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First published online on May 15, 2007
Chest, doi:10.1378/chest.07-0236
A more recent version of this article appeared on September 1, 2007
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Analyzing the Short-term Effect of Placebo Therapy in Pulmonary Arterial Hypertension: Potential Implications for the Design of Future Clinical Trials

Donald L. Helman, Jr, MD, FCCP1; Alexander W. Brown, MD1; Jeffrey L. Jackson, MD, MPH2 and Andrew F. Shorr, MD, MPH, FCCP3

1Dwight David Eisenhower Army Medical Center. Ft. Gordon, GA 30905 2The Uniformed Services University of the Health Sciences. Bethesda, MD 20814 3Washington Hospital Center. Washington, DC 20010

donald.helman{at}gmail.com

Abstract

BackgroundPlacebo is commonly used in short-term randomized trials for pulmonary arterial hypertension. Currently, outcomes data regarding placebo are lacking. We conducted a systematic review and performed a meta-analysis to assess its effect.

MethodsArticles were identified via a query of MEDLINE and EMBASE using the terms: pulmonary hypertension, clinical trial, six minute walk, pulmonary hemodynamic, and survival. A manual bibliography search of selected trials, reviews and guidelines was performed. Inclusion criteria were: randomized, placebo controlled with baseline and 12-18 week data reported. Two reviewers independently abstracted: six minute walk distance, pulmonary hemodynamic measures and frequency of death, clinical worsening and change in New York Heart Association/World Health Organization functional class. Data were pooled using a random effects model.

ResultsThirteen of 688 articles identified met criteria (a total of 868 placebo treated patients). After 12-18 weeks six minute walk distance decreased 8.4 meters (95% CI: -14.6 to -2.2) and pulmonary vascular resistance increased 58.9 dyn.sec.cm-5 (95% CI: 27.6 to 90.1). Placebo-treated patients were 1.81 times more likely to suffer a clinical worsening (95% CI: 1.30 to 2.53). Placebo treatment was not associated with a difference in mortality.

ConclusionsPatients with pulmonary arterial hypertension who receive placebo are more likely to experience clinical deteriorations. Further debate is needed regarding the design of future clinical trials. Research efforts should focus on evaluating existing medications against one another and comparing novel therapies with currently accepted ones.

Key Words: Pulmonary arterial hypertension • meta-analysis • placebo • outcome • six minute walk distance • pulmonary hemodynamics • mortality






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