Kroiss 2005.
| Methods | Randomised placebo‐controlled trial | |
| Participants | 70 postmenopausal women (hospital outpatients; < 75 years old; body mass index 18 to 30 kg/m2) with newly diagnosed and histologically confirmed invasive or non‐invasive early‐stage breast cancer (< stage IIb), for which they were to receive surgical treatment (conservation therapy or modified radical mastectomy) followed by tamoxifen (20 mg/d). The women were required to have had their last natural menstrual period > 1 year before diagnosis of breast cancer (mean time since menopause 107 months) and to have a serum oestradiol concentration < 30 pg/mL. Mean age 58 years | |
| Interventions |
Administered for 12 months |
|
| Outcomes | Vaginal bleeding/spotting, endometrial hyperplasia, endometrial cancer, recurrence of breast cancer, hot flushes, sweating, vaginal dryness | |
| Notes | Menopausal symptoms were evaluated as frequency reduction from baseline (for participants who could be evaluated) and as mean change in number and severity from baseline. No data available on vaginal dryness Timing: July 1996 to July 2000 Location: unclear Multi‐centre: described as multi‐centre trial but unclear number and locations of sites |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Automated random assignment using ADLS system |
| Allocation concealment (selection bias) | Low risk | Automated random assignment using ADLS system |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled, double‐blind (identical medication) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not specified, but given the nature of outcomes assessed, their evaluation is likely to be "objective" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 3/35 participants in the placebo group did not receive study treatment |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
| Conflict of interest | High risk | Two study authors were employees of the drug manufacturer |