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BACKGROUND: Flibanserin, approved for the treatment of hypoactive sexual desire disorder (HSDD) in females, has demonstrated diverse therapeutic and adverse effect (AE) prospects in the extant randomized controlled trials (RCTs). This meta-analysis aimed to characterize the outcomes of flibanserin use in these patients comprehensively. METHODS: RCTs involving women with HSDD receiving flibanserin in the intervention arm and placebo in the control arm were sought after throughout the electronic databases. The primary outcomes were the changes from baseline in satisfying sexual events (SSE) per month and sexual desire score per month measured using an electronic diary (eDiary). RESULTS: From 478 initially screened articles, data from 8 RCTs involving 7906 women with HSDD were analyzed. In premenopausal women, flibanserin 100 mg was superior to placebo in improving the number of SSE per month (mean difference, MD 0.69, 95% CI [0.39, 0.99]), eDiary sexual desire score (MD 1.71, 95% CI [0.43, 2.98]), Female Sexual Function Index (FSFI) desire domain (FSFI-d) score (MD 0.30, 95% CI [0.29, 0.31]), FSFI total score (MD 2.51, 95% CI [1.47, 3.55]), Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score (MD -0.30, 95% CI [-0.31, -0.29]), and FSDS-R total score (MD -3.30, 95% CI [-3.37, -3.23]). Compared to placebo, a higher number of premenopausal women using flibanserin 100 mg achieved improvements in the Patient's Global Impression of Improvement score (OR 1.93, 95% CI [1.58, 2.36], Pâ <â .00001) and responded positively at Patient Benefit Evaluation (PBE) (odds ratio, OR 1.76, 95% CI [1.34, 2.31], Pâ <â .0001). Postmenopausal women receiving flibanserin 100 mg also benefited in terms of the number of SSE per month, FSFI-d and total scores, FSDS-R Item 13 and total scores, and PBE response. Although flibanserin use was associated with higher risks of dizziness, fatigue, nausea, somnolence, and insomnia, these adverse events were mild in nature; the serious AEs and severe AEs were comparable between the flibanserin and placebo groups. CONCLUSION: While flibanserin has demonstrated efficacy in the treatment of HSDD in both pre- and postmenopausal women, its therapeutic advantages may be overshadowed by the higher likelihood of AEs.
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Benzimidazóis , Disfunções Sexuais Psicogênicas , Feminino , Humanos , Benzimidazóis/uso terapêutico , Benzimidazóis/efeitos adversos , Libido/efeitos dos fármacos , Pré-Menopausa , Ensaios Clínicos Controlados Aleatórios como Assunto , Disfunções Sexuais Psicogênicas/tratamento farmacológico , Resultado do TratamentoRESUMO
OBJECTIVE: Teplizumab has emerged as a potential disease-modifying drug in type 1 diabetes (T1D). This meta-analysis sought to summarize the therapeutic effect of teplizumab in newly diagnosed patients with T1D. METHODS: Randomized controlled trials involving patients with T1D receiving teplizumab in the intervention arm and placebo (or no active intervention) in the control arm were searched throughout the electronic databases. The primary outcome was the change in area under the curve of C-peptide levels from baseline. RESULTS: Seven reports from 6 studies involving 834 subjects met the inclusion criteria. Compared to teplizumab, greater reductions in area under the curve of C-peptide from the baseline values were observed in the control group after 6 months (mean difference [MD] 0.07 nmol/L [0.01, 0.13], P = .02), after 12 months (MD 0.07 nmol/L [0.04, 0.11], P = .0001), after 18 months (MD 0.10 nmol/L [0.06, 0.14], P < .00001), and after 24 months (MD 0.07 nmol/L [0.01, 0.14], P = .03) of interventions. Moreover, fewer patients treated with teplizumab had a decreased C-peptide response after 6 months (odds ratio [OR] 0.21), after 12 months (OR 0.17), after 18 months (OR 0.30), and after 24 months (OR 0.12) of treatment. The preservation of endogenous insulin production was supported by reduced use of exogenous insulin with maintenance of comparable glycemic control for up to 18 months post-treatment. Teplizumab imparted higher risks of grade 3 or higher adverse events, adverse events leading to study medication discontinuation, nausea, rash, and lymphopenia. CONCLUSION: The results of the meta-analysis support teplizumab as a promising disease-modifying therapy for newly diagnosed T1D.
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Anticorpos Monoclonais Humanizados , Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 1/tratamento farmacológico , Humanos , Anticorpos Monoclonais Humanizados/uso terapêutico , Complexo CD3/imunologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Peptídeo C/sangueRESUMO
Objective: Sexual dysfunction among women with diabetes is a common but neglected health issue worldwide. The objective of the present study was to investigate the prevalence of sexual dysfunction and its associated factors among women with type 2 diabetes mellitus (T2DM). Subjects and methods: This cross-sectional comparative study comprises 150 women with diabetes and 100 healthy women without diabetes who visited the endocrinology outpatient department of Mymensingh Medical College Hospital (MMCH). The data were collected from July to December 2019. Sexual dysfunction was assessed by the 19-item Female Sexual Function Index (FSFI). Informed consent was obtained before participation. Collected data were analysed by SPSS 26. Results: More women with diabetes than control subjects reported sexual dysfunction (79% vs. 72%; p = 0.864). The global FSFI score was lower among the diabetes patients than among the healthy controls (20.8 ± 7.2 vs. 23.7 ± 4.8; p < 0.001). Patients with T2DM scored significantly lower in the domains of desire (p = 0.04), lubrication (p = 0.01), orgasm (p = 0.01), and satisfaction (p < 0.001), but not the domain of arousal (p = 0.09). A prolonged duration of diabetes was the primary contributor to orgasm problems (adjusted odds ratio, aOR 1.3, 95% CI 1.1-1.7) and painful intercourse (aOR 1.2, 95% CI 1.1- 1.5). Conclusion: Sexual problems are frequent in women with diabetes. Inclusion of sexual health in comprehensive diabetes management is crucial to address this problem as well as to improve the quality of life of female diabetes patients.
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Diabetes Mellitus Tipo 2 , Disfunções Sexuais Fisiológicas , Feminino , Humanos , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Estudos Transversais , Qualidade de Vida , Bangladesh/epidemiologia , Disfunções Sexuais Fisiológicas/epidemiologia , Disfunções Sexuais Fisiológicas/etiologia , Inquéritos e QuestionáriosRESUMO
ABSTRACT Objective: Sexual dysfunction among women with diabetes is a common but neglected health issue worldwide. The objective of the present study was to investigate the prevalence of sexual dysfunction and its associated factors among women with type 2 diabetes mellitus (T2DM). Subjects and methods: This cross-sectional comparative study comprises 150 women with diabetes and 100 healthy women without diabetes who visited the endocrinology outpatient department of Mymensingh Medical College Hospital (MMCH). The data were collected from July to December 2019. Sexual dysfunction was assessed by the 19-item Female Sexual Function Index (FSFI). Informed consent was obtained before participation. Collected data were analysed by SPSS 26. Results: More women with diabetes than control subjects reported sexual dysfunction (79% vs. 72%; p = 0.864). The global FSFI score was lower among the diabetes patients than among the healthy controls (20.8 ± 7.2 vs. 23.7 ± 4.8; p < 0.001). Patients with T2DM scored significantly lower in the domains of desire (p = 0.04), lubrication (p = 0.01), orgasm (p = 0.01), and satisfaction (p < 0.001), but not the domain of arousal (p = 0.09). A prolonged duration of diabetes was the primary contributor to orgasm problems (adjusted odds ratio, aOR 1.3, 95% CI 1.1-1.7) and painful intercourse (aOR 1.2, 95% CI 1.1-1.5). Conclusion: Sexual problems are frequent in women with diabetes. Inclusion of sexual health in comprehensive diabetes management is crucial to address this problem as well as to improve the quality of life of female diabetes patients.
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Background Metformin is frequently prescribed for polycystic ovary syndrome (PCOS). There is a well-established causal relationship between metformin use in type 2 diabetes and vitamin B12 deficiency; such a relationship is seldom studied in PCOS. We conducted this study to compare vitamin B12 levels among newly diagnosed and metformin-treated patients with PCOS. Methodology This crosssectional comparative study was conducted from July 2021 to June 2022, among patients with PCOS attending a specialized endocrinology clinic of a tertiary hospital in Mymensingh, Bangladesh. A total of 50 patients newly diagnosed with PCOS and 52 with PCOS who had received metformin for at least six months were evaluated. The serum vitamin B12 level was measured by utilizing the chemiluminescent microparticle immunoassay principle. Results The new drug-naïve and metformin-treated subjects with PCOS had similar clinical and laboratory parameters except for the metformin group's lower hemoglobin levels and higher plateletcrit. Metformin receivers had lower serum vitamin B12 levels than the drug-naïve subjects (385.5 pg/mL [interquartile range, or IQR, 298.7-535.2] vs. 272.0 pg/mL [IQR 217.0-395.7]; P < 0.001). The metformin group had higher frequencies of B12 deficiency and borderline deficiency (15.4% vs. 6% and 42.3% vs. 18%, respectively; P = 0.003). Conclusions This study observed lower serum B12 levels in PCOS patients using metformin than in the newly diagnosed ones. Large-scale data are needed to recommend routine periodic screening for B12 levels in metformin-treated PCOS.
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BACKGROUND AND OBJECTIVE: Researchers have identified neck circumference (NC) as a valuable tool to detect obesity and metabolic syndrome (MS). We conducted this study to define cutoffs of NC to identify obesity, abdominal obesity, and MS in adult women diagnosed with polycystic ovary syndrome (PCOS). METHODS: Adult women newly diagnosed with PCOS using the revised Rotterdam criteria having NC measure data in a cross-sectional study titled "Biochemical and Hormonal Profile of Patients with Polycystic Ovary Syndrome" were analyzed. RESULTS: Finally, 200 women were analyzed; their mean age was 23.3 (±4.9) years, body mass index (BMI) 26.47 (±5.09) kg/m2, NC 34.6 (±3.04) cm, waist circumference (WC) 88.18 (±11.98) cm, and visceral adiposity index (VAI) was 3.31 (±1.37). NC had positive correlations with age, BMI, WC, systolic and diastolic blood pressure, serum triglyceride, VAI, and testosterone levels. NC cutoff 32.75 cm showed 87.3% sensitivity and 74.4% specificity in detecting abdominal obesity (AUC 0.889, P < 0.001) and 88.0% sensitivity and 68.0% specificity for diagnosis of overweight/obesity (AUC 0.877, P < 0.001). NC 34.25 cm showed 63.0% sensitivity and 64.0% specificity for diagnosis of MS (AUC 0.681, P < 0.001). CONCLUSION: Neck circumference may be a simple and convenient tool in assessing obesity, central obesity, and MS in women with PCOS.
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Background: The features of polycystic ovary syndrome (PCOS) vary greatly among adolescent girls and adult women. Some of the features of PCOS may overlap with features of normal pubertal development in girls. Methods: This cross-sectional study was conducted among adolescents newly diagnosed with PCOS attending a tertiary hospital in Bangladesh. The relevant clinical, metabolic and hormonal profiles of 175 participants were evaluated. Results: The mean age of the study participants was 16.8 (±1.7) years. Oligomenorrhea was the predominant menstrual irregularity (88%). More than one-quarter of participants (27.4%) had a first-degree relative with PCOS, and 12% had a first-degree relative with type 2 diabetes. More than three-quarters (77.7%) had acanthosis nigricans. The majority (69.1%) were overweight (29.7%) or obese (39.4%), whereas 6.3% were underweight. A total of 65.7% had abdominal obesity. One-fifth (20%) of participants had pre-hypertension, and 3.4% were hypertensive. Around one-quarter (24%) had abnormal glucose tolerance (prediabetes 21.1%, diabetes 2.9%) and the majority (90.9%) had dyslipidaemia. The median Ferriman-Gallwey score was 12, 94.9% of participants had hirsutism and 33.7% had biochemical hyperandrogenism. Metabolic syndrome was present in 42.3% of participants. Higher body mass index and presence of hirsutism were associated with higher risks of metabolic syndrome. Conclusions: The clinical, metabolic and hormonal profiles of Bangladeshi adolescents with PCOS highlight risk factors and the need for clinical vigilance with respect to metabolic disease.
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INTRODUCTION: Separately, polycystic ovary syndrome (PCOS) and subclinical hypothyroidism (SCH) exert adverse effects on several reproductive and metabolic parameters; however, in conjunction, their effects are unclear. This study evaluated the impact of SCH on reproductive and metabolic parameters in women with PCOS. METHODS: In this cross-sectional study, women with newly diagnosed PCOS were evaluated. Data on their clinical presentation and anthropometric measurements were recorded, in addition to oral glucose tolerance test, fasting lipid profile, serum thyroid-stimulating hormone (TSH), free thyroxine (FT4) and anti-thyroid peroxidase (anti-TPO). RESULTS: Four hundred and sixty-five women, aged 12-40 years, with PCOS were included in this study; 10.8% of them had SCH and 18.3% were positive for anti-TPO. All participants had statistically similar mean age, body mass index (BMI), waist circumference, systolic blood pressure (BP) and diastolic BP. A similar number of participants in both the euthyroid PCOS and PCOS-SCH groups had menstrual irregularity, acne, subfertility, a first-degree family member with thyroid dysfunction, acanthosis nigricans and elevated BP. Participants with SCH-PCOS had a lower modified Ferriman-Gallwey score and hirsutism frequency, though serum total testosterone levels were similar in the two groups. More subjects in the SCH group were overweight/obese, and had central obesity and goiter compared to the euthyroid group. Blood glucose, lipids and prolactin levels were similar between the two groups; the frequencies of dysglycaemia and dyslipidaemia were also similar. A higher frequency of metabolic syndrome was observed in the SCH group, though the difference was not statistically significant (p=0.098). CONCLUSION: In women with PCOS, the presence of SCH does not amplify the risk of metabolic and reproductive dysfunctions.
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BACKGROUND: Polycystic ovary syndrome (PCOS) is a heterogeneous androgen-excess disorder. Data comparing the PCOS phenotypes in Bangladesh are scarce. OBJECTIVES: The objective of this study was to find out the distribution of Rotterdam classified PCOS phenotypes and to compare the phenotypes concerning clinical, anthropometric, metabolic, and hormonal parameters. SUBJECTS AND METHODS: In this cross-sectional study, 370 PCOS cases in the age group of 20-45 years diagnosed by the Rotterdam consensus criteria were recruited from the endocrinology outpatient departments of several tertiary hospitals of Bangladesh. Metabolic syndrome (MetS) was diagnosed using the International Diabetes Federation criteria. RESULTS: The prevalence of phenotypes A, B, C, and D were 59.2%, 14.1%, 11.9%, and 14.9%, respectively. More than one-third (34.6%) of the women had pre-hypertension (pre-HTN)/hypertension (HTN), 34.1% had abnormal glucose intolerance (AGT), 93.0% had dyslipidemia, and 57.0% had MetS. The hyperandrogenic phenotypes (A, B, and C) had higher prevalence of pre-HTN/HTN, AGT, dyslipidemia, and MetS compared to the normoandrogenic phenotype D, though the differences were statistically insignificant. The clinical and biochemical markers of hyperandrogenism (Ferriman-Gallwey score, hirsutism, acne, and serum testosterone levels) did not differ among the hyperandrogenic phenotypes. The serum prolactin level was highest in phenotype C. No differences were observed in most other clinical, anthropometric, metabolic, and hormonal parameters among the four phenotypes. CONCLUSION: Phenotype A is the most prevalent phenotype of PCOS in our setting. The prevalence of MetS was considerably high. Most of the clinical, anthropometric, and metabolic parameters were similar across the four PCOS phenotypes in this study.