In a double-blind study, we examined the efficacy of
allopurinol in the prevention of recurrent
calcium oxalate calculi of the kidney. Sixty patients with hyperuricosuria and normocalciuria who had a history of
calculi were randomly assigned to receive either
allopurinol (100 mg three times daily) or a placebo. After the study, the placebo group had 63.4 percent fewer
calculi (P less than 0.001), whereas the
allopurinol group had 81.2 percent fewer
calculi (P less than 0.001). During the study period, the mean rate of calculous events was 0.26 per patient per year in the placebo group and 0.12 in the
allopurinol group. When the treatment groups were compared by actuarial analysis, the
allopurinol group was found to have a significantly longer time before recurrence of
calculi (P less than 0.02). We conclude that
allopurinol is effective in the prevention of
calcium oxalate stones in patients with hyperuricosuria. The large reduction in the frequency of
calculi in the placebo group underscores the positive treatment bias that regularly occurs in trials of prophylaxis against
renal calculi when historical controls are used.