Randomized Controlled Trials for the Treatment of Hidradenitis Suppurativa.

Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. Several treatment modalities are available, but most of them lack high-quality evidence. A systematic search was performed to identify all randomized controlled trials for the treatment of HS in order to review and evaluate the evidence. Recommendations for future randomized controlled trials include using validated scores, inclusion of patient rated outcomes, and thorough report of side effects. Evidence for long-term treatment and benefit/risk ratio of available treatment modalities is needed in order to enhance evidence-based treatment in daily clinical practice. Combining surgery with antiinflammatory treatment warrants further investigation.

Mood and physical symptoms improve in women with severe cyclical changes by taking an oral contraceptive containing 250-mcg norgestimate and 35-mcg ethinyl estradiol.

BACKGROUND: The purpose of this study was to investigate how women without and with different severity of premenstrual symptoms react to treatment with a combined oral contraceptive containing 250-mcg norgestimate/35-mcg ethinyl estradiol (EE). Focus was placed on mood and physical symptoms. STUDY DESIGN: This open, prospective study evaluated 24 women using norgestimate/EE for three cycles in a 21/7 regimen. Symptoms and bleeding pattern were captured by daily ratings on the Cyclicity Diagnoser scale. RESULTS: Women with severe premenstrual mood symptoms improved in summarized negative mood (p<.001) and summarized positive mood (p<.05), as well as in swelling (p<.05) and effect on daily life (p<.05). Women with no or mild or moderate symptoms did not show any significant improvement or deterioration in any symptom after 3 months of treatment. CONCLUSIONS: Norgestimate 250 mcg/EE 35 mcg significantly improved premenstrual summarized negative mood symptoms during 3 treatment months compared to pretreatment in women with severe premenstrual symptoms, together with improvement in positive symptoms, swelling and effect on daily life.

Effect of oral contraceptive with and without associated estriol on ultrasound measurements of breast fibroadenoma: randomized clinical trial.

CONTEXT AND OBJECTIVE: Fibroadenomas are the most common benign tumors of the female breast. The aim of this study was to evaluate the proliferative activity of breast fibroadenoma as shown by ultrasound measurements, following administration of oral contraceptives with and without associated estriol. DESIGN AND SETTING: This was a randomized, double-blind, placebo-controlled clinical trial carried out in the Mastology Sector, Department of Gynecology, Universidade Federal de São Paulo. METHODS: We studied 33 women with fibroadenomas. Ten were placed in group 1 and took an oral contraceptive consisting of levonorgestrel and ethinyl estradiol together with placebo material in the same capsule, for four consecutive cycles with a seven-day interval between them. The other 23 patients constituted group 2 and took the oral contraceptive as above together with estriol in the same capsule, in the same way as done by the group 1 patients. We took ultrasound measurements of their tumors (in three dimensions) before and after the intake of medication. At the end of the study, all the patients had their tumors removed by surgery. RESULTS: We observed decreased fibroadenoma width among the users of oral contraceptives with placebo, and this decrease was statistically significant. In the other group, we did not observe any changes (in width, length or height). CONCLUSION: The results confirm that estriol may block the protective effect of oral contraceptives on fibroadenomas, since we observed decreased fibroadenoma width among the group 1 patients but not the group 2 patients.

Effect of oral contraceptive with and without associated estriol on ultrasound measurements of breast fibroadenoma: randomized clinical trial

CONTEXT AND OBJECTIVE: Fibroadenomas are the most common benign tumors of the female breast. The aim of this study was to evaluate the proliferative activity of breast fibroadenoma as shown by ultrasound measurements, following administration of oral contraceptives with and without associated estriol. DESIGN AND SETTING: This was a randomized, double-blind, placebo-controlled clinical trial carried out in the Mastology Sector, Department of Gynecology, Universidade Federal de São Paulo. METHODS: We studied 33 women with fibroadenomas. Ten were placed in group 1 and took an oral contraceptive consisting of levonorgestrel and ethinyl estradiol together with placebo material in the same capsule, for four consecutive cycles with a seven-day interval between them. The other 23 patients constituted group 2 and took the oral contraceptive as above together with estriol in the same capsule, in the same way as done by the group 1 patients. We took ultrasound measurements of their tumors (in three dimensions) before and after the intake of medication. At the end of the study, all the patients had their tumors removed by surgery. RESULTS: We observed decreased fibroadenoma width among the users of oral contraceptives with placebo, and this decrease was statistically significant. In the other group, we did not observe any changes (in width, length or height). CONCLUSION: The results confirm that estriol may block the protective effect of oral contraceptives on fibroadenomas, since we observed decreased fibroadenoma width among the group 1 patients but not the group 2 patients.

CONTEXTO E OBJETIVO: Fibroadenomas são os tumores benignos mais comuns na mama feminina. Avaliamos a atividade proliferativa do fibroadenoma mamário por medidas ultra-sonográficas após a administração de anticoncepcional hormonal combinado oral, associado ou não ao estriol. TIPO DE ESTUDO E LOCAL: Ensaio clínico randomizado, duplo-cego, placebo-controlado, realizado na Universidade Federal de São Paulo. MÉTODOS: Foram estudadas 33 pacientes portadoras de fibroadenoma, do setor de Mastologia da Disciplina de Ginecologia da Universidade Federal de São Paulo, sendo que 10 mulheres constituíram o grupo 1 e utilizaram anticoncepcional oral composto de levonorgestrel e etinilestradiol, associados a um comprimido de placebo, na mesma cápsula, por quatro ciclos consecutivos, com intervalo de sete dias entre os mesmos. As restantes 23 pacientes alocaram-se no grupo 2 e ingeriram, além do anticoncepcional oral descrito acima, um comprimido de estriol, que foi manufaturado conjuntamente ao anticoncepcional, em uma mesma cápsula, sendo utilizado da mesma forma que nas pacientes do grupo 1. Realizamos medidas ultra-sonográficas dos tumores (três dimensões) antes e após a ingestão da medicação. Ao término do estudo, as pacientes sofreram exérese de suas tumorações. RESULTADOS: Obtivemos diminuição da largura nos fibroadenomas de pacientes usuárias apenas de anticoncepcional oral e esse resultado foi estatisticamente significante. Não houve alteração de nenhuma dimensão (largura, altura ou comprimento) no outro grupo. CONCLUSÕES: Os resultados corroboraram que o estriol bloquearia o efeito protetor do anticoncepcional hormonal combinado oral sobre os fibroadenomas, já que observamos diminuição na largura dos fibroadenomas das pacientes do grupo 1 e não do grupo 2.

[Ectopia of cervix of the uterus and hormonal contraception].

The aim of the study was the investigation of impact of different hormonal contraceptive drugs on cervix of uterus of young nullipara women with ectopia. Cytologic smears were examined using Pappanikolau method. Cohort study was carried out by using simple blind method. The data were treated by statistics packet (SPSS). The results displayed correlation between taking the hormonal contraceptives Rigevidon and Marvelon and in transformation of ectopia into micro glandular hyperplasia, which did not occur in taking medicine Exluton. Drug Exluton is recommended for young nullipara women with ectopia to exclude micro glandular hyperplasia. In case of prescribing monophase contraceptives for young nullipara women with ectopia cytological control of endo- and exo-cervix is recommended.

Concomitant administration of lumiracoxib and a triphasic oral contraceptive does not affect contraceptive activity or pharmacokinetic profile.

This study evaluated the effect of lumiracoxib on the pharmacokinetics and pharmacodynamics of ethinyl estradiol (EE) and levonorgestrel (LN) in Triphasil-28 (a triphasic oral contraceptive). Females stabilized on Triphasil-28 continued on Triphasil-28 alone for another month (Treatment Period 1), then also received lumiracoxib (400 mg daily) or placebo for 28 days each (Periods 2 and 3) in a double-blind crossover design. Plasma pharmacokinetic profiles were assessed on Day 21 of Periods 2 and 3. Progesterone and plasma sex hormone binding globulin (SHBG) concentrations were measured before and 2 hours after Triphasil-28 administration on Day 21 of all three treatment periods. Lumiracoxib had no significant effect on EE or LN pharmacokinetics or on progesterone or SHBG concentrations, indicating that anovulation and Triphasil-28 effectiveness was maintained. Adverse events were similar for lumiracoxib and placebo. Therefore, no clinically important consequences are anticipated if lumiracoxib is coadministered with oral contraceptives containing EE or LN.

Acne resolution rates: results of a single-blind, randomized, controlled, parallel phase III trial with EE/CMA (Belara) and EE/LNG (Microgynon).

BACKGROUND AND OBJECTIVE: Acne in women can often be successfully treated by the intake of oral contraceptives containing gestagens with anti-androgenic properties. This study aimed to evaluate the efficacy of the monophasic oral contraceptive ethinylestradiol/chlormadinone acetate (EE/CMA; Belara for the treatment of mild to moderate papulopustular acne of the face and acne-related disorders in comparison to EE/levonorgestrel (LNG; Microgynon. METHODS: 199 female acne patients were enrolled in a single-blind, randomized, multicentre phase III study and divided into two groups who received either EE/CMA or EE/LNG. The primary end point was fulfilled if the number of papules/pustules per half of the face present on admission had decreased by at least 50% in the 12th medication cycle. RESULTS: 59.4% of the women under EE/CMA and 45.9% under EE/LNG were responders. The relative frequency of women with complete resolution was 16.5% under EE/CMA and 4.3% under EE/LNG at cycle 12. CONCLUSION: EE/CMA is an efficient treatment for women with mild and moderate papulopustular acne of the face and related disorders, reflecting the well-known anti-androgenic properties of the progestogen CMA.

[Hormonal correction of the resident microflora of the vagina and uterus cervix in women with chronic cervicitis]. / Gormonal'naia korrektsiia rezidentnoi mikroflory vlagalishcha i sheiki matki u zhenshchin s khronicheskimi tservitsitami.

Clinical, microbiological and hormonal examination of women with chronic cervicitis revealed lesions in the upper section of the reproductive tract in a high proportion of those examined, hormonal disturbances being registered in 96.7% of women. Dysbiotic manifestations (suppression of lacto- and bifidoflora and the excessive growth of opportunistic microorganisms) in the uterus cervix and vagina observed in patients with chronic cervititis were not associated with the etiology of the inflammatory process. The degree of dysmicrobiocenosis in the lower section of the genital tract in women with chronic cervicitis depends on the character of hormonal disturbances. The most significant inhibition of the resident flora was observed when ovarian dysfunction occurred and less significant--in cases of hyperprolactinemia and changes in the level of hypophysial hormones. Hormonal disturbances led to contamination of vagina and cervical canal with opportunistic microorganisms that was inversely proportional to the presence of lactic acid bacteria and bifidobacteria in these organs. Complex therapy of women with chronic cervicitis with the use of preparations for the correction of hormonal disturbances made it possible to restore the normal microflora of the genital tract and to improve the results of treatment.

Efectos del 17 Beta-estradiol oral o transdérmico, combinados con acetato de noretisterona oral secuencial sobre las concentraciones de lipoproteínas séricas / The effects of oral or transdermal 17 Beta-oestradiol combined with cyclical oral Norethisterone acetate on serum lipoprotein concentrations

OBJETIVO: analizar los efectos de 17 Beta-estradiol oral frente al transdérmico, administrados ambos con adición secuencial de acetato de noretisterona oral, sobre las concentraciones séricas de lípidos y lipoproteínas en mujeres posmenopáusicas. PACIENTES Y MÉTODO: análisis abierto, aleatorio, con grupos de estudio paralelos. Se incluyeron 56 mujeres posmenopáusicas, con problemas propios del climaterio, las cuales por lo demás estaban sanas. De éstas, 45 cumplieron los criterios del estudio. Un total de 45 mujeres posmenopáusicas fueron distribuidas aleatoriamente para recibir 17 Beta-estradiol-estriol oral o bien 17 Beta-estradiol transdérmico, junto con la adición cíclica de acetato de noretisterona durante 48 semanas. Las concentraciones séricas de colesterol total, triglicéridos, lipoproteínas de alta densidad (HDL), lipoproteínas de baja densidad (LDL), lipoproteínas de muy baja densidad (VLDL), apolipoproteínas y lipoproteínas (a) fueron determinadas basalmente, después de 46 semanas (fase estrogénica sola) y a las 48 semanas (fase estrogénico-progestágena) de tratamiento. RESULTADOS: la terapia oral con estradiol no afectó a las concentraciones de colesterol sérico total durante la fase únicamente estrogénica, pero durante la fase combinada hubo un descenso del 5,29 por ciento (p < 0,05) debido a una disminución del 6,89 por ciento en los valores de colesterol ligado a lipoproteínas de baja densidad (p < 0,01). La terapia oral también incrementó las concentraciones de triglicéridos séricos en un 14,28 por ciento durante la fase únicamente estrogénica (p < 0,05). Durante la fase combinada de terapia transdérmica hubo un descenso del 19,80 por ciento en las concentraciones de triglicéridos séricos (p < 0,01) y del 5,92 por ciento en los valores de HDL (p < 0,05). El estradiol oral redujo las concentraciones de lipoproteína en un 32,98 por ciento durante la fase únicamente estrogénica y en un 36,08 por ciento con la adición de acetato de noretisterona (p < 0,01). La terapia transdérmica no tuvo efectos significativos sobre la lipoproteína (a). CONCLUSIONES: aparte de un descenso menor en las concentraciones de HDL3 en mujeres a las cuales se les estaba administrando 17 Beta-estradiol transdérmico, la coadministración de progestágenos orales en general mejoró, en vez de empeorar, el perfil de lipoproteínas séricas (AU)

Oral contraceptives in the treatment of acne.

Oral contraceptives (OCs) can reduce acne by lowering the production of adrenal and ovarian androgens, by inhibiting 5-alpha-reductase, which in turn, reduces the levels of dihydrotestosterone, and by stimulating sex hormone binding globulin (SHBG), thus reducing the levels of free testosterone. In newer OCs, such as Tricyclen and Diane-35, the progestin component is minimally androgenic and anti-androgenic respectively, thereby enhancing the favorable profile of these products in the treatment of hyperandrogenic disorders, including acne. The efficacy of these agents and their long-term safety profile supports their use in various grades of acne in females: * As adjunctive therapy to topical agents for women with mild non-scarring acne desiring oral contraception * As primary therapy for patients with moderate non-scarring acne in combination with topical therapy and systemic antibiotics * As one of two preferred methods of contraception in patients with scarring and severe inflammatory acne being treated with systemic isotretinoin.

Oral contraceptives: a cause of hyperbilirubinemia in stem cell transplant patients.

Conjugated hyperbilirubinemia in the clinical setting of hematopoietic stem cell transplantation can have multiple etiologies that may prompt various therapeutic interventions. Two patients who received short courses of a high-dose estrogen-progesterone combination to treat breakthrough menstrual bleeding during transplant are reported. Conjugated hyperbilirubinemia developed in both patients within days of beginning therapy and resolved after the ethinyl estradiol and norgestrel (Ovral; Pharmacia and Upjohn, Kalamazoo, MI, U.S.A.) was discontinued. In one of the patients, this occurred on three separate occasions during the course of transplantation. Recognizing the cholestatic effect of estrogens during transplantation may prevent unnecessary alterations in therapy beyond the simple discontinuation of these medications.

[Our 3- to 5-year experience with Anteovin]. / Nash tri-pet godishen opit s Anteovin.

Anteovin was used in the treatment of dysmenorrhoea, climax precox, dysfunctional uterine bleeding, bleeding with IUD and oral contraceptive. 247 women and adolescents for 6761 cycles were treated with Anteovin for period of 3-5 years. Results were excellent. 21 women--8.17% had side effects.

[The use of the preparation Anteovin in dysfunctional uterine hemorrhages and PCOS]. / Prilozhenie na preparata Anteovin pri nepravilni matochni kruvotecheniia i PCOS.

UNLABELLED: The present prospective study is aimed at estimating the therapeutic effect of a biphasic oestrogen dominated contraceptive pill Anteovin in certain forms of dysfunctional uterine bleeding (DUB) and in polycystic ovary syndrome (PCOS) which is associated with dysfunctional bleeding. Two groups of women were studied--the first group (n = 34) consisted of women with DUB; the second group (n = 31) comprised PCOS. The nature and dynamics of uterine bleeding, contraceptive effectiveness and occurrence of side effects were followed up. In the second group the changes in the levels of testosterone (T), dehydroepiandrosterone sulfate (DHEA-S) and prolactin (Prl) were additionally investigated. RESULTS: A significant decrease in bleeding was observed in both groups. In the second group it is in parallel with a significant decrease of T even as early as on the third month and of DHEA-S on the sixth month of treatment. No significant changes in prolactin levels were found out during the treatment. CONCLUSION: The biphasic contraceptive pill Anteovin has a very good therapeutic effect in DUB and metrorrhagic forms of PCOS while at the same time the side effects are slightly expressed and transitory and an excellent contraception is achieved.

A randomized cross-over study on various hormonal parameters of two triphasic oral contraceptives.

The effect of two triphasic oral contraceptives (Triquilar [TRQ] and Trisiston [TRS]) containing ethinyl estradiol (EE) and levonorgestrel (LNG) on various hormonal parameters was investigated in 26 women during a cross-over study. TRS consisted of 0.03 mg EE + 0.05 mg LNG (six tablets), 0.04 mg EE + 0.075 mg LNG (six tablets), and 0.03 mg EE + 0.15 mg LNG (nine tablets), whereas TRQ was different in the second phase (five tablets) and third phase (10 tablets). Blood samples were taken on days 6, 11, 21, and 28 of the control and washout cycles and the third treatment cycle. Both formulations inhibited ovulation reliably and decreased the serum levels of gonadotropins, free testosterone, and dehydroepiandosterone sulfate in a time-dependent manner, whereas estradiol and testosterone were already suppressed on day 6, indicating a direct suppressive effect on ovarian steroid synthesis. Prolactin, which rose sporadically in some women, was not significantly changed. In contrast, the levels of sex hormone binding globulin, corticosteroid binding globulin, and cortisol were significantly elevated by 100%. During the hormone-free interval of 7 days, all parameters returned at least partly to baseline. There was no significant difference between the effects of both formulations. The results suggest the possibility of a direct inhibitory effect of contraceptive steroids on ovarian steroid synthesis.

PIP: A randomized crossover study involving 26 women in Germany investigated the effect of two triphasic oral contraceptives (OCs) on selected hormonal parameters. The first triphasic, Trisiston, contained 0.03 mg of ethinyl estradiol (EE) and 0.05 mg of levonorgestrel (LNG) (6 tablets), 0.04 mg EE and 0.075 mg LNG (6 tablets), and 0.03 mg EE and 0.15 mg LNG (9 tablets). The second, Triquilar, differed from the first in the second (5 tablets) and third (10 tablets) phases. Serum samples were collected on days 6, 11, 21, and 28 of the control and washout cycles and the third treatment cycle. There were no significant differences in the hormonal effects of the two formulations. Both triphasics inhibited ovulation reliably and decreased serum levels of gonadotropins, free testosterone, and dehydroepiandrosterone sulfate in a time-dependent manner. Estradiol and testosterone were already suppressed on day 6. Prolactin rose sporadically in some women, but was not significantly changed. In contrast, levels of sex hormone binding globulin, corticosteroid binding globulin, and cortisol were significantly elevated by 100%. During the 7-day hormone-free interval, all parameters returned at least partly to baseline. These findings suggest a direct inhibitory effect of OC steroids on ovarian steroid synthesis.

Effect of Depo-Provera or Microgynon on the painful crises of sickle cell anemia patients.

Forty-three homozygous (SS) female sickle cell anemic patients with a history of at least one painful crisis per month and desiring a reversible contraceptive were administered DMPA/3 months or Microgynon monthly. A third group of 16 surgically sterilized patients served as control. Patients were followed for 1 year to assess possible effects of the contraceptives on the patients' painful crises. No changes were observed in any of the groups in the hematological parameters. At the end of the study, 70% of the patients receiving DMPA were pain-free and only 16% of those still reporting painful crises rated them as intense. Patients receiving Microgynon also had an amelioration of the painful crises, although at a lower rate; after 12 months, 45.5% still experienced some crises. Although less marked than in the other groups, 50.5% of the control patients also reported an improvement of their painful crisis, which may be a result of closer medical care.

PIP: The effects of a combined oral contraceptive (Microgynon 30, containing ethinyl estradiol and levonorgestrel) and a progestogen-only injectable contraceptive (Depo-Provera) on the intensity and frequency of painful crises were investigated in 43 homozygous sickle cell anemia patients at the World Health Organization Collaborative Center for Research in Human Reproduction in Panama. Only women with a history of at least one painful crisis per month were enrolled. The patients were randomly assigned to receive Depo-Provera (n = 13) or Microgynon (n = 14) for 12 months; the remaining 16 patients--surgically sterilized controls-- received no treatment. No changes were recorded throughout the study period in any of the three groups in hematological parameters. In addition, there were no pregnancies or treatment-related side effects. In the Depo-Provera group, the percentage of patients with painful crises diminished steadily from 50% at 3 months to 30% at 12 months. Moreover, 84% of painful episodes experienced by Depo-Provera acceptors were characterized as moderate or mild. Among women in the Microgynon group, the rate of painful crises dropped from 72.7% at 3 months to 45.5% at 12 months. Controls also reported a 50.5% decline in painful crises, presumably as a result of increased individual attention from medical staff. These findings suggest that Depo-Provera can be safely and effectively used for contraceptive purposes in sickle cell anemic patients, with a concomitant beneficial effect on painful crises.

Augmentation of low ovarian response to superovulation before in vitro fertilization following priming with contraceptive pills.

Poor ovarian response to superovulation treatment is observed in a certain group of patients, the so-called 'low responders'. Despite the evolution of sophisticated controlled ovarian hyperstimulation (COH) regimens prior to the in vitro fertilization (IVF), the ideal stimulation protocol for the low responder has yet to be formulated. The objective of this study was to assess the effect of oral contraceptive pills (OCP), administered before the initiation of superovulation, on ovarian response and IVF treatment results in patients with previous 'low response' to exogenous gonadotropin stimulation. The study group comprised 42 patients who had exhibited poor ovarian response to standard superovulation protocols in at least two previous consecutive treatment attempts. Contraceptive pills were administered for 28-42 days and were immediately followed by menotropin treatment. The study group (n=50 cycles) was compared with the control group consisting of previous cycles (n=88) of the same women. Significant differences were noted in peak estradiol levels (983 +/- 739 vs. 517 +/- 249 pg/ml; P <0.01, paired Student's t test) and number of pre-ovulatory follicles between the study and the control groups. Thirty-three of the cycles (66%) reached the stage of ovum pick-up, compared with 22 (25%) of the previous IVF cycles in these women. The mean number of oocytes retrieved was 6.1 +/- 3.0 and 2.4 +/- 1.3 in the study and control groups, respectively (P <0.01; paired Student's t test). Embryo transfer (ET) was performed in 62% of the treatment cycles and resulted in five clinical pregnancies (16.1% per ET). No pregnancies were recorded in the control group. This study demonstrates the beneficial effect of OCP given prior to IVF treatment, and provides an efficient treatment modality for women who consistently respond poorly to standard COH protocols.