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 .
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 .
A phase II trial of Afimoxifene (4-hydroxytamoxifen gel) for cyclical mastalgia in premenopausal women
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
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 .
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 .