For decades, clinicians used some variation of “magic mouthwash” or “miracle mouthwash” to alleviate the discomfort of treatment-induced oral mucositis and reduce the risk of infection. Ingredients generally consisted of an antihistamine, antifungal, analgesic, and a coating agent (usually Mylanta or Maalox) prepared as an oral rinse or “swish and swallow.” Research in the late 1990s then determined that this solution was ineffective and represented an outdated practice.
Researchers at the Mayo Clinic in Jacksonville, Florida noted that a large, multicenter, randomized controlled trial had never been conducted to evaluate the efficacy of the “magic” mouthwash and conducted a phase III trial. The mouthwash used in the study was a diphenhydramine, lidocaine, and antacid (DLA) preparation.
Patients undergoing definitive head and neck radiotherapy (n = 275) experiencing oral mucositis pain rated at least 4 (on a 1-10 scale) were randomized to receive 1 of 3 treatments: magic mouthwash (DLA), doxepin oral rinse, or a placebo rinse. Doxepin had previously been shown to reduce oral mucositis pain in another sizeable phase III trial.
The primary endpoint was pain reduction, as measured by the area under the curve (AUC) of the pain scale over the 4 hours following a single dose of the rinse. There were significant differences in mean AUC reduction in pain between DLA and placebo (11.7 vs 8.7; P = .004), which represented a 35% reduction in pain over the 4-hour test period. Doxepin also was significantly effective in reducing pain compared to placebo (11.9 vs. 8.7; P = .01). The study was not designed to evaluate doxepin against the DLA mouthwash, so comparisons between the two cannot be made. Study results were presented at the 2016 American Society for Radiation Oncology (ASTRO) Annual Meeting (abstract LBA-3).