Not enough good quality trials to assess the most effective drug treatment for paracoccidioidomycosis

Paracoccidioidomycosis is a fungal infection that causes ulcers, swelling, fever, and pain. If it also gets into the lungs, it can produce coughing, shortage of breath, chest pain, weight loss, and sometimes death. Without treatment, those suffering this disease may die in a few months or years. There are endemic areas between Mexico and southern Argentina. Drug treatments need to go on for many months and maybe years. There are various drugs that are used, but this review found only two small trials with too few data to say which drug was best, and the drugs all seem to have adverse effects. More research is needed.

Authors' conclusions: 

The small number of participants and the short follow-up period impede definitive conclusions on comparative effects.

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Background: 

Paracoccidioidomycosis is a fungal infection that occurs only in some particular places in Latin America. Treatment is long, the drugs have side effects, and patients can relapse. However, the disease is potentially fatal.

Objectives: 

To evaluate drugs for treating paracoccidioidomycosis.

Search strategy: 

We searched the following databases: Cochrane Infectious Diseases Group Specialized Register (March 2011); Cochrane Central Register of Controlled Trials (CENTRAL), published in The Cochrane Library (2011, Issue 1); PubMed (1966 to March 2011); EMBASE (1974 to March 2011); and LILACS (1982 to March 2011)

Selection criteria: 

Randomized controlled trials comparing drugs for treating people with paracoccidioidomycosis.

Data collection and analysis: 

Two authors independently assessed trial eligibility and risk of bias, and extracted data, including adverse events.

Main results: 

Two trials, one with 42 participants and another with 53 participants met the inclusion criteria. Risk of bias in the two trials was high, but most patients showed considerable clinical and mycological improvement. The first trial compared imidazoles (itraconazole and ketoconazole) with sulfadiazine (n=42). No difference was detected for cure (RR 0.77, 95% CI 0.52 to 1.16) or clinical improvement, or serological titres after 10 months of treatment, and there was no difference detected in adverse events. The second compared voriconazole with itraconazole (n=53) and did not demonstrate a difference in response. Two patients were withdrawn from voriconazole due to raised liver enzymes.

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