62051
document
Comparative study of actinic keratosis treatment with 3 % diclofenac sodium and 5 % 5-fluorouracil . 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 . OBJECTIVES 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 . CONCLUSION We concluded that 5-Fluorouracil was more effective ; however , it showed lower tolerability than diclofenac sodium .
62052
Intervention_Pharmacological
3 % diclofenac sodium
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Intervention_Pharmacological
5 % 5-fluorouracil
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Intervention_Pharmacological
Diclofenac sodium
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Intervention_Pharmacological
5-Fluorouracil
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Intervention_Pharmacological
3 % diclofenac sodium
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Intervention_Pharmacological
2.5 % hyaluronic acid
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Intervention_Pharmacological
5 % 5-Fluorouracil
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Intervention_Pharmacological
diclofenac sodium
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Intervention_Pharmacological
5-Fluorouracil
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Intervention_Pharmacological
diclofenac sodium
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Intervention_Pharmacological
5-Fluorouracil
62063
Intervention_Pharmacological
5-Fluorouracil
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Intervention_Pharmacological
diclofenac
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Intervention_Pharmacological
5-Fluorouracil
62066
Intervention_Pharmacological
diclofenac
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Intervention_Pharmacological
5-Fluorouracil
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Intervention_Pharmacological
diclofenac sodium
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Intervention_Pharmacological
5-Fluorouracil
62070
Intervention_Pharmacological
5-Fluorouracil
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Intervention_Pharmacological
diclofenac sodium
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Outcome_Other
assess and compare the effectiveness
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Outcome_Physical
Modified versions of the Investigator and Patient Global Improvement Scores
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Outcome_Physical
average number of lesions
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Outcome_Other
in the diclofenac sodium group before and after treatment
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Outcome_Other
number of lesions in the 5-Fluorouracil group
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Outcome_Physical
therapeutic response
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Outcome_Adverse-effects
adverse effects
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Outcome_Adverse-effects
Erythema , edema , crusts and itching
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Participant_Condition
actinic keratosis
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Participant_Condition
Actinic keratosis
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Participant_Sample-size
28 patients