Griesser 2012.
| Methods | 3‐arm parallel design RCT | |
| Participants | 436 postmenopausal women with vaginal atrophy Age (mean, SD): Group A: 64.9 (8.1); Group B:65.4 (7.3); Group C: 64.8 (7.8) Inclusion criteria: postmenopausal women (last menstrual period more than 12 months ago or having undergone bilateral ovariectomy) aged 18 years or older with a clinical diagnosis of vaginal atrophy, a vaginal maturation index (VMI) < 40% and a vaginal pH value > 5 were eligible for inclusion. At least one subjective symptom of vaginal atrophy (dryness, pain/burning sensation, pruritus, discharge, dyspareunia) had to be rated at a score of ≥ 65 on the visual analogue scale (VAS) Exclusion criteria: hormone replacement therapy, therapy with phytoestrogens or local vaginal hormonal therapy during 12 weeks preceding baseline, as well as current or suspected estrogen‐dependent malignant tumour, a Pap smear ≥ III, endometrial thickness > 5 mm, current or suspected vaginal infection, current symptomatic urinary tract infection, existing or previous breast cancer or suspicion thereof, undiagnosed bleeding in the genital area, current venous thromboembolic disease, known severe renal insufficiency or hypersensitivity to estriol or any of the excipients (hard fat and emulsifiers) of the study medication |
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| Interventions |
Group A: estriol pessary 0.2 mg (n = 142). Estriol pessary 0.2 mg once‐daily application or 20 days, followed by twice‐weekly administration for a further 9 weeks as a maintenance therapy Group B: estriol pessary 0.03 mg (n = 147) (same administration as in Group A) Group C: placebo (n = 147). Treatment protocol as described for Group A Duration: 12 weeks |
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| Outcomes | Improvement in atrophy symptoms, vaginal pH, adverse events, tolerability | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias) | Low risk | Stated as “double blind” |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Stated as “double blind” (for participant‐ and clinician‐assessed outcomes) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportions of and reasons for withdrawals fairly balanced between the treatment groups |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
| Other bias | Low risk | Baseline demographic characteristic (age) was similar between the groups |