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Quality parameters for upper gastrointestinal endoscopy have introduced intraprocedural indicators, including adequate mucosal visualization free of saliva, mucus, or bubbles, which may increase the possibility of earlystage injury detection. The use of mucolytics and anti-foaming agents has shown great efficiency variability depending on the type of solution, concentrations, exposure times and visibility scale applied. Objectives: To determine the effectiveness of different premedication solutions for cleaning the digestive mucosa; to validate, by means of an interobserver concordance test, a new scale for the adequate visualization of the mucosa (TVMS) for the esophagus, stomach, and duodenum; and to report adverse events or complications associated with the solutions used and the procedures performed. Material and methods: Prospective, comparative cohort study. 412 adult patients, ASA I and ASA II, were included for diagnostic endoscopy under conscious sedation. They were distributed in 6 similar cohorts and divided into two groups: non-premedication, 2 in C1 (fasting 6 to 8 hours) and C2 (water 100 mL) cohorts; premedication, 4 C3 to C6 cohorts (C3: water 100 mL + simethicone 1000 mg; C4: water 100 ml + simethicone 200 mg + N-acetylcysteine 600 mg; C5: water 100 ml + simethicone 200 mg + N-acetylcysteine 1000 mg; C6: water 100 ml + simethicone 200 mg + Hedera helix 70 mg). The solution was swallowed 15 to 30 minutes passing through the cricopharyngeus muscle. The Kappa test was performed to measure interobserver concordance of the TVMS scale. Results: Of 412 patients, 58 % were female; 23 % (136) were included in the C1 and C2 cohorts; and 67 % (276) were in the C3 to C6 cohorts. The average exposure time to each solution was 24.4 minutes. The wash volume for proper visualization was significantly different between the two groups. In premedicated patients, 75.6 mL of solution were used, while in patients without premedication, 124 mL were used (p = 0.000), with an excellent quality of TVMS of 88.7% versus 41.4%, respectively. The C4 cohort (water 100 mL + simethicone 200 mg + N-acetylcysteine 600 mg) was the most effective with a significant difference (p = 0.001) compared with the C1 (fasting) and C2 (placebo with water 100 mL) cohorts. It also had better efficiency compared to the C3, C5 and C6 cohorts in that order. There were no adverse events or complications associated with endoscopy, sedation, or premedication products. Conclusions: The most effective solution as a premedication to achieve excellent visibility of the digestive mucosa was that used in the C4 cohort (SIM 200 + NAC 600 + H2OR 100 mL). The proposed TVMS scale is a very complete and easy tool to apply by more than one observer. Premedication ingested, with anti-foam, mucolytic and water up to 100 mL, between 15 and 30 minutes before endoscopy, is safe under the conditions described in this study. [ABSTRACT FROM AUTHOR]

Objectives: Early cancer detection is crucial in improving the patients' quality of life and upper gastrointestinal endoscopy (EGD) plays a key role in this detection. Many clearing mechanisms may be applied to create good endoscopic visualizations for the upper gastrointestinal tract using mucolytic agents, antifoaming agents, proteolytic enzymes and neutralizers. The aim of this study is to compare the effects of simethicone, N-acetylcysteine (NAC), sodium bicarbonate and peppermint as pre-medications for visualization of esophagogastroduodenoscopy (EGD). Methods: This study was a single center prospective randomized controlled trial. The patients were randomly allocated to one of four treatment groups. Group A: water; Group B: water with simethicone; Group C: water with simethicone plus NAC 600 mg; Group D: water with simethicone, NAC, sodium bicarbonate and peppermint. Results: A total of 128 patients were enrolled and evaluated in this study. Total visibility score (TVS) of Groups A, B, C, and D were 13.4 ± 1.86, 10.5 ± 1.45, 7.15 ± 0.98 and 6.4 ± 1.43, respectively. Group D showed lower TVS than other groups. The procedural durations of Groups C and D were significantly shorter than Group A. The volume of solution for mucosal cleansing of Groups C and D was significantly lower than Groups A and B. Conclusions: The application of simethicone plus NAC is safe, improves endoscopic visualization and requires a minimal amount of mucosal cleansing solution. The addition of sodium bicarbonate and peppermint further improved visualization for the upper and lower gastric body. Thai Clinical Trials Registry (TCTR) with a reference number; TCTR20190501002. [ABSTRACT FROM AUTHOR]

Introduction  With the advancements in diagnostic and therapeutic upper gastrointestinal endoscopy (UGIE), clear mucosal visualization is essential to ensure optimal outcomes. Though routinely followed in Japan and Korea, pre-endoscopic preparation is seldom used in India. We evaluated the efficacy of a pre-endoscopic drink of N-acetylcysteine (NAC) and simethicone in improving mucosal visibility during UGIE. Patients and Methods  This study was a retrospective, investigator blind study with a case–control study design. Cases included patients who received a pre-endoscopy drink of NAC and simethicone in 100 mL water administered 10 to 30 minutes prior to UGIE. Controls only had mandatory fasting for 6 to 8 hours prior to UGIE. Propensity score matching was done to ensure comparability between the groups. Digital images were taken at six standard landmarks during UGIE and stored. A blinded investigator subsequently analyzed the images and rated the mucosal visibility on a 3-point scale. The difference in the mean mucosal visibility between the cases and controls was compared. Results  Mean mucosal visibility during UGIE was significantly better using NAC with simethicone as compared with no preparation at esophagus (1.14 [0.37] vs. 1.47 [0.62], p < 0.05), gastric fundus (1.10 [0.30] vs. 1.55 [0.64], p < 0.05), gastric body (1.22 [0.50] vs. 1.62 [0.73], p < 0.05), gastric antrum (1.13 [0.37] vs. 1.47 [0.62], p < 0.05), and duodenal bulb (1.13 [0.34] vs. 1.33 [0.56], p < 0.05). In distal duodenum, though visibility improved with NAC with simethicone, the difference was insignificant. There were no adverse events related to the pre-endoscopy drink. Conclusion  A pre-endoscopy drink of NAC with simethicone can significantly improve mucosal visibility during UGIE. It is safe, cheap, easily available and maybe considered for routine utilization for ensuring optimal endoscopic outcomes. [ABSTRACT FROM AUTHOR]

Introduction: This method was applied to form a non-absorbable complex with uranium and thorium swallowed with contaminated dust or other sources to get rid of them before absorption into the blood and discarded outside the body. A non-GIT absorbable simethicone was used in this method for the adsorption of uranium (VI) and thorium (IV) from a solution similar to the gastrointestinal tract pH medium. Materials and Methods: Accurately measured 9 mg of pure standard uranyl nitrate and simethicone emulsion in concentration range (100-300 mg) at 37±1°C for 20 min in pH ranges like the medium of the stomach and intestine then take the supernatant after centrifugation to make sure of decreasing of the concentration of uranium and thorium ions by ICP Mass Spectroscopy (ICP-MS). Results and Discussion: The data recorded for different total uranium and thorium concentrations reveal convergent behavior. Increasing simethicone concentration inside the safe dose shifts the sorption of uranium and thorium to 100 % of the total concentration, calculated t and F values were compared with the reference method and the proposed method was equally precise and accurate. Conclusion: The data indicate that the method can successfully be applied for the complete adsorption of uranium and thorium on simethicone from GIT before reaching the blood. [ABSTRACT FROM AUTHOR]

Background. Esophagogastroduodenoscopy (EGDS) is the gold standard exam for upper gastrointestinal diseases. EGDS is very important in Early Gastric Cancer diagnosis and treatment but it is an operator-dependent exam and there are lots of factors that reduce its visibility (mucus, bubbles and foam). Aim. The aim of our study is to evaluate if the use of Lumevis™ improves mucosa visualization during EGDS without increasing the examination time and complications' rate and comparing the differences in patients prepared with water or no intervention. Materials and methods. we recruited 50 patients from 01/08/2020 to 31/08/2020 who came to our observation for epigastric pain, dyspepsia and gastroesophageal reflux (GERD). For each patient we evaluate the satisfaction of the procedure, vision quality, EGDS duration and the presence of bubbles following the administration of: nothing (group 1); 50 ml of water alone (W) (group 2); W + simethicone (S) 150 mg+N-acetylcysteine (NAC) 250 mg+10% acetic acid 2.5 ml (group 3); W+S 100 mg + NAC 300 mg + 10% acetic acid 2 ml (group 4); W + S 100 mg + NAC 200 mg + 10% acetic acid 1.5 ml (group 5). Results. Our results suggest that the lesion detection rate improves with the use of simethicone, acetylcysteine and acetic acid prior to EGDS, although this needs to be studied prospectively. Conclusions. Lumevis™ is proposed as a new product in the routine preparation of all patients who have to undergo an EGDS, raising the level in the quality of the exam. [ABSTRACT FROM AUTHOR]

Background and Aim: Additional simethicone (SIM) can improve adequate bowel preparation and adenoma detection rate (ADR). However, there is no consensus on the optimal dose of SIM. In this study, we compared the adequate bowel preparation rate with supplementation of split‐dose 2 L polyethylene glycol (PEG) with low‐dose SIM (200 mg) versus high‐dose SIM (1200 mg). Methods: This was a prospective, randomized, observer‐blinded trial involving consecutive subjects undergoing colonoscopy. The primary outcome was adequate bowel preparation as assessed by Boston Bowel Preparation Scale (BBPS) score. Results: Four hundred subjects were randomly allocated to low‐dose SIM or high‐dose SIM group. Baseline characteristics were comparable in the two groups (P > 0.05). No significant between‐group differences were observed with respect to total bubble scale (BS) (8.49 ± 1.00 vs 8.39 ± 1.10, P = 0.07), total BBPS score (8.70 ± 0.81 vs 8.29 ± 1.18, P = 0.98), ADR (33.68% vs 31.79%, P = 0.69) or withdrawal time (13 [range, 10–16] min vs 13 [10–15] min, P = 0.96). The intubation time in low‐dose SIM group was significantly shorter than that in high‐dose SIM group (8 (4–16) min vs 10 [6–17] min, P = 0.04). In addition, BS scores as well as diminutive ADR in right colon were superior in the low‐dose SIM group (2.68 ± 0.59 vs 2.52 ± 0.73, P = 0.03 and 54.29% vs 30.30%, P = 0.046, respectively). Conclusion: Addition of low‐dose SIM to split‐dose 2 L PEG was as effective as addition of high‐dose SIM with respect to adequate bowel preparation, ADR and patient tolerance. However, low‐dose SIM was superior with respect to intubation time, right colon BS scores, right colon diminutive ADR and cost savings. [ABSTRACT FROM AUTHOR]

Fourier transform infrared (FTIR) spectroscopy was mostly used in both pharmacopeia and literature studies to determine the assay of simethicone (SMT) in pharmaceuticals. It should be noted that HPLC is used less frequently. As an alternative to the mentioned methods a new, simple, fast, easy-to-apply and very cheap gravimetric method was developed and validated according to ICH guidance entitled Q2B Validation of Analytical Procedures: Methodology for the quantification analysis of simethicone in different pharmaceutical forms. For the simethicone suspension product provided to alleviate too much gas in the gastrointestinal tract, the simethicone amount was determined both by the validated gravimetric method and by the FTIR method defined in the USP and BP monographs, and the results were within the acceptance criteria. It is emphasized that there is no significant difference between the results of gravimetric and FTIR methods according to the calculated F- and t-test results. [ABSTRACT FROM AUTHOR]

Introduction: Dimethicone enhances diagnostic accuracy in Oesophagogastroduodenoscopy (EGD). Various regimens have been tried to ease the procedure for better mucosal visibility. Aim: To evaluate the efficacy of activated dimethicone in improving endoscopic visibility. Materials and Methods: The present prospective study was carried out from February 2017 to February 2018 in a tertiary teaching hospital, Chennai, India. A total of 2917 patients aged 18-70 years were enrolled for this study. The participants were divided into group S (1540 patients) and group C (1377 patients). Group S received activated dimethicone 30 minutes before the procedure and group C underwent procedure without any pre-procedure preparation. The mucosal visibility Score was evaluated in both the groups. Statistical analysis was conducted using IBM SPSS statistics (version 23.0). Unpaired student's t-test and Pearson Chi-Square test are used for statistical analysis of the data and in both, p<0.05 was considered as significant level. Results: The mucosal visibility Score in oesophagus, stomach, antrum and duodenum was significantly better in group S patients compared to group C patients. Duration of endoscopy was significantly (p value 0.0005) shorter (7.95 min) in the group S compared with the group C (8.17 min). The amount of flush used was on an average 3 mL less for group S than group C, which was also significant (p-value 0.0005). Conclusion: Activated dimethicone pre-preparation to EGD significantly increased the mucosal visibility during procedure and decreased the endoscopy duration. [ABSTRACT FROM AUTHOR]

Objective: To examine the effect of simethicone on reducing operative difficulty associated with bowel interference during minilaparotomy for postpartum modified Pomeroy partial salpingectomy.Study Design: We enrolled 20-45-year-old women planning the procedure from March 2018 to February 2019. We randomized participants to chew simethicone 160 mg with water 50 mL 2-8 h before surgery or no treatment. The participants were not blinded; however, surgeons, care providers, and outcome assessors were blinded to the study allocation. We measured surgeon-rated operative difficulty using a 10-cm visual analog scale that represented the difficulty perceived to be resulting from bowel interference. Secondary outcomes included operative time and intraoperative and postoperative complications.Results: We enrolled 60 women in each group; baseline characteristics and procedural profiles were comparable. Women in the intervention group used simethicone a median of 157 min (interquartile range 127-192) before the procedure. Surgeons rated the procedure difficulty score as 4.8 in the simethicone group and 4.5 in the control group (p = 0.57). Operative time in the two groups were 26 and 24 min, respectively (p = 0.14). We found no difference in intraoperative adverse events including blood loss and mesosalpinx tear, postoperative morbidities, hospital stay, and patient-rated satisfaction scores.Conclusion: Preprocedural simethicone has no demonstrable benefit in reducing operative difficulty caused by bowel interference during minilaparotomy for postpartum tubal sterilization.Implications: Preprocedural simethicone as given in this study did not result in reduced bowel interference and improved procedure difficulty. Further research examining simethicone in this setting would not be worthwhile as clinically meaningful benefit is unlikely. [ABSTRACT FROM AUTHOR]

The main pathological process associated to increased intestinal permeability is the translocation of toxic products, predominantly endotoxins/lipopolysaccharide (LPS), from the intestinal tract into the microcirculation. In blood, LPS binds to surface receptors on immune cells initiating an inflammatory response. LPS can also bind to platelets leading to preactivated platelets that have a lower threshold to be aggregated in presence heparin. The aim of this study was to validate a simple, fast and reliable test for screening LPS-loaded platelets. This test named PANDA (acronym for Platelet Number in Different Anticoagulants) consists in the measurement of the mean platelet number in blood samples collected into EDTA and heparin. We analyzed blood samples from 92 patients with gastrointestinal diseases and 23 healthy volunteers and found a markedly low number of platelets in heparinized blood compared to EDTA-anticoagulated blood in patients but not in healthy volunteers. Furthermore, ex vivo addition of endotoxin to blood samples induced a remarkable decrease in platelet count in heparinized blood of the volunteers but not in the patient's group, where platelets could be previously saturated by endotoxin circulating in blood. Platelet should be counted during the first hour after blood collection, in order to avoid false results due to a progressive platelet aggregation in heparinized blood in function of the time. Our results demonstrated that PANDA test can be used for screening LPS-loaded platelets as an indirect diagnostic biomarker for increased intestinal permeability and also for monitoring the gut barrier function during the treatment of gastrointestinal diseases. [ABSTRACT FROM AUTHOR]

Objective: To determine effect of pre-endoscopy intake of simethicone solution on endoscopic mucosal visibility. Methodology: A randomized, single blinded placebo control trial was done in patients undergoing oesophago-gastro-duodenoscopy for any indication at DOTs Endoscopy Suite, CHK during the period of April to June 2019. Informed consent was taken. Patients were randomly allocated in two groups. Group-A received placebo while Group-B received Simethicone. Evaluation of mucosal visibility was assessed at 4 sites (oesophagus, fundus, antrum & duodenum) by previously validated scoring. Mean of visibility scores were compared in two groups. Results: Two hundred and forty-eight patients were inducted and randomly allocate to two groups of 124 each. Mean of total sum of scores in Group-A was 8.14 ±2.44 and that of Group-B was 5.80 ±1.75 (p<0.001). Adequate visibility in Group-A was seen in 41.1% and that in Group-B was 78.2% (p<0.001). Conclusion: Use of Simethicone significantly improves mucosal visibility during OGD. [ABSTRACT FROM AUTHOR]

Background and Aim: PBK‐1701TC is a novel sulfate tablet‐based that contains 320 mg of simethicone and delivers 90% of the salt and water delivered by oral sulfate solution (OSS) preparation. This study evaluated the efficacy, safety, and tolerability of PBK‐1701TC compared with OSS in bowel preparation for colonoscopy. Methods: This randomized, multicenter, phase 3 non‐inferiority trial included adults aged 19 years or older with a body mass index of 19–30 kg/m2 undergoing colonoscopy at five university hospitals in Korea. The primary efficacy endpoint was successful bowel‐cleansing rate, defined as Harefield Cleansing Scale grade A or B as evaluated by blinded central readers. Secondary endpoints included the presence of residual air bubbles. Adverse events and laboratory evaluations were monitored to assess safety. Tolerability was assessed via participant interview. Results: Overall, 235 participants were randomized, and 224 were included in the per‐protocol analysis (PBK, 112; OSS, 112). Successful bowel cleansing was achieved for 95.5% (107/112) in the PBK group, which was non‐inferior to the OSS group (98.2%, 110/112) with a difference of −2.7% (one sided 97.5% confidence limit, −8.1%). The participants in the PBK group had fewer intraluminal bubbles (0.9% vs 81.3%, P < 0.001) and reported a lower incidence of nausea and vomiting, with better acceptance, taste, and willingness to repeat the regimen than those in the OSS group (all P < 0.05). Conclusion: The novel sulfate tablet, PBK‐1701TC, was non‐inferior to OSS with respect to bowel‐cleansing efficacy and exhibited better safety and tolerability in adults undergoing colonoscopy. [ABSTRACT FROM AUTHOR]

[Display omitted] • 3D printed vegan low-calorie gummies for personalised dosing of simethicone. • Ink with shear thinning, optimum yield stress and high thixotropy for semi solid extrusion-based 3D printing. • Concentration of pectin, sweetener and acidifying agents' impacts the rheological properties of ink and texture of gummies. • Critical parameters for printing are nozzle diameter, printing speed, printing pressure and layer height. Chewable gummies are an attractive dosage form for all age groups because of their appearance and texture. Although, this dosage form has been highly preferred administering nutraceuticals, its application in the pharmaceutical sector is worth exploring. In this study, simethicone (SMT), an OTC drug prescribed for anti-flatulence was incorporated in pectin- based, low-calorie, 3D printed gummies. Semi-solid extrusion (SSE)-based 3D printing was used to dispense personalized dose of SMT i.e 40 mg for children and 125 mg for adults. Formulation optimization was carried out based on the texture profile of the gummies, using a texture analyzer. The inks were thoroughly characterized for their rheological behavior since it is a critical attribute for SSE-based 3D printing. Printing parameters like the printing speed, layer height and the type of the nozzle were optimized based on the printing accuracy achieved. The printed gummies were further evaluated for their disintegration time, drug content, weight variation, water activity and total microbial count. SSE-based 3D printing was found to be an effective tool to print pectin-based shear thinning gels for accurate drug dispensing. The texture profile of the printed gummies was comparable to the gummies prepared by conventional method as well as the marketed samples. [ABSTRACT FROM AUTHOR]

Background: Proton pump inhibitors are effective for functional dyspepsia but ineffective in relieving postprandial distress syndrome. Curcuma longa might be effective for postprandial distress syndrome. The objective of this study was to compare the efficacy of Curcuma longa and simethicone for postprandial distress syndrome in an open-label randomized-controlled trial. Methods: This trial was conducted between July 2018 and February 2019. In total, 78 patients were randomly assigned to receive 4 weeks of treatment with 750 or 1,500 mg oral Curcuma longa per day or 240 mg simethicone per day. The patients assessed their symptoms using the dyspepsia Global Overall Symptom scale at baseline, week 2, and week 4. After stopping medication for 2 weeks, the patients assessed recurrent symptoms and day of recurrence by themselves at the end of week 6. Results: In total, 78 patients underwent randomization (27 in 750 mg Curcuma longa, 26 in 1500 mg Curcuma longa, and 25 in simethicone groups). After 2 weeks, there were no significant differences in all mean changes of symptoms scores (95%CI) of postprandial distress syndrome [-4.1 (-4.5, -2.6) vs -4.3 (-5.2, -3.3) vs -4.2 (-4.8, -3.5), P=0.954]. Over a period of 4 weeks, the reduction in mean scores was greater among participants receiving simethicone (although not statistically significant) compared with two intervention groups [-4.6 (-5.7, -3.6) vs -5.4 (-6.6, -4.1) vs -6.2 (-7.2, -5.2), P=0.122]. The rate of recurrence was significantly lower in simethicone than the two Curcuma longa groups (42.9 vs 45.5 vs 13.6%, P=0.047). There was no serious adverse event reported in all three groups. Conclusions: Curcuma longa had a similar effect on treatment outcomes to simethicone after 2 and 4 weeks, but the recurrence rate of symptoms was significantly higher without serious adverse events. Registration: Registered with the Thai Clinical Trials Registry on 31 January 2018; TCTR20180131001.

Introduction: To investigate the efficacy and safety of preprocedural simethicone (S) and pronase (P) for optimal mucosal visualization during esophagogastroduodenoscopy with sedation. The effect of postural change combined with premedication on mucosal visibility was also examined., Methods: The study randomized 496 patients into 8 groups based on the type of premedication provided and whether a postural change occurred. The premedication in the control group was 100 mL of normal saline solution (NS). The remaining 3 intervention groups were administered 100 mL of simethicone alone (S), pronase solution alone (P), and simethicone plus pronase solution (S + P). Each group was classified into subgroups according to whether there was a postural change (PC). The mucosal visibility score (MVS), total mucosal visibility score (TVS), procedure time, water consumption for mucosal cleansing, and proportion of patients with diminutive lesions <5 mm were recorded., Results: The P and S groups had a significantly better TVS than the NS group (11.86 ± 3.36 in group P vs 14.52 ± 2.57 in group NS, P < 0.001; 12.36 ± 2.93 in group S vs 14.52 ± 2.57 in group NS, P = 0.006). The TVS was better in the P group than in the S group (11.86 ± 3.36 vs 12.36 ± 2.93, P = 0.037). The MVS was significantly better in the esophagus and duodenum and worse in the upper and lower gastric body in the S group than in the P group. The P + S group had a significantly better TVS than the P and S groups (9.81 ± 2.90 in group P + S vs 11.86 ± 3.36 in group P and 12.36 ± 2.93 in group S, respectively, P < 0.001),\ and had a reduced amount of flushing water during the procedure (0 [interquartile range [IQR]: 0-33] mL in group P + S vs 40 [IQR: 0-70] mL in group P, P < 0.01; 0 [IQR: 0-33] mL in group P + S vs 50 [IQR: 20-98] mL in group S, P < 0.001). The TVS was significantly better in the P + S + PC group than in the P + S group (8.44 ± 2.10 vs 9.81 ± 2.90, P = 0.003). The MVS was significantly better in the gastric antrum, fundus, and upper and lower gastric body in the P + S + PC group than in the P + S group. There was no significant difference in the detection rate of diminutive lesions among the different groups during an endoscopic examination ( P > 0.05)., Discussion: The combination of preprocedural administration with simethicone and pronase achieved superior mucosal visualization compared with saline, simethicone, or pronase alone in patients receiving upper endoscopy. Postural change maneuvers performed before endoscopy further improved the mucosal visibility in most parts of the stomach when used with preprocedural simethicone and pronase., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Simethicone is an antiflatulent medication exclusively administered orally, thus its systemic effects remain unknown. We present a case of an inadvertent intravenous administration of simethicone to a 4-year-old patient, precipitating respiratory difficulty, cyanosis, and altered mental status. The patient's condition improved rapidly with appropriate interventions, leading to discharge in a fully recovered state. To date, only one documented instance of intravenous simethicone administration exists in medical literature., (Copyright © 2024 Agnė Lozovskytė, Robertas Badaras, Gabija Laubner Sakalauskienė. Published by Vilnius University Press.)