Nine studies were included.
Clinical effectiveness.
Clinical controlled trials suggest that griseofulvin is equal to, if not more effective, than ketoconazole. In one study, griseofulvin has been shown to have a higher clinical cure rate than ketoconazole (96% vs 73%), although mycologic cure rates appeared similar. Data from case reports and a single uncontrolled trial suggest that itraconazole is effective. Two open-label trials suggest that terbinafine results in clinical cure rates between 80 and 100%. In a single comparative trial with griseofulvin, cultures at 8 weeks were negative in 89% of patients receiving terbinafine and 90% in those receiving griseofulvin. By 12 weeks, 93% of patients taking terbinafine and 88% of those on griseofulvin were mycologically cured.
Adverse events.
Treatment with griseofulvin can result in 20% of patients experiencing adverse events. These include gastrointestinal distress and headaches. More serious events are rare but can include toxic epidermal necrolysis, photodermatitis, exacerbation or precipitation of lupus-like symptoms, myositis and peripheral neuropathy. Ketoconazole can cause hepatotoxicity in 1 out of 15,000 cases, mild asymptomatic elevations in liver enzymes occur in 5-10% of patients. Anorexia, malaise, nausea and vomiting may be useful early indicators for hepatotoxicity. In addition dermatologic eruptions, myopathy, adrenal insufficiency, hallucinations and haemolytic anaemia have all been reported. Itraconazole has also been reported to result in hepatotoxicity occurring in 1 out of 500,000 patients. The most common adverse events are headaches and gastrointestinal upset, but more serious events have been documented which include hallucinations, hypokalemia and marked edema. Terbinafine can cause gastrointestinal upset and skin reactions in 2-7% of patients and loss of taste may occur in 1 out of 800 cases. Hepatitis has also been reported, but it is less frequent than with ketoconazole, severe hepatotoxicity occurring in 1 out of 120,000 patients. Other severe side effects are dermatologic eruptions, Stevens-Johnson syndrome and blood dyscrasia, including leukopenia and pancytopenia.