Literature DB >> 31463606

Placebos and the Placebo Effect in Drug Trials.

Paul Enck1, Sibylle Klosterhalfen2.   

Abstract

In this review, we explored different ways of controlling the placebo effects in clinical trials and described various factors that may increase/decrease the placebo effect in randomized placebo-controlled trials. These factors can be subdivided into four groups, and while not all factors are effective in every study and under all clinical conditions, they show on the whole that - even under the ideal condition of drug therapy, where blinded placebo provision is much easier and warranted than in, e.g., psychotherapy - many factors need to be controlled to ascertain that the goal of the clinical trials, fair assessment of superiority of the drug over placebo in placebo-controlled trials and fair assessment of non-inferiority of the drug compared to another drug in comparator trials, is reached. Ignorance towards the placebo effect, which was common in the past, is no longer acceptable; instead, it should be the goal of all therapeutic trials to minimize the placebo effect in clinical trials, while utilizing and maximizing it in clinical routine.

Keywords:  Clinical trials; Control conditions; Design; Drug effect; Nocebo effect; Placebo effect

Year:  2019        PMID: 31463606     DOI: 10.1007/164_2019_269

Source DB:  PubMed          Journal:  Handb Exp Pharmacol        ISSN: 0171-2004


  8 in total

1.  The Effectiveness and Safety of Medical Cannabis for Treating Cancer Related Symptoms in Oncology Patients.

Authors:  Joshua Aviram; Gil M Lewitus; Yelena Vysotski; Mahmoud Abu Amna; Anton Ouryvaev; Shiri Procaccia; Idan Cohen; Anca Leibovici; Luiza Akria; Dimitry Goncharov; Neomi Mativ; Avia Kauffman; Ayelet Shai; Gil Bar-Sela; David Meiri
Journal:  Front Pain Res (Lausanne)       Date:  2022-05-20

Review 2.  The Placebo and Nocebo Responses in Clinical Trials in Inflammatory Bowel Diseases.

Authors:  Paul Enck; Sibylle Klosterhalfen
Journal:  Front Pharmacol       Date:  2021-03-31       Impact factor: 5.810

3.  Endocannabinoid Levels in Ulcerative Colitis Patients Correlate With Clinical Parameters and Are Affected by Cannabis Consumption.

Authors:  Shelly Tartakover Matalon; Shahar Azar; David Meiri; Rivka Hadar; Alina Nemirovski; Narjes Abu Jabal; Fred Meir Konikoff; Liat Drucker; Joseph Tam; Timna Naftali
Journal:  Front Endocrinol (Lausanne)       Date:  2021-08-31       Impact factor: 5.555

Review 4.  Influence of placebo effect in mental disorders research: A systematic review and meta-analysis.

Authors:  Rodrigo Fernández-López; Blanca Riquelme-Gallego; Aurora Bueno-Cavanillas; Khalid S Khan
Journal:  Eur J Clin Invest       Date:  2022-02-27       Impact factor: 5.722

5.  Effect of a Short-Term Intervention with Lactobacillus salivarius Probiotic on Early Childhood Caries-An Open Label Randomized Controlled Trial.

Authors:  Małgorzata Staszczyk; Małgorzata Jamka-Kasprzyk; Dorota Kościelniak; Beata Cienkosz-Stepańczak; Wirginia Krzyściak; Anna Jurczak
Journal:  Int J Environ Res Public Health       Date:  2022-09-29       Impact factor: 4.614

Review 6.  Placebo Responses and Placebo Effects in Functional Gastrointestinal Disorders.

Authors:  Paul Enck; Sibylle Klosterhalfen
Journal:  Front Psychiatry       Date:  2020-08-25       Impact factor: 4.157

7.  Placebo response mitigation with a participant-focused psychoeducational procedure: a randomized, single-blind, all placebo study in major depressive and psychotic disorders.

Authors:  Elan A Cohen; Howard H Hassman; Larry Ereshefsky; David P Walling; Vera M Grindell; Richard S E Keefe; Katarzyna Wyka; William P Horan
Journal:  Neuropsychopharmacology       Date:  2020-11-26       Impact factor: 7.853

8.  Frunevetmab, a felinized anti-nerve growth factor monoclonal antibody, for the treatment of pain from osteoarthritis in cats.

Authors:  Margaret E Gruen; Jamie A E Myers; Jezaniah-Kira S Tena; Csilla Becskei; Dawn M Cleaver; B Duncan X Lascelles
Journal:  J Vet Intern Med       Date:  2021-11-01       Impact factor: 3.333

  8 in total

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