Do patients with cystic fibrosis participating in clinical trials demonstrate placebo response? A meta-analysis
| Autor: | Perrine Janiaud, Philippe Reix, Julie Coton, Michel Cucherat, Ha-Hai Le, Behrouz Kassai-Koupai, Victor Veuillet, François Gueyffier |
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| Přispěvatelé: | Evaluation et modélisation des effets thérapeutiques, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), CIC CHU Lyon (inserm), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pneumologie Pédiatrique [Hôpital Femme Mère Enfant - CHU de Lyon], Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL)-lyon |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine medicine.medical_specialty Vital capacity Cystic Fibrosis Cystic fibrosis 03 medical and health sciences FEV1/FVC ratio 0302 clinical medicine Internal medicine Humans Medicine ComputingMilieux_MISCELLANEOUS Clinical Trials as Topic Placebo response business.industry Placebo Effect medicine.disease Confidence interval 3. Good health Clinical trial Treatment Outcome 030104 developmental biology 030228 respiratory system Meta-analysis Pediatrics Perinatology and Child Health [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology business Body mass index |
| Zdroj: | Journal of Cystic Fibrosis Journal of Cystic Fibrosis, Elsevier, 2019, ⟨10.1016/j.jcf.2019.02.003⟩ Journal of Cystic Fibrosis, 2019, ⟨10.1016/j.jcf.2019.02.003⟩ |
| ISSN: | 1569-1993 |
| Popis: | 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 (FEV1, 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 FEV1, 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 FEV1, CFQR-RD and BMI at the start and at the end of the RCTs. No significant PR was found on FEV1 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. |
| Databáze: | OpenAIRE |
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