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KMID : 0378019860290080129
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New Medical Journal
1986 Volume.29 No. 8 p.129 ~ p.132
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A Double-blind Study of Tri-potassium Dicitrato Bismuthate Tablets (De-Nol tablet) in Duodenal Ulcer
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Abstract
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To assess the efficacy and toxicity of tripotassium dicitrato bismuthate (De-Nol tablet) in a double-blind trial, 40 out patients with active duodenal ulcers proved by endoscopy were randomly allocated either to treatment with tripotassium dicitrato bismuthate tablets or placebo tablets for four weeks. 2 out of 20 tripotassium dicitrato bismuthate cases & 9 out of 20 placebo cases were dropped out during the period. One tablet of tripotassium dicitrato bismuthate or placebo was taken 30 minutes before each of the main meals and F2 hours after the last meal. The response to treatment was assessed by symptoms and antacid consumption and endoscopic ulcer healing. Patients were asked about adverse effects of treatment.
The results were as follows:
1. Relief of symptoms: 14 out of 15 De-Nol patients and 5 out of 8 placebo patients were completely relieved during treatment. The difference between two groups was significant (P<0.05).
2. Number of cases using antacid and number of antacid tablets used 2 out of 18 tripotassium dicitrato bismuthate cases and 6 out of 11 placebo cases took antacid tablets during the period. The difference between the two groups was significant. And much less consumption of antacid tablets in the tripotassium dicitrato bismuthate group than in the placebo group was observed.
3. Incidence of ulcer healing: After 4 wks, complete ulcer healing was observed in 15 out of 18 tripotassium dicitrato bismuthate patients(83.3%) and 5 out of 11 placebo patients(45. 4%). There was significant difference between the two groups.
4. Side effect: No significant clinical side effects were observed during the period except usual darkening of the tongue and stools.
In conclusion, above mentioned results suggest that tripotassium dicitrato bismuthate tablets can be considered as a safe and effective therapy for patients with duodenal ulcers.
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