Development and Characterization of A New Dimethicone Nanoemulsion and its Application for Electronic Gastroscopy Examination.

PURPOSE: Although the effective and safe medical defoamers, dimethicone (DM) and simethicone (SM) are widely used in electronic gastroscope examination (EGE), their preparations are presented in the form of suspensions or emulsions, these are untransparent or milk-like in appearance and can easily cause misdiagnosis as a result of an unclear field of vision if the doctor does not master the amount of defoamer or operates incorrectly. At the same time, it is also difficult to wash out the camera and pipeline, due to the large oil droplets of preparations. The purpose of this study was to develop a new clear and transparent oil in water (O/W) DM nanoemulsions (DMNs) and observe the effect of application in EGE. METHODS: The oil phase was chosen for its antifoaming activity and viscosity. The emulsifier and co-emulsifier were selected according to the solubility of the oil phase in them. The water titration method was used to make the pseudoternary phase diagrams of nanoemulsions and optimize the prescription composition. DM-in-water nanoemulsion was prepared by the low energy method and evaluated for appearance, antifoaming ability, droplet size, and stability. The effect of DMNs utilized in EGEs was also observed. RESULTS: The optimal formulation of DMNs contained CRH-40 as an emulsifier, PEG-400 as a co-emulsifier, DM as oil phase with the viscosity of 10 mPa.s, and their proportion was 4.5:4.5:1, respectively. DMNs obtained the average particle size of 67.98 nm with the polydispersity index (PDI) of 0.332, and 57.14% defoaming rate. The result of using an EGE showed that DMNs were superior in comparison to the emulsions with regard to the defoaming effect, visual clarity, and easy cleanup. CONCLUSION: DMNs were found to provide excellent visual clarity to its other preparations. The novel DMNs is a promising substitute for DM emulsions or suspensions in EGEs.

Simethicone use during gastrointestinal endoscopy: Position statement of the Gastroenterological Society of Australia.

Concern has been raised regarding the use of simethicone, a de-foaming agent, during endoscopic procedures. Following reports of simethicone residue in endoscope channels despite high level disinfection, an endoscope manufacturer recommended that it not be used due to concerns of biofilm formation and a possible increased risk of microorganism transmission. However, a detailed mucosal assessment is essential in performing high-standard endoscopic procedures. This is impaired by bubbles within the gastrointestinal lumen. The Gastroenterological Society of Australia's Infection Control in Endoscopy Guidelines (ICEG) Committee conducted a literature search utilizing the MEDLINE database. Further references were sourced from published paper bibliographies. Following a review of the available evidence, and drawing on extensive clinical experience, the multidisciplinary ICEG committee considered the risks and benefits of simethicone use in formulating four recommendations. Published reports have documented residual liquid or crystalline simethicone in endoscope channels after high level disinfection. There are no data confirming that simethicone can be cleared from channels by brushing. Multiple series report benefits of simethicone use during gastroscopy and colonoscopy in improving mucosal assessment, adenoma detection rate, and reducing procedure time. There are no published reports of adverse events related specifically to the use of simethicone, delivered either orally or via any endoscope channel. An assessment of the risks and benefits supports the continued use of simethicone during endoscopic procedures. Strict adherence to instrument reprocessing protocols is essential.

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.

Simethicone improves bowel cleansing with low-volume polyethylene glycol: a multicenter randomized trial.

BACKGROUND AND STUDY AIMS: For bowel preparation, using a reduced volume of polyethylene glycol (PEG) solution without influencing its effectiveness would be preferable. While simethicone shows great potential as an adjunctive agent, data on its use are limited. We aimed to clarify whether simethicone added to low-volume PEG solution improved bowel cleansing. PATIENTS AND METHODS : Consecutive adult patients registered for colonoscopy were recruited from seven medical centers in South China between 15 April and 15 July 2015 and prospectively randomized into two groups: 2 L PEG (conventional group) and 2 L PEG plus simethicone (simethicone group). The primary endpoint was the effectiveness of bowel cleansing according to the Boston Bowel Preparation Scale (BBPS). Secondary endpoints included cecal intubation time, adenoma detection rate (ADR), patient safety and compliance, and adverse events. RESULTS : We included 290 and 289 patients in the conventional and simethicone groups, respectively, for analysis. The proportion with acceptable bowel cleansing (BBPS ≥ 6) was significantly higher in the simethicone group than in the conventional group (88.2 % vs. 76.6 %; P < 0.001). The mean (SD) BBPS score was significantly lower in the conventional group (6.5 [1.8] vs. 7.3 [1.7]; P < 0.001), as was the bubble score (2.5 [0.7] vs. 2.8 [0.5]; P < 0.001). The average cecal intubation time was significantly shorter in the simethicone group (6.3 [3.1] vs. 7.5 [5.1] minutes; P < 0.001). The ADR in the right colon was higher in the simethicone group than in the conventional group (16.6 % vs. 10.3 %; P = 0.03). Safety and compliance, including the taste, smell, and dosage of PEG, were similar for both groups. CONCLUSIONS: Simethicone added to low-volume PEG solution improves bowel-cleansing efficacy, with similar safety and compliance, shorter cecal intubation time, and higher ADR.

A randomized double-blind placebo-controlled clinical trial on efficacy and safety of association of simethicone and Bacillus coagulans (Colinox®) in patients with irritable bowel syndrome.

INTRODUCTION: Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects 15-20% of the Western population. BACKGROUND: There are currently few therapeutic options available for the treatment of IBS. The aim of this study is to evaluate the efficacy and the safety of a medical device containing a combination of Simethicone and Bacillus coagulans in the treatment of IBS. PATIENTS AND METHODS: This is a monocentric double-blind, placebo-controlled parallel group clinical trial. Adult subjects suffering from IBS as defined by Rome III criteria were enrolled. Bloating, discomfort, abdominal pain were assessed as primary end point. Subjects received the active treatment or placebo 3 time a day after each meal for 4 weeks of study period. Subjects were submitted to visit at Day 0 (T1), at Days 14 (T2) and 29 (T3). RESULTS: Fifty-two patients were included into the study. Intragroup analysis showed a significant reduction of the bloating, discomfort and pain in Colinox® group (CG) compared to placebo group (PG). Between group analysis confirmed, at T1-T3, significant differences between CG and PG in bloating and discomfort. DISCUSSION: Simethicone is an inert antifoaming able to reduce bloating, abdominal discomfort. Literature offers increasing evidence linking alterations in the gastrointestinal microbiota and IBS and it is well known that probiotics are important to restore the native gut microbiota. The Colinox medical device is specifically targeted against most intrusive symptom of IBS (bloating) and it is also able to counteract the most accredited ethiopathogenetic factor in IBS (alterations of intestinal microbiota). CONCLUSIONS: This is the first randomized double-blind placebo-controlled clinical trial demonstrating the efficacy and safety of a combination of simethicone and Bacillus coagulans in treatment of IBS.

Should bowel preparation, antifoaming agents, or prokinetics be used before video capsule endoscopy? A systematic review and meta-analysis.

OBJECTIVES: The ideal bowel preparation regime before small bowel video capsule endoscopy (VCE) is not known. We carried out a systematic review and meta-analysis to study the effect of purgatives, antifoaming agents, and prokinetics on the outcomes associated with VCE. MATERIALS AND METHODS: We performed literature searches in MEDLINE and Cochrane Library and included randomized-controlled trials studying the effect of purgatives, antifoaming agents, and prokinetics in patients undergoing VCE. Our outcomes of interest were visualization quality, diagnostic yield, and completion rate. Meta-analyses were carried out using the RevMan software and heterogeneity was assessed using the I statistic. RESULTS: Fifteen studies fulfilled the inclusion criteria. As compared with no bowel preparation, bowel preparation with polyethylene glycol (PEG) led to adequate visualization in a significantly higher number of patients undergoing VCE [odds ratio (OR) 3.13; 95% confidence interval (CI) 1.70-5.75]. Both PEG and sodium phosphate significantly improved the diagnostic yield (OR 1.68; 95% CI 1.16-2.42 and OR 1.77; 95% CI 1.18-2.64, respectively) but did not affect the completion rate. All studies with simethicone showed significantly improved visualization quality with its use as compared with overnight fasting or purgatives alone. Prokinetics did not significantly improve the completion rate of VCE. CONCLUSION: On the basis of the data available, a combination of PEG and simethicone appears to be the best approach for small bowel preparation before VCE. However, large multicenter randomized-controlled trials are needed to validate this recommendation and to evaluate the ideal dose of PEG and timing of bowel preparation before VCE. Prokinetics administered before VCE do not improve the completion rate and should not be used.

Randomized, double-blind, placebo-controlled clinical trial of loperamide plus simethicone versus loperamide alone and simethicone alone in the treatment of acute diarrhea with gas-related abdominal discomfort.

OBJECTIVE: To compare efficacy and tolerability of a loperamide/simethicone (LOP/SIM) combination product with that of loperamide (LOP) alone, simethicone (SIM) alone, and placebo (PBO) for acute nonspecific diarrhea with gas-related abdominal discomfort. RESEARCH DESIGN AND METHODS: In this multicenter, double-blind, 48-h study, patients were randomly assigned to receive two tablets, each containing either LOP/SIM 2 mg/125 mg (n = 121), LOP 2 mg (n = 120), SIM 125 mg (n = 123), or PBO (n = 121), followed by one tablet after each unformed stool, up to four tablets in any 24-h period. The primary outcome measures were time to last unformed stool and time to complete relief of gas-related abdominal discomfort. For time to last unformed stool, an unformed stool after a 24-h period of formed stools or no stools was considered a continuance of the original episode (stricter definition) or a new episode (alternate definition). RESULTS: A total of 483 patients were included in the intent-to-treat analysis. The median time to last unformed stool for LOP/SIM (7.6 h) was significantly shorter than that of LOP (11.5 h), SIM (26.0 h), and PBO (29.4 h) (p < or = 0.0232 in comparison with survival curves) using the alternate definition; it was numerically but not significantly shorter than that of LOP (p = 0.0709) and significantly shorter than that of SIM and PBO (p = 0.0001) using the stricter definition. LOP/SIM-treated patients had a shorter time to complete relief of gas-related abdominal discomfort than patients who received either ingredient alone or placebo (all p = 0.0001). Few patients reported adverse events in the four treatment groups, none of which were serious in nature. Potential study limitations include the ability to generalize study results to the population at large, variability in total dose consumed, and subjectivity of patient diary data. CONCLUSIONS: LOP/SIM was well-tolerated and more efficacious than LOP alone, SIM alone, or placebo for acute nonspecific diarrhea and gas-related abdominal discomfort.

Brain embolic phenomena associated with cardiopulmonary bypass.

Various biologic and non-biologic materials may be embolized to the brain after the use of cardiopulmonary bypass (CPB) pumps during open heart surgery but their relative frequency and importance are uncertain. Among the nonbiologic materials, Antifoam A, which contains organosilicates and silicon, continues to be employed as an additive to prevent frothing. Recent improvements in filtration and oxygenation techniques have clearly reduced the incidence of large emboli and complications like stroke but other neurologic sequelae following open heart surgery are common and in many cases poorly explained. A recently developed histochemical technique for the demonstration of the endothelial alkaline phosphatase (AP) was employed in a post-mortem study of brains from 8 patients and 6 dogs dying within a few days after open heart surgery employing cardiopulmonary bypass perfusion. Brains from 38 patients and 6 dogs who were not subjected to heart surgery were studied as controls with the same technique. The AP-stained slides are suitable for both light microscopic examination of the thick celloidin sections as well as a subsequent processing for high-resolution microradiography. Small capillary and arteriolar dilatations (SCADs) were seen in the test subjects/animals but not controls. SCADs were seen in all parts of the brain. Approximately 50% of the SCADs showed birefringence when examined with polarized light. SCADs are putative embolic phenomena and the exact nature and source of the embolic material is under investigation. A glycolipid component is indicated by preliminary studies. SCADs are difficult to find in routine paraffin sections and most if not all of the offending material seems to be dissolved during processing.(ABSTRACT TRUNCATED AT 250 WORDS)

[Antifoaming agent microembolism in patients undergoing extracorporeal circulation. Its frequency in post mortem material and its pathogenic potential in vitro]. / Microembolias de antiespumante en pacientes sometidos a circulación extracorpórea. Frecuencia en material post mortem y su potencial patógeno in vitro.

Antifoam microembolisms in patients that undergo open heart surgery, represent a risk for postoperative complications. We decided to study its frequency in an autopsy population of patients who died after heart surgery. Forty-five patients were selected and histological sections from the kidneys were studied under light microscopy, scanning electron microscopy and X-ray microanalysis. Thirty-six cases (80%) showed microemboli in the glomerular capillaries lumens. There was a positive correlation between the number of particles found and the length of the surgery. Microemboli were composed of an amorphous fraction and a particulated one composed of silicon. In vitro experimentation demonstrated that the particles are capable to induce cell lysis in a dose related manner. They also are susceptible of been phagocitated by macrophages. We conclude that bubble oxygenator are capable to induce microembolisms in a high percentage of the cases studied. Components of the microemboli are cytotoxic. Therefore microembolisms could be participating in the morbidity of patients subjects to cardiopulmonary bypass.

Gripe water: what is it? Why is it given?

Large numbers of babies are given gripe water for no valid reason or for only trivial symptoms, write Cynthia Illingworth and John Timmins. When a health visitor survey of Sheffield mothers and babies showed how widespread was the practice of giving gripe water, they decided to seek information about the nature of gripe water, the conditions which it is supposed to treat and its use by a representative number of women.

Microemboli observed in deaths following cardiopulmonary bypass surgery: silicone antifoam agents and polyvinyl chloride tubing as sources of emboli.

Refractile foreign particles within clear vacuoles were observed in capillaries of 17 patients who underwent cardiopulmonary bypass surgery, died, and were autopsied at the George Washington University Hospital from December 1978 through April 1981. The postoperative survival time ranged from less than one day to more than eight months. The approximate maximal diameter of the individual particles was 10 micrometer and that of the vacuoles 60 micrometer. The particle-droplet complexes showed affinity for hydrophobic stains. In all 17 cases, the kidneys were involved in combination with several other organs. In two patients, the emboli were associated with microinfarcts in one or more organs. Scanning electron microscopy (SEM) of the polyvinyl chloride tubing used during four cardiopulmonary bypasses showed spallation and shredding of the luminal surface in the areas exposed to the roller pump heads. This suggested that fragments of polyvinyl chloride might be the particles in the emboli. Another possible source was the antifoam agent used in the bubble oxygenator. Scanning electron microscopy x-ray microprobe analysis of the foreign material within capillaries of several organs showed it to be strongly positive for silicon but not for chlorine. Therefore, it was concluded that the microemboli were droplets of antifoam agent, the refractile particles corresponding to the particulate silica component and the vacuoles corresponding to the dimethylpolysiloxane liquid component. Since x-ray microprobe analysis of the microemboli did not reveal a strong chloride peak, there is as yet no evidence that polyvinyl chloride fragments were involved in the microembolism. The morphologic findings reported here indicate that antifoam microembolization continues to complicate cardiopulmonary bypass surgery and must, therefore, be considered a potential cause of postoperative morbidity. The consequence of the fragments of polyvinyl chloride tubing released into the circulation remains to be established.