| Methods |
Randomisation method: not stated
Blinding: double
Allocation concealment: not stated
Design: cross‐over
Number screened for inclusion: not stated
Number randomly assigned: 51
Number dropped out: eight (seven for personal reasons, one for medical reasons not related to study)
Number lost to follow‐up: none stated
Intention‐to‐treat analysis: no
Power calculation: not stated
Duration: three months × 2
Timing: not stated
Location: tertiary menopause clinic, Australia
Funding: industry (Novogen Ltd, Australia) |
| Participants |
Inclusion criteria: minimum of mean of three hot flushes per day in week preceding trial
Exclusion criteria: intercurrent medical problems, HT or antibiotics in previous three months, FSH < 30 mIU/mL, menstruation in previous six months, hysterectomy, vegetarian (> 10 g legumes/d)
Age, years: 54 (±4.1)
Recruitment method: volunteers. Not further specified |
| Interventions |
Dose, duration and timing of administration: one tablet daily in the morning for three months, one month washout period, then cross‐over to opposite arm for three months and two weeks
|
| Outcomes |
Menopausal symptoms: daily flush frequency scored on daily diary card
Quality of life: Greene Climacteric Scale |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Allocated randomly and blindly," but method not reported |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Stated as double‐blind |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Stated as double‐blind: analysis of data performed by separate group |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
High dropout |
| Selective reporting (reporting bias) |
High risk |
Adverse events not reported |
