Optimal maintenance therapy in patients with non-erosive reflux disease reporting mild reflux symptoms--a pilot study.

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 expensive daily treatment. However, general satisfaction of treatment assessed by VRS was non-significantly different between any of the groups. CONCLUSIONS In patients with NERD and mild symptoms, both on-demand and daily treatment models of maintenance therapy showed a similar high efficacy, whereas intermittent therapy was significantly less effective. However, general satisfaction of each treatment options was high and non-significantly different between the groups. Due to a pilot character of this study further investigation based on a larger number of patients is necessary to confirm the clinical value of cheaper models of maintenance therapy which could be then recommended as more cost-effective.