Sayed 2011.

Study characteristics
Methods	Location: Faculty of Medicine, Assiut University, Egypt Randomised controlled trial: using numbered, sealed envelopes to receive either LNG‐IUS (N = 29) or combined oral contraceptive (N = 29).
Participants	Number of women randomised: 58 who had uterine fibroids examined by ultrasound. Inclusion criteria                                            Women were 20 to 50 years old, with heavy menstrual bleeding, requested contraception, had a regular cycle, and make follow‐up possible. Uterine fibroid was identified on pelvic ultrasound.                                                     Exclusion criteria: pregnancy; history of ectopic pregnancy; puerperal sepsis; pelvic inflammatory disease; evidence of defective coagulation; abnormalities on ultrasound including submucous fibroids of any size distorting the cavity of the uterus, or intramural, or subserous fibroids > 5 cm in diameter; history of malignancy; evidence of hyperplasia in the endometrial biopsy; incidental adnexal abnormality on ultrasound; previous endometrial ablation or resection; uninvestigated postcoital bleeding; untreated abnormal cervical cytology results; contraindication to combined oral contraceptive (COCs)
Interventions	LNG‐IUS (N = 29) LNG‐IUS (Mirena; Bayer Schering Pharma, Bayer Healthcare, Berlin, Germany) was inserted during the randomisation visit Low dose COC (N = 29) Twelve monthly low dose COC ( Microvlar [Bayer Schering Pharma]) were provided to the women. The pills contained 30 μg of ethinyl estradiol and 150 μg of levonorgestrel. Both groups used the same sanitary pads (Always Ultra; Proctor & Gamble, Cairo, Egypt)
Outcomes	Primary outcome was reduction of menstrual blood loss (MBL). MBL was measured by using a pictorial blood assessment chart (PBAC) at baseline, 6 months, and 12 months A direct measurement of MBL was also performed by the alkaline hematin method at baseline and at 12 months. Secondary outcomes were: haemoglobin and ferritin levels; health‐related quality of life; treatment failure (at 12 months e.g. LNG‐IUS expulsion, removal of the device, persistent bleeding treated by hysterectomy)
Notes	The size of the fibroids was categorized as less than 3 cm and 3 cm or greater. We contacted one study author for missing data, but did not get any response. Trial registration number: not stated Study dates: May 1, 2003, and March 31, 2004 Conflicts of interest: none stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation was conducted using a computer‐generated table of random numbers.
Allocation concealment (selection bias)	Unclear risk	Sealed envelope (did not describe whether it was opaque or not)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	It was not possible to blind LNG‐IUS and low dose COC from the women and investigators. The outcomes were not likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information available
Incomplete outcome data (attrition bias) All outcomes	High risk	At the end of the study, 6 cases (20.7%) were lost to follow‐up in the LNG‐IUS group, and 8 cases (27.6%) were lost to follow‐up in the COC group.
Selective reporting (reporting bias)	Unclear risk	No trial protocol available
Other bias	Unclear risk	No information available