Randomized, double-blind study on intralesional metronidazole versus intralesional sodium stibogluconate in Leishmania donovani cutaneous leishmaniasis.

OBJECTIVES: The aim of our study was to assess the efficacy of intralesional metronidazole on Leishmania donovani cutaneous leishmaniasis (CL). MATERIAL AND METHODS: A total of 188 patients with CL were randomly allocated to intralesional sodium stibogluconate (SSG) and intralesional metronidazole. Cure was assessed after 1-10 injections. Cure rates were assessed for statistical significance using chi-square test at p = .05 level (SLCTR/2014/028). RESULTS: When the treatment cutoff was taken at 100%, the rate of cure for SSG (n = 64, 65.6%) was higher than that of metronidazole (n = 45, 48.9%): statistically significant at p < .05 level (Yates corrected chi-square 5.37, df = 1, p < .5). When the treatment cutoff was taken at >80%, the rate of cure for SSG (n = 75, 77.1%) was also higher than that of metronidazole (n = 58, 63.0%): statistically significant at p < .05 level (Yates corrected chi-square 4.46, df = 1, p < .5). Since it is based on a smaller sample, we estimated the statistical power of the test at a cutoff of 100% [above 80%] results identified a risk ratio of 1.4 [1.3], and a statistical power based on normal approximation at 74.8% [70.0%], respectively. CONCLUSION: This study showed that intralesional SSG has the best response against CL, while intralesional metronidazole was an effective alternative treatment.

Factors influencing cure rates of non-dermatophyte mold and Candida onychomycosis: analysis of outcomes in 81 patients who completed treatment.

OBJECTIVES: Onychomycosis shows a poor response to current topical, oral, or device-related antifungal therapies. The aim of this study was to identify factors influencing the cure rates of non-dermatophyte mold and Candida onychomycosis. METHODS: Eighty-one patients who completed treatments were divided into "cured" and "non-cured" groups. The statistical significance of differences between the two groups was studied. RESULTS: Male gender (P < 0.01), long duration of disease before the initiation of treatment (P < 0.02), three or more infected nails (P < 0.0002), continuous exposure to water and detergents (P < 0.05), frequent exposure to mud and soil (P < 0.01), barefoot walking (P < 0.025), concomitant diabetes and hypertension (P < 0.04), eczema (P < 0.03), and associated paronychia (P < 0.01) had negative effects on cure rates of onychomycosis. Patient age, occupation, site of illness (hand, foot or big toe), type of disease (distal and lateral subungual onychomycosis, proximal subungual onychomycosis or total dystrophic onychomycosis), pathogenic fungi, and treatment modality had no statistically significant impact on cure rate. CONCLUSIONS: To minimize the failure rate of antifungal therapies in the treatment of onychomycosis, patients are advised to start treatment as soon as possible, and to avoid predisposing factors such as exposure to water, detergents, mud and soil, and barefoot walking.

Randomized, double-blind, comparative study on efficacy and safety of itraconazole pulse therapy and terbinafine pulse therapy on nondermatophyte mold onychomycosis: A study with 90 patients.

BACKGROUND: Nondermatophyte mold (NDM) onychomycosis shows poor response to current topical, oral or device-related antifungal therapies. This study was aimed to determine the efficacy and safety of itraconazole and terbinafine pulse therapy on NDM onychomycosis. METHODS: Mycologically proven subjects were treated with itraconazole 400 mg daily or terbinafine 500 mg daily for 7 days/month; two pulses for fingernails and three pulses for toenails(SLCTR/2013/013). RESULTS: One-hundred seventy-eight patients underwent mycological studies and 148 had positive fungal isolates. NDM were the prevailing fungi, 68.2%, followed by candida species 21.6%, and dermatophytes made up only 10.1%. Out of NDM Aspergillus spp (75.1%) predominated followed by 8.9% Fusarium spp and 4.95% Penicillium spp. The clinical cure at completion of pulse therapy was statistically significant 9.2% versus 2.0% (p < 0.05) in itraconazole group. But no statistically significant difference was detected between the two regimens at the end of 12 months; 65.1% versus 54.64%. Recurrences observed in both groups (6.5% vs. 4.1%) were not statistically significant. With itraconazole pulse 68.22% Aspergillus spp, 50.0% Fusarium spp and 84.6% Penicillium spp showed clinical cure, while terbinafine pulse cured 55.0% Aspergillus spp and 50.0% Fusarium spp. CONCLUSIONS: NDM was the prevailing fungi in onychomycosis in Sri Lanka. Both itraconazole and terbinafine were partially effective on NDM onychomycosis showing a clinical cure of 54-65%. Future research should focus on searching more effective antifungal for NDM onychomycosis.

Randomized, double-blind, controlled, comparative study on intralesional 10% and 15% hypertonic saline versus intralesional sodium stibogluconate in Leishmania donovani cutaneous leishmaniasis.

BACKGROUND: Intralesional 7% hypertonic saline (HS) has been shown to be effective and safe against Leishmania donovani and Leishmania major cutaneous leishmaniasis (CL), with cure rates of 92% and 96%, respectively. This study was designed to assess the efficacy and safety of 10% and 15% HS in CL. METHODS: A total of 444 patients (643 lesions) were randomly allocated to sodium stibogluconate (SSG), 10% HS and 15% HS at a ratio of 2 : 2 : 1, taking into consideration any unwanted side effects that might arise with 15% HS. The follow-up period was 18 months. Survival analysis using Cox proportional hazard regression was performed to assess the effectiveness of the three treatment modalities. The clinical trial was registered at the Sri Lanka Clinical Trial Registry (SLCTR/2013/024). RESULTS: Treatment with SSG resulted in a cure rate of 96.3% within one to seven injections (mean: 3.6 injections); the mean (median) duration of treatment was six weeks (6 weeks) per lesion. Treatment with 10% HS showed a cure rate of 93.0% within one to 10 injections (mean: 5.28 injections); the mean (median) duration of treatment was 9.3 weeks (9 weeks) per lesion. Treatment with 15% HS showed a cure rate of 93.6% within two to 10 injections (mean: 5.3 injections); the mean (median) duration of treatment was 11.3 weeks (10.0 weeks) per lesion. Treatment with 10% HS and 15% HS caused cutaneous necrosis in 3.1% and 30.6% of lesions, respectively. Despite continuous data collection for 14 months, we were unable to recruit a sample of sufficient size. Seventeen (3.8%) patients were lost to follow-up, and 24 (5.4%) were partial or non-responders. CONCLUSIONS: This study found 10% HS to be an effective and safe alternative to SSG. Treatment with HS at concentrations of 15% or above was not safe as a result of cutaneous necrosis. Safety was not studied for concentrations of 11-14%, and these concentrations should be avoided pending further evidence. Hypertonic saline is very cheap (< US$1 per 100 ml, whereas SSG is priced at US$160 per 100 ml), is prepared locally and has no systemic side effects and minimal local side effects.