• Faiza Shafiq, Dimos-Dimitrios Mitsikostas, and Panagiotis Zis.
• a Department of Neurology , Sheffield Teaching Hospitals NHS Trust , Sheffield , UK.
• Amyotroph Lateral Scler Frontotemporal Degener. 2017 Nov 1; 18 (7-8): 576-582.

IntroductionNocebo is very prevalent among neurological disorders, resulting in low adherence and treatment outcome. We sought to examine the AEs following placebo administration in placebo-controlled randomised clinical trials (RCTs) for motor neuron disease (MND).MethodsAfter a systematic literature search for RCTs for MND pharmacotherapy treatments, we assessed the number of discontinuations because of placebo intolerance.ResultsData were extracted from 12 RCTs fulfilling our search criteria. Approximately eight in 10 placebo-treated patients (78.3%, 95% CI 74.3-82.0%) reported at least one AE and approximately one in 12 placebo-treated patients discontinued placebo treatment because of AEs (8.4%, 95% CI 6.7-10.4%). All patients participating in the MND trials reported similar AEs independently of the study arm to which they belonged.ConclusionOur study indicates significant nocebo in trials for MND treatment, adversely affecting adherence and efficacy of current treatments in clinical practice, with additional implications for trial design.

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