Failure of an Innovative Low-Cost, Noninvasive Thermotherapy Device for Treating Cutaneous Leishmaniasis Caused by Leishmania tropica in Pakistan

Kämink, Suzette; Abdi, Ahmed; Kamau, Charity; Ashraf, Shakil; Ansari, Muhammad Asim; Qureshi, Naveeda Akhtar; Schallig, Henk D. F. H.; Grobusch, Martin P.; Fernhout, Jena; Ritmeijer, Koert

doi:10.4269/ajtmh.19-0430

Cited by 10 publications

(10 citation statements)

References 37 publications

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“…An experienced dermatologist made the clinical diagnosis after thorough assessment and excluding differential diagnoses in these cases. In addition, molecular specification could not be done, and it was assumed that the patients were suffering from CL caused by L. tropica, based on clinical research performed at the same hospital (MSBBGHQ) in November 2017, where 100% of tested CL lesions were caused by L. tropica [27].…”

Section: Discussionmentioning

confidence: 99%

“…However, until now, only limited case studies have been conducted to evaluate the efficacy of miltefosine in CL caused by L. tropica which is generally considered to be less drug sensitive [24][25][26]. It is not (yet) included in the Pakistan national guidelines, although it is recommended by the WHO in the manual for case management of CL in the EMRO region (2014) as a second line treatment [27,28].…”

Section: Introductionmentioning

confidence: 99%

“…In Pakistan, Médecins Sans Frontières (MSF) runs three clinics in urban Quetta (Balochistan Province), in an L.tropica endemic area. In 2017, for a study, species identification by PCR was conducted in one of these clinics; which revealed that 100% of the patient samples were identified as L. tropica [27]. Patients with CL are routinely treated with meglumine antimoniate, either by daily intramuscular (IM) injections of 20 mg/kg for 20 days, or by intralesional (IL) injections twice a week, for eight to 12 sessions with a dose depending on the number and size of the lesions [27,28].…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy—A retrospective analysis

Kämink

Masih²,

Ali³

et al. 2021

PLoS Negl Trop Dis

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Background Cutaneous leishmaniasis (CL) is a neglected tropical skin disease, caused by Leishmania protozoa. In Pakistan, where CL caused by L. tropica is highly endemic, therapy with pentavalent antimonials is the standard of care, but has significant toxicity when used in systemic therapy, while are no evidence-based safer alternative treatment options for L. tropica. The efficacy of oral miltefosine has not been studied in CL caused by L. tropica. We evaluated effectiveness and tolerability of miltefosine in patients with previous treatment failure or with contraindications to systemic antimonial treatment. Methods A retrospective review was conducted of a cohort of CL patients who were treated with a 28-day course of miltefosine between December 2017 and August 2019, in urban Quetta, Pakistan, an area endemic for L. tropica. Descriptive analyses were performed, and effectiveness was assessed by initial response after treatment, and final cure at routine follow up visits, six weeks to three months post-treatment. Tolerability was assessed by routinely reported adverse events. Results Of the 76 CL patients in the cohort, 42 (55%) had contraindications to systemic antimonial treatment, and 34 (45%) had failure or relapse after antimonial treatment. Twelve patients defaulted during treatment and 12 patients were lost to follow up. In the remaining 52 patients, final cure rate was 77% (40/52). In those with contraindications to systemic antimonial treatment the final cure rate was 83% (24/29) and in the failure and relapse group 70% (16/23). Twenty-eight patients (40.0%) reported 39 mild to moderate adverse events with the main complaints being nausea (41.0%), general malaise (25.6%), and stomach pain (12.8%). Conclusion Results indicate that miltefosine is an effective second line treatment in CL in areas endemic for L. tropica. Prospective studies with systematic follow up are needed to obtain definitive evidence of effectiveness and tolerability, including identification of risk factors for miltefosine treatment failure.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy—A retrospective analysis

Kämink

Masih²,

Ali³

et al. 2021

PLoS Negl Trop Dis

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“…They reported a 91% failure rate and suggested that this finding might be due to low heat sensitivity and slower spontaneous healing of L. tropica . [ 21 ]…”

Section: Study Methodsmentioning

confidence: 99%

Heat therapy for cutaneous leishmaniasis

Siadat

Iraji

Zolfaghari

et al. 2021

Journal of Research in Medical Sciences

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Cutaneous leishmaniasis (CL) is endemic in many parts of the world with a high economic and health impact. Despite many treatments that have been suggested for this zoonotic infection, there is still no definite therapy for CL. Meglumine antimony compounds are considered as a standard treatment for leishmaniasis, however, these medications have a relatively high side effect profile and not always effective. Physical modalities including cryotherapy, laser, and heat therapy have also been used for this purpose. As a source of heat therapy, different methods have been used including radiofrequency, ultrasound, infrared, exothermic crystallization thermotherapy, and microwave. We reviewed all of the articles in PubMed regarding the use of heat therapy for the treatment of CL up to January 2020. According to our literature review, heat therapy using different sources showed promising results for the treatment of CL that were comparable to meglumine antimony. In addition, heat therapy has very low side effect profiles that are localized to the treatment area suggesting this method as a safe procedure for CL therapy. This study is a brief review of the literature about the effect of heat therapy on the treatment of CL. Performing randomized clinical trials to compare different methods of heat therapy and to compare it with meglumine antimony compounds is recommended.

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“…13,15 However, the interim analysis of another study showed a failure rate of 91% for treatment with HECT-CL. 18 Because a vaccine or prophylactic treatment is not available, chemotherapy remains the mainstay in treatment and control of leishmaniasis. Availability of only a few antileishmanial drugs and emerging treatment failures are major challenges faced by Sri Lanka as well as other countries.…”

Section: Introductionmentioning

confidence: 99%

Therapeutic Response to Thermotherapy in Cutaneous Leishmaniasis Treatment Failures for Sodium Stibogluconate: A Randomized Controlled Proof of Principle Clinical Trial

Silva

Liyanage²,

Deerasinghe³

et al. 2021

The American Journal of Tropical Medicine and Hygiene

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Treatment failure to intralesional sodium stibogluconate (IL-SSG) is a health challenge for cutaneous leishmaniasis (CL) in Sri Lanka. A randomized controlled proof of principle clinical trial, with two arms (viz., radio frequency–induced heat therapy [RFHT] by a ThermoMed™ device and thermotherapy by a handheld exothermic crystallization thermotherapy for CL [HECT-CL] device) was conducted on 40 CL treatment failures to IL-SSG, from three hospitals in Tangalle, Hambantota, and Anuradhapura, from January 2017 to January 2018, followed up for 180 days post-thermotherapy with a final follow-up in February 2020. Intention-to-treat cure rates were calculated at day 90 (initial cure rate) and at day 180 (final cure rate) posttreatment. Radio frequency–induced heat therapy group: the initial cure rate was 100% (20/20) and the final cure rate was 95% (19/20), with one patient relapsing. The HECT-CL group: both the initial and final cure rates were 80% (16/20), with no relapses and one excluded from the trial. In February 2020 (1.6–3 years posttreatment), 27 traceable patients (RFHT = 16, HECT-CL = 11) remained healed. Second-degree burns were observed with RFHT in 65% (13/20), with HECT-CL in 15% (3/20), which completely resolved subsequently. The cure rates between the two treatment groups were comparable (P = 0.15). Radio frequency–induced heat therapy consumed less time and required only a single hospital visit. Handheld exothermic crystallization thermotherapy for CL is potentially usable at community settings with both being less costly than IL-SSG. This study is the first proof that thermotherapy is an efficacious and safe treatment for CL patients in Sri Lanka, complicated by treatment failure to IL-SSG.

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Failure of an Innovative Low-Cost, Noninvasive Thermotherapy Device for Treating Cutaneous Leishmaniasis Caused by Leishmania tropica in Pakistan

Cited by 10 publications

References 37 publications

Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy—A retrospective analysis

Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy—A retrospective analysis

Heat therapy for cutaneous leishmaniasis

Therapeutic Response to Thermotherapy in Cutaneous Leishmaniasis Treatment Failures for Sodium Stibogluconate: A Randomized Controlled Proof of Principle Clinical Trial

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