Methods |
Administration of medicine was random however due to error each treatment had different numbers so were not identical
Double blind
93 participants randomised |
Participants |
Inclusion: all cases of dysmenorrhoea except mild pain
Age: 10 to 40
Location: UK |
Interventions |
1. Norinyl 1 ‐ norethisterone 1mg, mestranol 0.05mg
2. Placebo
Duration: 2 cycles |
Outcomes |
Relief of pain
Duration of pain
Days off work/in bed
Analgesics required
Side effects |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
Unequal numbers because of errors |
Allocation concealment? |
Unclear risk |
B |
Blinding?
All outcomes |
Low risk |
Double blinding but the placebo group had packaging that was different different from treatment group although the patients were unaware which group they were assigned to |
Incomplete outcome data addressed?
All outcomes |
High risk |
|
Free of selective reporting? |
Low risk |
|
Power calculations |
High risk |
|
Dropouts reported |
High risk |
|
Baseline comparability |
Low risk |
|