Prevention and treatment of fungal infections in severely immunodepressed patients with nystatin

Gøtzsche PC, Johansen HK

Published Online:

November 9, 2011

People on chemotherapy for cancer, or receiving a transplant, or with AIDS are at risk of fungal infections. These infections can be life-threatening, especially when they spread throughout the body. Nystatin is sometimes given as a routine preventive measure or as treatment in these patients. The review found that nystatin was no better than placebo (no treatment).

Abstract (click to read)

Background:

Nystatin is sometimes used prophylactically in patients with severe immunodeficiency or in the treatment of fungal infection in such patients, although the effect seems to be equivocal.

Objectives:

To study whether nystatin decreases morbidity and mortality when given prophylactically or therapeutically to patients with severe immunodeficiency.

Search strategy:

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 4, 2007, PubMed (November 2007) and the reference lists of articles. We searched the proceedings of the ICAAC (from 1990 to 2007), General Meeting of the ASM (from 1990 to 2007), and the European Congress of Clinical Microbiology and Infectious Diseases (1995 to 2007) and contacted researchers in the field. For the 2011 update we searched PubMed from 1966 to 18 July 2011 and the reference lists of articles.

Selection criteria:

Randomised clinical trials comparing nystatin with placebo, an untreated control group, fluconazole or amphotericin B.

Data collection and analysis:

Data on mortality, invasive fungal infection and colonisation were extracted by both authors independently. A random effects model was used unless p > 0.10 for the test of heterogeneity.

Main results:

We included 14 trials (1569 patients). The drugs were given prophylactically in 12 trials and as treatment in two. Eleven trials were in acute leukaemia, solid cancer, or bone marrow recipients, one in liver transplant patients, one in critically ill surgical and trauma patients, and one in AIDS patients. Nystatin had been compared with placebo in three trials, with fluconazole in ten, and amphotericin B in one; the dose varied from 0.8 MIE to 72 MIE daily and was 2 mg/kg/d in a liposomal formulation. The effect of nystatin was similar to that of placebo on fungal colonisation (relative risk (RR) 0.85, 95% confidence interval (CI) 0.65 to 1.13). There was no statistically significant difference between fluconazole and nystatin on mortality (RR 0.75, 95% CI 0.54 to 1.03) whereas fluconazole was more effective in preventing invasive fungal infection (RR 0.40, 95% CI 0.17 to 0.93) and colonisation (RR 0.50, 95% CI 0.36 to 0.68). There were no proven fungal infections in a small trial that compared amphotericin B with liposomal nystatin. The results were very similar if the three studies which were not performed in cancer patients were excluded. For the 2011 update no additional trials were identified for inclusion.

Authors' conclusions:

Nystatin cannot be recommended for prophylaxis or treatment of Candida infections in immunodepressed patients.

This record should be cited as:

Gøtzsche PC, Johansen HK. Nystatin prophylaxis and treatment in severely immunodepressed patients. Cochrane Database of Systematic Reviews 2002, Issue 4. Art. No.: CD002033. DOI: 10.1002/14651858.CD002033

Assessed as up to date:

July 18, 2011

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Primary Review Group:

Gynaecological Cancer Group

Health topics:

Cancer > Generic cancer care > Infections in neutropenic patients

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Prevention and treatment of fungal infections in severely immunodepressed patients with nystatin

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