Comparison of desogestrel/ethinyl estradiol plus spironolactone versus cyproterone acetate/ethinyl estradiol in the treatment of polycystic ovary syndrome: A randomized controlled trial

BackgroundThe management of acne in adult females is problematic, with many having a history of treatment failure and some having a predisposition to androgen excess. Alternatives to oral antibiotics and combined oral contraceptives (COCs) are required.ObjectiveOur aim was to conduct a hybrid systematic review of the evidence for benefits and potential harms of oral spironolactone in the management of acne in adult females.MethodsThe review was conducted according to a previously published protocol. Three reviewers independently selected relevant studies from the search results, extracted data, assessed the risk of bias, and rated the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.ResultsTen randomized controlled trials (RCTs) and 21 case series were retrieved. All trials were assessed as being at a ‘high risk’ of bias, and the quality of evidence was rated as low or very low for all outcomes. Apart from one crossover trial that demonstrated statistical superiority of a 200 mg daily dose versus inflamed lesions compared with placebo, data from the remaining trials were unhelpful in establishing the degree of efficacy of lower doses versus active comparators or placebo. Menstrual side effects were significantly more common with the 200 mg dose; frequency could be significantly reduced by concomitant use of a COC. Pooling of results for serum potassium supported the recent recommendation that routine monitoring is not required in this patient population.ConclusionThis systematic review of RCTs and case series identified evidence of limited quality to underpin the expert endorsement of spironolactone at the doses typically used (≤100 mg/day) in everyday clinical practice.Electronic supplementary materialThe online version of this article (doi:10.1007/s40257-016-0245-x) contains supplementary material, which is available to authorized users.

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“…Declarations stating no conflicts of interest were provided for two trials [32, 35]. For further details, see Table 1.…”

Section: Resultsmentioning

confidence: 99%

“…One trial compared 25 mg/day spironolactone plus desogestrel/ethinyl estradiol (EE) versus cyproterone acetate/EE [35]. Assessed using the global acne grading system [80], both treatments were similarly effective in reducing the acne severity score from baseline, with an MD of −2.0 (95% CI −4.59 to 0.59; p = 0.13).…”

Section: Resultsmentioning

confidence: 99%

Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review

et al. 2017

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“…Leelaphiwat et al [31] did a comparison between the effects of EE 30 mcg/desogestrel 150 mcg plus spironolactone 25 mg/day, versus EE 35 mcg/cyproterone acetate 2 mg, demonstrating significantly decreased acne scores and free androgen index, while increasing SHBG levels. Cholesterol and high-density lipoprotein were significantly increased in patients treated with spironolactone, while androstenedione was significantly decreased in patients without spironolactone.…”

Section: Discussionmentioning

confidence: 99%

Clinical, hormonal and metabolic parameters in women with PCOS with different combined oral contraceptives (containing chlormadinone acetate versus drospirenone)

Podfigurna

Męczekalski

Luisi

2019

J Endocrinol Invest

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Introduction Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting 5-10% of women of reproductive age. It is characterized by chronic anovulation leading to menstrual disorders, and increased infertility. The syndrome can also manifest as hirsutism and acne. Aim of the study The aim of the study was to compare, over a duration of 6 months, the effects of drospirenone (DRSP) versus chlormadinone acetate (CMA) containing oral contraceptives (OCs) on clinical, hormonal, and metabolic parameters in 120 PCOS women. Materials and methods 120 women with the diagnosis of PCOS according to the Rotterdam 2003 criteria were recruited to the study. All patients were divided to two treatment groups of OCs, containing: 3 mg DRSP/30 mcg EE (ethinylestradiol) (60 patients) and 2 mg CMA/30 mcg EE (60 patients). Clinical parameters such as hirsutismus and acne were evaluated. Metabolic parameters such as serum insulin, glucose concentration, homeostatic model assessment of insulin resistance, body mass index, systolic and diastolic blood pressures were also measured. Among hormonal parameters, serum estradiol, luteinizing hormone, follicle-stimulating hormone, prolactin, testosterone, dehydroepiandrosterone sulfate, thyroid-stimulating hormone, and free thyroxine were measured. Results The use of both DRSP-or CMA-containing OCs provided similar positive therapeutic effects with regard to clinical, metabolic, and hormonal parameters. Among clinical parameters, like hirsutismus, after 6 months of continuous OC treatment, a statistically significant improvement was observed in both groups: DRSP (p < 0.0001) and CMA OC treatment (p < 0.0001). In addition, significant improvement was showed according to acne lesions both after DRSP (p < 0.0001) and CMA treatments (p < 0.0001). Among glucose, insulin levels and HOMA-IR, there were statistically significant higher levels in both groups after DRSP (p < 0.0001, p < 0.0001, p < 0.05) and CMA OC treatment (p < 0.02, p < 0.0001, p < 0.0001). Hormonal parameters such as LH, FSH, prolactin, testosterone and DHEA-S were statistically significant lower in both groups after DRSP (p < 0.0001, p < 0.0001, p < 0.01, p < 0,002, and p < 0.0001) and CMA OC treatment (p < 0.0001, p < 0.0001, p < 0.04, p < 0.002, and p < 0.0001). Conclusions Further research, however, is needed not only to define optimal duration, and to clarify the effects of treatment on long-term metabolic outcomes, but also to explore different treatment options and possible combined therapies.

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“…de 18 mujeres con SOP comparó el tratamiento con EE 0.030 mg/ desogestrel 150 mg/espironolactona 25 mg versus EE 35 mcg/ACP 2 mg, observándose una disminución significativa del score de acné en ambos grupos luego de 3 ciclos de terapia, sin diferencias entre las cohortes 73 . El trabajo de Hagag y cols.…”

Section: Medicamentos Antiandrógenos: Espironolactona Finasteride Y unclassified

Actualización del Síndrome de Ovario Poliquístico y su importancia en Dermatología

Molina

Carvajal

Fernández

2015

Rev. chil. dermatol

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IntroducciónEl Síndrome de Ovario Poliquístico (SOP) es uno de los trastornos endocrinos más frecuentes que afectan a las mujeres en edad reproductiva, cuya prevalencia ha sido estimada entre 8%-18%1 . Las mujeres con SOP tienen asociada una amplia gama de trastornos reproductivos y metabólicos, como diabetes mellitus tipo II, obesidad, dislipidemia, resistencia a la insulina, hipertensión arterial y enfermedad cardiovascular 2 . En la actualidad, constituye la primera causa de infertilidad asociada a anovulación en países desarrollados 3 . Las pacientes con SOP tienen un riesgo aumentado de trastornos psiquiátricos y mayor deterioro de su calidad de vida 4 . DiagnósticoLos criterios del Instituto Nacional de Salud de Estados Unidos del año 1990 definieron el SOP por la presencia de oligo o anovulación y signos clínicos o bioquímicos de hiperandrogenismo 5 . Posteriormente, el año 2003, los criterios de Rotterdam ampliaron la definición a la presencia de 2 de 3 de las siguientes características: oligo o anovulación, signos clínicos o bioquímicos de hiperandrogenismo y ovarios poliquísticos en la ecografía. Es importante enfatizar que ambas definiciones requieren la exclusión de otras causas de anovulación e hiperandrogenismo, como hiperplasia suprarrenal congénita, síndrome de Cushing y tumores secretores de andrógenos 6 . La Asociación Americana de Endocrinología recomienda tomar niveles de testosterona total y testosterona libre, dehidroepiandrostenediona sulfato, prolactina, LH, FSH y 17 hidroxiprogesterona durante los primeros 7 días del ciclo menstrual 7 . Hasta dos tercios de las mujeres con SOP tendrán elevados los niveles de testosterona, que están asociados con mayor morbilidad metabólica y reproductiva 8 . Se recomienda evaluar intolerancia a la glucosa y dislipidemia en todas las pacientes con SOP, especialmente en las pacientes obesas 7,6 . Otros análisis incluyen hormona tiroestimulante, T4L, hormona transportadora de esteroides sexuales (SHBG) y ecografía abdominal. Resumen

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Comparison of desogestrel/ethinyl estradiol plus spironolactone versus cyproterone acetate/ethinyl estradiol in the treatment of polycystic ovary syndrome: A randomized controlled trial

Abstract: Both regimens had quite similar efficacy on hyperandrogenism after three cycles of therapy and without any changes in metabolic parameters.

Cited by 13 publications

References 48 publications

Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review

Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review

Clinical, hormonal and metabolic parameters in women with PCOS with different combined oral contraceptives (containing chlormadinone acetate versus drospirenone)

Actualización del Síndrome de Ovario Poliquístico y su importancia en Dermatología

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