Can dietary integrators provide a clinical benefit in the treatment of functional dyspepsia? results from a prospective study with TUBES Gastro.

AIM: Given the limited efficacy of conventional medical therapy for functional dyspepsia, patients frequently seek alternative medical approaches. The use of suc h alternative therapies has dramatically increased during the last decades. The scope of this prospective study was to provide evidence of the clinical benefit of the treatment of functional dyspepsia with a dietary integrator composed by sodium alginate, sodium bicarbonate, bromelin and essential oils.

METHODS: This study enrolled a total of 100 patients affected by functional dyspepsia diagnosed primarily on the basis of typical symptoms and the exclusion of non-functional gastrointestinal diseases (negative upper gastrointestinaltract endoscopy and negative for H. pylori infections, including acid-related diseases), non-gastrointestinal diseases, and psychiatric illness. All patients enrolled were categorized in two symptom-predominant subgroups: dysmotility-like dyspepsia (N.=60) and reflux-like dyspepsia (N.=40). Patients were treated with TUBES Gastro (0.80 g oral tablets bid after main meals) for 4 weeks, on top of their current treatment with proton pump inhibitors or not. Efficacy was measured by a Numerical Rating Scale (NRS) at baseline and after 14 and 28 days of treatment with TUBES Gastro while safety and tolerability were evaluated based on the adverse event reporting from the patients.

RESULTS: Sixty patients were diagnosed with dysmotility-like dyspepsia and were enrolled into the study; the majority was females (68%) with a mean age of 48.5 years (19-81). The mean baseline NRS score was 5.7 (4-8). A high statistically significant reduction of the NRS score was observed at 14 and 28 days: -1.5 (-26.3%) and -3.4 (-59.6%), respectively (P<0.0001). Forty patients were diagnosed with reflux-like dyspepsia and were enrolled into the study; the majority was males (70%) with a mean age of 49.1 years (24-80). The mean baseline NRS score was 6.8 (5-9). A high statistically significant reduction of the NRS score was observed at 14 and 28 days: -2.8 (-41.2%) and -4.8 (70.6%), respectively (P<0.0001). No side effects were collected during the study duration.

CONCLUSION: The data obtained from this four-week study indicate that TUBES Gastro treatment was effective and well tolerated in reducing the symptomatology of patients affected by functional dysmotility-like and reflux-like dyspepsia.