Evaluation of the Efficacy and Adverse Reactions of Mirena Combined with Hysteroscopic Surgery When Treating AUB: Based on a Retrospective Cohort Study.

Objective: A case-control study was performed to explore the efficacy and adverse reactions of Mirena combined with hysteroscopy when treating AUB. Methods: 108 patients with perimenopausal AUB treated in our hospital from June 2019 to December 2021 were enrolled, and their clinical data were collected and analyzed retrospectively. According to the mode of treatment, the patients were assigned into control group (54 cases) and study group (54 cases). The therapeutic effects were compared. Visual analog score (VAS) was adopted to evaluate the degree of incision pain, Barthel index score was adopted to evaluate the ability of daily living, quality of life scale was adopted to investigate the quality of life before and after treatment, and the changes of sex hormone levels, endometrial thickness, and menstruation were detected before and after treatment. The incidence of adverse reactions was calculated. Results: In terms of the therapeutic effects, 46 cases were cured, 6 cases were effective, and 2 cases were ineffective in the study group, and the effective rate was 96.30%; in the control group, 32 cases were cured, 10 cases were effective, and 12 cases were ineffective, and the effective rate was 77.78%; the effective rate of the study group was higher than that of the control group (P < 0.05). In terms of VAS score, the VAS score decreased after treatment, and the VAS score in the study group was significantly lower than that in the control group at 1 week, 2 weeks, 1 month, and 3 months after treatment. With regard to the Barthel index scores after treatment, the Barthel index scores increased, and the Barthel index scores of the study group at 1 week, 2 weeks, 1 month, and 3 months after treatment were higher compared to the control group (P < 0.05). In terms of the Barthel index scores after treatment, the Barthel index scores increased, and the Barthel index scores of the study group at 1 week, 2 weeks, 1 month, and 3 months after treatment were higher compared to the control group (P < 0.05). Compared with those before treatment, the levels of FSH, LH, and E2 in both groups decreased remarkably (all P < 0.05). In terms of the changes of endometrium and menstruation, the endometrial thickness, menstrual time, and menstrual volume were significantly improved after treatment (P < 0.05). After treatment, the endometrial thickness, menstrual time, and menstrual volume in the study group were better than those in the control group (P < 0.05). With regard to the scores of qualities of life, the scores of qualities of life decreased after treatment. Compared between the two groups, the scores of physiological function, psychological function, social function, and health self-cognition in the study group were lower compared to the control group. Regarding the incidence of adverse reactions, in the study group, there were 1 case of breast pain, 2 cases of vaginal bleeding, and no dizziness and nausea, and the incidence of adverse reaction was 5.56%; In the control group, there were 1 case of dizziness, 2 cases of breast pain, 4 cases of nausea, and 3 cases of vaginal bleeding, and the incidence of adverse reactions in the study group was 18.52%. The incidence of adverse reactions in the study group was lower compared to the control group (P < 0.05). Conclusion: Hysteroscopy combined with Mirena when treating perimenopausal AUB can remarkably enhance the related symptoms, regulate the level of sex hormones, and remarkably reduce the amount of menstrual bleeding. The curative effect is better than hysteroscopy combined with dydrogesterone tablets, which is worth popularizing in clinic.

Breast reconstruction after complications following breast augmentation with massive filler injections.

INTRODUCTION: Breast filler injections are less commonly used due to their associated complications, such as pain and foreign body reactions. Yet, these fillers are often administered illegally, resulting in aesthetic or life-threatening complications. These are treated by removing the foreign material, and the breasts are reconstructed using silicone implants or autologous tissue/fat injection. PATIENT CONCERNS: Case 1. A 45-year-old woman with polyacrylamide gel injections in both breasts visited our clinic for breast pain and tenderness. Grade I ptosis was observed in each breast, without skin necrosis and discoloration. Case 2. A 51-year-old woman, with unknown breast filler injections, visited our clinic for painful masses. Intraoperatively, massive amounts of foreign material had severely infiltrated the nearby tissues; thus, an immediate breast reconstruction could not be performed. Three months later, severe deformities including shrinkage and irregular breast skin surfaces were observed. DIAGNOSIS: Case 1. Multiple cystic lesions, fluid collection in the retromammary spaces, and diffuse infiltration were observed on mammography, computed tomography, and ultrasonography. Case 2. Multiple cystic lesions, calcified areas, and diffuse infiltrations in the axillae and retromammary spaces were observed on mammography, computed tomography, and ultrasonography. INTERVENTIONS: Case 1. The foreign material was removed and the breasts were reconstructed using silicone implants into subpectoral pocket with acellular dermal matrices (Alloderm, Lipocell Corporation). Case 2. A delayed reconstruction was undertaken using silicone implants covered by latissimus dorsi muscle flaps, 3 months after the foreign material removal. OUTCOMES: Case 1. The foreign material was removed and there were no complications such as foreign body reaction, capsular contracture. Ptosis was corrected and both breasts were symmetric with proper projection. Case 2. Residual foreign material was removed and there were no complications such capsular contracture, implant malposition. CONCLUSION: Massive injections of foreign materials into the breast can cause severe infiltration and associated foreign body reactions. By a near-complete removal of the foreign materials and breast reconstruction using silicone implants, we achieved satisfactory results, without complications such as wound disruption, capsular contracture, and implant malposition.

Treatment strategies to prevent and reduce gynecomastia and/or breast pain caused by antiandrogen therapy for prostate cancer : Statement from the DEGRO working group prostate cancer.

AIM: To provide an overview on the available treatments to prevent and reduce gynecomastia and/or breast pain caused by antiandrogen therapy for prostate cancer. METHODS: The German Society of Radiation Oncology (DEGRO) expert panel summarized available evidence published and assessed the validity of the information on efficacy and treatment-related toxicity. RESULTS: Eight randomized controlled trials and one meta-analysis were identified. Two randomized trials demonstrated that prophylactic radiation therapy (RT) using 1â€¯× 10 Gy or 2â€¯× 6 Gy significantly reduced the rate of gynecomastia but not breast pain, as compared to observation. A randomized dose-finding trial identified the daily dose of 20 mg tamoxifen (TMX) as the most effective prophylactic dose and another randomized trial described that daily TMX use was superior to weekly use. Another randomized trial showed that prophylactic daily TMX is more effective than TMX given at the onset of gynecomastia. Two other randomized trials described that TMX was clearly superior to anastrozole in reducing the risk for gynecomastia and/or breast pain. One comparative randomized trial between prophylactic RT using 1â€¯× 12 Gy and TMX concluded that prophylactic TMX is more effective compared to prophylactic RT and furthermore that TMX appears to be more effective to treat gynecomastia and/or breast pain when symptoms are already present. A meta-analysis confirmed that both prophylactic RT and TMX can reduce the risk of gynecomastia and/or breast pain with TMX being more effective; however, the rate of side effects after TMX including dizziness and hot flushes might be higher than after RT and must be taken into account. Less is known regarding the comparative effectiveness of different radiation fractionation schedules and more modern RT techniques. CONCLUSIONS: Prophylactic RT as well as daily TMX can significantly reduce the incidence of gynecomastia and/or breast pain. TMX appears to be an effective alternative to RT also as a therapeutic treatment in the presence of gynecomastia but its side effects and off-label use must be considered.

Comparison of low dose versus ultra-low dose hormone therapy in menopausal symptoms and quality of life in perimenopause women.

The study was to compare the efficacy, safety, and tolerability of low dose versus ultra-low dose hormone therapy (HT) in the management of perimenopause symptoms and quality of life. Retrospective analysis of perimenopause patients prescribed for 25 weeks HT in the outpatient clinic of menopause. A total of 132 perimenopause women were included in two treatment regimens: one with low dose HT (LD-HT) and one with ultra-low dose HT (ULD-HT). Changes in serum levels of follicle-stimulating hormone, estradiol as well as transvaginal ultrasound (TVUS), the 36-item Short Form Health Survey (SF-36), the Kupperman Index (KI), and adverse effects were assessed at baseline, 4, 13, and 25 weeks. By the end of 25 weeks of treatment, each score of SF-36 domains for both LD-HT and ULD-HT groups were increased, the KI decreased, and the endometrial thickness increased in both groups and there was no statistical difference between two groups. Both groups have negligible differences in incidence of adverse effects. Low dose and ultra-low dose HT both can serve in improving symptoms of perimenopause, thereby offering a better quality of life with decreased incidence of side effects. Ultra-low dose treatment may have a better advantage on safety and tolerance.

Efectos adversos del implante anticonceptivo subdérmico en adolescentes / Adverse effects of the subdermal contraceptive implant in adolescents

Introducción: Los anticonceptivos subdérmicos deben ser seguros, con efectos colaterales mínimos, reversibles y de larga duración, sin embargo, se ha observado que ocasionan efectos adversos, fundamentalmente en los primeros meses de su uso. Objetivos: Describir efectos adversos, junto a antecedentes personales en adolescentes a quienes se realizó implante anticonceptivo subdérmico. Métodos: Se realizó un estudio descriptivo en 120 adolescentes a las que se les colocó implante subdérmico como método anticonceptivo. Fueron estudiadas las variables efectos adversos, edad y antecedente obstétrico. Resultados: El 36,6 por ciento de las pacientes tenía antecedentes de abortos provocados, y el 5 por ciento era menor de 15 años. Los efectos adversos más frecuentes fueron el aumento de peso (23,3 por ciento a los 6 meses y 21,6 por ciento al año), la cefalea (18,3 por ciento a los 6 meses y 8,3 por ciento al año) y la mastalgia (12,5 por ciento a los 6 meses y 15 por ciento al año). En el patrón de sangrado, se presentaron, sangrado infrecuente (36 por ciento a los 6 meses y 43,3 por ciento al año) y amenorrea (27,5 por ciento a los 6 meses y 35 por ciento al año). Conclusiones: Más de un tercio de las pacientes tenían abortos previos; los efectos adversos más frecuentes fueron: aumento de peso, cefalea y mastalgia, tanto a los 6 meses como al año y en el patrón de sangrado, el sangrado infrecuente y la amenorrea(AU)

Introduction: Subdermal contraceptives must be safe, with minimal side effects, reversible and long lasting, however, it has been observed that they cause adverse effects, mainly in the first months of its use. Objectives: To describe adverse effects, together with personal history in adolescents who underwent a subdermal contraceptive implant. Methods: A descriptive study was conducted in 120 adolescents who were placed as a subdermal implant as a contraceptive method. The variables adverse effects, age and obstetric history were studied. Results: 36.6 percent of the patients had a history of induced abortions, and 5 percent were younger than 15 years. The most frequent adverse effects were weight gain (23.3 percent at 6 months and 21.6 percent per year), headache (18.3 percent at 6 months and 8.3 percent per year) and mastalgia (12.5 percent at 6 months and 15 percent at year). In the pattern of bleeding, infrequent bleeding occurred (36 percent at 6 months and 43.3 percent per year) and amenorrhea (27.5 percent at 6 months and 35 percent per year). Conclusions: More than a third of the patients had previous abortions; The most frequent adverse effects were: weight gain, headache and mastalgia, both at 6 months and 1 year and in the pattern of bleeding, infrequent bleeding and amenorrhea(AU)

Efeitos adversos associados a uso de contraceptivos orais em discentes / Adverse effects associated with students' use of oral contraceptives

Objetivos: Investigar o número de mulheres, as causas que levam a fazer o uso e descrever os efeitos adversos mais comuns associados ao uso de contraceptivos orais de forma contínua. Métodos: Trata-se de estudo observacional, transversal ou de prevalência e quantitativo. A pesquisa teve população de 832 alunas do curso de Direito dos turnos matutino, vespertino e noturno, no período de agosto a setembro, tendo como amostra 248 participantes para esse estudo. O questionário versou sobre o uso de anticoncepcionais, o perfil das usuárias e os possíveis efeitos adversos observados ao longo do uso. Resultados: A prevalência de uso dos contraceptivos orais foi de 42,3%, justificada principalmente pelo desejo de evitar a concepção (42,9%), regular os níveis hormonais (25,7%) e tratar acne (15,2%). Cerca de 63,8% relataram que já sentiram algum desconforto associado ao uso destes medicamentos, sendo os mais frequentes aumento de peso corporal (32,4%), alterações de humor (24,3%), dor nas mamas (13,5%), cefaleia (4,1%), dor abdominal (2,7%). Conclusão: A prevalência de efeitos adversos decorrentes do uso contínuo de contraceptivos orais é alta, evidenciando-se a necessidade de conscientizar as usuárias a buscarem profissionais habilitados, para que elas façam uso do anticoncepcional mais adequado, minimizando o desconforto advindo dos efeitos adversos.

Objectives: To investigate the number of women, the causes that lead to making use, and to describe the most common adverse effects associated with oral contraceptive continuous use. Methods: This is an observational, cross-sectional, or prevalence and quantitative study. The research had a population of 832 students of the law course of the morning, afternoon and evening shifts, from August to September, with a sample of 248 participants for this study. The questionnaire was about contraceptive use, users' profile, and possible adverse effects observed during use. Results: The prevalence of oral contraceptive use was 42.3%, mainly explained by the desire to avoid conception (42.9%), regulate hormone levels (25.7%), and to treat acne (15.2%). About 63.8% reported already having some discomfort associated with the use of these medications, with the most frequent being body weight gain (32.4%), mood swings (24.3%), breast pain (13.5%), headache (4.1%), abdominal pain (2.7%). Conclusion: The prevalence of adverse effects resulting from the continued use of oral contraceptives is high, so there is a need to guide users to seek qualified professionals so that they make use of the most appropriate contraceptive, minimizing the discomfort arising from adverse effects.

Tissue-selective estrogen complex for women who experience breast discomfort or vaginal bleeding when on hormone therapy.

OBJECTIVE: The objective of this study was to evaluate the effects of switching from hormone therapy to tissue-selective estrogen complex (TSEC) in women who experience vaginal bleeding or breast discomfort. METHODS: This retrospective cohort study included 82 postmenopausal women who received TSEC after switching from another hormone therapy due to adverse events. Changes in symptoms and imaging after switching to TSEC were evaluated. RESULTS: The mean age was 56.9 years. The women were switched to TSEC due to vaginal bleeding in 56.1% and breast discomfort in 47.6% (multiple choices were allowed). After the switch, almost all women (97.6%) experienced an improvement in adverse events. However, 27% of the women had worsening of vasomotor symptoms, which was more common when hormone therapy was changed from 2 mg of estradiol (41.7%) compared with 1 mg of estradiol (16.7%), 0.625 mg of conjugated estrogen (30%), or tibolone (12.5%). Images of breast lesions and fibroids before the switch were assessed, showing no change in most women. CONCLUSIONS: This study suggests that TSEC is a good option for women who have breast discomfort or persistent bleeding during other hormone therapy when taking into account the differences in estrogen dose.

Time to first occurrence of breast pain and vaginal bleeding in phase 3 trials of CE/BZA.

OBJECTIVE: In studies of the menopausal therapy, conjugated estrogens/bazedoxifene, breast pain and vaginal bleeding rates were comparable to placebo and lower than conjugated estrogens/medroxyprogesterone acetate (MPA). This post hoc analysis determined median time to occurrence of these events. METHODS: Participants in phase 3 conjugated estrogens/bazedoxifene trials recorded breast pain and vaginal bleeding in daily diaries. Median time to first incident was determined in women taking conjugated estrogens 0.45 mg/bazedoxifene 20 mg, conjugated estrogens 0.625 mg/bazedoxifene 20 mg, placebo, and conjugated estrogens 0.45 mg/MPA 1.5 mg (active control in Selective estrogens, Menopause, And Response to Therapy [SMART]-5 trial). We included on-treatment data (12 weeks-2 years) in healthy postmenopausal women (SMART-1), those seeking treatment for menopausal symptoms (SMART-5), and those with moderate/severe vasomotor symptoms (SMART-2). Analyses were performed using SAS Proc Lifetest. RESULTS: With conjugated estrogens/MPA as comparator, median time to breast pain was 299 days for conjugated estrogens/MPA, 353 for placebo, and more than 365 (median not reached) for conjugated estrogens 0.45 mg/bazedoxifene 20 mg and conjugated estrogens 0.625 mg/bazedoxifene 20 mg. Median time to vaginal bleeding was 314, 341, 357, and 362 days, respectively. Breast pain and vaginal bleeding survival curves were not significantly different for conjugated estrogens/bazedoxifene and placebo in any study, but were (P < 0.0001) when conjugated estrogens/MPA was added to the sample in SMART-5. CONCLUSIONS: The time course of breast pain and vaginal bleeding with conjugated estrogens/bazedoxifene was similar to that of placebo during treatment for up to 2 years. Events occurred significantly earlier with conjugated estrogens/MPA versus conjugated estrogens/bazedoxifene or placebo.

[Systemic Adamantiades-Behçet's disease: adverse effects of an otherwise successful therapy with interferon-α-2a]. / Morbus Adamantiades-Behçet: erfolgreiche Therapie mit ungewöhnlichen Komplikationen.

BACKGROUND: Adamantiades-Behçet's disease is an immune-mediated vasculitis with relapsing course. It is characterised by the classic clinical trias of oral aphthous ulcers, genital ulcers and uveitis. HISTORY AND FINDINGS: A 37-year-old woman suffered from systemic Adamantiades-Behçet disease with recurrent uveitis, oral ulcers, genital ulcers, arthralgia, erythema nodosum and folliculitis. COURSE AND TREATMENT: Longterm interferon-α-2a (IFNα-2a) led to reduction of the clinical manifestations except for occasional occurrence of oral ulcers. One year after initiation of treatment however, the patient developed symptomatic hyperprolactinemia of unknown etiology. CONCLUSION: Even in otherwise successful treatment with IFNα-2a possible side effects and complications of treatment can affect the course. Mastodynia and hyperprolactinemia have not yet been described as potential side effects of IFNα-2a.

A comparison of bleeding patterns and cycle control using two transdermal contraceptive systems: a multicenter, open-label, randomized study.

OBJECTIVE(S): To investigate the bleeding pattern and cycle control parameters of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD) compared with a patch containing 0.6 mg EE and 6 mg norelgestromin (NGMN). STUDY DESIGN: In this phase III, open-label, randomized, parallel-group trial, healthy women aged 18-35 years (smokers aged 18-30 years) received either the EE/GSD patch (n=200) or the EE/NGMN patch (n=198). Treatment consisted of one patch per week for 3 weeks followed by a 7-day, patch-free interval for seven cycles. Bleeding control was assessed in two 90-day reference periods. RESULTS: In reference period 1, mean number of bleeding/spotting days was comparable across treatment groups (p>0.05). However, in reference period 2, there were fewer bleeding/spotting days in the EE/GSD patch group (15.7 versus 18.4; p<0.0001). Mean number of bleeding/spotting episodes was comparable across groups for both reference periods, but bleeding/spotting episodes were shorter for the EE/GSD patch than the EE/NGMN patch during reference period 1 (5.13 days versus 5.53 days, respectively; p<0.05) and reference period 2 (5.07 versus 5.66; p=0.0001). Both treatment groups showed a similar frequency of withdrawal bleeding episodes; however, across all seven cycles, the length of these episodes was consistently shorter with the EE/GSD patch (p<0.01). There were no notable treatment differences in intracyclic bleeding. CONCLUSION(S): Bleeding pattern and cycle control achieved with the EE/GSD patch was similar to that of the EE/NGMN patch. IMPLICATIONS STATEMENT: The paper presents data on the bleeding pattern and cycle control parameters of an investigational transdermal contraceptive patch containing EE and GSD compared with an approved contraceptive patch containing EE and NGMN. This descriptive study found that bleeding patterns associated with the EE/GSD patch were similar to those of an EE/NGMN patch providing higher EE exposure.

[Effect of change to flutamide for prostate cancer patient who developed breast pain during bicalutamide treatment (BIP-F study)].

In Japan, prostate cancer is treated with non-steroidal anti-androgen (flutamide and bicalutamide). Development of breast pain during bicalutamide treatment, in prostate cancer patients reduces their quality of life (QOL) and treatment compliance. We studied the safety and effectiveness of switching from bicalutamide to flutamide in 13 prostate cancer patients who developed breast pain during bicalutamide treatment. We estimated the change in breast pain using a face scale and the Expanded Prostate Cancer Index Composite (EPIC) and EPIC-hormone domain (HD) score. The switch to flutamide relieved breast pain in nine patients, had no effect in one patient, and increased breast pain in two patients. One patient dropped out. Furthermore, summary score and hormone function were improved with a significant difference in the EPIC-HD score. Switching to flutamide in prostate cancer patients who develop breast pain during bicalutamide is safe and effective.

[Selected aspects of oral contraception side effects]. / Wybrane aspekty dzialan niepozadanych zloionej doustnej antykoncepcji hormonalnej.

The first hormonal pill was approved in the 60s of the twentieth century Since that time, oral contraception has been used worldwide by dozens of women due to its high availability as well as relative ease and safety of taking. The main side effects of oral contraception include elevated risk for venous thromboembolism (VTE). Estrogens increase the probability of VTE development, depending on the dose in medication, and third-generation progestins increase the risk of VTE development more than older-generation progestins. Also, the coexistence of hereditary thrombophilia increases the risk of VTE development in women using oral contraceptives. Other side effects include changes in the carbohydrate and lipid economy Progestins in oral contraceptives decrease HDL cholesterol levels but increase LDL cholesterol and total cholesterol levels. Additionally estrogens are a recognized mitogenic factor for the epithelium of the mammary gland, acting proliferative on the glandular tissue and in the same way influence on the increased risk of breast cancer development. Patients sometimes complain about some subjective side symptoms such as headache, mood changes, nausea, back pain, breast pain and swelling, as well as decreased libido. Some patients discontinue oral contraception due to fear of side effects or temporary ailments before con- sulting their doctor what may result in unintended pregnancy The aim of the following paper was to present most frequent side effects of oral contraception, ways of their moni- toring and diagnosis.

[Clinical comparision of alpha dihydroergocryptine against cabergoline in the treatment of the fibrocystic mastopathy]. / Comparación clínica de alfa dihidroergocriptina contra cabergolina en el tratamiento de la mastopatía fibroquística.

BACKGROUND: Fibrocystic breast disease is one of the most frequent conditions of the breast among women from 30 to 49 years, with a frequency of about 60%, hence the interest in studying and treating it with the most advanced and effective resources. OBJECTIVE: To compare the efficacy and adverse events of alpha dihydroergocryptine with cabergoline in patients with fibrocystic breast disease. MATERIAL AND METHODS: A prospective, longitudinal, open, comparative study between alpha-dihydroergocryptine and cabergoline, made in the service of Gynecology and Obstetrics at the Dr. Miguel Silva General Hospital in Morelia, Michoacán. 171 patients diagnosed with fibrocystic breast disease were randomly assigned to the alpha-dihydroergocryptine or the cabergoline group. Assessments were made at baseline and every month subsequently. The following symptoms were evaluated: breast tenderness, breast pain, lumps and nipple discharge. The concentrations of prolactin were determined and an ultrasound was performed at baseline and at 3 and 6 months, patients were questioned about adverse events. RESULTS: 171 patients were included (81treated with alpha-dihydroergocryptine and 90 with cabergoline); 156 completed the study. The age limits were 18 and 51 years. The evolution time prior to study entry was 17.71 +/- 18.3 months for the alpha-dihydroergocryptine group and 18.57 +/- 20.35 for the cabergoline group. 15 patients discontinued treatment due to adverse events (8 of the alpha-dihydroergocryptine group and 7 of the cabergoline group). The most common adverse event was headache. CONCLUSIONS: In this study alpha-dihydroergocryptine was better tolerated and had better clinical response compared with cabergoline; breast pain and breast tenderness disappeared within the first month of treatment. Adverse events were similar for both treatments.

Tamoxifen for the management of breast events induced by non-steroidal antiandrogens in patients with prostate cancer: a systematic review.

BACKGROUND: Tamoxifen has emerged as a potential management option for gynecomastia and breast pain due to non-steroidal antiandrogens, and it is considered an alternative to surgery or radiotherapy. The objective of this systematic review was to assess the benefits and harms of tamoxifen, in comparison to other treatment options, for either the prophylaxis or treatment of breast events induced by non-steroidal antiandrogens in prostate cancer patients. METHODS: We searched CENTRAL, MEDLINE, EMBASE, reference lists, the abstracts of three major conferences and three trial registers to identify ongoing randomized controlled trials (RCTs). Two authors independently screened the articles identified, assessed the trial quality and extracted data. The protocol was prospectively registered (CRD42011001320; http://www.crd.york.ac.uk/PROSPERO). RESULTS: Four studies were identified. Tamoxifen significantly reduced the risk of suffering from gynecomastia (risk ratio 9RR0 0.10, 95% CI 0.05 to 0.22) or breast pain (RR 0.06, 95% CI 0.02 to 0.17) at six months compared to untreated controls. Tamoxifen also showed a significant benefit for the prevention of gynecomastia (RR 0.22, 95% CI 0.08 to 0.58) and breast pain (RR 0.25, 95% CI 0.10 to 0.64) when compared to anastrozole after a median of 12 months. One study showed a significant benefit of tamoxifen for the prevention of gynecomastia (RR 0.24, 95% CI 0.09 to 0.65) and breast pain (RR 0.20, 95% CI 0.06 to 0.65) when compared with radiotherapy at six months. Radiotherapy increased the risk of suffering from nipple erythema and skin irritation, but there were no significant differences for any other adverse events (all P>0.05). CONCLUSIONS: The currently available evidence suggests good efficacy of tamoxifen for the prevention and treatment of breast events induced by non-steroidal antiandrogens. The impact of tamoxifen therapy on long-term adverse events, disease progression and survival remains unclear. Further large, well-designed RCTs, including long-term follow-ups, are warranted. Also, the optimal dose needs to be clarified.

Prevention of gynecomastia and breast pain caused by androgen deprivation therapy in prostate cancer: tamoxifen or radiotherapy?

PURPOSE: To determine, in a meta-analysis, whether gynecomastia and breast pain rates in men with prostate cancer treated with androgen deprivation therapy (ADT) are reduced if treated with prophylactic radiotherapy (RT) or tamoxifen (TMX). METHODS AND MATERIALS: The MEDLINE, EMBASE, CANCERLIT, and Cochrane Library databases, as well as proceedings of annual meetings, were systematically searched to identify randomized, controlled studies comparing RT or TMX with observation for men with prostate cancer using ADT. RESULTS: Six RCTs (three RT trials and three TMX trials, N = 777 patients total) were identified that met the study criteria. Pooled results from these RCTs comparing RT vs. observation showed a significant reduction in the incidence of gynecomastia and breast pain rates in patients treated with RT (odds ratio [OR] = 0.21, 95% confidence interval [CI] = 0.12-0.37, p < 0.0001, and OR = 0.34, 95% CI 0.20-0.57, p < 0.0001, respectively). Use of RT resulted in an absolute risk reduction (ARR) of 29.4% and 19.9%, with a number needed to treat (NNT) of 3.4 and 5 to avoid one case of gynecomastia and breast pain, respectively. Pooled results from trials comparing TMX vs. observation showed a statistical benefit for breast pain and gynecomastia in favor of TMX arms (OR = 0.04, 95% CI = 0.02-0.08, p < 0.0001 and OR = 0.07, 95% CI = 0.0-0.14, p < 0.00001). TMX resulted in an ARR = 64.1% and 47.6%, with an NNT of 1.56 and 2.1 to avoid one case of gynecomastia and breast pain, respectively. Considering adverse effects, TMX was 6 times more adverse effects than RT. CONCLUSIONS: Our data have shown that both TMX and RT prevented gynecomastia and breast pain in patients with prostate cancer receiving ADT for prostate cancer. Although TMX was two times more effective in preventing gynecomastia, RT should represent an effective and safe treatment option, to take into account mainly in patients with cardiovascular risk factors or thrombotic diathesis.

Breast tenderness and breast cancer risk in the estrogen plus progestin and estrogen-alone women's health initiative clinical trials.

The associations between breast tenderness during use of conjugated equine estrogen (CEE) therapy with or without medroxyprogesterone (MPA) therapy and subsequent breast cancer risk are unknown. We analyzed data from the Women's Health Initiative Estrogen plus Progestin (N = 16,608, 5.6 years intervention) and estrogen-alone (N = 10,739, 6.8 years intervention) clinical trials until trial close-out (Spring 2005). At baseline and annually, participants underwent mammography and clinical breast exam. Self-reported breast tenderness was assessed at baseline and 12 months. Invasive breast cancer was confirmed by medical record review. The risk of new-onset breast tenderness after 12 months was significantly higher among women assigned to active therapy than placebo (CEE-alone vs. placebo risk ratio [RR] 2.15, 95% confidence interval [CI] 1.97-2.35; CEE + MPA vs. placebo RR 3.07, 95% CI 2.85-3.30). CEE + MPA doubled the risk of invasive breast cancer among women with baseline breast tenderness (hazard ratio [HR] 2.16, 95% CI 1.29-3.74), but had a smaller effect among women without baseline breast tenderness (HR 1.17; 95% CI 0.97-1.41). New-onset breast tenderness was associated with a higher risk of breast cancer among women assigned to CEE + MPA (HR 1.33, 95% CI 1.02-1.72, P = 0.03), but not among women assigned to CEE-alone (HR 0.98, 95% CI 0.62-1.53). New-onset breast tenderness during use of CEE + MPA was associated with increased subsequent breast cancer risk. The association of CEE + MPA therapy with increased breast cancer risk was especially pronounced among women with baseline breast tenderness.

Breast tenderness after initiation of conjugated equine estrogens and mammographic density change.

We examined the association between new-onset breast tenderness and change in mammographic density after initiation of conjugated equine estrogens (CEE). We analyzed baseline, year 1 and 2 data from 695 participants of the Women's Health Initiative Estrogen + Progestin (daily CEE 0.625 mg + medroxyprogesterone acetate 2.5 mg [MPA] or placebo) and Estrogen-Alone (CEE 0.625 mg or placebo) trials who participated in the Mammogram Density Ancillary Study. Using multivariable repeated measures models, we analyzed the association between new-onset breast tenderness (i.e. absence of baseline tenderness and presence of tenderness at year 1 follow-up) and change from baseline in percent mammographic density. Active therapy increased the odds of new-onset breast tenderness (CEE + MPA vs. placebo risk ratio [RR] 3.01, 95% confidence interval [95% CI] 1.96-4.62; CEE vs. placebo RR 1.70, 95% CI 1.14-2.53). Among women assigned to CEE + MPA, mean increase in mammographic density was greater among participants reporting new-onset of breast tenderness than among participants without new-onset breast tenderness (11.3 vs. 3.9% at year 1, 9.4 vs. 3.2% at year 2, P < 0.001). Among women assigned to CEE alone, increase in mammographic density at year 1 follow-up was not significantly different in women with new-onset breast tenderness compared to women without new-onset breast tenderness (2.4 vs. 0.6% at year 1, 2.2 vs. 1.0% at year 2, P = 0.30). The new-onset of breast tenderness after initiation of CEE + MPA, but not CEE alone, is associated with greater increases in mammographic density.