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Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data.
Islam, RM, Bell, RJ, Green, S, Page, MJ, Davis, SR
The lancet. Diabetes & endocrinology. 2019;(10):754-766
Abstract
BACKGROUND The benefits and risks of testosterone treatment for women with diminished sexual wellbeing remain controversial. We did a systematic review and meta-analysis to assess potential benefits and risks of testosterone for women. METHODS We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and Web of Science for blinded, randomised controlled trials of testosterone treatment of at least 12 weeks' duration completed between Jan 1, 1990, and Dec 10, 2018. We also searched drug registration applications to the European Medicine Agency and the US Food and Drug Administration to identify any unpublished data. Primary outcomes were the effects of testosterone on sexual function, cardiometabolic variables, cognitive measures, and musculoskeletal health. This study is registered with the International Prospective Register of Systematic Reviews (PROSPERO), number CRD42018104073. FINDINGS Our search strategy retrieved 46 reports of 36 randomised controlled trials comprising 8480 participants. Our meta-analysis showed that, compared with placebo or a comparator (eg, oestrogen, with or without progestogen), testosterone significantly increased sexual function, including satisfactory sexual event frequency (mean difference 0·85, 95% CI 0·52 to 1·18), sexual desire (standardised mean difference 0·36, 95% CI 0·22 to 0·50), pleasure (mean difference 6·86, 95% CI 5·19 to 8·52), arousal (standardised mean difference 0·28, 95% CI 0·21 to 0·35), orgasm (standardised mean difference 0·25, 95% CI 0·18 to 0·32), responsiveness (standardised mean difference 0·28, 95% CI 0·21 to 0·35), and self-image (mean difference 5·64, 95% CI 4·03 to 7·26), and reduced sexual concerns (mean difference 8·99, 95% CI 6·90 to 11·08) and distress (standardised mean difference -0·27, 95% CI -0·36 to -0·17) in postmenopausal women. A significant rise in the amount of LDL-cholesterol, and reductions in the amounts of total cholesterol, HDL-cholesterol, and triglycerides, were seen with testosterone administered orally, but not when administered non-orally (eg, by transdermal patch or cream). An overall increase in weight was recorded with testosterone treatment. No effects of testosterone were reported for body composition, musculoskeletal variables, or cognitive measures, although the number of women who contributed data for these outcomes was small. Testosterone was associated with a significantly greater likelihood of reporting acne and hair growth, but no serious adverse events were recorded. INTERPRETATION Testosterone is effective for postmenopausal women with low sexual desire causing distress, with administration via non-oral routes (eg, transdermal application) preferred because of a neutral lipid profile. The effects of testosterone on individual wellbeing and musculoskeletal and cognitive health, as well as long-term safety, warrant further investigation. FUNDING Australian National Health and Medical Research Council.
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Effects of testosterone supplementation therapy on lipid metabolism in hypogonadal men with T2DM: a meta-analysis of randomized controlled trials.
Zhang, KS, Zhao, MJ, An, Q, Jia, YF, Fu, LL, Xu, JF, Gu, YQ
Andrology. 2018;(1):37-46
Abstract
Testosterone supplementation may be effective for the treatment of hypogonadism in men with type 2 diabetes mellitus (T2DM), but the evidence from randomized controlled trials (RCTs) is inconclusive. We aimed to systematically summarize results from intervention studies and assess the effects of testosterone supplementation therapy (TST) on lipid metabolism in RCTs of hypogonadal men with T2DM by meta-analysis. PubMed, Embase, and Cochrane Library databases were searched for studies reporting the effect of TST on lipid metabolism in hypogonadal men with T2DM until December 31, 2016. Seven RCTs from 252 trials, enrolling a total of 612 patients in the experimental and control groups with a mean age of 58.5 years, were included in this study. The pooled results of the meta-analysis demonstrated that TST significantly decreased TC and TG levels in hypogonadal men with T2DM compared with the control group, with mean differences (MDs) of -6.44 (95% CI: -11.82 to -1.06; I2 = 28%; p = 0.02) and -27.94 (95% CI: -52.33 to -3.54; I2 = 76%; p = 0.02). Subgroup analyses revealed that the heterogeneity (I2 = 76%) of TG originated from different economic regions, in which economic development, genetic and environmental factors, and dietary habits affect lipid metabolism of human, with a decrease (I2 = 45%) in developed countries. Additionally, subgroup analyses showed that TST increased HDL-C level in developing countries compared with the control group (MD = 2.79; 95% CI: 0.73 to 4.86; I2 = 0%; p = 0.008), but there was no improvement in developed countries (MD = 1.02; 95% CI: -4.55 to 6.60; I2 = 91%; p = 0.72). However, LDL-C levels were not improved consistently. Because the relationship between lipid metabolism and atherosclerosis is unequivocal, TST, which ameliorates lipid metabolism, may decrease the morbidity and mortality of cardiovascular disease in hypogonadal men with T2DM by preventing atherogenesis.
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3.
Effects of testosterone supplement treatment in hypogonadal adult males with T2DM: a meta-analysis and systematic review.
Zhang, J, Yang, B, Xiao, W, Li, X, Li, H
World journal of urology. 2018;(8):1315-1326
Abstract
PURPOSE Testosterone supplement treatment (TST) is a classic therapy for hypogonadal men with type 2 diabetes mellitus (T2DM), but the effects of TST in different studies are inconsistent. We conducted this meta-analysis to evaluate the precise role of TST in hypogonadal men with T2DM. METHODS PubMed, Embase, Cochrane Library and Web of Science were searched to identify qualified randomized controlled trials (RCTs). Pooled mean differences (MDs) with 95% confidence intervals (CIs) were calculated to measure the specific effects of TST. Trial sequential analysis was performed to verify the pooled results. RESULTS A total of eight RCTs were enrolled in our meta-analysis, including 596 hypogonadal participants with T2DM. Compared with comparators, TST can significantly improve glycemic control by reducing homeostatic model assessment of insulin resistance (MD - 0.79, 95% CI - 1.23 to - 0.34), fasting glucose (MD - 0.98, 95% CI - 1.13 to - 0.54), fasting insulin (MD - 2.47, 95% CI - 3.99 to - 0.95) and HbA1c% (MD - 0.45, 95% CI - 0.73 to - 0.16). In addition, TST can result in a decline in cholesterol (MD - 0.29, 95% CI - 0.38 to - 0.19) and triglyceride (MD - 0.37, 95% CI - 0.59 to - 0.15). CONCLUSION Our results indicated that TST can improve glycemic control and decrease TC and TG in hypogonadal patients with T2DM. We recommend TST during the anti-diabetic therapy in these patients.
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Subclinical Hypothyroidism Impact on the Characteristics of Patients with Polycystic Ovary Syndrome. A Meta-Analysis of Observational Studies.
de Medeiros, SF, de Medeiros, MAS, Ormond, CM, Barbosa, JS, Yamamoto, MMW
Gynecologic and obstetric investigation. 2018;(2):105-115
Abstract
BACKGROUND/AIMS: Definitive polycystic ovary syndrome (PCOS) diagnosis should exclude thyroid dysfunctions. The purpose of the study is to examine the impact of subclinical hypothyroidism on the characteristics of PCOS patients. METHODS A meta-analysis of the published observational studies was conducted. Medline, Scopus, and Cochrane database search was performed to identify the studies that compared euthyroid PCOS and subclinical hypothyroidism (SCH)-PCOS patients. A total of 9 studies were selected, totalizing the inclusion of 1,537 euthyroid PCOS and 301 SCH-PCOS. The data were expressed as raw mean difference and standard error, using the random-effects model. Heterogeneity among studies was examined using the Cochran's test (Q) and I2 statistics. RESULTS Anthropometrical parameters were similar in both groups. Total cholesterol (TC) and triglyceride (TG) were higher in SCH-PCOS (p = 0.036 and p = 0.012). High-density lipoprotein cholesterol was lower in the SCH-PCOS group (p = 0.018). Fasting glucose was lower in euthyroid PCOS (p = 0.022). All androgen levels were similar in both group (p > 0.05 for all). CONCLUSION TC, TG and fasting glucose were higher in SCH-PCOS patients. Because of the heterogeneity among studies, some summarized results should be interpreted with caution. Consistent data for future studies addressing PCOS diagnosis are provided.
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Lifestyle interventions to alleviate side effects on prostate cancer patients receiving androgen deprivation therapy: a meta-analysis.
Ying, M, Zhao, R, Jiang, D, Gu, S, Li, M
Japanese journal of clinical oncology. 2018;(9):827-834
Abstract
BACKGROUND Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) are prone to suffer a series of potential side effects, including metabolic change, declining physical strength and worsening fatigue. Recent studies found that the change of lifestyle interventions can help to alleviate some adverse reactions, but the results were controversial. Therefore, the aim of this review was to comprehensively evaluate the effects of these lifestyle interventions on the side effects on PCa patients who received ADT. METHODS We searched several electronic databases, including ScienceDirect, PubMed, Cochrane library, CNKI and Wanfang database, without language restrictions. Among the literature, such lifestyle interventions as dietary advice, exercise and physical activities were carried out in the way of randomized controlled trials (RCTs) on PCa patients taking ADT. Pooled estimates were performed using fixed-effects or random-effects model. RESULTS Eleven RCTs involving 905 participants were included in this review. Compared with usual care group, exercise intervention could significantly improve the quality of life (QoL) of PCa patients undergoing ADT (P = 0.05, SMD = 0.17, 95% CI -0.00 to 0.34), but exercise plus dietary advice could not significantly improve the QoL (P = 0.15, SMD = 0.45, 95% CI -0.17 to 1.08). Moreover, lifestyle intervention could significantly change body composition (P = 0.03, SMD = -0.1, 95% CI -0.19 to -0.01). However, there showed no obvious difference in mitigating fatigue and depression (P = 0.46, SMD = 0.11, 95% CI -0.18 to 0.39; P = 0.31, SMD = -0.18, 95% CI -0.54 to 0.17). CONCLUSIONS The results of this meta-analysis from present study indicated that exercise interventions can better improve the QoL and alleviate treatment-related side effects on prostate cancer patients taking ADT, and better therapeutic regimens for PCa patients are likely to emerge in the process.