RANDOMIZED CONTROLLED TRIAL
Long-term acid suppressive therapy may prevent the relapse of lower esophageal (Schatzki's) rings: a prospective, randomized, placebo-controlled study.
American Journal of Gastroenterology 2005 September
OBJECTIVES: Distal esophageal (Schatzki's) rings are a frequent cause of dysphagia. Bougienage is generally effective, but relapses are common. The aim of this study was to evaluate the effect of long-term antisecretory therapy on the relapse rate of lower esophageal rings after successful bougienage with Savary dilators.
PATIENTS AND METHODS: The study was performed on 44 consecutive patients with symptomatic Schatzki's rings, detected endoscopically, and/or radiologically. Graded esophageal dilation was performed as an outpatient procedure in a single session. After appropriate assessment with esophageal manometry and 24-h ambulatory esophageal pH monitoring, patients with documented GERD (n = 14) were treated with long-term omeprazole therapy. The remaining patients were blindly randomized to receive maintenance treatment with either omeprazole (group A-15 patients) or placebo (group B-15 patients). The necessity for redilation after documentation of the ring with endoscopy and/or radiology was considered as a relapse of the ring. The relapse rate was evaluated in all groups.
RESULTS: All bougienages were performed without significant side effects. Eight patients (8 of 44, 18.2%) had one or more relapses after a mean (SD) of 19.0 (10.1) months. Patients with (n = 14) or without (n = 30) GERD were comparable with respect to sex, age, body mass index, cigarette and alcohol consumption, diameter of the esophageal lumen at the level of the ring, resting lower esophageal sphincter pressure, duration of dysphagia, need for taking antacids during the follow-up period, and duration of follow-up. There were no recurrences of Schatzki's ring in the group of patients with documented GERD (follow-up [mean +/- SD]: 43.8 +/- 9.3 months, range: 27-62). In group A (follow-up [mean +/- SD]: 37.1 +/- 17.1 months, range: 11-66), one patient relapsed after 13 months, while in group B (follow-up [mean +/- SD]: 34.3 +/- 14.6 months, range: 10-58), seven patients relapsed after a mean (SD) of 19.9 (10.6) months. The actuarial probability of relapse was higher in patients without therapy (group B) (p= 0.008).
CONCLUSIONS: Our data support the hypothesis that, in patients with symptomatic Schatzki's rings, acid suppressive maintenance therapy after bougienage may prevent relapse of the ring.
PATIENTS AND METHODS: The study was performed on 44 consecutive patients with symptomatic Schatzki's rings, detected endoscopically, and/or radiologically. Graded esophageal dilation was performed as an outpatient procedure in a single session. After appropriate assessment with esophageal manometry and 24-h ambulatory esophageal pH monitoring, patients with documented GERD (n = 14) were treated with long-term omeprazole therapy. The remaining patients were blindly randomized to receive maintenance treatment with either omeprazole (group A-15 patients) or placebo (group B-15 patients). The necessity for redilation after documentation of the ring with endoscopy and/or radiology was considered as a relapse of the ring. The relapse rate was evaluated in all groups.
RESULTS: All bougienages were performed without significant side effects. Eight patients (8 of 44, 18.2%) had one or more relapses after a mean (SD) of 19.0 (10.1) months. Patients with (n = 14) or without (n = 30) GERD were comparable with respect to sex, age, body mass index, cigarette and alcohol consumption, diameter of the esophageal lumen at the level of the ring, resting lower esophageal sphincter pressure, duration of dysphagia, need for taking antacids during the follow-up period, and duration of follow-up. There were no recurrences of Schatzki's ring in the group of patients with documented GERD (follow-up [mean +/- SD]: 43.8 +/- 9.3 months, range: 27-62). In group A (follow-up [mean +/- SD]: 37.1 +/- 17.1 months, range: 11-66), one patient relapsed after 13 months, while in group B (follow-up [mean +/- SD]: 34.3 +/- 14.6 months, range: 10-58), seven patients relapsed after a mean (SD) of 19.9 (10.6) months. The actuarial probability of relapse was higher in patients without therapy (group B) (p= 0.008).
CONCLUSIONS: Our data support the hypothesis that, in patients with symptomatic Schatzki's rings, acid suppressive maintenance therapy after bougienage may prevent relapse of the ring.
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