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Table 1 GRADE evaluation of placebo-controlled studies evaluating efficacy and tolerability of onabotA

From: Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European Headache Federation

Studies (participants) Outcome Comparison Type Quality Effect size GRADE quality of evidence Direction Strength Comment
Dodick (1384) Headache days OnabotA 155 U–195 U versus placebo R −1 0 Moderate For Strong Quality points deducted for risk of bias (−1)
Diener (2436) Adverse events OnabotA 75 U–260 U versus placebo R -1 + 1 High For Strong Quality points deducted for risk of bias (−1). Effect size point added for small frequency of AE
  1. The Dodick paper [11] was a pooled analysis of the Aurora [4] and 2010 Diener [5] studies. The 2014 Diener paper [19] was a pooled analysis of two phase 2 studies in chronic daily headache [20, 21] and the two PREEMPT studies [4, 5]. Type: R randomized controlled trial
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