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. 2019 Mar 3;2019(3):CD008018. doi: 10.1002/14651858.CD008018.pub3

Badawy 2009.

Study characteristics
Methods Study design: single‐centre RCT
Study duration: not mentioned
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)
  • Country: Egypt

  • Number: GnRH agonist + chemotherapy (n = 40); chemotherapy (n = 40)

  • Age (mean ± SD)

    • GnRH‐agonist + chemotherapy: 30 ± 3.51 years

    • Chemotherapy: 29.2 ± 2.93 years


Exclusion criteria: women with macroscopic metastatic spread of the disease
Interventions Treatment group
  • GnRH‐agonist + chemotherapy

  • Women received subcutaneous goserelin at a dose of 3.6 mg 2 weeks before the initiation of chemotherapy then every 28 days for 6 months


Control group
  • Chemotherapy

  • Women received chemotherapy alone. Chemotherapy included FAC, TP, VAC and BEP

Outcomes Women were followed up monthly for up to 8 months after completion of treatment:
  • Menstruation recovery or maintenance

  • Ovulation: confirmed by serial ultrasound

  • Hormone levels: FSH, LH, estradiol and progesterone

Notes
  • Funding source: not mentioned

  • Declarations of interest: not mentioned

  • We contacted Badawy 2009 [pers comm] for additional data

  • There was no difference between groups regarding age, body weight, height, number of dissected lymph nodes and serum LH levels. The chemotherapy dose of 2 groups were not significantly different

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