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- Title
Adverse events during placebo vs. no drug administration-results of a randomised interventional trial in 160 volunteers.
- Authors
Erbguth, Frank; Hamacher-Erbguth, Angelika; Fuhr, Uwe; Sörgel, Fritz
- Abstract
The article discusses a study presenting comparison to placebo in clinical trials for the proper assessment of efficacy and tolerability of a drug if there is no established treatment for a druggable medical condition. Topics discussed include underestimation of risk of patients related to the missed treatment when randomised to placebo, dependency of type of adverse events reported for placebo on the specific effects expected for active treatment, and effects of medical intervention.
- Subjects
ANXIETY; DRUG administration; DRUG side effects; FATIGUE (Physiology); PLACEBOS; SLEEP disorders; RANDOMIZED controlled trials; DESCRIPTIVE statistics; XEROSTOMIA
- Publication
European Journal of Clinical Pharmacology, 2015, Vol 71, Issue 11, p1403
- ISSN
0031-6970
- Publication type
Letter
- DOI
10.1007/s00228-015-1900-5