Randomized, multicentre comparison of sodium alginate and cisapride in the symptomatic treatment of uncomplicated gastro-oesophageal reflux.

AIM To assess the efficacy and tolerance of sodium alginate compared to cisapride in patients suffering from reflux symptoms, without severe oesophagitis. METHODS A total of 353 patients with symptoms of reflux oesophagitis (average age 40 years, 51% men, 33% smokers, 43% consumers of alcoholic drinks) were selected at random--180 treated with sodium alginate (4 sachets per day) and 173 treated with cisapride (5 mg four times a day) for 1 month, with a consultation every 2 weeks. Patients with severe oesophagitis or with predominant symptoms of motor dyspepsia were not included. The principal assessment criterion was the change in the severity of the reflux symptoms as evaluated using a visual analogue scale (VAS) at 4 weeks (extremes 0-100). The secondary criteria were the VAS score at 2 weeks, the number of patients considered as treatment failures, the number of episodes of pain, the impact of the reflux on daily activities and on sleep, and an estimate of costs. The statistical analyses were planned without any knowledge of the treatments allocated and on an intention-to-treat basis. RESULTS There was no difference between the groups at the time of randomization. There were differences in the VAS in favour of the alginate at 2 weeks (29 +/- 22 vs. 35 +/- 25, P = 0.01) at 4 weeks (13 +/- 17 vs. 20 +/- 23, P = 0.001), for the number of episodes at 4 weeks (2 +/- 2 vs. 3 +/- 4, P = 0.001), for pain interfering with daily activities (3% vs. 10%, P = 0.009), for pain disturbing sleep (2% vs. 9%, P = 0.004), and for the proportion of patients considered as treatment failures (11% vs. 24%, P < 0.001). Compliance was similar in the two groups. The average cost for 1 month was lower for alginate (130 fr.) than for cisapride (175 fr.). CONCLUSION Sodium alginate is more effective, and costs less, than cisapride for the treatment of symptoms presented by patients suffering from reflux without severe oesophagitis.