bismuth-tripotassium-dicitrate and Pain

Randomised trials have shown that duodenal ulcers treated by H2 blockers heal faster if Helicobacter pylori is eradicated concurrently. It remains unknown whether eradication of H pylori without suppression of acid-secretion, is sufficient to allow healing. 153 patients with H pylori infection and duodenal ulcer were randomised to receive either a 1-week course of bismuth subcitrate, tetracycline, and metronidazole (76), or omeprazole for 4 weeks with the same three-drug regimen for the first week (77). Endoscopy and antral biopsies were done at entry and 4 weeks after treatment. 132 patients were suitable for analysis. Duodenal ulcers healed in 60 (92%; 95% CI 86-100%) patients taking bismuth, tetracycline, and metronidazole compared with 63 (95%; 88-100%) taking omeprazole in addition to the three other drugs. H pylori was eradicated in 61 (94%; 88-100%) who received only three drugs compared with 66 (98%; 96-100%) who received omeprazole as well. Symptoms were reduced more effectively during the first week in patients who received omeprazole (p = 0.003). We conclude that a 1-week regimen of bismuth, tetracycline, and metronidazole for patients with H pylori and duodenal ulcer eradicates the organism and heals the ulcer in most patients. Concurrent administration of omeprazole reduces ulcer pain more rapidly but has no effect on ulcer healing.

Topics: Adult; Aged; Antacids; Biopsy; Drug Resistance, Microbial; Drug Therapy, Combination; Duodenal Ulcer; Endoscopy, Gastrointestinal; Female; Helicobacter Infections; Helicobacter pylori; Humans; Male; Metronidazole; Middle Aged; Omeprazole; Organometallic Compounds; Pain; Stomach Diseases; Tetracycline; Wound Healing

Topics: Adult; Aged; Antacids; Anti-Ulcer Agents; Bismuth; Cimetidine; Clinical Trials as Topic; Double-Blind Method; Female; Guanidines; Humans; Male; Middle Aged; Organometallic Compounds; Pain; Placebos; Recurrence; Stomach Ulcer

Colloidal bismuth subcitrate (CBS, DE-NOL) and cimetidine have been compared in a double-blind randomized trial in the management of 75 patients with duodenal ulcer. The drugs had similar potency with respect to ulcer healing. At one month the healing rates were 66% for CBS and 59% for cimetidine. At two months the rates were 89% and 85% respectively. When the drugs were withdrawn patients who had received CBS had significantly lower relapse rates than those who had received cimetidine. Relapse rates for CBS and cimetidine were 13% and 70% at six months and 39% and 85% at one year respectively.

Topics: Adolescent; Adult; Aged; Antacids; Anti-Ulcer Agents; Bismuth; Cimetidine; Clinical Trials as Topic; Double-Blind Method; Duodenal Ulcer; Female; Guanidines; Humans; Male; Middle Aged; Organometallic Compounds; Pain; Recurrence; Time Factors

A randomized, double-blind, double-dummy comparative 6-week study of tri-potassium di-citrato bismuthate (TDB) (Ulcerone; De-Nol) chewing tables and cimetidine was carried out in 60 patients suffering from duodenal ulceration. The data on 51 patients (27 on TDB and 24 on cimetidine) were analysed (9 patients absconded). Both treatments appeared to be highly effective in ulcer healing at the 6-week endoscopic assessment. The healing rate for TDB chewing tablets was 89% and that for cimetidine tablets 92%. Both forms of therapy were comparable in respect of improvement of pain and effect on all other observed symptoms. Neither drug had a statistically significant effect on any of the haematological or clinical chemical parameters tested during the trial, except that the cimetidine-treated group showed a significant linear reduction in white blood cell count. No side-effects were reported. It is suggested that TDB chewing tablets are a safe, effective and cheaper alternative to cimetidine in the treatment of patients with duodenal ulceration.

Topics: Adult; Bismuth; Cimetidine; Clinical Trials as Topic; Double-Blind Method; Duodenal Ulcer; Female; Guanidines; Humans; Male; Middle Aged; Organometallic Compounds; Pain; Random Allocation; Smoking; Time Factors

Topics: Adult; Aged; Amoxicillin; Campylobacter Infections; Drug Therapy, Combination; Female; Gastritis; Humans; Male; Middle Aged; Organometallic Compounds; Pain; Tinidazole