| Methods |
Randomisation: random number table
Open‐label single‐centre,
parallel group trial
Number of women randomised: 59
Number
of women analysed: 53
Number of withdrawals: 6 (2 in group 1 owing
to mastalgia, nausea, and bleeding and 2 from each group owing to bleeding)
Power calculation and ITT analysis: not described
Sources of
funding: Upjohn (Canada), Wyeth‐Ayerst (Canada) and Ogen provided medication
for the study |
| Participants |
Country: Canada
Inclusion criteria: healthy postmenopausal at least
1‐year post natural menopause, with intact uterus, vasomotor symptoms and
normal endometrial histology
Exclusion criteria: previous use of
HT |
| Interventions |
Continuous
(1) 0.625 mg CEE + 2.5 mg MPA
(2) 0.625 mg EIS +
2.5 mg MPA
Duration: 2 years (104 weeks) |
| Outcomes |
Irregular bleeding, endometrial histology, amenorrhoea |
| Power calculation described |
No |
| Analysis by Intention to Treat |
Not mentioned and results are based on data from the 53 women who completed
the study (90% of those randomised) |
| Notes |
‐ |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number table |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Open label |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Reasons for withdrawal described |
| Other bias |
Low risk |
2 parallel groups, balanced at baseline |
