Hidalgo 2005.
| Methods | Design: cross‐over Number of women screened: not stated Number randomly assigned: 60 Number of dropouts: 12% (7/60): not clear which group: five no reason, two adverse events Intention‐to‐treat analysis: no Power calculation: yes, but insufficient Duration: 12 weeks, seven‐day washout, then another 12 weeks on alternate treatment Timing: July 2003 to August 2004 Location: Guayaquil, Ecuador Funding: Melbrosin International (provision of intervention and control) | |
| Participants | Inclusion criteria: over 40 years of age, no menses for past 12 months, non‐users of HT, moderate to severe menopausal symptoms (Kupperman Index score ≥ 15, basal determination Exclusion criteria: no consent, indication of non‐compliance, conventional HT, isoflavone supplements, thyroid medication or history of thyroid disease, medication that could interfere with vasomotor symptoms and/or lipid serum levels Mean age, years: 51 Recruitment method: clinical database, private practice or from the general population through advertising and flyers | |
| Interventions |
Dose, duration and timing of administration: Participants acted as their own control—two capsules a day of the randomly assigned treatment for 90 days, a seven‐day washout period, then alternate treatment for a further 90 days |
|
| Outcomes | Hot flush and night sweat Kupperman scores (severity) expressed as percentages Vaginal cytology | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computerised random number generation |
| Allocation concealment (selection bias) | Low risk | Opaque containers with investigators blinded to codes |
| 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 |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not clear whether dropouts likely to influence results |
| Selective reporting (reporting bias) | High risk | Adverse effects not measured |