RESUMO
STUDY QUESTION: Does luteal phase estrogen valerate pretreatment improve oocyte yield and clinical outcomes in patients with low ovarian response during ovarian stimulation with the antagonist protocol? SUMMARY ANSWER: Pretreatment with oral estrogen valerate from Day 7 after ovulation to Day 2 of the next menstrual cycle did not increase oocyte yield in patients with a low ovarian response compared to no pretreatment. WHAT IS KNOWN ALREADY: Previous studies showed that patients with a normal ovarian response can obtain better clinical outcomes after pretreatment with estrogen in the antagonist protocol. For patients with advanced age and low ovarian response, it remains unclear if estrogen valerate pretreatment with the antagonist protocol yields more oocytes and improves pregnancy outcomes. STUDY DESIGN, SIZE, DURATION: This non-blinded randomized controlled trial (RCT) was conducted between November 2017 and March 2021. Participants were 552 women with low response who requested IVF treatment. The primary endpoint was comparison of the total number of retrieved oocytes between the two groups. The secondary endpoints were the total number of retrieved metaphase II (MII) oocytes, duration and total dosage of recombinant FSH (rFSH), good-quality embryo rate and clinical pregnancy rate. PARTICIPANTS/MATERIALS, SETTING, METHODS: The study was conducted at a reproductive center. The RCT enrolled 552 infertile women with a low ovarian response (according to the Bologna criteria) who were undergoing IVF. In the study group, on Day 7 after ovulation patients were administered oral estrogen valerate (2 mg twice a day) until Day 2 of their next menstruation. Ovary stimulation was performed using rFSH, and a GnRH antagonist (0.25 mg/day) was started when a dominant follicle had a mean diameter ≥13 mm. MAIN RESULTS AND THE ROLE OF CHANCE: No significant difference was observed in the number (mean [SD]) of oocytes retrieved from the estrogen valerate pretreatment and control group (3.2 [2.8] versus 3.4 [2.6], respectively). The treatment difference was -0.18 (95% CI -0.67, 0.32, P = 0.49). No significant differences were observed in the number of MII oocytes (2.9 [2.5] versus 3.1 [2.4], mean difference -0.23, 95% CI (-0.69, 0.23), P = 0.16) and good-quality embryos (1.0 [1.3] versus 1.20 [1.6], mean difference -0.23, 95% CI (-0.50, 0.04), P = 0.19) between the two groups. The duration of rFSH treatment was significantly longer in the estrogen valerate pretreatment group than in the control group (10.3 [2.2] versus 8.6 [2.1] days, mean difference 1.7, 95% CI (1.3, 2.2), P = 0.00), and the total rFSH dosage was significantly higher in the estrogen valerate pretreatment group than in the control group (3081 [680] versus 2548 [649] IU, mean difference 553.7, 95% CI (405.8, 661.6), P = 0.00). The clinical pregnancy rate in the pretreatment group (19.3% [23/119]) was not significantly different from that in the control group (28.7% [43/150]). The mean difference was -0.09, 95% CI (-0.20, 0.01), P = 0.08. LIMITATIONS, REASONS FOR CAUTION: The major limitation was the high dropout rate of patients. Some patients did not return to the hospital for treatment because of predicted low success rates and for economic reasons. In addition, it is possible that the fixed dose of 300 IU rFSH was not sufficient to see differences in oocyte yield between the groups. WIDER IMPLICATIONS OF THE FINDINGS: Estrogen valerate pretreatment with an antagonist protocol did not increase oocyte yield in patients with low ovarian response. Similar to the number of retrieved oocytes, there was no significant difference in clinical pregnancy rate between estrogen pretreatment group and control group. More research is needed on whether patients with low ovarian response need pretreatment and which pretreatment is more appropriate. STUDY FUNDING/COMPETING INTEREST(S): This study was supported in part by a research grant from the Investigator-Initiated Studies Program of MSD (China) Holding Co., Ltd. and Organon (Shanghai) Pharmaceutical Technology Co., Ltd. (Grant number: IIS 56284). The authors declare that they have no competing interests regarding authorship or publication of this study. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03300518. TRIAL REGISTRATION DATE: 28 September 2017. DATE OF FIRST PATIENT'S ENROLMENT: 15 November 2017.
Assuntos
Recuperação de Oócitos , Ovário , Coeficiente de Natalidade , China , Estrogênios/uso terapêutico , Feminino , Fertilização in vitro/métodos , Hormônio Liberador de Gonadotropina , Humanos , Ovário/fisiologia , Indução da Ovulação/métodos , Gravidez , Taxa de Gravidez , ValeratosRESUMO
Genistein possesses estrogenic activity and has been considered a potential replacement for estrogen replacement therapy after menopause. In the current study, we investigated the neuroprotective effects of dietary genistein at varied lengths of estrogen deprivation in middle-aged ovariectomized Sprague-Dawley rats under ischemic conditions. Two weeks of treatment with dietary genistein at 42 mg/kg but not 17ß-estradiol implants improved cognitive flexibility (Morris water maze test) after short-term estrogen deprivation (2 weeks) but not long-term estrogen deprivation (12 weeks). 17ß-estradiol implants but not dietary genistein improved locomotor asymmetry (cylinder test) after long-term but not short-term estrogen deprivation. Dietary genistein but not 17ß-estradiol implant improved early phase motor learning (rotarod test) after long-term estrogen deprivation. Neither 17ß-estradiol implant nor dietary genistein reduced infarct size after either short-term or long-term estrogen deprivation. Genistein, however, reduced ionized calcium-binding adaptor molecule-1 (Iba1) expression, a marker of brain inflammation, at the ipsilateral side of stroke injury after short-term but not long-term estrogen deprivation. This study suggests that the neuroprotective effects of dietary genistein on motor and cognitive functions are distinctly influenced by the length of estrogen deprivation following focal ischemia. SIGNIFICANCE: There is an increasing postmenopausal population opting for homeopathic medicines for the management of menopausal symptoms due to the perceived distrust in estrogen use as hormone replacement. Basic and clinical studies support the notion that early, but not delayed, hormone replacement after menopause is beneficial. Furthermore, evidence suggests that delaying hormone replacement augments the detrimental, rather than the beneficial effects of estrogens. Because of the active consideration of soy isoflavones including genistein as alternatives to estrogen replacement, it is necessary to understand the ramifications of soy isoflavones use when their administration is begun at various times after menopause.
Assuntos
Genisteína , Fármacos Neuroprotetores , Animais , Cognição , Estradiol/farmacologia , Estradiol/uso terapêutico , Estrogênios/metabolismo , Estrogênios/farmacologia , Feminino , Genisteína/farmacologia , Humanos , Isquemia/tratamento farmacológico , Ovariectomia , Ratos , Ratos Sprague-DawleyRESUMO
BACKGROUND: Endometriosis is a chronic inflammatory disease that causes difficult-to-treat pelvic pain. Thus being, many patients seek help in complementary and alternative medicine, including homeopathy. The effectiveness of homeopathic treatment for endometriosis is controversial due to the lack of evidences in the literature. The aim of the present randomized controlled trial is to assess the efficacy of potentized estrogen compared to placebo in the treatment of chronic pelvic pain associated with endometriosis. METHODS/DESIGN: The present is a randomized, double-blind, placebo-controlled trial of a homeopathic medicine individualized according to program 'New Homeopathic Medicines: use of modern drugs according to the principle of similitude' (http://newhomeopathicmedicines.com). Women with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to the adverse events caused by estrogen were recruited at the Endometriosis Unit of Division of Clinical Gynecology, Clinical Hospital, School of Medicine, University of São Paulo (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP). The participants were selected based on the analysis of their medical records and the application of self-report structured questionnaires. A total of 50 women meeting the eligibility criteria will be randomly allocated to receive potentized estrogen or placebo. The primary clinical outcome measure will be severity of chronic pelvic pain. Statistical analysis will be performed on the intention-to-treat and per-protocol approaches comparing the effect of the homeopathic medicine versus placebo after 24 weeks of intervention. DISCUSSION: The present study was approved by the research ethics committee of HCFMUSP and the results are expected in 2016. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: https://clinicaltrials.gov/ct2/show/NCT02427386.
Assuntos
Endometriose/terapia , Estrogênios/uso terapêutico , Homeopatia/métodos , Dor Pélvica/terapia , Método Duplo-Cego , Feminino , Humanos , Materia Medica/uso terapêutico , Projetos de PesquisaRESUMO
Breast-feeding is not advisable in certain situations and some women do not want to breast-feed. If the woman does not breast-feed, lactation ceases after one or two weeks. Where does the evaluation of methods used to prevent onset of lactation stand in 2012? To answer this question, we reviewed the available evidence, based on the standard Prescrire methodology. Among the physical methods sometimes proposed, breast binding causes greater discomfort than wearing a bra. Dopamine agonists, such as bromocriptine, are effective in inhibiting lactation. But the serious, mainly cardiovascular, adverse effects they provoke are disproportionate to the discomfort they prevent.These drugs are best avoided. High doses of oestrogens inhibit lactation, but the risk of thromboembolism they pose is unreasonable in the postpartum setting. Neither diuretics nor homeopathy have been shown to have any tangible efficacy against the discomfort associated with onset of lactation. In practice, a standard analgesic such as paracetamol generally eases the few days of discomfort or pain associated with the onset of lactation. Wearing a bra is risk-free and sometimes provides relief. Breast discomfort, however intense, does not justify exposing women to the serious adverse effects linked to postpartum administration of dopamine agonists or oestrogens.
Assuntos
Lactação/efeitos dos fármacos , Ejeção Láctea/efeitos dos fármacos , Analgésicos/uso terapêutico , Aleitamento Materno , Agonistas de Dopamina/efeitos adversos , Agonistas de Dopamina/uso terapêutico , Estrogênios/efeitos adversos , Estrogênios/uso terapêutico , Feminino , HumanosRESUMO
BACKGROUND: Combined oral contraceptives are known to confer a risk of venous thromboembolism, including cerebral venous sinus thrombosis (CVST), to otherwise healthy women. NuvaRing (Organon USA, Inc., Roseland, NJ) is a contraceptive vaginal ring that delivers 120 µg of etonogestrel and 15 µg of ethinyl estradiol per day. Its use has been associated with rare venous thromboembolic events, but few cases of CVST associated with NuvaRing have been reported. OBJECTIVE: To describe a case that illustrates the increased risk of CVST associated with use of NuvaRing. We describe the case of a NuvaRing user who presented to our emergency department with a headache, who was diagnosed with CVST. CONCLUSION: Evidence suggests that NuvaRing has at least as much prothrombotic potential as combined oral contraceptives. Thus, emergency physicians should suspect serious venous thromboembolic events, including CVST, deep venous thrombosis, and pulmonary embolism, in NuvaRing users in the proper clinical setting.
Assuntos
Anticoncepcionais Femininos/efeitos adversos , Dispositivos Anticoncepcionais Femininos/efeitos adversos , Estrogênios/efeitos adversos , Trombose dos Seios Intracranianos/induzido quimicamente , Adulto , Desogestrel , Etinilestradiol , Feminino , Cefaleia/etiologia , Humanos , Dispositivos Intrauterinos Medicados/efeitos adversos , Tomografia Computadorizada por Raios XRESUMO
OBJECTIVE: To investigate the effect of Yi Fu Ning Soft Gelatin Capsules (YFN) on reproductive endocrine-immune function of ovariectomized rats. METHODS: 60 3-month old female Sprague-Dawley rats were used, 50 of them were ovariectomized and randomly divided into 5 groups: ovariectomizy (OVX) group, OVX with diethylstilbestrol tablets (DT) group, OVX with YFN (high dose, middle dose and low dose) group. The others were sham-operated group. The rats were administrated initially in the 4th week after the operation. After drugs had been given for 12 weeks the rats were sacrificed, blood serum hormone, IL-2 content and T lymphocyte subpopulation were detected with methods radioimmunoassay and flow cytometry (FCM). RESULTS: (1) Compared with sham group, the level of serum E2, Te and P significantly decreased (P < 0.01), FSH, LH content significantly increased; Blood T lymphocyte subpopulation CD3+ cells, CD4+ cells and CD4+/CD8+ ratio significantly decreased, serum IL-2 content also significantly decreased (P < 0.01). (2) Compared with model group, after treated by YFN, the level of serum E2 and P significantly increased (P < 0.01), serum FSH and LH content significantly decreased; T lymphocyte subpopulation CD3+ cells, CD4+ cells and CD4+/CD8+ ratio were improved significantly and serum interleukin-2 (IL-2) content increased significantly. CONCLUSION: YFN can increase serum sexual hormone content,reduce the level of FSH and LH, and improve imbalanced T lymphocyte subpopulation, stimulate IL-2 excretion, which means YFN can regulate inordinate reproductive endocrine-immune network in ovariectomized rats.
Assuntos
Medicamentos de Ervas Chinesas/farmacologia , Estradiol/sangue , Estrogênios/sangue , Materia Medica/farmacologia , Subpopulações de Linfócitos T/imunologia , Animais , Cápsulas , Curcuma/química , Combinação de Medicamentos , Medicamentos de Ervas Chinesas/uso terapêutico , Feminino , Citometria de Fluxo , Hormônio Foliculoestimulante/sangue , Hexestrol/farmacologia , Hexestrol/uso terapêutico , Interleucina-2/sangue , Materia Medica/uso terapêutico , Ovariectomia , Plantas Medicinais/química , Radioimunoensaio , Distribuição Aleatória , Ratos , Ratos Sprague-Dawley , Subpopulações de Linfócitos T/efeitos dos fármacosRESUMO
BACKGROUND AND METHODOLOGY: Combined oral contraceptives (COCs) provide reliable and convenient contraception, although contraindications and tolerability issues may limit their use in some women. Progestogen-only pills (POPs) may be more suitable for some women, however, traditional POPs do not have the same contraceptive efficacy as COCs. A literature search was performed in order to assess the incidence of ovulation with available COCs, traditional POPs and with a desogestrel POP [Cerazette, 75 microg desogestrel (DSG)]. The following databases were searched: MEDLINE, EMBASE, Biosis, Derwent Drug File, Current Contents and the in-house Organon database 'Docs' (which contains all published reports of Organon products). Searches used free-text terms [e.g. Contraceptive$ in combination with (Ovulat$ adj Rate$), (Ovar$ adj Activ$) or (Escap$ adj Ovulat$)] and were limited to the search criteria 'Human' and 'from 1979 onwards'. The searches included publications up to July 2008. RESULTS: Many of the studies were hampered by inadequate ovulation criteria; however, the overall incidence of ovulation determined by the reports uncovered in the literature search was 2.0% [95% confidence interval (CI) 1.1-3.3] with COCs containing 30-35 microg ethinylestradiol (EE), 1.1% (95% CI 0.60-2.0) with 15-20 microg EE COCs, 4.6% (95% CI 2.8-6.9) with phasic COCs, 1.25% (95% CI 0.03-6.8) with Cerazette and 42.6% (95% CI 33.4-52.2) with traditional POPs. CONCLUSIONS: The findings indicate that COCs and the desogestrel POP are equally effective in suppressing ovulation, whilst the traditional POP formulations are less effective.
Assuntos
Anticoncepcionais Orais , Ovulação , Relação Dose-Resposta a Droga , Estrogênios/administração & dosagem , Feminino , Humanos , Congêneres da Progesterona/administração & dosagemRESUMO
Evaluar la eficacia y seguridad del estrógeno potenciado en comparación con el placebo en el tratamiento homeopático del dolor pélvico asociado a endometriosis (EAPP, por sus siglas en inglés). Diseño del estudio: El presente fue un estudio clínico aleatorizado, doble ciego, controlado con placebo, de 24 semanas, el cual incluyó a 50 mujeres de entre 18 y 45 años de edad con diagnóstico de endometriosis infiltrante profunda con base en ultrasonido transvaginal o imágenes de resonancia magnética después de preparación intestinal, así como puntaje ≥ 5 en una escala visual analógica (VAS: rango de 0 a 10 puntos) para el dolor pélvico asociado con la endometriosis. Se administró estrógeno potenciado (12cH, 18cH y 24cH) o placebo dos veces al día por vía oral. La medida principal de resultado fue el cambio en la severidad de los puntajes parcial y global de EAPP (VAS) de la línea basal a la semana 24, determinada como la diferencia en el puntaje medio de cinco modalidades de dolor pélvico crónico (dismenorrea, dispareunia profunda, dolor pélvico no cíclico, dolor intestinal cíclico y/o dolor urinario cíclico). Las medidas secundarias de resultado fueron la diferencia media de puntaje para la calidad de vida evaluada con el Cuestionario de Salud SF-36, los síntomas de depresión en el Inventario de la Depresión de Beck (BDI) y los síntomas de ansiedad en el Inventario de Ansiedad de Beck (BAI). Resultados: El puntaje global de EAPP (VAS: rango de 0 a 50 puntos) se redujo en 12.82 (p < 0.001) en el grupo tratado con estrógeno potenciado de la línea basal a la semana 24. El grupo que utilizó estrógeno potenciado también presentó una reducción en el puntaje parcial (VAS: rango de 0 a 10 puntos) en tres modalidades de EAPP: dismenorrea (3.28; p < 0.001), dolor pélvico no cíclico (2.71; p = 0.009) y dolor intestinal cíclico (3.40; p < 0.001). El grupo de placebo no mostró cambio significativo alguno en los puntajes global o parcial de EAPP. Además, el grupo de estrógeno potenciado mostró un mejoramiento significativo en tres de ocho ámbitos de SF-36 (dolor de cuerpo, vitalidad y salud mental) y síntomas de depresión (BDI). El grupo de placebo no mostró un mejoramiento significativo a este respecto. Estos resultados demuestran la superioridad del estrógeno potenciado sobre el placebo. Se asociaron pocos eventos adversos con el estrógeno potenciado. Conclusiones: El estrógeno potenciado (12cH, 18cH y 24cH) en dosis de 3 gotas dos veces al día durante 24 semanas fue significativamente más efectivo que el placebo para reducir el dolor pélvico asociado con la endometriosis. Registro del estudio clínico: ClinicalTrials.gov Identificador: https://clinicaltrials.gov/show/NCT02427386.
To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, doubleblind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p < 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p < 0.001), non-cyclic pelvic pain (2.71; p = 0.009), and cyclic bowel pain (3.40; p < 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.
Assuntos
Humanos , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Terapêutica Homeopática , Dor Pélvica/terapia , Endometriose/complicações , Estrogênios/uso terapêutico , Placebos , Método Duplo-CegoRESUMO
OBJECTIVE: To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). STUDY DESIGN: The present was a 24-week, randomized, double-blind, placebo-controlled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score≥5 on a visual analogue scale (VAS: range 0 to 10) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). RESULTS: The EAPP global score (VAS: range 0 to 50) decreased by 12.82 (P<0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10) reduction in three EAPP modalities: dysmenorrhea (3.28; P<0.001), non-cyclic pelvic pain (2.71; P=0.009), and cyclic bowel pain (3.40; P<0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. CONCLUSIONS: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02427386.
Assuntos
Endometriose/complicações , Estrogênios/administração & dosagem , Dor Pélvica/terapia , Adolescente , Adulto , Método Duplo-Cego , Estrogênios/uso terapêutico , Feminino , Homeopatia , Humanos , Pessoa de Meia-Idade , Dor Pélvica/etiologia , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: To pilot an investigation of individualized homeopathy for symptoms of estrogen withdrawal in breast cancer survivors. DESIGN: Randomized, double-blinded, placebo-controlled trial. SETTING: Outpatient department of a National Health Service (NHS) homeopathic hospital. PARTICIPANTS: Fifty-seven (57) women met inclusion criteria and 53 were randomized to the study. INTERVENTION: After 2 weeks of baseline assessment, all participants received a consultation plus either oral homeopathic medicine or placebo, assessed every 4 weeks for 16 weeks. OUTCOME MEASURES: The primary outcome measures were the activity score and profile score of the Measure Yourself Medical Outcome Profile (MYMOP). RESULTS: Eighty-five percent (85%) (45/53) of women completed the study. There was no evidence of a difference seen between groups for either activity (adjusted difference =-0.4, 95% confidence interval CI -1.0 to 0.2, p = 0.17) or profile scores (adjusted difference = -0.4, 95% CI -0.9 to 0.1, p = 0.13) using this trial design, although post hoc power calculations suggests that 65-175 would be needed per group to detect differences of this magnitude with sufficient precision. Clinically relevant improvements in symptoms and mood disturbance were seen for both groups over the study period. CONCLUSION: Improvements were seen for symptom scores over the study period. However, presuming these improvements were caused by the individualized homeopathic approach, the study failed to show clearly that the specific effect of the remedy added further to the nonspecific effects of the consultation. Future trial design must ensure adequate power to account for the nonspecific impact of such complex individualized interventions while pragmatic designs may more readily answer questions of clinical and cost effectiveness.
Assuntos
Neoplasias da Mama , Estrogênios/deficiência , Homeopatia/métodos , Sobreviventes , Adulto , Neoplasias da Mama/terapia , Intervalos de Confiança , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Razão de Chances , Projetos Piloto , Qualidade de Vida , Projetos de Pesquisa , Índice de Gravidade de Doença , Inquéritos e Questionários , Resultado do TratamentoRESUMO
The study was done to assess the clinical performance and in vivo steroid release rate of 3-keto-desogestrel subdermal implants designed to deliver 5 different doses of the progestin. Volunteers were healthy women of proven fertility who provided blood samples at scheduled intervals during treatment. No pregnancy occurred in 514 woman-months in users of implants delivering 30 and 40 micrograms per day of 3-keto-desogestrel. Three pregnancies, one ectopic, were observed in 109 woman-months recorded with implants delivering 20 micrograms per day or less. Ovulation was inhibited, as judged by depressed progesterone levels, in 57 of 59 (97%) blood samplings in women whose 3-keto-desogestrel plasma levels were greater than 0.28 nmol/L and in 39 of 75 (52%) of cases with lower levels. Users of 4 cm implants manufactured by The Population Council, New York, showed mean levels above 0.28 nmol/L until 18 months of use. Levels achieved with 4.4 cm implants manufactured by Organon, Oss, Holland, were less consistent. No changes were observed in the plasma lipoprotein pattern or clinical chemistry during treatment. The main complaint was the occurrence of bleeding irregularities, particularly with the lower doses. Ovarian cysts found during pelvic examination in 11 (22%) subjects disappeared spontaneously within 7-90 days. 3-keto-desogestrel implants releasing around 40 ug/day and providing plasma levels around 0.28 nmol/L afford efficient contraceptive protection.
Assuntos
Desogestrel , Norpregnenos/normas , Adolescente , Adulto , Anticoncepcionais Femininos/administração & dosagem , Anticoncepcionais Femininos/sangue , Anticoncepcionais Femininos/normas , Relação Dose-Resposta a Droga , Implantes de Medicamento , Estrogênios/sangue , Feminino , Fertilização/efeitos dos fármacos , Humanos , Injeções Intradérmicas , Norpregnenos/administração & dosagem , Norpregnenos/sangue , Ovulação/efeitos dos fármacos , Progesterona/sangueRESUMO
Intravenously administered oxytocin caused a dose-related fall in blood pressure of the rabbit. When oxytocin was administered in oestrogen-primed animals, the depressor response was converted to a pressor one "Oxytocin reversal". The "oxytocin reversal." was abolished after treatment with dihydroergotamine, hexamethonium or adrenalectomy. The "oxytocin reversal" did not appear in reserpinized animals.
Assuntos
Pressão Sanguínea/efeitos dos fármacos , Estrogênios/farmacologia , Ocitocina/farmacologia , Adrenalectomia , Animais , Di-Hidroergotamina/farmacologia , Estriol/análogos & derivados , Estriol/farmacologia , Feminino , Compostos de Hexametônio/farmacologia , Masculino , Pancurônio/análogos & derivados , Pancurônio/farmacologia , Coelhos , Reserpina/farmacologia , Estimulação QuímicaRESUMO
OBJECTIVE: Through investigating the changs of sex hormone, nitric oxide (NO), nitric oxide synthase (NOS), superoxide dismutase (SOD) and malonaldehyde (MDA) in the serum of ovariectomized, rats, the mechanism of cardiovascular disease occurring in post-menopause rats and the effect of Yi-Fu-Ning soft capsule (YFN) on above-menticned indexes were discussed. METHOD: Fifty female mature Sprague-Dawley rats were randomly divided into 5 groups: sham operation, ovariectomy (OVX), OVX with diethylstilbestrol tables (DT), OVX with YFN (high dose and low dose). After administrating drugs of 4 weeks, sex hormone, NO, NOS, SOD and MDA levels in rat serum were detected. RESULT: In ovariectomized rats serum, with the drop of E2 concentration, NO, NOS, SOD levels decreased, while MDA content increased. And the E2 concentration was correlated with other index levels. YFN can obviously regulate above-mentioned indexes. CONCLUSION: The cardiovascular disease occurring in post-menopause rats is possibly due to the decrease of serum sex hormone, which cause the disease through the loss of the NO and damage of the free radical. YFN can prevent and cure the cardiovascular disease by regulating above-mentioned indexes in post-menopause rats.
Assuntos
Medicamentos de Ervas Chinesas/farmacologia , Estrogênios/sangue , Radicais Livres/sangue , Materia Medica/farmacologia , Óxido Nítrico/sangue , Animais , Cápsulas , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/prevenção & controle , Combinação de Medicamentos , Feminino , Malondialdeído/sangue , Óxido Nítrico Sintase/sangue , Ovariectomia , Plantas Medicinais/química , Ratos , Ratos Sprague-DawleyAssuntos
Método Duplo-Cego , Endometriose , Estrogênios , Feminino , Homeopatia , Humanos , Dor PélvicaAssuntos
Método Duplo-Cego , Endometriose , Estrogênios , Feminino , Homeopatia , Humanos , Dor Pélvica , Resultado do TratamentoRESUMO
Objetivo: Avaliar a eficácia e a segurança do estrogênio potencializado em comparação com o placebo no tratamento homeopático da dor pélvica associada à endometriose (DPAE). Desenho do estudo: Ensaio randomizado, duplo-cego e placebocontrolado de 24 semanas de duração, que incluiu 50 mulheres com idade entre 18-45 anos de idade, diagnóstico de endometriose infiltrativa profunda com base em ressonância magnética nuclear ou ultrassonografia transvaginal após preparo intestinal e escore ≥ 5 na escala analógica visual (EAV: intervalo de 0 a 10 pontos) para DPAE. Estrogênio potencializado (12cH, 18cH e 24cH) ou placebo foi administrado 2 vezes ao dia por via oral. A medida de desfecho primário foi a mudança na severidade da DPAE com base no escore global e parcial (EAV) entre as semanas 0-24, determinado pela diferença entre a pontuação média de 5 modalidades de dor pélvica crônica (dismenorreia, dispareunia de profundidade, dor pélvica acíclica, dor intestinal cíclica e/ou dor urinária cíclica). Os desfechos secundários foram: diferença nos escores médios para qualidade de vida (SF-36), sintomas de depressão (Inventário de Depressão de Beck, IDB) e sintomas de ansiedade (Inventário de Ansiedade de Beck, IAB). [...]O grupo placebo não mostrou qualquer melhora significativa nesses desfechos secundários. Esses resultados demonstraram a superioridade do estrogênio potencializado em comparação ao placebo. Alguns efeitos adversos foram associados com o estrogênio dinamizado. Conclusões: Estrogênio potencializado (12cH, 18cH e 24cH) na dose de 3 gotas 2 vezes ao dia durante 24 semanas foi significativamente mais eficaz que o placebo na redução da dor pélvica associada à endometriose.Registro do estudo: ClinicalTrials.gov Identificador: NCT02427386. (AU)
Objective: To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, double-blind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). [...] Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. Trial registration: ClinicalTrials.gov Identifier: NCT02427386. (AU)fier: NCT02427386. (AU)
Assuntos
Humanos , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Homeopatia , Medicamento Homeopático , Efeito Rebote , Endometriose , Estrogênios/uso terapêutico , Dor Pélvica/terapiaRESUMO
Objective: To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, double-blind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p< 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p< 0.001), non-cyclic pelvic pain (2.71; p= 0.009), and cyclic bowel pain (3.40; p< 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. [...] Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. Trial registration: ClinicalTrials.gov Identifier: https://clinicaltrials.gov/show/NCT02427386. (AU)
Assuntos
Humanos , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Homeopatia , Medicamento Homeopático , Efeito Rebote , Endometriose , Estrogênios/uso terapêutico , Dor Pélvica/terapiaRESUMO
Objetivo: Avaliar a eficácia e a segurança do estrogênio potencializado em comparação com o placebo no tratamento homeopático da dor pélvica associada à endometriose (DPAE). Desenho do estudo: Ensaio randomizado, duplo-cego e placebocontrolado de 24 semanas de duração, que incluiu 50 mulheres com idade entre 18-45 anos de idade, diagnóstico de endometriose infiltrativa profunda com base em ressonância magnética nuclear ou ultrassonografia transvaginal após preparo intestinal e escore ≥ 5 na escala analógica visual (EAV: intervalo de 0 a 10 pontos) para DPAE. Estrogênio potencializado (12cH, 18cH e 24cH) ou placebo foi administrado 2 vezes ao dia por via oral. A medida de desfecho primário foi a mudança na severidade da DPAE com base no escore global e parcial (EAV) entre as semanas 0-24, determinado pela diferença entre a pontuação média de 5 modalidades de dor pélvica crônica (dismenorreia, dispareunia de profundidade, dor pélvica acíclica, dor intestinal cíclica e/ou dor urinária cíclica). Os desfechos secundários foram: diferença nos escores médios para qualidade de vida (SF-36), sintomas de depressão (Inventário de Depressão de Beck, IDB) e sintomas de ansiedade (Inventário de Ansiedade de Beck, IAB). [...]O grupo placebo não mostrou qualquer melhora significativa nesses desfechos secundários. Esses resultados demonstraram a superioridade do estrogênio potencializado em comparação ao placebo. Alguns efeitos adversos foram associados com o estrogênio dinamizado. Conclusões: Estrogênio potencializado (12cH, 18cH e 24cH) na dose de 3 gotas 2 vezes ao dia durante 24 semanas foi significativamente mais eficaz que o placebo na redução da dor pélvica associada à endometriose.Registro do estudo: ClinicalTrials.gov Identificador: NCT02427386. (AU)
Assuntos
Humanos , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Homeopatia , Medicamento Homeopático , Efeito Rebote , Endometriose , Estrogênios/uso terapêutico , Dor Pélvica/terapiaRESUMO
OBJECTIVE: To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, double-blind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). RESULTS: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p< 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p< 0.001), non-cyclic pelvic pain (2.71; p= 0.009), and cyclic bowel pain (3.40; p< 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. [...] CONCLUSIONS: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain. Trial registration: ClinicalTrials.gov Identifier: https://clinicaltrials.gov/show/NCT02427386.
Assuntos
Feminino , Humanos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Homeopatia , Medicamento Homeopático , Efeito Rebote , Endometriose , Estrogênios/uso terapêutico , Dor Pélvica/terapiaRESUMO
The contraceptive vaginal ring offers effective contraception that is self-administered, requires less frequent dosing than many other forms of contraception, and provides low doses of hormones. NuvaRing (Organon, Oss, The Netherlands), the only contraceptive vaginal ring approved for use in the United States, contains etonogestrel and ethinyl estradiol. It is inserted into the vagina for 3 weeks, followed by a 1-week ring-free period, and works by inhibiting ovulation. Most women note a beneficial effect on bleeding profiles and are satisfied with NuvaRing. Commonly reported adverse events include vaginitis, leukorrhea, headaches, and device-related events such as discomfort. Serious adverse events are rare. In Chile and Peru, progesterone-only vaginal contraceptive rings are available for nursing women. Studies are ongoing examining new formulations of vaginal contraceptive rings.