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Previous Volume 336:1487-1493 May 22, 1997 Number 21 Next

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ABSTRACT

Background In patients with advanced human immunodeficiency virus (HIV) infection, aphthous ulceration of the mouth and oropharynx can become extensive and debilitating. Preliminary reports suggest that thalidomide may promote the healing of oral aphthous ulcers.

Methods We performed a double-blind, randomized, placebo-controlled study of thalidomide as therapy for oral aphthous ulcers in HIV-infected patients. The patients received a four-week course of either 200 mg of thalidomide or placebo orally once per day. They were evaluated weekly for the condition of the ulcers, their quality of life, and evidence of toxicity. Assays were performed for plasma tumor necrosis factor (TNF-), soluble TNF- receptors, and HIV RNA.

Results Sixteen of 29 patients in the thalidomide group (55 percent) had complete healing of their aphthous ulcers after four weeks, as compared with only 2 of 28 patients in the placebo group (7 percent; odds ratio, 15; 95 percent confidence interval after adjustment for group sequential testing, 1.8 to 499; unadjusted P<0.001). Pain diminished and the ability to eat improved with thalidomide treatment. The adverse effects noted with thalidomide included somnolence and rash (7 patients each), and 6 of the 29 patients discontinued treatment because of toxicity. Thalidomide treatment increased HIV RNA levels (median increase, 0.42 log₁₀ copies per milliliter; increase with placebo, 0.05; P = 0.04). With thalidomide treatment there were unexpected increases in the plasma concentrations of TNF- and soluble TNF- receptors.

Conclusions Thalidomide is an effective treatment for aphthous ulceration of the mouth and oropharynx in patients with HIV infection.

Source Information

From the Departments of Medicine, Bronx Veterans Affairs Medical Center and Mount Sinai School of Medicine, New York (J.M.J.); the Department of Stomatology, University of California at San Francisco, San Francisco (J.S.G., L.A.M.); the Statistical and Data Analysis Center, Harvard School of Public Health, Boston (J.S., M.C.); the Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Md. (N.K., L.F.); the Department of Medicine, University of California at Los Angeles, Los Angeles (J.L.F.); the Departments of Pathology (J.B.J.) and Medicine (A.W.W.), Johns Hopkins University School of Medicine, Baltimore; the Department of Medicine, University of Puerto Rico Medical School, San Juan (G.J.V.); and the Department of Medicine, University of North Carolina, Chapel Hill (D.A.W.).

Address reprint requests to Dr. Jacobson at the Bronx Veterans Affairs Medical Center, 130 W. Kingsbridge Rd., Bronx, NY 10468.

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Thalidomide for Aphthous Ulcers in HIV Infection
Birnkrant D., Jacobson J. M., Greenspan J. S., Spritzler J.
Extract | Full Text  
N Engl J Med 1997; 337:1086-1087, Oct 9, 1997. Correspondence

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