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. 2016 Oct 12;2016(10):CD008536. doi: 10.1002/14651858.CD008536.pub3

Mendoza 2002.

Methods Randomised controlled trial
Participants 165 women with intact uterus younger than 60 years (mean 50 years), who had been amenorrhoeic for 1 to 5 years (mean 22.3 months). Women who had had a hysterectomy or had received hormone treatment in the 3 months before the trial were excluded, as were those with a history of a malignant gynaecological process, oestrogen‐producing tumour or obesity (body mass index > 32)
Interventions
  • Tibolone 2.5 mg/d

  • Cyclical combined regimen of transdermal oestrogen and progestogen: transdermal patch of 17β‐oestradiol 50 μg/d during 14 days and transdermal patch of 17β‐oestradiol 50 μg/d plus 0.25 mg/d of norethisterone acetate during the following 14 days

  • Intermittent progesterone regimen: transdermal 17β‐oestradiol 50 μg/d and oral micronised natural progesterone 200 mg twice a week


For 1 year
Outcomes Irregular bleeding, vasomotor symptoms frequency 0 = never, 1 = occasionally, 2 = frequently
Notes Data on vasomotor symptoms expressed as number of women with reduced symptoms
Timing: September 1996 to April 1998
Location: Spain
Multi‐centre: no; single site
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was done following a table of random numbers
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Defined as "simple‐blind", but no details given
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not specified, but given the nature of outcomes assessed, their evaluation is likely to be "objective"
Incomplete outcome data (attrition bias) 
 All outcomes High risk 32/165 women did not start HRT, no reasons given
Selective reporting (reporting bias) Unclear risk Study protocol not available
Conflict of interest Unclear risk Not reported