Examining the Nocebo Effect in Trials of Neuromodulators for Use in Disorders of Gut-Brain Interaction.

Jeremy Romek Glissen BrownAva SanayeiSamantha ProctorRyan FlanaganSarah BallouPaul A BainJudy Nee

Published in: The American journal of gastroenterology (2022)

Patients with DGBIs in RCTs randomized to placebo groups frequently experience AEs and AEs that lead to withdrawal consistent with a strong nocebo effect. Non-specific AEs such as dizziness, headaches and diarrhea occurred similarly in patients receiving placebo compared to those receiving neuromodulators.

Keyphrases

double blind
phase iii
placebo controlled
open label
clinical trial
white matter
multiple sclerosis
resting state
phase ii
study protocol
subarachnoid hemorrhage