Pentoxifylline May Be Helpful for Treatment of Recurrent Aphthous Stomatitis

April 20, 2007 — Pentoxifylline has some benefit on recurrent aphthous stomatitis (canker sores) but cannot be recommended as first-line treatment, according to the results of a randomized, double-blind, 60-day trial reported in the April issue of Archives of Dermatology.

"Pentoxifylline (also called oxpentifylline) is a drug used in the treatment of peripheral vascular disease, and it has a good safety record even in long-term use," write Martin H. Thornhill, MBBS, PhD, from the University of Sheffield School of Clinical Dentistry in England, and colleagues. "Like thalidomide, it inhibits TNF [tumor necrosis factor]-? production, and like colchicine, it inhibits neutrophil function and chemotaxis, without the well-known adverse effects of these drugs. Theoretically, therefore, it is a good candidate for the treatment of RAS [recurrent aphthous stomatitis]."

At an oral medicine specialist referral center in Manchester, 49 volunteers who passed the initial assessment for recurrent aphthous stomatitis entered a pretrial phase in which they were evaluated for trial eligibility. Of the 49 volunteers, 16 were ineligible, 7 failed to attend or withdrew, and the remaining 26 subjects were randomized to placebo or treatment (pentoxifylline, 400 mg 3 times daily). Of these 26 subjects, 6 subjects withdrew because of adverse effects, and 1 was unavailable for follow-up.

The primary endpoint was a reduction in the median pain score, ulcer size, number of ulcers, or total number of ulcer episodes.

Patients taking pentoxifylline had less pain and reported smaller and fewer ulcers compared with baseline, whereas patients taking placebo reported no improvement in these outcomes. Patients taking pentoxifylline also reported more ulcer-free days than did those taking placebo. Between-group differences were small and did not reach statistical significance, except for median ulcer size (P = .05).

Adverse effects were reported by 69% of patients taking pentoxifylline. The most common were dizziness, headaches, stomach upset, increased heart rate, and nausea. However, 50% of patients taking placebo also reported 1 or more of these adverse effects.

"Although pentoxifylline may have some benefit in the treatment of recurrent aphthous stomatitis, the benefit is limited," the authors write.

Study limitations include high attrition of subjects and small sample size.

"Pentoxifylline did not prevent the ulcer episodes from occurring or result in a long-term cure," the authors conclude. "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 RAS, although it may have a second-line role in the management of patients unresponsive to other treatments or as an adjunct to other treatments."

Hoechst Marion Roussel provided pentoxifylline and the matching placebo tablets. The authors have disclosed no relevant financial relationships.

Arch Dermatol. 2007;143:463-470.

Source: http://www.medscape.com/viewarticle/555498?src=mp