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Diarrhoea in systemic sclerosis patients as a nocebo effect of nintedanib

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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… Click to show full abstract

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]. 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

Keywords: nocebo effect; nocebo effects; systemic sclerosis; sclerosis patients; patients nocebo; diarrhoea systemic

Journal Title: European Respiratory Journal
Year Published: 2021

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