Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Contributing EditorIndividualAuthor
Copyright 2000 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2000
To the Editor: In attempting to perform a meta-analysis
comparing fluconazole with amphotericin B in neutropenic cancer patients,
Drs Johansen and Gøtzsche1 encounted
several issues in the drug development process. I wish to comment on 3 of
First, the authors question the effectiveness of oral amphotericin B
and nystatin as antifungal agents. We agree with their assessment that these
agents do not have a role in the treatment of serious systemic fungal infections.
In the prophylactic studies described, the intent was to prevent fungal colonization
and subsequent infections in high-risk, neutropenic patients with cancer.
At the time these studies were conducted in the 1980s and early 1990s, recognized
prophylactic antifungal regimens for selective bowel decontamination were
oral amphotericin B or nystatin.2 As a result,
the medical community deemed a trial of the oral polyenes against the new
antifungal agent fluconazole worthwhile and scientifically relevant. Data
supporting the use of fluconazole for treatment of systemic fungal infections
are based on well-designed treatment studies,3
not the prophylactic studies included in the meta-analysis.
Panzer H. Improving the Conduct and Reporting of Clinical Trials. JAMA. 2000;283(21):2787-2790. doi:10.1001/jama.283.21.2787