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.