METHODS

Design:

randomised placebo controlled trial.

Allocation:

{concealed*}†.

Blinding:

blinded {patients, healthcare providers, data collectors, outcome assessors}†.*

Follow up period:

6 weeks.

Setting:

17 sites (including urban, suburban, and rural clinics) in the US.

Patients:

165 women ⩾18 years of age (mean age 54 y) who were menopausal (defined as amenorrhoea for ⩾12 consecutive mo, amenorrhoea for 6 mo and meeting the biochemical criteria for menopause, or history of bilateral oophorectomy ⩾6 wks before screening), experienced ⩾2–3 daily hot flashes or ⩾14 bothersome hot flashes/week, had discontinued hormone replacement therapy for ⩾6 weeks, and had discontinued psychotropic drugs for 2–12 weeks (specified for class of …