NEW YORK (Reuters Health) April 16 Pentoxifylline therapy provides only limited efficacy against recurrent aphthous stomatitis and should not be considered a first-line agent, new research indicates. However, the drug may be considered if other treatments prove unsuccessful.
As researchers note in the April issue of Archives of Dermatology, pentoxifylline has effects similar to both thalidomide and colchicine, two agents that have proven effective in some patients with recurrent aphthous stomatitis. Previous studies have examined the use of pentoxifylline for this indication, but all of them have been open-label studies and have not included a placebo control.
The current study involved 26 patients who were randomized to receive pentoxifylline (400 mg three times daily) or a placebo for 60 days. Four subjects taking placebo and two taking pentoxifylline withdrew from the study due to adverse effects and one pentoxifylline-treated patient was lost to follow-up.
Pentoxifylline use was associated with a drop in ulcer pain and numbers relative to baseline values, note lead author Dr. Martin H. Thornhill, from The University of Sheffield School of Clinical Dentistry in the UK, and his colleagues. By contrast, no improvement was seen in the control group.
Patients treated with the active agent also had more ulcer-free days than those given a placebo, the report indicates.
Still, the authors emphasize that the differences between the groups were small and with the exception of median ulcer size, fell short of statistical significance. Although side effects were often seen with pentoxifylline therapy, they were comparable to what was noted with placebo.
"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 aphthous stomatitis," the investigators conclude.
Arch Dermatol 2007;143:463-470.
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