Skip to main content
. 2016 Oct 12;2016(10):CD008536. doi: 10.1002/14651858.CD008536.pub3

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
  • Tibolone 2.5 mg/d

  • Tibolone 1.25 mg/d

  • Placebo


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