Vieira 2009.
| Methods | Randomised placebo‐controlled trial | |
| Participants | 30 postmenopausal women with systemic lupus erythematosus, between 30 and 65 years of age (mean age 51.7 years), who had not menstruated for over a year (mean 7.1 years); had follicle‐stimulating hormone (FSH) levels > 20 mIU/mL in 2 (chemiluminescence) tests performed 30 days apart; had not used any HRT for ≥ 6 months; and had presented with symptoms of hypoestrogenism (night sweats, hot flashes or symptoms of urogenital atrophy) at inclusion. Other than oral corticosteroids, use of other medications for treatment of SLE was allowed if doses remained stable for ≥ 3 months before study outset | |
| Interventions |
For 1 year |
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| Outcomes | Menopausal symptoms, breast cancer, endometrial cancer, venous thromboembolic events, mortality from any cause | |
| Notes | Data on menopausal symptoms were assessed through Kupperman Index; it is not possible to derive results on those specific symptoms provided in the protocol Timing: enrolment between March 2002 and December 2004 Location: Brazil 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 | GraphPad StatMate® (Graphpad Software, San Diego, CA) software programme was used to randomise participants into 2 groups |
| 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, their evaluation is likely to be "objective" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 3/30 excluded owing to SLE reactivation |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
| Conflict of interest | Unclear risk | Not reported |