Skip to main content
. 2014 Dec 11;2014(12):CD009281. doi: 10.1002/14651858.CD009281.pub3

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
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
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
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
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