Do you have something stronger than Benadryl?

Top Line: The dreaded mucositis during chemoradiation to the head and neck (H&N) is perhaps the single biggest cause of treatment morbidity and even leads some patients to fail to complete therapy altogether.
The Study: This is why effective palliation of mucositis pain is a critical component of the successful delivery of H&N radiation. Some suggest a mouthwash with the tricyclic antidepressant doxepin can be effective. More commonly, oncologists turn to some variation on a lidocaine / diphenhydramine / antacid combo deemed by many as “magic mouthwash.” But how often do your patients return to clinic singing the praises of any one of your magic mouthwashes du jour? Be honest. Remarkably, Alliance 221304 is the first of its kind to test either of the two above purported mucositis pain relievers head-to-head against placebo in a phase 3 double-blind fashion. 275 patients with a mucositis pain score of ≥4 during H&N radiation were randomized 1:1:1 to doxepin mouthwash, magic mouthwash, or placebo. The primary endpoint of mucositis pain reduction in the first four hours of use (measured as an area under the curve) was roughly 12 points with either doxepin or magic mouthwash. Which sounds great until you learn it was 9 points with placebo, meaning the between group differences of 3 points fell below the a priori “clinically meaningful” threshold. Womp womp.
Bottom Line: Sadly, a mouthwash with either doxepin or the classic combo lidocaine / diphenhydramine / antacid failed to produce a clinically meaningful reduction in radiation-mucositis pain over placebo alone. | Sio, JAMA 2019


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