EVIDENCE-BASED ANSWER
Nystatin oral suspension is a safe first-line therapy; fluconazole is more effective (strength of recommendation [SOR]: B, 1 small randomized controlled trial [RCT]) but has not been approved by the Food and Drug Administration (FDA) for use in immunocompetent infants. Miconazole oral gel is also more effective than nystatin suspension, but is not commercially available in the united states (SOR: B, one small RCT). Gentian violet may be effective, but it stains skin and clothes and is associated with mucosal ulceration (SOR: B, 1 small retrospective cohort study).
Clinical commentary
Fluconazole isn’t worth the higher cost
Daniel Triezenberg, MD
St. Joseph Regional Medical Center, South Bend, Ind
I reassure parents that oral thrush in infants is rarely a sign of serious illness and recommend nystatin suspension 0.5 cc qid––a smaller dose than reported in this review. Larger doses are more often spit out or swallowed, and at the smaller dose, a 60-mL bottle suppresses the yeast adequately for 2 weeks. My goal is to suppress yeast overgrowth until the infant’s immune system and bacterial flora mature. This review doesn’t convince me that fluconazole, which costs more than nystatin, is worth the added expense. Gentian violet is very messy, and I rarely recommend it. For refractory thrush in breastfed infants, I recommend that the mother apply a topical antifungal to the nipple area.
Evidence summary
Few studies have compared treatment options for oropharyngeal candidiasis in immunocompetent infants. In a survey of 312 health care providers, approximately 75% of the respondents reported treating thrush with oral nystatin, citing fewer side effects and lower cost.1 However, nystatin has proved less effective than either miconazole gel or oral fluconazole.
Nystatin is safe and available, but other options work better
Miconazole vs nystatin. An unblinded RCT assigned 83 immunocompetent infants with culture-positive oral thrush to receive either 25 mg miconazole oral gel (not commercially available in the United States) or nystatin suspension (1 mL of 100,000 IU/mL) qid after meals. The clinical cure rate, defined as absence of plaques by day 12, was significantly higher in the miconazole group (99% for miconazole, 54% for nystatin; P<.0001, number needed to treat [NNT]=2). The eradication rate, confirmed by cultures collected in a blinded manner on the day of clinical cure, was also higher in the miconazole group (55.7% for miconazole, 15.2% for nystatin; P<.0001, NNT=3). In successfully treated patients, infection recurred with similar frequency in both treatment groups within 4 weeks (miconazole, 12.4%; nystatin, 13.0%). Side effects—mostly vomiting and, infrequently, diarrhea—were rare in both groups (miconazole, 4.5%; nystatin 3.5%).2
An earlier, unblinded RCT of 95 infants compared miconazole gel to 2 nystatin oral gels (gel A: 250,000 IU/g with 250,000 IU administered as single dose; gel B: 100,000 IU/g with 50,000 IU administered as single dose). Each medication was given qid over the course of 8 to 14 days. The study confirmed higher clinical cure rates with miconazole gel (85.1% for miconazole vs 42.8% for nystatin gel A [P<.0007, NNT=2] and 48.5% for nystatin gel B [P<.004, NNT=3]).3