Long-Term Treatment with 300 Mg Ranitidine Once Daily after Dilatation of Peptic Oesophageal Strictures P. G. FARUP, B. MODALSLI & J . K. THOLFSEN Depts. of Medicine and Otorhinolaryngology, G j ~ v i kCounty Hospital, Gj@vik,and Dept. of Medicine, Lillehammer County Hospital, Lillehammer, Norway
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Farup PG, Modalsli B, Tholfsen JK. Long-term treatment with 300mg ranitidine once daily after dilatation of peptic oesophageal strictures. Scand J Gastrocnterol 1992;27:594-598. This clinical, double-blind, multicentre trial evaluates the long-term effect of ranitidine in patients dilated for peptic oesophageal strictures. Seventy-one consecutive outpatients were dilated with hydrostatic balloons to a diameter o f 18-20 mm and randomized to a I-year treatment with 300 mg ranitidine in the evening o r with placebo. Endoscopies with measurement of the stricture size were performcd before the initial dilatation, after 6 and 12 months, and in between when necessary. Symptoms and use of antacids were registered at inclusion and after 3, 6 , 9, and 12 months. Thirteen patients were withdrawn before study end point. Fifteen of 30 (SO%) in the ranitidine group and 11 of 28 (39.3%) in the placebo group were redilated. The difference in disfavour of ranitidine was 10.7% (95% confidence interval, - 14.9; 36.2%)). Nor were there any statistically significant differences between the treatment groups with regard to stricture size at end point. symptoms, or use of antacids. In conclusion, there is no evidence of any clinically significant effect of a 1-year treatment with 300 mg ranitidine once daily after dilatation of peptic oesophageal strictures. Kev words: Clinical trial; dilatation; oesophageal stricture; ranitidine; reflux oesophagitis Per G . Forup, M . D., Dept. of Medicine, Gjmoik Fylkessykehus, N-2800 Gjmoik, Norway
Peptic oesophageal stricture is a complication of long-lasting chronic reflux oesophagitis. The main symptom, progressive dysphagia, is effectively treated by dilatation (1-3). However, this is a purely symptomatic procedure to keep the food passage open and is without any effect on the cause of the stricture. It might even open the floodgates to reflux, worsen the oesophagitis, and make recurrent stricture formation inevitable (2). Nearly half the patients need a redilatation within 1 year, and most patients need one or more redilatations during a 3- to 5-year follow-up (3-5). It is therefore illogical to perform dilatations without attempting pharmacologic or surgical reflux control. Full-dose H2-receptor antagonists significantly reduce gastro-oesophageal reflux as assessed by 24-h oesophageal p H monitoring and are recommended both for long-term treatment of reflux oesophagitis and after dilatation of peptic oesophageal strictures ( 6 9 ) . The effect of this treatment after dilatation is, however, conflicting (10, 11). This trial was undertaken to study the effect of a 1-year treatment with 300 mg ranitidine in the evening on time until redilatation and on symptoms in patients dilated for peptic oesophageal strictures. PATIENTS AND METHODS
Patients Five Norwegian gastroenterologic units recruited consecutive outpatients with peptic oesophageal strictures.
Patients with caustic, iatrogenic, malignant, and other nonpeptic strictures were excluded, as were patients with active peptic ulcers, malignancies, other serious focal or system diseases, previous upper gastrointestinal surgery, and a history of drug or alcohol abuse. Pregnant and breast-feeding women and women who planned to be pregnant were not allowed to take part in the trial. Patients with severe oesophageal inflammation, peptic oesophageal ulcers, or severe reflux symptoms were excluded for ethical reasons because the study was placehocontrolled. Thus only patients with none or rnild/moderate reflux oesophagitis were included. Of the 75 patients included in the study, 4 were excluded from the analysis. Two of the excluded patients had malignancies in biopsies specimens taken at the pre-trial endoscopy, one was erroneously included (previous gastric operation), and one decided the day after inclusion not to participate in the trial. The treatment groups were well balanced, except for a longer history of reflux symptoms in the placebo group (Table I). Four patients in each treatment group suffered from asthma, and two in each group used steroids during the trial. Four and five patients in the placebo and ranitidine group, respectively, were taking continuous non-steroid anti-inflammatory drug therapy.
Methods Study design. The study was carried out as a block-randomized, double-blind, placebo-controlled, multicentre trial
Ranitidine in Oesophageal Strictures
Table I. Patients’characteristics. The results are given as the numher of patients or as mean with standard deviation in pdrenthescs Trcatment groups
Scand J Gastroenterol Downloaded from informahealthcare.com by Thomas Jefferson University on 01/09/15 For personal use only.
Characteristics
Placebo
Ranitidine
Patients (no. j
34
37
Male to fcrnale ratio (no.)
21 : 13
23: I4
Age (years)
66 (17)
66 ( I S )
Weight (kgj
70 (14)
69 (12)
Hiatus hernia N o . (11 patients Length (cm)
27
29 5 (1.9)
29 4 1
30 5 2
27 7 0
26 11 0
21 (19.4)
11 (9.2)
7 (7.0)
7 (6. I )
Smoking h;thits (no.) Nonc 20 cig;irettes/day Alcohol intakc (no.) Nonc so g/day Symptom duration Duration o f reflux symptoms (year\) Duration o f dysphagia ( ycsrs) Prcviow dilatations No. (11 patients No. 01 previous dilatations Time since last dilatation (months) Stricture diameter (no.)
Scand J Gastroenterol Downloaded from informahealthcare.com by Thomas Jefferson University on 01/09/15 For personal use only.
Farup PG, Modalsli B, Tholfsen JK. Long-term treatment with 300mg ranitidine once daily after dilatation of peptic oesophageal strictures. Scand J Gastrocnterol 1992;27:594-598. This clinical, double-blind, multicentre trial evaluates the long-term effect of ranitidine in patients dilated for peptic oesophageal strictures. Seventy-one consecutive outpatients were dilated with hydrostatic balloons to a diameter o f 18-20 mm and randomized to a I-year treatment with 300 mg ranitidine in the evening o r with placebo. Endoscopies with measurement of the stricture size were performcd before the initial dilatation, after 6 and 12 months, and in between when necessary. Symptoms and use of antacids were registered at inclusion and after 3, 6 , 9, and 12 months. Thirteen patients were withdrawn before study end point. Fifteen of 30 (SO%) in the ranitidine group and 11 of 28 (39.3%) in the placebo group were redilated. The difference in disfavour of ranitidine was 10.7% (95% confidence interval, - 14.9; 36.2%)). Nor were there any statistically significant differences between the treatment groups with regard to stricture size at end point. symptoms, or use of antacids. In conclusion, there is no evidence of any clinically significant effect of a 1-year treatment with 300 mg ranitidine once daily after dilatation of peptic oesophageal strictures. Kev words: Clinical trial; dilatation; oesophageal stricture; ranitidine; reflux oesophagitis Per G . Forup, M . D., Dept. of Medicine, Gjmoik Fylkessykehus, N-2800 Gjmoik, Norway
Peptic oesophageal stricture is a complication of long-lasting chronic reflux oesophagitis. The main symptom, progressive dysphagia, is effectively treated by dilatation (1-3). However, this is a purely symptomatic procedure to keep the food passage open and is without any effect on the cause of the stricture. It might even open the floodgates to reflux, worsen the oesophagitis, and make recurrent stricture formation inevitable (2). Nearly half the patients need a redilatation within 1 year, and most patients need one or more redilatations during a 3- to 5-year follow-up (3-5). It is therefore illogical to perform dilatations without attempting pharmacologic or surgical reflux control. Full-dose H2-receptor antagonists significantly reduce gastro-oesophageal reflux as assessed by 24-h oesophageal p H monitoring and are recommended both for long-term treatment of reflux oesophagitis and after dilatation of peptic oesophageal strictures ( 6 9 ) . The effect of this treatment after dilatation is, however, conflicting (10, 11). This trial was undertaken to study the effect of a 1-year treatment with 300 mg ranitidine in the evening on time until redilatation and on symptoms in patients dilated for peptic oesophageal strictures. PATIENTS AND METHODS
Patients Five Norwegian gastroenterologic units recruited consecutive outpatients with peptic oesophageal strictures.
Patients with caustic, iatrogenic, malignant, and other nonpeptic strictures were excluded, as were patients with active peptic ulcers, malignancies, other serious focal or system diseases, previous upper gastrointestinal surgery, and a history of drug or alcohol abuse. Pregnant and breast-feeding women and women who planned to be pregnant were not allowed to take part in the trial. Patients with severe oesophageal inflammation, peptic oesophageal ulcers, or severe reflux symptoms were excluded for ethical reasons because the study was placehocontrolled. Thus only patients with none or rnild/moderate reflux oesophagitis were included. Of the 75 patients included in the study, 4 were excluded from the analysis. Two of the excluded patients had malignancies in biopsies specimens taken at the pre-trial endoscopy, one was erroneously included (previous gastric operation), and one decided the day after inclusion not to participate in the trial. The treatment groups were well balanced, except for a longer history of reflux symptoms in the placebo group (Table I). Four patients in each treatment group suffered from asthma, and two in each group used steroids during the trial. Four and five patients in the placebo and ranitidine group, respectively, were taking continuous non-steroid anti-inflammatory drug therapy.
Methods Study design. The study was carried out as a block-randomized, double-blind, placebo-controlled, multicentre trial
Ranitidine in Oesophageal Strictures
Table I. Patients’characteristics. The results are given as the numher of patients or as mean with standard deviation in pdrenthescs Trcatment groups
Scand J Gastroenterol Downloaded from informahealthcare.com by Thomas Jefferson University on 01/09/15 For personal use only.
Characteristics
Placebo
Ranitidine
Patients (no. j
34
37
Male to fcrnale ratio (no.)
21 : 13
23: I4
Age (years)
66 (17)
66 ( I S )
Weight (kgj
70 (14)
69 (12)
Hiatus hernia N o . (11 patients Length (cm)
27
29 5 (1.9)
29 4 1
30 5 2
27 7 0
26 11 0
21 (19.4)
11 (9.2)
7 (7.0)
7 (6. I )
Smoking h;thits (no.) Nonc 20 cig;irettes/day Alcohol intakc (no.) Nonc so g/day Symptom duration Duration o f reflux symptoms (year\) Duration o f dysphagia ( ycsrs) Prcviow dilatations No. (11 patients No. 01 previous dilatations Time since last dilatation (months) Stricture diameter (no.)
