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

Huber 2002.

Methods	Randomised controlled trial
Participants	502 postmenopausal women, with last menstrual period ≥ 12 months previously, younger than 65 years of age (mean age 55). If the date of natural menopause could not be established because of hormonal treatment, participants had to be ≥ 53 years of age and must have been receiving hormonal therapy for ≥ 2 years; if applicable, hormone therapy had to end with a progestogen phase. All participants were required to have an intact uterus and a body mass index (BMI) of 18 to 29 kg/m²
Interventions	Tibolone 2.5 mg/d Conjugated equine oestrogens 0.625 mg continuously combined with medroxyprogesterone acetate 5 mg (CEE–MPA)/d Administered for 12 months
Outcomes	Vaginal bleeding/spotting (defined as requiring sanitary protection with more than 1 sanitary pad per day vs just 1 or none), dyspareunia, severity of VM symptoms, stroke, pulmonary embolism
Notes	Severity of VM symptoms quantified as none = 0, light = 1, moderate = 2, severe = 3, very severe = 4 Timing: Feb 1996 to June 1998 Location: Austria, Denmark, Spain, Sweden, Switzerland, UK Multi‐centre: 37 sites
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias)   All outcomes	Low risk	Double dummy
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Not specified, but given the nature of outcomes assessed and/or self‐evaluation by blind patients, their evaluation is likely to be "objective"
Incomplete outcome data (attrition bias)   All outcomes	High risk	Several participants (about 80, depending on different outcomes) were excluded from final analyses for adverse events and insufficient compliance/efficacy
Selective reporting (reporting bias)	Unclear risk	Study protocol not available
Conflict of interest	High risk	Financed by the drug producer. One study author was the employee of a drug producer