The Placebo Effect in Chronic Thromboembolic Pulmonary Hypertension Trials: A Systematic Review and Meta-Analysis
<b>Introduction:</b> Placebo-controlled studies are crucial in clinical trials, but the placebo effect can vary across conditions. We aimed to assess the placebo effect in chronic thromboembolic pulmonary hypertension (CTEPH) trials. <b>Methods:</b> We conducted a systematic...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-05-01
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| Series: | Medical Sciences |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-3271/13/2/57 |
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| Summary: | <b>Introduction:</b> Placebo-controlled studies are crucial in clinical trials, but the placebo effect can vary across conditions. We aimed to assess the placebo effect in chronic thromboembolic pulmonary hypertension (CTEPH) trials. <b>Methods:</b> We conducted a systematic review and included randomized placebo-controlled trials investigating CTEPH interventions. Primary outcomes were the pre–post changes in the 6 min walk test (6MWT) and quality of life in the placebo arms. Secondary outcomes included mean pulmonary artery pressure (mPAP), pulmonary vascular resistance (PVR), cardiac index, and NT-proBNP levels. Meta-analyses were performed using random-effects models. <b>Results:</b> Seven trials with 270 CTEPH patients in placebo arms were analyzed. The average 6MWT change was not significant (−1.31 m; 95%CI −12.49 to +9.79). Quality of life with EQ-5D was not significantly improved (−0.04; 95%CI −0.10 to +0.02). mPAP, PVR, cardiac index, and NT-proBNP also demonstrated non-significant changes with small magnitudes. <b>Conclusions:</b> The placebo effect in CTEPH trials was not statistically significant and had small magnitude but should not discourage the use of placebo-controlled trials where applicable and ethical. |
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| ISSN: | 2076-3271 |