Sayyah‐Melli 2007.
Methods | Single centre (Iran), parallel group RCT. Number of women randomised: N = 50. No withdrawals. No power calculation for sample size reported. Source of funding: not reported. |
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Participants | Inclusion criteria: women with uterine myoma nodules > 5 cm in diameter with irregular menstrual cycle and candidates for myomectomy. Exclusion criteria: > 40 years of age, abnormal uterine pathology, infection, hypersensitivity to any ergot alkaloids, hepatic and renal disorders, history of toxemia of pregnancy, cardiovascular disease, peptic ulcer, taking antipsychotic medications. Mean age: 30 and 32 years. Recruited from Alzahra University Hospital, Tabriz, Iran. |
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Interventions |
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Outcomes | Reduction in fibroid volume, symptoms, adverse effects. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "...assigned randomly" but no method reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not reported and highly unlikely because of different administration of intervention regimens (injection and tablet). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not reported and unlikely. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No reported withdrawals. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes fully reported. |
Other bias | Low risk | Groups appeared comparable at baseline. |