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document
Comparison of menopausal symptoms during the first year of adjuvant therapy with either exemestane or tamoxifen in early breast cancer : report of a Tamoxifen Exemestane Adjuvant Multicenter trial substudy . PURPOSE Hormonal breast cancer treatment increases menopausal symptoms in women . This study investigated differences between the symptoms associated with either adjuvant tamoxifen or exemestane . PATIENTS AND METHODS Ten common symptoms were assessed by self-report questionnaire administered to 1,614 consecutive patients at baseline and every 3 months during the first year of a double-blind , randomized trial of postmenopausal women with early hormone receptor-positive breast cancer . Symptoms were categorized as none , mild , moderate , or severe . A hot flash score was calculated at each time point . Symptoms were analyzed by repeated-measures analysis of variance . Each time period was tested repeatedly against the baseline ; an overall P value was assigned for each reported symptom . RESULTS Compliance was excellent , with 7,286 questionnaires analyzed . Baseline symptom prevalence ranged from 2 % ( vaginal bleeding ) to 60 % to 70 % ( bone/muscle aches and low energy ) . There were no significant differences in vaginal bleeding , mood alteration , or low energy . Patients receiving tamoxifen had significantly more vaginal discharge ( P < .0001 ) . Exemestane patients reported more bone/muscle aches ( P < .0001 ) , vaginal dryness ( P = .0004 ) , and difficulty sleeping ( P = .03 ) . In both groups , the hot flash score peaked at 3 months and decreased thereafter . At 12 months , patients receiving tamoxifen had a significantly higher mean hot flash score ( P = .03 ) , with daily hot flashes increasing from baseline by 33 % compared with a 7 % increase from baseline with exemestane . CONCLUSION At 12 months , exemestane was associated with fewer hot flashes and less vaginal discharge than tamoxifen , but with more vaginal dryness , bone/muscle aches , and difficulty sleeping . Symptoms were common in both groups .
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Intervention_Pharmacological
exemestane or tamoxifen
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Intervention_Pharmacological
adjuvant tamoxifen or exemestane
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Outcome_Physical
menopausal symptoms
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Outcome_Physical
hot flash score
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Outcome_Physical
symptom
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Outcome_Physical
bone/muscle aches
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Outcome_Physical
low energy
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Outcome_Physical
vaginal bleeding ,
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Outcome_Mental
mood alteration
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Outcome_Physical
, or low energy
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Outcome_Physical
vaginal discharge
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Outcome_Physical
bone/muscle aches
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Outcome_Physical
vaginal dryness
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Outcome_Physical
difficulty sleeping
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Outcome_Physical
hot flash score
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Outcome_Physical
hot flash score
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Outcome_Physical
hot flashes
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Outcome_Physical
hot flashes
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Outcome_Physical
vaginal discharge
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Outcome_Physical
vaginal dryness
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Outcome_Physical
bone/muscle aches
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Outcome_Mental
difficulty sleeping
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Participant_Condition
breast cancer
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Participant_Sex
women
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Participant_Sample-size
1,614
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Participant_Condition
postmenopausal
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Participant_Sex
women
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Participant_Condition
early hormone receptor-positive breast cancer