[On-demand treatment of nonerosive reflux disease: omeprazole plus bicarbonate powder versus omeprazole capsules].

BACKGROUND

Nonerosive reflux disease (NERD) has a chronic and benign course. On-demand therapy would constitute a useful strategy for its management.

OBJECTIVE

To assess efficacy of on-demand treatment with omeprazole powder (OBA: omeprazole 20 mg, sodium bicarbonate 1680 mg, alginic acid 250 mg) versus omeprazole capsules 20 mg (OMZ) in the control of symptoms.

METHOD: In this multicenter, open-label, randomized, crossover study, patients with NERD, of both genders and 21 to 65 years old, were included. They underwent alternate treatments, 42 days with each pharmaceutical form (PF), wash out 6 days, beginning with a cycle of 7 consecutive days after the first symptomatic manifestation and repeating the same cycles in the event of similar circumstances. Efficacy was assessed with patient global impression (PGI), visual analogue scale (VAS) for heartburn and time to relieve symptoms. Tolerability was assessed.

RESULTS

Forty-eight patients (40 women, average age 37 years old) entered the study. Both PF were effective according to PGI: 98% with OBA and 92% with OMZ. VAS for heartburn was: baseline 7.29 +/- 1.51; post-OMZ 2.82 +/- 1.85; post-OBA 2.25 +/- 1.61. The percentage of patients who received 7 days' cycles with each treatment were: OMZ 1-2: 29.17%; 3-4: 58.33%; 5-6: 12.5%; OBA 1-2: 43.75%; 3-4: 52.08%; 5-6: 4.17%. Dose was doubled in 35% of cases. OBA acted faster than OMZ for 83% of the patients (87 min versus 140 min, P < 0.01). Both PF were well tolerated.

CONCLUSIONS

On-demand treatment of NERD with omeprazole in cycles of 7 days was equally effective for both PE OBA acted faster to relieve symptoms.