Relapse rate of patients after healing of oesophagitis—a prospective study of alginate as self-care treatment for 6 months

In order to estimate the rate of symptomatic relapse and to identify factors associated with this relapse, 1030 patients were included in a multicentre study. All patients included had clinically and endoscopically healed oesophagitis (grade I (erosion, 57%), grade II (confluent erosion, 33%) or grade III (circular erosion, 9%)) after treatment with an H₂ blocker or omeprazole. Patients were given conservative advice and were told to take sodium alginate only in response to pain. Relapse was defined as pain justifying more than eight sodium alginate sachets over 48 hours or treatment with another drug, or the need for a new endoscopy. Forty risk factors were recorded initially and patients were seen every 2 months; they filled out diary-cards describing symptoms and drug consumption. Data were available for 883 patients during follow up. The cumulative percentage of patients without relapse at 6 months estimated by Kaplan Meier method was 76 ± 2 % (mean ± S.E.M.). Among these patients without relapse, 95% took less than two sachets per day. Only two factors were identified as associated with relapse—the grade of oesophagitis (P < 0.007), and the occurrence of stress during follow-up (P < 0.05). The percentage of patients free from relapse at six months was 85 ± 2% in patients with grade I oesophagitis, 69 ± 3% in patients with grade II, and 56 ± 6% in patients with grade III oesophagitis (P < 0.0001).