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[ Profiles of irregular bleeding induced by low-dose hormone therapy and Chinese formulated herbs products ] . OBJECTIVE To compare profiles and related factors of irregular bleeding induced by different types of low-dose hormone therapy ( HT ) and a Chinese formulated herbs products . METHODS Applied with open-labeled , randomized , and clinical trial design , 136 postmenopausal women were assigned into four groups : group A : estradiol valerate ( E2 V ) 1 mg/d + medroxyprogesterone acetate ( MPA ) 2 mg/d ; group B : conjugated equine estrogen 0.45 mg/d + MPA 2 mg/d ; group C : tibolone 1.25 mg/d ; group D : a Chinese formulated herbs product ( Kuntai ) 4 # tid . Each subject took element calcium 400 mg/d and vitamin D 200 IU/d concomitantly . Modified Kupperman scores were assessed on baseline and every 3 months thereafter and irregular bleeding was recorded on menopausal diary every day . The duration of this study was 1 year . Results The efficacies were similar in three HT-managed groups , but was better than in group D , although the latter was also effective in alleviating menopausal symptoms . Hazard ratio ( HR ) of irregular bleeding was 1.00 in group C , 2.43 in group A ( 95 % CI : 1.08-5.46 ) , 3.12 in group B ( 95 % CI : 1.42-6.88 ) , and 0.73 in group D ( 95 % CI : 0.26-2.04 ) . Most cases initially experienced bleeding in the first 3 months but such initiation was a bit later in group C. Endometrium , as detected by B-mode ultrasound , increased approximately 1 mm in HT groups , while it was a bit thicker in group C. Long periods in reproductive age and short time since menopause were high risk factors for irregular bleeding . CONCLUSION Profiles of irregular bleeding in 3 commonly used types of low-dose HT are different and some factors such as long period in reproductive age and short time since menopause may contribute to bleeding initiation .
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Intervention_Physical
low-dose hormone therapy
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Intervention_Pharmacological
Chinese formulated herbs products
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Intervention_Physical
low-dose hormone therapy ( HT )
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Intervention_Pharmacological
Chinese formulated herbs products
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Intervention_Pharmacological
estradiol valerate ( E2 V ) 1 mg/d
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Intervention_Pharmacological
medroxyprogesterone acetate ( MPA ) 2 mg/d
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Intervention_Pharmacological
conjugated equine estrogen 0.45 mg/d
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Intervention_Pharmacological
MPA 2
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Intervention_Pharmacological
tibolone
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Intervention_Pharmacological
a Chinese formulated herbs product ( Kuntai )
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Intervention_Pharmacological
calcium
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Intervention_Pharmacological
vitamin D
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Intervention_Pharmacological
low-dose HT
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Outcome_Physical
irregular bleeding
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Outcome_Physical
irregular bleeding
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Outcome_Physical
irregular bleeding
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Outcome_Other
efficacies
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Outcome_Other
effective
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Outcome_Physical
Hazard ratio ( HR ) of irregular bleeding
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Outcome_Physical
bleeding
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Outcome_Physical
initiation
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Outcome_Physical
Endometrium
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Outcome_Physical
irregular bleeding
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Outcome_Physical
irregular bleeding
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Participant_Sample-size
136
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Participant_Condition
postmenopausal
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Participant_Sex
women