| Methods |
Randomisation/allocation method unclear
Double‐blind, cross‐over trial
70 women randomised, 60 analysed
Withdrawals: 7 women did not take any study medication, 3 women did not have acceptable efficacy data for 2 or more cycles
Method of assessing adverse effects: evaluated retrospectively by "spontaneous reports and non‐suggestive questioning" |
| Participants |
Inclusion: primary dysmenorrhoea with moderate to severe pain for at least 4 consecutive months
Exclusion: any other conditions associated with recurrent pelvic or lower abdominal pain; hypersensitivity to aspirin or NSAIDs; serious illness; history of substance abuse; IUD use; pregnant or nursing
Age: 18 to 39
Location: USA |
| Interventions |
Ketoprofen (3 groups: loading dose of 25 mg, 50 mg or 75 mg then 25 mg doses)
Naproxen (500 mg loading dose then 250 mg doses)
Placebo
Taken 4 times a day for 3 days starting when pain moderate to severe
Duration: 3 cycles; 1 of each treatment |
| Outcomes |
Pain relief
Remedication |
| Notes |
This review has considered the 75 mg loading dose of ketoprofen, for the purpose of comparison |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method not described |
| Allocation concealment (selection bias) |
Unclear risk |
Method not described |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double‐blinded, "identical" placebo |
| Selective reporting (reporting bias) |
Unclear risk |
No evidence that adverse effects data prospectively solicited |
| Complete follow‐up? |
High risk |
60/70 women analysed (86%) |
| Potential bias related to study funding |
Unclear risk |
Wyeth‐Ayerst sponsors |
