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To identify studies where oral treatments -itraconazole (continuous and pulse), fluconazole, terbinafine (continuous and pulse) and griseofulvin - were used to treat adults with toenail or fingernail onychomycosis caused by dermatophytes, we searched Medline (1966-2002) for randomised controlled trials (RCTs). The reference sections of the published reports were also examined for potential studies not listed in the database.

Some of the studies were completely26,27,36-135 or partially33,34,136-145 excluded for the following reasons.

Open trials, studies conducted in a special population (for example diabetics, patients with Down's syndrome, transplant recipients) and reports where we were unable to extract the relevant data, double publications, non-English language studies, and retrospective studies were excluded.

The use of nail lacquers such as ciclopirox and amorolfine to treat onychomycosis is not considered. There are many anecdotal reports of various topical agents being effective for the management of onychomycosis; however, published reports of the efficacy of topical agents in onychomycosis in the indexed, peer-reviewed literature are far fewer. Other clinical trials have included tioconazole 28% solution, bifonazole with urea, fungoid tincture, miconazole, and tea tree oil.

Also excluded were studies that used nonstandard treatment dosage or duration for toenails (for example terbinafine therapy for less than 3 months or more than 4 months; continuous itraconazole therapy for less than 3 months or more than 4 months and less than 200 mg/day; itraconazole pulse therapy for fewer than three pulses or more than four pulses; fluconazole dosage other than 150mg/week; griseofulvin therapy for less than 3 months), fingernails (terbinafine therapy for more than 6 weeks, continuous itraconazole therapy for more than 6 weeks, pulse itraconazole for more than two pulses, fluconazole dosage other than 150 mg/week), or other non-standard regimens, such as sequential or combination therapy.

We have not considered trials where ketoconazole was used to treat onychomycosis, given the potential of this agent to cause hepatotoxicity and the availability of alternative agents.

The use of ravuconazole for the management of onychomycosis has not been considered further because information currently available in a published format is restricted to abstracts.26

This chapter discusses the distal and lateral presentation of onychomycosis, which is the most common type; treatment of the other types of onychomycosis is not considered.3,146 Onychomycosis caused by Candida spp. and non-dermatophyte moulds is less common and is not considered in this chapter.

Evidence was graded using the quality of evidence scale system employed by Cox and colleagues147 (Box 33.1).

Figure 33.1 This patient is a 47-year-old non-diabetic male exhibiting an infection of the left great toenail with no other health problems. He gave a history of approximately 15-year duration of nail abnormality that may be related to previous nail trauma. The thickened nail had large areas of yellowish-white discoloration typical of fungal nail infection. Culture revealed infection with the dermatophyte fungus, Trichophyton rubrum.

Figure 33.1 This patient is a 47-year-old non-diabetic male exhibiting an infection of the left great toenail with no other health problems. He gave a history of approximately 15-year duration of nail abnormality that may be related to previous nail trauma. The thickened nail had large areas of yellowish-white discoloration typical of fungal nail infection. Culture revealed infection with the dermatophyte fungus, Trichophyton rubrum.

Griseofulvin was the first significant oral antifungal agent available for the management of dermato-mycoses. Although its use in the treatment of onychomycosis has decreased over the years, it is still widely used for the treatment of tinea capitis.148 Ketoconazole, an oral imidazole, is no longer recommended for the treatment of onycho-mycosis, which requires a long duration of therapy, because of the potential for hepatotoxicity.148 The introduction of the new oral antifungal agents, terbinafine, itraconazole and fluconazole has led to improved efficacy, decreased treatment duration and fewer adverse events.

What are the effects of systemic treatments on fingernail and toenail onychomycosis?

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