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Clinical studies evaluate potential treatments for mouth ulcers

April 17, 2007

The drug pentoxifylline appears to have limited benefit in the first-line treatment of mouth ulcers due to recurrent apthous stomatitis, according to a report in the April issue of Archives of Dermatology, one of the JAMA/Archives journals. However, a second report in the same issue finds that a cream commonly used to treat eczema may be effective in patients with another ulcer-causing mouth disease, oral erosive lichen planus.

Mouth ulcers are among the most common oral health problems, according to background information in the articles. Recurrent apthous stomatitis is characterized by recurring episodes of mouth ulcers in an otherwise healthy individual, and affects approximately 20 percent of the population. Oral erosive lichen planus is a severe inflammatory condition that causes painful wounds in the mouth. Approximately 1 percent of the population is affected—about the same percentage as are affected by psoriasis—and those who develop the condition may lose weight because of pain during eating. Few effective treatments are available for either condition.

In the first study, Martin H. Thornhill, M.B.B.S., Ph.D., of the University of Sheffield School of Clinical Dentistry, Sheffield, England, and colleagues conducted a 60-day, randomized, double-blind trial in 26 individuals (average age 33) with recurrent apthous stomatitis. In a 60-day pre-trial phase, participants kept a daily ulcer diary in which they recorded the number and size of ulcers if any were present, and also the pain associated with them on a scale of one to 10. Then, 14 patients were assigned to take one tablet containing 400 milligrams of pentoxifylline three times per day for 60 days, while 12 took three placebo pills per day. Both groups continued to keep diaries and also returned to the clinic for examinations after 30 and 60 days, and again 60 days after completing treatment.

"Patients taking pentoxifylline had less pain and reported smaller and fewer ulcers compared with baseline," the authors write. "Patients taking placebo reported no improvement in these variables. Patients taking pentoxifylline also reported more ulcer-free days than those taking placebo. However, the differences were small and, with the exception of median ulcer size, did not reach statistical significance."

More patients taking the active treatment experienced adverse effects, including dizziness, headaches, stomach upset, increased heart rate and nausea. Sixty days after stopping treatment, all patients reported ulcers similar to those they had in the pre-trial phase.

"Pentoxifylline did not prevent the ulcer episodes from occurring or result in a long-term cure," the authors conclude. "Thus, given the potential for significant adverse effects and the small benefits of the drug demonstrated in this clinical trial, we cannot recommend pentoxifylline as the drug of first choice for treatment of recurrent apthous stomatitis, although it may have a second-line role in the management of patients unresponsive to other treatments or as an adjunct to other treatments."

In the second article, Thierry Passeron, M.D., and colleagues at the University of Nice, France, conducted a double-blind randomized trial of 1 percent pimecrolimus cream for the treatment of oral erosive lichen planus. Six patients received pimecrolimus cream and six received a placebo cream without the active ingredient; both applied the cream on mouth sores twice a day for four weeks. The efficacy of the treatment was measured along a 12-point clinical score, and the blood level of pimecrolimus was measured at the beginning of the study and again after 14 and 28 days.

"In the pimecrolimus group, all the patients but one reported a moderate to important improvement of their symptoms and were satisfied by the treatment," the authors write. "This improvement was observed from the first week of treatment, usually within the first two days, and most notably patients reported less pain when eating."

The average clinical score among those taking pimecrolimus decreased from 6.83 at baseline to 3.33 at day 28 of the study, while scores for the placebo group decreased from 4.67 to 3.33. The treatment was well tolerated in both groups with few adverse effects. However, all patients who improved during the trial had a relapse within a month following treatment.

"According to the present data, 1 percent pimecrolimus cream seems to be an effective and well-tolerated treatment for oral erosive lichen planus," the authors write. "Further studies on a larger population with long-term follow-up and monitoring of the blood level of pimecrolimus are required to better evaluate its usefulness and safety compared with other therapeutic modalities."

JAMA and Archives Journals