Ward 1991.
Methods | Single‐centre, randomised, double‐blind, placebo‐controlled, 6‐period cross‐over study Single oral dose administered to treat a headache rated ≥ 2 on the McGill Pain Questionnaire Only 1 test dose could be taken on any given day Duration: 2 h, with assessments at baseline, 0.5, 1, 2 h |
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Participants | Headache: participants with no history of migraines and with headaches that had no migrainous features ≥ 6 headaches per month during the past 3 months with pain severity averaging ≥ 2 on a 5‐point scale Participants were 18 to 60 years of age N = 60 completed the study (53 for efficacy) M 17, F 36 Mean age 37 years |
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Interventions | Paracetamol 648 mg + caffeine 65 mg, n = 53 Paracetamol 648 mg + caffeine 130 mg, n = 53 Paracetamol 648 mg, n = 53 Caffeine 65 mg, n = 53 Caffeine 130 mg, n = 53 Placebo, n = 53 No caffeine or other analgesics during the 2‐h study period. Participants documented any caffeine consumed in the 24 h before dosing |
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Outcomes | PI: 100 mm VAS ('no pain' at left end, 'pain as bad as it could be' at right end' and 'mild, moderate, severe' in sequence below the line) | |
Notes | Oxford Quality Score: R1, DB1, W0. Total = 2/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method used to generate random sequence not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Method not described |
Size | High risk | All relevant treatment groups borderline at 53 participants each |