Treatment of cutaneous leishmaniasis with sodium stibogluconate and allopurinol in a routine setting in Ethiopia: clinical and patient-reported outcomes and operational challenges

Cutaneous leishmaniasis (CL) is common in Ethiopia, but the national guideline does not offer specific treatment recommendations. Consequently, different treatment regimens are used in the country, without quality evidence. In Boru Meda Hospital, sodium stibogluconate (SSG) is routinely used combined with allopurinol for systemic CL treatment, although evidence on effectiveness is limited. An observational cohort study was done to document clinical treatment outcomes in patients receiving SSG/allopurinol at the end of each 28-day treatment cycle and after 180 days. Patient-reported outcomes were assessed by asking patients to rate lesion severity and by the dermatological life quality index. A total of 104 patients were included. After one treatment cycle only four patients were clinically cured, although patient-reported outcomes significantly improved. The majority (88) of patients were appointed for a second treatment cycle, of which only 37 (42%) came. Among 36 patients who came for final outcome assessment, 50% was cured. Follow-up and treatment was severely affected by conflict; drug stockouts and insufficient ward capacity for treatment were additional challenges. Treatment outcomes of SSG/allopurinol were relatively poor, and most patients required more than one cycle of treatment. Shortage of drugs and beds indicates the existing gaps in providing CL treatment in Ethiopia. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by the Directorate-General Development cooperation and Humanitarian Aid (DGD), under the FA4 framework collaboration of the Institute of Tropical Medicine (Antwerp, Belgium) and the University of Gondar (Gondar, Ethiopia), of which Boru Meda was funded as a satellite site. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The following Ethics committees gave ethical approval for this work: ethical review committees of the Institute of Tropical Medicine, Antwerp (Ref 1351/20, 23 March 2020); the University hospital of Antwerp (Ref 20/15/183, 27 April 2020), and Wollo University College of Medicine and Health Sciences Ethics committee, Dessie (Ref 127/02/13, 14 October 2020). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data will not be made openly accessible due to ethical and privacy concerns. Data can however be made available after approval of a motivated and written request to ITMs Research Data Access Committee (ITMresearchdataaccess{at}itg.be).