Telimaa 1987.
Methods | Location: University of Oulu, Finland
No. of centres: 1 Recruitment period: not stated |
|
Participants | Inclusion criteria: advanced endometriosis Exclusion criteria: NS No. randomised: 60 No. analysed: 51 (pain), 59 (pregnancy) | |
Interventions | Post‐surgical medical therapy Gr A (n = 20): danazol oral 600 mg daily x 180 days Gr B (n = 20): MPA 100 mg daily x 180 days Gr C (n=20): placebo | |
Outcomes | Pain scores AFS scores Pregnancy rates Patient satisfaction Adverse drug reactions: weight gain, breakthrough bleeding, acne | |
Notes | Power calculation: NS Funding: Research and Science Foundation Farmos Ltd, Turku; Cultural Foundation of Keski‐Pohjanmaa, Finland; Farmos Group, Turku, Finland supplied drugs | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized" no information on method of sequence generation |
Allocation concealment (selection bias) | Unclear risk | not mentioned |
Blinding (performance bias and detection bias) All outcomes | Low risk | double blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Numbers and reasons for post randomisation exclusions similar in each group. 3,2,3 excluded in groups A,B & C due to pregnancy. 1 adverse event in placebo group |
Selective reporting (reporting bias) | Low risk | important outcomes of pregnancy recurrence and pain reported |
Other bias | Low risk | groups appear comparable at baseline and authors state that" no other medication was used during the trial" |