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Evidence-Based Medicine 2008;13:43; doi:10.1136/ebm.13.2.43
Copyright © 2008 by the BMJ Publishing Group Ltd.

THERAPEUTICS

Both low-dose and micro-dose 17β-oestradiol reduced hot flushes

The first 150 words of the full text of this article appear below.

G A Bachmann

Dr G A Bachmann, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ, USA; gloria.bachmann@umdnj.edu


STUDY DESIGN

Design:

randomised, placebo-controlled trial.

Allocation:

concealed.*

Blinding:

blinded (patients, healthcare providers, and data collectors).*


STUDY QUESTION

Setting:

48 centres in the USA.

Patients:

425 healthy postmenopausal women >=40 years of age (mean age 53 y, mean time since menopause 9 y) who had an average of >=7 (mean 10) moderate or severe hot flushes per day for >=1 week during screening. Exclusion criteria included abnormal Pap test result, abnormal vaginal bleeding, and a history of thrombophlebitis or thromboembolic disorder.

Intervention:

transdermal patches delivering 0.023 mg/day 17β-oestradiol (E2) plus 0.0075 mg/day levonorgestrel (low-dose group, n = 145), 0.014 mg/day E2 (micro-dose group, n = 147), or no E2 (placebo group, n = 133).

Outcomes:

frequency and severity of hot flushes, treatment response (>=75% or >=90% reduction in hot flush frequency), and adverse events.

Follow-up period:

12 weeks.

Patient follow-up:

84% (intention-to-treat analysis).


MAIN RESULTS

All . . . [Full text of this article]

Jeff Andrews

Vanderbilt University Medical Center, Nashville, Tennessee, USA


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