| Methods |
Randomisation list on a 1:2 ratio with no blinding.
Number of women randomised: N = 24.
No withdrawals reported.
No power calculation made.
No source of funding reported. |
| Participants |
Women aged 24 to 38 years (mean 33.6 years) with symptomatic multiple uterine fibroids recruited from a clinic in Milan, Italy. Prevalent symptoms were infertility in 18 and menorrhagia in 6 women.
No exclusion criteria reported. |
| Interventions |
Rx: Intranasal buserelin 1200 µg/day before myomectomy, N = 8.
Control: Immediate myomectomy surgery, N = 16.
Duration: 3 months. |
| Outcomes |
Preoperative uterine volume (mL)
Duration of surgery (minutes)
Intra‐operative blood loss (mL).
Adverse events (specific information not available from author).
Postoperative febrile complications.
Recurrence of myomas at 6 months. |
| Notes |
Author contacted for additional information on adverse events but no reply received. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
“Using a randomisation list the patients were allocated in a 1:2 ratio”. List unclear whether this was sequential or random. |
| Allocation concealment (selection bias) |
Unclear risk |
No information pertaining to allocation concealment was provided. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
No information pertaining to blinding was provided but unlikely as control participants had immediate surgery ‐ however recurrence is an objective outcome. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
“Measurements were performed… in all patients by a physician unaware of the patient’s group allocation”. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
There were no withdrawals from the study. Data for all 24 participants were reported. |
| Selective reporting (reporting bias) |
Low risk |
No previous protocol information was available but all outcomes from methods section were reported in the results section. |
| Other bias |
Unclear risk |
Insufficient information to determine if groups comparable at baseline |
