Between October 1988 and December 1990, 60 patients with leukaemia (25
with AML, 19 ALL and 16 CML) undergoing BMT were randomised in a doub
le-blind clinical trial to receive prostaglandin E2 (PGE) (Prostin E2,
0.5 mg per tablet) or placebo for prophylaxis of oral mucositis. Pati
ents had to dissolve tablets in the mouth three times daily starting 7
days before BMT and continuing until 21 days after BMT. The incidence
of severe oral mucositis was similar for both groups, 55% in patients
receiving PGE and 52% in patients receiving placebo. The duration of
severe mucositis did not differ between PGE and placebo groups (chi-sq
uare 0.95, p = NS). The incidence of HSV infection was significantly h
igher in patients receiving PGE. Patients with HSV infection receiving
PGE also had a higher incidence of severe oral mucositis. The results
presented indicate that PGE is not effective for prophylaxis of oral
mucositis in BMT recipients.