Extract
Nocebo effects, the opposite of placebo effects, are defined as unfavourable changes in a patient's symptoms or condition occurring due to negative anticipation and possibly leading to suboptimal outcomes via treatment discontinuation or non-adherence [1]. Symptoms most commonly associated with nocebo in both dedicated neurobiological research and randomised controlled trial (RCT) settings are non-specific complaints, such as pain, malaise, dizziness or gastrointestinal upset [2]. Despite evidence highlighting the implications of placebo and nocebo effects on daily practice and RCT design and interpretation, determining their true frequency and intensity remains a challenge [1, 2].
Abstract
Nocebo effects may partly account for the high rates of diarrhoea reported in scleroderma patients enrolled in nintedanib RCTs. Investing in the doctor–patient relationship and improved informed consent procedures can reduce nocebo phenomena in trials. https://bit.ly/2VyoVhi
Footnotes
Conflict of interest: V-K. Bournia reports grants from Boehringer Ingelheim and GlaxoSmithKline, outside the submitted work.
Conflict of interest: O. Distler reports grants and personal fees from Bayer, Boehringer Ingelheim and Mitsubishi Tanabe Pharma, personal fees from Abbvie, Acceleron Pharma, Amgen, AnaMar, Catenion, Drug Development International Ltd, CSL Behring, ChemomAb, GSK, Horizon (Curzion) Pharmaceuticals, Inventiva, Italfarmaco, iQvia, Lilly, Medac, Medscape, MSD, Novartis, Pfizer, Roche, Sanofi, Serodapharm, Target Bio Science and UCB, outside the submitted work; and has a patent US8247389, EP2331143 issued.
Conflict of interest: E. Kravvariti has nothing to disclose.
Conflict of interest: D. Mitsikostas has nothing to disclose.
Conflict of interest: P.P. Sfikakis reports grants and personal fees from Actelion, grants from Boehringer Ingelheim, outside the submitted work.
- Received August 4, 2020.
- Accepted November 30, 2020.
- Copyright ©ERS 2021
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