Folic acid supplementation prevents phenytoin-induced gingival overgrowth in children

Neurology
Q1
Apr 2011
Citations:49
Influential Citations:5
Interventional (Human) Studies
89
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Methods
Randomized, double-blind, placebo-controlled trial; 120 children aged 6-15 years with epilepsy on phenytoin monotherapy started within 1 month prior to enrollment; 62 assigned to folic acid and 58 to placebo. Exclusions: preexisting gingival overgrowth due to other causes, macrocytic anemia, and concomitant therapy with other folic acid antagonists.
Intervention
0.5 mg/day folic acid, oral, for 6 months.
Results
Folic acid 0.5 mg/day reduced incidence of phenytoin-induced gingival overgrowth from 88% (placebo) to 21% (folic acid) after 6 months (p<0.001). Absolute risk reduction 67% (95% CI 53.8%-80.1%); relative risk reduction 0.76; number to treat ≈1.5. Severe overgrowth (grade ≥2) decreased from 13.8% to 3.2% (p=0.036). Plaque index remained similar between groups; dose or serum phenytoin levels did not predict PIGO in the folic acid group. Conclusion: Daily folic acid supplementation should be considered to minimize PIGO in children on phenytoin monotherapy.
Limitations
Single-centre; short duration (6 months); lack of dental photographs for objective assessment; folate levels not measured; some protocol violations and dose adjustments; generalizability limited to pediatric phenytoin users.

Abstract

Objective: Gingival overgrowth is an important adverse effect of phenytoin (PHT) therapy, occurring in about half of the patients. This study aimed to evaluate the effect of oral folic acid supplementation (0.5 mg/day) for the prevention of PHT-induc...