title: The effect of budesonide mouthwash on oral chronic graft versus host disease.
abstract: Oral chronic graft versus host disease (cGVHD) is common and a major cause of morbidity and loss of quality of life in long term survivors. Cyclosporine with prednisone remains the first line therapy for oral manifestations of cGVHD. However, even with routine administration of systemic agents, many patients with oral manifestations of cGVHD do not have resolution of their disease and may benefit from incorporation of local therapy. Budesonide is a highly potent steroid which has minimal systemic side effects and being used for oral cGVHD. We designed a retrospective study to compare treatment results of patients with oral cGVHD who received topical budesonide in addition to systemic therapy that consists of combined prednisone and cyclosporine (Group A, n = 12), with the treatment results of patients who were administered the same systemic therapy alone (Group B, n = 11) to determine whether budesonide mouthwash had any advantage on response rates. Three mg topical budesonide/10 ml saline was used 3-4 times a day for up to 6 months in group A. Diagnosis, clinical staging, and treatment response scoring for cGVHD were performed according to National Institutes of Health (NIH) consensus criteria. At the baseline examination, there were no statistically significant differences in terms of median oral cGVHD examination scores between two groups. After treatment, there was statistically significant decrease in median oral cGVHD examination scores compared to baseline (P < 0.001 and 0.021), and significant differences were found between two groups (P < 0.032). Overall response rate was 83% and 36% for group A and B, respectively (P = 0.036). However, no statistically significant differences were found between median pain scores of two groups before and after treatment (P = 0.740 and P = 0.091). No major systemic side effects and oral candidiasis were observed in two groups of patients. We concluded that topical budesonide might be added to systemic therapy to obtain better response rates in patients with oral cGHVD.
authors.affiliation: Department of Hematology, Faculty of Medicine, M.K. Dedeman Oncology Hospital, Erciyes University, Cappadoccia Transplant Center, Kayseri, Turkey. hisari@erciyes.edu.tr
authors.forename: Ismail
authors.initials: I
authors.lastname: Sari
authors.forename: Fevzi
authors.initials: F
authors.lastname: Altuntas
authors.forename: Ismail
authors.initials: I
authors.lastname: Kocyigit
authors.forename: Yildiray
authors.initials: Y
authors.lastname: Sisman
authors.forename: Bulent
authors.initials: B
authors.lastname: Eser
authors.forename: Aydin
authors.initials: A
authors.lastname: Unal
authors.forename: Turgay
authors.initials: T
authors.lastname: Fen
authors.forename: Ayten
authors.initials: A
authors.lastname: Ferahbas
authors.forename: Ahmet
authors.initials: A
authors.lastname: Ozturk
authors.forename: Ali
authors.initials: A
authors.lastname: Unal
authors.forename: Mustafa
authors.initials: M
authors.lastname: Cetin
mesh_terms: D000328:Adult; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002180:Candidiasis, Oral / Q000209:etiology; D002908:Chronic Disease; D015331:Cohort Studies; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D006086:Graft vs Host Disease / Q000188:drug therapy*; D019337:Hematologic Neoplasms / Q000150:complications / Q000601:surgery; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes; D010147:Pain Measurement; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use; D012189:Retrospective Studies; D012965:Sodium Chloride / Q000627:therapeutic use; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology; D019172:Transplantation Conditioning; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D009067:Mouthwashes; D012965:Sodium Chloride; D019819:Budesonide; D016572:Cyclosporine; D011241:Prednisone