|Methods||Location: Faculty of Medicine of Assiut University in Egypt.|
Randomised controlled trial: using numbered, opaque, sealed envelopes to receive either LNG-IUS (n = 29) or combined oral contraceptive (n = 29).
|Participants||Number of women randomised: 58 having uterine fibroids examined by ultrasound.|
Women were 20-50 years with heavy menstrual bleeding,requested contraception, had a regular cycle, and make follow up possible. Uterine fibroid was identified on pelvic ultrasound.
history of ectopic pregnancy,
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 in 29 randomised women.
Low dose COC (n = 29)
Twelve monthly low dose COC ( Microvlar [Bayer Schering Pharma]) was performed in 29 women. The pills contained 30 μg of ethinyl estradiol and 150 μg of levonorgestrel.
Both groups used same sanitary pads (Always Ultra; Proctor & Gamble, Cairo, Egypt).
|Outcomes||A 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.|
|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 (not described whether it was opaque or not).|
|Blinding of participants and personnel (performance bias) |
|Low risk||It was not possible to blind LNG-IUS and low dose COC from the participants and investigators.|
|Blinding of outcome assessment (detection bias) |
|Unclear risk||No information available.|
|Incomplete outcome data (attrition bias) |
|High risk||At the end of the study 6 cases (20.7%) were lost to follow up in LNG-IUS and 8 cases (27.6%) were lost to follow up in COC.|
|Selective reporting (reporting bias)||Unclear risk||No information available.|
|Other bias||Unclear risk||No information available.|