Thalidomide for the treatment of esophageal aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Disease AIDS Clinical Trials Group.
A multicenter, double-blind, randomized, placebo-controlled clinical trial was conducted to determine the safety and efficacy of thalidomide for treating esophageal aphthous ulceration in persons infected with human immunodeficiency virus (HIV). Twenty-four HIV-infected patients with biopsy-confirmed aphthous ulceration of the esophagus were randomly assigned to receive either oral thalidomide, 200 mg/day, or oral placebo daily for 4 weeks. Eight (73%) of 11 patients randomized to receive thalidomide had complete healing of aphthous ulcers at the 4-week endoscopic evaluation, compared with 3 (23%) of 13 placebo-randomized patients (odds ratio, 13.82; 95% confidence interval, 1.16-823.75; P=.033). Odynophagia and impaired eating ability caused by esophageal aphthae were improved markedly by thalidomide treatment. Adverse events among patients receiving thalidomide included somnolence (4 patients), rash (2 patients), and peripheral sensory neuropathy (3 patients). Thalidomide is effective in healing aphthous ulceration of the esophagus in patients infected with HIV.
Jacobson
J M
JM
Mount Sinai Medical Center, New York, NY 10029, USA. jeffrey_jacobson@smtplink.mssm.edu
Spritzler
J
J
Fox
L
L
Fahey
J L
JL
Jackson
J B
JB
Chernoff
M
M
Wohl
D A
DA
Wu
A W
AW
Hooton
T M
TM
Sha
B E
BE
Shikuma
C M
CM
MacPhail
L A
LA
Simpson
D M
DM
Trapnell
C B
CB
Basgoz
N
N
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications; D000328:Adult; D015703:Antigens, CD / Q000032:analysis; D004311:Double-Blind Method; D004935:Esophageal Diseases / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D005006:Ethnicity; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D008297:Male; D010919:Placebos; D011788:Quality of Life; D018124:Receptors, Tumor Necrosis Factor / Q000032:analysis; D047889:Receptors, Tumor Necrosis Factor, Type II; D013281:Stomatitis, Aphthous / Q000188:drug therapy; D013792:Thalidomide / Q000009:adverse effects / Q000627:therapeutic use*; D014409:Tumor Necrosis Factor-alpha / Q000032:analysis; D014456:Ulcer / Q000150:complications / Q000188:drug therapy*; D014481:United States
D015703:Antigens, CD; D010919:Placebos; D018124:Receptors, Tumor Necrosis Factor; D047889:Receptors, Tumor Necrosis Factor, Type II; D014409:Tumor Necrosis Factor-alpha; D013792:Thalidomide