scholarly journals Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manuel Luque-Ramírez ◽  
Andrés E. Ortiz-Flores ◽  
Lía Nattero-Chávez ◽  
M.Ángeles Martínez-García ◽  
María Insenser ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Iron Overload ◽  
Oral Contraceptives ◽  
Polycystic Ovary ◽  
Experimental Period ◽  
Adult Women ◽  
Open Label ◽  
Iron Depletion ◽  
Functional Hyperandrogenism

AbstractNormoferritinemic women with functional hyperandrogenism show a mild iron overload. Iron excess, hyperandrogenism, and cardioautonomic dysfunction contribute to blood pressure (BP) abnormalities in these patients. Furthermore, combined oral contraceptives (COC) prescribed for hyperandrogenic symptoms may worse BP recordings. Iron depletion by phlebotomy appears to lower BP in other acquired iron overload conditions. We aimed to determine the effect of iron depletion on the office BP, ambulatory BP monitoring, and frequency of hypertension in patients with functional hyperandrogenism submitted to standard therapy with COC. We conducted a phase 2 randomized, controlled, parallel, open-label clinical trial (NCT02460445) in adult women with functional hyperandrogenism including hyperandrogenic polycystic ovary syndrome and idiopathic hyperandrogenism. After a 3-month run-in period of treatment with 35 µg ethinylestradiol plus 2 mg cyproterone acetate, participants were randomized (1:1) to three scheduled bloodlettings or observation for another 9 months. Main outcome measures were the changes in office BP, 24-h-ambulatory BP, and frequency of hypertension in both study arms. From June 2015 to June 2019, 33 women were included in the intention-to-treat analyses. We observed an increase in mean office systolic BP [mean of the differences (MD): 2.5 (0.3–4.8) mmHg] and night-time ambulatory systolic BP [MD 4.1 (1.4–6.8) mmHg] after 3 months on COC. The percentage of nocturnal BP non-dippers also increased, from 28.1 to 92.3% (P < 0.001). Office and ambulatory BP did not change throughout the experimental period of the trial, both when considering all women as a whole or as a function of the study arm. The frequency of the non-dipping pattern in BP decreased during the experimental period [OR 0.694 (0.577–0.835), P < 0.001], regardless of the study arm. Decreasing iron stores by scheduled bloodletting does not override the BP abnormalities caused by COC in women with functional hyperandrogenism.

Iron Overload in Functional Hyperandrogenism: In a Randomized Trial, Bloodletting Does Not Improve Metabolic Outcomes

2021 ◽  
Author(s):  
Andrés E Ortiz-Flores ◽  
María Ángeles Martínez-García ◽  
Lía Nattero-Chávez ◽  
Francisco Álvarez-Blasco ◽  
Elena Fernández-Durán ◽  
...  
Keyword(s):  
Insulin Sensitivity ◽  
Iron Overload ◽  
Polycystic Ovary ◽  
Sensitivity Index ◽  
Adult Women ◽  
Open Label ◽  
Iron Depletion ◽  
Intention To Treat ◽  
Plasma Hemoglobin ◽  
Functional Hyperandrogenism

Abstract Context Functional hyperandrogenism may be associated with a mild increase in body iron stores. Iron depletion exerts a beneficial effect on metabolic endpoints in other iron overload states. Objectives (i) To determine the effect of iron depletion on the insulin sensitivity and frequency of abnormal glucose tolerance in patients with functional hyperandrogenism submitted to standard therapy with combined oral contraceptives (COC). ii) To assess the overall safety of this intervention. Design Randomized, parallel, open-label, clinical trial. Setting Academic hospital. Patients Adult women with polycystic ovary syndrome or idiopathic hyperandrogenism. Intervention After a 3-month run-in period of treatment with 35 μg ethinylestradiol plus 2 mg cyproterone acetate, participants were randomized (1:1) to 3 scheduled bloodlettings or observation for another 9 months. Main outcome measures Changes in insulin sensitivity index and frequency of prediabetes/diabetes, and percentage of women in whom bloodletting resulted in plasma hemoglobin &lt;120 g/L and/or hematocrit &lt;0.36. Results From 2015 to 2019, 33 women were included by intention-to-treat. During the follow-up, insulin sensitivity did not change in the whole group of women or between study arms [mean of the differences (MD): 0.0 (95%CI: −1.6 to 1.6)]. Women in the experimental arm showed a similar odds of having prediabetes/diabetes than women submitted to observation [odds ratio: 0.981 (95%CI: 0.712 to 1.351)]. After bloodletting, 4 (21.1%) and 2 women (10.5%) in the experimental arm had hemoglobin (Hb) levels &lt;120 g/L and hematocrit (Hct) values &lt;0.36, respectively, but none showed Hb &lt;110 g/L or Hct &lt;0.34. Conclusions Scheduled bloodletting does not improve insulin sensitivity in women with functional hyperandrogenism on COC.

scholarly journals Combined oral contraceptives plus spironolactone compared with metformin in women with polycystic ovary syndrome: a one-year randomized clinical trial

2017 ◽  
Vol 177 (5) ◽  
pp. 399-408 ◽  
Author(s):  
Macarena Alpañés ◽  
Francisco Álvarez-Blasco ◽  
Elena Fernández-Durán ◽  
Manuel Luque-Ramírez ◽  
Héctor F Escobar-Morreale
Keyword(s):  
Clinical Trial ◽  
Polycystic Ovary Syndrome ◽  
Glucose Tolerance ◽  
Polycystic Ovary ◽  
Total Testosterone ◽  
Open Label ◽  
Ovary Syndrome ◽  
Insulin Sensitizer ◽  
Menstrual Dysfunction ◽  
One Year

Objective We aimed to compare a combined oral contraceptive (COC) plus the antiandrogen spironolactone with the insulin sensitizer metformin in women with polycystic ovary syndrome (PCOS). Design We conducted a randomized, parallel, open-label, clinical trial comparing COC (30 μg of ethinylestradiol and 150 μg of desogestrel) plus spironolactone (100 mg/day) with metformin (850 mg b.i.d.) for one year in women with PCOS (EudraCT2008–004531–38). Methods The composite primary outcome included efficacy (amelioration of hirsutism, androgen excess and menstrual dysfunction) and cardiometabolic safety (changes in the frequencies of disorders of glucose tolerance, dyslipidemia and hypertension). A complete anthropometric, biochemical, hormonal and metabolic evaluation was conducted every three months and data were submitted to intention-to-treat analyses. Results Twenty-four patients were assigned to COC plus spironolactone and 22 patients to metformin. Compared with metformin, COC plus spironolactone caused larger decreases in hirsutism score (mean difference 4.6 points, 95% CI: 2.6–6.7), total testosterone (1.1 nmol/L, 0.4–1.7), free testosterone (25 pmol/L, 12–39), androstenedione (5.5 nmol/L, 1.8–9.2) and dehydroepiandrosterone sulfate (2.7 μmol/L, 1.4–4.0). Menstrual dysfunction was less frequent with COC plus spironolactone (OR: 0.06, 95% CI: 0.02–0.23). No differences were found in frequencies of abnormal glucose tolerance (OR: 1.7, 95% CI: 0.7–4.4), dyslipidemia (OR: 0.6, 95% CI: 0.2–1.8) or hypertension (OR: 0.3, 95% CI: 0.5–2.0). No major adverse events occurred and biochemical markers were similarly safe with both treatments. Conclusions COC plus spironolactone was more effective than metformin for symptoms of PCOS showing similar safety and overall neutral effects on cardiometabolic risk factors.

scholarly journals Nicardipine Hydrochloride Injectable Phase IV Open-Label Clinical Trial: Study on the Anti-Hypertensive Effect and Safety of Nicardipine for Acute Aortic Dissection

2002 ◽  
Vol 30 (3) ◽  
pp. 337-345 ◽  
Author(s):  
KH Kim ◽  
IS Moon ◽  
JS Park ◽  
YB Koh ◽  
H Ahn
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Aortic Dissection ◽  
Acute Aortic Dissection ◽  
Open Label ◽  
Multicentre Phase ◽  
The Third ◽  
Arterial Blood ◽  
Blood Pressures ◽  
Phase Iv

We performed a multicentre, phase IV, open-label clinical trial to examine the clinical usefulness of a continuous infusion of nicardipine hydrochloride to control hypertension in 31 patients with acute aortic dissection. Target blood pressure levels were reached within 15 min in 16 patients; in 15–30 min in 10 patients; in 30–45 min in three patients; and in 45–60 min in two patients. Baseline average systolic, diastolic and mean arterial blood pressures were 147 ± 23 mmHg, 82 ± 18 mmHg and 104 ± 18 mmHg, respectively, with third-day pressures significantly reduced at 119 ± 12 mmHg, 69 ± 9 mmHg and 86 ± 8 mmHg. Blood pressures after discontinuation of the infusion were not significantly different from those measured on the third day of infusion and no definite adverse effects attributable to the treatment were observed. Nicardipine hydrochloride was both effective and safe at controlling blood pressure in patients with acute aortic dissection.

scholarly journals The Effect of Oligopin Supplementation on Hormonal and Metabolic Profiles in the Polycystic Ovary Syndrome: A Randomized Controlled Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Mostafa Qorbani ◽  
Milad Sanginabadi ◽  
Mohammad Reza Mohajeri-Tehrani ◽  
Sara Karimi ◽  
Hadis Gerami ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Metabolic Parameters ◽  
Sex Hormone Binding Globulin ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Specific Serum

BackgroundA double blind clinical trial was performed to evaluate whether the polycystic ovary syndrome (PCOS)-specific serum markers and metabolic parameters would change in the women with PCOS during the three-month administration of oligopin.MethodsIn this double-blind multicenter trial, we randomly assigned 80 PCOS women, based on a 1:1 ratio, to receive oligopin (n= 40) or maltodextrin as placebo (n = 40) for up to 3 months. As PCOS-specific outcomes, we investigated the changes in testosterone, sex hormone binding globulin (SHBG), free androgen index (FAI), dehydroepiandrosterone (DHEA), follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Secondary end points were metabolic (fasting glycaemia, hemoglobin A1c (HbA1c), lipids, insulin resistance (HOMA-IR)), anthropometrics parameters and blood pressure from the baseline to the end of treatment. We investigated serum transaminase, alkaline phosphatase (ALP), creatinine (Cr) and blood urea nitrogen (BUN) levels as hepatic and kidney outcomes, respectively.ResultsThe first participant was enrolled on April 18, 2018, and the last study visit took place on May 14, 2019. PCOS-specific serum parameters did not change during the three-month administration of oligopin (p &gt; 0.05), except for a small increase in the FSH levels (p=0.03). Oligopin neither changed the metabolic profile nor the anthropometric parameters or blood pressure. ALP levels was significantly increased in placebo group, as compared with oligopin (p=0.01).ConclusionOligopin supplementation does not seem to be exerting a beneficial effect on both hormonal and metabolic parameters in the women with PCOS.Clinical Trial Registrationwww.irct.ir, identifier IRCT20140406017139N3.

scholarly journals Evaluation of Magnesium, Vitamin D, Calcium, and Metformin Supplements on Cardiometabolic Variables in Infertile Women Diagnosed with Polycystic Ovary Syndrome (PCOS): A Randomized, Controlled, Clinical Trial

2020 ◽  
Author(s):  
Roghayeh Anvari Aliabad ◽  
Mohsen Gharakhani ◽  
Marzie Farimani
Keyword(s):  
Blood Pressure ◽  
Metabolic Syndrome ◽  
Clinical Trial ◽  
Vitamin D ◽  
Polycystic Ovary Syndrome ◽  
Polycystic Ovary ◽  
Density Lipoprotein ◽  
Controlled Clinical Trial ◽  
Ovary Syndrome ◽  
Significant Difference

Abstract Background Polycystic ovary syndrome (PCOS) is known as an important etiology of ovulation failure which probably is related to resistance to insulin and other possible related metabolic states. The current study aimed to investigate the effect of supplements such as calcium, vitamin D, and magnesium on cardiometabolic risk factors of infertile PCOS patients. Methods This randomized trial was registrered at Iranian Registry of Clinical Trial (reference code: IRCT2013110615307N1). First, bio-demographic data were gathered and complete physical examinations were performed, for all cases. After meeting the inclusion and exclusion criteria, 106 individuals were randomized into the metformin and vitamin D/calcium (37 patients), metformin and magnesium (34 patients), and metformin (35 patients) groups. After 12 weeks, cardiometabolic parameters including blood pressure, fasting blood sugar (FBS), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride (TG), and dehydroepiandrosterone-sulfate (DHEA-S) were compared among the mentioned groups. In order to compare treatment groups per protocol analysis was performed. All data were analyzed by SPSS and any p-value less than 0.05 was considered statistically significant. Results The results showed no significant difference in age, infertility duration, frequency of metabolic syndrome, and the cause and duration of infertility among the groups. Also, no statistically significant difference was found between patients diagnosed with (N=12, 35%) and without metabolic syndrome. Many of the metabolic factors (body mass index (BMI), blood pressure (BP), FBS, LDL, and cholesterol) were decreased significantly in all groups after the treatments (p<0.001). However, this difference was not statistically significant for HDL, DHEA-S, TG, and testosterone for either of the groups. The mean changes of HDL, testosterone, and LDL were statistically different among the groups (P-values= 0.005, 0.004, and 0.008 for group 1, 2, and 3, respectively). Also, in the metformin and magnesium group, the positive changes of some laboratory parameters were more than the other groups; however, this difference was not statistically significant in most cases. Also, BMI and BP in metformin and magnesium group were more reduced, however, the difference was not statistically significant. Conclusion It seems that treatment with metformin and magnesium may have benefits for patients with PCOS but further clinical trials are necessary.

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