Review of the Therapeutic Use of Simethicone in Gastroenterology

NAIR [5]). Background: The history of simethicone covers more than 50 years. The main properties of simethicone are the defoaming reduction of surface tension and the reduction of surface viscosity and hydrophobicity which enable simethicone to spread easily over surfaces. It is not absorbed and is virtually non-toxic. While its use is well-established in diagnostic procedures, therapeutic studies have sometimes been contradictory. Objective: To assess the therapeutic efficacy and safety of simethicone taking into account clinically relevant end points and following the guidelines provided by the Cochrane Collaboration. Methods: The data sources consulted were bibliographic databases, references from review articles and books, as well as personal contacts up to September 07. All papers were screened and those dealing with prospective clinical trials were summarized in a table by indication, study design and methodological quality. Results: Out of a total of 83 publications, 14 concerning diagnostic procedures and 23 therapeutic trials were retained for closer analysis. Good evidence of efficacy was found for antifoaming in diagnostic work-ups and as a therapeutic agent in: 1st) Functional dyspepsia, (4 trials; 266 patients simethicone vs. 310 controls) with simethicone superior to placebo and to cisapride, and 2nd) traveller’s diarrhoea, (2 large trials; 248 simethicone patients vs. 244 placebo) with simethicone superior to placebo (increased efficacy when combined with an μ-opioid-agonist). Data are not conclusive in: 1) ‘IBS-like’ symptoms (2 trials; 80 patients simethicone vs. 54 controls); 2) in post-operative management of intestinal activity (4 mostly old trials; 847 patients simethicone vs. 631 controls); 3) Infantile colics, (7 trials; 306 infants simethicone vs. 296 controls); and 4) as an add-on, against symptoms of gastroesophageal reflux, (3 studies) and in partial adhesive small-bowel obstruction (1 trial). Conclusions: Simethicone may be beneficial in the various indications in which its intraluminal defoaming and coating action are desired. RCTs have shown its efficacy in some indications, in addition to its well-established uses in diagnostic procedures. More RCTs for non-confirmed indications are needed, particularly in view of the very large safety margin of simethicone.