By DAVID WILLIAMSON
UNC-CH News Services
CHAPEL HILL -- Thalidomide, the notorious drug that caused severe malformations in thousands of newborn infants more than a generation ago, safely and effectively heals mouth ulcers among people infected with the virus that causes AIDS, a new study concludes.
The study, published in Thursday's (May 22) New England Journal of Medicine, involved treating 29 HIV-positive patients complaining of painful mouth sores with thalidomide. Twenty-eight other patients received an inactive compound, or placebo.
Within four weeks, ulcers in 16 of 29 people who received the drug had healed completely. Only two of the 28 people receiving placebo showed ulcer healing. Thalidomide treatment also reduced pain the ulcers caused and boosted patients' ability to eat.
Ninety percent of treatment group volunteers showed at least partial healing, and some healed completely within one week of receiving 200 milligrams of the drug daily.
Authors of the journal report include Drs. Jeffrey M. Jacobson of the Bronx Veterans Affairs Medical Center and David A. Wohl of the University of North Carolina at Chapel Hill School of Medicine. Scientists and patients at Johns Hopkins and Harvard universities, the universities of California at San Francisco and Los Angeles and other institutions also participated.
"From this study we learned that thalidomide, probably the most notorious drug ever marketed in modern times, is clearly beneficial to people with this devastating problem," said Wohl, research associate in infectious diseases at UNC-CH. "Several of our patients were about to have tubes put in their stomachs because they were no longer able to eat. We used thalidomide successfully with these patients, and it helped them greatly by allowing them to eat on their own and to leave the hospital."
Wohl and his UNC-CH colleagues enrolled 13 of 57 patients treated nationwide, more than any other institution.
Seven patients said the thalidomide caused sleepiness, and seven others experienced rashes, he said. Six people in the treatment group dropped out of the study because of side effects, but most could be managed well by reducing the dose. No significant differences were found between the treated and non-treated groups in serious side effects, which were minimal.
Dr. Charles van der Horst, director of the AIDS Clinical Trials Unit at UNC-CH, collaborated with Wohl.
Since the long-term side effects of thalidomide in people with HIV infection are not yet known, Wohl and his colleagues urged caution in using the drug for more than the two to four weeks needed to heal the ulcers. Why the ulcers occur is not known, but possible causes include viruses, immune system changes, hormones and stress.
Clinicians counseled the seven women in the study about the drug's power to cause birth defects and made them promise to use two to three birth control methods simultaneously if they engaged in sex. Men also received counseling about the hazards.
The AIDS Clinical Trials Group, the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources supported the research.
Thalidomide, a sedative, originally was marketed as a safe alternative to barbiturates for people who were anxious or could not sleep.
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Note: Wohl and van der Horst can be reached at (919) 966-2536. Wohl's pager
number is 216-0629.
Contact: David Williamson