Randomized, double‐blind, controlled, comparative study on intralesional 10% and 15% hypertonic saline versus intralesional sodium stibogluconate in <i><scp>L</scp>eishmania donovani</i> cutaneous leishmaniasis

Ranawaka, Ranthilaka R.; Weerakoon, Hema S; Silva, Padmal de

doi:10.1111/ijd.12685

Cited by 20 publications

(17 citation statements)

References 22 publications

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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%

“…Although complete re‐epithelisation of the ulcer was the definition of ‘cure’ in 100% and 86.5% of the studies which included initial and definitive cure, respectively, additional criteria were variably present, including absence of active lesion, negative parasitology, ‘complete improvement’ (lesions flattened, no induration, epidermal creases) and/or reversible hypopigmentation. In 11 studies (11.6%), definitive cure was defined as re‐epithelisation >60% , >75% , >80% or >90% (Table c). For all the studies including nodular and papular lesions, cure was defined as resolution and flattening of the lesion.…”

Section: Resultsmentioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 99%

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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“…Intralesional hypertonic (7%) sodium chloride is almost as effective as intralesional sodium stibogluconate but does not have systemic side effects . However, this inexpensive treatment method should not be used at concentrations of 10% and higher because it may cause cutaneous necrosis …”

Section: Treatmentmentioning

confidence: 99%

Clinical practice guidelines for the diagnosis and treatment of cutaneous leishmaniasis in Turkey

et al. 2018

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“…Intra-lesional SSG and hypertonic saline have shown some encouraging results. 17,18 Timely laboratory confirmation is useful to prevent unnecessary administration of toxic and expensive drugs and unpleasant sequelae of long-lasting untreated illness. Light microscopy is generally considered the first-line investigation in CL while in vitro culturing and PCR remain as second-line investigations.…”

Section: Introductionmentioning

confidence: 99%

Use of a clinical tool for screening and diagnosis of cutaneous leishmaniasis in Sri Lanka

Siriwardana

Senarath

Chandrawansa

et al. 2015

Pathogens and Global Health

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Cutaneous leishmaniasis (CL) was first detected in Sri Lanka in 1992.Local disease is caused by a genetically different variant of Leishmania donovani. Early case detection and management is the mainstay of L. donovani control. High degree of clinical suspicion is critical but a clinical diagnostic tool is not available for leishmaniasis. Current study described, for the first time, a two-staged clinical algorhythm that facilitates screening of CL in Sri Lanka by primary health care worker in stage 1 and management by medical professional in stage 2.Selected clinical markers of 400 patients suspected of CL were analysed retrospectively with laboratory confirmation of leishmaniasis. Ten clinical markers predicted CL with a over 90% accuracy. Subsets of markers showed high levels of sensitivities (60-97.2%) and/or significant association with positive laboratory results as compared to negative lesions [typical onset (acne-form, painless non-itchy), (P 5 0.026), size up to 2 cm (P 5 0.046), well-defined edges (P 5 0.002), regular edges (P 5 0.018), rounded shape (P 5 0.030), and lesions at 5-8 months (P 5 0.052)]. Five of them (typical onset, number up to 2, small size, rounded edges, and rounded shape) also had w 70% sensitivity levels as compared to laboratory findings. Typical onset had the highest sensitivity of 97% and a PPV of 72%. Lesions at 5-8 months duration having defined edges (P 5 0.013, specificity 89.7%, PPV 83.1) or having regular edges (P 5 0.006, specificity 86.2%, PPV 82.4%) were also predictive of CL. Most of early laboratory-confirmed (v12 months) lesions remained v3 cm (sensitivity w 67%, PPV w 70%) and had defined edges (sensitivity of 52-71%, specificity 46.7-68.8%), (PPV 75.1-86%). Four clinical markers served as good diagnostic markers in both early (j4) and late (w12 months) lesions, viz. typical onset (91.3-98.4%), presence of j2 lesions (sensitivity 82.6-94.7%), size j2 cm (66.9-73.7%), and regular edges (68.6-76.3%). Reliability of clinical markers generally declined in chronic lesions. However, small lesions of over 12 months were highly indicative of CL (sensitivity of 66%, specificity 66.7%). None of the single/combination markers, however, were 100% sensitive or specific, highlighting the undeniable usefulness of laboratory confirmation, in diagnosis. Decision-making algorithm used 10 basic clinical features for screening and seven specific clinical markers for clinical handling and referral for investigations.

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

Cited by 20 publications

References 22 publications

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

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

Clinical practice guidelines for the diagnosis and treatment of cutaneous leishmaniasis in Turkey

Use of a clinical tool for screening and diagnosis of cutaneous leishmaniasis in Sri Lanka

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