One hundred seventeen patients with recently healed duodenal ulcers were entered into a one-year ... more One hundred seventeen patients with recently healed duodenal ulcers were entered into a one-year maintenance study. Patients were randomly assigned to treatment with sucralfate 2 g at night, cimetidine 400 mg, or placebo. The sucralfate versus placebo leg of the study was double-blind, whereas the cimetidine leg was single-blind. Endoscopy was repeated on clinical relapse and routinely at six and 12 months. Ninety-six of the 117 patients were followed up for one year or to an endoscopically proven recurrence. The remaining 21 patients were excluded from analysis because of default or protocol violation. The one-year analysis showed by endoscopy that ulcers had recurred in 17 of the 31 sucralfate-treated patients, 19 of the 32 cimetidine-treated patients, and in 28 of the 33 placebo-treated patients. These data included asymptomatic recurrences in four, four, and three patients, respectively. The relapse rate at 24 weeks was greater in patients healed initially with a histamine (H2)-blocker alone than in those healed initially with sucralfate alone, a combination of sucralfate with a H2-blocker or an antacid alone.
South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1993
Helicobacter pylori is an important cause of gastritis and a number of therapeutic trials suggest... more Helicobacter pylori is an important cause of gastritis and a number of therapeutic trials suggest that it may be important in the genesis of duodenal ulcer recurrence. The reported prevalence of gastric colonisation by the organism varies considerably. The aim of this cross-sectional survey was to determine its prevalence in non-ulcer dyspeptics and to determine whether this is influenced by age, race, sex, socio-economic status, educational level and the number of persons sharing accommodation. One hundred and sixty-nine patients underwent endoscopy; biopsy specimens were taken from the antrum and H. pylori status was determined histologically. Gastric colonisation was found in 106 patients (63%). The prevalence showed a marked ethnic difference: 40% in whites and 71% in coloureds (P < 0.001). The ethnic groups were characterised by significant differences in socio-economic status (P < 10(-6)), educational level (P < 10(-6)), number of persons sharing accommodation (P <...
South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, Jan 23, 1984
Fifty-seven patients with recently healed duodenal ulcers were entered into a 1-year trial of mai... more Fifty-seven patients with recently healed duodenal ulcers were entered into a 1-year trial of maintenance therapy with ranitidine ( Zantac ; Glaxo) 150 mg at night to assess the safety and efficacy of the drug. Twenty-two of the patients were withdrawn because they violated the trial protocol. No serious side-effects were noted, but only 19 of the 35 patients who met the requirements of the study were free of endoscopic evidence of ulcer recurrence at the end of the trial period. The relapse rate of 46% in the present study was of the same order as those found in two previous South African studies of maintenance therapy with cimetidine given in a dose of 400 mg at night. These findings leave the question whether routine maintenance therapy is warranted in our patients unanswered.
South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, Jan 30, 1982
A double-blind placebo-controlled study of ranitidine 150 mg given twice daily for 4 weeks was ca... more A double-blind placebo-controlled study of ranitidine 150 mg given twice daily for 4 weeks was carried out in 80 ambulant patients with endoscopically proven duodenal ulceration. Fifteen patients were withdrawn because of poor compliance or default. Of the remaining 65 patients, endoscopic healing (with or without residual erosion) was noted in 28 of the 34 ranitidine-treated patients (82%) and in 14 of the 31 placebo-treated patients (45%) (P less than 0.005). Twenty-three patients whose ulcers were unhealed after 4 weeks of ranitidine therapy or placebo were then given ranitidine for a further 4-week period. Four of these patients were withdrawn, but ulcer healing was achieved in 16 of the remaining 19 patients (4 out of 5 (80%) initially treated with ranitidine and 12 of 14 (86%) initially treated with placebo). No significant clinical, biochemical or haematological adverse reactions were noted in either treatment group. It is concluded that ranitidine is a safe and effective the...
Duodenal ulcer relapse rates after therapy with sucralfate or bismuth are lower than those after ... more Duodenal ulcer relapse rates after therapy with sucralfate or bismuth are lower than those after H2-receptor antagonist therapy. This may be mediated by an antibacterial effect of these drugs on Helicobacter pylori. Bismuth has become an integral part of &#39;triple therapy&#39; because of its documented anti-H. pylori effect. In vitro and clinical data suggest that sucralfate may also have an anti-H. pylori effect. The aim of this randomized, prospective therapeutic trial was to compare the efficacy of triple therapy containing bismuth with that containing sucralfate and to determine the effect of therapy with these combinations on duodenal ulcer relapse. Forty H. pylori-positive duodenal ulcer patients were healed with omeprazole and randomized to receive either 1 g sucralfate four times daily or 120 mg bismuth compound four times daily. All patients received 400 mg metronidazole three times daily and either 250 or 500 mg tetracycline four times daily for 7-14 days. Thirty-five patients could be analysed. Overall eradication rates did not differ in the treatment groups (10 of 17 eradicated with sucralfate and 11 of 18 with bismuth). Relapse rates were significantly lower in the eradicated group (1 of 21 compared with 8 of 14 in the non-eradicated group) and did not differ between treatment groups in those patients not eradicated. A triple therapy regimen utilizing sucralfate appears to be as effective as the bismuth-containing regimen.
The conventional dosage schedule for sucralfate is 1 g 4 i.d., but a dose of 2 g 2 i.d. may be eq... more The conventional dosage schedule for sucralfate is 1 g 4 i.d., but a dose of 2 g 2 i.d. may be equally effective in duodenal ulcer healing. We compared the efficacy of these two regimens in duodenal ulcer healing. Seventy-seven patients with endoscopically proven duodenal ulceration were entered into a double-blind, controlled study and randomized to treatment with sucralfate 2 g 2 i.d. (on waking and at bedtime) or 1 g 4 i.d. (1/2 h before meals and at bedtime). The patients were endoscoped before entry into the study, after 4 weeks, and after 8 weeks if unhealed at 4 weeks. Of the patients considered suitable for analysis at 4 weeks, 79% (26/33) of those taking 2 g 2 i.d. had healed ulcers in comparison to 72% (23/32) of those taking 1 g 4 i.d. After 8 weeks, cumulative healing rates were 85% (28/33) and 80% (24/30), respectively. The results suggest that the more convenient dosage schedule of 2 g 2 i.d. is as effective as the 1 g 4 i.d. regimen in the short-term treatment of duodenal ulcer.
One hundred seventeen patients with recently healed duodenal ulcers were entered into a one-year ... more One hundred seventeen patients with recently healed duodenal ulcers were entered into a one-year maintenance study. Patients were randomly assigned to treatment with sucralfate 2 g at night, cimetidine 400 mg, or placebo. The sucralfate versus placebo leg of the study was double-blind, whereas the cimetidine leg was single-blind. Endoscopy was repeated on clinical relapse and routinely at six and 12 months. Ninety-six of the 117 patients were followed up for one year or to an endoscopically proven recurrence. The remaining 21 patients were excluded from analysis because of default or protocol violation. The one-year analysis showed by endoscopy that ulcers had recurred in 17 of the 31 sucralfate-treated patients, 19 of the 32 cimetidine-treated patients, and in 28 of the 33 placebo-treated patients. These data included asymptomatic recurrences in four, four, and three patients, respectively. The relapse rate at 24 weeks was greater in patients healed initially with a histamine (H2)-blocker alone than in those healed initially with sucralfate alone, a combination of sucralfate with a H2-blocker or an antacid alone.
South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 1993
Helicobacter pylori is an important cause of gastritis and a number of therapeutic trials suggest... more Helicobacter pylori is an important cause of gastritis and a number of therapeutic trials suggest that it may be important in the genesis of duodenal ulcer recurrence. The reported prevalence of gastric colonisation by the organism varies considerably. The aim of this cross-sectional survey was to determine its prevalence in non-ulcer dyspeptics and to determine whether this is influenced by age, race, sex, socio-economic status, educational level and the number of persons sharing accommodation. One hundred and sixty-nine patients underwent endoscopy; biopsy specimens were taken from the antrum and H. pylori status was determined histologically. Gastric colonisation was found in 106 patients (63%). The prevalence showed a marked ethnic difference: 40% in whites and 71% in coloureds (P < 0.001). The ethnic groups were characterised by significant differences in socio-economic status (P < 10(-6)), educational level (P < 10(-6)), number of persons sharing accommodation (P <...
South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, Jan 23, 1984
Fifty-seven patients with recently healed duodenal ulcers were entered into a 1-year trial of mai... more Fifty-seven patients with recently healed duodenal ulcers were entered into a 1-year trial of maintenance therapy with ranitidine ( Zantac ; Glaxo) 150 mg at night to assess the safety and efficacy of the drug. Twenty-two of the patients were withdrawn because they violated the trial protocol. No serious side-effects were noted, but only 19 of the 35 patients who met the requirements of the study were free of endoscopic evidence of ulcer recurrence at the end of the trial period. The relapse rate of 46% in the present study was of the same order as those found in two previous South African studies of maintenance therapy with cimetidine given in a dose of 400 mg at night. These findings leave the question whether routine maintenance therapy is warranted in our patients unanswered.
South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, Jan 30, 1982
A double-blind placebo-controlled study of ranitidine 150 mg given twice daily for 4 weeks was ca... more A double-blind placebo-controlled study of ranitidine 150 mg given twice daily for 4 weeks was carried out in 80 ambulant patients with endoscopically proven duodenal ulceration. Fifteen patients were withdrawn because of poor compliance or default. Of the remaining 65 patients, endoscopic healing (with or without residual erosion) was noted in 28 of the 34 ranitidine-treated patients (82%) and in 14 of the 31 placebo-treated patients (45%) (P less than 0.005). Twenty-three patients whose ulcers were unhealed after 4 weeks of ranitidine therapy or placebo were then given ranitidine for a further 4-week period. Four of these patients were withdrawn, but ulcer healing was achieved in 16 of the remaining 19 patients (4 out of 5 (80%) initially treated with ranitidine and 12 of 14 (86%) initially treated with placebo). No significant clinical, biochemical or haematological adverse reactions were noted in either treatment group. It is concluded that ranitidine is a safe and effective the...
Duodenal ulcer relapse rates after therapy with sucralfate or bismuth are lower than those after ... more Duodenal ulcer relapse rates after therapy with sucralfate or bismuth are lower than those after H2-receptor antagonist therapy. This may be mediated by an antibacterial effect of these drugs on Helicobacter pylori. Bismuth has become an integral part of &#39;triple therapy&#39; because of its documented anti-H. pylori effect. In vitro and clinical data suggest that sucralfate may also have an anti-H. pylori effect. The aim of this randomized, prospective therapeutic trial was to compare the efficacy of triple therapy containing bismuth with that containing sucralfate and to determine the effect of therapy with these combinations on duodenal ulcer relapse. Forty H. pylori-positive duodenal ulcer patients were healed with omeprazole and randomized to receive either 1 g sucralfate four times daily or 120 mg bismuth compound four times daily. All patients received 400 mg metronidazole three times daily and either 250 or 500 mg tetracycline four times daily for 7-14 days. Thirty-five patients could be analysed. Overall eradication rates did not differ in the treatment groups (10 of 17 eradicated with sucralfate and 11 of 18 with bismuth). Relapse rates were significantly lower in the eradicated group (1 of 21 compared with 8 of 14 in the non-eradicated group) and did not differ between treatment groups in those patients not eradicated. A triple therapy regimen utilizing sucralfate appears to be as effective as the bismuth-containing regimen.
The conventional dosage schedule for sucralfate is 1 g 4 i.d., but a dose of 2 g 2 i.d. may be eq... more The conventional dosage schedule for sucralfate is 1 g 4 i.d., but a dose of 2 g 2 i.d. may be equally effective in duodenal ulcer healing. We compared the efficacy of these two regimens in duodenal ulcer healing. Seventy-seven patients with endoscopically proven duodenal ulceration were entered into a double-blind, controlled study and randomized to treatment with sucralfate 2 g 2 i.d. (on waking and at bedtime) or 1 g 4 i.d. (1/2 h before meals and at bedtime). The patients were endoscoped before entry into the study, after 4 weeks, and after 8 weeks if unhealed at 4 weeks. Of the patients considered suitable for analysis at 4 weeks, 79% (26/33) of those taking 2 g 2 i.d. had healed ulcers in comparison to 72% (23/32) of those taking 1 g 4 i.d. After 8 weeks, cumulative healing rates were 85% (28/33) and 80% (24/30), respectively. The results suggest that the more convenient dosage schedule of 2 g 2 i.d. is as effective as the 1 g 4 i.d. regimen in the short-term treatment of duodenal ulcer.
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