Efficacy of a simethicone, activated charcoal and magnesium oxide combination (Carbosymag®) in functional dyspepsia: Results of a general practice-based randomized trial

SummaryBackgroundA simethicone, activated charcoal and magnesium oxide combination (Carbosymag®) has been used for almost 20 years in functional dyspepsia, but there is limited scientific evidence of efficacy.AimWe evaluated the efficacy of Carbosymag® in 18- to 49-year-old patients with functional dyspepsia.MethodsA total of 276 dyspeptic patients consulting a general practitioner and meeting the Rome III criteria were included in this prospective placebo-controlled study. Variations in overall and individual dyspeptic symptoms were evaluated after 1 month of treatment.ResultsAt the end of the treatment period, overall dyspeptic symptom intensity was significantly lower in the Carbosymag® group (P = 0.01). The intensity of post-prandial fullness, epigastric pain, epigastric burning and abdominal bloating was significantly reduced in the Carbosymag® group relative to the placebo group (P < 0.05). The number need to treat to induce a 70-% decrease in overall dyspeptic symptoms by Carbosymag® was 7 (IC 95%: 4–32).ConclusionA simethicone, activated charcoal and magnesium oxide combination (Carbosymag®) was significantly more effective than a placebo on overall symptom intensity in dyspeptic patients consulting a general practitioner.