Maintenance therapy with colloidal bismuth subcitrate reduces duodenal ulcer relapse.
OBJECTIVE
To investigate the efficacy and safety of daily low-dose colloidal bismuth subcitrate in reducing duodenal ulcer relapse.


METHODS
Double-blind, double-dummy group comparative clinical trial with random allocation. Healing Phase: colloidal bismuth subcitrate 240 mg twice daily vs ranitidine 150 mg twice daily for up to 12 weeks. Maintenance Phase: nightly, colloidal bismuth subcitrate 120 mg vs ranitidine 150 mg vs placebo for up to 12 months (high-risk patients received active treatment only).


RESULTS
clinical, endoscopy, random blood bismuth levels (and rapid urease test for Helicobacter pylori in a subgroup).


METHODS
194 with active duodenal ulcer.


RESULTS
Cumulative healing at 12 weeks was 93% on colloidal bismuth subcitrate (of 92 patients) and 97% on ranitidine (of 102 patients). Relapse at 1 year was significantly less on active treatment as follows: placebo (50 patients) 60%; ranitidine (71 patients) 21%; colloidal bismuth subcitrate (64 patients) 33%. This was independent of the results of the rapid urease test which was positive in 78%, 88% and 76% of the patients respectively. Treatment was well tolerated. The highest median blood bismuth level (mcg/L) was 25 in the healing phase and fluctuated between 6 and 10 in the maintenance phase.


CONCLUSIONS
Colloidal bismuth subcitrate, 120 mg nightly, is effective in reducing duodenal ulcer relapse and is well tolerated.
Bardhan
K D
KD
Rotherham General Hospital NHS Trust, South Yorkshire, UK.
Singh
S
S
Morris
P
P
Thompson
M
M
Hinchliffe
R F
RF
Cary
B A
BA
Wall
R M
RM
Blakemore
C B
CB
D000328:Adult; D000368:Aged; D000863:Antacids / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001729:Bismuth / Q000627:therapeutic use*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy / Q000503:physiopathology; D016480:Helicobacter pylori / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000627:therapeutic use*; D011899:Ranitidine / Q000627:therapeutic use*; D012008:Recurrence
D000863:Antacids; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D011899:Ranitidine; C002791:bismuth tripotassium dicitrate; D001729:Bismuth