCOS, such as hyperprolactinaemia, thyroid disease, Cushing\u0026apos;s syndrome, atypical congenital adrenal hyperplasia, tumours of the ovaries or adrenal glands that release testosterone, functional hypothalamic amenorrhea, and early-onset ovarian insufficiency;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(3) Excluding patients with uterine bleeding caused by pregnancy, coagulation disorders, endometrial polyps and local anomalies, adenomyosis, fibroids, endometrial malignancy and atypical hyperplasia;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(4) Patients with combined serious heart, liver, kidney, blood, oncological system, and other primary diseases; patients with severe anaemia requiring blood transfusion; and patients with mental illness;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(5) Those who have taken hormone drugs or drugs affecting sex hormones, blood sugar, insulin, lipid metabolism, etc. in the past 3 months.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(6) Those who are allergic to proteins and those who have broken or ulcerated skin at the site of the proposed buried thread to affect the operation;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e(7) Those who participate in other clinical studies simultaneously affect the results of this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eKidney tonifying and stasis removing cohort\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eA:\u0026nbsp;\u003c/strong\u003eKidney tonifying and stasis removing herbal medicine group: herbal medicine provided by the herbal pharmacy of Shaanxi Provincial Hospital of Traditional Chinese Medicine and the First Affiliated Hospital of Xi\u0026apos;an Jiaotong University Formula for tonifying the kidneys and eliminating stasis: Rehmanniae radix praeparata (Shoudihuang)15g, Angelicae sinensis radix(Danggui)15g,\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePaeoniae Radix Alba (Baishao)15g, Poria(Fuling)15g, Cortex Moutan(Mudanpi)15g, Epimedium brevicornu（Yinyanghuo）15g, Salvia miltiorrhiza(Danshen)15g, Achyranthis bidentatae radix (Niuxi)15g, Leonurus japonicus (Yimucao)15g, Rhizoma Cyperi(Xiangfu)15g. Dosage: 400ml of Chinese herbal medicines in water, 1 dose daily, 200ml in the morning and 200ml in the evening, warm, 3 consecutive courses of treatment (1 menstrual cycle is 1 course of treatment), stop the medicine during menstruation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eB:\u0026nbsp;\u003c/strong\u003eBurying threads under ultrasound for tonifying the kidney and resolving stasis in the muscles and bones:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePreparatory equipment: absorbable surgical suture, collagen material, specification 4-0-2cm (Shandong Boda Medical Supplies Co.Ltd.), needle with sterile disposable injection needle, specification: 0.7*30TWLB (Jiangsu Suyun Medical Instrument Co.Ltd.), aseptic medication change kit (Zhende Medical), medical infusion bottle mouth sticker specification: 28mm*16mm (Yangzhou Fleury Biotechnology Co.Ltd.). Medical Infusion Vial Paste Specification: 28mm*16mm (Yangzhou Fleury Biotechnology Co. Ltd.)\u003c/p\u003e\n\u003cp\u003eSelection of acupuncture points (tonifying the kidney, eliminating blood stasis, and promoting circulation): BL23 (bilateral), EX-CA1 (bilateral), uterus(bilateral), RN4, SP10 (bilateral), ST36 (bilateral), SP6 (bilateral), ST25 (bilateral).\u003c/p\u003e\n\u003cp\u003eAfter the patient emptied the bladder, according to the location of the acupoints, the patient was placed in the position (supine/post-prone) to perform the acupoint burrowing. Specific operation process: open the single-use sterile dressing change bag, disinfect both hands with sterile gloves, local disinfection of acupoints, ultrasonographers using Neusoft N7 ultrasound equipment, select C2-5 ultrasound probe, set the frequency of 1.5Hz, respectively, aligned with the selected acupoints, acupuncturist use cotton swabs to wipe off excess coupling agent on the skin surface at the acupoints and disinfect the skin with iodine povidone, iodine swabs to disinfect the acupoints from the inside to the outside twice, hold the disposable No.5 buried needle in the left hand, hold sterile tweezers with the right hand to clip and put absorbable surgical suture into the buried sterile injecting needles, and then send the collagen threads into the acupoints and leave it behind under the ultrasound guidance of the acupuncturist with at least 5 years of experience, and then withdraw the sterile injecting needles. This procedure was done 1 time per 14 days, with an overall treatment for 3 months. The needle was withdrawn, and the acupuncture point was fixed with a disposable infusion bottle mouth sticker.14 Treatment was once a day for 3 months.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eC\u003c/strong\u003e: Kidney tonifying and blood stasis removing traditional Chinese medicine combined with burying the thread group: the above two groups of programmes were combined, taking medication and burying the thread time treatment and operation as the above two groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eControl group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIndividualised life management: according to the patient\u0026apos;s polycystic treatment goal, multidisciplinary doctors made a joint decision to formulate a plan based on the patient\u0026apos;s current problems and needs, self-set goals, acceptable plan, willingness to accept feedback and communication frequency, combined with the patient\u0026apos;s previous examination, combined with the guidelines, and high-quality meta-analysis for the correction of the plan. Communicate and develop a detailed individualised management plan with the patient.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNecessary basic western medicine includes: 1. adjustment of menstrual cycle, 2. treatment of hyperandrogenism, 3. metabolic adjustment, 4. induction of ovulation, 5. in vitro fertilisation-embryo transfer, etc.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this study, previous studies[18], and our observational study, we chose the changes in menstrual evidence points of the three treatment groups of buried threads, traditional Chinese medicine, and buried threads combined with traditional Chinese medicine, with a test level of \u0026alpha;=0.05 (bilateral) and a test efficacy of 1-\u0026beta;=0.9. The sample size of the three groups was calculated to require a total sample size of 93 cases by the PASS 15 software. The randomised controlled sample size was about 117 cases, considering a lapse rate of 20%.\u003c/p\u003e\n\u003cp\u003eAccording to the sample size estimation formula of the cohort study, taking into account the dropout rate of 20%, the total sample size of this study is about 316 cases.\u003c/p\u003e"},{"header":"Outcomes","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eMain outcome indicators\u003c/h2\u003e \u003cp\u003e(1)Pre- and post-treatment improvement of menstruation in PCOS patients,Referring to the Guiding Principles for Clinical Research of New Chinese Medicines in the evidence ratings.Evaluation in terms of menstrual cycle, menstrual flow, menstrual period with a maximum score of 18 points; the more severe the symptoms, the higher the score ;\u003c/p\u003e \u003cp\u003e(2) Determination of the efficacy of Chinese medicine symptoms: Referring to the Guiding Principles for the Clinical Research of New Chinese Medicines issued by the State Drug Administration in 2002 (trial version), the efficacy index was calculated according to the points of Chinese medicine symptoms before and after the treatment (evaluating in terms of the menstrual cycle, menstrual volume, the colour of menstruation, dark red tongue, and dull and astringent pulse, with a maximum score of 56 points; the more severe the symptoms, the higher the score), and the formula (Nimodipine method) was as follows: efficacy index (n) = (treatment period). The formula (Nimodipine method) is efficacy index (n) = (pre-treatment symptom score - post-treatment symptom score) / pre-treatment symptom score X 100%.\u003c/p\u003e \u003cp\u003eSymptoms basically disappeared, n\u0026thinsp;\u0026gt;\u0026thinsp;95%; apparent effect:\u003c/p\u003e \u003cp\u003eSymptoms are significantly reduced after treatment, 95%\u0026thinsp;\u0026gt;\u0026thinsp;n\u0026thinsp;\u0026gt;\u0026thinsp;70%;\u003c/p\u003e \u003cp\u003eEffective: reduction of symptoms after treatment, 70%\u0026thinsp;\u0026gt;\u0026thinsp;n\u0026thinsp;\u0026gt;\u0026thinsp;30%;\u003c/p\u003e \u003cp\u003eIneffective: no reduction or aggravation of symptoms after treatment, n\u0026thinsp;\u0026lt;\u0026thinsp;30%.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eSecondary outcome indicators\u003c/h2\u003e \u003cp\u003eSex hormones, AMH(anti-M\u0026uuml;llerianhormone), ultrasound; changes in scores on the remaining scales such as polycystic cognition, PCOSQ-50 score, menstruation, hirsutism, Ffq168, IPAQ-SFHADS, etc., were reviewed at week 12 after discontinuation of medication and week 24 of follow up. Fasting insulin, glycaemia, lipids, liver, and renal function were reviewed for the presence of metabolic problems, and follow-up on the pregnancy rate and the incidence of spontaneous abortions was carried out.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eSafety Observations\u003c/h2\u003e \u003cp\u003eSubjects were analysed once a month during the trial for the occurrence of the primary target endpoint event completion during the treatment period. Attention was paid to the presence or absence of adverse reactions, such as allergy, needle sickness, fever, haemorrhage, infection, etc.\u003c/p\u003e \u003cp\u003eDetailed records were kept of the time of occurrence and disappearance, clinical symptoms, duration, treatment measures of the adverse reactions to evaluate their safety further and determine whether to continue the treatment.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003egrade\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003edegree of safety\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eadverse reaction\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSecurity Indicators\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eprocess\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade Ⅰ\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003esafe\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003enone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003enone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eNo treatment required. Continue treatment\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade Ⅱ\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecomparatively safe\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLight\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003enone\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eNo treatment required, can be treated\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade Ⅲ\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ehave a security problem\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMedium\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003emild abnormality\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCan continue treatment after symptomatic treatment\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGrade Ⅳ\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eA serious security problem\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eHeavy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003esignificant abnormality\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eEnd of study\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eWithdrawal/discontinuation of test indicator\u003c/h2\u003e \u003cp\u003eSudden onset of heavy uterine or vaginal bleeding requiring urgent surgical or transfusion treatment;\u003c/p\u003e \u003cp\u003eImmediate termination of the trial if pregnancy, sudden onset of other serious illness, or accident is established;\u003c/p\u003e \u003cp\u003eRecord details of serious adverse events/reactions in subjects where the investigator deems it necessary to terminate the trial;\u003c/p\u003e \u003cp\u003eSubjects should try to complete the following items when withdrawing from the study during the follow-up phase of treatment: safety items such as the three major routine, liver and kidney function, and electrocardiogram; and perform efficacy index scores;\u003c/p\u003e \u003cp\u003eRecord the occurrence of adverse endpoint events: spontaneous abortion, haemorrhage, etc.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eData management and quality control\u003c/h2\u003e \u003cp\u003eThe trial protocol discussed by gynaecology, endocrinology, acupuncture, Chinese medicine, ultrasound nutrition and reproductive medicine specialists. All staff were aware of the specifics study protocol, study procedures before starting this study.\u003c/p\u003e \u003cp\u003e Data will be stored and managed following Chinese ethical guidelines. REDCap will be used for questionnaire distribution, communication with experts, and outcome data collection. Chinese medicines were prescribed by Chinese medicine practitioners with at least 5 years of clinical experience.The acupuncture therapists with more than 5 years of qualification in acupuncture and moxibustion at the First Affiliated Hospital of Xi'an Jiaotong University carried the burying threads under the guidance of ultrasound.\u003c/p\u003e \u003cp\u003eConfidentiality of participants' data,and it will not be possible to identify specific individuals in the published results.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analyses\u003c/h2\u003e \u003cp\u003eSPSS 20.0 (SPSS Inc. China) was used for statistical analysis. (1) Measurement data: Mean earth standard deviation was used for statistical description, and a normality test was conducted first. If it conformed to a normal distribution, a paired samples t-test was used. If it did not conform to normal distribution, a non-parametric test was used, and hypothesis tests were all based on the criterion of P\u0026lt;0.05 as statistically significant; (2) Counting data: Statistical descriptions using frequencies, percentages, and composition ratios. Reasons for poor life management outcomes will be analysed using linear, logistic, Cox proportional risk, etc., to assess individualized life management's advantages and favourable factors.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis is a clinical study of the advantages and favourable factors of individualised life management of PCOS, the safety, efficacy, and long-term efficacy of CHM and acupuncture point burrowing treatment. Currently, the efficacy of life management of PCOS is poor, and multidisciplinary (gynaecological, psychological, nutritional, etc.) studies[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e][\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]have found that there is a lack of individualized protocols and guidance for polycystic patients. At the same time, both the patient and the physician advocate for the achievement of individualized management[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e][\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e][\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The present study provides high-quality support for the advantages and factors conducive to the individualized life management of PCOS. Compared with previous studies, there are fewer high-quality clinical studies on TCM, and this study will provide information on the efficacy of ultrasound-under-embedded threads, TCM compounding, and the combination of the two.\u003c/p\u003e \u003cp\u003eThe efficacy of kidney tonifying and blood-activating herbs[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e][\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e][\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e][\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e][\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e][\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e][\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] and buried thread treatment[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e][\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e][\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] in improving PCOS is certain, feasible and safe. The PI3K/AKT/mTOR signaling pathway was activated in PCOS-IR rats,by Chinese medicine with blood activation Gui Zhi Fu Ling Wan[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]relieved ovulation dysfunction. Natural remedy for kidney tonicity in a mouse model of chronic stress PCOS disease[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]decreased granulosa cell apoptosis through the PERK-ATF4-CHOP signaling pathway. The herbal kidney tonic BSTJF[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]effectively reduced the pathophysiology of PCOS by enhancing glucose metabolism and oxidative stress via mitochondrial SIRT3 and the insulin signaling system.The kidney tonifying and resolving formula[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]was associated with reduced serum LPS and TLR4 expression levels, which inhibited the activation of NF-κB signalling-mediated inflammatory response in ovarian tissues and improved PCOS. A meta-analysis also found that acupuncture medication was more effective than Western medication in terms of ovulation rate and pregnancy rate, with ovulation rate of acupoint burrowing combined with medication (93.3%) and pregnancy rate of acupuncture burrowing treatment and medication ( 69.4%)[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Moreover, Furthermore, the necessary acupoints of Sanyinjiao (SP6), Guanyuan (CV4), Zusanli (ST36), Pishu (BL20), Shenshu (BL23), Zigong (EX-CA1) and other locations have an effect similar to that of estrogen, which may be significant and influence the p38MAPK signaling pathway[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. In rats treated with DHEA to simulate PCOS, acupuncture may enhance ovarian shape and function[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The mutant sex hormone receptor genes are improved by electroacupuncture at the acupoints of Zusanli (ST36), Sanyinjiao (SP6), and Neiguan (PC6).Furthermore, it improves glucose intolerance and insulin intolerance[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePharmacognosy: \"Radix Rehmanniae has the properties of tranquillising the five viscera, harmonising the blood vessels, nourishing the true yin, and sealing and filling the bone marrow[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. It also has multiple pharmacological actions, such as hemostasis, antioxidation, anti-osteoporosis, lowering blood sugar, anti-inflammation, antidepression, and anti-anxiety[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Jingyue quanquan - Ben cao zheng: \"Angelica sinensis has a sweet and heavy flavour that can tonify blood and light and pungent qi that can move blood[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u0026rdquo; Danggui contains β-magnetene, α-pinene, camphene, and other components, which have the effect of excitation of uterine smooth muscle and improvement of immune blood flow[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Danggui (Angelicae Sinensis Radix) had a beneficial effect on a rat with PCOS, and the underlying mechanism was partly related to the JAK2/STAT3 signaling pathway mediated by interleukin-6[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Moreover, poria enters the kidney meridian and can be used as a meridian-inducing agent or combined with kidney tonic drugs to help the kidneys generate yin. The active ingredients in Poria are mainly Poria triterpenes and Poria polysaccharides[\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Fuling formulae plus hypoglycaemic agents can further reduce FGB, 2hPG, HbA1c, TG, LDL, FINs, and IR levels and have a potential effect on the improvement of the inflammatory response of PCOS, combined with pancreatic island resistance, hyperlipidaemia, and other conditions[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] Mudanpi has the function of clearing heat and cooling blood, activating blood circulation, and removing blood stasis, and modern pharmacological studies have concluded that it has antibacterial and anti-inflammatory, immunomodulatory, hypoglycemic, antithrombotic, and antioxidant damage effects[\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e] White peony has the efficacy of nourishing blood and regulating menstruation. The chemical composition of white peony has glycosides, triterpenoids, flavonoids, etc, which have the efficacy of improving metabolism and immunity[\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. Szechuan hyssop enters the blood division and is good at descending; it can activate blood circulation, dispel blood stasis, and regulate menstruation. It is used for women with menstrual closure and irregular menstruation. Hyssop contains triterpenoids, steroids, and polysaccharides, and it has the effect of excitation of the uterus and improvement of fertility[\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. Xiangsui can disperse gas and depression, gas sparse depression dispersal, then the new blood and the body and carry on.\" The \"Compendium of Materia Medica\" said it \"is the gas disease of the General Secretary, the female section of the commander-in-chief also.\" Chongqing Hall Essentials: \"Salvia divinorum, descending and line blood, blood heat and stagnation of the appropriate, so for the regulation of menstruation and postpartum to be medicine[\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e].\" Modern studies have shown that Salvia miltiorrhiza has an important effect on polycystic reproduction and metabolism[\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. Yinyanghuo, warm in nature, pungent, and sweet in flavour, is good at tonifying the kidney and strengthening the yuan-yang[\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e].Yinyanghuo plays immune inflammation regulatory and sex hormone regulatory roles in infertility treatment[\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. The Materia Medica Seeking Truth, Yun Yi Mu Cao, \"promotes blood circulation, dispels blood stasis and generates new blood, regulates menstruation and removes toxins, and is an important agent for the prenatal and postpartum periods[\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e].\" The chemical composition mainly contains motherwort alkaloids, which have the effects of uterine excitation, improving immunity, anticoagulation, and lipid regulation[\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e]. Modern pharmacology of the above drugs has shown that they improve uterine and ovarian function, immunity, and metabolism. The Chinese medicine compound selected for this study can tonify kidney essence[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e][\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e], regulate yin and yang, qi and blood[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] and the function of each organ, and expel disease and stasis[\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e], thus improving the imbalance of yin and yang and dysfunction of internal organs, so that the metabolism of qi, blood, and fluids is normal. Furthermore, menstruation is restored[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e][\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e], and the polycystic symptom[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e][\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e][\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e][\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]is improved.\u003c/p\u003e \u003cp\u003eProblems faced by the acupuncture point buried thread treatment: 1. lack of accuracy of the buried thread points, buried thread depth is too shallow fat liquefaction, 2. touching blood vessels when burying the thread, there may be subcutaneous bleeding, and so on. Therefore, the programme will be under the ultrasonic positioning of muscle and bone-buried wire treatment. With this technique, you can see the acupoints buried wire level, observe the buried wire needle position, depth, and adjacent activities of the tissue structure, and accurately show the needle and blood vessels, nerves, tissues, and the interrelationship between the timely adjustment of the direction and angle, and avoid damage to the important internal organs and tissues. To achieve the visualization of the needle and implantation of the wire body material, a clear gas, and the needle level relationship are needed to improve the accuracy of minimally invasive buried wire implantation. Minimally invasive buried thread implantation level of accuracy and enhanced clinical efficacy[\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e][\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e][\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. Acupuncture point buried thread procedures are easy to use, safe, and can shorten patient visits while increasing patient compliance.[\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e][\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. Therefore, based on previous work and literature[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e][\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e][\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e][\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e][\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e][\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e][\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e][\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e], the above acupoints were selected for the buried thread treatment.\u003c/p\u003e \u003cp\u003eREDCap is the largest online trial database system for clinica research. In addition to all the advantages of EDC, REDCap also has the advantages and features of being free of charge, secure with restricted user access, easy to follow up with regular emails or SMS, the ability to design electronic case report forms, data entry, external data import, and electronic signatures for informed consent to satisfy the requirements of data management and quality assurance. This trial was a multicentre, prospective, cohort study, and the use of Redcap in the management of polycystic patients provides high-quality evidence to evaluate the safety, efficacy, and long-term efficacy of individualised life management, CHM, and acupoint acupuncture for the treatment of polycystic ovary syndrome.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003epolycystic ovary syndrome (PCOS)\u0026nbsp;,Chinese herbal medicine(CHM),AMH\u003c/p\u003e\n\u003cp\u003e(anti-M\u0026uuml;llerianhormone);basal body temperature (BBT) ;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics and Dissemination:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNeither the full paper nor parts of it have been submitted or published elsewhere.\u003c/p\u003e\n\u003cp\u003ePapers will not be submitted elsewhere until the journal\u0026apos;s editorial process is complete.\u003c/p\u003e\n\u003cp\u003eThe study protocol was reviewed and approved by the Ethics Committee of Shaanxi Provincial Hospital of Traditional Chinese Medicine and complied with the ethical standards for medical research involving human subjects as set out in the 1964 Declaration of Helsinki and its subsequent amendments. Participants submitted informed consent before taking part in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA statement to confirm that all methods were carried out in accordance with relevant guidelines and regulations.This study was conducted in accordance with the requirements of the Declaration of Helsinki and approved by the Chinese Clinical Trial Institution Review Committee (registration number：ChiCTR2300073832)，All participant have signed informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConnect author RS,[email protected]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis project was supported by the Shaanxi Provincial Science and Technology Council Fund (Project No. 2023-YBSF-043).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eYHL conceived the study, initiated the design and revised the manuscript,RS\u0026nbsp;is responsible for drafted the Manuscript and\u0026nbsp;writing,Participant recruitment and data entry is provided byYHL,DYY,NL,KLJ, YX, HHZ, LQS, RS,Acupuncture treatments is administered by RS,Ultrasound observation is administered by HX;RW,RS\u0026nbsp;is responsible for inform consent and finished trail registration procedures and measures, LQS, YHL is responsible for outcome assessment and manuscript revision. All authors commented on and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThank you to each of the physicians for their contribution to patient inclusion and patient cooperation.\u003c/p\u003e\n\u003cp\u003eThe authors thank AiMi Academic Services (www.aimieditor.com) for English language editing and review services.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors of this manuscript are RS,DYY,NL,HX,YX, HHZ, who, are affiliated with Shaanxi Provincial Hospital of Traditional Chinese Medicine,KLJ, who are affiliated with The Second Affiliated Hospital, Air Force Medical University,YHL,LQS,RWis affiliated with the First Affiliated Hospital of Xi\u0026apos;an Jiaotong University.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eChoudhury AA, Rajeswari VD. Polycystic ovary syndrome (PCOS) increases the risk of subsequent gestational diabetes mellitus (GDM): A novel therapeutic perspective. Life Sci. 2022;310:121069. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.lfs.2022.121069\u003c/span\u003e\u003cspan address=\"10.1016/j.lfs.2022.121069\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Epub 2022 Oct 13. PMID: 36243118.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuan C, Zahid S, Minhas AS, et al. Polycystic ovary syndrome: a risk-enhancing factor for cardiovascular disease. Fertil Steril. 2022;117(5):924\u0026ndash;35. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.fertnstert.2022.03.009.PMID\u003c/span\u003e\u003cspan address=\"10.1016/j.fertnstert.2022.03.009.PMID\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoran LJ, Tan ZQ, Bayer S, et al. Perspectives of Allied Health Professionals on Implementation of the Lifestyle Polycystic Ovary Syndrome Guidelines: A Qualitative Study. J Acad Nutr Diet. 2022;122(7):1305\u0026ndash;16. Epub 2021 Nov 18. PMID: 34800697.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChhour I, Blackshaw L, Moran LJ, et al. Barriers and facilitators to the implementation of lifestyle management in polycystic ovary syndrome: Endocrinologists' and obstetricians and gynaecologists' perspectives. Patient Educ Couns. 2022;105(7):2292\u0026ndash;8. Epub 2021 Dec 23. PMID: 34980547.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTeede HJ, Tay CT, Laven J, et al. International PCOS Network. Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome. Fertil Steril. 2023;120(4):767\u0026ndash;93. Epub 2023 Aug 14. PMID: 37589624.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJi, Lin. Meta-analysis and prescription characteristics of tonifying the kidney and activating blood in the treatment of polycystic ovary syndrome [D]. Guangzhou University of Traditional Chinese Medicine(China); 2019.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDong, Yufang. Meta-analysis of traditional Chinese medicine in the treatment of polycystic ovary syndrome[D]. Gansu University of Traditional Chinese Medicine(China); 2020.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSong Y-J, Liang F-X, Wu S. Network meta-analysis on the effects of the acupuncture-related therapy on ovulation rate and pregnancy rate in patients with polycystic ovary syndrome[J]Zhongguo Zhen Jiu(China). 2019;39(7):792\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang F, Ma T, Tong X, et al. Electroacupuncture improves metabolic and ovarian function in a rat model of polycystic ovary syndrome by decreasing white adipose tissue, increasing brown adipose tissue, and modulating the gut microbiota. Acupunct Med. 2022;40(4):347\u0026ndash;59. Epub 2021 Dec 10. PMID: 34892981.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi J, Wu W. Elisabet Stener-Victorin,et al,A prospective pilot study of the effect of acupuncture on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance[J]. Acupunct Med. 2020;38(5):310\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZheng R, Qing P, Han M et al. The Effect of Acupuncture on Glucose Metabolism and Lipid Profiles in Patients with PCOS: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.[J]Evid Based Complement Alternat Med. 2021; 2021:5555028.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang HL, Huo ZJ, Wang HN, et al. Acupuncture ameliorates negative emotion in PCOS patients: a randomized controlled trial[. J] Zhongguo Zhen Jiu. 2020;40(4):385\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSong Y, Li R. Interpretation of Chinese diagnosis and treatment guidelines for polycystic ovary syndrome[J]. J practical Obstet gynaecology(China) 2018,34(10).737\u0026ndash;41.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXie Xing K, Beihua D, Tao C, Hongbo, associate, editors. Obstetrics and gynaecology 9th edition [M]. Beijing: People's Health Publishing House(China), 2018.07.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eObstetrics and Gynaecology Committee of the Chinese Society of Integrative Medicine. Guidelines for combined Chinese and Western medicine diagnosis and treatment of abnormal uterine bleeding in ovulatory disorders[J],Chinese. J Integr Medicine(China). 2020;40(04):391\u0026ndash;400.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChao-chao YU, Chao-yang MA,Yuan XIONG, et al. Effectiveness of acupoint catgut embedding therapy for polycystic ovary syndrome: a systematic review and meta-analysis,[J]World. J Acupuncture-Moxibustion. 2017;27(04):41\u0026ndash;51.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu M, Zhu H, Zhu Y, Hu X. Guizhi Fuling Wan reduces autophagy of granulosa cell in rats with polycystic ovary syndrome via restoring the PI3K/AKT/mTOR signaling pathway. J Ethnopharmacol. 2021;270:113821. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jep.2021.113821\u003c/span\u003e\u003cspan address=\"10.1016/j.jep.2021.113821\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePan X, Liu Y, Liu L, et al. Bushen Jieyu Tiaochong Formula reduces apoptosis of granulosa cells via the PERK-ATF4-CHOP signaling pathway in a rat model of polycystic ovary syndrome with chronic stress. J Ethnopharmacol. 2022;292:114923. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jep.2021.114923\u003c/span\u003e\u003cspan address=\"10.1016/j.jep.2021.114923\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang Q, Ren J, Wang F, et al. Chinese herbal medicine alleviates the pathogenesis of polycystic ovary syndrome by improving oxidative stress and glucose metabolism via mitochondrial Sirtuin 3 signaling. Phytomedicine. 2023;109:154556. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.phymed.2022.154556\u003c/span\u003e\u003cspan address=\"10.1016/j.phymed.2022.154556\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang Y, Xiao H, Liu Y, et al. Effects of Bu Shen Hua Zhuo formula on the LPS/TLR4 pathway and gut microbiota in rats with letrozole-induced polycystic ovary syndrome. Front Endocrinol (Lausanne). 2022;13:891297. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3389/fendo.2022.891297\u003c/span\u003e\u003cspan address=\"10.3389/fendo.2022.891297\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Published 2022 Aug 9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSong YJ, Liang FX, Wu S et al. [Network meta-analysis on the effects of the acupuncture-related therapy on ovulation rate and pregnancy rate in patients with polycystic ovary syndrome]. Zhongguo Zhen Jiu. 2019;39(7):792-8. Chinese. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.13703/j.0255-2930.2019.07.029\u003c/span\u003e\u003cspan address=\"10.13703/j.0255-2930.2019.07.029\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. PMID: 31286745.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang SC, Jiang YM, Qiu LR, Su M. Efficacy of needling acupoints of Guanyuan (CV4), Sanyinjiao (SP6), Zusanli (ST36), Pishu (BL20), Shenshu (BL23), Zigong (EX-CA1) on expression of p38 mitogen-activated protein kinase in ovarian tissue in rats with premature ovarian failure induced by cyclophosphamide. J Tradit Chin Med. 2021;41(6):953\u0026ndash;8. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.19852/j.cnki.jtcm.2021.06.012\u003c/span\u003e\u003cspan address=\"10.19852/j.cnki.jtcm.2021.06.012\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi D, Bai P, Wu JY, et al. Effect of Acupuncture on Ovary Morphology and Function in DHEA-Induced Polycystic Ovary Syndrome Model Rats. Chin J Integr Med. 2021;27(3):220\u0026ndash;4. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s11655-021-3290-0\u003c/span\u003e\u003cspan address=\"10.1007/s11655-021-3290-0\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJi C, Xu W, Zhang Z, Cui S, Yi W. Effect of Electroacupuncture on Reproductive Disorders and Insulin Resistance in a Murine Polycystic Ovary Syndrome Model. Evid Based Complement Alternat Med. 2021;2021:9968463. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1155/2021/9968463\u003c/span\u003e\u003cspan address=\"10.1155/2021/9968463\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Published 2021 Dec 26.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMing. Jia Shoxue; (Qing) Li Yanhua; Yang Jinping and others. Drugs chemical meaning [M]. Beijing: China Traditional Chinese Medicine; 2015. p. 01.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi M, Jiang H, Hao Y, et al. A systematic review on botany, processing, application, phytochemistry and pharmacological action of Radix Rehmnniae. J Ethnopharmacol. 2022;285:114820. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jep.2021.114820\u003c/span\u003e\u003cspan address=\"10.1016/j.jep.2021.114820\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Epub 2021 Nov 10. PMID: 34767834.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMing. Zhang Jingyue. Jingyue encyclopaedia series Materia Medica Zheng [M]. Beijing: China Medical Science and Technology; 2017. p. 09.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYanchun M, Jianhui H, Wenxuan W, et al. Progress in the study of chemical composition and pharmacological effects of Angelica sinensis[J]. J Traditional Chin Medicine(China). 2022;50(01):111\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGao Y, Lian YY, Huang XY. Protective effect of aqueous extract from angelica Sinensis on rats with polycystic ovary syndrome. Pharmacol Clin Chin Materia Med. 2021;37(02):69\u0026ndash;74.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXinyu ZHANG, Wei LIN, Shuyue LEI et al. Progress of pharmacological effects of Poria cocos polysaccharides and triterpenoids[J]. Shandong Chem Ind 2023,52(11):82\u0026ndash;5.\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.19319/j.cnki.issn.1008-021x.2023.11.003\u003c/span\u003e\u003cspan address=\"10.19319/j.cnki.issn.1008-021x.2023.11.003\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYang Peishu Z, Na. Poria pharmacological effects and research progress[J]. Inner Mongolia Traditional Chin Medicine(China). 2021;40(11):155\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhai Chunmei M, Xiangying F, Jingju et al. Progress of modern pharmacological research on peony bark[J]. Chin Med information(China) 2020,37(01):109\u0026ndash;14.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJiang H, Li J, Wang L, et al. Total glucosides of paeony: A review of its phytochemistry, role in autoimmune diseases, and mechanisms of action. J Ethnopharmacol. 2020;258:112913. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jep.2020.112913\u003c/span\u003e\u003cspan address=\"10.1016/j.jep.2020.112913\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVanadium LY, Wen O. Progress of research on the material basis and pharmacological activity of saponins and steroid ketones in Cow's Knee[J]. Chin Mod Traditional Chin Medicine(China). 2020;22(12):2122\u0026ndash;36.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e(Qing Dynasty). Wang Xuequan; Shi Renchao, Cai Dingfang. The Essays of Chongqing Hall [M]. Nanjing: Jiangsu Science and Technology; 1986. p. 12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShen W, Jin B, Han Y, et al. The Effects of Salvia miltiorrhiza on Reproduction and Metabolism in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2021;2021:9971403. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1155/2021/9971403\u003c/span\u003e\u003cspan address=\"10.1155/2021/9971403\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Published 2021 May 15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi LIL, Jiarui,WANG WANG, Jing et al. Progress of research on the main chemical constituents, pharmacological effects and predictive analysis of quality markers of Epimedium[J]. Chin J Traditional Chin Med 2023,41(11):143\u0026ndash;51.\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.13193/j.issn.1673-7717.2023.11.030\u003c/span\u003e\u003cspan address=\"10.13193/j.issn.1673-7717.2023.11.030\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXie L, Zhao S, Zhang X et al. Wenshenyang recipe treats infertility through hormonal regulation and inflammatory responses revealed by transcriptome analysis and network pharmacology. Front Pharmacol 2022 Aug 8;13:917544. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3389/fphar.2022.917544\u003c/span\u003e\u003cspan address=\"10.3389/fphar.2022.917544\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. PMID: 36003498; PMCID: PMC9393626.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e(qing) Huang Gongxiu; Wang Shumin. Materia Medica [M]. Beijing: China Press of Traditional Chinese Medicine, 1997.03.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang, Bin. Research on the pharmacological effects of motherwort and its clinical application progress in obstetrics and gynaecology diseases[J]. Hebei Traditional Chin Medicine(China). 2021;43(11):1933\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJingjing Q, Guizhen C, Xueyu W. Application and consideration of musculoskeletal ultrasound in acupoint embedding therapy[J]. Shanghai J Acupunct Moxibustion(China). 2020;39(10):1330\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHan Z, Li X, Liu Z et al. The study on the clinical effectiveness and safety of traditional Chinese medicine acupoint catgut embedding guided by musculoskeletal ultrasound in the treatment of nerve root sciatica: A protocol for systematic review and meta-analysis of randomized controlled trials.[J].Medicine (Baltimore). 2021,100(13):e25387.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYu B, Xuan L, Jin Y et al. Efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial.[J]Trials. 2021;22(1):755.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHuang Shouqiang X, Haiyan X, Jun. A systematic evaluation of the effectiveness of acupuncture in the treatment of infertility in polycystic ovary syndrome[J]. Chin J Evidence-Based Medicine(China). 2021;21(04):431\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCui SRi-liangL, Nan Y. Research progress of acupuncture treatment of polycystic ovary syndrome[J].Henan Traditional Chinese Medicine(China),2022,42(07), 1114\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJin XI, Hao CHEN. CHENG Jie,Quality evaluation of systematic evaluation of acupuncture for polycystic ovary syndrome[J]Chinese. J Evidence-Based Med (China) 2019,19(02)205\u0026ndash;11.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHongli ZHU, Xiaoyun ZHAO. RAO Long,Acupoint spectrum of acupuncture for polycystic ovary syndrome based on data mining[J]Western Traditional Chinese Medicine(China). 2020,33(05),123\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHuang M, Liu M, Gao SQ. Based on data mining to explore the selection law of acupoint embedding in the treatment of polycystic ovary syndrome,[J]World Chinese Medicine(China). 2020,15(17),2579\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChaochao YU, Guojin YAO. ZHOU Yilun,A study on the clinical selection pattern of acupuncture points for polycystic ovary syndrome[J],Acupuncture and Moxibustion Clinical Journal(China). 2016,32(11).73\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhou X, Fu QH, Pei J. Clinical efficacy of acupuncture point embedded thread in the treatment of polycystic ovary syndrome and quality evaluation of RCT report[J]. Chin Electron J Acupunct Moxibustion(China). 2020;9(04):159\u0026ndash;64.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Polycystic ovary syndrome, Embedding, Chinese herbal formula, Protocol, Cohort study","lastPublishedDoi":"10.21203/rs.3.rs-3896980/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3896980/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e: Polycystic ovary syndrome (PCOS) presents as a multi-complicated syndrome and increases the risk of other diseases. Life management is clinically ineffective as a first-line basic treatment for polycystic ovary syndrome. Acupuncture and Chinese herbal medicine (CHM) have excellent clinical efficacy for PCOS. however,there is currently a dearth of high-quality data demonstrating its efficacy.The purpose of this experiment is to assess the safety and efficacy, especially the long-term efficacy,of individualized life management、CHM, acupoint thread-embedding therapy for treating PCOS.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods and analysis\u003c/strong\u003e: We present a multicentre, prospective, combined randomised clinical trial and observational cohort study design, with a target sample size of 316 patients with PCOS of the kidney deficiency and blood stasis type aged between 18-45years. Patients were divided into an observational cohort with a renal supplementation and blood-stasis-restoration cohort based on whether or not they were exposed to the tonifying-kidney, resolving-blood stasis-and-tongue method. Based on the examination results, the observation cohort received individualised life management and appropriate pharmacological interventions and was followed up for 6 months. The kidney tonifying and resolving stasis through the channels cohort was randomly divided into A) Kidney tonifying and resolving stasis traditional Chinese medicine group, B) Kidney tonifying and resolving stasis buried under ultrasound in the musculoskeletal bone group, and C) Kidney tonifying and resolving stasis traditional Chinese medicine combined with burying group by the method of randomised numerical table based on the above. The kidney tonifying and resolving stasis through the channels cohort treatment cycle was 3 months, and the follow-up period was 3 months. Main results: (1) the change of menstrual of PCOS patients before and after treatment ; (2) the efficacy of traditional Chinese medicine symptoms. Secondary results: Sex hormones, AMH, ultrasound;changes in scores such as polycystic cognition,PCOSQ-50 score,menstruation,hirsutism,Ffq168,IPAQ-SFHADS etc.All assessments were followed up with redcap questionnaires at baseline at weeks 4, 8, and 12 after the start of the intervention and at weeks 16, 20, and 24 after the end of the intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration number\u003c/strong\u003e: (2023) Lun Shen No.41; Pre-results.The trial was launched on July 2023 through https://www.chictr.org.cn/ Registrationnumber:ChiCTR2300073832.\u003c/p\u003e","manuscriptTitle":"The \"tonifying the kidneys, resolving blood stasis and clearing collaterals\" method in polycystic ovary syndrome (PCOS) research: study protocol for a multicentre cohort study nested randomised controlled trials","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-02-06 17:11:00","doi":"10.21203/rs.3.rs-3896980/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e3252dde-3d35-46c5-aaef-c607cf0d9fc4","owner":[],"postedDate":"February 6th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-03-26T12:03:50+00:00","versionOfRecord":[],"versionCreatedAt":"2024-02-06 17:11:00","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3896980","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3896980","identity":"rs-3896980","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}