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KMID : 0378019810240090052
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New Medical Journal
1981 Volume.24 No. 9 p.52 ~ p.54
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Clinical Trial of Polybutine^(®) (Trimebutine Maleate) in Patients with Irritable Colon Symptoms
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李時元/Lee, S.W.
金仁淑/宋俊鎬/李祥鍾/Kim, I.S./Song, J.H./Lee, S.J.
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Abstract
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It is well Known that irritable colon is the common disease seen by the internists. Linhart defined the criteria for diagnosis as: (i) multiple symptoms, (ii) association with psychological problems and stress, (iii) previous enteric infections, and (iv) absence of organic findings. The cardinal symptoms were described as abdominal pain, distention and alternating diarrhea and constipation. Control of these symptoms has in the past been unsatisfactory because the underlying disturbance of colonic motility is largely unaffected.
The object of this observation by us was to establish the value of polybutine in the treatment of irritable colon in general practice in controlled trials against placebo.
Fourty patients taking part in these studies were adult ambulant patients of either sex who diagnosed as having irritable colon on the basis of their symptoms as well as radiologic-and sigmoidoscopic examination.
Treatment with polybutine, 100mg (1 tablet) three times daily, or an identical placebo, was given according to a random code which allowed half the patients to be started on each patients to be started on each treatment. Tablets were taken before meals and all patients received 4 week´s treatment with both polybutine and placebo.
All patients in this study suffered from constipation and abdominal pain of moderate to severe degree. The number of patients showing improvement of abdominal pain and constipation was significantly increased during the first 2 weeks of treatment irrespective of whether polybutine or placebo was being taken (table 1). At the end of the second treatment period, there was significantly greater number of polybutine-treated patients showing improvement of symptoms over their previous placebo treatment period (table 2).
No untoward actions attributable to polybutine during these studies were observed.
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