Tokola 1984.
Methods | Randomised, double‐blind, placebo‐controlled, cross‐over study Each participant treated up to 12 consecutive migraine attacks with up to 2 oral doses of medication; first dose taken at first warning of pain, second dose available after 1.5 h if the response to the first was not good enough Assessment at baseline and 1.5 h, but total study duration and other assessment time points not reported |
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Participants | Migraine as defined by the Ad Hoc Committee on the Classification of Headache Participants at least 18 years of age N = 49 (with a total of 482 attacks treated) M 3, F 46 Mean age 37 years |
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Interventions | Numbers of attacks treated: Tolfenamic acid 200 mg + caffeine 100 mg, n = 79 Tolfenamic acid 200 mg, n = 200 mg, n = 85 Tolfenamic acid 200 mg + metoclopramide 10 mg, n = 80 Caffeine 100 mg, n = 81 Metoclopramide, n = 75 Placebo, n = 82 |
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Outcomes | Severity of attack at 1.5 h: 4‐point scale (no symptoms, slight, moderate, severe) Baseline pain intensity not reported so unable to determine level of pain relief from reported pain intensity data at 1.5 h Serious adverse events |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 | |
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) | Low risk | "assigned sequentially from individual packages prepared in random order" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Capsules of identical appearance" |
Size | Unclear risk | 50 to 200 participants in relevant treatment arms |