Safety of prasterone in breast cancer survivors treated with aromatase inhibitors: the VIBRA pilot study.

BACKGROUND: Due to safety concerns on estrogen-based treatments for genitourinary syndrome of menopause (GSM) in breast cancer survivors (BCS), new options are appearing, such as androgen-based treatments, which according to proprieties would not be transformed systemically to estrogens in patients receiving aromatase inhibitors (AIs). OBJECTIVE: The aim of this pilot study is to assess the security and efficacy of vaginal prasterone (dehydroepiandrostenedione [DHEA]) in BCS treated with AIs. METHODS: This open, prospective, pilot study included 10 BCS treated with AIs. All participants complained of severe GSM. DHEA was administrated as a vaginal ovule. Participants were instructed to use one ovule every night during the first month, and one ovule every two nights for the entire five remaining months. The patients were requested to attend seriated visits after the beginning of the prasterone treatment to evaluate symptoms, physical improvement and serum estradiol. RESULTS: Mean serum estradiol remained low from 3.4 pg/ml to 4.3 pg/ml (p = 0.9136) after 6 months of follow-up. The visual analog scale of dyspareunia improved from 8.5 to mean values after treatment of 0.4 (p = 0.0178). The Vaginal Health Index (VHI) scale and Female Sexual Function Index improved from 9.75 to 15.8 (p = 0.0277) and from an initial score of 11.2 to 20.6 (p = 0.0277), respectively. Vaginal pH changed from basal 8.1 to final 6.5 (p = 0.0330). CONCLUSION: Symptoms and physical examination regarding sexuality and vaginal health improved significantly, while serum estradiol remained at low levels. Prasterone seems a safe and effective option to treat GSM in BCS receiving AIs.

Transvaginal ultrasound for diagnosis of deep endometriosis involving uterosacral ligaments, torus uterinus and posterior vaginal fornix: prospective study.

OBJECTIVE: To evaluate the accuracy of transvaginal ultrasound (TVS) in diagnosing deep endometriosis (DE) involving the uterosacral ligaments (USLs), torus uterinus (TU) or posterior vaginal fornix (PVF) in women with suspected endometriosis scheduled for laparoscopic surgery. METHODS: In this prospective study, consecutive women with clinically suspected pelvic endometriosis who were scheduled for laparoscopic surgery were invited to participate. TVS was performed before surgery. TVS findings were compared with those obtained at laparoscopy and confirmed histologically. The accuracy of TVS for diagnosing DE involving the USLs, TU or PVF was assessed. Additionally, the association of DE involving the USLs, TU or PVF on TVS with symptoms and with DE affecting other pelvic locations was assessed. RESULTS: In total, 172 patients were included. The global sensitivity and specificity of TVS in diagnosing DE affecting the USLs, TU and/or PVF were 92% and 87%, respectively. For DE involving the USLs, the accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio and negative likelihood ratio of TVS were 89.5%, 96.6%, 82.1%, 85.0%, 95.8%, 5.41 and 0.04, respectively; the respective values for DE involving the TU were 86.6%, 83.9%, 89.4%, 89.0%, 84.4%, 7.92 and 0.18, and the respective values for DE involving the PVF were 93.6%, 87.0%, 94.6%, 71.4%, 97.9%, 16.20 and 0.14. Logistic regression analysis showed a significant association between DE affecting the USLs, TU and/or PVF and DE affecting the rectosigmoid (odds ratio, 5.43; P < 0.001). Dyschezia was associated strongly with DE involving the USLs, TU and PVF, while dysmenorrhea was associated significantly with DE involving the TU. CONCLUSION: TVS has high accuracy, sensitivity, specificity, PPV and NPV for the detection of DE involving the USLs, TU and PVF in women with suspected endometriosis scheduled for laparoscopic surgery. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Evaluation of Bacillus clausii CSI08, Bacillus megaterium MIT411 and a Bacillus cocktail on gastrointestinal health: a randomised, double-blind, placebo-controlled pilot study.

In the present study, the safety, tolerance and impact of 1×109 cfu Bacillus clausii CSI08, 1×109 cfu Bacillus megaterium MIT411 and a probiotic cocktail containing Bacillus subtilis DE111®, Bacillus megaterium MIT411, Bacillus coagulans CGI314, and Bacillus clausii CSI08 with a total count of 2.0×109 cfu administered daily were assessed as compared with a maltodextrin containing placebo control. A total of 98 study participants received daily doses for 45 days, followed by a washout period of 2 weeks. A questionnaire to capture the incidence and duration of upper respiratory tract, urinary tract and/or gastrointestinal complaints and a diary to capture stool regularity and consistency was kept daily to record compliance throughout the 45 days. Faecal and blood samples were collected for microbiological and haematological analysis at the start and end of the treatment period. The probiotic cocktail significantly decreased the incidence of loose stools throughout the entire study. The recorded respiratory, urinary and gastrointestinal symptoms, defecation frequency and other stool consistency were not influenced. No clinically relevant changes in blood parameters, such as liver and kidney function and no serious adverse events appeared during and after administration. There were no changes in symptoms including sadness, irritability, energy, appetite, tension, stress, sleep, cardiovascular events, aches and pains, and dizziness as determined by a mood questionnaire administered to participants at baseline and at the end of the treatment period. Similarly, the measured inflammatory cytokines, antioxidant levels, cholesterol, triglycerides, free amino acids or minerals remained unaffected. There were no negative changes in alpha or beta diversity of the microbiota with any of the treatment groups. These promising data suggest that these treatments were safe and well tolerated, and further work with larger cohorts are justified to determine the efficacy of these potential probiotics in select demographic groups. Trial registration number with clinicaltrials.gov at NCT04758845.

Müllerian defects in women with normal reproductive outcome.

The incidence of uterine congenital anomalies because of müllerian defects in the normal fertile population is 3.2% (22/679). Twenty (90%) of them are septate uteri, whereas a bicornuate (5%) and a didelphys uterus (5%) have been also found in this population. Based on these findings, we question the usefulness of the septum resection in patients with septate uterus and no previous reproductive failure.

Ovarian sex cord tumor with annular tubules in a woman with premature ovarian failure.

OBJECTIVE: To report a case of premature ovarian failure (POF) associated with an ovarian sex cord tumor with annular tubules. DESIGN: Case report. SETTING: Reproductive endocrinology unit in a tertiary academic center. PATIENT(S): A 20-year-old woman with POF. INTERVENTION(S): Biopsy of the rudimentary ovary by laparoscopy. MAIN OUTCOME MEASURE(S): Protocol for POF investigation and histological study of the ovarian sample. RESULT(S): An ovarian sex cord tumor with annular tubules was detected in the rudimentary right ovary. CONCLUSION(S): The rare ovarian sex cord tumor with annular tubules, which may be hormonally active, was detected in a case of POF.

Influence of the ovary on parameters of LH secretion during the recovery from buserelin-induced desensitization.

This study examined the effect of the ovary on LH pulsatility and on the secretory performance of gonadotrophs during the phase of recovery after treatment with buserelin, a GnRH analogue. We included 12 patients, who received buserelin (1.2 mg/day, intranasally for 3 months) as a reductive therapy for uterine leiomyomatosis prior to hysterectomy. Six patients were oophorectomized and the other 6 patients had their ovaries preserved. LH was measured in samples taken basally up to 36 days after suppression of buserelin. LH pulsatility was studied on day 9 along a 24-h cycle, and the response of the hormone to a double-stimulus GnRH test on days 0, 9, 20, and 34. The concentration of LH reached normal premenopausal levels after an average of 2 weeks in women with ovaries but increased until 4-5 weeks in oophorectomized patients. The pulsatility of LH on day 9 was similar for both groups, but parameters related to LH amplitude or to baseline secretory activity of gonadotrophs were higher in the oophorectomized women. The response of LH to the GnRH tests was also significantly higher in the oophorectomized group from day 9. The conclusions are as follows. (1) At the early stage of recovery from desensitization, as represented by day 9, LH pulsatility was not substantially influenced by the presence or absence of the ovary. (2) There was an increase in parameters related to the amplitude of the LH bursts in the oophorectomized women. Although a higher amplitude of the endogenous GnRH pulses cannot be discarded, most probably that difference is due to a higher sensitivity at a pituitary level, as reflected by the GnRH stimulation tests.

Ten-year results of a phase II study with a single fraction of high-dose-rate brachytherapy (FAST-boost) after whole breast irradiation in invasive breast carcinoma.

PURPOSE: We present the results of a prospective ten-year follow-up study to prove the effectiveness of a single fraction of 192-Ir high-dose-rate (HDR) brachytherapy (BT) as a boost. PATIENTS AND METHODS: Between 1999 and 2000, 84 consecutive patients with invasive breast carcinoma, with over 4 mm free margins after conservative surgery, were treated. All cases were stages T1-2, except for one case, a stage T3, 81% pN0, 19% pN1-2. Chemotherapy was used in 47% and hormonal therapy in 87%. Whole breast external beam radiotherapy (46 Gy) was followed 1-2 weeks later by an implant with metallic needles. A 7 Gy single dose of HDR BT to the 90% isodose line was delivered on an outpatient basis. Dosimetry was performed theoretically. This technique is called FAST-boost because the whole treatment is delivered in about two hours. RESULTS: With a median follow-up of 120 months, three patients relapsed in the margin of the implant and two in a different quadrant (5/84, 6%). Actuarial local control at five and ten years was 98.5% and 95.6%. Overall survival was 92.7% and 90.2%, and disease-free survival 90.2% and 79.9%. Cosmetic results were good or excellent in 92.5%. CONCLUSIONS: A single-fraction HDR boost with rigid needles (FAST-boost) is a good, quick, simple technique when surgical margins are free.

[Results of 125-iodine seed implant with preplanning system in 250 patients with prostate cancer]. / Resultados de implante de semillas de iodo-125 con sistema de preplanificación en 250 pacientes con carcinoma de próstata.

INTRODUCTION: We review the experience with prostate carcinoma patients treated with permanent implants of 125-I seeds and the outcome eight years after the beginning of this technique. MATERIAL AND METHODS: From 2002 to 2007 we have performed 250 implants with LDR brachytherapy with RapidStrand(®) and preplanning system. Mean age was 68 (49-78). Mean PSA was 7.32 (2.31 - 14.6). T1-T2a was the stage in 98%, and Gleason ≤ 6 in 96%. Low risk cases were 81% and intermediate risk 19% (ten of them received 46 Gy EBRT). Hormonal treatment was used in 42%. RESULTS: With a mean follow-up of 48 months, 14 patients (5.7%) showed biochemical failure (BF). Eleven patients (4.5%) with theoretical BF were observed and PSA decreased without treatment. Actuarial PSA relapse-free survival at 5 years was 91%, (92% low risk, 86% intermediate cases), and 92% vs 81% with PSA <10 vs >10 (p<0.05). Rectum complications were G2 in 0.6%. A urinary catheter was necessary in 6.5%. Sexual function was conserved in 60%. Mean V100 was 89% and D90 143 Gy. CONCLUSION: The outcome of patients with low risk prostate carcinoma treated with I-125 seed is very good with very low complications rate. Cases with PSA bounces should be controlled before starting a salvage treatment.

[Diagnostic considerations in unilateral hyperlucency of the lung (Swyer-James-MacLeod Syndrome)]. / Consideraciones diagnósticas sobre el llamado síndrome del pulmón hiperclaro unilateral (síndrome de Swyer-James o de Mc-Leod).

Swyer-James-MacLeod Syndrome (SJMS) is considered to be a relatively uncommon and complex disease characterized by roentgenographic hyperlucency of one lung, lobe, or part of a lobe, due the pulmonary vascular structure and alveolar overdistension. It is sometimes associated with bronchiectasis. This syndrome seems to be an acquired disease that develops after viral bronchiolitis and/or viral pneumonia in early childhood. Microscopically, there is evidence of patchy bronchitis and bronchiolitis.SJMS is usually asymptomatic and discovered accidentally by chest radiography in a child with respiratory symptoms and should be differentiated from other causes of unilateral hyperlucency on chest radiography, such as those related to congenital bronchial and/or vascular abnormalities. Treatment includes early control of lung infections, as well as influenza and pneumococcal vaccination. Few reports of this syndrome in children have been published. We describe the case of a 12-year-old boy with unilateral hyperlucency of the lung and respiratory symptoms of acute pneumonia and discuss the main diagnostic features of this syndrome.

Analysis of the attitudes and emotional processes in couples undergoing artificial insemination by donor.

Osgood's Semantic Differential Questionnaire was used to study 40 couples undergoing an artificial insemination by donor (AID) programme. The following reference concepts were used: Father, Mother, Work, Marriage, Myself, Children, Pregnancy, Guilt, Sex and Family. The results show that women consider ¿being a Mother' as something emotionally ¿warm', take a positive position, feel ¿nervous' and wish the event happened quickly; this is significantly different to men, who give less importance to this fact. Men are more concerned about the pregnancy and consider it a ¿hard', ¿strong' and ¿heavy' experience. The score in the concept Guilt significantly stands out from the rest of the concepts in both men and women; it is also striking how AID women relate the concept Mother with the concept Father, whereas men establish the association between Mother and Work.

The effect of estrogen replacement therapy with or without progestogen on the fibrinolytic system and coagulation inhibitors in postmenopausal status.

OBJECTIVE: The aim of this study was to analyze several fibrinolytic components and coagulation inhibitors in postmenopausal women and had to evaluate the effect of hormone replacement therapy. STUDY DESIGN: Several hemostatic parameters were evaluated in 75 postmenopausal women before and after 3 to 4 and 12 months of hormone therapy. RESULTS: An increase in plasma fibrinolytic activity primarily related to a significant increase in tissue-type plasminogen activator and a decrease in plasminogen activator inhibitor type 1 was observed in women receiving hormone replacement therapy. A significant decrease in protein S and lipoprotein(a) was detected under therapy. No modifications in tissue-type plasminogen activator/plasminogen activator inhibitor-1 and activated protein C/alpha 1-antitrypsin complexes, urokinase activity, plasminogen, and antithrombin III were detected. CONCLUSIONS: The increase in fibrinolytic activity and the decrease in lipoprotein(a) levels observed in women receiving hormone replacement therapy could help decrease the risk of coronary disease associated with the postmenopausal state.