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Mouthwashes for Oral Mucositis Pain From Head and Neck Radiotherapy

By: Cordi Craig
Posted: Tuesday, May 14, 2019

Although the use of doxepin mouthwash or diphenhydramine/lidocaine/antacid mouthwash reduced oral mucositis pain during the first 4 hours after administration among patients undergoing radiotherapy for head and neck cancer, the reduction did not meet the standard for minimal clinically important difference, according to a phase III study published in JAMA. Terence T. Sio, MD, MS, of Mayo Clinic Hospital, Phoenix, and colleagues concluded that the mouthwash treatments may be effective in reducing pain, but further research is necessary to assess their longer-term treatment safety and efficacy.

In the Alliance A221304 clinical trial, the authors randomly assigned 275 patients who underwent radiotherapy for head and neck cancer to receive doxepin mouthwash (n = 92), diphenhydramine/lidocaine/antacid mouthwash (n = 91), or placebo (n = 92). The minimal clinically important difference was a 3.5-point change.

During the first 4 hours, mucositis pain decreased by 11.6 and 11.7 points among patients treated with the doxepin mouthwash and the diphenhydramine/lidocaine/antacid mouthwash, respectively. By contrast, mucositis pain decreased by 8.7 points among patients who received the placebo treatment. Patients treated with doxepin reported greater side effects, including drowsiness (1.5-point difference, P = .03), unpleasant taste (1.5-point difference, P = .002), and stinging and burning (4.0-point difference, P < .001) than those treated with placebo. In both treatment groups, 4% of patients experienced grade 3 adverse events versus 2% of patients in the placebo group.

There was no significant difference in the percentage of patients who reported a preference for continued therapy among the doxepin (60%), diphenhydramine/lidocaine/antacid (63%), and placebo groups (54%).

Disclosure: The study authors’ disclosure information may be found at jamanetwork.com.

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