ACYCLOVIR GIVEN AS PROPHYLAXIS AGAINST ORAL ULCERS IN ACUTE MYELOID-LEUKEMIA - RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Objectives-To evaluate (a) the prophylactic effect of the antiherpetic drug acyclovir on oral ulcers in patients with acute myeloid leukaemi a receiving remission induction chemotherapy and thus (b), indirectly, the role of herpes simplex virus in the aetiology of these ulcers. De sign-Randomised, double blind, placebo controlled trial. Subjects-74 h erpes simplex virus seropositive patients aged 18-84. Thirty seven pat ients received acyclovir (800 mg by mouth daily) and 37 placebo. The p atients were examined daily for 28 days. Main outcome measures-Occurre nce of herpes labialis, intraoral ulcers, and acute necrotising ulcera tive gingivitis. Results-The two populations were comparable in age, s ex, 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% confi dence interval 0.55 to 0.87)). This difference was due to a reduction in the incidence of herpes labialis (one case versus eight cases; rela tive risk 0.13 (0.02 to 0.95)), intraoral ulcers excluding the soft pa late (one case versus 13 cases; relative risk 0.08 (0.01 to 0.56)), an d acute necrotising ulcerative gingivitis (one case versus eight cases ; relative risk 0.13 (0.02 to 0.95)). However, ulcers on the soft pala te 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)). Conclusion-Intraoral ulcers excluding the soft pal ate 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 consider ed for patients with acute myeloid leukaemia during remission inductio n therapy.