Mendoza 2000.
Methods | Parallel‐group RCT | |
Participants | 76 hysterectomised women < 50 years old. Excluded if had had any previous malignant gynaecological process, oestrogen‐producing tumour, endocrinological or metabolic problems, cardiovascular disease, uncontrolled hypertension, active hepatic disease, serious skin illness, intestinal sickness or chronic obstructive respiratory disease. Patients with psychiatric problems or receiving anxiolytic or antidepressive drugs were also excluded Unclear whether all women were symptomatic |
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Interventions |
Administered for 1 year |
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Outcomes | Climacteric symptoms through a modified version of the Kupperman Index Vasomotor symptoms measured as frequently (2), occasionally (1) or never (0) Reports binary measure of "reduction in vasomotor symptoms" Dyspareunia reported as part of a composite outcome of sexual symptoms (“behavioural changes”), which included libido |
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Notes | Timing: Feb 1, 1995, to January 31, 1996 Trial location: Nicaragua 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 | Table of random numbers with simple blind randomisation |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No mention of blinding |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding of participants and personnel not stated and therefore unlikely |
Incomplete outcome data (attrition bias) All outcomes | High risk | 14/76 participants interrupted or changed therapy, or were lost to follow‐up; 6/76 did not start therapy |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
Conflict of interest | Unclear risk | No information provided |