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

Clin Res Hepatol Gastroenterol. 2011 Jun;35(6-7):494-9. doi: 10.1016/j.clinre.2011.02.009. Epub 2011 Apr 7.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antacids / therapeutic use
  • Antidotes / therapeutic use
  • Antifoaming Agents / therapeutic use
  • Charcoal / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Dyspepsia / drug therapy*
  • Female
  • General Practice
  • Humans
  • Magnesium Oxide / therapeutic use*
  • Male
  • Prospective Studies
  • Severity of Illness Index
  • Simethicone / therapeutic use*

Substances

  • Antacids
  • Antidotes
  • Antifoaming Agents
  • Drug Combinations
  • Charcoal
  • Magnesium Oxide
  • Simethicone