30706
document
A randomized , double-blind , placebo-controlled trial of pentoxifylline for the treatment of recurrent aphthous stomatitis . OBJECTIVE To evaluate pentoxifylline for the treatment of recurrent aphthous stomatitis . DESIGN A 60-day , randomized , double-blind , placebo-controlled trial with a 60-day no treatment follow-up . SETTING An oral medicine specialist referral center in Manchester . PARTICIPANTS Forty-nine volunteers who passed the initial assessment for recurrent aphthous stomatitis entered a pretrial phase in which their eligibility for the trial phase of the study was assessed . Sixteen subjects were deemed ineligible , and 7 failed to attend or withdrew . The remaining 26 subjects were randomized to placebo or treatment . Six subjects withdrew because of adverse effects , and 1 was unavailable for follow-up . INTERVENTION Pentoxifylline ( also called oxpentifylline ) , 400 mg 3 times daily , or matching placebo . MAIN OUTCOME MEASURE A reduction in the median pain score , ulcer size , number of ulcers , or total number of ulcer episodes . RESULTS Patients taking pentoxifylline had less pain and reported smaller and fewer ulcers compared with baseline . 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 ( P = .05 ) , did not reach statistical significance . Adverse effects were common with pentoxifylline , but not significantly different from those experienced by patients taking placebo . CONCLUSIONS Although pentoxifylline may have some benefit in the treatment of recurrent aphthous stomatitis , the benefit is limited . It may have a role in the treatment of patients unresponsive to other treatments , but can not yet be recommended as a first-line treatment .
30707
Intervention_Control
placebo-controlled
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Intervention_Pharmacological
pentoxifylline
30709
Intervention_Pharmacological
pentoxifylline
30710
Intervention_Control
placebo-controlled
30711
Intervention_Pharmacological
Pentoxifylline
30712
Intervention_Control
placebo
30713
Intervention_Pharmacological
pentoxifylline
30714
Intervention_Control
placebo
30715
Intervention_Pharmacological
pentoxifylline
30716
Intervention_Control
placebo
30717
Intervention_Pharmacological
pentoxifylline
30718
Intervention_Control
placebo
30719
Intervention_Pharmacological
pentoxifylline
30720
Outcome_Pain
median pain score
30721
Outcome_Physical
ulcer size
30722
Outcome_Physical
number of ulcers
30723
Outcome_Physical
total number of ulcer episodes
30724
Outcome_Pain
less pain
30725
Outcome_Physical
smaller and fewer ulcers
30726
Outcome_Physical
no improvement
30727
Outcome_Physical
more ulcer-free days
30728
Outcome_Physical
differences were small
30729
Outcome_Physical
did not reach statistical significance
30730
Outcome_Adverse-effects
Adverse effects
30731
Outcome_Other
not significantly different
30732
Participant_Condition
aphthous stomatitis
30733
Participant_Sample-size
Forty-nine
30734
Participant_Condition
aphthous stomatitis
30735
Participant_Sample-size
Sixteen
30736
Participant_Sample-size
26