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      Clinical effects of Shou-Wu Jiang-Qi Decoction combined acupuncture on the treatment of Polycystic Ovarian Syndrome with kidney deficiency, phlegm and blood stasisness : Study protocol clinical trial (SPIRIT Compliant)

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          Abstract

          Background:

          Polycystic ovary syndrome (PCOS) is a female endocrine disease with a high incidence. At present, drug treatment is still the main therapeutic strategy for PCOS. Traditional Chinese medicine has a long history in the treatment of menstrual disorders. Shouwu Jiangqi Decoction (SWJQD) is a traditional herbal medicine prescribed in a clinical setting as a remedy for PCOS. Acupuncture also plays an important role in regulating the menstrual cycle and treating PCOS. This study aims to examine the efficacy and safety of the combination of SWJQD and acupuncture in the treatment of PCOS.

          Methods:

          This randomized controlled trial will be conducted with a total of 81 participants diagnosed with PCOS. The participants will be randomly divided into 3 treatment groups: group A will receive SWJQD combined with acupuncture; group B, SWJQD combined with sham acupuncture; and group C, metformin. Each treatment will last 3 months. The primary outcomes include the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index and the Oral Glucose Tolerance Test. The secondary outcome measures include sex hormone levels, body mass index, ovulation rate, clinical pregnancy rate, and complete genome sequencing data. Adverse events will be recorded during the intervention and follow-up.

          Results:

          This study will investigate whether the combination of SWJQD and acupuncture can alleviate the clinical symptoms and improve insulin resistance in patients with PCOS. The results of this study are expected to provide clinical evidence for the application of the combination of SWJQD and acupuncture in patients with PCOS.

          Trial registration:

          Chinese Clinical Trial Registry: ChiCTR1900028106, ChiMCT1900002826 (registered on December 12, 2019).

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          Most cited references 26

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          The Pathogenesis of Polycystic Ovary Syndrome (PCOS): The Hypothesis of PCOS as Functional Ovarian Hyperandrogenism Revisited.

           Robert Rosenfield (corresponding) ,  David A Ehrmann (2016)
          Polycystic ovary syndrome (PCOS) was hypothesized to result from functional ovarian hyperandrogenism (FOH) due to dysregulation of androgen secretion in 1989-1995. Subsequent studies have supported and amplified this hypothesis. When defined as otherwise unexplained hyperandrogenic oligoanovulation, two-thirds of PCOS cases have functionally typical FOH, characterized by 17-hydroxyprogesterone hyperresponsiveness to gonadotropin stimulation. Two-thirds of the remaining PCOS have FOH detectable by testosterone elevation after suppression of adrenal androgen production. About 3% of PCOS have a related isolated functional adrenal hyperandrogenism. The remaining PCOS cases are mild and lack evidence of steroid secretory abnormalities; most of these are obese, which we postulate to account for their atypical PCOS. Approximately half of normal women with polycystic ovarian morphology (PCOM) have subclinical FOH-related steroidogenic defects. Theca cells from polycystic ovaries of classic PCOS patients in long-term culture have an intrinsic steroidogenic dysregulation that can account for the steroidogenic abnormalities typical of FOH. These cells overexpress most steroidogenic enzymes, particularly cytochrome P450c17. Overexpression of a protein identified by genome-wide association screening, differentially expressed in normal and neoplastic development 1A.V2, in normal theca cells has reproduced this PCOS phenotype in vitro. A metabolic syndrome of obesity-related and/or intrinsic insulin resistance occurs in about half of PCOS patients, and the compensatory hyperinsulinism has tissue-selective effects, which include aggravation of hyperandrogenism. PCOS seems to arise as a complex trait that results from the interaction of diverse genetic and environmental factors. Heritable factors include PCOM, hyperandrogenemia, insulin resistance, and insulin secretory defects. Environmental factors include prenatal androgen exposure and poor fetal growth, whereas acquired obesity is a major postnatal factor. The variety of pathways involved and lack of a common thread attests to the multifactorial nature and heterogeneity of the syndrome. Further research into the fundamental basis of the disorder will be necessary to optimally correct androgen levels, ovulation, and metabolic homeostasis.
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            Women with polycystic ovary syndrome have intrinsic insulin resistance on euglycaemic-hyperinsulaemic clamp.

            What is the prevalence of insulin resistance (IR) and the contributions of intrinsic and extrinsic IR in women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria? We report novel clamp data in Rotterdam diagnosed PCOS women, using World Health Organization criteria for IR showing that women with PCOS have a high prevalence of IR, strengthening the evidence for an aetiological role of IR in both National Institutes of Health (NIH) and Rotterdam diagnosed PCOS in lean and overweight women. PCOS is a complex endocrine condition with a significant increased risk of gestational diabetes and type 2 diabetes. Using a cross-sectional study design, 20 overweight and 20 lean PCOS (Rotterdam criteria), 14 overweight and 19 lean body mass index (BMI)-matched control non-PCOS women underwent clinical measures of IR after a 3-month withdrawal of insulin sensitizers and the oral contraceptive pill. In an academic clinic setting, glucose infusion rate (GIR) on euglycaemic-hyperinsulinaemic clamp was investigated as a marker of insulin sensitivity. PCOS women were more IR than BMI-matched controls (main effect for BMI and PCOS; P < 0.001). IR was present in 75% of lean PCOS, 62% of overweight controls and 95% of overweight PCOS. Lean controls (mean ± SD; GIR 339 ± 76 mg min⁻¹ m⁻²) were less IR than lean PCOS (270 ± 66 mg min⁻¹ m⁻²), overweight controls (264 ± 66 mg min⁻¹ m⁻²) and overweight PCOS (175 ± 96 mg min⁻¹ m⁻²). The negative relationship between BMI and IR reflected by GIR was more marked in PCOS (y = 445.1 - 7.7x, R² = 0.42 (P < 0.0001) than controls (y = 435.5 - 4.6x, R² = 0.04 (P < 0.01)). The study did not use glucose tracer techniques to completely characterize the IR, as well as the lack of matching for body composition and age. IR is exacerbated by increased BMI, supporting intrinsic IR in PCOS. BMI impact on IR is greater in PCOS, than in controls, irrespective of visceral fat, prioritizing lifestyle intervention and the need for effective therapeutic interventions to address intrinsic IR and prevent diabetes in this high-risk population. This investigator-initiated trial was supported by grants from the National Health & Medical Research Council (NHMRC) Grant number 606553 (H.J.T., N.K.S. and S.K.H.) as well as Monash University and The Jean Hailes Foundation. H.J.T. is an NHMRC Research Fellow. N.K.S. is supported through the Australian Government's Collaborative Research Networks (CRN) programme. A.E.J. is a Jean Hailes and NHMRC scholarship holder. The authors declare that there is no conflict of interest associated with this manuscript.
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              Hirsutism: implications, etiology, and management.

              Hirsutism usually results from a subtle excess of androgens. As such, it is a clue to possible endocrine disturbance in addition to presenting cosmetic problems. We use the term hirsutism to mean male-pattern hirsutism--excessive growth of hair in areas where female subjects normally have considerably less than male subjects. An elevation of the plasma free (unbound) testosterone level is the single most consistent endocrinologic finding in hirsutism. The plasma free testosterone level is sometimes elevated when the total level of plasma testosterone is normal because testosterone-estradiol--binding globulin (TEBG) levels are often depressed in hirsute women. Frequent blood sampling is sometimes necessary to demonstrate subtle hyperandrogenic states since androgen levels in the blood are pulsatile and seemingly reflect episodic ovarian and adrenal secretion. The source of hyperandrogenemia can usually be determined from dexamethasone suppression testing. Those patients whose plasma free androgen levels do not suppress normally usually have functional ovarian hyperandrogenism (polycystic ovary syndrome variants). Very high plasma androgen levels or evidence of hypercortisolism, which is not normally suppressible by dexamethasone, should lead to the search for a tumor or Cushing's syndrome. Those patients in whom hyperandrogenemia is suppressed normally by dexamethasone have a form of the adrenogenital syndrome, a prolactinoma, obesity, or idiopathic hyperandrogenemia. In such patients, glucocorticoid therapy may reduce hirsutism and acne and normalize menses. The treatment of hirsutism resulting from functional ovarian hyperandrogenism is not as satisfactory; estrogen-progestin treatment is the most useful adjunct to cosmetic approaches to hirsutism in this country. However, other manifestations of polycystic ovary syndrome, such as infertility, may take precedence over hirsutism when an optimal therapeutic program is designed for many patients.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                20 March 2020
                March 2020
                : 99
                : 12
                Affiliations
                Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China.
                Author notes
                []Correspondence: Lihong Wang, Department of Reproduction, Zhangjiagang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Suzhou, Jiangsu, China (e-mail: zjgzywlh@ 123456njucm.edu.cn ).
                Article
                MD-D-19-10248 19045
                10.1097/MD.0000000000019045
                7220733
                32195930
                Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                Product
                Funding
                Funded by: Suzhou Municipal Science and Technology Bureau
                Award ID: No. SYSD2018002
                Award Recipient : Wenting Xu
                Funded by: Suzhou Municipal Science and Technology Bureau
                Award ID: SYSD2018195
                Award Recipient : Lihong Wang
                Funded by: The 333 Project in Jiangsu Province in 2019
                Award ID: BRA2019140
                Award Recipient : Lihong Wang
                Funded by: The Projects For Science and Technology of Chinese Medicine of Jiangsu Province in 2019
                Award ID: YB201959
                Award Recipient : Lihong Wang
                Funded by: The Special funds of the key clinical disease in diagnosis and treatment technology of SuZhou in 2019
                Award ID: LCZX201920
                Award Recipient : Lihong Wang
                Categories
                3800
                Research Article
                Study Protocol Clinical Trial
                Custom metadata
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