human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 
    Output:
    
agent
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 .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: 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 
    Output:
    