A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis
A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis
This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline
 (oxpentifylline) for the treatment of recurrent mouth ulcers.
There are few effective treatments for recurrent aphthous stomatitis (cancer sores, recurrent
 mouth ulcers). Most existing treatments are palliative topical treatments. Some systemic
 drugs e.g. steroids and thalidomide can suppress the recurrence of mouth ulcers but have
 serious long term side effects. Pentoxifylline (also known as oxpentifylline) has been used
 systemically for many years to treat peripheral vascular disease and has a good side effect
 profile. It shares several actions with thalidomide but does not share its serious side
 effects. Furthermore, some small scale, open label clinical studies have indicated it may be
 very effective in treating recurrent aphthous stomatitis (RAS). This study enrolled patients
 with RAS for which no underlying cause could be identified. Patients kept a diary of the
 pattern of their mouth ulcers for 60 days to confirm the pattern of ulceration and provide
 baseline data. Those still qualified for the study were then randomized to treatment with
 pentoxifylline 400mg three times daily or an identical placebo tablet three times daily for a
 further 60 days during which they continued to keep a daily ulcer diary. At the end of this
 period, treatment was stopped and they kept the daily ulcer diary for a further 60 days to
 identify if any benefit from the treatment was continued after ceasing treatment.
Inclusion Criteria:

 -  Diagnosis of minor recurrent aphthous stomatitis

 -  2 or more mouth ulcers per month for more than 6

 -  No current treatment for oral ulceration or willing to stop treatment

 -  Age 16 to 65 years

 Exclusion Criteria:

 -  Taking ketorolac, theophylline or anti-hypertensive medication except diuretics
 (contra-indicated in patients treated with pentoxifylline)

 -  Systemic diseases that contra-indicate the use of pentoxifylline i.e. pregnancy,
 hypotension, ischaemic heart disease, acute myocardial infarction, cerebral or occular
 hemorrhage, renal or hepatic failure, porphyria or allergy to pentoxifylline.

 -  Patients with an underlying deficiency state or systemic disease that could cause
 recurrent mouth ulcers e.g. iron, vitamin B12 or foliate deficience, coeliac disease,
 Crohn's disease, ulcerative colitis, Behcet's disease or Aids.