Effect of @entity10112 on the course of reflux- XXXX : a placebo-controlled double-blind crossover study.

@entity1 @entity7552 @entity10112 @entity354
BACKGROUND: The optimal management of @entity1 with reflux- @entity7552 is unclear. We performed a placebo-controlled crossover trial in @entity1 with @entity354 and @entity7552 to determine the effect of @entity10112 and to gain information on the natural course of the disease. METHODS: Sixty-two consecutive non-smoking @entity1 with hoarseness and @entity7552 were examined. Scores with respect to the larynx and for subjective complaints were determined and 24-h pH-metry to assess acid reflux in the lower oesophagus and pharynx was performed. @entity1 with pathologic reflux were given the chance to enter a double-blinded randomized crossover trial with @entity10112 40 mg b.i.d. and placebo for a duration of 3 months each, separated by a 2-week washout period. RESULTS: Twenty-four of 62 @entity1 showed pathological reflux; 21 @entity1 were included in the study and 14 concluded all parts of the study. Both @entity10112 and placebo resulted in a marked improvement in @entity7552 scores (decrease of 8.0 +/- 1.4 versus 5.6 +/- 2.6; no significant difference between the 2 treatments) and symptoms after the first 3 months (decrease of oesophageal symptom score of 2.2 +/- 1.4 versus 5.4 +/- 2.8; decrease of laryngeal scores of 8.3 +/- 3.6 versus 10.3 +/- 3.9; also no significant difference between the 2 treatments). A second pH-metry 2 weeks thereafter proved the persistence of reflux in most of these @entity1 . Switching to @entity10112 led to a further improvement of scores. In the group switched to placebo there was recurrence only in a minority of @entity1 . CONCLUSIONS: The self-limited nature of reflux- @entity7552 in non-smokers is largely underestimated. @entity7552 improves despite the persistence of reflux. @entity10112 may be helpful especially in relieving acute symptoms, but the advantage of long-term treatment over placebo has been greatly overestimated.
