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© All-Russian National Academy of Mycology,
2001
© A. Sergeev, 1999-2001
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The
problem of clinical trials |
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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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Well,
but what are the real cure rates? |
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