| 1. |
- Abdalla, Mohammed A., et al.
(author)
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Effect of pharmacological interventions on lipid profiles and C-reactive protein in polycystic ovary syndrome : A systematic review and meta-analysis
- 2022
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In: Clinical Endocrinology. - : John Wiley & Sons. - 0300-0664 .- 1365-2265. ; 96:4, s. 443-459
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Research review (peer-reviewed)abstract
- Context: Polycystic ovary syndrome (PCOS) is a heterogeneous condition affecting women of reproductive age. It is associated with dyslipidaemia and elevated plasma C-reactive protein (CRP), which increase the risks of cardiovascular disease (CVD).Objective: To review the existing evidence on the effects of different pharmacological interventions on lipid profiles and CRP of women with PCOS.Data Sources: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane Library, and Web of Science in April 2020 and updated the results in March 2021.Study Selection: The study included randomized controlled trials (RCTs) and follows the 2020 Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA).Data Extraction: Two independent researchers extracted data and assessed for risk of bias using the Cochrane risk of bias tool. Covidence systematic review software were used for blinded screening and study selection.Data Synthesis: In 29 RCTs, there were significant reductions in triglycerides with atorvastatin versus placebo [mean difference (MD): -0.21 mmol/L; 95% confidence interval (CI): -0.39, -0.03, I-2 = 0%, moderate grade evidence]. Significant reductions were seen for low-density lipoprotein cholesterol (LDL-C) with metformin versus placebo [standardized mean difference (SMD): -0.41; 95% CI: -0.85, 0.02, I-2 = 59%, low grade evidence]. Significant reductions were also seen for total cholesterol with saxagliptin versus metformin (MD: -0.15 mmol/L; 95% CI: -0.23, -0.08, I-2 = 0%, very low grade evidence). Significant reductions in C-reactive protein (CRP) were seen for atorvastatin versus placebo (MD: -1.51 mmol/L; 95% CI: -3.26 to 0.24, I-2 = 75%, very low-grade evidence).Conclusion: There were significant reductions in the lipid parameters when metformin, atorvastatin, saxagliptin, rosiglitazone and pioglitazone were compared with placebo or other agents. There was also a significant reduction of CRP with atorvastatin.
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| 2. |
- Abdalla, Mohammed Altigani, et al.
(author)
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Impact of metformin on the clinical and metabolic parameters of women with polycystic ovary syndrome : a systematic review and meta-analysis of randomised controlled trials
- 2022
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In: Therapeutic Advances in Endocrinology and Metabolism. - : Sage Publications. - 2042-0188 .- 2042-0196. ; 13
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Research review (peer-reviewed)abstract
- Context: Polycystic ovary syndrome (PCOS) is one of the commonest endocrine disorders affecting women of reproductive age, and metformin is a widely used medication in managing this condition.Aim: To review the available literature comprehensively on the therapeutic impact of metformin on the clinical and metabolic parameters of women with PCOS.Data source: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane Library and the Web of Science and selected sources for grey literature from their inception to April 2020. An updated search in PubMed was performed in June 2022.Data synthesis: Two reviewers selected eligible studies and extracted data, and the review is reported following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).Results: In 24 eligible randomised controlled trials (RCTs) involving 564 participants who received metformin therapy, metformin was associated with significant reduction in body weight by 3.13 kg (95% CI: -5.33, -0.93), body mass index (BMI) by 0.82 kg/m(2) (95% CI: -1.22, -0.41), fasting blood glucose [standardised mean difference (SMD): -0.23; 95% CI: -0.40, -0.06], low-density lipoprotein cholesterol (LDL-C) (SMD: -0.41; 95% CI: -0.85, 0.03), total testosterone (SMD: -0.33; 95% CI: -0.49, -0.17), androstenedione (SMD: -0.45; 95% CI: -0.70, -0.20), 17-hydroxyprogesterone (17-OHP) (SMD: -0.58; 95% CI: -1.16, 0.00) and increase the likelihood of clinical pregnancy rate [odds ratio (OR): 3.00; 95% CI: 1.95, 4.59] compared with placebo.Conclusion: In women with PCOS, metformin use has shown a positive impact in reducing body weight, BMI, total testosterone, androstenedione, 17-OHP, LDL-C, fasting blood glucose and increasing the likelihood of pregnancy in women with PCOS.
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| 3. |
- Abdalla, Mohammed A., et al.
(author)
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Impact of pharmacological interventions on anthropometric indices in women with polycystic ovary syndrome : A systematic review and meta-analysis of randomized controlled trials
- 2022
-
In: Clinical Endocrinology. - : John Wiley & Sons. - 0300-0664 .- 1365-2265. ; 96:6, s. 758-780
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Research review (peer-reviewed)abstract
- Context: Polycystic ovary syndrome (PCOS) is a heterogeneous condition affecting women of reproductive age and is associated with increased body weight.Objective: To review the literature on the effect of different pharmacological interventions on the anthropometric indices in women with PCOS.Data sources: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane library, and the Web of Science in April 2020 with an update in PubMed in March 2021.Study selection: The study followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA)2020.Data extraction: Reviewers extracted data and assessed the risk of bias using the Cochrane risk of bias tool.Results: 80 RCTs were included in the meta-analysis. Metformin vs placebo showed significant reduction in the mean body weight (MD: -3.13 kg; 95% confidence interval [CI]: -5.33 to -0.93, I-2 = 5%) and the mean body mass index (BMI) (MD: -0.75 kg/m(2); 95% CI: -1.15 to -0.36, I-2 = 0%). There was a significant reduction in the mean BMI with orlistat versus placebo (MD: -1.33 kg/m(2); 95% CI: -2.16 to -0.66, I-2 = 0.0%), acarbose versus metformin (MD: -1.26 kg/m(2); 95% CI: -2.13 to -0.38, I-2 = 0%), and metformin versus pioglitazone (MD: -0.91 kg/m(2); 95% CI: -1.62 to -0.19, I-2 = 0%). A significant increase in the mean BMI was also observed in pioglitazone versus placebo (MD: + 2.59 kg/m(2); 95% CI: 1.78-3.38, I-2 = 0%) and in rosiglitazone versus metformin (MD: + 0.80 kg/m(2); 95% CI: 0.32-1.27, I-2 = 3%). There was a significant reduction in the mean waist circumference (WC) with metformin versus placebo (MD: -1.21 cm; 95% CI: -3.71 to 1.29, I-2 = 0%) while a significant increase in the mean WC with pioglitazone versus placebo (MD: + 5.45 cm; 95% CI: 2.18-8.71, I-2 = 0%).Conclusion: Pharmacological interventions including metformin, sitagliptin, pioglitazone, rosiglitazone orlistat, and acarbose have significant effects on the anthropometric indices in women with PCOS.
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| 4. |
- Abdalla, Mohammed Altigani, et al.
(author)
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Impact of pharmacological interventions on biochemical hyperandrogenemia in women with polycystic ovary syndrome : a systematic review and meta-analysis of randomised controlled trials
- 2022
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In: Archives of Gynecology and Obstetrics. - : Springer. - 0932-0067 .- 1432-0711.
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Research review (peer-reviewed)abstract
- Context: Polycystic ovary syndrome (PCOS) is a complex endocrine disease that affects women of reproductive age and is characterised by biochemical and clinical androgen excess.Aim: To evaluate the efficacy of pharmacological interventions used to decrease androgen hormones in women with PCOS.Data source: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane library and the Web of Science from inception up to March 2021. Data synthesis Two reviewers selected eligible studies and extracted data, and the review is reported according to the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).Results: Of the 814 randomised clinical trials (RCTs) located in the search, 92 met the eligibility criteria. There were significant reductions in total testosterone level with metformin versus (vs) placebo (SMD: - 0.33; 95% CI - 0.49 to - 0.17, p < 0.0001, moderate grade evidence) and dexamethasone vs placebo (MD:-0.86 nmol/L; 95% CI - 1.34 to - 0.39, p = 0.0004, very low-grade evidence). Significant reductions in the free testosterone with sitagliptin vs placebo (SMD: - 0.47; 95% CI - 0.97 to 0.04, p = 0.07, very low-grade evidence), in dehydroepiandrosterone sulphate (DHEAS) with flutamide vs finasteride (MD: - 0.37 mu g/dL; 95% CI - 0.05 to - 0.58, p = 0.02, very low-grade evidence), a significant reduction in androstenedione (A4) with rosiglitazone vs placebo (SMD: - 1.67; 95% CI - 2.27 to - 1.06; 59 participants, p < 0.00001, very low-grade evidence), and a significant increase in sex hormone-binding globulin (SHBG) with oral contraceptive pill (OCP) (35 mu g Ethinyl Estradiol (EE)/2 mg cyproterone acetate (CPA)) vs placebo (MD: 103.30 nmol/L; 95% CI 55.54-151.05, p < 0.0001, very low-grade evidence) were observed.Conclusion: Metformin, OCP, dexamethasone, flutamide, and rosiglitazone use were associated with a significant reduction in biochemical hyperandrogenemia in women with PCOS, though their individual use may be limited due to their side effects.PROSPERO registration No CRD42020178783.
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| 5. |
- Abdalla, Mohammed A., et al.
(author)
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Impact of pharmacological interventions on insulin resistance in women with polycystic ovary syndrome : A systematic review and meta-analysis of randomized controlled trials
- 2022
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In: Clinical Endocrinology. - : John Wiley & Sons. - 0300-0664 .- 1365-2265. ; 96:3, s. 371-394
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Research review (peer-reviewed)abstract
- Objective: Polycystic ovary syndrome (PCOS) is a complex endocrine condition affecting women of reproductive age. It is characterized by insulin resistance and is a major risk factor for type 2 diabetes mellitus (T2DM). The objective was to review the literature on the effect of different pharmacological interventions on insulin resistance in women with PCOS.Design: We searched PubMed, MEDLINE, Scopus, Embase, Cochrane library and the Web of Science in April 2020 and updated in March 2021. The study follows the 2020 Preferred Reporting Items for Systematic reviews and Meta-ana. Reviwers extracted data and assessed the risk of bias using the Cochrane risk of bias tool.Results: In 58 randomized controlled trials there were significant reductions in the fasting blood glucose (FBG) with metformin versus placebo (standardized mean difference [SMD]: -0.23; 95% confidence interval [CI]: -0.40, -0.06; I-2 = 0%, low-grade evidence), and acarbose versus metformin (mean difference [MD]: -10.50 mg/dl; 95% CI: -15.76, -5.24; I-2 = 0%, low-grade evidence). Significant reductions in fasting insulin (FI) with pioglitazone versus placebo (SMD: -0.55; 95% CI: -1.03, -0.07; I-2 = 37%; p = .02, very-low-grade evidence). A significant reduction in homoeostatic model assessment of insulin resistance (HOMA-IR) was seen with exenatide versus metformin (MD: -0.34; 95% CI: -0.65, -0.03; I-2 = 0%, low-grade evidence). No effect on homoeostatic model assessment of beta cells (HOMA-B) was observed.Conclusions: Pharmacological interventions, including metformin, acarbose, pioglitazone and exenatide have significant effects on FBG, FI, HOMA-IR but not on HOMA-B.
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| 6. |
- Mosenzon, Ofri, et al.
(author)
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Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5) : a placebo-controlled, randomised, phase 3a trial
- 2019
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In: The Lancet Diabetes and Endocrinology. - : ELSEVIER SCIENCE INC. - 2213-8587 .- 2213-8595. ; 7:7, s. 515-527
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Journal article (peer-reviewed)abstract
- Background: Oral semaglutide is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for glycaemic control in patients with type 2 diabetes. Type 2 diabetes is commonly associated with renal impairment, restricting treatment options. We aimed to investigate the efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment.Methods: This randomised, double-blind, phase 3a trial was undertaken at 88 sites in eight countries. Patients aged 18 years and older, with type 2 diabetes, an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m(2), and who had been receiving a stable dose of metformin or sulfonylurea, or both, or basal insulin with or without inetformin for the past 90 days were eligible. Participants were randomly assigned (1:1) by use of an interactive web-response system, with stratification by glucose-lowering medication and renal function, to receive oral semaglutide (dose escalated to 14 mg once daily) or matching placebo for 26 weeks, in addition to background medication. Participants and site staff were masked to assignment. Two efficacy-related estimands were defined: treatment policy (regardless of treatment discontinuation or rescue medication) and trial product (on treatment without rescue medication) in all participants randomly assigned. Endpoints were change from baseline to week 26 in HbA k (primary endpoint) and bodyweight (confirmatory secondary endpoint), assessed in all participants with sufficient data. Safety was assessed in all participants who received at least one dose of study drug.The trial is registered on ClinicalTrials. gov, number NCT02827708, and the European Clinical Trials Registry, number EudraCT 2015-005326-19, and is now complete.Findings: Between Sept 20,2016, and Sept 29,2017, of 721 patients screened, 324 were eligible and randomly assigned to oral semaglutide (n=163) or placebo (n=161). Mean age at baseline was 70 years (SD 8), and 168 (52%) of participants were female. 133 (82%) participants in the oral semaglutide group and 141 (88%) in the placebo group completed 26 weeks on treatment. At 26 weeks, oral semaglutide was superior to placebo in decreasing HbA(1c) (estimated mean change of -1.0 percentage point (SE 0.1; -11 mmol/mol [SE 0.8]) vs-0.2 percentage points (SE 0.1; -2 mmol/mol [SE 0.8]); estimated treatment difference [ETD]: -0.8 percentage points, 95% CI -1.0 to -0.6; p<0.0001) and bodyweight (estimated mean change of -3.4 kg [SE 0.3] vs -0.9 kg [SE 0.3]; ETD, -2.5, 95% CI -3.2 to -1.8; p<0.0001) by the treatment policy estimand. Significant differences were seen for the trial product estimand: mean change in HbA(1c) -1.1 percentage points (SE 0.1; -12 mmol/mol [SE 0.8] versus -0.1 percentage points (SE 0.1; -1 mmol/mol [SE 0.8]; ETD -1.0 percentage points, 95% CI -1.2 to -0.8; p<0.0001); mean change in bodyweight -3.7 kg (SE 0.3) versus -1.1 kg (SE 0.3; ETD -2.7 kg, 95% CI -3.5 to -1.9; p<0-0001). More patients taking oral semaglutide than placebo had adverse events (120 [74%] of 163 vs 105 [65%] of 161), and discontinued treatment as a result (24 [15%] vs eight [5%]). Gastrointestinal events, mainly mild-to-moderate nausea, were more common with oral semaglutide than with placebo. Three deaths occurred during the treatment period that were not condsidered to be treatment related, one in the semaglutide group and two in the placebo group.Interpretation: Oral semaglutide was effective in patients with type 2 diabetes and moderate renal impairment, potentially providing a new treatment option for this population. Safety, including renal safety, was consistent with the GLP-1 receptor agonist class.
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| 7. |
- Otun, Jemiliat, et al.
(author)
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Systematic Review and Meta-analysis on the Effect of Soy on Thyroid Function
- 2019
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In: Scientific Reports. - : Nature Publishing Group. - 2045-2322. ; 9
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Research review (peer-reviewed)abstract
- Soy foods have had an important dietary role in Asian countries for centuries, and in recent years they have become increasingly popular in Western countries as a result of their suggested health benefits. Nevertheless, there are some concerns that soy can have a negative effect on thyroid function and can alter the levels of thyroid hormones. The aim of this systematic review was to investigate the link between soy or soy product consumption and thyroid function via the measurement of thyroid hormone levels. A systematic review and meta-analysis was undertaken on all randomised controlled trials of studies including soy as an intervention and where free triiodothyronine (fT3), free thyroxine (fT4) and thyroid stimulating hormone (TSH) was measured. The search included PubMed, MEDLINE, EMBASE, Cochrane and sources for the grey literature. Quantitative data synthesis was performed using a random-effects model, with standardized mean difference (SMD) and 95% confidence interval as summary statistics. A total of 18 articles were suitable for review. The meta-analysis showed no significant changes in fT3 (WMD: 0.027 pmol/L, 95% CI: -0.052, 0.107, p = 0.499; I-2: 55.58%), fT4 (WMD: -0.003 pmol/L, 95% CI: -0.018, 0.011, p = 0.656; I-2: 87.58%) while an elevation in TSH levels was observed (WMD: 0.248 mIU/L, 95% CI: 0.001, 0.494, p = 0.049; I-2: 80.31%) levels with soy supplementation. There was no evidence of publication bias. Soy supplementation has no effect on the thyroid hormones and only very modestly raises TSH levels, the clinical significance, if any, of the rise in TSH is unclear.
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