A randomized prospective study comparing the efficacy of on-demand therapy versus continuous therapy for 6 months for long-term maintenance with omeprazole 20 mg in patients with gastroesophageal reflux disease in Japan

Abstract

Aim: To assess the efficacy of continuous therapy (cont) and on-demand therapy (on-demand) as maintenance therapy for gastroesophageal reflux disease (GERD).

Methods: Patients with upper GI endoscopy (EGD)-proven GERD who completed 8 weeks of initial therapy were randomized to cont (omeprazole 20 mg od) or on-demand (omeprazole 20 mg on-demand) group. Assessments by the Global Overall Symptom (GOS) scale at baseline (at the start of maintenance therapy) and at 8-week, 16-week, and 24-week visits were made and EGD was performed at 24 weeks. Symptom relief was defined as percentages of patients whose GOS score of 1 or 2.

Results: Of the 117 enrolled patients, cont/on-demand was 59/58 and nonerosive reflux disease (NERD)/reflux esophagitis (RE) before the initial therapy was 35/82. Symptom relief in cont/on-demand were 57.6%/48.3% at baseline (n.s.), 66.7%/54.7% at 8 week (n.s.), 64.6%/54.7% at 16 weeks (n.s.), and 66.7%/74.0% at 24 weeks (n.s.). When subjects were divided into NERD and RE, symptom relief in cont/on-demand were 33.3%/41.2% at baseline (n.s.), 43.8%/64.3% at 8 weeks (n.s.), 50.0%/42.9% at 16 weeks (n.s.), and 50.0%/69.2% at 24 weeks (n.s.) in NERD, while those were 68.3%/51.2% at baseline (n.s.), 76.3%/51.3% at 8 weeks (p < 0.05), 70.6%/59.0% at 16 weeks (n.s.), and 72.7%/75.7% at 24 weeks (n.s.) in RE, respectively. At 24-week EGD, all patients in NERD remained as NERD but number of healed patients was significantly higher in cont (85.3%) than in on-demand (44.4%) (p < 0.01) in RE.

Conclusions: Since NERD is defined by symptoms, as a result of the limited efficacy of continuous therapy, on-demand therapy would be sufficient as maintenance therapy in NERD patients. Regarding RE, continuous therapy would be recommended in terms of reduced symptoms and maintaining mucosal healing.

Figure 1.

Percentages of patients who achieved symptom relief in the continuous and on-demand groups according to GOS scores at baseline and at the 4-, 8-, 16-, and 24-week visits. There were no significant between-group differences in the percentage of patients who achieved symptom relief at any visit.

Figure 2.

Mean number of consumed tablets per week recorded on a daily chart. Data are shown with standard deviation.

Figure 3.

Percentage of patients who were symptom free for 6 or more days a week as recorded on a daily chart. **p < 0.01, *p < 0.05 versus on-demand group.

Figure 4.

Percentages of patients classified as (a) Grade M or (b) Grade ≥ A who achieved symptom relief in the continuous and on-demand groups according to the GOS. *p < 0.05 versus on-demand group.

Figure 5.

Percentages of patients classified as (a) Grade M or (b) Grade ≥ A who were symptom free for ≥6 days a week in the continuous and on-demand groups according to daily chart entries. **p < 0.01, *p < 0.05 versus on-demand group.