Administration of mucolytic solution before upper endoscopy - double-blind, monocentric, randomized study

Abstract

Aims. Sufficient visibility of the mucosa during upper endoscopy is crucial for successful diagnosis, especially for early neoplastic lesions. Data documenting the effect of administration of mucolytic solution prior to gastroscopy in order to improve mucosal visibility are limited in Europe. The aim of the study was to assess the score of mucosal visibility in the upper gastrointestinal tract after administration of the mucolytic solution defined by us. Patients and Methods. This is a monocentric, double-blind, randomized study involving 134 patients indicated for diagnostic upper endoscopy. Patients were randomly assigned to one of three arms, with mucolytic solution (100 mL water + 400 mg N-acetylcysteine + 20 mg simethicone), without the solution , and with 100 mL pure water. During the examination, 11 photographs were taken in defined areas. The visibility score was given by the sum of the score 0-5 from 5 defined localities evaluated by a blinded endoscopist and subsequently by two blinded endoscopists. Other parameters monitored were examination time and a semiquantitative evaluation of residual gastric fluid. Results. The basic characteristics of the group (sex, age, indications for examination) were comparable between arms. The visibility score was similar in all arms -17.4 ± 1.9 vs. 17.0 ± 2.0 vs. 17.6 ± 1.8 (P=0.32). The examination time and the amount of residual fluid in the stomach were comparable in all arms. Conclusions. Administration of the mucolytic solution in our study did not increase the mucosal visibility score in the esophagus, stomach and duodenum. Trial Registration: ClinicalTrials.gov, NCT02967094.

Administration of maximum dose of mucolytic solution before upper endoscopy – a double-blind, randomized trial

“…Also, Manfredi et al demonstrated that premedication with 2 ml of simethicone and 600 mg of n-acetylcysteine facilitated significantly better endoscopic visualization of gastric mucosa [14]; however, Elvas et al did not demonstrate improved mucosal clarity when using a solution containing 200 mg simethicone, 600 mg n-acetylcysteine, and water versus 200 mg simethicone alone with water [17]. Stepan et al then in their study did not demonstrate improved mucosal clarity when using low doses of the substances, that is, 20 mg simethicone, and 400 mg n-acetylcysteine with water [16]. Therefore, in our study, we chose the maximum recommended daily doses of both substances that can be given to adults of the general population, according to the Summary of Product Characteristics of the State Institute for Drug Control of the Czech Republic, which is 400 mg and 4 ml for simethicone and 600 mg for n-acetylcysteine, respectively, if we do not consider patients with mucoviscidosis, where the doses are higher.…”

“…Stepan et al . then in their study did not demonstrate improved mucosal clarity when using low doses of the substances, that is, 20 mg simethicone, and 400 mg n -acetylcysteine with water [16]. Therefore, in our study, we chose the maximum recommended daily doses of both substances that can be given to adults of the general population, according to the Summary of Product Characteristics of the State Institute for Drug Control of the Czech Republic, which is 400 mg and 4 ml for simethicone and 600 mg for n -acetylcysteine, respectively, if we do not consider patients with mucoviscidosis, where the doses are higher.…”

“…Therefore, in our study, we chose the maximum recommended daily doses of both substances that can be given to adults of the general population, according to the Summary of Product Characteristics of the State Institute for Drug Control of the Czech Republic, which is 400 mg and 4 ml for simethicone and 600 mg for n-acetylcysteine, respectively, if we do not consider patients with mucoviscidosis, where the doses are higher. The amount of water we used in the solution, 100 ml, as well as the timing of the administration of the solution before gastroscopy, appears to be effective and safe according to the study's performer [8][9][10][11][12][13][14][15][16][17][18][19]. Our study showed a significantly higher overall mucosal visibility score in the upper gastrointestinal tract after administration of the solution, with the maximum dose of mucolytic solution compared to the branch without administration of solution or water, when the visibility score was evaluated by the endoscopist performing the procedure.…”

“…On the basis of a power analysis, where the primary objective was to compare group D (gastroscopy without administration of mucolytic solution and water) to group A (with maximum mucolytic dose), estimates of 26 patients per branch were determined. We assumed a 10% increase in the mean visibility score, power 0.8, based on data from our previous study, where the visibility score in the group of patients without administration of mucolytic solution or water was 17 ± 2.0 [16]. Branches B and C were the control branches.…”

“…Simethicone, as an antifoaming agent, is recommended by the ESGE for administration as part of bowel preparation prior to colonoscopy [6]. A number of studies, mostly Asian, have been conducted to evaluate the effect of these agents on increasing mucosal transparency in the upper gastrointestinal tract [7][8][9][10][11][12][13][14][15][16][17][18][19]. Most of these studies have demonstrated an effect primarily of simethicone [8][9][10][11]17,18].…”