Badawy 2009.
Study characteristics | ||
Methods |
Study design: single‐centre RCT Study duration: not mentioned |
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Participants |
Inclusion criteria: women diagnosed with unilateral adenocarcinoma of the breast, with positive or negative lymph node status, and with no metastasis who had undergone modified radical mastectomy or breast‐conserving surgery plus full axillary lymph node dissection. All women were menstruating normally and aged 18 to 40 years (basal FSH levels < 10 mU/mL)
Exclusion criteria: women with macroscopic metastatic spread of the disease |
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Interventions |
Treatment group
Control group
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Outcomes | Women were followed up monthly for up to 8 months after completion of treatment:
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not mentioned |
Allocation concealment (selection bias) | Low risk | Quote: "sealed, dark envelopes" were used |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not mentioned whether participant/personnel/outcome assessment was blinded or not |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 woman in each group dropped out. Reasons not mentioned |
Selective reporting (reporting bias) | Low risk | Results of all outcomes mentioned in Methods section were reported in Results section |
Other bias | Unclear risk | Protocol was not mentioned. There was no difference between groups regarding age, body weight, height, number of dissected lymph nodes, serum LH, and chemotherapy dose |