Trial reportBMJ (Clinical research ed.)1999
Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis. The LION Study Group.
Trial report in BMJ (Clinical research ed.), 1999. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Oral antifungal medication for toenail onychomycosis.The Cochrane database of systematic reviews · 2017Pooled it
- Treatment of Onychomycosis - a Clinical Study.Medical archives (Sarajevo, Bosnia and Herzegovina) · 2015Trial
- Trial
- Article
- Antifungal Selection for the Treatment of Onychomycosis: Patient Considerations and Outcomes.Infection and drug resistance · 2024Review
- Onychomycosis: Old and New.Journal of fungi (Basel, Switzerland) · 2023Review
- Combination Therapy Should Be Reserved as Second-Line Treatment of Onychomycosis: A Systematic Review of Onychomycosis Clinical Trials.Journal of fungi (Basel, Switzerland) · 2022Review
- Article
- Putting theCanadian family physician Medecin de famille canadien · 2019Article
- Article
- [Onychomycosis: Practical treatment strategies].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2018Review
- A Retrospective Study Comparing K101 Nail Solution as a Monotherapy and in Combination with Oral Terbinafine or Itraconazole for the Treatment of Toenail Onychomycosis.Skin appendage disorders · 2018Article
- Fungicidal Activity in the Presence of Keratin as an Important Factor Contributing to In Vivo Efficacy: A Comparison of Efinaconazole, Tavaborole, and Ciclopirox.Journal of fungi (Basel, Switzerland) · 2017Article
- An invertebrate infection model for evaluating anti-fungal agents against dermatophytosis.Scientific reports · 2017Article
- Pathogenic Dermatophytes Survive in Nail Lesions During Oral Terbinafine Treatment for Tinea Unguium.Mycopathologia · 2017Article
- Patient considerations in the management of toe onychomycosis - role of efinaconazole.Patient preference and adherence · 2015Review
- Efinaconazole in the treatment of onychomycosis.Infection and drug resistance · 2015Review
- The low keratin affinity of efinaconazole contributes to its nail penetration and fungicidal activity in topical onychomycosis treatment.Antimicrobial agents and chemotherapy · 2014Article
- The role of topical antifungal therapy for onychomycosis and the emergence of newer agents.The Journal of clinical and aesthetic dermatology · 2014Review
- Bacterial and fungal endophthalmitis in upper Egypt: related species and risk factors.Asian Pacific journal of tropical biomedicine · 2012Article
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the efficacy and safety of continuous terbinafine with intermittent itraconazole in the treatment of toenail onychomycosis.
designProspective, randomised, double blind, double dummy, multicentre, parallel group study lasting 72 weeks.
setting35 centres in six European countries. SUBJECTS: 496 patients aged 18 to 75 years with a clinical and mycological diagnosis of dermatophyte onychomycosis of the toenail.
interventionsStudy patients were randomly divided into four parallel groups to receive either terbinafine 250 mg a day for 12 or 16 weeks (groups T12 and T16) or itraconazole 400 mg a day for 1 week in every 4 weeks for 12 or 16 weeks (groups I3 and I4).
main outcome measuresAssessment of primary efficacy at week 72 was mycological cure, defined as negative results on microscopy and culture of samples from the target toenail.
resultsAt week 72 the mycological cure rates were 75.7% (81/107) in the T12 group and 80. 8% (80/99) in the T16 group compared with 38.3% (41/107) in the I3 group and 49.1 % (53/108) in the I4 group. All comparisons (T12 v I3, T12 v I4, T16 v I3, T16 v I4) showed significantly higher cure rates in the terbinafine groups (all P<0.0001). Also, all secondary clinical outcome measures were significantly in favour of terbinafine at week 72. There were no differences in the number or type of adverse events recorded in the terbinafine or itraconazole groups.
conclusionContinuous terbinafine is significantly more effective than intermittent itraconazole in the treatment of patients with toenail onychomycosis.
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