Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial.
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SUBMITTER: Wen Q
PROVIDER: S-EPMC8888993 | biostudies-literature | 2022 Mar
REPOSITORIES: biostudies-literature
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Effect of acupuncture and metformin on insulin sensitivity in women with polycystic ovary syndrome and insulin resistance: a three-armed randomized controlled trial.
Wen Qidan Q Hu Min M Lai Maohua M Li Juan J Hu Zhenxing Z Quan Kewei K Liu Jia J Liu Hua H Meng Yanbing Y Wang Suling S Wen Xiaohui X Yu Chuyi C Li Shuna S Huang Shiya S Zheng Yanhua Y Lin Han H Liang Xingyan X Lu Lingjing L Mai Zhefen Z Zhang Chunren C Wu Taixiang T Ng Ernest H Y EHY Stener-Victorin Elisabet E Ma Hongxia H
Human reproduction (Oxford, England) 20220301 3
<h4>Study question</h4>Does acupuncture improve insulin sensitivity more effectively than metformin or sham acupuncture in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)?<h4>Summary answer</h4>Among women with PCOS and IR, acupuncture was not more effective than metformin or sham acupuncture in improving insulin sensitivity.<h4>What is known already</h4>Uncontrolled trials have shown that acupuncture improved insulin sensitivity with fewer side effects compared with metf ...[more]
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Project description:BackgroundOur prospective pilot study of acupuncture affecting insulin sensitivity on polycystic ovary syndrome (PCOS) combined with insulin resistance (IR) showed that acupuncture had a significant effect on improving the insulin sensitivity of PCOS. But there is still no randomized controlled trial to determine the effect of acupuncture on the insulin sensitivity in women with PCOS and IR. In this article, we present the protocol of a randomized controlled trial to compare the effect of true acupuncture on the insulin sensitivity of these patients compared with metformin and sham acupuncture. Acupuncture may be an effective therapeutic alternative that is superior to metformin and sham acupuncture in improving the insulin sensitivity of PCOS combined with IR.MethodsThis study is a multi-center, controlled, double-blind, and randomized clinical trial aiming to evaluate the effect of acupuncture on the insulin sensitivity in PCOS combined with IR. In total 342 patients diagnosed with PCOS and IR will be enrolled. Participants will be randomized to one of the three groups: (1) true acupuncture + metformin placebo; (2) sham acupuncture + metformin, and (3) sham acupuncture + metformin placebo. Participants and assessors will be blinded. The acupuncture intervention will be given 3 days per week for a total of 48 treatment sessions during 4 months. Metformin (0.5 g per pill) or placebo will be given, three times per day, and for 4 months. Primary outcome measures are changes in homeostasis model assessment of insulin resistance (HOMA-IR) and improvement rate of HOMA-IR by oral glucose tolerance test (OGTT) and insulin releasing test (Ins). Secondary outcome measures are homeostasis model assessment-β (HOMA-β), area under the curve for glucose and insulin, frequency of regular menstrual cycles and ovulation, body composition, metabolic profile, hormonal profile, questionnaires, side effect profile, and expectation and credibility of treatment. Outcome measures are collected at baseline, at the end of treatments, and 3 months after the last acupuncture treatment. On completion of the screening visit, randomization will be conducted using a central randomization system.DiscussionThis study will investigate the effects of acupuncture on the insulin sensitivity of PCOS and IR women compared with metformin and sham acupuncture. We will test whether true acupuncture with needles placed in skeletal muscles and stimulated manually and by electrical stimulation is more effective than metformin and sham acupuncture with superficial needle placement with no manual or electrical stimulation in improving the insulin sensitivity in PCOS women with IR.Trial registrationClinicalTrials.gov, NCT02491333 ; Chinese Clinical Trial Registry, ChiCTR-ICR-15006639. Registered on 24 June 2015.
| S-EPMC5343367 | biostudies-literature
Project description:IntroductionHyperinsulinaemia and insulin resistance (IR) are key features of polycystic ovary syndrome (PCOS) and metabolic syndrome. The effect of 5 weeks of acupuncture treatment has been investigated in a completed prospective pilot trial (Clinicaltrials.gov: NCT01457209), and acupuncture with electrical stimulation applied to insulin-resistant rats with dihydrotestosterone-induced PCOS was shown to improve insulin sensitivity. Therefore, we now aim to conduct a prospective pilot study to evaluate whether using the same acupuncture treatment protocol given over a longer period of time (6 months) than in the previous pilot trial will improve insulin sensitivity in women with PCOS and IR. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles will improve insulin sensitivity in women with PCOS and IR.Methods/analysisThis is a prospective pilot trial. A total of 112 women with PCOS and IR will be recruited and categorised according to their body mass index (BMI) as normal weight (BMI=18.5-23 kg/m(2)) or as overweight/obese (BMI>23 kg/m(2)). Acupuncture will be applied three times per week for 6 months at 30 min per treatment. The primary outcome will be the change in insulin sensitivity before and after 6 months of acupuncture treatment, as measured by an oral glucose tolerance test.Ethics/disseminationEthical approval of this study has been granted from the ethics committee of the First Affiliated Hospital of Guangzhou Medical University (No. 2013039). Written and informed consent will be obtained from each patient before any study procedure is performed, according to good clinical practice. The results of this trial will be disseminated in a peer-reviewed journal and presented at international congresses.Trial registration numbersNCT02026323 and ChiCTR-OCH-13003921.
| S-EPMC4420969 | biostudies-literature
Project description:ObjectiveThis study explored the efficacy of acupuncture and metformin in enhancing insulin sensitivity among women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), distinguishing between overweight/obese and lean groups.MethodsA post-hoc analysis of a randomized trial (NCT02491333) was undertaken. Participants were women aged 18-40 with PCOS and IR. They were randomized to receive true acupuncture with a placebo, metformin with sham acupuncture, or sham acupuncture with a placebo for 4 months, with follow-up visits over 3 months. Our study, involving 339 women, assessed the differential impact of acupuncture and metformin on insulin sensitivity in overweight/obese [body mass index (BMI) ≥ 24] versus lean women (BMI < 24). Primary outcomes measured changes in the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 4 and 7 months. Secondary outcomes assessed changes in glucose area under the curve (glucoseAUC) during the oral glucose tolerance test (OGTT) and BMI changes at 4 months.ResultsOverweight/obese participants were generally older with higher measurements in various health metrics, but lower levels in specific hormonal metrics compared to lean women (p < 0.05). Among overweight/obese women, metformin outperformed acupuncture in reducing HOMA-IR levels (p = 0.004) and showed a significant drop from the baseline after 4 months (p < 0.05). In contrast, acupuncture's effect on HOMA-IR did not significantly differ from sham acupuncture at 4 and 7 months. For lean women, metformin and acupuncture showed comparable improvements in HOMA-IR, with notable declines at 4 and 7 months (p < 0.05). Acupuncture proved more beneficial for lean women than their overweight/obese counterparts after 4 months (p = 0.021).ConclusionIn overweight/obese women with PCOS and IR, acupuncture was less effective than metformin in enhancing insulin sensitivity. However, in lean women, acupuncture's efficacy was comparable to metformin. Further studies are required to validate these observations.
| S-EPMC10753002 | biostudies-literature
Project description:ContextAlthough metformin is widely used to improve insulin resistance in women with polycystic ovary syndrome (PCOS), its mechanism of action is complex, with inconsistent effects on insulin sensitivity and variability in treatment response.ObjectiveThe aim of the study was to delineate the effect of metformin on glucose and insulin parameters, determine additional treatment outcomes, and predict patients with PCOS who will respond to treatment.Design and settingWe conducted an open-label, interventional study at an academic medical center.SubjectsWomen with PCOS (n = 36) diagnosed by the National Institutes of Health criteria participated in the study.InterventionsSubjects underwent fasting blood sampling, an IV glucose tolerance test, dual-energy x-ray absorptiometry scan, transvaginal ultrasound, and measurement of human chorionic gonadotropin-stimulated androgen levels before and after 12 weeks of treatment with metformin extended release 1500 mg/d. Interval visits were performed to monitor anthropometric measurements and menstrual cycle parameters.Main outcome measuresChanges in glucose and insulin parameters, androgen levels, anthropometric measurements, and ovulatory menstrual cycles were evaluated.ResultsInsulin sensitivity did not change despite weight loss. Glucose effectiveness (P = .002) and the acute insulin response to glucose (P = .002) increased, and basal glucose levels (P = .001) decreased after metformin treatment. T levels also decreased. Women with improved ovulatory function (61%) had lower baseline T levels and lower baseline and stimulated T and androstenedione levels after metformin treatment (all P < .05).ConclusionsUsing an IV glucose tolerance test, which distinguishes improvements in glucose effectiveness and insulin sensitivity, metformin does not improve insulin sensitivity in women with PCOS but does improve glucose effectiveness. The improvement in glucose effectiveness may be partially mediated by decreased glucose levels. T levels also decreased with metformin treatment. Ovulation during metformin treatment was associated with lower baseline T levels and greater T and androstenedione decreases during treatment, but not with insulin or LH levels. Thus, the action of metformin in PCOS primarily affects glucose levels and steroidogenesis, which may be mediated by mechanisms that affect both pathways, such as inhibition of mitochondrial complex I.
| S-EPMC4010712 | biostudies-literature
Project description:BackgroundHydroxychloroquine (HCQ) is frequently utilized in rheumatic immune disorders and has been discovered to exert hypoglycemic effects in some obese women with polycystic ovary syndrome(PCOS), however, the precise efficacy and mechanism of action remain ambiguous.ObjectiveTo examine the impact of HCQ on glucose and lipid metabolism as well as sex hormone levels in obese women with PCOS.MethodFifty obese women with PCOS were randomly allocated into two groups: HCQ group (n = 25) and metformin (MET) group (n = 25). The HCQ group received a daily dose of 200 mg hydroxychloroquine, while the MET group received a daily dose of 1000 mg metformin. Body fat parameters, glucose and lipid metabolism levels, as well as hormone levels were evaluated. Additionally, the incidence of pregnancy within six months following treatment was also assessed. Network pharmacology was also employed to analyze the potential molecular mechanism.ResultPatients in the HCQ group (n = 20) and MET group (n = 23) were ultimately included for analysis. Following treatment, both groups exhibited significant improvements in body fat distribution and glucose metabolism status, with the HCQ group demonstrating a notable advantage over the MET group in increasing insulin sensitivity index (ISI)(HCQ:1.87 ± 0.21,MET:1.75 ± 0.29). Serum lipid levels [Serum total cholesterol(TC, mmol/L)(HCQ:4.51 ± 0.87,MET:5.05 ± 0.65), triglyceride(TG, mmol/L)(HCQ:1.36 ± 0.51,MET:1.67 ± 0.72), low-density lipoprotein (LDL, mmol/L)(HCQ:2.66 ± 0.98,MET:0.47 ± 1.42),decreased in both groups post-treatment, with the HCQ group displaying clear advantages compared to the MET group. The improvement of sex hormone levels was not pronounced in either group, although there was an overall downward trend.ConclusionThe potential benefits of HCQ in the management of in obese women with PCOS include significant improvements in body fat distribution, glucose and lipid metabolism levels, as well as correction of hormonal disorders.Clinical trial registrationThe study was officially registered as a clinical trial on April 17, 2022, with the registration number ChiCTR2200058816. https://www.chictr.org.cn/showproj.html?proj=160099 .
| S-EPMC11697925 | biostudies-literature
Project description: Not available
| S-EPMC6915832 | biostudies-literature
Project description:ObjectiveTo examine whether subcutaneous (SC) abdominal adipose stem cell differentiation into adipocytes in vitro predicts insulin sensitivity (Si) in vivo in normal-weight women with polycystic ovary syndrome (PCOS) and controls.DesignProspective cohort study.SettingAcademic medical center.Patient(s)Eight normal-weight women with PCOS and 8 age- and body mass index-matched controls.Intervention(s)Women underwent circulating hormone/metabolic determinations, intravenous glucose tolerance testing, total-body dual-energy x-ray absorptiometry, and SC abdominal fat biopsy.Main outcome measure(s)PPARγ and CEBPa gene expression and lipid content of adipocytes matured in vitro were compared between women with PCOS and control women, and correlated with patient characteristics, systemic Si, and adipose insulin resistance (adipose-IR).Result(s)Serum androgen levels, adipose-IR, and percentage of android fat were greater in women with PCOS than control women. Stem cell PPARγ and CEBPa gene expression increased maximally by day 12 without a female-type effect. In control cells, gene expression positively correlated with fasting serum insulin levels (both genes) and adipose-IR (CEBPa) and negatively correlated with Si (CEBPa). Conversely, CEBPa gene expression in PCOS cells negatively correlated with adipose-IR and serum free testosterone, whereas total lipid accumulation in these cells positively corelated with Si.ConclusionIn normal-weight women with PCOS, accelerated SC abdominal adipose stem cell differentiation into adipocytes in vitro favors Si in vivo, suggesting a role for hyperandrogenism in the evolution of metabolic thrift to enhance fat storage through increased cellular glucose uptake.
| S-EPMC8209112 | biostudies-literature
Project description:Some actions of insulin are mediated by inositolphosphoglycan (IPG) mediators. Deficient release of a putative D-chiro-inositol-containing (DCI) IPG mediator may contribute to insulin resistance in women with polycystic ovary syndrome (PCOS). Previously, we demonstrated that oral DCI supplementation improved ovulation and metabolic parameters in women with PCOS. However, whether oral DCI mediates an increase in the release of the DCI-IPG mediator and an improvement in insulin sensitivity in women with PCOS is unknown. We conducted a randomized controlled trial of DCI supplementation vs placebo in 11 women with PCOS who were assessed at 2 time points 6 weeks apart. Plasma DCI, DCI-IPG release during oral glucose tolerance test (AUC(DCI-IPG)), and insulin sensitivity (S(i)) by frequently sampled intravenous glucose tolerance test were assessed at baseline and end of study. The study was terminated early because of a sudden unavailability of the study drug. However, in all subjects without regard to treatment assignment, there was a positive correlation between the change in AUC(DCI-IPG)/AUC(insulin) ratio and the change in S(i) during the 6-week period (r = 0.69, P = .02), which remained significant after adjustment for body mass index (P = .022) and after further adjustment for body mass index and treatment allocation (P = .0261). This suggests that, in women with PCOS, increased glucose-stimulated DCI-IPG release is significantly correlated with improved insulin sensitivity. The significant relationship between DCI-IPG release and insulin sensitivity suggests that the DCI-IPG mediator may be a target for therapeutic interventions in PCOS.
| S-EPMC2574418 | biostudies-literature
Project description:ObjectiveTo perform a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate acupuncture's clinical effect on insulin resistance (IR) in women with polycystic ovary syndrome (PCOS).MethodsPubMed, Cochrane Library, Embase databases, and Chinese databases, including China National Knowledge Infrastructure, Technology Journal Database, and Wanfang Database, were searched without language restrictions from inception to December 20, 2021. Only RCTs in which acupuncture had been examined as the sole or adjunctive PCOS-IR treatment were included. Our primary endpoint was the homeostasis model assessment of insulin resistance (HOMA-IR). The secondary outcomes were fasting blood glucose (FBG), fasting insulin (FINS), body mass index (BMI), and adverse events.ResultsOur analysis included 17 eligible RCTs (N = 1511 participants). Compared with other treatments, acupuncture therapy yielded a greater mean reduction in HOMA-IR (MD = -0.15; 95% CI, -0.27 to -0.03; P = 0.01) and BMI (MD = -1.47; 95% CI, -2.46 to -0.47; P = 0.004). Besides acupuncture was associated with a lower risk of adverse events than other treatments (RR, 0.15; 95% CI, 0.10 to 0.22; P < 0.01). Additionally, the combination treatment of acupuncture and medicine is more effective in improving HOMA-IR (MD = -0.91; 95% CI, -1.11 to -0.71; P < 0.01), FBG (MD = -0.30; 95% CI, -0.56 to -0.04; P = 0.02), FINS (MD = -2.33; 95% CI, -2.60 to -2.06; P < 0.01) and BMI (MD = -1.63; 95% CI, -1.94 to -1.33; P < 0.01) than medicine alone.ConclusionsAcupuncture is relatively effective in improving HOMA-IR and BMI in PCOS-IR. Besides, it's safer than other treatments and could be an adjuvant strategy for improving PCOS-IR. Further large-scale, long-term RCTs with strict methodological standards are justified.
| S-EPMC10009463 | biostudies-literature
Project description:IntroductionThis study investigated changes in plasma microbial-derived extracellular vesicles (EVs) in patients with polycystic ovary syndrome and insulin resistance (PCOS-IR) before and after metformin treatment, and aimed to identify bacterial taxa within EVs that were biologically and statistically significant for diagnosis and treatment.MethodsThe case-control study was conducted at Xiamen Chang Gung Hospital, Hua Qiao University. Plasma samples were collected from five PCOS-IR patients of childbearing age before and after 3 months of metformin treatment, and the samples were sequenced. The diversity and taxonomic composition of different microbial communities were analyzed through full-length 16 S glycosomal RNA gene sequencing.ResultsAfter metformin treatment, fasting plasma glucose levels and IR degree of PCOS-IR patients were significantly improved. The 16 S analysis of plasma EVs from metformin-treated patients showed higher microbial diversity. There were significant differences in EVs derived from some environmental bacteria before and after metformin treatment. Notably, Streptococcus salivarius was more abundant in the metformin-treated group, suggesting it may be a potential probiotic.DiscussionThe study demonstrated changes in the microbial composition of plasma EVs before and after metformin treatment. The findings may offer new insights into the pathogenesis of PCOS-IR and provide new avenues for research.
| S-EPMC11218234 | biostudies-literature