Treatment and prevention of relapse of mild oesophagitis with omeprazole and cisapride: comparison of two strategies.

BACKGROUND

Oesophagitis is usually a chronic condition. Healing with omeprazole is often followed by early relapse. Combination treatment and subsequent maintenance treatment with the prokinetic cisapride may be of benefit in relapse prevention.

METHODS

Patients with endoscopically proven oesophagitis, grade I (n = 120) or grade II (n = 105), were randomized in an open fashion to receive 8 weeks of healing treatment with omeprazole 20 mg daily (OM) followed by 12 months of follow-up without maintenance treatment, or 8 weeks of combined treatment of omeprazole 20 mg daily plus cisapride 5 mg t.d.s. (OMCIS) followed by 12 months of maintenance treatment with cisapride 5 mg t.d.s. (CIS). Only the patients healed after acute treatment were included in the 12-month follow-up study for evaluation of endoscopic relapse.

RESULTS

In the group of patients with oesophagitis grade I (n = 58 receiving OM, n = 62 receiving OMCIS), healing rates were comparable for both acute treatment regimens. In the group of patients with grade II (n = 54 receiving OM, n = 51 receiving OMCIS), the healing rates were slightly but not significantly in favour of OMCIS after 4 and 8 weeks of treatment. During the 12 months of follow-up, CIS maintenance treatment was associated with a significant reduction of relapse. In the group of patients with initial grade I oesophagitis, the relapse rates after 3 months were 20% in the OMCIS group receiving CIS maintenance treatment, compared to 48% in the group healed on OM without further maintenance treatment (P = 0.04). After 6 months, these relapse rates were 31% and 85% respectively (P < 0.001), and after 12 months 40% and 96% (P < 0.001). In the group of patients with initial grade II oesophagitis, they were, respectively, 20% vs. 39% after 3 months (P = 0.056), 41% vs. 78% after 6 months (P < 0.001) and 52% vs. 95% after 12 months (P < 0.001).

CONCLUSIONS

The results of this open study indicate that continued treatment with cisapride 5 mg t.d.s. (after initial healing with omeprazole 20 mg daily plus cisapride 5 mg t.d.s.) is beneficial in the long-term management of grade I and II oesophagitis: this treatment approach significantly reduces the high relapse rate observed after stopping healing treatment with omeprazole.