title: Randomized clinical trial of imiquimod: an adjunct to treating cervical dysplasia.
abstract: OBJECTIVE
  Human papillomavirus (HPV) infection is a major risk factor for cervical cancer. Imiquimod is a topical medication that enhances the immune response to HPV-induced genital warts. This study evaluated cervical application of imiquimod as an adjunct to standard treatment for cervical dysplasia.
  
  
  METHODS
  Fifty-six patients were randomized to standard excisional/ablative treatment vs applications of imiquimod followed by standard treatment. The primary endpoint was dysplasia recurrence within 2 years.
  
  
  RESULTS
  There were no differences in dysplasia recurrence between the 2 groups. Treatment was well tolerated, with side effects being mild but significantly worse in women receiving imiquimod for, chills, fatigue, fever, headache, myalgias, and vaginal discharge.
  
  
  CONCLUSIONS
  This trial does not support the hypothesis that imiquimod, as used in this trial, has an impact on recurrence of cervical dysplasia, but the adequacy of findings are limited by sample size. The trial does support the feasibility and acceptability of the use of imiquimod on the cervix.
authors: Department of Medicine, Mayo Clinic, Rochester, MN 55905, USA.
authors: Deirdre R
authors: DR
authors: Pachman
authors: Debra L
authors: DL
authors: Barton
authors: Amy C
authors: AC
authors: Clayton
authors: Renee M
authors: RM
authors: McGovern
authors: John A
authors: JA
authors: Jefferies
authors: Paul J
authors: PJ
authors: Novotny
authors: Jeff A
authors: JA
authors: Sloan
authors: Charles L
authors: CL
authors: Loprinzi
authors: Bobbie S
authors: BS
authors: Gostout
mesh_terms: D000328:Adult; D000634:Aminoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use; D003218:Condylomata Acuminata / Q000188:drug therapy / Q000821:virology; D004333:Drug Administration Routes; D005260:Female; D006801:Humans; D000077271:Imiquimod; D030361:Papillomavirus Infections / Q000188:drug therapy / Q000601:surgery; D012720:Severity of Illness Index; D016896:Treatment Outcome; D002578:Uterine Cervical Dysplasia / Q000188:drug therapy* / Q000601:surgery / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000601:surgery / Q000821:virology; D055815:Young Adult
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000998:Antiviral Agents; D000077271:Imiquimod