Drug-loaded vegan gummies for personalized dosing of simethicone: A feasibility study of semi-solid extrusion-based 3D printing of pectin-based low-calorie drug gummies.

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.

Efficacy and Safety of Pea Protein and Xyloglucan Versus Simethicone in Functional Abdominal Bloating and Distension.

BACKGROUND: Functional Abdominal Bloating and Distension (FABD) is a multifaceted condition related in part to trapped gas, with changes in the intestinal barrier and small intestinal bacterial overgrowth (SIBO), which lead to gas production. Currently, there are no treatments targeting the etiology of FABD. METHODS: This double-blind, multicenter, randomized study evaluated the safety and efficacy of a product containing xyloglucan and pea proteins (XG + PP) compared with simethicone, both administered orally (three times daily) for 20 consecutive days. Eighty-eight patients with FABD were randomly assigned to the two groups in a 1:1 ratio. Primary outcome was safety; secondary outcomes were (i) efficacy in alleviating the symptoms of FABD and (ii) efficacy in reducing SIBO, as assessed by hydrogen breath test (HBT). RESULTS: No Adverse Events or Serious Unexpected Adverse Reactions were reported during the study. XG + PP showed a faster onset of action and a significant reduction in bloating and abdominal pain compared with simethicone. At Day 20, XG + PP drastically reduced abdominal girth when compared with simethicone, with an average reduction of 4.7 cm versus 1.8 cm. At Day 20, the XG + PP arm showed a significant reduction in HBT compared to baseline. CONCLUSIONS: This study supports the evidence that FABD patients may benefit from a XG + PP-based treatment that acts on etiology and not just the symptoms.

The Effect of Using Premedication of Simethicone/Pronase With or Without Postural Change on Visualization of the Mucosa Before Endoscopy: A Prospective, Double Blinded, Randomized Controlled Trial.

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.

Atypical Presentation of Klebsiella pneumoniae Necrotizing Fasciitis of the Lower Extremities: Silent but Deadly: A Case Report.

CASE: There has been an emerging trend of Klebsiella pneumoniae necrotizing fasciitis (KP-NF). We report a 50-year-old Chinese woman with rapidly progressive KP-NF, presenting atypically with innocuous skin symptoms. She had newly diagnosed diabetes mellitus. She had extensive subcutaneous crepitus in her lower limbs with subcutaneous gas on x-rays. Despite aggressive surgical debridement, she succumbed to septic shock and multiorgan failure. CONCLUSION: KP-NF is an emerging clinical entity and is associated with a compromised host immunity and high mortality rates. Clinicians must be aware that not all may present with the typical fulminant features and should maintain a high index of suspicion.

Development and validation of a simple microwave-assisted digestion sample preparation technique for the estimation of aluminium and magnesium in a few pharmaceutical dosage forms by an inductively coupled-mass spectrometer (ICP-MS).

Rationale: A simple, sensitive, reliable, validated, inductively coupled plasma mass spectrometric method for the determination of aluminium and magnesium using a simple common microwave-assisted digestion sample preparation technique for a few commonly used formulations was developed and validated according to International Conference on Harmonization Q3D and the United States Pharmacopeia general chapter <232> and <233>. The following pharmaceutical dosage forms were considered for estimation of aluminium and magnesium: Alumina, magnesia simethicone oral suspension, Alumina, magnesia simethicone chewable tablets, alumina and magnesia oral suspension, alumina and magnesium carbonate oral suspension. Methods: The methodology included optimizing a common microwave assisted digestion method, selecting the isotopes, choosing the measurement technique, and designating internal standards. The finalized microwave assisted procedure was a two-step program where in the first step the samples were ramped for 10 min to a temperature of 180 °C and hold for 5 min followed by ramping for 10 min to a temperature of 200 °C and hold for 10 min. Magnesium (24Mg) and aluminium (27Al) isotopes were finalized, internal standard assigned for both the isotopes was yttrium (89Y) with Helium (kinetic energy discrimination-KED) as the measuring mode. System suitability was run before initiating analysis to ensure that system performance was consistent. Results: Analytical validation parameters like specificity, linearity (from 25% to 200% of sample concentration), the detection limit and the limit of quantification were established. For all these dosage forms, the method's precision was demonstrated by analyzing the percentage relative standard deviation for six injections. Accuracy was established from 50% to 150% of instrument working concentration (J-levels) for aluminium and magnesium for all the formulations and was found to be within the range of 90-120%. Conclusion: This common analysis method, along with the common microwave-digestion technique applies to numerous types of matrices for a finished dosage form with aluminium and magnesium.

When should patients take simethicone orally before colonoscopy for avoiding bubbles: A single-blind, randomized controlled study.

BACKGROUND: Many studies have reported the use of simethicone before colonoscopy removes bubbles. However, guidelines weakly recommend simethicone administration before colonoscopy. The present study aimed to confirm the advantages of taking simethicone and determine the appropriate time for taking simethicone. METHODS: We randomly assigned patients to the following 5 groups according to the administration time: 4 groups were divided based on 2 parameters (the day before and on the day of colonoscopy and before and after bowel cleansing) and the remaining group was the control group. We compared bubble score (BS), number of simethicone solution irrigations when visually obscured, satisfaction score of the endoscopist, insertion time. RESULTS: A total of 204 patients were included in the study. There was a difference in BS according to the timing of simethicone administration (P < .001). The group taking simethicone on the day of the test had a better BS than the group taking simethicone the day before (P < .001). The group taking simethicone on the previous day had a better BS than the control group (P = .001). In the group of taking simethicone on the examination day, the number of irrigations was lower, and satisfaction with the inspector was higher than group of taking simethicone on previous day and control group (both P < .001). The insertion time showed a non-significantly decreasing trend (P = .417). CONCLUSION: Administering simethicone reduced bubbles and facilitated effective colonoscopy, especially when administrating it on the day of examination. It needs to be administered on the day of the examination regardless of bowel preparation.

A water-soluble alternative to simethicone for gastrointestinal endoscopy: Results of a clinical trial.

During endoscopy, simethicone defoaming agents are commonly used to improve visualization, but they leave residues and impact drying. This clinical trial involved patients undergoing colonoscopy procedures with substantial bubbles that impeded mucosal wall visibility. As an alternative to simethicone, investigators evaluated a water-soluble, ginger-based gastrointestinal supplement (GI-Ease) that did not contain sugars, thickeners, or binding agents. In 112/114 cases (98%), the bubbles were reduced sufficiently to allow visualization of the gastrointestinal tract, with no adverse events.

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

OBJECTIVE: The aim of the study was to demonstrate that an administration of mucolytic solution with a maximum dose of simethicone and n -acetylcysteine before upper endoscopy improves mucosal visibility compared to a group without administration of mucolytic solution or water. METHODS: This study was a double-blind, randomized controlled trial. Patients were randomized into four groups, with the administration of 100 ml of water + 600 mg n -acetylcysteine + 400 mg simethicone, 100 ml of water + 400 mg n -acetylcysteine + 20 mg simethicone, 100 ml of water, and without any water or mucolytic solution. During the examination, a total of 10 images were taken in the defined areas. The overall visibility score was given by the sum of the 0-5 scores of the five areas and was assessed by the endoscopist performing the procedure and the blinded endoscopists using static images. RESULTS: A total of 129 patients were randomized. The group of patients did not differ in age, sex distribution, and indications significantly. The overall visibility score as assessed by the endoscopist performing the procedure was significantly higher in the group with the maximum dose of mucolytic solution compared to the group without solution or water (18.9 ±â€…2.9 vs. 16.6 ±â€…3.3, P  = 0.023). This difference was not evident by the blinded evaluation of static photographs. CONCLUSION: Administration of mucolytic solution with a maximum dose of n -acetylcysteine and simethicone before upper endoscopy improved mucosal visibility in the upper gastrointestinal tract compared with the group without any preparation while evaluated by performing endoscopist.

Cleaning effect and tolerance of 16 bowel preparation regimens on adult patients before colonoscopy: a network meta-analysis.

PURPOSE: Colonoscopy is the gold standard for the diagnosis of colorectal cancer (CRC). Before a colonoscopy, an adequate bowel preparation (BP) is required. Currently, more novel regimens with different effects have been proposed and used successively. This network meta-analysis aims to compare the cleaning effects and patients' tolerability of several BP regimens. METHODS: We performed a network meta-analysis of randomized controlled trials including sixteen kinds of BP regimens. We searched PubMed, Cochrane Library, Embase, and Web of Science databases. The outcomes of this study were bowel cleansing effect and tolerance. RESULTS: We included a total of 40 articles with 13,064 patients. For the primary outcomes, polyethylene glycol (PEG) + ascorbic acid (Asc) + simethicone (Sim) (OR, 14.27, 95%CrI, 2.68-127.87) regimen is ranked first in Boston Bowel Preparation Scale (BBPS). PEG + Sim (OR, 2.0, 95%CrI 0.64-6.4) regimen is ranked first in Ottawa Bowel Preparation Scale (OBPS), but without significant differences. For the secondary outcomes, PEG + Sodium Picosulfate/Magnesium Citrate (SP/MC) (OR, 4.88e + 11, 95%CrI, 39.56-1.82e + 35) regimen is the best in cecal intubation rate(CIR). PEG + Sim (OR,1.5, 95%CrI, 1.0-2.2) regimen is ranked first in adenoma detection rate(ADR). Senna (OR, 3.23, 95%CrI, 1.04-9.97) and SP/MC (OR, 249.91, 95%CrI, 78.49-958.19) regimens are ranked first in abdominal pain and willingness to repeat, respectively. There is no significant difference in cecal intubation time (CIT), polyp detection rate (PDR), nausea, vomiting, and abdominal bloat. CONCLUSION: PEG + Asc + Sim regimen is more effective at cleaning the bowel. PEG + SP/MC will be helpful to increase CIR. For ADR, PEG + Sim regimen will be more helpful. In addition, PEG + Asc + Sim is the least likely to cause abdominal bloat, while Senna regimen is more likely to cause abdominal pain. Patients prefer to re-use the SP/MC regimen for bowel preparation.

Effect of an Antacid (Aluminum Hydroxide/Magnesium Hydroxide/Simethicone) or a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) in Healthy Adult Subjects.

Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is a novel oral carbapenem prodrug being developed for the treatment of serious bacterial infections. This open-label, 3-period, fixed sequence study evaluated the effect of gastric acid-reducing agents, aluminum hydroxide/magnesium hydroxide/simethicone, and omeprazole on the pharmacokinetics (PK) of tebipenem (TBP), the active moiety, following coadministration with immediate release TBP-PI-HBr during fasting. In Period 1, subjects received a single oral dose of TBP-PI-HBr 600 mg (2 × 300 mg tablets). In Period 2, subjects received a single oral dose of aluminum hydroxide 800 mg/magnesium hydroxide 800 mg/simethicone 80 mg suspension co-administered with a single dose of TBP-PI-HBr 600 mg. In Period 3, subjects received a single oral dose of omeprazole 40 mg once daily over 5 days, followed by single dose administration of TBP-PI-HBr 600 mg on day 5. In each period, whole blood samples were obtained prior to, and up to 24 h, following TBP-PI-HBr dose administration in order to characterize TBP PK. A 7-day washout was required between periods. Twenty subjects were enrolled and completed the study. Following co-administration of TBP-PI-HBr with either aluminum hydroxide/magnesium hydroxide/simethicone or omeprazole, total TBP exposure (area under the curve [AUC]) was approximately 11% (geometric mean ratio 89.2, 90% confidence interval: 83,2, 95.7) lower, and Cmax was 22% (geometric mean ratio 78.4, 90% confidence interval: 67.9, 90.6) and 43% (geometric mean ratio 56.9, 90% confidence interval: 49.2, 65.8) lower, respectively, compared to administration of TBP-PI-HBr alone. Mean TBP elimination half-life (t1/2) was generally comparable across treatments (range: 1.0 to 1.5 h). Concomitant administration of TBP-PI-HBr with omeprazole or aluminum hydroxide/magnesium hydroxide/simethicone is not expected to impact the efficacy of TBP-PI-HBr, as there is minimal impact on TBP plasma AUC, which is the pharmacodynamic driver of efficacy. Co-administration was generally safe and well tolerated.

Taking Oral Sulfate Tablets with Simethicone for Bowel Preparation Leads to Higher Adenoma Detection Rate than Polyethylene Glycol: A Propensity Score Analysis.

BACKGROUND: Efficient bowel preparation is essential for preventing colorectal cancer by improving endoscopic adenoma detection. Tablet for bowel preparation containing sulfate salts, OSTs (oral sulfate tablets), has been developed and it is gaining more popularity. However, its efficacy compared to standard preparation agent, PEG-AA (polyethylene glycol), has not been well discovered. We assessed the efficacy of PEG and OSTs using a real-time clinical data warehouse (CDW) model. METHODS: We performed a propensity score-matched (PSM) analysis of consecutive adult patients undergoing colonoscopy who received PEG-AA or OSTs prior to colonoscopy at a tertiary academic hospital. The endoscopic records of 992 adult patients were retrospectively analyzed. The clinical data warehouse collected data including bowel preparation, insertion time, observation time, and the detection of polyps and adenomas. Multivariate regression analysis was performed to reveal the factors associated with endoscopic outcomes. RESULTS: Among 992 patients included in the study, 770 and 222 patients received PEG-AA and OSTs, respectively. Among the propensity score-matched population (n = 1897), OSTs resulted in better bowel cleansing quality (8.16 vs 7.84, p = 0.014) and a higher adenoma detection rate (38.6% vs 27.1%, p = 0.003). Using PEG-AA, older age, inadequate bowel preparation (BBPS score < 6) and endoscopy by fellows were found to be factors associated with poor adenoma detection. In the elderly over 65 years of age, a significant difference in cleansing quality between the two groups (7.21 vs 8.19, p < 0.001) was found, but its impact on ADR was not prominent (49.5% vs 45.4%, p = 0.653). CONCLUSIONS: OSTs with simethicone achieved better endoscopic cleanliness, improving adenoma detection rate compared to the conventional PEG-AA protocol. The synergistic effect of both the convenience of taking tablets and the reduction of intraluminal bubble by adjunctive simethicone improves the clinical efficacy of colonoscopy.

Prospective cohort study to evaluate premedication with simethicone and n-acetilcysteine for upper diagnostic gastrointestinal endoscopy.

INTRODUCTION: The use of premedication for upper gastrointestinal endoscopy (UGE) is not widely established in western countries. The primary aim of the study was to compare gastric visibility according to the total visibility score (TVS). The secondary aim was to assess complications, diagnostic yield, endoscopic procedure time, sedation dose and patient satisfaction. METHODS: A single center prospective cohort study was performed of consecutive adults undergoing an UGE in the afternoon working shift. After completing enrolment in the control group, patients were administered 200 mg simethicone and 500 mg N-acetylcysteine diluted in 100 ml of water >15 minutes before the procedure. All procedures were recorded and a single, blinded endoscopist evaluated the TVS after recruitment of both cohorts. Patient satisfaction was evaluated using the Spanish translation of the American Society of Gastrointestinal Endoscopy satisfaction questionnaire. RESULTS: 205 patients were included in the study, 103 females (50.2%) with a median age of 54.8-years (IQR: 41.2-65.2). 104 were enrolled to the control group and 101 to the intervention group. Patients receiving premedication presented a higher rate of adequate (74.3% vs 45.2; difference 95% CI: 16,3-41,9%, p<0.001) and excellent gastric visibility (23.8% vs 7.7%; difference 95% CI: 6,3-25,8%, p=0.002). Propofol dose was similar, although the median procedure time was lower in the group of no intervention [5 (IQR: 4-7) vs 6 minutes (IQR: 5-7); p=0.03]. Procedure related adverse events were similar, except that patient without premedication experienced more nausea episodes. Major and minor endoscopic findings and the satisfaction questionnaire showed no differences between both groups. CONCLUSION: Patients receiving premedication with simethicone and N-acetylcysteine had a better gastric visibility score, without any increase in adverse events or affecting the patients' satisfaction.

Minimizing the Risks of Simethicone in Endoscope Reprocessing.

This statement was written under the auspices of the World Gastroenterology Organization's Guidelines Committee. The authors are members of the Review Team of the WGO Endoscope Disinfection Guideline and have experience in endoscopy, endoscope reprocessing, and microbiology, including biofilms. During the preparation of the WGO Update on Endoscope Disinfection Guidelines, concerns about simethicone on endoscope channel surfaces compromising cleaning and disinfection were raised. Publications on simethicone, including modes of delivery, effectiveness, and risks, have been reviewed. The paper was written as a companion to the new guidelines with a focus on minimizing the risks of simethicone in endoscope reprocessing.

Prospective cohort study to evaluate premedication with simethicone and n-acetilcysteine for upper diagnostic gastrointestinal endoscopy

Introduction: The use of premedication for upper gastrointestinal endoscopy (UGE) is not widely established in western countries. The primary aim of the study was to compare gastric visibility according to the total visibility score (TVS). The secondary aim was to assess complications, diagnostic yield, endoscopic procedure time, sedation dose and patient satisfaction. Methods: A single center prospective cohort study was performed of consecutive adults undergoing an UGE in the afternoon working shift. After completing enrolment in the control group, patients were administered 200 mg simethicone and 500 mg N-acetylcysteine diluted in 100 ml of water >15 minutes before the procedure. All procedures were recorded and a single, blinded endoscopist evaluated the TVS after recruitment of both cohorts. Patient satisfaction was evaluated using the Spanish translation of the American Society of Gastrointestinal Endoscopy satisfaction questionnaire. Results: 205 patients were included in the study, 103 females (50.2%) with a median age of 54.8-years (IQR: 41.2-65.2). 104 were enrolled to the control group and 101 to the intervention group. Patients receiving premedication presented a higher rate of adequate (74.3% vs 45.2; difference 95% CI: 16,3-41,9%, p<0.001) and excellent gastric visibility (23.8% vs 7.7%; difference 95% CI: 6,3-25,8%, p=0.002). Propofol dose was similar, although the median procedure time was lower in the group of no intervention [5 (IQR: 4-7) vs 6 minutes (IQR: 5-7); p=0.03]. Procedure related adverse events were similar, except that patient without premedication experienced more nausea episodes. Major and minor endoscopic findings and the satisfaction questionnaire showed no differences between both groups. Conclusion: Patients receiving premedication with simethicone and N-acetylcysteine had a better gastric visibility score, without any increase in adverse events or affecting the patients’ satisfaction (AU)

Preparation of small bowel capsule endoscopy (SBCE) with simethicone: A meta-analysis.

BACKGROUND: It is disputed about optimal bowel preparation for small bowel capsule endoscopy (SBCE). This meta-analysis aimed to investigate the role of simethicone in intestinal preparation for SBCE. METHODS: We searched four databases (PubMed, web of science, Embase, and Scopus databases) for relevant studies. Studies evaluating the effect of simethicone as an adjunct to SBCE bowel preparation were included. The random-effects model was applied to calculate the risk estimates. Primary outcomes include the degree of gas bubbles and small bowel visualization quality (SBVQ). Secondary outcomes include diagnostic yield (DY), gastric transit time (GTT), small bowel transit time (SBTT), and completion rate (CR). RESULTS: A total of 10 studies were included (8 RCTs, 1 prospective, and 1 retrospective study). Compared with the control group, the simethicone group showed significant improvements in the degree of gas bubbling (RR = 2.05, 95%CI:1.56-2.71, P < 0.001, I2 = 62%) and SBVQ (RR = 1.41, 95%CI: 1.20-1.65, P < 0.001, I2 = 16%). Subgroup analysis showed that the SBVQ of simethicone group was better than fasting (RR = 2.62, 95% CI:1.49-4.59, P < 0.001, I2 = 0%), mannitol (RR = 1.35, 95% CI: 1.14-1.59, P < 0.001, I2 = 0%) and PEG group (RR = 1.32, 95%CI:1.06-1.65, P = 0.01, I2 = 0%). No significant associations were found for DY, GTT, SBTT, and CR. CONCLUSIONS: Simethicone for bowel preparation is useful to improve visualization and reduce the gas bubbling of SBCE.

Clinical utility of purgative bowel preparation before capsule endoscopy: a multicenter, blinded, randomized controlled trial.

BACKGROUND AND AIMS: Optimal bowel preparation before capsule endoscopy (CE) is currently unknown. In this multicenter, blinded, randomized controlled trial, we assessed clinical effectiveness of 2 types of purgative regimen and a control arm of clear fluid only. METHODS: Patients with suspected small intestinal bleeding were randomized into 3 arms: arm A, clear fluids only for 18 hours before CE and simethicone 200 mg in 150 mL water immediately before CE; arm B, same as A + 2 L of polyethylene glycol (PEG) 12 hours before CE; and arm C, same as A + 1 L PEG + sodium ascorbate 3 hours before CE. To assess diagnostic yield, lesions were classified either as highly relevant (P2) or less relevant (P0 or P1) lesions. Small-bowel visualization quality (SBVQ) was assessed using the Brotz score. Patient tolerability was assessed using the visual analog scale (0-10, with lower scores indicating better tolerability). RESULTS: Two hundred twenty-nine patients completed the study. The mean age was 58.7 years (95% confidence interval, 29.3-87.9), and 47.2% were men. There was no significant difference in diagnosis of P2 lesions in arms A, B, and C (48.7%, 48.0%, and 45.9%, respectively; P = .94). Overall SBVQ and distal SBVQ were similar across the 3 arms (P = .94 and P = .68, respectively). Patients reported better tolerability in arm A (mean score, 1.5) compared with arms B and C (mean score, 3.5 and 2.6, respectively; P < .001). CONCLUSIONS: The use of a purgative bowel preparation before CE does not improve diagnostic yield or small-bowel visualization and is associated with lower patient tolerance. (Clinical trial registration number: ACTRN 12614000883617.).

Randomised controlled trial on the effect of simethicone bowel preparation on rectal variability during image-guided radiation therapy for prostate cancer (SPoRT study).

INTRODUCTION: The purpose of this study was to assess whether simethicone reduces the rectal volume (RV) and gas volume (GV), to increase treatment accuracy and to decrease toxicity of prostate radiation therapy. METHODS: 30 patients were randomised to simethicone or no intervention. Cone-beam computed tomography (CBCT) scans were performed on Days 1-3 and weekly until completion of radiation. RV and GV were measured using volume delineation. Toxicity data were collected. RESULTS: 264 CBCTs were analysed. RV and GV were not significantly different in the simethicone group compared with the control group at each time point (P >0.05) after adjusting for Week 0 values as a covariate. The simethicone group showed an average reduction in RV and GV of 10% and 21%, respectively, compared with the control group (P >0.05). Standard deviations were calculated over 10 time points, which were grouped to represent the first 2-3 weeks of radiation therapy versus subsequent weeks. These were not significantly different between the simethicone and control group. However, there was a statistically significant decrease in the variability of RV at time points 6-10 compared with time points 1-5 within the simethicone group (P = 0.012), but no significant difference was found between these grouped time points in the control group (P = 0.581). The toxicity questionnaires showed no significant difference between the groups. CONCLUSIONS: Simethicone did not decrease the RV or GV overall. However, simethicone appeared to significantly decrease the RV variability from Week three onwards. This suggests that taking simethicone two to three weeks before starting radiation therapy may reduce RV variability, although a larger study is needed to confirm this.

Effect of oral simethicone on the quality of colonoscopy: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: In this systematic review and meta-analysis, we aimed to investigate the effect of oral simethicone (SIM), an antifoaming agent, on the quality of colonoscopy in terms of bowel preparation quality, adenoma or polyp detection rate (ADR/PDR) and cecal intubation rate (CIR). METHODS: All randomized controlled trials (RCTs) on the use of SIM during bowel preparation for colonoscopy published up to 17 March 2021 were identified from the PubMed, EMBASE and Cochrane Library databases. Bowel preparation quality, ADR/PDR/CIR, cecal intubation time (CIT), withdrawal time (WT), patients' tolerability, acceptability and volume of foam and bubbles were compared between the SIM and non-SIM groups. RESULTS: Thirty-eight RCTs with 10 505 patients were included. Oral SIM significantly increased the rate of total Boston bowel preparation scale (BBPS) score ≥6 (risk ratio [RR]  1.13, P < 0.0001), acceptability (RR  1.15, P = 0.01) and the rate of no or minimal foam and bubbles (RR  1.28, P < 0.00001) and decreased abdominal distension (RR  0.64, P < 0.0001). However, it had no significant impact on overall ADR, overall PDR, CIR, CIT or WT. The rate of total BBPS score ≥6 remained significantly higher in the SIM group when a single-dose laxative regimen or a SIM dosage of ≥320 mg was employed; and ADR, PDR and CIR were significantly increased in the SIM group among colonoscopy clinicians who achieved an ADR <31%, PDR <45% and CIR <96%, respectively. CONCLUSIONS: Oral SIM can improve bowel preparation quality, especially in patients receiving a SIM dosage of ≥320 mg or a single-dose laxative regimen. SIM may be preferred by junior colonoscopy physicians/trainees with a lower ADR/PDR or CIR.

Relative bioavailability and pharmacokinetic comparison of a fixed-dose combination tablet of mosapride, pancreatin, and simethicone relative to single-component mosapride tablets in healthy Mexican subjects.

Abbott Laboratories de México S.A. de C.V. developed a new fixed-dose combination of mosapride 5 mg, pancreatin 170 mg, and simethicone 125 mg as an alternative to the mosapride monotherapy to improve overall satisfaction and adequate relief of gastrointestinal disorders symptoms and to reduce multiple pill burden. As a part of the fixed-dose combination registration process in Mexico, a pharmacokinetic and relative bioavailability study was carried out to demonstrate nonexistence of pharmacokinetic interaction when mosapride is administered alone or in combination with pancreatin and simethicone using DOSIER® (mosapride) 5-mg tablets as a reference product. Tolerability of the fixed-dose combination tablet was assessed. In this open-label, randomized, oral single-dose, two-way crossover study, 65 healthy male and female subjects received either the fixed-dose combination tablet or the reference product during each study period. The two study periods were separated by a 7-day washout period. Mosapride concentrations in plasma samples were determined using a validated ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method. Blood samples were collected for up to 16 h post dose. The primary evaluation criteria were Cmax and AUC0-t for mosapride. The 90% confidence intervals for the ratio of geometric means for Cmax (96.12% to 110.90%) and AUC0-t (99.07% to 108.06%) were within the defined acceptance limits of 75% to 133% and 80% to 125% for Cmax and AUC0-t , respectively, indicating bioequivalence between the two products. Both products were safe and well tolerated. Therefore, mosapride in combination with pancreatin and simethicone tablet is bioequivalent to mosapride alone, and no new safety signals emerged.

Efficacy of artichoke and ginger extracts with simethicone to treat gastrointestinal symptoms in endurance athletes: a pilot study.

BACKGROUND: Exercise-induced gastrointestinal (GI) symptoms are frequently reported by athletes during training and competitions. A standardized combination of artichoke leaves and ginger root extracts has shown beneficial effects in managing GI discomfort in otherwise healthy subjects. METHODS: In this pilot study, we assessed the effectiveness of artichoke leaves and ginger root extracts combination associated with simethicone in reducing exercise-related GI symptoms in endurance athletes. The effects of the combination on upper/lower GI and systemic symptoms were assessed at baseline and after 4 weeks through a questionnaire. RESULTS: Fifty endurance athletes took the extracts' combination 320 mg + simethicone 40 mg chewable pills. The extracts combination and simethicone were effective in reducing the mean intensity of upper GI (86.6%) lower GI (85.9%) and systemic symptoms (81.9%), with superior results compared to placebo. The most remarkable effects were reported in the lower GI tract, with a significant decrease in flatulence, intestinal cramps, loose stools and diarrhea. Athletes also benefited from a reduction in belching and bloating and in dizziness, headache and muscle cramps, although the decrease in systemic symptoms was not significant. CONCLUSIONS: The supplementation of standardized artichoke and ginger extracts, combined with simethicone, may be effective in decreasing digestive discomfort and alteration of gastric motility not only in healthy subjects but also in endurance athletes.