1. Oral doxepin rinse significantly reduces the incidence of painful oral mucositis (OM) during radiotherapy for head and neck cancers.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Painful oral mucositis is commonly associated with radiotherapy for head and neck cancers, and frequently requires treatment with systemic analgesics. The purpose of this study was to evaluate the use of doxepin hydrochloride, a tricyclic antidepressant with anesthetic properties, in the management of the pain associated with this condition. The primary endpoint measured was pain reduction measured by the area under the curve (AUC) on the pain scale. At the conclusion of this study, the authors found that AUC was significantly reduced in the doxepin arm compared to placebo. The limitation of this study is that doxepin was not compared to magic mouthwash rinses, the current most commonly prescribed therapy for mucositis, and further investigation is warranted.
In-Depth [randomized controlled trial]: In this randomized, controlled trial, 155 patients were enrolled who were undergoing radiotherapy with or without chemotherapy for histologically proven head and neck malignancy. Patients were randomized to either a doxepin oral rinse or to placebo, then crossed over to receive the alternate treatment on the following day. Pain questionnaires were given at the time of treatment, then at 5, 15, 30, 60, 120 and 240 minutes. Patients were also given the option to continue the doxepin treatment. This was a double-blinded study. The primary endpoint measured was pain reduction measured by the area under the curve (AUC) on the pain scale. At the conclusion of this study, the authors found that AUC was significantly reduced in the doxepin arm compared to placebo (-9.1 versus -4.7, P < 0.001).
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