Long-term treatment of duodenal ulcer with pirenzepine. A double-blind, placebo-controlled trial.
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Abstract:
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.Keywords:
Tolerability
Cimetidine
Placebo group
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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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Antacid
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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.
Cimetidine
Antacid
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Placebo group
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34 patients were treated with cimetidine and placebo in a double blind trial and 42 were treated with cimetidine alone. Criteria investigated were the pain response, consumption of antacids when required and especially the endoscopically demonstrated scarring of the duodenal ulcer. Compared with placebo, cimetidine is capable of soothing pain and also reducing the consumption of antacids more quickly and to a greater extent. The differences are statistically significant. Complete anatomical healing of the ulcer was established in the double blind study in 80% of the patients in the cimetidine group and in 40% of the placebo group. Similar results were also shown in the group which received cimetidine alone.
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The effect of pirenzepine and cimetidine on healing, symptoms and relapse rate of duodenal ulcer was studied in a placebo-controlled double-blind trial. Cimetidine (1 g daily) was superior at the beginning of therapy to a low dose of pirenzepine (75 mg daily) and placebo with regard to symptoms. No significant differences in ulcer healing were found between the 3 groups of treatment. The relapse rate after treatment with pirenzepine was lower than after treatment with cimetidine.
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Thirty-eight of forty patients satisfactorily concluded a double-blind, placebo-controlled trial to study the effects of pirenzepine (100 mg/day) on duodenal ulcers. After six weeks of treatment 14 of 18 patients (78%) in the pirenzepine-treated group and 7 of 20 patients (35%) in the placebo groups were healed. There was a statistically significant difference (P less than 0.05). The relief of day-time and night-time pain was significantly greater in the pirenzepine-treated group. Pirenzepine-treated patients consumed significantly fewer antacid tablets. The tolerability of pirenzepine was good. Pirenzepine (100 mg/day for six weeks) should be an effective and safe treatment for duodenal ulcers.
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Antacid
Placebo group
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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.
Tolerability
Cimetidine
Placebo group
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Fifty-five patients with active duodenal ulcer have completed, up to today, a one-month double-blind trial to compare the effects of pirenzepine (150 mg daily), cimetidine (1 g daily) and placebo on the healing of duodenal ulcer. Fifteen (71%) of the 21 patients treated with pirenzepine had healed ulcers compared with 14 (82%) receiving cimetidine (P less than 0.05. In the placebo group there were 7 (41%) healed ulcers. Symptomatic improvement in patients given pirenzepine was as substantial as in cimetidine-treated patients. No adverse effects were noted.
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The effect of pirenzepine and cimetidine on healing, symptoms, and relapse rate of duodenal ulcer was studied in a placebo controlled double blind trial. With regard to symptoms, cimetidine (1 g daily) was superior at the beginning of therapy to a low dose of pirenzepine (75 mg daily) and to placebo. No significant differences in ulcer healing were found between the 3 treatment groups. The relapse rate after treatment with pirenzepine was lower than after treatment with cimetidine.
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