© All-Russian National Academy of Mycology, 2001
© A. Sergeev, 1999-2001

  The problem of clinical trials
  Let us show the drawbacks of having no common approach for clinically (severity) based treatment in comparative studies.

Since someone still compares non-comparable cases or, at least, cases with no documented clinical similarity of groups compared, we can expect different results from different studies. Exactly this situation may be observed in studies reporting or comparing the efficacy of two widely prescribed antifungals for toenail onychomycosis – terbinafine and itraconazole. Terbinafine dosing for toenail onychomycosis is 250 mg daily for 3 months (12 weeks). For the same indication itraconazole is prescribed in pulsed regimen, 200 mg b.i.d. for every 1st week of a three months. The difference between trials comparing efficacy of these regimens is usually no less than 10–20%, favoring either terbinafine or itraconazole. When examining all trials it may reach even 60%, or at least 37 % as in the recent L.I.O.N. study. Average mycological and clinical cure rates also approximate 60-70% for terbinafine and itraconazole.
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