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Oral Treatments for Toenail Onychomycosis a Systematic Review

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Oral Treatments for Toenail Onychomycosis a Systematic Review EVIDENCE-BASED DERMATOLOGY: ORIGINAL CONTRIBUTION Oral Treatments for Toenail Onychomycosis A Systematic Review Fay Crawford, PhD; Philip Young, PhD; Christine Godfrey, BA; Sally E. M. Bell-Syer, MSc; Rachel Hart, BSc; Elizabeth Brunt, BMBS; Ian Russell, PhD Objective: To identify and synthesize the evidence for outcomes in favor of terbinafine (risk difference, −0.23 the efficacy of oral treatments for fungal infections of the [95% confidence interval, −0.32 to −0.15]; number needed toenails. to treat, 5 [95% confidence interval, 4 to 8]). An analy- sis of clinical cure rates was not possible because of the Design: Systematic review of randomized controlled diversity of definitions used in researching the effective- trials. ness of oral antifungal drugs for onychomycosis. Only 3 trials gave a clear definition of clinical cure and pre- Interventions: Oral treatments for dermatophyte in- sented data for these outcomes. fections of the toenails. Conclusions: There is good evidence that a continuous Main Outcome Measures: Cure confirmed by mi- regimen of terbinafine (250 mg/d) for 3 months is the croscopy and culture results in patients with clinically most effective oral treatment for fungally infected toe- diagnosed fungal infections. Data relating to the clinical nails. Consensus among researchers evaluating oral an- cure rates were also extracted from the trials. tifungal drugs for onychomycosis is needed to establish meaningful definitions of clinical cure. Most trials were Results: A pooled analysis of 2 trials comparing myco- funded by the pharmaceutical industry; we found little logical cure rates from continuous treatment with terbi- independent research, and this may have introduced bias nafine (250 mg/d for 12 weeks) and continuous treat- to the review. ment with itraconazole (200 mg/d for 12 weeks) found a statistically significant difference in 11- and 12-month Arch Dermatol. 2002;138:811-816 RAL TREATMENT may be eficially used to treat potentially life- the only effective treat- threatening conditions.2 ment for infected toe- The ingredient costs of oral antifun- nails. A previous system- gal drugs alone accounted for £30 mil- atic review of topical lion of the National Health Service (NHS) Ocompounds for fungal toenail infections prescribing budget in 1998 (personal com- found little evidence of effectiveness for munication, Department of Health, Statistics topical therapies.1 Division, Branch SD1E, September 1, 1999). From the Dental Health Because 5% of UK adults older than 55 years Services Research Unit, The For editorial comment haveinfectedtoenails,theprescribingcosts— University of Dundee, Dundee, coupled with consultation costs—represent Scotland (Dr Crawford); the see page 829 substantial NHS expenditure if all those af- Department of Health Sciences fected sought treatment.3 and Clinical Evaluation Griseofulvin, for many years the only Trials of oral antifungal drugs for toe- (Drs Young, Brunt, and Russell oral therapy, is inexpensive but has a pro- nail infections have described a variety of and Ms Godfrey) and Health tracted administration time. The newer cure rates for the drugs that are pre- Studies (Ms Bell-Syer), The University of York, York, drugs, azoles and allylamines, have im- scribed. The present systematic review ex- England; and The London Foot proved cure rates of nail infections but amines all available data from evalua- Hospital and School of are vastly more expensive than griseoful- tions of these therapies and includes a Podiatric Medicine, London, vin, and some general physicians believe statistical summary of their clinical effec- England (Ms Hart). that these resources might be more ben- tiveness. (REPRINTED) ARCH DERMATOL / VOL 138, JUNE 2002 WWW.ARCHDERMATOL.COM 811 ©2002 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/30/2021 METHODS DATA EXTRACTION AND QUALITY ASSESSMENT All reviewers independently summarized the included trials SEARCH STRATEGY and appraised their quality of reporting based on items from published checklists.4-6 The 12-quality criteria included the We searched the following 5 databases up to March 2000: following: aims clearly defined, prior sample size calculation MEDLINE, EMBASE, CINAHL, Bath Information and Data reported, inclusion and exclusion criteria defined, subjects Services (BIDS), and the Cochrane Controlled Trials Reg- blinded, method of randomization defined, baseline compa- ister. The MEDLINE search strategy is published else- rabilityofgroupsreported(age,sex,anddurationofcomplaint), where.4 The following 2 economic databases were searched interventions defined, outcome assessment blinded, compli- up to January 2000: NHS Economic Evaluation Database ance assessed, and trial analyzed by intention to treat. (NEED) and ECONLIT. Four other databases were searched up to January 1997: CAB Health Abstracts, HEALTHSTAR, MYCOLOGICAL AND and Database of Abstracts of Reviews of Effectiveness CLINICAL CURE RATES (OUTCOMES) (DARE) but did not identify any additional randomized clini- cal trials. The following 3 podiatry journals not listed in Reports were scrutinized for cure rates from mycological these databases were searched manually: The Foot, Journal investigations (microscopy and culture) and clinical cure of British Podiatric Medicine, and British Journal of Podiat- rates. The definition(s) of clinical cure was noted, and data ric Medicine and Surgery. We obtained the Cochrane Skin that could be used in a reanalysis (absolute numbers or Group’s partial hand search of the British Journal of Der- means and a measure of variance) sought. matology. We searched the bibliographies of all review ar- ticles identified and contacted all schools of podiatry in the STATISTICAL ANALYSIS United Kingdom and pharmaceutical companies to iden- tify unpublished or unlisted trials. For each trial we calculated the cure rates at follow-up (3, 6, 9, and 12 months) from the reported mycological results, with SELECTION CRITERIA “cure” defined as negative results on microscopy and no growth of dermatophyte in culture. We also collected data We considered all randomized clinical trials that evalu- regarding clinical cure. We estimated the difference in the ated oral treatments for dermatophyte infections of the proportion of patients cured with 95% confidence intervals toenails. We included trials that used microscopy and cul- in the unpaired proportions that constitute the risk differ- ture to confirm the presence of dermatophytes. We in- ence.7 We also calculated the numbers needed to treat for those cluded duplicate trials only once. We excluded trials that comparisons that were statistically significantly different. To also evaluated the treatment of fungal infections of the estimate differences between treatments, we pooled trials that fingernails in which the foot-specific data were not pre- evaluated similar interventions and controls. Because there sented and trials that included patients with yeast and was clear evidence of heterogeneity between trials (PϽ.001 mold infections of the toenails. Four reviewers working in for the Q-combinability test [part of the DerSimonian-Laird pairs (F.C. and E.B.; R.H. and S.E.M.B.S.) independently random effects analysis], which is known to have low power) applied these criteria to each trial located. There were no we used a random effects model.8 Finally, we combined the European language restrictions. evidence of direct “head-to-head” treatment comparisons. RESULTS cally meaningful assessment of the treatment were out- comes at 9 months. We identified 50 trials evaluating treatment efficacy,9-58 32 of which we included9-40 (Tables 1, 2, 3, 4, and 5, Itraconazole vs Terbinafine: available at http://www.archdermatol.com). Eighteen tri- 11- and 12-Month Outcomes als were excluded for the following reasons: duplicate After 12 Weeks of Treatment reports,42,43,46,48-50,52,53 combined hand and feet data or combined with topical data,41,47,51,54,55,57 no mycology as- Only 2 trials of direct comparisons between treatment sessment,56 protocol deviation,45 and data not clearly with itraconazole (200 mg/d) and terbinafine (250 mg/d) presented.44,58 gave data on outcomes at 11 and 12 months. These were pooled in a meta-analysis using a random effects model, MYCOLOGICAL CURE RATES which showed a risk difference in favor of terbinafine AND EFFECTIVENESS (−0.23 ([95% CI, −0.15 to −0.32]) (N=501) (Figure).30,40 Itraconazole vs Terbinafine: Both trialists found terbinafine to produce clinically sig- 12-Week Outcomes After 12 Weeks of Treatment nificant improvements in the length of the unaffected nail in great toenails. We found 6 placebo-controlled trials of terbinafine and itraconazole that presented outcomes at 12 weeks11-16: Dose-Finding Studies of Itraconazole 3 trials evaluating itraconazole vs placebo (N=433) found and Terbinafine Treatments that itraconazole had greater effectiveness,11-13 and 3 tri- als evaluating terbinafine vs placebo (N=337) found that Two studies compared different regimens of itracona- terbinafine was more effective.14-16 We regarded out- zole with terbinafine.17,38 Tosti et al38 compared inter- comes at 3 months as clinically irrelevant; a more clini- mittent treatment with itraconazole (400 mg/d) with (REPRINTED) ARCH DERMATOL / VOL 138, JUNE 2002 WWW.ARCHDERMATOL.COM 812 ©2002 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/30/2021 intermittent treatment with terbinafine (500 mg/d) and continuous treatment with terbinafine (250 mg/d) Brautigam et al30 (N=60), while Evans and Sigurgeirsson17 compared 12- and 16-week regimens of continuous terbinafine (250 mg/d) with intermittent itraconazole (400 mg/d) for 12 40 and 16 weeks (N=421). The resultant data from these 2 De Backer et al trials lie within the confidence intervals for the dose- finding analysis, which suggest no advantage in higher or prolonged dosages. Only 1 trial investigated the use of terbinafine in a dosing schedule.18 Alpsoy et al18 did not detect a differ- –0.4 –0.3 –0.2 –0.1 0 ence in cure rates when comparing a continuous regi- Pooled Risk Difference men of terbinafine (79%) with an intermittent regimen Risk difference plots (random effects).
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