A quasi-placebo may have a role in some randomised controlled trials
Abstract
Dear Editor, Migraine-prevention trials in children and young people have been disappointing. As chief investigator for P3MC, the placebo-controlled migraine-prevention trial of pizotifen and propranolol in the UK [1] that was abandoned because of poor recruitment, I have had a great deal to reflect on. And while having a placebo was not the main factor in the trial’s failure, I think that it could have contributed to some of the set-up sites recruiting no participants. More recently, CHAMP, the placebo-controlled migraineprevention trial of topiramate and amitriptyline in the USA [2] was also closed early, not because of poor recruitment, but because the high placebo responder rate made the study futile. Great, a relatively cheap and safe intervention, the placebo, significantly reduced the headache frequency in 60% of participants. However, that outcome cannot be replicated clinically. The placebo is a trial intervention, which cannot exactly be replicated in clinical practice. These abandoned trials failed to answer the important clinical questions about the efficacy of the two most prescribed treatments for preventing migraine in children in the UK and the USA respectively: ‘What is an effective treatment to recommend for this indication in these patients?’ This is particularly frustrating as they cost significant money, time and effort, and patient and parent/ guardian investment. Now there are a number of popular unproven treatments that are relatively cheap and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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