Mac Bride 2014.
Methods | 2‐arm parallel RCT | |
Participants | 38 postmenopausal women with bothersome symptoms of vulvo vaginal atrophy Inclusion criteria: healthy postmenopausal women with bothersome symptoms of vulvo vaginal atrophy Exclusion criteria: not reported |
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Interventions |
Group A: very low dose oestradiol vaginal cream (n = 19) applied to the vagina daily for 2 weeks followed by twice weekly for 10 weeks Group B: placebo (n = 19) applied as described for the active treatment group Duration: 12 weeks |
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Outcomes | Vaginal pH, maturation index, symptoms relating to atrophy | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information was reported on randomisation process |
Allocation concealment (selection bias) | Unclear risk | No information was provided on allocation concealment |
Blinding (performance bias) | Unclear risk | No information was given with respect to the blinding of participants and/or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information was provided on the blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information was given on withdrawals/losses to follow‐up per treatment groups |
Selective reporting (reporting bias) | Unclear risk | Although all the outcomes specified in the methods section ware reported no data were, however, available on any of the outcomes |
Other bias | Unclear risk | Insufficient information was reported to make a conclusive judgement |