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Fungal nail infection (onychomycosis) - Evidence
Evidence on pulse compared with continuous oral terbinafine treatment
There is evidence from one large randomized controlled trial (RCT) that continuous treatment with oral terbinafine may be superior to an intermittent (pulsed) regimen.
- A double-blind RCT (n = 618) included people with more than 25% distal subungual onychomycosis and compared continuous terbinafine (250 mg daily for 3 months) with an intermittent regimen (500 mg daily for 1 week each month, for 3 months) [Warshaw et al, 2005].
- At 18 months, the continuously treated group were significantly more likely to be cured than the intermittently treated group:
- Mycological cure (negative fungal cultures) of the target toenail: 70.9% compared with 58.7%, relative risk (RR) 1.21 (95% CI 1.02 to 1.4), p = 0.03.
- Clinical cure (normal appearance) of the target toenail: 44.5% compared with 29.3%, RR 1.52 (95% CI 1.11 to 2.07), p = 0.007.
- Complete cure (clinical and mycological cure) of the target toenail: 40.5% compared with 28.0%, RR 1.45 (95% CI 1.04 to 2.01), p = 0.02.
- Mycological cure of all the other nine toenails: 73% compared with 53%, RR 1.37 (95% CI 1.14 to 1.64), p = 0.001.
- Complete cure of all 10 toenails: 25% compared with 15%, RR 1.71 (95% CI 1.05 to 2.79), p = 0.03.
- An open-label, randomized, pilot study (n = 17) studied three regimens for people with onychomycosis [Warshaw et al, 2001].
- Participants were randomized to 4 months of treatment with one of:
- Continuous terbinafine 250 mg daily.
- Intermittent terbinafine 500 mg daily for 1 week each month.
- Single dose terbinafine 1000 mg once a month.
- At 12 months, complete cure rates were:
- Continuous terbinafine: 20% (1/5).
- Intermittent terbinafine: 40% (2/5).
- Single dose terbinafine: 0% (0/5).
- Statistical tests of significance were not made because of the small size of the study.
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