RANDOMIZED, MULTICENTER COMPARISON OF SODIUM ALGINATE AND CISAPRIDE IN THE SYMPTOMATIC TREATMENT OF UNCOMPLICATED GASTROESOPHAGEAL REFLUX

Aim: To assess the efficacy and tolerance of sodium alginate compared to cisapride in patients suffering from reflux symptoms, without sever e oesophagitis, Methods: A total of 353 patients with symptoms of refl ux oesophagitis (average age 40 years, 51% men, 33% smokers, 43% consu mers of alcoholic drinks) were selected at random-180 treated with sod ium 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, Pati ents with severe oesophagitis or with predominant symptoms of motor dy spepsia were not included, The principal assessment criterion was the change in the severity of the reflux symptoms as evaluated using a vis ual analogue scale (VAS) at 4 weeks (extremes 0-100), The secondary cr iteria were the VAS score at 2 weeks, the number of patients considere d 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 t reatments allocated and on an intention-to-treat basis, Results: There was no difference between the groups at the time of randomization, Th ere 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 fo r the proportion of patients considered as treatment failures (11% Vs. 24%, P < 0.001), Compliance was similar in the two groups. The averag e cost for 1 month was lower for alginate (130 fr.) than for cisapride (175 fr.), Conclusion: Sodium alginate is more effective, and costs l ess, than cisapride for the treatment of symptoms presented by patient s suffering from reflux without severe oesophagitis.