Experts: Magic Mouthwash Should 'Vanish Into Thin Air'

But Phase 3 Trial Is Contrary, May Materialize Soon

Nick Mulcahy

November 28, 2018

So-called magic mouthwash, a treatment for oral inflammation and pain caused by cancer therapies, is ineffective, and clinicians would be well served by its "vanishing into thin air," concludes an essay published online November 19 in JAMA Internal Medicine.

The ascerbic proposal is accompanied by a more serious-minded charge — that the mouth rinses, which have no set formula, may cause more harm than good.

The authors of the essay, led by Angad Uberoi, MD, of the Icahn School of Medicine at Mount Sinai in New York City, list side effects that were reported in a 2005 US survey of 40 institutional pharmacies in 21 states. The results showed that patients reported taste disturbances (49%), burning/tingling in the oral cavity (29%), and drowsiness/central nervous system disturbances (11%).

Furthermore, efficacy data do not support use of the rinses, which commonly consist of some mix of anticholinergics, antacids, mucosal protective agents, and anesthetics, the authors say.

A lone randomized, double-blind trial conducted in 2000 compared the efficacy of three different oral rinses: chlorhexidine; salt and baking soda; and magic mouthwashes, including one containing lidocaine, diphenhydramine, and aluminum hydroxide. There were no differences among the rinses with respect to ratings of pain relief or time to cessation of symptoms.

A 2013 systematic review concluded that for oral mucositis, which is the catchall term for tissue damage caused by systemic chemotherapy and by radiotherapy to the head and neck, no evidence supported the use of the mouthwashes.

True enough, said another expert.

"The [current] article is correct in that there has not been high-level evidence published to date supporting the use of mixed-combination mouth rinses for cancer therapy–related mucositis," said Robert Miller, MD, of the Mayo Clinic in Jacksonville, Florida, who was asked for comment.

We found a significant reduction in patient-reported pain in patients receiving both magic mouthwash and doxepin. Dr Robert Miller

But that will change soon, he suggested.

Miller was referring to a study that he led, a 275-patient, multi-institutional, federally funded phase 3 clinical trial. The results from that study were first presented at the annual meeting for the American Society of Radiation Oncology in 2016. The three-arm study compared a multi-ingredient rinse containing lidocaine to a rinse containing the tricyclic antidepressant doxepin and to a rinse that served as a placebo.

"We found a significant reduction in patient-reported pain in patients receiving both magic mouthwash and doxepin for mucositis pain during radiation therapy," he summarized.

"We hope to have these results published in a peer-reviewed manuscript soon," he told Medscape Medical News.

The essay authors are aware of the Miller abstract, but, inasmuch as the study was presented as an abstract, they did not regard it as evidence, said second author Timothy Brown, MD, of the University of Texas Southwestern Medical Center, Dallas. "As far as we can tell, it has not been published in long form," he tweeted the day after their essay was published.

In their essay, the authors recommend an old-fashioned remedy for mild cases of oral mucositis.

"Careful dental care with a soft toothbrush and rinses with an inexpensive, homemade salt and sodium bicarbonate mouthwash (1 teaspoon of salt and sodium bicarbonate each in 1 liter of water) are advised," they write.

The rudimentary mouthwash, say the authors, dissolves collected debris, promotes granulation tissue formation, and prevents infections by raising the oral pH level.

Single-agent morphine or doxepin mouthwashes can be helpful for pain control, but sucralfate, steroids, and empirical antimicrobials may be harmful and should be avoided, they add.

JAMA Intern Med. Published online November 19, 2018. Abstract

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