Article

Evaluation of the Therapeutic Efficacy of Tea Tree Oil in Treatment of Onychomycosis

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Abstract

Background: Onychomycosis is a fungal infection that affects toenails or fingernails and may involve any component of the nail unit. Tea tree oil (TTO), or Melaleuca oil, is a pale yellow to nearly colorless, clear oil with a fresh camphoraceous odor that has antifungal effect if used from 5-100% concentration according to site of fungal affection. Aim: This study aimed to provide a new line for treatment of onychomycosis. Patients and methods: A randomized double blind interventional cohort prospective effectiveness trial, in which 66 patients with onychomycosis were recruited after their written consent was obtained. Patients on local or systemic treatment or with coexisting inflammatory skin disease were excluded. TTO efficacy in treatment of onychomycosis was evaluated by application of 100% TTO for 6 months with pre and post treatment nail culturing. Results: After 6 months treatment with TTO, 27% of patients were completely cured, 65% were partially cured and 8% had no response according to appearance of the index nail (the nail with the greatest fungal burden at the time of entry into the study). Calculation of P value by Chi-Square test, it equal 0.001 which is highly significant. Conclusion: TTO may play a role in treatment of onychomycosis without side effects of medications or surgical hazards caused by surgery.

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... Ten studies included data on fungal species. Of those studies, four included only dermatophyte molds [13,[16][17][18], while the other six included a combination of dermatophyte molds, nondermatophyte molds, and/or yeasts [15,[19][20][21][22]. Treatment courses ranged from 8 weeks to 1 year [16,21], with the most common treatment course being 6 months. ...
... Five studies examined the efficacy of tea tree oil in treating onychomycosis, with two of the studies treating participants with a nail oil containing vitamin E, lime, oregano, and tea tree oil [22,25]. Mycological cure rates for onychomycosis treated with tea tree oil twice daily for 6 months were reported to be between 82 and 89%, and clinical cure rates ranged from 27 to 78.5% [20,22,26]. A double-blind, randomized, controlled study of 117 patients with distal subungual onychomycosis compared twice daily 100% tea tree oil versus twice daily 1% clotrimazole for 6 months [26]. ...
... Authors noted that perhaps 8 weeks was not a sufficient amount of time for the tea tree oil to achieve full efficacy [16]. Two of these trials reported adverse effects to tea tree oil including dermatitis and subjective mild inflammation in 6-10% of patients using tea tree oil [16,20]. Jadad scoring for these trials ranged from zero to four. ...
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Introduction: Onychomycosis is notoriously difficult to treat. While oral antifungals are the most efficacious treatment for onychomycosis, they are contraindicated in certain patient populations, and patients may desire lower risk and accessible alternatives to systemic agents. In this study, we examine the clinical evidence supporting the use of complementary and alternative therapies in the treatment of onychomycosis. Methods: PubMed, Embase, and Cochrane Library were searched for clinical trials, observational studies, and case reports/case series, examining the efficacy of a complementary or alternative therapy for the treatment of onychomycosis. Results: We identified 17 articles studying a complementary and alternative therapy for onychomycosis, including tea tree oil (n = 5), Ageratina pichinchensis (n = 3), Arthrospira maxima (n = 2), natural coniferous resin lacquer (n = 2), Vicks VapoRub® (n = 2), propolis extract (n = 2), and ozonized sunflower oil (n = 1). Conclusion: Given the rise of antifungal resistance, complementary and alternative therapies should continue to be studied as adjunctive or alternative therapy for onychomycosis. While preliminary evidence exists for several complementary and alternative therapies in the treatment of onychomycosis, large-scale, randomized, placebo-controlled trials are needed prior to endorsing their use to patients.
... Ten studies included data on fungal species. Of those studies, four included only dermatophyte molds [13,[16][17][18], while the other six included a combination of dermatophyte molds, nondermatophyte molds, and/or yeasts [15,[19][20][21][22]. Treatment courses ranged from 8 weeks to 1 year [16,21], with the most common treatment course being 6 months. ...
... Five studies examined the efficacy of tea tree oil in treating onychomycosis, with two of the studies treating participants with a nail oil containing vitamin E, lime, oregano, and tea tree oil [22,25]. Mycological cure rates for onychomycosis treated with tea tree oil twice daily for 6 months were reported to be between 82 and 89%, and clinical cure rates ranged from 27 to 78.5% [20,22,26]. A double-blind, randomized, controlled study of 117 patients with distal subungual onychomycosis compared twice daily 100% tea tree oil versus twice daily 1% clotrimazole for 6 months [26]. ...
... Authors noted that perhaps 8 weeks was not a sufficient amount of time for the tea tree oil to achieve full efficacy [16]. Two of these trials reported adverse effects to tea tree oil including dermatitis and subjective mild inflammation in 6-10% of patients using tea tree oil [16,20]. Jadad scoring for these trials ranged from zero to four. ...
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Background: While the Internet remains a popular source of health information, YouTube may contain bias and incomplete information regarding common dermatological conditions. Objective: Our objective was to quantify onychomycosis treatment recommendations on YouTube. Methods: We searched YouTube for “nail fungus,” “toenail fungus,” “onychomycosis treatment,” “onychomycosis,” and “nail fungus treatment” in separate searches. The top 30 videos meeting inclusion criteria in each search were viewed for video demographics and treatment recommendations. Results: Analysis was performed on 102 videos. The majority of videos (81.3%) were intended for patient education. Analyzing videos by speaker, 50.0% featured a podiatrist, 13.7% a nondermatologist physician or other medical professional, 10.8% a patient or blogger, 6.9% a dermatologist, and 2.0% a nail technician. Videos recommended FDA-approved therapies, as well as OTC products. The most recommended medical therapies included oral terbinafine and laser therapy, mentioned in 29 and 28 videos, respectively. Various natural remedies were recommended, with tea tree oil being endorsed in 23 videos. Conclusion: YouTube offers patient education on a range of treatment options for onychomycosis. We caution patients against starting treatments based on social media recommendations and encourage dermatologists to utilize social media to educate the public on common dermatological conditions.
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Background: Onychomycosis refers to fungal infections of the nail apparatus that may cause pain, discomfort, and disfigurement. This is an update of a Cochrane Review published in 2007; a substantial amount of new research warrants a review exclusively on toenails. Objectives: To assess the clinical and mycological effects of topical drugs and device-based therapies for toenail onychomycosis. Search methods: We searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We also searched five trials registers, and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials. Selection criteria: Randomised controlled trials of topical and device-based therapies for onychomycosis in participants with toenail onychomycosis, confirmed by positive cultures, direct microscopy, or histological nail examination. Eligible comparators were placebo, vehicle, no treatment, or an active topical or device-based treatment. Data collection and analysis: We used standard methodological procedures expected by Cochrane. Primary outcomes were complete cure rate (normal-looking nail plus fungus elimination, determined with laboratory methods) and number of participants reporting treatment-related adverse events. Main results: We included 56 studies (12,501 participants, average age: 27 to 68 years), with mainly mild-to-moderate onychomycosis without matrix involvement (where reported). Participants had more than one toenail affected. Most studies lasted 48 to 52 weeks; 23% reported disease duration (variable). Thirty-five studies specifically examined dermatophyte-caused onychomycosis. Forty-three studies were carried out in outpatient settings. Most studies assessed topical treatments, 9% devices, and 11% both. We rated three studies at low risk of bias across all domains. The most common high-risk domain was performance bias. We present results for key comparisons, where treatment duration was 36 or 48 weeks, and clinical outcomes were measured at 40 to 52 weeks. Based on two studies (460 participants), compared with vehicle, ciclopirox 8% lacquer may be more effective in achieving complete cure (risk ratio (RR) 9.29, 95% confidence interval (CI) 1.72 to 50.14; low-quality evidence) and is probably more effective in achieving mycological cure (RR 3.15, 95% CI 1.93 to 5.12; moderate-quality evidence). Ciclopirox lacquer may lead to increased adverse events, commonly application reactions, rashes, and nail alteration (e.g. colour, shape). However, the 95% CI indicates that ciclopirox lacquer may actually make little or no difference (RR 1.61, 95% CI 0.89 to 2.92; low-quality evidence). Efinaconazole 10% solution is more effective than vehicle in achieving complete cure (RR 3.54, 95% CI 2.24 to 5.60; 3 studies, 1716 participants) and clinical cure (RR 3.07, 95% CI 2.08 to 4.53; 2 studies, 1655 participants) (both high-quality evidence) and is probably more effective in achieving mycological cure (RR 2.31, 95% CI 1.08 to 4.94; 3 studies, 1716 participants; moderate-quality evidence). Risk of adverse events (such as dermatitis and vesicles) was slightly higher with efinaconazole (RR 1.10, 95% CI 1.01 to 1.20; 3 studies, 1701 participants; high-quality evidence). No other key comparison measured clinical cure. Based on two studies, compared with vehicle, tavaborole 5% solution is probably more effective in achieving complete cure (RR 7.40, 95% CI 2.71 to 20.24; 1198 participants), but probably has a higher risk of adverse events (application site reactions were most commonly reported) (RR 3.82, 95% CI 1.65 to 8.85; 1186 participants (both moderate-quality evidence)). Tavaborole improves mycological cure (RR 3.40, 95% CI 2.34 to 4.93; 1198 participants; high-quality evidence). Moderate-quality evidence from two studies (490 participants) indicates that P-3051 (ciclopirox 8% hydrolacquer) is probably more effective than the comparators ciclopirox 8% lacquer or amorolfine 5% in achieving complete cure (RR 2.43, 95% CI 1.32 to 4.48), but there is probably little or no difference between the treatments in achieving mycological cure (RR 1.08, 95% CI 0.85 to 1.37). We found no difference in the risk of adverse events (RR 0.60, 95% CI 0.19 to 1.92; 2 studies, 487 participants; low-quality evidence). The most common events were erythema, rash, and burning. Three studies (112 participants) compared 1064-nm Nd:YAG laser to no treatment or sham treatment. We are uncertain if there is a difference in adverse events (very low-quality evidence) (two studies; 85 participants). There may be little or no difference in mycological cure at 52 weeks (RR 1.04, 95% CI 0.59 to 1.85; 2 studies, 85 participants; low-quality evidence). Complete cure was not measured. One study (293 participants) compared luliconazole 5% solution to vehicle. We are uncertain whether luliconazole leads to higher rates of complete cure (very low-quality evidence). Low-quality evidence indicates there may be little or no difference in adverse events (RR 1.02, 95% CI 0.90 to 1.16) and there may be increased mycological cure with luliconazole; however, the 95% CI indicates that luliconazole may make little or no difference to mycological cure (RR 1.39, 95% CI 0.98 to 1.97). Commonly-reported adverse events were dry skin, paronychia, eczema, and hyperkeratosis, which improved or resolved post-treatment. Authors' conclusions: Assessing complete cure, high-quality evidence supports the effectiveness of efinaconazole, moderate-quality evidence supports P-3051 (ciclopirox 8% hydrolacquer) and tavaborole, and low-quality evidence supports ciclopirox 8% lacquer. We are uncertain whether luliconazole 5% solution leads to complete cure (very low-quality evidence); this outcome was not measured by the 1064-nm Nd:YAG laser comparison. Although evidence supports topical treatments, complete cure rates with topical treatments are relatively low. We are uncertain if 1064-nm Nd:YAG laser increases adverse events compared with no treatment or sham treatment (very low-quality evidence). Low-quality evidence indicates that there is no difference in adverse events between P-3051 (ciclopirox hydrolacquer), luliconazole 5% solution, and their comparators. Ciclopirox 8% lacquer may increase adverse events (low-quality evidence). High- to moderate-quality evidence suggests increased adverse events with efinaconazole 10% solution or tavaborole 5% solution. We downgraded evidence for heterogeneity, lack of blinding, and small sample sizes. There is uncertainty about the effectiveness of device-based treatments, which were under-represented; 80% of studies assessed topical treatments, but we were unable to evaluate all of the currently relevant topical treatments. Future studies of topical and device-based therapies should be blinded, with patient-centred outcomes and an adequate sample size. They should specify the causative organism and directly compare treatments.
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