Abstract
Background: The current chemotherapy agents against various forms of leishmaniasis have some problems and side effects, including high toxicity, high cost, and the emergence of resistant strains. Here, we aimed to review the preclinical studies (in vitro and in vivo) on the anti-leishmanial activity of chitosan and chitosan-based particles against Leishmania spp. Methods: This study was conducted based on the 06-PRISMA guidelines and registered in the CAMARADES-NC3Rs Preclinical Systematic Review and Meta-Analysis Facility (SyRF) database. Various English databases such as PubMed, Google Scholar, Web of Science, EBSCO, ScienceDirect, and Scopus were used to find the publications related to the anti-leishmanial effects of chitosan and its derivatives and other pharmaceutical formulations, without a date limitation, to find all the published articles. The keywords included "chitosan", "chitosan nanoparticles", "anti-leishmanial", "Leishmania", "leishmaniasis", "cutaneous leishmaniasis", "visceral leishmaniasis", "in vitro", and "in vivo". The language for data collection were limited to English. Results: Of 2669 papers, 25 papers, including 7 in vitro (28.0%), 7 in vivo (28.0%), and 11 in vitro/in vivo (44.0%) studies conducted up to 2020 met the inclusion criteria for discussion in this systematic review. The most common species of Leishmania used in these studies were L. major (12, 48.0%), L. donovani (7, 28.0%), and L. amazonensis (4, 16.80%). In vivo, the most used animals were BALB/c mice (11, 61.1%) followed by hamsters (6, 33.3%) and Wistar rats (1, 5.5%), respectively. In vitro, the most used Leishmania form was amastigote (8, 44.4%), followed by promastigote (4, 22.2%), and both forms promastigote/amastigote (6, 33.3%). Conclusion: According to the literature, different types of drugs based on chitosan and their derivatives demonstrated considerable in vitro and in vivo anti-leishmanial activity against various Leishmania spp. Based on the findings of this review study, chitosan and its derivatives could be considered as an alternative and complementary source of valuable components against leishmaniasis with a high safety index. Nevertheless, more investigations are required to elaborate on this result, mainly in clinical settings.