Comparing the Efficacy for Pulse Versus Continuous Dose Terbinafine Therapy in Patients With Onychomycosis

October 2023 | Volume 22 | Issue 10 | 1017 | Copyright © October 2023


Published online September 29, 2023

Muhammad Amer Saleem MDa, Rohan R. Shah BAb, Shawana Sharif MDa, Dip Rana BAb, Nadia Waqas MDa, Babar K. Rao MDc,d

aRawalpindi Medical Center Benazir Bhutto Hospital, Rawalpindi, Pakistan 
bRutgers New Jersey Medical School, Newark, NJ
cWeill Cornell Medical School, Department of Dermatology, New York, NY 
dRutgers Robert Wood Johnson Medical School, Department of Dermatology, Piscataway, NJ

Abstract
Recently, treatment outcomes in patients with toenail onychomycosis have improved considerably due to more effective oral antifungal medications such as terbinafine and itraconazole. These medications can either be used continuously for several weeks at a lower dose or intermittently (pulsed) at a higher dose. Previous literature comparing pulse and continuous therapy has generated mixed results. 

Our study aims to compare the efficacy, in terms of clinical cure rate, of continuous vs pulse dose terbinafine regimens for toenail onychomycosis. Sixty patients with onychomycosis of Fitzpatrick skin types IV to VI, between 15 and 65 years of age, were divided into a continuous treatment group receiving 250 mg terbinafine once daily for 12 weeks and a pulse treatment group receiving 250 mg twice daily terbinafine for 1 week repeated every 4 weeks for 12 weeks. Each patient was followed up at weeks 4, 8, and 12. 

Efficacy of the continuous treatment group was significantly greater at 76.67% compared with 26.67% in the pulse treatment group. Thus, we conclude that the clinical cure rate of a continuous dose regimen of terbinafine is a superior treatment option for toenail onychomycosis. However, we also suggest further studies including combinations of multiple agents and hybrid regimen models for the optimal onychomycosis treatment.  

J Drugs Dermatol. 2023;22(10):     doi:10.36849/JDD.7323R1

INTRODUCTION

Onychomycosis is a fungal infection of the nails and surrounding skin often presenting as thickening of the nail, onycholysis, and discoloration. It is the most common nail pathology and accounts for nearly 90% of toenail infections globally.1 Causes of onychomycosis are broad but the most common are due to dermatophytes, specifically Trichophyton and Epidermophyton. Toenails are more often involved than fingernails, with the great toenail being the most affected area.2 It is important to diagnose and treat onychomycosis in a timely manner to prevent secondary symptoms such as pain, paresthesia, spread to other nails, and impairment of daily activities. Additionally, onychomycosis does not resolve without treatment, further emphasizing the need for a proper therapy regimen.1 

Onychomycosis is considered a chronic infection and is difficult to treat in patients with other comorbidities like diabetes, cardiovascular disease, HIV, and widespread immunosuppression. Given nail thickness and the slow growth rate of nails, prolonged and recurrent treatment is often required.3 Additional factors responsible for disease progression include warm environments, suboptimal footwear, genetic predisposition, and nail injury. While debridement allows some symptom relief and improves cosmetic appearance, it does not address the fungal infection and therefore should be used in combination with medication.4

The goal of treatment is to eradicate the fungal infection and restore a healthy nail. Management considers disease severity, comorbidities, drug interactions, and cost. Over the past decade, treatment options for onychomycosis have expanded, primarily with the introduction of more effective oral antifungal medications.5 Older, systemic medications such as griseofulvin and ketoconazole are associated with low cure rates, prolonged treatment durations, and increased risk for side effects. 

The newer oral antifungals such as itraconazole and terbinafine have higher cure rates, shorter treatment periods, and fewer