Abstract
Background and Objectives: This research attempts to provide a clear view of the literature on randomized clinical trials (RCTs) concerning the efficacy of topical dexamethasone, clobetasol and budesonide in oral graft versus host disease (GVHD). Materials and Methods: An electronic search of the PubMed, Web of Science and Scopus databases was carried out for eligible RCTs. Studies were included if they had adult patients with oral GVHD treatment with topical corticosteroids, and if the RCT study was published in English. The Cochrane Risk of Bias tool was used to assess the quality of these studies. Overall, three RCTs were included (an Open, Randomized, Multicenter Trial; a Randomized Double-Blind Clinical Trial; and an Open-Label Phase II Randomized Trial). Results: The trials involved 76 patients, of which 44 patients received topical dexamethasone, 14 patients received topical clobetasol and 18 patients received topical budesonide. Topical agents were most frequently used when oral tissues were the sole site of involvement. It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone. The limitation of the current study is mainly represented by the fact that overall response was derived in two of the studies from other parameters. Moreover, both budesonide and clobetasol were used in only one study each, while two assessed dexamethasone. Conclusions: Based on the clinical trials, all three agents seem to be effective in treating oral GVHD and had a satisfactory safety profile. There is still a need for assessing high quality RCTs to assess the efficacy of these therapies on a larger cohort.
Highlights
Allogeneic hematopoietic cell transplantation is protocol treatment for hematological cancers and for non-malignant disorders [1]
Because of the heterogeneity of the studies, we considered for Elad et al [25] the modified oral mucosal rating scale (mOMRS) any response, for Noce et al [26] the symptomatic response and for Treister et al [27] the overall response described by the authors
Albuquerque et al observed that there are a limited number of randomized clinical trials (RCTs), and, the evidence sustaining the use of topical agents for the inflammatory lesions in oral graft versus host disease (GVHD) is low [10]
Summary
Allogeneic hematopoietic cell transplantation (allo-HCT) is protocol treatment for hematological cancers and for non-malignant disorders [1]. In hematopoietic cell transplantation (HCT) patients, mucositis may often occur along the entire orodigestive tract. This research attempts to provide a clear view of the literature on randomized clinical trials (RCTs) concerning the efficacy of topical dexamethasone, clobetasol and budesonide in oral graft versus host disease (GVHD). Topical agents were most frequently used when oral tissues were the sole site of involvement It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and by dexamethasone. The limitation of the current study is mainly represented by the fact that overall response was derived in two of the studies from other parameters Both budesonide and clobetasol were used in only one study each, while two assessed dexamethasone. There is still a need for assessing high quality RCTs to assess the efficacy of these therapies on a larger cohort
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