Optimal maintenance therapy in patients with non-erosive reflux disease reporting mild reflux symptoms--a pilot study
Abstract
PURPOSE: This pilot study aimed at finding trend for further investigation of the optimal maintenance therapy with lansoprazole in patients with non-erosive reflux disease (NERD) suffering from mild symptoms.
MATERIAL AND METHODS: Sixty consecutive patients with diagnosed NERD reporting mild symptoms were included in the study. After successfully finishing a four-week treatment with lansoprazole (30 mg daily), the patients were randomized into three groups administered: 1--lansoprazole 30 mg "on-demand", 2--lansoprazole 15 mg daily, 3--lansoprazole 30 mg in four-week courses during a relapse. The intensity of symptoms was assessed with the Visual Analogue Scale (VAS) at the baseline, as well after 4 weeks, 3, 6 and 12 months of therapy. The general satisfaction of treatment was evaluated with the Verbal Rating Scale (VRS) at the same time.
RESULTS: At the baseline, the mean intensity of symptoms assessed by VAS was 2.8 +/- 1.0 points and fell to 0.4 +/- 0.5 points after a 4-week therapy. In Group 1, after 3, 6 and 12 months, it was 0.85 +/- 0.6, 1.0 +/- 0.8 and 1.0 +/- 0.8, in Group 2: 0.65 +/- 0.7, 0.65 +/- 0.7, 0.5 +/- 0.3, and in Group 3: 1.1 +/- 0.6, 1.55 +/- 0.7, 1.65 +/- 0.8 points, respectively. No significant differences were observed between Groups 1 and 2. Intermittent therapy (Group 3) showed a significantly lower efficacy in comparison to other groups (p < 0.05). "On-demand" therapy was 30% cheaper whereas intermittent therapy was 55% cheaper than the most…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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