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An analysis of subjects in the control arm of randomized trials about fibromyalgia shows that people with the disorder are unusually prone to adverse effects that lead to treatment discontinuation.
As if it weren't already enough of a challenge to treat fibromyalgia, a systematic review finds that fully two-thirds of patients in the placebo-treated control arm in randomized trials of proposed drugs for the condition experience adverse effects (AEs). Nearly one in ten drop out of the trial altogether because of perceived adverse effects, even though they have been taking only a dummy "treatment."
This is four times as common as the AE rate in placebo arms of multiple sclerosis trials, and twice as common as among control subjects in migraine studies, according to the report in the European Journal of Neurology.
This information is important not only for doctors contemplating trials of new treatments for fibromyalgia, say the authors from two hospitals in Athens.This "nocebo" phenomenon must also affect patients in clinical practice,they observe, so it is crucial to identify the predisposing factors and determine how to counsel patients accordingly.
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