A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan

Stahl, Hans-Christian; Ahmadi, Faridullah; Schleicher, Ulrike; Sauerborn, Rainer; Bermejo, Justo Lorenzo; Amirih, Mohammed; Sakhayee, Ibrahim; Bogdan, Christian; Stahl, Kurt-Wilhelm

doi:10.1186/s12879-014-0619-8

Cited by 17 publications

(34 citation statements)

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“…CL was diagnosed if patients had a compatible clinical illness and Leishmania was identified in Giemsa-stained smears, culture or biopsy. In a few studies, detection of parasite DNA through the polymerase chain reaction (PCR) was also considered to confirm Leishmania infection [ 13 , 18 – 24 ].…”

Section: Resultsmentioning

confidence: 99%

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Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis: A systematic review

2017

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BackgroundThe mainstays of cutaneous leishmaniasis (CL) treatment, in several world regions, are pentavalent antimony (Sbv) compounds administered parenterally, despite their recognized toxicity, which requires frequent laboratory monitoring and complicates their use in areas with scarce infrastructure. As result of these drawbacks, the WHO Expert Committee on leishmaniasis has expanded the recommendations for the use of local therapies, including Sbv intralesional infiltration (IL-Sbv), as CL therapy alternatives even in the New World. However, the efficacy of these approaches has never been compiled. The aim of this study was to critically and systematically assess the efficacy of IL-Sbv for CL treatment.MethodologyThe PRISMA guidelines for systematic reviews and the Cochrane manual were followed. The sources used were the MEDLINE and LILACS databases and the International Clinical Trials Registry Platform of the World Health Organization. The outcome of interest was a clinical cure, defined as complete re-epithelialization of all lesions. The IL-Sbv pooled cure rate was estimated for several subgroups and direct comparisons were performed when possible.ResultsThirty nine articles (40 studies) involving 5679 patients treated with IL-Sbv infiltration were included. In direct comparison, only three studies involving 229 patients compared IL-Sbv infiltration versus placebo and no difference was observed (OR: 1,9; 95%IC 0,93 to 3,82) based on cure rate 69.6% (95%CI 17.6–96.1%) and 83,2% (95%CI 66–92.7%) for placebo and IL-Sbv, respectively. In an alternative and non-comparative analysis, gathering all study arms using the intervention, the pooled IL-Sbv efficacy rate was 75% (95%CI 68–81%). In the Old World, the observed overall IL-Sbv efficacy rate was 75% (95%CI 66–82%), and the cure rates were significantly higher with sodium stibogluconate (SSG) than with meglumine antimoniate (MA): 83% (95%CI 75–90%) versus 68% (95%CI 54–79%), p = 0.03. Studies directly comparing IL-Sbv with topical 15% paromomycin ointment, IL hypertonic saline, radiofrequency-induced heat therapy, topical trichloroacetic acid and cryotherapy showed no significant difference in efficacy between the interventions. The analyses suggested a higher efficacy of IL-Sbv combined with cryotherapy (81.8%, 95%IC 62.4–92.4%) when compared with IL-Sbv alone (53.3%, 95%IC 46.1–66%), OR: 3.14 (95%CI 1.1–8.9), p = 0.03. In the New World, the global IL-Sbv efficacy was 77%(95%CI 66–85%). In contrast with the Old World, a significant difference favoring MA in relation to SSG was observed: 61% (95%CI 49–73%) versus 82% (95%CI 70–89%).By comparing IL infiltration schedules, it was determined that patients submitted to IL-Sbv treatments longer than 14 days had higher cure rates.ConclusionsDespite the high heterogeneity and low methodological quality of studies, an indirect comparison shows that the antimony infiltration efficacy rate is similar to that reported for antimony systemic use. The evidence gathered thus far is insufficient to identify the ideal IL the...

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Section: Resultsmentioning

confidence: 99%

“…Leishmania species characterization was achieved in only seven studies (18%) [ 13 , 15 , 18 , 19 , 21 , 39 , 40 ]. L .…”

Section: Resultsmentioning

confidence: 99%

Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis: A systematic review

2017

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“…Sex was considered an inclusion criterion in 94.3% ( n = 100) of studies enrolling 11 081 patients; 87.7% ( n = 93) enrolled participants of both sexes , seven studies (6.6%) enrolled only men ; in five studies (4.7%), although sex was not specified in the inclusion criteria, inclusions can be derived from the results , and one study did not refer to the sex of the participants (Table ). For pregnancy and lactation, see Exclusion criteria below (Table ).…”

Section: Resultsmentioning

confidence: 99%

“…Species identification was required in 20 studies (19%), but only one did so for all study participants (Table ). An additional 19 studies (17.9%), while not identifying species, reported the most prevalent species in the study area (Table ).…”

Section: Resultsmentioning

confidence: 99%

Eligibility criteria and outcome measures adopted in clinical trials of treatments of cutaneous leishmaniasis: systematic literature review covering the period 1991–2015

López-Carvajal

Vélez

Arbeláez

et al. 2018

Tropical Med Int Health

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Abstractobjective To document the sources of heterogeneity in outcomes and shortcomings in trial designs reported by previous systematic reviews.methods Systematic review of clinical trials of CL treatments published since 1991, to assess and compare eligibility criteria and outcome measures in trials (any type of treatment) of CL (any form) reported before and after the publication of the CONSORT statement.results We identified 106 eligible trials published between 1991 and 2015, 74% after the 2001 CONSORT statement; 58% (n = 63) were on Old-World CL and 37% (n = 40) in New-World CL; overall, 11 531 patients enrolled in 243 treatment groups on 30 different treatments. Both requirements and definitions for eligibility and outcome criteria varied. Compliance with CONSORT requirements increased for studies published after the 2010 update. As for entry criteria, 94% of studies had a requirement for sex (74% of those enrolling also women excluded those who were pregnant or lactating), 69% for age (variable age ranges), 99% parasitological confirmation, 43% prior duration of illness (14% excluded cases with previous episodes), 46% defined the number, 28% the size and 13% the type of lesions (27% with restrictions as to their anatomical location). Follow-up ranged 1-24 months, with 14% and 91% of studies, respectively, having defined initial and final cure.conclusions This review documents changes in reporting before and after the publication of the CONSORT statement. Lack of standardisation, compounded with the small number of trials relative to the magnitude of the disease in its multiple forms, and with the range of treatments tested explains why evidence to inform treatment guidelines is generally weak for CL. Adopting standardised methodologies will improve the quality and consistency of clinical trials, and ultimately yield better treatments for CL.

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“…Local treatment modalities include thermotherapy, cryotherapy, electrocauterization with or without 0.045% pharmaceutical chlorite (DAC N-055) (10,11). These can be used during the follow-up management of residual lesions that are not fully healed after systemic treatment.…”

Section: Discussionmentioning

confidence: 99%

A Rare Skin Lesion During Pregnancy: Localized Cutaneous Leishmaniasis

Çetin

Büyükkurt

Köksal

et al. 2016

Gynecol Obstet Reprod Med

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Leishmaniasis is an infectious disease that is spread by phlebotomine sand flies. These flies cause infections called cutaneous and/or visceral leishmaniasis in humans. In this paper, we present a pregnant patient who was diagnosed with localized cutaneous leishmaniasis, a localized form of the disease, and the treatment we applied to the patient. The patient was given systemic amphotericin-B treatment, however the immunosuppressive state of pregnancy and the diabetes of the patient complicated the treatment. Although the size of the lesion regressed during pregnancy, we could not completely cure the disease.

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A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan

Cited by 17 publications

References 53 publications

Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis: A systematic review

Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis: A systematic review

Eligibility criteria and outcome measures adopted in clinical trials of treatments of cutaneous leishmaniasis: systematic literature review covering the period 1991–2015

A Rare Skin Lesion During Pregnancy: Localized Cutaneous Leishmaniasis

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