Ziaei 2010.
| Methods | Randomised controlled trial | |
| Participants | 150 healthy postmenopausal women (mean age at menopause: 49 years), 45 to 60 years of age (mean age 52 years), whose last menstrual period was more than a year ago with plasma 17β‐oestradiol < 35 pg/mL | |
| Interventions |
Administered for 6 months |
|
| Outcomes | Vaginal bleeding (requiring > 1 sanitary napkin per day), vaginal spotting (requiring just 1 sanitary napkin per day), vaginal dryness, vasomotor symptoms, lubrication and pain during sexual intercourse, as scored at baseline and at post treatment | |
| Notes | An arm with 50 women who received only 1 Cal + D tablet (500 mg + 200 IU) was not considered Timing: unclear Location: Iran Multi‐centre: only 2 sites (in Tehran) |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated list of random numbers |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not specified whether blind/double‐blind trial. All women received Ca + vit D but 1 control group did not receive active treatments; no dummy placebo mentioned |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Only blood samples stated to have been assessed in blinded fashion (corresponding outcome is not of interest for this review) |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 5/150 lost to follow‐up for bleeding outcomes; 20/150 (13%) for vasomotor symptoms |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
| Conflict of interest | Low risk | Publicly financed; study authors state no competing interests |
ADLS: Almedica Drug Labeling System
AE: adverse event.
BKMI: Blatt‐Kupperman menopausal index.
BMD: bone mineral density.
BMI: body mass index.
CE: conjugated oestrogen.
CEE: conjugated equine oestrogen.
ETTH: Episodic tension‐type headache
EV: oestradiol valerate.
FDA: Food and Drug Administration.
FSH: follicle‐stimulating hormone.
HRT: hormone replacement therapy.
HT: hormone therapy.
MPA: medroxyprogesterone acetate.
RCT: randomized controlled trial.
SLE: systemic lupus erythematosus.
TIA: transient ischaemic attack.
TVUS: transvaginal ultrasonography.
VM: vasomotor symptoms.