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

Mendoza 2000.

Methods Parallel‐group RCT
Participants 76 hysterectomised women < 50 years old. Excluded if had had any previous malignant gynaecological process, oestrogen‐producing tumour, endocrinological or metabolic problems, cardiovascular disease, uncontrolled hypertension, active hepatic disease, serious skin illness, intestinal sickness or chronic obstructive respiratory disease. Patients with psychiatric problems or receiving anxiolytic or antidepressive drugs were also excluded
Unclear whether all women were symptomatic
Interventions
  • Tibolone 2.5 mg per day (n = 38)

  • Transdermic 17β‐oestradiol 50 micrograms per day (n = 38)


Administered for 1 year
Outcomes Climacteric symptoms through a modified version of the Kupperman Index
Vasomotor symptoms measured as frequently (2), occasionally (1) or never (0)
Reports binary measure of "reduction in vasomotor symptoms"
Dyspareunia reported as part of a composite outcome of sexual symptoms (“behavioural changes”), which included libido
Notes Timing: Feb 1, 1995, to January 31, 1996
Trial location: Nicaragua
Multi‐centre: no; single site
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Table of random numbers with simple blind randomisation
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No mention of blinding
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Blinding of participants and personnel not stated and therefore unlikely
Incomplete outcome data (attrition bias) 
 All outcomes High risk 14/76 participants interrupted or changed therapy, or were lost to follow‐up; 6/76 did not start therapy
Selective reporting (reporting bias) Unclear risk Study protocol not available
Conflict of interest Unclear risk No information provided