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.
Highlights
Saad Abdulrahman Hussain,1 Hazha Abdulah Mohammed Ameen,2 Mohammed Omer Mohammed,2 Khadija Muhamed Ahmed,3 Rebaz Hama-Gareb Ali,4 Banaz Mubarak Safar,5 and Kamal Ahmed Saeed6
Objective. e 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)
Oral mucositis is one of the most commonly recognized disabling complications of both chemotherapy and radiotherapy [4] and mostly attributed to complex pathophysiology [5]. is drug-induced adverse reaction was reported in 20– 40% of cancer patients receiving CT and in all patients treated with head and neck radiotherapy [6]. ere are many treatment-related problems caused by OM for both the patients and the healthcare system including dysphagia [7], debilitating pain [8], and elevated patients’ care costs [9]
Summary
E current randomized, open-label controlled study with two parallel arms was performed at Hiwa Oncology Hospital, Sulaimani City, Iraq, from May 2017 to June 2018. Consent, were enrolled and randomized to one of two groups (magic mouthwash arm that includes 27 patients, utilized as control; the NS oil arm that includes 27 patients) using simple randomization and an allocation ratio of 1 :1. E allocation sequence and preparation of the magic mouthwash formula and the NS oil mouth rinse are performed by subjects not involved in the recruitment, data collection, and analysis. E patients in both groups received the NS oil mouth rinse and the magic mouthwash topically as a mouth rinse (10 ml each 6 hr) daily, starting from the first day after the initiation of CT up to day 28 (the end of the CT) PVT., LTD, Karachi, Pakistan). e magic mouthwash formula was freshly prepared daily before use and contains nystatin 100,000 U, tetracycline 0.02%, lidocaine 0.5%, and dexamethasone 0.5%. e patients in both groups received the NS oil mouth rinse and the magic mouthwash topically as a mouth rinse (10 ml each 6 hr) daily, starting from the first day after the initiation of CT up to day 28 (the end of the CT)
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