[ XXXX VERSUS PLACEBO IN NON ULCER DYSPEPSIA TREATMENT]

@entity1 @entity6359 @entity1066 @entity2210 @entity1534 @entity158
BACKGROUND: Non @entity1066 is an important health problem with a very high prevalence in the general population, being its pathophysiology still unclear and its association with @entity1534 highly controversial. Many trials have been carried out assessing the effects of different drugs on the symptoms in dyspeptic @entity1 , being one of the most common the use of H2 antagonist, even though the results have shown conflicting as far as efficacy is concerned. The goal of the present study is to determine the efficacy of @entity6359 (administered in three different regimens) as compared to placebo in relieving the symptoms of non @entity1066 .METHODS: @entity1 with chronic non @entity1066 were included and were selected by random in four groups; group I received @entity6359 40 mg before breakfast, placebo before dinner and at bedtime; group II received @entity6359 20 mg before breakfast and dinner and placebo at bedtime; group III received @entity6359 40 mg at bedtime, placebo before breakfast and dinner; group IV received placebo before breakfast, dinner and at bedtime. A four week treatment period was completed. Endoscopy, measure of the gastric juice pH, and biopsy (including study for H.p) was done at the beginning of the study, at week 4 and at week 8. The @entity1 was asked for a global assessment of improvement in the overall symptoms of @entity2210 at the end of weeks 1,4 and 8.RESULTS: Forty-eight @entity1 (12 @entity1 and 36 @entity1 ) participated in the study. There was not statistical difference between any of the four schemes of treatment and the effect over the @entity158 and the symptoms during the study. Nevertheless there was a highly statistically difference (p<0.01) of the well being of the @entity1 with all the groups of treatment received. There was a significant difference (p<0.05) between the pH of the groups II, III, IV, being the pH at fourth week, the one with a high mean value. There was not statistical difference in the pH value between @entity1 that improve its symptoms and those that not H.p. presence was the same along the study in the group that showed improvement of @entity158 and related symptoms and the group that did not improve. There was no significant changes in the histological pattern and the grade of inflammatory activity in relation to symptoms improvement. During the study there was not any clinical laboratory adverse experience.CONCLUSIONS: Non of the three schemes with @entity6359 used in this trial has proven to have any therapeutical benefit in non @entity1066 compared to placebo, even though @entity1 improved their symptoms in all the four groups. It seems that gastric juice does not play a rol in the genesis of non @entity1066 . In this study, nor the presence of H.p. neither inflammatory activity are associated with the symptoms of non @entity1066 . More studies carefully designed are required not only to understand pathophysiological mechanism, also to identify effective treatments for this frequent entity.
