BACKGROUND: A 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. AIM: We evaluated the efficacy of Carbosymag(®) in 18- to 49-year-old patients with functional dyspepsia. METHODS: A 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. RESULTS: At 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). CONCLUSION: A 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.
RCT Entities:
BACKGROUND: A 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. AIM: We evaluated the efficacy of Carbosymag(®) in 18- to 49-year-old patients with functional dyspepsia. METHODS: A 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. RESULTS: At 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). CONCLUSION: A 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.