| Methods |
Study Design: parallel, double‐blind, multicentre, placebo‐control, randomised clinical trial
Randomisation: treatments assigned symmetrically in blocks of four according to a computer‐generated randomisation scheme
Number of Centres: 3
Duration of Trial: 16 weeks
Power Calculations: no
Number of women randomised: 82 to two treatment groups
Number of women analysed: varied according to outcome; 70 for hot flush frequency, and 78 for hot flush severity
Intention‐to‐treat analysis: yes
Losses to follow‐up: varied according to outcome; 12/82 (= 15% for hot flush frequency) and 4/82 (= 5%) for hot flush severity
Withdrawals from treatment: 35/82 (= 43%) did not complete treatment. Breakdown: adverse effects (6), lack of effect (18), unspecified (11). Withdrawal rate was significantly higher in placebo group.
Compliance: assessed by unused pill counts but degree of compliance not stated
Source of Funding: Novo Nordisk Pharmaceuticals |
| Participants |
Menopausal status: peri‐ and post‐menopausal (all natural)
Age: 50 years (mean)
Location: USA Ethnicity: not stated
Source: not stated
Inclusion Criteria: age 40 to 60 years, menopause symptoms with at least 20 vasomotor events/week (and a minimum of five moderate‐severe), serum FSH > 40 IU/ml
Exclusion Criteria: estrogen therapy within the last month, steroid therapy within the past 3 months, a history of major diseases that would contraindicate oestrogen therapy, long term treatments that would interfere with outcomes
Confirmation of Ovarian Failure: serum FSH > 40 IU/ml (inclusion criteria)
Baseline Equality: equality for vasomotor symptoms, general climacteric symptoms and Beck Depression Index reported
Baseline Symptoms: all participants had vasomotor symptoms (>20/week) at baseline (inclusion criteria) |
| Interventions |
Rx1 (E+P, cyclic ): 2mg 17 beta oestradiol days 1 to 12, 2 mg 17 beta oestradiol + 1mg norethisterone acetate days 13 to 22, 1mg 17 beta oestradiol days 23/28 (triphasic sequential therapy)
Rx2: placebo
HRT and placebo preparations were identical
Co‐interventions: none reported |
| Outcomes |
1. Hot flush frequency
2. Hot flush severity (vasomotor component of Greene's Climacteric Scale, 0‐12 scale)
3. Losses to follow‐up |
| Notes |
Attempts were made to contact the author but were unsuccessful. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
