CHARLOTTESVILLE, Va., Oct. 10 -- Topiramate (Topamax), a migraine agent, appeared to help alcoholic patients curtail their heavy-drinking behavior, according to investigators here.

When used off-label in a randomized trial sponsored by the drug-maker, Ortho-McNeil Janssen, topiramate led to a reduction in the percentage of heavy drinking days, compared with placebo, Bankole A. Johnson D. Sc., M.D., Ph.D., of the University of Virginia, and colleagues at 16 other sites, reported in the Oct. 10 issue of the Journal of the American Medical Association.

These findings showed that individuals while drinking heavily can still be treated safely and reliably with topiramate, the researchers wrote. Unlike other drugs, establishing abstinence before starting treatment was not required.

The JAMA report, particularly an associated press package issued by the university, triggered an impassioned protest by Sidney Wolfe, M.D., of Public Citizen, the drug-safety advocacy group. He complained to the FDA that a question-and-answer sheet for journalists amounted to illegal off-label promotion for topiramate.

"It is not the research or the publication of the study that is illegal but the promotional material that goes beyond the research to solicit new sales for the drug," said Dr. Wolfe.