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CLINICAL TRIAL
JOURNAL ARTICLE
Benefit of dietary integrators for treating functional dyspepsia: a prospective pilot study.
Minerva Gastroenterologica e Dietologica 2009 September
AIM: Because of the multifactorial pathogenesis of functional dyspepsia, strategies alternative to antacid therapy are being sought for treating the disorder. This prospective study evaluated the benefit of treatment with a dietary integrator composed of sodium alginate, sodium bicarbonate, bromelin and essential oils.
METHODS: The study population included 53 consecutive patients (22 males, 31 females; mean age, 54+/-2.5 years) with functional dyspepsia and negative for Helicobacter pylori infection. The patients were categorized into four subgroups according to predominant symptom: ulcer-like dyspepsia, motility-like dyspepsia, reflux-like dyspepsia, and nonspecific dyspepsia. All received TUBES gastro (0.80 g oral tablets bid) for a minimum of 3 months (range, 3-11). Treatment efficacy was measured by means of a Visual Analogue Scale (VAS).
RESULTS: Two patients were lost to follow-up; of the remaining 51 patients who completed the study, 35 (68%) showed an improvement in VAS score. The difference in scores between the initial and the final visit was -1.9+/-2.1 cm (range, -6 to +3), or 23.8+/-40.8% (range, -150% to 100%) compared to the scores at the baseline visit (P=0.0001).
CONCLUSIONS: The study results indicate that in the short term TUBES gastro can significantly improve dyspeptic symptoms in dyspeptic patients negative for H. pylori infection through the synergistic action of its components: alginate buffers gastric acid; bicarbonate helps to eliminate gas and rebalance pH; essential oils regulate motility; and bromelin stimulates enzymatic activity.
METHODS: The study population included 53 consecutive patients (22 males, 31 females; mean age, 54+/-2.5 years) with functional dyspepsia and negative for Helicobacter pylori infection. The patients were categorized into four subgroups according to predominant symptom: ulcer-like dyspepsia, motility-like dyspepsia, reflux-like dyspepsia, and nonspecific dyspepsia. All received TUBES gastro (0.80 g oral tablets bid) for a minimum of 3 months (range, 3-11). Treatment efficacy was measured by means of a Visual Analogue Scale (VAS).
RESULTS: Two patients were lost to follow-up; of the remaining 51 patients who completed the study, 35 (68%) showed an improvement in VAS score. The difference in scores between the initial and the final visit was -1.9+/-2.1 cm (range, -6 to +3), or 23.8+/-40.8% (range, -150% to 100%) compared to the scores at the baseline visit (P=0.0001).
CONCLUSIONS: The study results indicate that in the short term TUBES gastro can significantly improve dyspeptic symptoms in dyspeptic patients negative for H. pylori infection through the synergistic action of its components: alginate buffers gastric acid; bicarbonate helps to eliminate gas and rebalance pH; essential oils regulate motility; and bromelin stimulates enzymatic activity.
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