Most randomized controlled trials for psoriasis used placebo comparators despite the availability of effective treatments.
J Clin Epidemiol
; 133: 72-79, 2021 05.
Article
in En
| MEDLINE
| ID: mdl-33482295
ABSTRACT
BACKGROUND:
The availability of effective treatments for psoriasis raises ethical questions about the use of a placebo group in therapeutic trials. We evaluated the use of the placebo over time in such trials.METHODS:
From trials in a living Cochrane review and network meta-analysis for psoriasis, we included trials comparing a biologic to a placebo or other systemic treatment. First, we tested the changes in placebo rate from 2001 to 2019 by linear regression, then constructed networks for 2004-2019 and evaluated the contribution of the placebo to the network meta-analysis estimates per trial and per comparison.RESULTS:
We included 81 trials (36,774 patients). The placebo rate did not decrease significantly over time. The proportion contribution of trials with a placebo decreased from 100% in 2004 to 86% in 2008 and 75% in 2019. However, the proportion contribution of trials without a placebo remained low (from 0% in 2004 to 25% in 2019).CONCLUSION:
The design of future psoriasis trials should be reviewed to improve the number of patients to be included in a placebo group.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Placebos
/
Psoriasis
/
Randomized Controlled Trials as Topic
/
Guidelines as Topic
/
Biomedical Research
/
Anti-Inflammatory Agents
Type of study:
Clinical_trials
/
Guideline
/
Systematic_reviews
Aspects:
Ethics
Limits:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
J Clin Epidemiol
Journal subject:
EPIDEMIOLOGIA
Year:
2021
Document type:
Article
Affiliation country:
France