Evans, E.G. & Sigurgeirsson, B. (1999, April Peer Reviewed Journal

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Evans, E.G. & Sigurgeirsson, B. (1999, April 17). Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis. British Medical Journal, 318, pp. 1031-1036.

Key Points: This study examined the effectiveness of two new medications for the treatment of toenail fungus compared to the current recommended treatment. Both new medicines were found to be more effective.

This was a prospective, randomized, double blind, double dummy, multicenter, parallel group study. The study took place over a period of 72 weeks (about 16-1/2 months) and involved 38 investigators from 35 centres in six different European countries (Finland, Germany, Iceland, Italy, the Netherlands, and the United Kingdom).

Objective: To compare the efficacy and safety of continuous terbinafine with intermittent itraconazole in the treatment of toenail onychomycosis. Onychomycosis is among the most common diseases of the nail as well as being among the few curable diseases if the condition is diagnosed sufficiently early and accurately. Innovations in pharmacological preparations have provided new treatments for onychomycosis which include: (a) terbinafine (this is an allylamine that is primarily fungicidal) and (b) itraconazole (this is a triazole that is primarily fungistatic).

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Both of these medications are significant improvements over the conventional treatment which relied on griseofulvin to treat this condition.

Subjects: A total of 496 patients aged 18 to 75 years with a clinical and mycological diagnosis of dermatophyte onychomycosis of the toenail participated in the study.

Experiment: The subjects were divided randomly into four parallel groups:

1. Two groups (groups T12 and T16) received terbinafine 250 mg a day for 12 or 16 weeks, respectively; (groups T12 and T16)

2. Two groups (groups I3 and I4) received itraconazole 400 mg a day for 1 week in every 4 weeks for 12 or 16 weeks, respectively.

Main outcome measures: The efficacy of the intervention was evaluated at week 72 to determine the extent of the mycological cure, defined as negative results on microscopy and culture of samples from the target toenail, if any.

Results: At the time of evaluation (week 72), slightly more than three-quarters (75.7%) of the subjects' mycological cure rates were:

1. T12 group: 75.7% (81/107);

2......

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