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. 2016 Jun 16;2016(6):CD011889. doi: 10.1002/14651858.CD011889.pub2

Mehlisch 1998.

Methods R, DB, PC, parallel‐group study
1 episode treated with a single dose of study medication when pain was ≥ mod intensity
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
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
Outcomes PI: 4‐point scale over 4 h
PR: 5‐point scale over 4 h
Meaningful relief. Functional impairment. Patient global
AEs
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)