| Methods |
Method of randomisation not stated
Open label, parallel design, multicentre (14) participants randomised 2:1 ratio Pathologists blinded
Number of women randomised: n = 219 (Estring 147, pessaries 72)
Number of women analysed: n = 190/171 (ring 116, pessary 55)
Number of withdrawals: n = 29 (ring 19, suppository 10). 19 more women excluded (ring 12, suppository 7)
Reasons for withdrawal: not stated
No power calculation
No ITT
Source of funding: Pharmacia and Upjohn |
| Participants |
Inclusion criteria: at least 2 years after spontaneous or surgical menopause presenting with one or more signs and symptoms of atrophic vaginitis due to oestrogen deficiency, pruritus vulvae, dyspareunia, dysuria, urinary urgency; on examination; petechiae, friability or vaginal dryness
Age: not stated
Source of participants: not stated
Exclusion criteria: if received sex hormone therapy within previous 3 months, or had severe hepatic or renal diseases, oestrogen dependant neoplasms and urinary tract infections despite antibiotics, or had endometrial thickness > 5 mm or vaginal ulceration, irritation or bleeding from causes other than epithelial atrophy
Location: Austria, Switzerland, Germany |
| Interventions |
Treatment: oestradiol‐releasing silicone ring (Estring) core containing 2 mg 17β‐oestradiol releasing 7.5 mcg/24 hours for 90 days
Control: oestradiol pessary 0.5 mg (Ovestin)
Duration: 3 months |
| Outcomes |
Vaginal pH, response, adverse events, adherence to treatment |
| 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) |
High risk |
Open label trial |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Single blinding but some outcomes were self‐assessed |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Proportions of withdrawals differed between the two treatment groups and data analysis was not based on ITT |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a conclusive judgement |
| Other bias |
Unclear risk |
Insufficient information to make a conclusive judgement |
