Use of Vitex agnus-castus in patients with menstrual cycle disorders: a single-center retrospective longitudinal cohort study.

PURPOSE: To evaluate clinical characteristics, quality of life (QoL) and effectiveness in patients with menstrual cycle disorders (MCDs) including abnormal uterine bleeding, dysmenorrhea and mastodynia/mastalgia related to premenstrual syndrome taking the Vitex agnus-castus (VAC) products Cyclodynon® or Mastodynon® in a real-world setting. METHODS: A single-center retrospective longitudinal cohort study (3 ± 1 months), using data obtained from healthcare data archive and telephone interviews. The main study variables were changes in bleeding, menstrual pain, breast tenderness and patients' QoL. RESULTS: Data from 1700 women with a mean age of 30.2 years (± 6.3) were analyzed. The most common MCDs were dysmenorrhea (43.8%) and mastodynia/mastalgia (21.1%). Three-month treatment with VAC extract substantially decreased the percentage of patients with irregular cycle (from 9.1% to 0.1%) and breast tenderness (from 39.9% to 0.8%). Improvement in bleeding intensity, frequency and menstrual pain was experienced by 83.4%, 79.2%, and 85.2% of the patients, respectively. When analyzed by disease category, these parameters improved in almost all dysmenorrhea patients, while they improved to a lesser extent in mastodynia/mastalgia patients. QoL improved in all aspects, but was reported by a higher proportion of dysmenorrhea patients compared to mastodynia/mastalgia patients. Treatment was overall well tolerated with a favorable safety profile. CONCLUSION: These real-world data demonstrate the effectiveness of the VAC-containing products Cyclodynon® and Mastodynon® in the three-month treatment of MCDs, with a pronounced improvement in key disease symptoms and QoL. Intriguingly, while QoL was generally greatly improved, the response to VAC therapy varied depending on the type of underlying MCD.

The Effectiveness of Herbal Medicines on Cyclic Mastalgia: A Systematic Review on Meta-analysis.

OBJECTIVE: Different drugs are used to treat mastalgia, such as danazol and bromocriptine, and both are associated with side effects, due to which most of women and healthcare providers are interested in herbal medicines. Therefore we aim to study the effectiveness of phytoestrogens on the severity of cyclic mastalgia. METHODS: To carry out the present study, English electronic resources such as the Cochrane Library, ISI Web of Science, Scopus, and PubMed were used systematically and with no time limitation up to February 10, 2020. RESULTS: In total, 20 studies were included in the present meta-analysis. The results of the meta-analysis showed that herbal medicines versus the control group (standard mean difference [SMD] = - 0.585; 95% confidence interval [CI]: - 0.728-- 0.44; heterogeneity; p = 0.02; I2 = 42%), herbal medicines versus the B group (SMD = - 0.59; 95%CI: - 0.75-- 0.44; heterogeneity; p = 0.03; I2 = 42%), and its subgroups, such as phytoestrogen (SMD = - 0.691; 95%CI: - 0.82-- 0.55; heterogeneity; p = 0.669; I2 = 0%), Vitex-agnus-castus (SMD = - 0.642; 95%CI: - 0.84-- 0.44; p < 0.001; p = 203; I2 = 32%), flaxseed (SMD = - 0.63; 95%CI: - 0.901-- 0.367; p = 0.871; I2 = 0%), and evening primrose (SMD= - 0.485; 95%CI:- 0.84-- 0.12; p = 0.008; heterogeneity; p = 0.06; I2 = 56%] may have effective and helpful effects on improving cyclic breast mastalgia. Also, chamomile, isoflavone, cinnamon, and nigella sativa significantly reduced mastalgia symptoms. CONCLUSION: Herbal medicines and their subgroups may have effective and helpful effects on improving cyclic breast mastalgia. The findings of our meta-analysis must be done cautiously because low methodological quality in some evaluated studies of this systematic review.

OBJETIVO: Diferentes drogas são utilizadas para tratar a mastalgia, como danazol e bromocriptina, e ambas estão associadas a efeitos colaterais, devido aos quais a maioria das mulheres e dos profissionais de saúde está interessada em medicamentos fitoterápicos. Portanto, nosso objetivo no presente estudo é estudar a eficácia dos fitoestrogênios na gravidade da mastalgia cíclica. MéTODOS: Para a realização do presente estudo, foram utilizados recursos eletrônicos em inglês como a Cochrane Library, ISI Web of Science, Scopus e PubMed, de forma sistemática e sem limitação de tempo até 10 de fevereiro de 2020. RESULTADOS: No total, 20 estudos foram incluídos na presente metanálise. Os resultados da metanálise mostraram que fitoterápicos versus grupo controle (SMD = - 0,585; intervalo de confiança (IC) 95%: - 0,728­- 0,44; heterogeneidade; p = 0,02; I2 = 42%), fitoterápicos versus grupo B (SMD = - 0,59; IC95%: - 0,75­- 0,44; heterogeneidade; p = 0,03; I2 = 42%) e seus subgrupos, como fitoestrogênios (SMD = - 0,691; IC95%: - 0,82­- 0,55; heterogeneidade; p = 0,669; I2 = 0%), Vitex-agnus-castus (SMD = - 0,642; IC95%: - 0,84­- 0,44; p < 0,001; p = 203; I2 = 32%), linhaça (SMD = - 0,63; IC95%: - 0,901­- 0,367; p = 0,871; I2 = 0%) e prímula (SMD = - 0,485; IC95%: - 0,84­- 0,12; p = 0,008; heterogeneidade; p = 0,06; I2 = 56%) podem ter efeitos eficazes e úteis na melhora da mastalgia cíclica da mama. Além disso, camomila, isoflavona, canela e Nigella sativa reduziram significativamente a mastalgia. CONCLUSãO: Os medicamentos fitoterápicos e seus subgrupos podem ter efeitos eficazes e úteis na melhora da mastalgia mamária cíclica. Os achados do presente estudo devem ser explantados com atenção devido ao pequeno número de estudos existentes sobre o tema, a maioria dos quais com um tamanho de amostra pequeno.

The mechanisms underlying the role of Vitex agnus-castus in mastalgia.

Medicinal plants exert therapeutic effects or have beneficial healing functions on the human or animal body. Medicinal plants are widely used in traditional medicine as an interesting alternative and/or complementary to science-based medicine. Compared to chemical drugs, medicinal plants have a lower risk of side effects, are eco-friendly, and have cost-effective production. This encouraged researchers to extensively exploit them for their therapeutic use. One of the most well-known medicinal plants is Vitex agnus-castus L., which belongs to the Verbenaceae family. This shrub tree is mainly grown in tropical and sub-tropical regions. The parts of VAC, especially berries and leaves, contain essential oils, flavonoids, and diterpenes. Many medical benefits of VAC have already been reported, including mastalgia, regulating menstrual cycles and premenstrual complaints, and infertility. Respiratory and cardiovascular effects are also reported. In this review, we will analyze and characterize the known roles of VAC in mastalgia, as well as the mechanism of action reported in in vitro and/or in vivo studies, and show the potential for alternative therapeutic uses in mastalgia, also known as breast pain (Fig. 2, Ref. 40). Keywords: mastalgia, Vitex agnus-castus, therapy, traditional medicine.

The progestin-only pills drospirenone 4 mg and desogestrel 0.075 mg as an option for the management of dysmenorrhea and mastodynia.

INTRODUCTION: Dysmenorrhea and mastodynia are the most common gynecologic pain causes in women of all ages and races during their reproductive life. The following study aimed to show the influence of two POP´s in the development of dysmenorrhea and mastodynia after nine months of use. MATERIAL AND METHODS: A total of 858 women with 6691 drospirenone (DRSP) cycles and 332 women with 2487 desogestrel (DSG) cycles were analyzed. Women included in this study were all child-bearing potentials, at risk of pregnancy, agreeing to use only the study medication for contraception for the duration of the study medication treatment, aged 18 to 45. RESULTS: At screening, 168 (19.6%) of the 858 patients using DRSP and 64 (19,3%) of the DSG patients reported that they had suffered from dysmenorrhea within six cycles prior to the first visit before starting with the medication. 20,2% of the DRSP and 10,9% of the DSG group had a sever dysmenorrhea. After 9 cycles this was reduced to 0,6% and 3,1% respectively. In total, 96 women (11.2%) in the DRSP and 49 (14,8%) experienced mastodynia within six cycles before the screening. Of these 91.6% in the DRSP group and 91,8% in the DSG group had no or mild mastodynoa at follow-up. DISCUSSION: The progestins 4 mg and desogestrel 0,075 mg showed a marked effect in the non-contraceptive aspects of dysmenorrhea and mastodynia so that new possibilities are opened for these two benign gynecological diseases. Future studies must reaffirm these first data.

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.

Tamoxifen in Mastalgia: A Meta-Analysis.

OBJECTIVES: Tamoxifen is prescribed for chronic mastalgia at a dosage of one 10- or 20-mg tablet for 3-6 months. A topical preparation of this drug has recently been approved. The aim of this study was to meta-analyze the effectiveness of tamoxifen and its different regimens for the treatment of mastalgia. We also sought to summarize the side effects and the follow-up results of these treatments. DATA SOURCES: We searched the databases of PubMed/ MEDLINE, Central, Embase, and EBSCO from August 2021 to September 2021. STUDY SELECTION: Articles on the effects of tamoxifen in mastalgia were searched, and randomized controlled trials were retrieved for inclusion in this study. PRISMA guidelines were followed, and we selected 9 articles for the meta-analysis. DATA EXTRACTION AND SYNTHESIS: A proforma was prepared for data collection. RevMan 5.4 software was used for methodological quality assessment, statistical analysis, and preparation of forest plots. Oral tamoxifen performed better than placebo (risk ratio [RR] 2.04; 95% CI 1.49-2.78, P < 0.001). No significant difference in efficacy was seen between the 10- and 20-mg dosages (RR 1.08; 95% CI 0.97-1.21, P = 0.18) when used for 3 months. CONCLUSION: Oral tamoxifen is helpful in long-standing mastalgia. It is safe and effective at an oral dose of 10 mg.

A Systematic Review and Meta-Analysis of the Efficacy of Evening Primrose Oil for Mastalgia Treatment.

Mastalgia, or breast pain, is common among women which can lead to significant impairment in daily living. Hence, finding an effective treatment that can alleviate the symptom is very important. Thus, we carry out this study to determine the efficacy of evening primrose oil (EPO) for mastalgia treatment in women. The review included published randomised clinical trials that evaluated EPO used for treating mastalgia against a placebo or other treatments, irrespective of the blinding procedure, publication status, or sample size. Two independent authors screened the titles and abstracts of the identified trials; full texts of relevant trials were evaluated for eligibility. Two reviewers independently extracted data on the methods, interventions, outcomes, and risk of bias. The random-effects model was used for estimating the risk ratios and mean differences with 95% confidence intervals. Thirteen trials with 1752 randomised patients were included. The results showed that EPO has no difference to reduce breast pain compared to topical NSAIDS, danazol, or vitamin E. The number of patients who achieved pain relief was no different compared to the placebo or other treatments. The EPO does not increase adverse events, such as nausea, abdominal bloating, headache or giddiness, increase weight gain, and altered taste compared to a placebo or other treatments. EPO is a safe medication with similar efficacy for pain control in women with mastalgia compared to a placebo, topical NSAIDS, danazol, or vitamin E.

Multi-study randomised controlled trial to develop, implement and evaluate bra prescription to reduce breast pain and improve quality of life.

BACKGROUND: and Purpose: Breast pain is a common condition presented at breast care clinics and bras are often recommended to reduce symptoms, although criteria and pathways for obtaining appropriate bras are limited. This multi-study, randomised controlled trial (RCT) aimed to establish criteria and performance variables to prescribe bras for breast pain patients, to implement this bra prescription, and evaluate whether, compared to standard care alone, the bra prescription improves breast pain and quality of life (QoL). MATERIALS AND METHODS: Eighteen breast pain patients from a UK hospital were assigned to standard care or bra prescription groups and completed the study. Bra prescription patients were prescribed a bra to wear every day for eight weeks. Patient Global Impression of Change (PGIC), breast pain intensity, QoL, and adherence were assessed. RESULTS: Between-groups there were no differences in baseline breast pain or QoL and no differences in PGIC or breast pain following the intervention. Within-groups, improvements in QoL within bra prescription patients were identified. CONCLUSION: This study developed a framework for bra prescription for breast pain patients and the intervention demonstrated improvements in QoL.

It's Not Yeast: Retrospective Cohort Study of Lactating Women with Persistent Nipple and Breast Pain.

Introduction: Health care providers treating lactating women for nipple and breast pain often attribute symptoms to Candida albicans infection. However, multiple other conditions may present with pain, erythema, and pruritis. We explored the experience of a breastfeeding medicine practice that received referrals for patients failing antifungal therapy and who desired further evaluation for alternative diagnoses. Materials and Methods: We conducted a retrospective chart review of breastfeeding women referred for evaluation of "yeast" to a breast surgery/breastfeeding medicine practice from July 2016 to August 2019. Results: Twenty-five women met inclusion criteria. Median age was 33 (range 24-43) and median months postpartum was 4 (range 0.5-18). All 25 women reported minimal to no improvement on oral and/or topical antifungal therapy. In addition to history and examination, milk culture was obtained in four women, punch biopsy in one, and core needle biopsy in one. No woman was confirmed to have a diagnosis of Candida. Diagnoses were changed to the following: subacute mastitis/mammary dysbiosis (n = 8), nipple bleb (n = 6), dermatitis (n = 6), vasospasm (n = 2), milk crust (n = 1), hyperlactation (n = 1), and postpartum depression (n = 1). Treatment included discontinuation of antifungal medication, as well as the following per individual diagnoses: antibiotics and probiotics; 0.1% triamcinolone cream; heat therapy; discontinuation of exclusive pumping; and antidepressant medication and counseling referral. All women experienced resolution of symptoms following revision of diagnosis and change in management (range 2-42 days). Conclusion: While persistent nipple and breast pain in breastfeeding is often attributed to Candida, this cohort demonstrates that providers should consider multiple other conditions in their differential diagnosis. Accurate, timely diagnosis is crucial, as pain is a risk factor for premature cessation of breastfeeding. Symptomatic resolution occurs on appropriate therapy.

Clinical Factors Affecting the Therapeutic Efficacy of Evening Primrose Oil on Mastalgia.

BACKGROUND: Saturated fatty acid esters may cause mastalgia via hypersensitivity of breast epithelium to circulating hormones. Evening primrose oil (EPO) may restore the saturated/unsaturated fatty acid balance and decrease sensitivity to steroidal hormones or prolactin. Conflicting results exist regarding EPO treatment for mastalgia. The aim of this study was to determine the effectiveness of EPO and factors affecting its efficacy in treatment of mastalgia. METHODS: The study included 1015 patients, ages 14-82 (mean age 42.21 ± 10.8), admitted to Acibadem Breast Clinic between January 2015 and March 2018. The patients were divided into group I (n = 581) treated with EPO (1300 mg, twice a day) and group II (n = 434) treated with paracetamol (500 mg, twice a day). The visual analog scale was used to assess EPO's therapeutic efficacy, compared with paracetamol, measured at admittance, 2 weeks, and 6 weeks. Clinical factors affecting the efficacy of EPO were analyzed. RESULTS: The therapeutic efficacy of EPO on mastalgia was significantly higher than with paracetamol (p < 0.001). Factors significantly affecting the efficacy of EPO treatment were hormone replacement therapy (HRT), IUD-with-levonorgestrel, iron deficiency, overt hypothyroidism, and Hashimoto thyroiditis (p < 0.01). Replacement of iron or thyroid hormone efficiently treated mastalgia in patients that did not respond to EPO treatment. Side effects (allergy, anxiety, blurred vision, constipation, and nausea) were rare and not statistically significant (p = 0.88). CONCLUSION: EPO can be used in the treatment of mastalgia without significant side effects. HRT, IUD-with-levonorgestrel, iron deficiency, overt hypothyroidism, and Hashimoto thyroiditis significantly affect the efficacy of EPO on mastalgia.

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.

Vitex Agnus-Castus for the Treatment of Cyclic Mastalgia: A Systematic Review and Meta-Analysis.

Background: Cyclic mastalgia (CM) is premenstrual bilateral and diffuse breast pain that presents cyclically and affects women in their reproductive years. It may associate with latent hyperprolactinemia due to the insufficient inhibitory effect of dopamine on the pituitary gland. Vitex agnus-castus (VAC) is known for its dopaminergic activity and its possible actions on CM and latent hyperprolactinemia. However, the treatment effect of VAC on CM remains unclear. Materials and Methods: To perform a systematic review and meta-analysis of clinical trials that report on the efficacy of VAC treatment in CM patients, literature search was performed in major research databases. Results: This review includes 25 studies (17 randomized control trials plus eight nonrandomized trials). VAC was effective in relieving breast pain intensity and lowering the increased serum prolactin level in reproductive age CM patients (18-45 years) with or without premenstrual syndromes. Typical dosage was 20-40 mg/day with a treatment duration of 3 months. A conservative meta-analysis included only six studies (n = 718, VAC = 356, placebo = 362) and revealed a moderate effect size (SMD: 0.67, 95% CI: 0.5-0.85) favoring VAC over a placebo. Seven trials demonstrated VAC to be a noninferior alternative to pharmaceutical therapies for CM, including dopamine agonists, nonsteroidal anti-inflammatory drugs, serotonin reuptake inhibitors, and hormonal contraceptives. VAC was safe and associated with only mild and reversible adverse events. However, the risk of bias in most studies was unclear due to insufficient information. Conclusions: VAC is a safe and effective treatment option for CM. More high-quality clinical trials are needed to strengthen the evidence base.

Regulation effect and mechanism of Sheng-Hua-Tang on female reproductive system: From experimental transcriptomic analysis to clinical applications.

ETHNOPHARMACOLOGICAL RELEVANCE: Sheng-Hua-Tang (SHT) is commonly used to treat female illnesses, especially postpartum conditioning. However, its effects and mechanisms on female reproductive system remain unclear. The aim of the present study was to investigate the effect of SHT on female brain-ovary-uterus axis from bench to clinic. MATERIALS AND METHODS: Mice were administrated SHT (200 mg/kg) orally for seven consecutive days. Brain, ovary, and uterus tissues were then collected for microarray analysis. A nationwide database analysis and a pilot randomized, open-label clinical trial were further applied to evaluate the clinical application and effects of SHT on postpartum women. RESULTS: Microarray analysis showed that oral administration of SHT induced a cascade reaction of gene expression, with 17, 883, and 1592 genes were significantly regulated by SHT in brain, ovary, and uterus, respectively. Population-based analysis of one million subjects in Taiwan's National Health Insurance Research Database between 1997 and 2013 showed that SHT was commonly used in menstrual disorders in female population, especially dysmenorrhea, abnormal uterine bleeding, and variation of menstrual cycle. Clinical trial on postpartum women showed that oral administration SHT for one week alleviated uterine contraction pain and breast swelling pain. Furthermore, Mmp2, Mmp3, Mmp9, Mmp11, Mmp15, Oxtr, Plrl, and Tph2 gene expression affected by SHT in mice were correlated with clinical effects of SHT in human subjects. CONCLUSION: This report provided the scientific evidences of mechanisms and clinical efficacies of SHT. Moreover, our findings might afford insights for clinical doctors in terms of SHT prescription.

Oral versus topical tamoxifen in cyclical mastalgia-A randomized controlled trial.

Mastalgia affects premenopausal in which cyclical mastalgia affects up to 40% of women. In approximately 8% of these women, pain will be severe and interfere with their normal activities. oral tamoxifen widely used in the treatment of mastalgia is associated with a wide range of side effects. Topical tamoxifen has the potential to be a more efficacious and safer alternative with lower blood drug levels hence having lower systemic side effects. To compare reduction in the pain, nodularity and blood drug levels of tamoxifen using topical verus oral tamoxifen in cyclical mastalgia. Patients who presented to the surgery outpatient department with complaints of breast pain were provided with a breast pain evaluation questionnaire. Patients were randomized using a computer generated sequence into two groups with 75 participants in each group. In Group 1, the participants received topical tamoxifen gel and a placebo tablet for 3 months, and in Group 2, the participants received Oral Tab Tamoxifen 10 mg OD and a placebo gel for 3 months. They were provided with a Cardiff Breast Pain assessment chart and asked to mark the severity of their pain and response to treatment in the following month and asked to report to the investigator. Patients were called for review every month, and the pain chart was monitored and documented. The response to therapy (relief of pain) was assessed after 3 months of treatment and once more at the end of 6 months for recurrence. After completion of 1 month of treatment, blood sample was drawn to check for the blood drug levels. There is a significant difference of mean pain score between oral and topical tamoxifen groups (P < .001) at the end of 1 month, 3 months (P < .001), and 6 months (P < .001). There is a significant difference in the Nodularity found between oral and topical groups at presentation (P = .004), at 1 month (P = .003) and at 6 months (P < .001). There is a significant difference of mean blood tamoxifen level (ng/mL) in oral and topical tamoxifen groups (P < .001). From this study, we conclude that topical tamoxifen is more effective than oral tamoxifen treatment in reducing cyclical breast pain and decreasing breast nodularity with lesser side effects and lower recurrence rates.

Effect of vitamin E on severity and duration of cyclic mastalgia: A systematic review and meta-analysis.

OBJECTIVES: A systematic review was conducted to assess the effect of vitamin E on the severity and duration of Cyclic Mastalgia compared to vitamin B6, fish oil, herbal medicines and placebo. DESIGN: A systematic review and meta-analysis of clinical trials. METHODS: A search was carried out in PubMed, Cochrane Library, Embase, Scopus and Google Scholar and Persian databases for articles published from 1980 to 2018. The data obtained were analyzed in RevMan and reported in forest plots. The Odds Ratio (OR) was used to find the effect for the dichotomous data and the Standardized Mean Difference (SMD) for the continuous data. The heterogeneity of the studies was assessed using I2 and the Random Effects Model was used instead of the Fixed Effects Model if I2>25%. RESULTS: A total of 1051 titles and abstracts were extracted. Fourteen articles ultimately remained, and 11 of them were entered into the meta-analysis. The meta-analysis showed significant differences between vitamin E and placebo in the severity (SMD=-0.51; 95% CI=-0.21 to -0.82) and duration (MD=-1.47; 95% CI=-0.91 to -2.57) of cyclic mastalgia, although herbal medicines had a greater effect on the severity of mastalgia than vitamin E (SMD = 0.51, 95% CI = 0.06 to 0.96). CONCLUSION: Although herbal medicines are more effective than vitamin E, vitamin E reduces both the severity and duration of the disorder compared to placebos, which only reduce its severity, and can therefore be considered a treatment with minimum side-effects. Due to the high heterogeneity of the studies, the researchers recommend further research on the subject using a standard tool based on the CONSORT statement.

The effect of centchroman on mastalgia: a systematic review.

OBJECTIVES: We carried out a systematic review of the literature to evaluate the effect of centchroman on mastalgia as well as any side effects. METHODS: The databases of the Cochrane Library, Medline (PubMed), Embase, ProQuest and ClinicalTrials.gov were systematically searched. The quality of randomised controlled clinical trials (RCTs) was assessed using the Cochrane Collaboration's tool for assessing risk of bias in randomised clinical trials. The quality of non-randomised clinical trials was assessed using the Cochrane risk of bias assessment tool for non-randomised studies of interventions (ROBINS-I). Owing to different outcomes reporting, a meta-analysis of the results was not possible. RESULTS: Thirteen papers were included in the study. Of these, 12 showed a significant effect of centchroman in reducing breast pain at 3 months. One study that compared the effect of centchroman with that of tamoxifen reported a significant reduction in breast pain in both groups at 3 months; the difference between the two groups was not significant. Six studies showed the effectiveness of centchroman at 6 months. None of the papers reported any serious side effects of centchroman. CONCLUSIONS: Since a meta-analysis could not be conducted and the quality of the papers was low, there was insufficient evidence to evaluate the effect of centchroman on mastalgia. It is therefore recommended to conduct well-designed RCTs to compare the effect of centchroman on mastalgia with that of a placebo or other medication.

Comparison Of Cimicifuga foetida extract and different hormone therapies regarding in causing breast pain in early postmenopausal women.

This study aimed to compare the influence between Cimicifuga foetida extract and different hormone therapies on breast pain in early postmenopausal women. A prospective, randomized, controlled clinical trial was conducted among 96 early postmenopausal women. Participants were randomly assigned to three groups: group A received 1 mg/day estradiol valerate plus 4 mg/day medroxyprogesterone acetate on days 19-30; group B received 1 mg/day estradiol valerate plus 100 mg/day micronized progesterone on days 19-30; group C received C. foetida extract, 1talet (contains 33.3 mg extract), t.i.d. Breast pain diary and numerical rating scale was used to access the breast pain. For 6 months' treatment, the total incidence of breast pain in group A and B was significantly higher than that in group C (p < .05). The duration (day) of breast pain in each month decreased over time in group A and B while it was continuously low and without significant change in group C (p > .05). The intensity of breast pain was mild in most participants and did not differ among three groups (p > .05). During treatment of early postmenopausal women with C. foetida extract for 6 months, the incidence and duration of breast pain were lower than upon treatment with E2 plus cyclic MPA or m-P and did not change over time.

Effects of Kuntai capsule on breast pain and vaginal bleeding in postmenopausal women.

Aim of the present work was to investigate the clinical efficacy of Kuntai capsule in the treatment of postmenopausal women with endometriosis, Breast pain and Vaginal Bleeding. 120 elderly female outpatients over 50 years old with Breast pain were randomly divided into control group (60 cases) and observation group (60 cases). All patients were given diclofenac sodium enteric-coated tablets 25mg, 3 times a day. The observation group was given additional Kuntai capsules at a dose of 4 capsules per time, 3 times a day. Serum estradiol (E2), follicle stimulating hormone (FSH), and luteinizing hormone (LH) were detected in all patients before and at 12 weeks after treatment. Modified Kupperman score (K score) for evaluating menopausal symptoms. The post therapeutic serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) level and endometrial thickness decreased significantly (p<0.05). After treatment, KMI scores of kunati group was significantly decreased compared with baseline (<0.01) and there was no significant difference between groups (p>0.05). After treatment, hot flush and insomnia scores were both improved significantly. After therapy, serum E2 level obviously higher than the control groups, while FSH and LH levels were obviously lower (p<0.05). The incidence of vaginal bleeding, breast distending pain in group was obviously higher in control group than Kuntai group. Thus, Kuntai capsule improved the ovarian function of patients, raised the level of estrogen in vivo and alleviates the clinical manifestations of Breast pain.

Quantitative Sensory Testing, Antihistamines, and Beta-Blockers for Management of Persistent Breast Pain: A Case Series.

BACKGROUND: It is not uncommon for mothers to have persistent pain with breastfeeding beyond the first few weeks after birth. Persistent pain can be multifactorial, with neuropathic pain maintained by central sensitization being one dimension. Our knowledge in delineating categories of persistent pain is simple and not very sophisticated. METHODS: We have developed and tested a Lactation Quantitative Sensory Test (L-QST) to quantify the neuropathic component of persistent breastfeeding pain. We present three case reports of neuropathic breastfeeding pain and treatment, and we discuss the potential role of histamine and catecholamines in persistent breastfeeding-associated pain. CONCLUSIONS: The L-QST can be a useful tool to quantify neuropathic pain. Further studies are needed to test inter-observer reliability and reproducibility of this tool. Antihistamines can be considered for treating persistent pain in breastfeeding women with a history of allergy or atopy, and beta-blockers may be helpful in women with multiple pain disorders.