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 |
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 |
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| 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 |