Adverse events in trials of licensed drugs for irritable bowel syndrome with constipation or diarrhea: Systematic review and meta-analysis.
Brigida BarberioEdoardo Vincenzo SavarinoChristopher J BlackAlexander Charles FordPublished in: Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society (2021)
Patients with IBS randomized to placebo have a high risk of reporting adverse events, which might relate to both nocebo and non-nocebo factors. Although patients' expectations and psychosocial factors may be involved, further understanding of the mechanisms are important to control or optimize these effects in RCTs, as well as in clinical practice.
Keyphrases
- irritable bowel syndrome
- end stage renal disease
- clinical practice
- double blind
- chronic kidney disease
- newly diagnosed
- ejection fraction
- peritoneal dialysis
- placebo controlled
- phase iii
- prognostic factors
- mental health
- clinical trial
- randomized controlled trial
- emergency department
- electronic health record
- study protocol
- patient reported