| Methods |
Randomised to control or placebo group according to randomisation code Parallel group design with double blinding at 2 centres
Number of women randomised: n = 109 (56 to treatment 53 to placebo)
Number of withdrawals: not stated
No power calculation and no ITT analysis
Source of funding: not stated |
| Participants |
Inclusion criteria: moderate to severe urogenital and systemic postmenopausal complaints and follicle stimulating and oestradiol (E2) serum levels within postmenopausal range, last menses one year prior to treatment, score at least 6 points on UGI (urogenital scale) and 20 on KI (Kupperman Index)
Age: 32‐66 (mean 54.9)
Exclusion criteria: not stated
Location: Belgium |
| Interventions |
Treatment: vaginal suppository containing 3.5 mg oestriol (E3) or placebo, twice weekly for 3 weeks followed by 1 suppository weekly for 6 months
Duration: 6 months |
| Outcomes |
Efficacy: UGI score, vaginal pH
Safety: change in endometrium |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Sequence was said to have been generated through randomisation code, no further details were reported |
| Allocation concealment (selection bias) |
Unclear risk |
No details reported |
| Blinding (performance bias) |
Low risk |
Double‐blinded trial |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear whether outcome assessors other than the participants were blinded e.g. the pathologists |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Withdrawals were not reported and unclear whether data were analysed on the basis of ITT |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a conclusive judgement |
| Other bias |
Unclear risk |
Insufficient information to make a conclusive judgement |
