title: Acyclovir given as prophylaxis against oral ulcers in acute myeloid leukaemia: randomised, double blind, placebo controlled trial.
abstract: OBJECTIVE
  To evaluate (a) the prophylactic effect of the antiherpetic drug acyclovir on oral ulcers in patients with acute myeloid leukaemia receiving remission induction chemotherapy and thus (b), indirectly, the role of herpes simplex virus in the aetiology of these ulcers.
  
  
  METHODS
  Randomised, double blind, placebo controlled trial.
  
  
  METHODS
  74 herpes simplex virus seropositive patients aged 18-84. Thirty seven patients received acyclovir (800 mg by mouth daily) and 37 placebo. The patients were examined daily for 28 days.
  
  
  METHODS
  Occurrence of herpes labialis, intraoral ulcers, and acute necrotising ulcerative gingivitis.
  
  
  RESULTS
  The two populations were comparable in age, sex, type of antineoplastic treatment, and history of herpes labialis. Acute oral infections occurred in 25 of the acyclovir treated patients and 36 of the placebo treated patients (relative risk 0.69 (95% confidence interval 0.55 to 0.87)). This difference was due to a reduction in the incidence of herpes labialis (one case versus eight cases; relative risk 0.13 (0.02 to 0.95)), intraoral ulcers excluding the soft palate (one case versus 13 cases; relative risk 0.08 (0.01 to 0.56)), and acute necrotising ulcerative gingivitis (one case versus eight cases; relative risk 0.13 (0.02 to 0.95)). However, ulcers on the soft palate were diagnosed with similar frequency in the two groups. Isolation of herpes simplex virus type 1 in saliva was reduced from 15 cases in the placebo group to one case in the acyclovir group (relative risk 0.07 (0.01 to 0.48)).
  
  
  CONCLUSIONS
  Intraoral ulcers excluding the soft palate are most often due to infection with herpes simplex virus, whereas ulcers on the soft palate have a non-herpetic aetiology. The findings suggest that acute necrotising ulcerative gingivitis may also be due to herpes simplex virus. Prophylaxis with acyclovir should be considered for patients with acute myeloid leukaemia during remission induction therapy.
authors.affiliation: Department of Medicine and Haematology, Aarhus University Hospital, Amtssygehuset, Denmark.
authors.forename: O J
authors.initials: OJ
authors.lastname: Bergmann
authors.forename: S
authors.initials: S
authors.lastname: Ellermann-Eriksen
authors.forename: S C
authors.initials: SC
authors.lastname: Mogensen
authors.forename: J
authors.initials: J
authors.lastname: Ellegaard
mesh_terms: D000208:Acute Disease; D000212:Acyclovir / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D005892:Gingivitis, Necrotizing Ulcerative / Q000517:prevention & control; D006560:Herpes Labialis / Q000517:prevention & control; D006561:Herpes Simplex / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D007951:Leukemia, Myeloid / Q000150:complications* / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009059:Mouth Diseases / Q000517:prevention & control* / Q000821:virology; D009894:Opportunistic Infections / Q000150:complications / Q000517:prevention & control*; D013283:Stomatitis, Herpetic / Q000517:prevention & control; D014456:Ulcer / Q000517:prevention & control / Q000821:virology
chemical_list: D000212:Acyclovir