Recurrent gallstones are the limiting factor for every non surgical tr
eatment. In order to determine the optimal prevention therapy, 30 pati
ents after successful dissolution therapy of microcholelithiasis (MCL)
with ursodeoxycholic acid (UDCA), were randomized by the double blind
method to receive UDCA therapy. This was administered either as 150 m
g (N = 15, group I) or 300 mg per day (N = 15, group Il). There was a
follow-up period of 12 months with clinical examination every month an
d upper abdominal sonography on days 180 and 360. Recurrent gallstones
, after a 12-month period, was 6.7% (1/15) in group II versus 66% (10/
15) in group I (P < 0.005). When recurrence was examined according to
the number of gallstones, it reached 8% (1/12) in the solitary MCL vs
55.5% (10/18) in multiple MCL (P < 0.005). The recurrence was always s
ymptomatic (biliary pain) and developed in 11 out of 30 pts, as MCL in
7 and as biliary sludge in the remainder 4. We conclude that a daily
dose of 300 mg of UDCA was effective in reducing the recurrent gallsto
nes in more than 90% of cases treated for 12 months. The significant r
isk factors associated with recurrence were the UDCA low dose and mult
iple stones. Biliary sludge represented 36% of the recurrence.