Do patients with cystic fibrosis participating in clinical trials demonstrate placebo response? A meta-analysis - Archive ouverte HAL
Article Dans Une Revue Journal of Cystic Fibrosis Année : 2019

Do patients with cystic fibrosis participating in clinical trials demonstrate placebo response? A meta-analysis

les patients atteints de mucoviscidose ont ils un effet placebo lors des essais cliniques. Résultats d'une méta analyse

Résumé

Background: Patients' and families' expectation that a cure for cystic fibrosis (CF) will be found is high. In other debilitating conditions, high expectation has been shown to drive a strong placebo response (PR). Therefore, our goal was to evaluate PR on objective continuous outcomes (FEV 1 , BMI) and the CF Questionnaire Revised-Respiratory Domain (CFQR-RD) monitored during randomised clinical trials (RCTs) for CF. Methods: We conducted a meta-analysis after a systematic review of the literature carried out to identify RCTs with FEV 1 , CFQR-RD and BMI as outcome measures. The standardised mean difference (SMD) was calculated to estimate the PR. A meta-regression analysis was conducted to assess other contributing factors on PR such as study design, trial duration, patient age and disease severity. Results: Out of 289 RCTs found in the search, we identified 61 articles (published from 1987 to 2017) with respectively 59, 17 and 9 reporting FEV 1 , CFQR-RD and BMI at the start and at the end of the RCTs. No significant PR was found on FEV 1 or CFQR-RD. However, a small but significant PR was found on BMI SMD, 0.09 (95% CI (0.01; 0.17); p = 0.03). Conclusion: The PR seems higher when measuring BMI. However, it is not clear whether this improvement can be explained by a PR alone.

Dates et versions

hal-04752337 , version 1 (05-11-2024)

Identifiants

Citer

Julie Coton, Ha-Hai Le, Victor Veuillet, Perrine Janiaud, Michel Cucherat, et al.. Do patients with cystic fibrosis participating in clinical trials demonstrate placebo response? A meta-analysis. Journal of Cystic Fibrosis, 2019, 18 (4), pp.461 - 467. ⟨10.1016/j.jcf.2019.02.003⟩. ⟨hal-04752337⟩
3 Consultations
2 Téléchargements

Altmetric

Partager

More