ABSTRACT
OBJECTIVE: The present study aims at evaluating the beneficial effect of Nigella sativa (NS) oil mouth rinse in the management of chemotherapy- (CT-) induced oral mucositis (OM) in patients with acute myeloid leukemia (AML). METHODS: Fifty-four AML patients were participated in this study and randomly allocated to either the test group or a control group. The patients of the test group received NS oil mouth rinse during 28-day CT, while the participants of the control group received a "magic mouthwash" formula. The primary outcome of this study was the incidence and severity of CT-induced OM in terms of erythema and ulcer. The secondary outcomes were the pain severity score, swallowing function, and the salivary concentrations of interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α). RESULTS: NS oil mouth rinse attenuated the progression of CT-induced OM compared with the control formula (AUC = 5.9 vs. 38.4, P < 0.05) and significantly decreased the erythema and ulceration scores (AUC of total OMAS = 11.4 vs. 85.9, P < 0.001) compared with the magic mouthwash formula. It also reduced the pain score and enabled all the participants of this group to consume normal food during treatment. It significantly decreased salivary IL-6 (AUC = 7376 vs. 16599, P < 0.001), while the changes of TNF-α levels were not significant (AUC = 676.9 vs. 885.2, P > 0.05). CONCLUSIONS: NS oil mouth rinse is effective in attenuating the severity of CT-induced OM and improves the pain and swallowing function in AML patients.
Subject(s)
Leukemia, Myeloid, Acute/drug therapy , Nigella sativa/chemistry , Plant Oils/administration & dosage , Stomatitis/therapy , Adult , Female , Gene Expression Regulation, Neoplastic/drug effects , Humans , Interleukin-6/genetics , Leukemia, Myeloid, Acute/complications , Leukemia, Myeloid, Acute/genetics , Leukemia, Myeloid, Acute/pathology , Male , Middle Aged , Mouthwashes/therapeutic use , Plant Oils/chemistry , Stomatitis/chemically induced , Tumor Necrosis Factor-alpha/geneticsABSTRACT
BACKGROUND: Oral mucositis is the most common side effects of chemotherapy of all cancer with intensive treatments regimen, and is the most common side effects of head and neck radiation therapy. For steam cell transplantation, its also regarded as the most debilitating side effects. AIMS OF THE STUDY: The objectives of this study were to assess the effect of a mouth rinse containing olive leaf extract (OLE) in preventing severe oral mucositis in patients receiving chemotherapy, and to estimate its effect in decreasing pro-inflammatory cytokine production after chemotherapy. MATERIALS AND METHODS: This study utilized a placebo-controlled, randomized, double-blind, and cross-over design. Twenty-five patients undergoing intensive chemotherapy were randomly assigned to receive a mouth wash containing OLE, benzydamine hydrochloride, or placebo in 3 different cycles of chemotherapy. Oral mucositis severity was assessed using the World Health Organization criteria and Oral Mycositis Assessment Scale. Patients were evaluated weekly until 15 days after chemotherapy for each cycle. Salivary levels of interleukin-1 beta (IL-1ß) and tumor necrosis factor-alpha (TNF-α) were evaluated by enzyme-linked immunosorbant assay. RESULTS: Oral mucositis rates and severity after 2 weeks were significantly lower in the OLE and benzydamine groups compared to the placebo group. The IL-1ß and TNF-α levels were significantly decreased in the OLE group compared to the other groups. CONCLUSION: Preliminary findings indicate that OLE is effective in reducing IL-1ß and TNF-α levels after chemotherapy and exert a therapeutic effect and prevent development of severe oral mucositis.
