[Therapy of duodenal ulcer with cimetidine, pirenzipine and placebo: report on a double-blind randomized study].
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Abstract:
A double-blind randomized controlled study with pirenzepine (75 mg/day), cimetidine (1 g/day) and placebo was performed in 50 consecutive out-patients with duodenal ulcer. The patients also received an antacid containing aluminium hydroxide. Pirenzepine, cimetidine and placebo had similar effects on the 4-week healing rate. Dryness of the mouth was more frequent with pirenzepine than with the other two types of treatment. The incidence of other side effects did not differ in the three groups. A tendency towards more rapid disappearance of subjective symptoms in the patients treated with pirenzepine was not statistically significant. In conclusion, pirenzepine and cimetidine were not superior to placebo in the treatment of duodenal ulcer.Keywords:
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90 patients with active duodenal ulcer were admitted to a double-blind trial to compare the effects of pirenzepine (150 mg/daily), cimetidine (1 g/daily) and placebo on the healing of duodenal ulcer. 5 patients did not complete the trial. In 21 of 29 patients (72%) receiving pirenzepine and in 21 of 28 (75%) of those receiving cimetidine, the ulcers had healed after 4 weeks of treatment compared with 10 of 28 (36%) patients receiving placebo (p < 0.01). Symptomatic improvement and reduction of antacid consumption were significantly more marked in the pirenzepine- and cimetidine-treated groups than in the placebo group. Tolerability of drugs was good. The results show that pirenzepine is as effective as cimetidine for the treatment of duodenal ulcer.
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A double-blind randomized controlled study with pirenzepine (75 mg/day), cimetidine (1 g/day) and placebo was performed in 50 consecutive out-patients with duodenal ulcer. The patients also received an antacid containing aluminium hydroxide. Pirenzepine, cimetidine and placebo had similar effects on the 4-week healing rate. Dryness of the mouth was more frequent with pirenzepine than with the other two types of treatment. The incidence of other side effects did not differ in the three groups. A tendency towards more rapid disappearance of subjective symptoms in the patients treated with pirenzepine was not statistically significant. In conclusion, pirenzepine and cimetidine were not superior to placebo in the treatment of duodenal ulcer.
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A double-blind 4-week trial of cimetidine (1 g daily) versus placebo was conducted in 68 adult outpatients with active duodenal ulceration endoscopically confirmed. 3 of the patient admitted to the study (1 on cimetidine and 2 on placebo) did not complete the trial. After 4 weeks of treatment, 25 of 33 patients (76%) receiving cimetidine had healed their ulcers compared with 15 (47%) of 32 patients receiving placebo (p less than 0.02). Antacid consumption was also significantly decreased by cimetidine when compared with placebo. Tolerability of the drug was good.
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Sixty patients with endoscopically proven healed duodenal ulcers were treated for a year with either pirenzepine (Gastrozepin; Boehringer Ingelheim) 100 mg daily, cimetidine 400 mg at night, or placebo, The monthly relapse rate (patients per month) in the first 3 months (pirenzepine 2,3, cimetidine 2,3, placebo 3,0) and in the next 9 months (pirenzepine 0,33, cimetidine 0,44, placebo 0,56) is lower for pirenzepine and cimetidine than for placebo. This trend is in favour of pirenzepine and cimetidine as effective means of keeping duodenal ulcers in remission. Asymptomatic relapses were also less common with pirenzepine (50%) and cimetidine (45%) than with placebo (64%). No serious side-effects of pirenzepine were observed during the trail.
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An intensive antacid regimen, 15 to 30 ml 1 and 3 hours after each meal and at bedtime, has a significant effect on duodenal ulcer healing as compared to placebo and is as effective as cimetidine in endoscopically assessed trials. The healing rates at 4 weeks for placebo, antacid, and cimetidine are about 24%, 59%, and 62%, respectively. Smoking reduces the frequency of ulcer healing irrespective of therapy. Ulcer recurrences are as frequent after antacid as after cimetidine. Extensive placebo-controlled trials have not been reported for antacid treatment of gastric ulcer, but regular antacid dosing was as effective as cimetidine in one trial. Both the acute relief of ulcer pain and the pain relief during several weeks of therapy are similar between antacid and placebo, but pain relief per se is not a reliable indicator of ulcer healing.
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Sixty out-patients with duodenal ulcers that were healed at the end of a 4-week treatment with pirenzepine, cimetidine or placebo were admitted to a double-blind placebo-controlled trial to study the effectiveness of pirenzepine (100 mg/daily) in preventing recurrence of ulcers. Six patients did not complete the trial. After 12 months of treatment 15 of the 26 patients had recurrences in the pirenzepine-treated group and 27 of the 28 in the placebo group. The difference is highly significant (X2 = 9.570, P less than 0.01). The tolerability of pirenzepine was good.
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A total of 60 patients with endoscopically diagnosed duodenal ulcer were treated with pirenzepine or cimetidine for 8-10 weeks until endoscopic healing of the ulcer. After ulcer healing 20 random patients received 50 mg pirenzepine per os daily for 6 months, 20 received 400 mg cimetidine per os daily for 6 months, and the remaining 20 received topic antacids for 6 months whenever they complained of pyrosis and/or epigastric pain. Endoscopic checks were repeated after 6 months (or earlier, if clinical picture was consistent with relapsing ulcer). Relapsing duodenal ulcer or erosive duodenitis was observed in 5 patients treated with pirenzepine (25%), in 4 patients treated with cimetidine (20%), and in 13 patients treated with occasional antacids (65%). Differences were significant between the antacid-treated patients and each of the other two groups, but not significant between pirenzepine-treated and cimetidine-treated groups.
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Eighty-four patients with endoscopically-proved active duodenal ulcer were admitted to a multicentre double-blind trial with either pirenzepine tablets (25 mg three times per day for 1 week followed by 25 mg two times per day for 3 weeks) or placebo. Seventy-nine patients completed the trial, 44 treated with pirenzepine and 35 with placebo. After 4 weeks, complete healing had been achieved in 52% of the pirenzepine-treated patients and in 34% of the placebo-treated ones. Symptomatic responses were signigicantly better in those receiving pirenzepine than in those receiving placebo. In addition, the supplementary antacid consumption was significantly lesser in the pirenzepine group than in the placebo group. No important side-effects were observed in the two groups.
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Gonvers J-J, Realini S, Bretholz A, Voirol M, Arnold J, Birchler R, OUyo JB, Guyot J, Capitaine Y. Gastric ulcer: a double-blind comparison of 100 mg pirenzepine plus antacid versus 800 mg cimetidine plus antacid. Scand J Gastroenterol 1986, 21, 806-808Fifty-five patients with endoscopically confirmed gastric ulcers received either cimetidine (28 patients) or pirenzepine (27 patients) in a randomized double-blind manner. Fifty-seven per cent of the patients treated with cimetidine and 48% of those treated with pirenzepine presented with endoscopically healed ulcers after 4 weeks of treatment. By 8 weeks complete healing had occurred in 83% of the patients taking cimetidine and 76% of those taking pirenzepine. These differences were not statistically significant. Severity of pain on entering the study was correlated with slower healing of the ulcer. Side effects occurred in 5 of 27 patients in the pirenzepine group and 3 of 28 in the cimetidine group. They were mostly mild and did not differ from side effects observed in other studies.
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Weberg R, Berstad A. Low-dose antacids and pirenzepine in the treatment of patients with non-ulcer dyspepsia and erosive prepyloric changes. A randomized, double-blind, placebo-controlled trial.One hundred consecutive patients with non-ulcer dyspepsia (NUD) and the endoscopic diagnosis of erosive prepyloric changes (EPC) were included in a 4-week double-blind, placebo-controlled trial. The patients were randomly allocated to treatment with either AI-Mg antacids (one tablet four times daily; acid-neutralizing capacity, 120 mmol/day) or antacid placebo, in combination with either pirenzepine (50 mg twice daily) or pirenzepine placebo. Ninety patients completed the study. Symptoms improved during the 4 weeks in all treatment groups, irrespective of the treatment given. Neither pirenzepine nor antacid was significantly superior to placebo. Re-endoscopy after 4 weeks of treatment showed no significant change in the EPC grade. No serious side effects were observed, but xerostomia occurred more frequently in patients treated with pirenzepine than in those treated with placebo (p < 0.01).
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