Shortening Oral Simethicone-to-Colonoscopy Interval Increases Bowel Preparation Quality.

BACKGROUND Simethicone can improve bowel preparation quality, but the optimal timing of oral simethicone before colonoscopy has not been determined. This study aimed to explore the effect of the time interval between oral simethicone and the start of colonoscopy (S-C) on bowel preparation quality. MATERIAL AND METHODS A total of 364 patients undergoing colonoscopy at our department from August 1, 2021 to November 30, 2021 were included in the training cohort, and 420 consecutive patients from December 15, 2021 to January 31, 2022 comprised the validation cohort. They were classified into short and long S-C groups according to the median S-C. Bowel preparation quality evaluated by the Boston Bowel Preparation Scale was compared between the 2 groups. Logistic regression analyses were performed to explore the correlation between S-C and bowel preparation quality, and we explored the effect of run-way time and time of starting colonoscopy on bowel preparation quality. RESULTS In the training cohort, 182 and 182 patients were classified into the short and long S-C groups, respectively; in the validation cohort, 210 and 210 patients were classified into the 2 groups, respectively. In the 2 cohorts, the short S-C group had a significantly higher rate of adequate/excellent bowel preparation than the long S-C group. Logistic regression analyses showed that shorter S-C, shorter run-way time, and colonoscopy in the morning were all correlated with adequate/excellent bowel preparation. CONCLUSIONS Bowel preparation quality may be affected by S-C, run-way time, and time of starting colonoscopy. S-C shortening should be given equal importance as run-way time shortening.

Effect of simethicone for the management of early abdominal distension after laparoscopic cholecystectomy: a multicenter retrospective propensity score matching study.

OBJECTIVE: To investigate whether simethicone expediates the remission of abdominal distension after laparoscopic cholecystectomy (LC). METHODS: This retrospective study involved LC patients who either received perioperative simethicone treatment or not. Propensity score matching (PSM) was employed to minimize bias. The primary endpoint was the remission rate of abdominal distension within 24 h after LC. Univariable and multivariable logistic regression analyses were conducted to identify independent risk factors affecting the early remission of abdominal distension after LC. Subsequently, a prediction model was established and validated. RESULTS: A total of 1,286 patients were divided into simethicone (n = 811) and non-simethicone groups (n = 475) as 2:1 PSM. The patients receiving simethicone had better remission rates of abdominal distension at both 24 h and 48 h after LC (49.2% vs. 34.7%, 83.9% vs. 74.8%, respectively), along with shorter time to the first flatus (14.6 ± 11.1 h vs. 17.2 ± 9.1 h, P < 0.001) compared to those without. Multiple logistic regression identified gallstone (OR = 0.33, P = 0.001), cholecystic polyp (OR = 0.53, P = 0.050), preoperative abdominal distention (OR = 0.63, P = 0.002) and simethicone use (OR = 1.89, P < 0.001) as independent factors contributing to the early remission of abdominal distension following LC. The prognosis model developed for predicting remission rates of abdominal distension within 24 h after LC yielded an area under the curve of 0.643 and internal validation a value of 0.644. CONCLUSIONS: Simethicone administration significantly enhanced the early remission of post-LC abdominal distension, particularly for patients who had gallstones, cholecystic polyp, prolonged anesthesia or preoperative abdominal distention. TRIAL REGISTRATION: ChiCTR2200064964 (24/10/2022).

Effect of alverine citrate plus simethicone in colonoscopy: a randomized controlled trial.

Colonoscopy is the standard procedure for screening, and surveillance of colorectal cancer, including the treatment for colonic lesions. Colonic spasm is an important problem from colonoscopy that affects both surgeons and patients. The spasm also might be the cause of longer cecal intubation time, difficulty of the procedure, and increased pain. Previous reports indicated that antispasmodic agents can decrease such symptoms. Therefore, we conducted this study to investigate the cecal intubation time of antispasmodic agents. A single blinded randomized controlled trial was conducted from 01/11/2020 to 31/08/2021. One hundred four patients were allocated to antispasmodic agent group and control group, in 1:1 ratio. The efficacy of median (range) cecal intubation time showed similar results of 5 (2, 14) and 5 (2, 15) minutes with no statistically significant difference. The mean scores of all domains i.e., pain, spasm, cleanliness, and difficulty were better in the antispasmodic agent group about 2.6 (1.4), 1.8 (0.8), 2.4 (0.9), and 2.0 (0.9), respectively, than control group but there were spasm and cleanliness showed statistically significant difference. Moreover, the satisfaction scores showed better efficacy in decreased spasm, decreased difficulty, and increased cleanliness than control group. Prescribing of antispasmodic drugs before colonoscopy might be the choice of treatment for the patients. The antispasmodic drugs will be beneficial to both of the patient and the doctor.

Simethicone use in drug-induced sleep endoscopy improves visibility.

PURPOSE: To assess the effect of simethicone, a defoaming agent, on improving visibility during drug-induced sleep endoscopy (DISE) in obstructive sleep apnea (OSA). METHODS: The study was a retrospective case-series study on patients with OSA who failed positive airway pressure (PAP) treatment. Patient parameters were recorded including age, BMI, neck and abdominal circumference, and apnea-hypopnea index (AHI). Comparisons were made between DISE procedures performed with and without the administration of simethicone. Visibility during DISE was independently graded by two surgeons, and inter-rater reliability was assessed. RESULTS: Simethicone significantly improved DISE visibility (p = 0.03). "Best visibility" was achieved in 55% of cases with simethicone compared to 27% without simethicone (p = 0.02). Sub-analysis showed that only simethicone administration had a significant effect on visibility (p = 0.02). Inter-rater reliability between the grading surgeons was strong (Cohen-Kappa score 0.7, p < 0.001). CONCLUSION: The findings suggest that simethicone enhances DISE visibility for OSA surgical planning. Further research should explore optimizing simethicone administration timing and the potential clinical implications for surgical outcomes and patient care.

A randomized controlled trial of high volume simethicone to improve visualization during capsule endoscopy.

BACKGROUND: The optimal dose of simethicone before capsule endoscopy is unknown. Prior studies have reported inconsistent cleansing, with some showing improved visualization only in the proximal small intestine. We hypothesized a higher volume of simethicone may improve cleansing and diagnostic yield, especially in the distal small bowel. METHODS: A phase III randomized controlled trial was conducted comparing high volume (1125 mg simethicone in 750 ml water) versus standard volume (300 mg simethicone in 200 ml water) solutions, both at 1.5 mg/ml. The primary outcome was adequate bowel preparation, defined as a KOrea-CanaDA (KODA) score >2.25, overall and stratified by the proximal and distal half of the small bowel. Secondary outcomes included mean KODA score, diagnostic yield, completion rate, and adverse events. All analyses were intention-to-treat. RESULTS: A total of 167 patients were randomized (mean (SD) age 58.7 (15.7), 54% female) and the most common indication was obscure gastrointestinal bleeding (71.7%). Adequate cleansing was achieved in 39 (50%) patients in the high volume group and in 39 (48%) patients in the standard volume group (RR 1.04, 95% CI 0.76-1.43, p = 0.82), with no differences observed in the proximal half (71% vs 64%, p = 0.40) or the distal half -of the small bowel (36% vs. 37%, p = 0.88). There was no differences in the mean (SD) KODA score (2.20 (0.41) vs. 2.18 (0.44), p = 0.73), diagnostic yields (53% vs. 56%, p = 0.71), or completion rates (both 95%). One adverse event, nausea, occurred in the control group. CONCLUSION: High volume simethicone does not improve visualization during capsule endoscopy. CLINICAL TRIAL REGISTRATION: Clinical trial: NCT02334631.

Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study.

The aim of the study was to determine effects of administration of simethicone and a multi-strain synbiotic on the crying behaviour of colicky babies. The study design consisted of an open-label, two parallel treatment group study involving 87 infants aged 3-6 weeks with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 3 weeks prior to enrolment) randomly, unequally [1:1.5] assigned to receive simethicone (n=33) or a multi-strain synbiotic (n=54) orally for 4 weeks. The multi-strain synbiotic contained Lactobacillus acidophilus LA-14, Lacticaseibacillus casei R0215, Lacticaseibacillus paracasei Lp-115, Lacticaseibacillus rhamnosus GG, Ligilactobacillus salivarius Ls-33, Bifidobacterium lactis Bl-04, Bifidobacterium bifidum R0071, Bifidobacterium longum R0175 and fructooligosaccharides). Primary outcome measures were the responder rates (effect ≥50% reduction from baseline) of the measures 'crying days last 3 weeks', 'average evening crying duration last 3 weeks' and 'reduction of average number of crying phases per day last three weeks' at the end of treatment. The study is registered at ClinicalTrials.gov under NCT04487834. Significantly higher responder rates (effect ≥50% reduction from baseline) of the multi-strain synbiotic compared to simethicone were found for the measures 'crying days last 3 weeks' (72% vs 18%, P<0.0001) and 'average evening crying duration last 3 weeks' (85% vs 39%, P=0.0001). No significant difference was found for the measure 'reduction of average number of crying phases per day last three weeks' (50% vs 42%, P=0.4852). No adverse effects were reported for the two treatment groups. Based on these results, the multi-strain synbiotic can be considered as an interesting therapeutic possibility for the treatment of infantile colic, worthwhile to be investigated further in non-clinical and clinical studies.

Efficacy of low-dose versus high-dose simethicone with polyethylene glycol for bowel preparation: A prospective randomized controlled trial.

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.

[Optimal Bowel Preparation for Capsule Endoscopy and Device-assisted Enteroscopy].

For improved examination of video capsule endoscopy (VCE) and device-assisted enteroscopy (DAE), bowel preparation is an essential issue. Multiple factors like air bubbles, food material in the small bowel, and gastric and small bowel transit time affect the small bowel visualization quality (SBVQ), diagnostic yield (DY) and cecal completion rate (CR). Bowel preparation with polyethylene glycol (PEG) solution enhances SBVQ and DY, but it has no effect on CR. Bowel preparation with PEG solution 2 L is similar to PEG 4 L in SBVQ, DY, and CR. Bowel preparation with fasting or PEG solution combined with anti-foaming agents like simethicone enhance SBVQ, but it has no effect on CR. Bowel preparation with prokinetics is not commonly recommended. Optimal timing for purgative bowel preparation has yet to be established. However, the studies regarding bowel preparation for DAE are not sufficient. European Society of Gastrointestinal Endoscopy (ESGE) recommends 8-12 hours fasting from solid food and 4-6 hours fasting from liquids prior to the antegrade DAE. For retrograde DAE, colonoscopy preparation regimen is recommended. This article reviews the literature and ESGE, 2013 Korean published guidelines regarding bowel preparation for VCE and DAE, following suggestion for optimal bowel preparation for VCE and balloon enteroscopy.

Effect of simethicone on reducing operative difficulty associated with bowel interference during minilaparotomy for modified Pomeroy salpingectomy: A randomized controlled trial.

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.

The effect of oral polyethylene glycol combined with simethicone for colonoscopy on cecal intubation rate, tolerability and acceptability : a systematic review and meta-analysis.

OBJECTIVE: To assess the efficacy adjunction of oral simethicone to polyethylene glycol as bowel preparation agent on cecal intubation rate. METHODS: We searched EMBASE, PubMed and Cochrane library for randomized controlled trials regarding simeticone plus polyethylene glycol as oral drinking agents before gastroscopy,we used the soft RevMan5.3 to perform statistical analysis and stata12.0 for publication bias. RESULTS: 12 randomized trials that met the inclusion criteria were therefore pooled into a meta-analysis, which included a total of 5,112 patients. There were no significant differences on cecal intubation rate in two groups(RR=1.0,95%CI : 0.99-1.01, P=0.93) with moderate level of evidence;Subgroups analysis of 2LPEG+ Simethicone VS 2LPEG(RR =1.0, 95% CI : 0.98,1.01), 2LPEG+ Simethicone VS 4L PEG (RR=1.00, 95% CI : 0.98,1.02), PEG+ Simethicone with bisacodyl vs PEG (RR =1.00, 95% CI : 0.99,1.02), PEG+Simethicone without bisacodyl vs PEG (RR =1.00, 95% CI : 0.98,1.02) showed no difference on cecal intubation rate.There was aslo no significant difference on cecal intubation time.Abdominal bloating incidence was lower in PEG+Simethicone group than that in PEG group (RR=0.53, 95%CI : 0.31, 0.91, P=0.02). The meta-analysis result also showed a better acceptability in PEG+Simethicone group (RR=1.28, 95% CI : 1.01, 1.49, P=0.001). CONCLUSION: Adjunction of oral simethicone to polyethylene glycol as bowel preparation agent dose not improve cecal intubation rate on colonoscopy,but with better gastrointestinal tolerability and acceptability.

An in vitro and clinical dose-finding study of antifoaming effects of simethicone during colonoscopy.

Simethicone is an antifoaming agent frequently added to endoscopic rinse solutions but has recently been implicated as a risk factor for transmission of infections due to the formation of simethicone deposits within scope channels. Since the build-up of residue is likely dose-related, the smallest effective dose of simethicone should be used but there are no data available on the effective dose. Thus, we conducted a dose-finding study in an "in vitro bubble model" to determine the appropriate simethicone dose. Six 100-mL test tubes were filled with a 1% (v/v) solution of kitchen detergent (Fairy®, Procter & Gamble, London, England) in water for irrigation (Baxter®, Sydney, Australia). One test tube served as the control, while different doses of simethicone (Infacol®, Nice Pak, Melbourne, Australia) were added to the other five tubes (0.02, 0.2, 2.0, 20, and 200 mg/100 mL). Oxygen was streamed for 30 s into the test tubes at a rate of 2 L/min. After 10 s, photographs were taken and the visible bubbles were semi-quantitatively rated by independent assessors blinded to the dosing of simethicone. Simethicone at doses of 2 mg/100 mL had no appreciable antifoaming effect, whereas concentrations ≥ 20 mg/100 mL were sufficient to suppress bubble formation. This is substantially lower compared with frequently used doses of up to 200 mg/100 mL. Subsequently, we tested the lower simethicone dose with previously used higher doses, in 1475 and 1340 patients, respectively. We found it to have no impact on polyp detection with a rate of 56.7% (54.2-59.3% [95% CI]) at the lower dose and 56.5% (53.8-59.1% [95% CI]) at the higher dose.

Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019.

ESGE recommends a low fiber diet on the day preceding colonoscopy.Strong recommendation, moderate quality evidence.ESGE recommends the use of enhanced instructions for bowel preparation.Strong recommendation, moderate quality evidence.ESGE suggests adding oral simethicone to bowel preparation.Weak recommendation, moderate quality evidence.ESGE recommends split-dose bowel preparation for elective colonoscopy.Strong recommendation, high quality evidence.ESGE recommends, for patients undergoing afternoon colonoscopy, a same-day bowel preparation as an acceptable alternative to split dosing.Strong recommendation, high quality evidence.ESGE recommends to start the last dose of bowel preparation within 5 hours of colonoscopy, and to complete it at least 2 hours before the beginning of the procedure.Strong recommendation, moderate quality evidence.ESGE recommends the use of high volume or low volume PEG-based regimens as well as that of non-PEG-based agents that have been clinically validated for routine bowel preparation. In patients at risk for hydroelectrolyte disturbances, the choice of laxative should be individualized.Strong recommendation, moderate quality evidence.

Optimal Timing of Simethicone Addition for Bowel Preparation Using Polyethylene Glycol Plus Ascorbic Acid.

BACKGROUND: Colonic bubbles obscure the colonic mucosa during colonoscopy following bowel preparation with polyethylene glycol plus ascorbic acid (PEG-Asc). Simethicone is used to enhance visualization during colonoscopy. We aimed to determine the optimal timing of simethicone addition to improve bowel preparation using PEG-Asc. METHODS: This prospective, randomized study enrolled patients undergoing elective colonoscopy from April 2017 to January 2018. They were randomly assigned to one of the following three groups: PEG-Asc only (control) or simethicone addition in the morning on the day of colonoscopy (PEG-S1) or in the evening of the day prior to colonoscopy (PEG-S2). The primary outcome was the quality of colon cleansing, and the secondary outcomes were the adenoma detection rate (ADR), polyp detection rate (PDR), and diminutive (≤ 5 mm) ADR. RESULTS: In total, 240 patients were randomly allocated to the three groups; six patients were withdrawn. Of the 234 patients evaluated, 78, 79, and 77 were allocated to the control, PEG-S1, and PEG-S2 groups, respectively. The bubble scores of all colonic segments were lowest in the PEG-S2 group. There was no significant difference in ADR or PDR among the three groups. However, the diminutive ADR was significantly higher in the PEG-S2 group compared to the other two groups (control 5.1% vs. PEG-S1 8.9% vs. PEG-S2 20.8%; P = 0.009). CONCLUSION: Addition of simethicone to PEG-Asc at the optimal time prevents the formation of air bubbles and so improves the quality of bowel preparation, especially enhancing diminutive ADR.

Widespread clinical use of simethicone, insoluble lubricants, and tissue glue during endoscopy: A call to action for infection preventionists.

BACKGROUND: Current methods for reprocessing flexible endoscopes do not consistently eliminate organic soil. The off-label use of simethicone as a defoaming agent may contribute to reprocessing failures, and endoscope manufacturers have cautioned against its use. METHODS: We sought evidence of simethicone use by interviewing hospital personnel, conducting audits, inspecting endoscopes, and conducting tests. RESULTS: Researchers examined 69 fully reprocessed endoscopes in 4 hospitals. Microbial cultures were positive for ≥50% of endoscopes. Researchers observed cloudy, shimmery fluid resembling simethicone inside channels and under a duodenoscope elevator mechanism. Crystallized white fragments were observed protruding from a gastroscope water jet outlet. Oily, sticky residue was found on endoscopes, and a 3-dimensional mass was found inside an endoscopic ultrasound endoscope. Hospital personnel reported the use of simethicone, cooking oil and silicone sprays, and tissue glue during endoscopy. DISCUSSION: The off-label use of defoaming agents, lubricants, and tissue glue is common and many endoscopists consider these products essential. Our findings suggest these substances are not removed during reprocessing and may impact reprocessing effectiveness. CONCLUSIONS: Infection preventionists should determine whether these products are used in their institutions and evaluate methods for removing them. New policies may be needed to support procedural success and effective endoscope reprocessing.

Comparison of asymmetric (low morning-dose) and standard split-dose regimen of PEG plus bisacodyl for bowel preparation: A randomized controlled trial.

BACKGROUND: Reducing the morning dose of PEG solution may be a reliable strategy to improve the patient compliance of split-dose regimens without affecting efficacy of bowel cleansing. AIMS: to compare the efficacy for bowel cleansing of an asymmetric split-dose regimen (25% of the dose on the day of colonoscopy and 75% on the day before) with the standard split-dose regimen. METHODS: Outpatients were enrolled in a randomized, single-blind, non-inferiority clinical trial. All subjects received a split-dose preparation with a 2L PEG-citrate-simethicone plus Bisacodyl. Patients were randomly assigned to: group A, asymmetric split-dose regimen; group B, symmetric split-dose regimen. Primary endpoint was the proportion of adequate bowel cleansing. RESULTS: Split-dose was taken by 81 and 80 patients in group A and B. Adequate bowel cleansing was achieved in 92.6% and 92.5% patients in group A and B (p = 1.000). No differences were observed regarding Boston Bowel Preparation Scale total score, adenoma detection rate and scores of each colon segment. CONCLUSIONS: The reduction of morning dose of PEG in a split-dose regimen is not inferior to the standard split-dose regimen in achieving an adequate bowel cleansing. However, further studies are needed to evaluate whether asymmetric preparation is associated to a higher tolerability compared to symmetric split-dose regimen. (NCT03146052).

The benefit of adding oral simethicone in bowel preparation regimen for the detection of colon adenoma: A systematic review and meta-analysis.

BACKGROUND AND AIM: Simethicone is an anti-foaming agent commonly used during colonoscopy. Although several randomized trials have shown that oral simethicone in the bowel preparation regimen may improve bowel cleanness, whether it improves adenoma detection rate (ADR) or polyp detection rate remains undetermined. The aim of this study was to determine if oral simethicone in bowel preparation regimen before colonoscopy improves the ADR. METHODS: A comprehensive literature review was conducted using PubMed, SDOL, Cochrane Library, and ProQuest databases through December 2017. Randomized controlled trials that compared bowel preparation regimens with simethicone versus those without it were included. Effect estimates from each study were extracted and underwent meta-analysis using appropriate models. The primary outcomes were ADR and polyp detection rate, and secondary outcomes included bowel preparation, bubble score, and withdrawal time. RESULTS: Twelve published randomized controlled studies with 6003 participants were included for meta-analysis. There was no difference in the overall ADR (pooled risk ratio = 1.06, 95% confidence interval = 0.91-1.24) and right-side ADR (risk ratio = 1.50, 95% confidence interval = 0.82-2.75) between the groups with or without simethicone. However, the addition of simethicone improved adenoma detected per patient (2.20 ± 1.36 vs 1.63 ± 0.89) according to one of the included studies. Meta-regression revealed that the baseline ADR < 25% of the included studies was associated with significant benefit of oral simethicone; the number needed to treat was 15. CONCLUSIONS: The adjunction of oral simethicone significantly improved bowel preparation quality and might benefit adenoma detection in specific settings with low baseline ADR.

Pharmacokinetic Interaction Study Between Saxagliptin and Omeprazole, Famotidine, or Magnesium and Aluminum Hydroxides Plus Simethicone in Healthy Subjects: An Open-Label Randomized Crossover Study.

Saxagliptin is an orally administered, highly potent, and selective dipeptidyl peptidase-4 inhibitor for the management of type 2 diabetes mellitus. This study was conducted to determine the effect of magnesium and aluminum hydroxides plus simethicone, famotidine, and omeprazole on the pharmacokinetics of saxagliptin and its active metabolite, 5-hydroxy saxagliptin. This was an open-label, randomized, 5-treatment, 5-period, 3-way crossover study in 15 healthy subjects. Mean Cmax of saxagliptin was 26% lower, but AUC was almost unchanged when saxagliptin was coadministered with Maalox Max. Mean Cmax was 14% higher, but AUC was almost unchanged when saxagliptin was coadministered with famotidine. Changes in pharmacokinetics of 5-hydroxy saxagliptin generally paralleled the changes in saxagliptin. These pharmacokinetic changes were unlikely to be clinically meaningful. Coadministration of omeprazole did not affect saxagliptin Cmax or AUC. Saxagliptin in combination with these medicines resulted in no unexpected safety or tolerability findings in these healthy subjects. No dose adjustment of saxagliptin or separation in the time of saxagliptin dosing is necessary with medicines that raise gastric pH when coadministered with saxagliptin.

Effect of supplemental simethicone for bowel preparation on adenoma detection during colonoscopy: A meta-analysis of randomized controlled trials.

BACKGROUND AND AIM: Although several randomized controlled trials (RCTs) have reported that supplemental simethicone (SIM) can improve bowel preparation based on polyethylene glycol, there is no consensus as to whether SIM can ultimately increase the adenoma detection rate (ADR) during colonoscopy. A meta-analysis was performed to assess the effect of SIM on ADR during colonoscopy. METHODS: Databases including PubMed, EMBASE, and the Cochrane Library were searched to find relevant RCTs. RCTs evaluating the effect of pre-procedure SIM on the ADR during colonoscopy were finally included, and fixed effect models were applied. RESULTS: Six trials involving 1855 patients were finally included. The present meta-analysis suggested that the ADR during colonoscopy was significantly increased by supplemental SIM (27.9% vs 23.3%, P = 0.02), with a relative risk of 1.20 (95% confidence interval 1.03-1.39). Subgroup analysis suggested that supplemental SIM may be more useful to improve ADR during colonoscopy in endoscopic centers with low baseline ADR. CONCLUSIONS: Supplemental SIM for bowel preparation based on polyethylene glycol is useful to improve the ADR during colonoscopy.

Influence of Simethicone Added to the Rinse Water during Colonoscopies on Polyp Detection Rates: Results of an Unintended Cohort Study.

BACKGROUND AND AIMS: Simethicone is a common antifoaming agent that is added to endoscopic rinse solutions, but data regarding its effect on polyp detection rates is lacking. In this study, we report the effect of discontinuation of this practice on polyp detection rates. METHODS: Procedure data of 4,254 consecutive colonoscopies were used. Patients underwent standard bowel preparation with polyethyleneglycol (Glycoprep®). Colonoscopies were performed utilising Olympus EVIS EXERA III, CV-190 equipment, while quality data (withdraw times, polyp detection rates, quality of bowel preparation) was assessed utilising an endoscopy reporting system (Provation®). Following an educational event that highlighted that simethicone may form deposits in the channels of endoscopes, the practice to add simethicone (InfacolR, Nice Pak) to the auxiliary channel water pump was abandoned, but endoscopists were not notified about this change. After 5 days and performing 75 colonoscopies, the change of practice was identified and addition of simethicone recommenced. RESULTS: The discontinuation of simethicone use reduced the polyp detection rate from 55% (95% CI 53-56) to 45% (95% CI 34-56, 1-sided, p = 0.028); the polyp detection rate returned to the pre-intervention levels of 55% (95% CI 52-58) upon resumption of normal practice. CONCLUSION: The addition of simethicone to the auxiliary water pump during colonoscopy results in a 10% increase in polyp detection rates.

Upper gastrointestinal tract capsule endoscopy using a nurse-led protocol: First reported experience.

AIM: To test the feasibility and performance of a novel upper gastrointestinal (GI) capsule endoscope using a nurse-led protocol. METHODS: We conducted a prospective cohort analysis of patients who declined gastroscopy (oesophagogastroduodenoscopy, OGD) but who consented to upper GI capsule endoscopy. Patients swallowed the upper GI capsule following ingestion of 1 liter of water (containing simethicone). A series of positional changes were used to exploit the effects of water flow and move the upper GI capsule from one gravity-dependent area to another using a nurse-led protocol. Capsule transit time, video reading time, mucosal visualisation, pathology detection and patient tolerance was evaluated. RESULTS: Fifty patients were included in the study. The mean capsule transit times in the oesophagus and stomach were 28 s and 68 min respectively. Visualisation of the following major anatomical landmarks was achieved (graded 1-5: Poor to excellent): Oesophagus, 4.8 (± 0.5); gastro-oesophageal junction (GOJ), 4.8 (± 0.8); cardia, 4.8 (± 0.8); fundus, 3.8 (± 1.2); body, 4.5 (± 1); antrum, 4.5 (± 1); pylorus, 4.7 (± 0.8); duodenal bulb, 4.7 (± 0.7); second part of the duodenum (D2), 4.7 (± 1). The upper GI capsule reached D2 in 64% of patients. The mean video reading time was 48 min with standard playback mode and 20 min using Quickview (P = 0.0001). No pathology was missed using Quickview. Procedural tolerance was excellent. No complications were seen with the upper GI capsule. CONCLUSION: The upper GI capsule achieved excellent views of the upper GI tract. Future studies should compare the diagnostic accuracy between upper GI capsule and OGD.