Publication:

Evaluation of efficacy and safety of terbinafine and itraconazole in superficial mycoses: a prospective, randomized, controlled and cost-effective analysis study

Background Superficial mycoses are common worldwide. Dermatophytic infections can greatly affect quality of life. Several newer antimycotic agents, have been reported effective and safe. Hence this study was planned to analyse effectiveness as well as cost effectiveness of these treatments.

Methods It were a prospective, randomized, parallel, open label, comparative study. Fifty patients were included in the study and divided into 2 groups. They were randomized to receive either oral terbinafine 250 mg or itraconazole 100 mg once daily for 4 weeks. Scaling, erythema and pruritus were rated as clinical score 0 to 3: 0 - absent, 1 - mild, 2 - moderate, and 3 - severe for the above three target symptoms. Total symptom score was assessed. Pruritus was also graded on visual analogue scale (VAS). Mycological cure was assessed by skin scraping with KOH mounts and fungal culture. Clinical efficacy scoring and VAS were assessed before the study and at each follow up visit at 2 and 4 weeks. Patients were followed up for another 4 weeks after completion of the treatment.

Results There was highly significant decrease p<000.1 in the mean total symptoms scores in both the study groups from baseline. No significant difference in the mean total symptoms score was observed when compared between groups. ADRs were more in terbinafine group.

Conclusions Both terbinafine and itraconazole are effective and safe against superficial mycoses, but adverse effects are more with terbinafine. Itraconazole was found to be cost effective compared to terbinafine.