38 research outputs found

    A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls

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    STUDY QUESTION Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? SUMMARY ANSWER The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. WHAT IS KNOWN ALREADY ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. STUDY DESIGN, SIZE, DURATION This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. PARTICIPANTS, SETTING, METHODS The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. MAIN RESULTS AND THE ROLE OF CHANCE ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight of ≥70 kg at admission was unrelated to pregnancy. Method continuation rates for ENG and LNG implants at 2.5 years were 69.8 (95% CI 66.8-72.6) and 71.8 per 100 W-Y (68.8-74.5), and at 3 years 12.1 (95% CI 5.2-22.0) and 52.0 per 100 W-Y (95% CI 41.8-61.2), respectively. Bleeding disturbances, the most frequent reason for method discontinuation, were significantly more common in the ENG group [16.7 (95% CI 14.4-19.3)] than in the LNG group [12.5 (95% CI 10.5-14.9)] (P 0.019). The 3-year cumulative loss to follow-up was lower in the ENG- than in the LNG-implant group, 8.1 (95% CI 6.4-10.2) and 14.4 per 100 W-Y (95% CI 12.1-17.1), respectively. The median duration of implant removal was 50 s shorter among women with ENG than among women with LNG implant (P < 0.0001). In the observational comparison between IUD and implant users, the 3-year relative risk for pregnancy in IUD group compared with the combined implant group was 5.7 per 100 W-Y (95% CI 4.4-7.3) (P = 0.0003). The 3-year expulsion rate of the IUD was 17.8 per 100 W-Y (95% CI 14.5-21.9), while the discontinuation rate for bleeding disturbances was 8.5 (95% CI 6.7-10.9). Frequency of complaints of headache and dizziness was not significantly different between implant and IUD users (P = 0.16 and 0.77, respectively), acne and bleeding irregularities were more frequent among implant users (P < 0.0001), while heavy bleeding and lower abdominal pain occurred more often among IUD than implant users (P < 0.0001). LIMITATIONS, REASONS FOR CAUTION Few women were ≤19 years old or nulligravida, the proportion of implant users ≥70 kg was <20% and <8% were obese. WIDER IMPLICATIONS OF THE FINDINGS Findings of the study can inform policy makers and clinicians about choice of implant, but also about TCu380A IUD in relation to implants. STUDY FUNDING/COMPETING INTEREST(S) UNDP/UNFPA/WHO/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization (WHO). This report contains the views of an international expert group and does not necessarily represent the decisions or the stated policy of the WHO. TRIAL REGISTRATION ISRCTN33378571 registered on 22 March 2004. The first participant was enrolled on 12 May 200

    The dynamic stability of a rotating pre-twisted asymmetric cross-section Timoshenko beam subjected to lateral parametric excitation

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    A finite element model is presented to study the dynamic stability of a pre-twisted Timoshenko beam having asymmetric aerofoil cross-section subjected to lateral parametric excitation. Solutions referred to as combination resonance are investigated. The effects of shear deformation and rotary inertia are included in the analysis. The effects of coupling due to centre of flexure distance from the centroid and the shear coefficient on the stability are considered. The change in these effects due to pre-twist angle is investigated. It is concluded from the results that the pre-twist angle has an influence on the effects of coupling and the shear coefficient. (C) 2006 Elsevier Ltd. All rights reserved

    Dynamic stability of a rotating pre-twisted asymmetric cross-section Timoshenko beam subjected to an axial periodic force

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    A finite element model is presented to study the static and dynamic stability of a pre-twisted Timoshenko beam having asymmetric acrofoil cross-section subjected to an axial periodic force. The change in the effects of coupling due to centre of flexure distance from the centroid and the shear coefficient on the stability due to the pre-twist angle is considered. It is concluded from the results that the pretwist angle has an influence on the effects of coupling and the shear coefficient. (c) 2006 Elsevier Ltd. All rights reserved

    Dynamic stability of a rotating asymmetric cross-section Timoshenko beam subjected to an axial periodic force

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    Static and dynamic stability of a blade having asymmetric aerofoil cross-section subjected to an axial periodic force is studied by using the finite element method. The effects of shear deformation and rotary inertia are included in the analysis. The effects of the shear coefficient, the beam length, coupling due to the centre of flexure distance from the centroid and rotation on the stability are considered. It is found that as the length of the beam decreases, the effect of rotation on the static buckling load parameters decreases and the effects of coupling and the shear coefficient on the stability become significant. (c) 2005 Elsevier B.V. All rights reserved

    The dynamic stability of a rotating asymmetric cross-section Timoshenko beam subjected to lateral parametric excitation

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    The dynamic stability of a blade having asymmetric aerofoil cross-section subjected to lateral parametric excitation is studied by using the finite element method. The effects of shear deformation and rotary inertia are included in the analysis. Solutions referred to as combination resonance are investigated. The effects of the shear coefficient, the beam length, coupling due to the centre of flexure distance from the centroid and rotation on the stability are considered. It is found that as the length of the beam decreases, the effect of the shear coefficient on stability becomes significant and with an increase in the rotational speed, the blade becomes more stable. (c) 2005 Elsevier B.V. All rights reserved

    Thirty-four patients with Cushing's syndrome: Our clinical experience in the past 20 years

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    Objective: Cushing's syndrome is a relatively rare disorder caused by chronic endogenous hypercortisolemia. We aimed to present patients with Cushing's syndrome who were diagnosed and followed at our endocrinology clinic. Materials and Methods: 34 patients (26 female, 8 male) with Cushing's syndrome were enrolled in this retrospective study. Results: Of 34 patients, 20 had Cushing's disease and 14 had Cushing's syndrome. Regarding the clinical signs of Cushing's syndrome, purple striae were present in 31 subjects (91.2%), hirsutismus in 21 (72.4 %), buffalo hump in 33 (97.1%), moon face in 33 (%97.1), plethora in 33 (%97.1), and menstrual irregularities in 21 (84%) subjects. Diabetes mellitus (DM), hypertension and osteoporosis were found to be 13/34 (39.4%), 23/34 (69.7%) and 18/34 (66.7%), respectively. Following the treatment, primary adrenal failure, secondary adrenal failure, central hypothyroidism, central hypogonadism and central diabetes insipidus were found to be 3 (8.8%), 3 (8.8%), 4 (11.7%), 4 (11.7%) and 4 (11.7%), respectively. Conclusions: As reported in the literature, Cushing's disease is the most common form of Cushing's syndrome and various complications such as adrenal failure, hypogonadism, diabetes insipidus can develop following the treatment

    Is it reliable to estimate insulin resistance by the methods of HOMA-IR or QUICKI in different disorders including type 2 diabetes mellitus, obesity, nonalcoholic fatty liver disease and chronic hepatitis C?

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    Aims: Insulin resistance is a very prevalent disturbance in clinical practice and associated with morbidity and mortality. Homeostasis Model Assessment (HOMA) and Quantitative insulin sensitivity check index (QUICKI) are two practical insulin resistance estimating methods. We compared these two methods in different disorders including type 2 diabetes mellitus, obesity, nonalcoholic fatty liver disease and chronic hepatitis C. Materials and methods: Considering the inclusion criterions, total 200 subjects (type 2 diabetics 40, obese 40, nonalcoholic fatty liver disease 40, chronic hepatitis C 40 and control 40) were included the study. All subjects were measured for waist circumference, and body mass index (BMI) calculated. HOMA model for insulin resistance and QUICKI for insulin sensitivity were used. Cut off level for insulin resistance was accepted as ? 2.24; and <0.3469 for HOMA and QUICKI, respectively. Following 12-h fasting, serum glucose (oral glucose tolerance test for non diabetics), insulin, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglycerides were measured. Results: The results of 200 subjects were evaluated. The ages of patients ranged 18 to 73 years. All disease groups showed significantly higher HOMA and lower QUICKI than the control group (p<0.001). The highest HOMA value (4.73±3.05) was found in type 2 diabetic subjects. QUICKI values of type 2 diabetic group were also significantly lower than the control subjects (p<0.001). Insulin resistance by HOMA were found as 87.5%, 75%, 65%, 55% and 12.5% in type 2 diabetes mellitus, obesity, nonalcoholic fatty liver disease, chronic hepatitis C and control group, respectively. Insulin resistance by QUICKI were found 90%, 82.5%, 72.5%, 60% and 22.5% in type 2 diabetes mellitus, obesity, nonalcoholic fatty liver disease, chronic hepatitis C and control group, respectively. Conclusion: In clinical practice both HOMA and QUICKI are easy and efficient methods to assess the insulin resistance, in type 2 diabetes mellitus, obesity, nonalcoholic fatty liver disease and chronic hepatitis C

    Markers of Metabolic Syndrome in Patients with Pituitary Adenoma: A Case Series of 303 Patients

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    PubMedID: 31683340To assess the demographic characteristics and hormonal status of patients who presented to our clinic with pituitary adenoma and to demonstrate the presence, prevalence, and relationship of metabolic syndrome parameters in these patients. The study included 303 patients with known or newly diagnosed pituitary adenoma and 52 age-and sex-matched healthy controls. The patients were classified into 3 groups; acromegaly (ACRO) (n=54),prolactinoma (PRLoma) (n=163), and non-functional adenoma (NFA) (n=86). in 55.6% (n=172) and 52% (n=163) of the patients, respectively. The waist circumference of all patients (p<0.001) and body mass index (BMI) of patients with PRLoma (p=0.03) and ACRO (p<0.001) were found to be significantly higher than in the controls. The HbA1c, insulin and HOMA-IR values were significantly higher in the ACRO and PRLoma groups, whereas the insulin and HOMA-IR values were significantly higher in the NFA group compared with the control group (p<0.001 and p<0.001, respectively). When the 3 patient groups were compared, waist circumference and BMI were significantly higher in the ACRO group than in the PRLoma group (p=0.04 and p=0.03, respectively). In patients developing pituitary failure after treatment, age, waist circumference, plasma glucose, low-density lipoproteins and triglyceride values were significantly increased when compared with those without pituitary failure after treatment (p<0.001). In our study, it was found that there was increased metabolic and cardiovascular risk in functional pituitary adenoma and NFA. © 2019 Georg Thieme Verlag. All rights reserved
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