title: Symptomatic treatment of premenstrual mastalgia in premenopausal women with lisuride maleate: a double-blind placebo-controlled randomized study. Efficacy of topical nonsteroidal antiinflammatory drugs in mastalgia treatment. Clinical evaluation of mastalgia. A double-blind randomized controlled trial of isoflavones in the treatment of cyclical mastalgia. Centchroman Regresses Mastalgia: A Randomized Comparison with Danazol What Effect, if any, does Soy Protein have on Breast Tissue? A phase II trial of Afimoxifene (4-hydroxytamoxifen gel) for cyclical mastalgia in premenopausal women Role of Centchroman in Regression of Mastalgia and Fibroadenoma Management of cyclical mastalgia in oriental women: pioneer experience of using gamolenic acid (Efamast) in Asia. Cyclical mastalgia: prevalence and associated health and behavioral factors Comparison of Naproxen with Placebo for the Management of Noncyclical Breast Pain: A Randomized, Double-Blind, Controlled Trial The effect of tamoxifen on bone mineral content in premenopausal women with breast cancer Centchroman vs tamoxifen for regression of mastalgia: a randomized controlled trial. Multicentre study of gestrinone in cyclical breast pain FRIEDOLF PETERS Therapeutic effects of vitamin E on cyclic mastalgia. Topical nonsteroidal anti-inflammatory drugs versus oil of evening primrose in the treatment of mastalgia. A double-blind randomized controlled trial of toremifen therapy for mastalgia. Low intensity laser therapy is comparable to bromocriptine-evening primrose oil for the treatment of cyclical mastalgia in Egyptian females. A randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity. The effect of psychoeducation on anxiety and pain in patients with mastalgia DOUBLE-BLIND CONTROLLED TRIAL OF TAMOXIFEN THERAPY FOR MASTALGIA The effect of decreased caffeine consumption on benign proliferative breast disease: a randomized clinical trial. A randomised controlled trial of medroxyprogesterone acetate in mastalgia. Vitamin E and evening primrose oil for management of cyclical mastalgia: a randomized pilot study. Treatment of mastalgia with bromocriptine: a double-blind cross-over study. Treatment of cyclical mastalgia with a solution containing a Vitex agnus castus extract: results of a placebo-controlled double-blind study. A randomized double blind-cross over trial of soya protein for the treatment of cyclical breast pain. European multicentre trial of bromocriptine in cyclical mastalgia A randomized multicenter study of gamolenic acid (Efamast) with and without antioxidant vitamins and minerals in the management of mastalgia. Randomized controlled trial of the management of premenstrual syndrome and premenstrual mastalgia using luteal phase-only danazol. Sports Brassiere: Is It a Solution for Mastalgia? Effectiveness of topical non-steroidal anti-inflammatory drugs in the management of breast pain.
abstract: OBJECTIVE To determine the therapeutic effect of lisuride maleate on premenstrual mastalgia in premenopausal women . DESIGN Double-blind r and omized prospect i ve study . SETTING Department of obstetrics and gynecology at a university hospital . PATIENT(S ) Sixty women with premenstrual mastalgia were included in the study . Study and control groups consisted of 30 women each . INTERVENTION(S ) Women enrolled in the study and control group were given one tablet daily ( 0.2 mg ) of lisuride maleate or placebo orally for 2 months . Severity of mastalgia was evaluated using the visual analog scale . MAIN OUTCOME MEASURE(S ) Severity of mastalgia and side effects of the drug administered . RESULT ( S ) Mastalgia subsided significantly in women receiving lisuride maleate compared with controls . There were no significant side effects from lisuride maleate .  Prolactin levels decreased significantly in the group receiving lisuride , which correlated well with pain resolution . CONCLUSION ( S ) Lisuride maleate may be useful for the symptomatic treatment of premenstrual mastalgia BACKGROUND The aim of the study was to investigate the effects of topical nonsteroidal antiinflammatory drugs ( NSAIDs ) on mastalgia . STUDY DESIGN A prospect i ve , r and omized , blinded , placebo-controlled study was performed to evaluate the effects of topical NSAIDs on cyclic and noncyclic mastalgia . A total of 108 patients , 60 with cyclic ( group I ) and 48 with noncyclic ( group II ) breast pain were enrolled . Patients within each group were r and omly assigned to receive either topical NSAIDs or placebo three times daily for at least 6 months . Severity of pain was measured before and after 6 months of treatment . RESULTS The pain score decreased significantly when the mean initial breast pain score was compared with the sixth-month breast pain score of the treatment or the placebo group of cyclic ( p = 0.0001 and p = 0.0001 , respectively ) or noncyclic mastalgia ( p = 0.0001 and p = 0.0001 , respectively ) . Significant differences were found when the mean within-person change in pain values in each treatment group were compared with the change in the respective placebo group for either cyclic or noncyclic mastalgia ( p = 0.0001 and p = 0.0001 , respectively ) . Changes in pain within treatment groups or placebo groups for cyclic versus noncyclic mastalgia were not found to be statistically different ( p = 0.53 and p = 0.96 , respectively ) . No side effect was seen in any group . CONCLUSIONS Topical application of NSAIDs was effective in both cyclic and noncyclic mastalgia with minimal side effects OBJECTIVE To describe an accurate and reproducible method to quantify a patient 's subjective experience of breast pain .  DESIGN Prospect i ve diary study . SETTING Military tertiary care hospital . PATIENTS Thirty female military health care beneficiaries from the Walter Reed Army Medical Center , Washington , DC , gynecology and general surgery clinics . MAIN OUTCOME MEASURES Daily mastalgia was recorded using a visual analog scale and menstrual symptoms were measured using a daily question naire . These measures were correlated with results of a screening question naire completed prior to study entry . RESULTS Patients identified as having cyclical mastalgia based on the  screening question naire ( n= 15 ) were found to have higher peak perimenstrual mastalgia according to their daily diaries than patients who did not meet diagnostic criteria ( n=15 ) ( 5.3+/-0.7 vs 3.5+/-0.5 , P<.001 ) . Applying the same criteria used in the screening question naire to the diary data , 17 of 30 patients met diagnostic criteria for cyclical mastalgia . The ability of the screening question naire to predict the results of the prospect i ve diary data was calculated , and positive and negative predictive values were 73 % and 60 % , respectively . Most patients with cyclical mastalgia also have other perimenstrual psychological and somatic complaints , although a subset of patients has high levels of mastalgia with minimal associated symptoms . CONCLUSIONS Accurate assessment of mastalgia can not be done with a retrospective question naire and requires prospect i ve diary evaluation , owing to the variable and subjective nature of symptoms and recall bias . A daily visual analog scale provides reproducible results and is easy for patients to use Cyclical mastalgia is very common in Western population s and is believed to have an hormonal basis . Simple measures such as vitamins or evening primrose oil are not very effective , yet the disease rarely warrants anti-oestrogen therapies . Isoflavones are a subgroup of phytoestrogens which we hypothesized might be a simple and effective means of therapy as they act as a weak anti-oestrogen in pre-menopausal women and have no side-effects . A double-blind r and omized control trial of either placebo , 40 mg or 80 mg of isoflavones was undertaken after an initial 2 month single-blind ' Placebo Lead-in ' to exclude women with a significant placebo response . Eighteen women were r and omized to the treatment phase of the trial . Nine of the 12 women on treatment had a worthwhile improvement in their pain compared to only two of six on placebo . The reduction in pain was 13 % for placebo , 44 % for 40 mg of isoflavone per day and 31 % for 80 mg per day . There have been no previous clinical studies of isoflavones for the treatment of mastalgia and the benefit demonstrated in this study adds another valuable arm to therapy We conducted a r and omized trial to evaluate effectiveness of Centchroman in control of mastalgia and compared it with Danazol . Research Question - Is proportion of pain relief achieved by Centchroman similar to or inferior to that achieved by Danazol ? In a r and omized controlled trial of Centchroman vs. Danazol in mastalgia , 81 patients with mastalgia were studied . Thirty-nine patients were r and omized to Danazol arm and 42 in Centchroman arm . The treatment was given for 12 weeks , followed by observation for 12 weeks . The pain was measured by visual analogue scale ( VAS ) of 0–10 . At 12 weeks 89.7 % women achieved reduction in pain score to ≤3 in Centchroman group ( pvalue 0.001 ) . In Danazol group 69.44 % women achieved reduction in pain score to ≤ 3 ( p = 0.001 ) . Three months after stopping therapy , Centchroman was more effective in pain score reduction at 24 weeks as compared to Danazol ( p = 0.019 ) . Centchroman is an effective , safe and inexpensive alternative to Danazol for treatment of mastalgia Differences in breast tissue can be determined using breast-enhanced scintigraphy test ( BEST ) imaging . Minimal work in vivo has been done previously to determine the effects of soy protein on breast tissue . The authors ' earlier work demonstrated reduction in inflammatory changes in breast tissue . This work was conducted to examine the effect of daily soy protein consumption on a larger group of women over the course of 1 year . Sixty-four premenopausal women were studied after initial BEST imaging evaluation revealed fibrocystic changes of the breast . Women were asked to consume a medical- grade soy protein on a daily basis , making no other dietary or lifestyle changes during that time . Each woman underwent BEST imaging 1 year later with the results compared to the initial findings . Women and their physicians reported a subjective reduction in both breast tenderness and fibrocystic disease ( FCD ) . There was a nonstatistical reduction in both the average and maximal count breast activity following 1 year of daily soy consumption . There was a statistically significant reduction ( P < .01 ) in variability of tissue activity following 1 year of soy protein treatment . This is the first in vivo study looking at the effect of soy protein on breast tissue health . The findings are promising and showed both objective and subjective findings consistent with a reduction in fibrocystic disease of the breast . Further research is needed to confirm these findings in a greater number of women and to determine if soy protein has the same beneficial effect in atypia and breast cancer Background Many women experience symptoms of cyclical mastalgia , such as breast pain , tenderness , and nodularity . Tamoxifen and other drugs have been used to alleviate cyclical mastalgia symptoms ; however , their use is associated with potentially serious side effects . The current study compared the safety and efficacy of two doses of a topical gel containing 4-hydroxytamoxifen ( Afimoxifene , formerly known as 4-OHT ) with placebo gel for the treatment of moderate to severe cyclical mastalgia . Methods Premenopausal women aged at least 18 years experiencing moderate to severe symptoms were r and omized to receive placebo , 2 mg , or 4 mg of Afimoxifene daily delivered as a transdermal hydroalcoholic gel for 4 menstrual cycles . The primary efficacy parameter was change in mean pain intensity as measured by the Visual Analog Scale ( VAS ) for the seven worst pain score days within a cycle from baseline to the fourth cycle . Results After 4 cycles of treatment , statistically significant improvements relative to placebo were measured in mean VAS score in the 4-mg Afimoxifene group ( −12.71 mm [ 95 % confidence interval , −0.96 to −24.47 ; P = 0.034 ] ) . Patient global assessment of pain , physician ’s assessment of pain , tenderness on palpation , and nodularity following 4 cycles of treatment were significantly more likely to show improvements in the 4-mg group , compared with placebo ( P = 0.010 [ pain ] ; P = 0.012 [ tenderness ] ; P = 0.017 [ nodularity ] ) . Overall , Afimoxifene was well tolerated with few adverse events and no drug-related SAE occurred in any group . There were no changes in menstrual pattern or plasma hormone levels and no breakthrough vaginal bleeding in patients treated with Afimoxifene . Conclusion After 4 months of treatment , daily topical breast application of Afimoxifene result ed in statistically significant improvements in signs and symptoms of cyclical mastalgia across patient- and physician-rated scales with excellent tolerability and safety Objectives Centchroman ( Ormeloxifene ) is a novel non-steroidal , selective antiestrogen . Because of its selective antiestrogen action , centchroman has been used for treatment of mastalgia and fibroadenoma .  Material s and Methods Benign breast disease patients up to 35 years of age attending our surgery outpatient department from August 2003 to September 2004 and fulfilling the inclusion criterion were included in this study . They were started on centchroman 30 mg on alternate days for a period of 3 months and were followed up for 6 months . Results were recorded as per clinical examination , visual analog scale ( VAS ) for pain , and ultrasonography for breast lump size . Results A total of 60 patients were included in this pilot study , 42 ( 70 % ) of whom had mastalgia with or without nodularity , and 18 ( 30 % ) had fibroadenoma .  Noncyclical pain was recorded in 38 patients ( 90 % ) , and cyclical pain was recorded in only 4 ( 10 % ) patients . A VAS score of 10 was recorded by 33 ( 80 % ) patients ( severe pain ) , and the remaining 9 patients ( 20 % ) had VAS scores from 7 to 10 . Fibroadenoma size ranged from 1.5 to 5 cm . , single or multiple in one or both breasts . There was a good response in the mastalgia group , with a decrease in the VAS scoring from 10 to 3 in 90 % of the patients in the first week . Almost all of the patients were painless at the end of one month , with complete disappearance of the nodularity . In the fibroadenoma group there was a mixed response , with complete disappearence in 40 % , partial regression in 20 % , and no response at all in the remaining 40 % . There were very few side effects . Conclusions Centchroman is a safe nonsteroidal drug for the treatment of mastalgia and fibroadenoma . It has shown good results in mastalgia and is a safe drug as compared to the drugs of choice used at present ( danazole and bromocriptine ) . Further r and omized studies are in progress and are needed to determine its definitive role in this patient group BACKGROUND In most Western countries gamolenic acid is the first-line treatment for women with cyclical mastalgia . METHODS A prospect i ve study was carried out in the breast referral clinic of the Department of Surgery , University of Hong Kong to evaluate the treatment of cyclical mastalgia using gamolenic acid provided in evening primrose oil ( Efamast , Scotia Pharmaceuticals Ltd , Scotia House , Stirling , Scotl and ) as a pioneer experience in Asia . In addition , the features of cyclical mastalgia in Oriental women were studied by conducting a survey using anonymous question naires . RESULTS Sixty-six women with disturbing cyclical mastalgia seen by one breast surgeon were followed up with a breast pain diary . Thirty-four women had persistently disturbing mastalgia and were commenced on Efamast . Responses were measured at 3 and 6 months according to a st and ardized protocol . An overall useful response rate of 97 % was observed at 6 months . Side-effects were found in 12 % but all were insignificant . CONCLUSIONS Efamast may be recommended as a first-line specific treatment for Oriental women with disturbing cyclical mastalgia Perimenstrual breast pain ( cyclical mastalgia ) is a common problem that can be sufficiently severe to interfere with usual activities , and has been associated with elevated  mammography usage in young women . This study was undertaken to replicate clinic-based research on cyclical mastalgia , and to examine the association between this disorder and health-related behaviors and perceived stress . Using r and om digit dialing throughout Virginia , 874 women aged 18 - 44 were interviewed . Sixty-eight per cent of women experienced cyclical breast symptoms ; 22 % experienced moderate to extreme discomfort ( classified as cyclical mastalgia ) . Hormonal contraceptive usage was associated with significantly less mastalgia and premenstrual syndrome ( PMS ) . Smoking , caffeine consumption and perceived stress were associated with mastalgia ( odds ratios = 1.52 , 1.53 and 1.7 , respectively ) . Young women ( under 35 years ) with mastalgia were more likely to have had a mammogram ( 20.2 % ) than those without mastalgia ( 9.9 % ) . Most women with this disorder ( 77.5 % ) did not have PMS . The prevalence of cyclical mastalgia and its association with mammography replicate clinic-based findings . Associations with smoking and stress had not previously been reported . Prospect i ve research is needed to determine the biopsychosocial factors contributing to this disorder Background Breast pain is a common symptom in patients attending breast clinics . Although most patients experience mastalgia of mild to moderate severity , approximately 15 % of patients suffer from severe pain that causes significant distress and some disturbance in their daily life that lead them to seek treatment . Despite a considerable number of drugs suggested for decreasing the severity of mastalgia , there is no st and ard treatment for the complaint . In this study , we investigated the effect of naproxen on reducing the complaint of breast pain compared with placebo . Methods Eighty-one women suffering from noncyclic breast pain were recruited to a r and omized , double-blind , clinical trial between January 2002 and September 2004 . All patients were suffering from this complaint for at least 3 months before the study . Patients were r and omly assigned to two groups . Patients in the case group received naproxen 250 mg BD . Patients in the placebo group took placebo in a similar manner . The intensity of mastalgia was assessed before and twice after intervention by using a Visual Analogue Scale . Results Forty-two of 81 patients were recruited r and omly as cases and the remaining 39 were assigned placebo . Of these 24 and 22 patients fulfilled the study protocol respectively . The mean age of patients was 35 ( SD = 7.5 ; range , 19–55 ) years . The mean pain severity at the beginning of the study was 5.8 and 6.1 in naproxen and placebo groups , respectively . The severity of pain was decreased significantly at the end of the study in both groups ( 3.9 in patients and 3.7 in controls ( P = 0.005 and 0.0001 ) ) . Although the decrease in pain severity in each individual group was statistically significant , it was not significant compared with one another ( P = 0.64 ) . Conclusions Breast pain is a complex symptom that can be relieved significantly with reassurance . According to the result of this study , naproxen has no superiority over placebo in reducing noncyclic breast pain Thirty‐one of 62 consecutive premenopausal women with primary cancer of the breast completed a 1‐year investigation period , receiving either 30 mg tamoxifen daily ( 15 patients ) or placebo ( 16 patients ) . They were examined at the operation ( t0 ) and at 3‐month intervals ( t1 , t2 , t3 , and t4 ) . Bone mineral content ( BMC ) was measured at operation and after 12 months . Fifty‐six patients with benign tumors were included as healthy controls . All values of both cancer treatment groups and of the benign tumor group were comparable at the time of operation . BMC decreased significantly in both cancer patient groups when 12‐month values were compared to the initial level ( tamoxifen , −3.2 % , P < 0.001 and placebo −2.5 % , P < 0.01 ) . However , no significant difference in BMC changes was noted between tamoxifen and placebo treatment . The serum phosphate was significantly decreased in the tamoxifen treatment group at each examination . In the placebo  group , the alkaline phosphatase level increased significantly at each examination , whereas the serum magnesium fell at the 6‐ and 12‐month examinations . All other biochemical indices of calcium metabolism were basically unchanged . It is concluded that BMC is reduced in metastatic breast cancer through osteolytic metastatic bone foci . Tamoxifen also decreases the BMC . It is , however , unclear if this effect is due to a progression of the disease in spite of the treatment or if it is caused by a direct action of tamoxifen on bone INTRODUCTION Several agents have been tried in the management of  mastalgia .  Centchroman ( Ormeloxifene ) , a novel non-steroidal selective estrogen receptor modulator ( SERM ) , has also been recently used in the management of  mastalgia . METHODS Eligible patients , who had mastalgia for more than 3 months , were r and omized into two groups - Group A received centchroman 30 mg daily and Group B received tamoxifen 10 mg daily . Treatment was continued for a total of 12 weeks ; thereafter , patients were followed for another 12 weeks without medication to assess the continuum of relief . Pain severity was measured with VAS score . Patients were considered to have complete pain relief if their VAS score decreased to 3 or less . RESULTS Patients , in both the groups , showed gradual improvement in mastalgia with passage of time up to 12 weeks . Following cessation of treatment at 12 weeks , partial relapse of pain was observed at 24 weeks . There was no significant difference between Group A and Group B in terms of mean VAS Score and proportion of women reporting pain relief at 4 , 8 , 12 , and 24 weeks . Fifteen patients in Group A had side effects namely dizziness , menstrual irregularities and development of ovarian cysts . There was no side effect noted in group B. CONCLUSION Centchroman and tamoxifen were found to be of similar effectiveness in providing pain relief in mastalgia . High frequency of side effects , particularly development of ovarian cyst , in patients receiving centchroman is a matter of concern Although the aetiology of cyclical mastalgia is poorly understood , the consistent finding of an increased prolactin stimulation response probably due to oestrogen dominance has led to the use of treatment with prolactin-lowering drugs and antioestrogens . The efficacy and safety in cyclical mastalgia of gestrinone , which has and rogenic , anti-oestrogenic , and antiprogestagenic properties , were investigated in a multicentre study . In a double-blind r and omisation procedure , 72 patients were allocated placebo and 73 treatment with gestrinone  ( 2.5 mg twice a week ) for 3 months . The patients recorded the severity of breast pain on a visual analogue scale before and during treatment and scored other breast symptoms as not present ( 0 ) , mild ( 1 ) , moderate ( 2 ) , or severe ( 3 ) . The gestrinone group had significantly greater reductions than the placebo group in breast pain score at months 1 , 2 , and 3 of treatment ( mean reduction 59.5 [ SD 22.6 ] to 11.7 [ 17.0 ] vs 58.2 [ 17.6 ] to 36.7 [ 23.0 ] at month 3 ; p less than 0.0001 ) . All six breast symptoms had lower scores in the gestrinone than in the placebo group by the end of treatment . In a subset of 30 participants ( 15 from each group ) , serum concentrations of oestradiol , progesterone , and tri-iodothyronine were significantly lower than baseline after 3 months of gestrinone , but concentrations of luteinising hormone , follicle-stimulating hormone , prolactin , thyroid-stimulating hormone , and thyroxine did not change . 41 % of gestrinone-treated and 14 % of placebo-treated patients reported at least one side-effect ; most of these were and rogen-mediated . 11 placebo-treated patients and 4 on gestrinone discontinued treatment . Thus , gestrinone was very effective in the treatment of cyclical mastalgia  and was well tolerated Cyclic mastalgia is one of the most prevalent disorders among fertile women . To date , hormonal agents , despite their side effects , have been widely used for treatment of this ailment . This study was performed to clarify the therapeutic effects of Vitamin E ( Vit E ) as a safe treatment for cyclic mastalgia among fertile women . This study was conducted as a double blind clinical trial ; 150 women with cyclic mastalgia , referred by three public health centers in Qazvin City in Iran , were enrolled in the trial and r and omly divided into two distinct case and control groups ; each containing 75 patients . The severity and duration of breast pain were measured according to both the Cardiff Breast Pain Chart and the Visual Analog Scale . Simple , chewable tablets of either Vit E or a placebo were prescribed twice a day for 4 months for case and control participants , respectively . Follow-up was performed at the end of both the second and the fourth months and , at that time , the severity , duration and side effects of intervention were evaluated . The administration of Vit E had significant curative results as tested at both the 2- and 4-month benchmarks . Chi-square testing indicated that after both 2 and 4 months of therapy , the efficacy demonstrated by the Vit E recipient case group was superior to that of the group that received a placebo . Applying the Mc Nemar Test , it also was shown that there was no significant difference in the benefits received between treatment courses of 2 versus 4 months . A 2-month prescription of Vit E has positive therapeutic effects on cyclic mastalgia . Given its lack of significant side effects , Vit E , therefore , can be considered a safe alternative to hormonal therapies currently being used in the treatment of cyclic mastalgia OBJECTIVE To compare oil of evening primrose ( OEP ) and topical nonsteroidal anti-inflammatory ( NSAIDs ) with respect to safety , effectiveness , rapidity of response , cost effectiveness and acceptability in the treatment of breast pain . STUDY DESIGN An open , non-r and omised , comparative study of topical ( NSAI ) gel versus OEP was carried out , over a period of one year . PATIENTS AND METHODS Fifty female patients attending the outpatient department with moderate to severe breast pain were given one of the two agents alternatively , after selection . RESULTS Results showed that out of 25 patients treated with OEP , 64 % had a clinical ly significant response after three months of treatment , compared with 92 % with topical NSAIDs . Only one patient ( 4 % ) had side effects with OEP , while no patient had side effects with topical NSAIDs . Twenty per cent and seventy per cent showed acceptability as far as costs were concerned and mode of administration respectively , with OEP . The acceptability rate was 68 % and 96 % respectively , with topical NSAIDs . CONCLUSION This study has shown topical NSAIDs to be safe , effective , rapid and acceptable mode of treatment for cyclical and non-cyclical mastalgia HYPOTHESIS Toremifen is effective in reducing  breast pain  and does not increase the incidence of adverse events as a therapy for moderate to severe mastalgia . DESIGN AND PATIENTS In a double-blind r and omized controlled trial , patients with moderate to severe mastalgia received toremifen citrate , 30 mg daily , or a placebo tablet for 3 menstrual cycles and were followed up for breast pain score and adverse events . The serum levels of estradiol , progesterone , and prolactin were examined before treatment and correlated with the response rate to toremifen treatment . RESULTS Seventy-two ( 69.2 % ) of 104 patients receiving toremifen  and 29 ( 31.9 % ) of 91 receiving placebo  responded to the treatment , with reduction in breast pain score of more than 50 % ( P<.001 ) . Among the patients with cyclical mastalgia , the response rate for toremifen was 76.7 % ( 59/77 ) , whereas the response rate for placebo was 34.8 % ( 23/66 ; P<.001 ) . In contrast , the response rate of patients with noncyclical mastalgia was 48.1 % ( 13/27 ) for toremifen and 24.0 % ( 6/25 ) for placebo ( P = .09 ) . Adverse events were observed in 44 ( 42.9 % ) of 104 patients receiving placebo and 46 ( 50.5 % ) of 91 patients receiving toremifen ( P = .45 ) . A positive correlation between baseline breast pain score and serum estradiol level was observed in patients with cyclical mastalgia ( r = 0.35 , P = .003 ) . CONCLUSIONS Toremifen effectively relieves moderate and severe cyclical mastalgia and tends to exert a positive therapeutic effect on noncyclical mastalgia . In addition , toremifen therapy does not increase the incidence of intolerable adverse event . Therefore , it is a feasible therapy for mastalgia , especially cyclical mastalgia One of the successful treatments for cyclical mastalgia is bromocriptine evening primrose combination . A double blind study was applied on 80 patients with cyclical mastalgia . They were r and omly divided into two groups ( A and B ) . In group A , patients were treated by bromocriptine/evening primrose . To group B , LILT with specified dosimetry was applied , using a device that delivers He-Ne laser combined with 4 infra-red diode laser . Evaluation of treatment was both subjective ( using VAS ) and objective ( study ing the degree of drop in plasma cortisol level ) . The drop of plasma cortisol with treatment was studied using the student -t distribution . A good response was observed in the laser group in 82.5 % , compared to 63.9 % in the bromocriptine/evening primrose group . There was a significant deference before and after treatment in both groups ( P<0.05 ) . This difference was more for the drug treated group than for the laser treated group , but in the latter , it acted on a wider sector of patients . In conclusion , LILT is recommended as a new treatment modality for cyclical mastalgia BACKGROUND Breast pain and non-discrete breast nodularity are common in women . METHODS We did a r and omized , double-blind , placebocontrolled trial of oral ormeloxifene 30 mg , a selective oestrogen receptor modulator ( SERM ) or placebo twice a week for 3 months in 20 - 50-year-old women with breast pain with or without lumpiness . Women with a discrete benign lump or cancer were excluded from the study . Serial assessment s of pain on a visual analogue scale and nodularity grade on a 5-point ordinal Lucknow-Cardiff scale were done . A total of 151 patients were r and omly allocated to two interventions using a block size of 4 . RESULTS Of the 151 patients , 121 ( active 57 , placebo 64 ) were available for efficacy analysis . The mean pain level showed a systematic downward trend over five visits ( F=105.23 , p<0.0001 ) that significantly reduced in the active group compared to that in the placebo group ( F=18.66 , p<0.0001 ) . The patterns of variation in pain over time for the individual groups differ from the overall mean pattern for the two groups and thus from one another ( F=44.43 , p<0.0001 ) . Cumulative frequencies of breast nodularity grade s during successive visits showed significant improvement ( p=0.001 ) compared to placebo at the end of the third month . The effect of the active drug persisted till the completion ( 6 months ) of treatment ( p<0.001 ) . At the last visit , 93.3 % of women in the active group had grade 2 or lower nodularity as compared to 71.1 % in the placebo group . Oligomenorrhoea alone was reported by 12 patients . CONCLUSION Ormeloxifene showed significant efficacy for treating breast pain and nodularity Abstract Background : Mastalgia is a debilitating disorder , which has serious effects on one 's daily life and causes significant medical costs . Aim : Mastalgia patients determine the overall approach and improve the quality of life of patients . Methods : In this study , the outcomes of psychoeducation on anxiety and pain in a group of patients with mastalgia without an organic etiology have been investigated . 88 patients were included in this study . The socio-demographic data form , the Symptom Checklist 90 ( SCL-90 ) , the Toronto Alexithymia Scale-20 ( TAS-20 ) , the Hamilton Anxiety Scorer ( HAM-A ) , the State – Trait Anxiety Inventory ( STAI-I , STAI-2 ) and the Visual Analogue Scale ( VAS ) were all applied to the patients . 64 r and omly selected patients ( Group 1 ) were given psychoeducation while the remaining 24 ( Group 2 ) were not . All patients were called back after 1 month for repeats of the HAM-A , STAI-I , STAI-2 and VAS tests . Results : The results of this study demonstrated that psychoeducation has positive impacts on the perception of pain besides stationary , contemporary and total anxiety scores . Conclusions : It is concluded that the administration of psychoeducation is a good choice in the degradation of anxiety symptoms and pain 60 patients with severe mastalgia of more than 6 months ' duration were r and omly selected for treatment with either tamoxifen 20 mg daily or placebo for 3 months . As measured by linear analogue scoring , pain relief was achieved in 22/31 ( 71 % ) of those receiving tamoxifen and 11/29 ( 38 % ) of those taking placebo . Patients who did not respond to the first course of treatment were allocated to the alternative treatment for 3 months . Pain control was achieved in 8/12 ( 75 % ) of those receiving tamoxifen and 2/6 ( 33 % ) of those receiving placebo . The commonest side-effects were hot flushes ( 27 % of patients receiving tamoxifen and 11 % of those receiving placebo ) and vaginal discharge ( 17 % tamoxifen , 7 % placebo ) . Side-effects caused 6 patients in each group to discontinue treatment . Tamoxifen is of value in the management of severe cyclical and non-cyclical mastalgia , and relief can be achieved without undue side-effects in the majority of patients A single-blind , r and omized clinical trial of 56 female subjects was conducted to determine whether decreased consumption of caffeine decreases  breast pain/tenderness or nodularity in patients with suspected benign proliferative breast disease . The subjects were r and omly assigned to one of three groups -- a control group ( no dietary restrictions ) , a placebo group ( cholesterol-free diet ) , and an experimental group ( caffeine-free diet ) . At the initial examination , the subjects reported on the presence of breast pain , the degree to which pain affects daily activities , the frequency of pain , the degree of pain associated with breast examinations , and the degree of pain associated with close-fitting clothing . Subjects were then examined and the four quadrants of each breast were rated on a scale of 0 to 3 ( 0 = normal , fatty tissue , 1 = little seedy bumps or fine nodularity , 2 = discrete nodules or ropy tissue , 3 = confluent areas , hard or soft masses ) . Subjects in all three groups returned for 2- and 4-month follow-up examinations . Total nodularity scores , degree of pain/tenderness , and compliance with dietary restrictions were analyzed . The data showed that decreased caffeine consumption did not result in a significant reduction of palpable breast nodules or in a lessening of breast pain/tenderness A double-blind crossover study giving 20 mg/day of medroxyprogesterone acetate during the luteal phase was carried out in 26 women with cyclical mastalgia .  Symptomatic response to this progestogen supplementation or placebo was assessed objective ly by clinical examination and subjectively by linear analogue scales and breast pain charts . No significant relief of pain or tenderness was found on placebo or active treatment , irrespective of treatment order , and breast nodularity was similarly unaltered . No evidence of progesterone deficiency or prolactin abnormality was found . Side-effects were incurred in 11 patients ( five on placebo , five on active treatment and one while on both ) and were mostly vague premenstrual symptoms . We conclude that the therapeutic response of medroxyprogesterone acetate in cyclical mastalgia is no better than placebo and that progestogen supplementation can no longer be recommended for routine use in the management of breast pain OBJECTIVE To evaluate the effectiveness of vitamin E , evening primrose oil ( EPO ) , and the combination of vitamin E and EPO for pain control in women with cyclical mastalgia . PROCEDURE A double-blind , r and omized , placebo-controlled trial was conducted at two U.S. academic medical centers . Eighty-five women with premenstrual cyclical breast discomfort were enrolled . Participants were r and omly assigned to one of four six-month oral treatments : vitamin E ( 1,200 IU per day ) , EPO ( 3,000 mg per day ) , vitamin E ( 1,200 IU per day ) plus EPO ( 3,000 mg per day ) , or double placebo . The primary outcome measure was change in breast pain , measured by the modified McGill Pain Question naire at enrollment and at six months . RESULTS Forty-one patients completed the study . Intent-to-treat analysis ( pretesting and post testing ) showed a difference in worst-pain improvement with the treatments EPO ( p=0.005 ) , vitamin E ( p=0.04 ) , and EPO plus vitamin E ( p=0.05 ) , but no difference with placebo ( p=0.93 ) . Results from two- sample t-test showed a nonsignificant decrease in cyclical mastalgia individually for the three treatment groups compared with the placebo group ( EPO , p=0.18 ; vitamin E , p=0.10 ; and EPO plus vitamin E , p=0.16 ) . The data were also analyzed with the separation test by Aickin , which showed a trend toward a reduction of cyclical mastalgia with vitamin E and EPO individually and in combination . CONCLUSION Daily doses of 1,200 IU vitamin E , 3,000 mg EPO , or vitamin E and EPO in combination at these same dosages taken for six months may decrease the severity of cyclical mastalgia Severe mastalgia was the dominant feature in 10 women with diffuse fibrocystic disease of the breast as judged by palpation and mammography and verified histologically . One patient ( case 1 ) had galactorrhoea . None had prominent characteristics of the premenstrual syndrome . Mastalgia had been present for from six months to several years . In a double-blind crossover trial patients were allocated at r and om to receive either bromocriptine or identical placebo capsules , each for a period of two months , in a dose of one capsule ( bromocriptine 2 - 5 mg or placebo ) daily during the first week of each period and thereafter two capsules daily . For one month before the trial and throughout the period of medication the presence and intensity of pain were recorded daily by each patient . They were seen in the outpatient clinic every four weeks . The code was broken at the end of each trial . Serum prolactin concentration was measured before the trial , on the day of crossover , and on the final day of the trial ( normal range 3 - 0 - 13 - 5 jug/l ) . During treatment with bromocriptine  pain was totally or almost totally relieved in eight patients and in two the pain was much reduced ( table ) . Placebo treatment failed to relieve mastalgia in any patient except one ( case 9 ) , in whom the relief during bromocriptine continued while taking placebo . Statistical analysis by Koch 's method ' showed that the relief obtained during bromocriptine therapy was significantly greater ( P<002 ) than that during placebo medication , while period effects as well as carry-over effects were absent ( P > 0 - 05 ) . Mastalgia reappeared as soon as active medication was stopped , with the exception of the patient in case 9 . The breasts became smaller , softer , and less tender during bromocriptine treatment . The pretrial serum prolactin concentration was slightly raised in three patients and normal in seven . During treatment with bromocriptine these concentrations were significantly lowered ( P<0 - 01 , sign test ) . There were no side effects from placebo . While taking bromocriptine five patients had slight , transitory nausea and dizziness , which is a recognised side effect . Three others had persistent and more pronounced nausea , dizziness , and general malaise In a placebo-controlled , r and omized , double-blind study the efficacy of a Vitex agnus castus extract-containing solution ( VACS ) was investigated in patients suffering from cyclical mastalgia . Patients had mastalgia on at least 5 days in the pre-treatment cycle . During this cycle and during treatment ( 3 cycles ; 2 x 30 drops/day ) , the intensity of mastalgia was recorded once per cycle using a visual analogue scale ( VAS ) . After one/two treatment cycles , the mean decrease in pain intensity ( mm , VAS ) was 21.4 mm /33.7 mm in women taking VACS ( n=48 ) and 10.6 mm/20.3 mm with placebo ( n=49 ) . The differences of the VAS-values for VACS were significantly greater than those with placebo ( p=0.018 ; p=0.006 ) . After three cycles , the mean VAS-score reduction for women taking VACS was 34.3 mm , a reduction of ' borderline significance ' ( p=0.064 ) on statistical testing compared with placebo ( 25.7 mm ) . There was no difference in the frequency of adverse events between both groups ( VACS : n=5 ; placebo : n=4 ) . VACS appears effective and was well tolerated and further evaluation of this agent in the treatment of cyclical mastalgia is warranted Twenty patients with cyclical breast pain were enrolled in a double-blind cross-over trial in which either a soy protein drink or a flavoured cow 's milk was taken orally each day for 3 months before crossing over to the alternate drink for a further 3 months . Records of pain scores were taken throughout the study . Blood was also taken before and after 3 and 6 months for the measurement of phytoestrogents to assess compliance . Two women withdrew from the study at the outset leaving 18 evaluable patients who completed the study . Of these 10 ( 56 % ) felt that soy protein improved breast pain ( two of whom received soy as first treatment ) and two ( 11 % ) felt that cow 's milk alleviated symptoms ( one receiving this as first preparation ) and the remaining six ( 33 % ) experienced no relief of pain with either dietary preparation . Blood levels of diadzein and genistein were elevated after the ingestion of soy protein in only 13 patients ( seven of whom felt that soy improved their breast pain ) ; in the remaining five patients ( three of whom suggested that soy protein improved breast pain ) phytoestrogen levels were no higher than pretreatment values . Although the ingestion of soy protein may be associated with relief of breast pain , these results illustrate the problem of non-specific effects in studies of mastalgia in that 1 ) cow 's milk also relieved breast pain in some patients and 2 ) that the benefits of soy protein were not always associated with evidence of elevated circulating levels of phyto-estrogens , indicating the difficulty of compliance in dietary intervention studies using soy foods In a r and omised parallel-block trial in thirteen European centres  bromocriptine 2.5 mg twice a day was compared with placebo therapy for cyclical mastalgia . 272 patients were enrolled into the study .  Linear analogue charts and diary pain cards were used for assessment of response . Reduction in breast pain , heaviness , tenderness , and serum prolactin after 3 and 6 months ' therapy were significantly greater with bromocriptine than with placebo . Improvement in symptoms with bromocriptine was maintained for at least 6 months after therapy . Overall 29 % of patients dropped out while on therapy , more from the bromocriptine than from the placebo group . Adverse effects , especially nausea and dizziness , were commoner among the bromocriptine-treated patients , but blood pressure was unaffected In a double-blind , placebo-controlled , parallel group , multicenter study , 555 women with moderate to severe mastalgia were r and omized to one of the four treatment groups to receive ( a ) gamolenic acid ( GLA ) and antioxidants , ( b ) placebo fatty acids and antioxidants , ( c ) GLA and placebo antioxidants , or ( d ) placebo fatty acids and placebo antioxidants , for four menstrual cycles . This was followed by a further eight menstrual cycles of open treatment in which all patients received GLA , but continued to be r and omized to active or placebo antioxidants as in the preceding parallel phase . Diary pain cards and linear analog charts were used for assessment of response . A reduction in breast pain was seen in all four treatment groups during the blinded treatment phase . There was a substantial improvement in the placebo fatty acids groups ( response rate of 40 % ) , and there were no significant differences among the four treatment groups . During the open treatment phase , a further reduction in breast pain was seen in all groups , with no statistically significant differences between groups . This study showed that GLA ( Efamast ) efficacy did not differ from that of placebo fatty acids , regardless of whether or not antioxidant vitamins were present OBJECTIVE Our goal was to evaluate the efficacy and side effects of danazol 200 mg daily given only in the luteal phase of the menstrual cycle to treat premenstrual syndrome and premenstrual mastalgia . STUDY DESIGN We conducted a r and omized , double-blind , placebo-controlled study of 3 menstrual cycles in a postgraduate medical school and National Health Service hospital . The subjects of the study were 100 women who had been referred to the premenstrual syndrome clinic at the North Staffordshire Hospital for the management of premenstrual syndrome and premenstrual breast pain . Outcome measures for the study included assessment of improvement in symptoms measured by specific daily visual analogue scales for 4 principal symptoms of premenstrual syndrome and for premenstrual mastalgia and assessment of side effects and adverse events . RESULTS Significant improvement in symptoms was seen in visual analog scores for mastalgia in months 1 ( P = .03 ) , 2 ( P = .004 ) , and 3 ( P = .01 ) of the study during active therapy compared with placebo . No improvement was seen for any other symptom or for the global premenstrual syndrome score . Side effects on danazol and on placebo were equal and minimal . CONCLUSIONS Luteal phase-only danazol is not effective for the treatment of the general symptoms of premenstrual syndrome but appears highly effective for the relief of premenstrual mastalgia . This approach to therapy is associated with few side effects . Studies of cyclic mastalgia using strict diagnostic criteria are required to see whether the freedom from symptomatic side effects is found in longer-term studies and to determine whether such a regimen avoids potentially detrimental effects on the lipid status Breast pain is a very common complaint in women presenting to the outpatient department . It causes a certain degree of discomfort , anxiety leading to repeated investigations , and to some degree disturbs their lifestyle . This prospect i ve study was carried out at King Fahd Hospital of the University , Alkhobar . Two hundred women presenting to the outpatient surgical department with mastalgia were included ; 100 women received treatment with danazole , and the other 100 were asked to wear sports brassieres for 12 weeks . They were requested to answer a structured question naire during the specified period , and an extensive review of the literature was also performed . Patients were compliant with the instructions . The first group had 58 % relief of symptoms , but 42 % experienced drug side effects ; in the second group , all participants had some degree of initial discomfort followed by relief of symptoms in 85 % of cases . Most patients cl aim ed that their lifestyle had changed dramatically after using the sports brassieres . Mastalgia is a common disease that may run a chronic course . Many patients are unsatisfied with prescribed medications and tend to discontinue treatment when side effects develop . Active breast movement on its weak suspensory ligaments may contribute considerably to mastalgia . Good external support by sports brassieres can relieve most of the patient 's symptoms A prospect i ve study of the effectiveness of the topical application of non-steroidal anti-inflammatory drugs ( NSAIDs ) as a gel preparation was carried out in 26 women with severe breast pain . The results showed a satisfactory relief of pain in 81 % of the women : 11 of 13 with cyclical pain , eight of 11 with non-cyclical pain , and in two women with severe scar pain after lumpectomy and radiotherapy .  Topical NSAID gel was applied as required ; the relief of severe pain was rapid and no side effects were reported . These factors compare favourably with established recommended treatments which usually involve months of continuous treatment , tailoring of drug dosages and a significant incidence of intolerable side effects . This study has shown that topical NSAID application is an effective , safe , acceptable and easily administered treatment for severe cyclical and non-cyclical breast pain
target: RESULTS Reassurance plus bra-fitting advice provides relief for most women .
  There is some benefit in reducing dietary coffee and fat intake .
  Dopamine agonists are useful , but less effective than endocrine treatments such as Danazol or Tamoxifen .
  Of the Selective Oestrogen Receptor Modulator drugs , Ormeloxifene appears most effective , but is not licenced in the United Kingdom .
  Relaxation therapy , acupuncture and kinesiology may be useful but currently lack good evidence of effectiveness .
  Subsequent drug therapy should be balanced against its side-effects ; topical NSAIDs and Ormeloxifene show greatest benefit with least side-effects .
background: INTRODUCTION Idiopathic mastalgia ( benign breast pain of unknown origin ) is often poorly managed because of its subjective nature and unclear aetiology .
  Mastalgia is a reason for up to 50 % of breast outpatient referrals .
  Existing systematic review s discuss date d treatment options that provide limited symptomatic relief .