Aim:
In an international, multicentre, double‐blind trial, to document the therapeutic equivalence of two dosing regimens of cisapride on endoscopic healing and symptom improvement in patients with proven reflux oesophagitis grade I or II (Savary–Miller).
Methods:
Four hundred and seven patients were randomly allocated to treatment with either cisapride 10 mg q.d.s or cisapride 20 mg b.d. for 8–12 weeks depending on whether complete healing was found at endoscopy. The primary parameters of efficacy were cure of oesophagitis and improvement of the reflux symptom score.
Results:
The healing rates at endpoint were 73% in both treatment groups. The mean total reflux symptom score decreased from baseline to endpoint from 7.9–2.1 (cisapride 10 mg q.d.s.) and 7.9–2.5 (cisapride 20 mg b.d.). Each of the two treatment regimens was well tolerated. The most frequently (6.9%) reported adverse event (diarrhoea) was mild or moderate in most cases and can be explained by the pharmacological action of cisapride.
Conclusions:
The results of the study demonstrate that cisapride 10 mg q.d.s. and 20 mg b.d. are equivalent in terms of efficacy and safety in the treatment of reflux oesophagitis.
A large intrahepatic fistula between the hepatic artery and portal vein was detected at angiography in a patient with portal hypertension and bleeding esophageal varices. Hemodynamic studies demonstrated that increased vascular resistance in the liver rather than increased flow through the fistula was responsible for the portal hypertension and a portocaval shunt was performed. A repeat angiogram two months after the operation showed that the fistula had closed spontaneously.
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