Mehlisch 1998.
Methods | R, DB, PC, parallel‐group study 1 episode treated with a single dose of study medication when pain was ≥ mod intensity |
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Participants | Episodic tension headache (IHS), 1‐10 episodes/month Excl: pregnancy/lactating; history of other headache types; significant medical history; chronic analgesia use; drug dependence; hypersensitivity to study medications n = 737 randomised, 703 took medication (631 in analysis) M 201, F 430 Mean age 32 years Baseline pain 88% mod, 12% severe |
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Interventions | Paracetamol 1000 mg, n = 174 (166) Ketoprofen 12.5 mg, n = 181 (158) Ketoprofen 25 mg, n = 176 (156) Placebo, n = 172 (151) Rescue medication allowed after 2 h |
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Outcomes | PI: 4‐point scale over 4 h PR: 5‐point scale over 4 h Meaningful relief. Functional impairment. Patient global AEs |
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Notes | Oxford Quality Score: R1, DB2, W1 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Details of randomisation method not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double dummy method |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double dummy method |
Incomplete outcome data (attrition bias) All outcomes | Low risk | WOCF for withdrawals, LOCF for other, linear interpolation for missing points |
Size | Unclear risk | 50‐200 participants per treatment arm (151‐166) |