Polypodium leucotomos extract in atopic dermatitis: a randomized, double-blind, placebo-controlled, multicenter trial

Actas Dermosifiliogr. 2012 Sep;103(7):599-607. doi: 10.1016/j.ad.2012.01.008. Epub 2012 May 3.
[Article in En, Spanish]

Abstract

Introduction: Topical corticosteroids are used to treat inflammation and relieve itching in atopic dermatitis, but their use is limited by adverse reactions.

Objectives: The main aim of this study was to investigate whether daily treatment with Polypodium leucotomos extract would reduce the use of topical corticosteroids in children and adolescents with atopic dermatitis. We also analyzed oral antihistamine use and changes in disease severity.

Patients and methods: We performed a phase IV randomized, double-blind, placebo-controlled, multicenter trial involving 105 patients aged between 2 and 17 years who were receiving topical corticosteroids to treat moderate atopic dermatitis. The patients were randomized to receive, in addition to their standard treatment, Polypodium leucotomos extract or placebo (both in capsule form) for 6 months. The percentage of days on which topical corticosteroids and other atopic dermatitis treatments were used was calculated.

Results: Use of Polypodium leucotomos extract did not significantly reduce the mean (SD) percentage of days on which topical corticosteroids were used (11% [12%] vs 12% [11%] for placebo). A significant reduction was, however, observed for oral histamine use (median percentage of days, 4.5% in the Polypodium leucotomos group and 13.6% in the placebo group [P= .038]). The percentage of patients who used oral antihistamines was also lower in the Polypodium leucotomos group.

Conclusion: Long-term treatment with Polypodium leucotomos extract has benefits for children and adolescents with atopic dermatitis who require pharmacologic treatment to reduce inflammation and relieve itching.

Publication types

  • Clinical Trial, Phase IV
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Administration, Oral
  • Adolescent
  • Child
  • Child, Preschool
  • Dermatitis, Atopic / drug therapy*
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Histamine Antagonists / administration & dosage
  • Histamine Antagonists / therapeutic use
  • Humans
  • Infant
  • Male
  • Methylprednisolone / administration & dosage
  • Methylprednisolone / analogs & derivatives
  • Methylprednisolone / therapeutic use
  • Phytotherapy*
  • Plant Extracts / administration & dosage
  • Plant Extracts / therapeutic use*
  • Polypodium*
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Histamine Antagonists
  • Plant Extracts
  • methylprednisolone aceponate
  • Methylprednisolone