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Randomized Controlled Trial
. 2011 Jun;35(6-7):494-9.
doi: 10.1016/j.clinre.2011.02.009. Epub 2011 Apr 7.

Efficacy of a Simethicone, Activated Charcoal and Magnesium Oxide Combination (Carbosymag®) in Functional Dyspepsia: Results of a General Practice-Based Randomized Trial

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Randomized Controlled Trial

Efficacy of a Simethicone, Activated Charcoal and Magnesium Oxide Combination (Carbosymag®) in Functional Dyspepsia: Results of a General Practice-Based Randomized Trial

Benoit Coffin et al. Clin Res Hepatol Gastroenterol. .

Abstract

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.

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