title: Comparative study of actinic keratosis treatment with 3% diclofenac sodium and 5% 5-fluorouracil.
abstract: BACKGROUND
  Actinic keratosis is a frequent lesion which occurs in sunlight exposed areas. Diclofenac sodium and 5-Fluorouracil are effective, non-invasive and easy-to-apply topical treatment options.
  
  
  OBJECTIVE
  To assess and compare the effectiveness of 3% diclofenac sodium associated with 2.5% hyaluronic acid and of 5% 5-Fluorouracil for the treatment of actinic keratosis, as well as the patient's degree of satisfaction and tolerability.
  
  
  METHODS
  28 patients with a clinical diagnosis of actinic keratosis were randomized to receive diclofenac sodium or 5-Fluorouracil and were clinically assessed before and after treatment as well as 8 weeks after the end of treatment. Modified versions of the Investigator and Patient Global Improvement Scores were used.
  
  
  RESULTS
  The average number of lesions in the diclofenac sodium group before and after treatment was 13.6 and 6.6 (p<0,001), respectively, while it was 17.4 and 3.15 (p<0.001) in the 5-Fluorouracil group. There was a significant reduction in the number of lesions in the 5-Fluorouracil group in relation to the diclofenac sodium group (p<0.001). To the non-blinded physician, there was a higher satisfactory therapeutic response in the 5-Fluorouracil group (p<0.001); to the blinded physician, there was a higher satisfactory response in this same group, although not statistically significant (p=0.09). There was a high degree of satisfaction in both groups (73% in the diclofenac sodium group and 77% in the 5-Fluorouracil group; p=0.827). Regarding adverse effects, the diclofenac sodium group presented a higher degree of satisfaction (93.3% vs 38.4%; p=0.008). Erythema, edema, crusts and itching were significantly higher in the 5-Fluorouracil group.
  
  
  CONCLUSIONS
  We concluded that 5-Fluorouracil was more effective; however, it showed lower tolerability than diclofenac sodium.
authors.affiliation: Federal University of Health Sciences of Porto Alegre, Porto AlegreRS, Brazil.
authors.forename: Majoriê Mergen
authors.initials: MM
authors.lastname: Segatto
authors.forename: Sérgio Ivan Torres
authors.initials: SI
authors.lastname: Dornelles
authors.forename: Vera Bauer
authors.initials: VB
authors.lastname: Silveira
authors.forename: Gabriela de Oliveira
authors.initials: Gde O
authors.lastname: Frantz
mesh_terms: D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D004008:Diclofenac; D005472:Fluorouracil