Oral beclomethasone dipropionate for treatment of intestinal graft-versus-host disease: a randomized, controlled trial.
OBJECTIVE
Beclomethasone dipropionate (BDP), a topically active steroid, seemed to be an effective treatment for intestinal graft-versus-host disease (GVHD) in a phase I study. The aim of this study was to compare the effectiveness of oral BDP to that of placebo capsules in treatment of intestinal GVHD.


METHODS
Sixty patients with anorexia and poor oral intake because of intestinal GVHD were randomized to receive prednisone (1 mg.kg-1.day-1) plus either oral BDP (8 mg/day) or placebo capsules. Initial responders who were eating at least 70% of caloric needs at evaluation on day 10 continued to take study capsules for an additional 20 days while the prednisone dose was rapidly tapered. The primary end point was the frequency of a durable treatment response at day 30 of treatment.


RESULTS
The initial treatment response at day 10 was 22 of 31 (71%) in the BDP/prednisone group vs. 16 of 29 (55%) for the placebo/prednisone group. The durable treatment response at day 30 was 22 of 31 (71%) vs. 12 of 29 (41%), respectively (P = 0.02).


CONCLUSIONS
The combination of oral BDP capsules and prednisone was more effective than prednisone alone in treating intestinal GVHD. Oral BDP allowed prednisone doses to be rapidly tapered without recurrent intestinal symptoms.
McDonald
G B
GB
Gastroenterology/Hepatology Section, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Bouvier
M
M
Hockenbery
D M
DM
Stern
J M
JM
Gooley
T
T
Farrand
A
A
Murakami
C
C
Levine
D S
DS
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006086:Graft vs Host Disease / Q000188:drug therapy*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use
D001507:Beclomethasone; D011241:Prednisone