Hosseinzadeh 2015.
| Methods | 2‐arm parallel RCT Number of centres: 1 Number of women randomised: 160 Number of women analysed: ?160 Number of withdrawals: ?0 |
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| Participants |
Inclusion criteria: 160 postmenopausal women with clinical diagnosis of vaginal atrophy Age (mean, SD): 50‐70 years: Group A: 56.55 ± 8.63; Group B: 55.28 ± 6.12 BMI (kg/m2): Group A: 23.21 ± 3; Group B: 25 22.48 ± 2.56 Exclusion criteria: history of carcinoma of the breast or endometrium, abnormal genital bleeding, acute thrombophlebitis, or thromboembolic disorders associated with previous oestrogen therapy, treated with systemic or vaginal oestrogen within 6 months of the study, or had any contraindication for oestrogen therapy |
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| Interventions |
Group A: vaginal oestrogen cream (1 tube per night for 14 nights, then 1 tube 2 nights in 1 week for 10 weeks) Group B: Vagifem (oestrogen tablet) 25 mcg tablets (with similar treatment plan) |
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| Outcomes | Severity of vaginal atrophy (assessed by gynaecologist), 4 main symptoms of atrophic vaginitis: dysuria, dyspareunia, vaginal itching and dryness (participant self report), Satisfaction with treatment, acceptability of treatment (pain, vaginal leakage, need for sanitary towels, user friendliness), adverse events | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "women were randomly divided into Vagifem (from Novo Nordisk) or vaginal estrogen cream (Equin from Actoverco) treatment groups (80 women in each group)" |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias) | Unclear risk | Not reported but participants were likely to be unblinded since the 2 treatments required different administration |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Gynaecologists were “unaware of the treatment group” and so there is a low risk of bias for the gynaecologist assessment of vaginal atrophy but other outcomes were answered by participant self‐report |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | It appears that there were no dropouts after randomisation |
| Selective reporting (reporting bias) | Low risk | All outcomes pre‐specified in the methods section were reported |
| Other bias | Low risk | Baseline demographic characteristics similar in both treatment groups |