Hard liver, soft results.

Hard liver, soft results

Researchers last week reported dramatically positive results for an experimental therapy against liver cirrhosis -- a leading cause of death in the United States and a major worldwide health problem for which no effective treatment exists. But enthusiasm for the findings was tempered by the possibility that random factors might have influenced results of the research, which is the largest, most thorough study of colchicine for cirrhosis.

Cirrhosis of the liver, usually the result of chronic viral infection (such as hepatitis) or alcoholism, involves the gradual fibrosis, or "hardening," of liver tissue. Researchers from four medical centers in Mexico City and Canada followed 100 cirrhosis patients for 14 years. About half the patients were treated with oral doses of colchicine, an anti-inflammatory drug used for gout; the rest received placebo.

As reported in the June 30 NEW ENGLAND JOURNAL OF MEDICINE, the median survival time after 14 years was 3.5 years in the placebo group and 11 years in the colchicine group. Deaths from liver failure were 24 percent and 15 percent respectively. But significant differences in pre-existing medical problems between the two groups, lack of nutritional data and a loss of 20 percent of the patients to follow-up -- with no clue as to whether they were alive or dead at the end of the study -- "weaken an endorsement of what is otherwise the most impressive outcome yet described for any treatment of patients with cirrhosis," say Yale physicians James L. Boyer and David F. Ransohoff in an accompanying editorial.