Swanson 2006.
| Methods | Randomised placebo‐controlled trial | |
| Participants | 396 healthy postmenopausal women (≥ 40 years of age; mean age 52 years) who had been amenorrhoeic ≥ 6 months (women with a uterus only) and who were experiencing a minimum of 7 moderate to severe hot flashes per day (or 60 per week). In addition, women had to be within 70% to 140% of their ideal body weight, smoke fewer than 15 cigarettes daily and have tested negative for pregnancy. Mean time since menopause 84 months | |
| Interventions |
Administered for 12 weeks |
|
| Outcomes | Hot flashes, vaginal dryness, dyspareunia, endometrial hyperplasia, endometrial cancer, breast cancer | |
| Notes | Menopausal symptoms evaluated as mean change from baseline using a non‐validated scale: 1 = mild sensation of heat without perspiration; 2 = moderate sensation of heat with perspiration, able to continue activity; 3 = severe sensation of heat with sweating, causing the woman to stop activity Timing: unclear Location: United States Multi‐centre: 31 sites |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled. Defined as "double‐blind"; 3 daily interventions were compared |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Evaluation of endometrial hyperplasia and cancers should not suffer from detection bias. Methods for (and blinding when) diagnosing heart failure not specified |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 5/396 excluded for not receiving any study treatment |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
| Conflict of interest | High risk | Financed by the drug manufacturer. Two study authors were employees of drug manufacturer |