Efficacy of the Combination of Pinaverium Bromide 100 mg Plus Simethicone 300 mg in Abdominal Pain and Bloating in Irritable Bowel Syndrome: A Randomized, Placebo-controlled Trial.

GOALS: We aimed to evaluate the efficacy and safety of PB+S (pinaverium bromide 100 mg plus simethicone 300 mg) in patients with irritable bowel syndrome (IBS). BACKGROUND: IBS is a multifactorial disorder; thus, combination therapy with different mechanisms of action is expected to be useful. PB+S has shown effectiveness in an open-label clinical study in IBS. However, there are no placebo-controlled trials. MATERIALS AND METHODS: IBS-Rome III patients with abdominal pain/discomfort for at least 2 days within the week prior to baseline assessment were included in this 12-week, randomized, double-blind, placebo-controlled study of PB+S versus placebo, bid. The primary endpoint was overall symptom improvement, evaluated weekly by the patient (Likert Scale). Secondary endpoints included the weekly improvement in the severity of abdominal pain and bloating assessed both by patients (10-cm Visual Analogue Scale) and investigators (Likert Scale); frequency of Bristol Scale stool types (consistency) evaluated by patients and the IBS Quality of Life scores. RESULTS: A total of 285 patients (female: 83%; 36.5±8.9 y old) received at least 1 dose of PB+S (n=140) or placebo (n=145). No difference was observed in overall symptom improvement between the groups (P=0.13). However, PB+S was superior in abdominal pain (effect size: 31%, P=0.038) and bloating (33%, P=0.019). Patients with IBS-C and IBS-M showed the best improvement in the frequency of stool types with PB+S. No differences were observed in IBS Quality of Life scores and adverse events. CONCLUSIONS: PB+S was superior to placebo in improving abdominal pain and bloating in patients with active IBS. The effect on the frequency of stool consistency was particularly significant in IBS-C and IBS-M.

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.

Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy: a randomized clinical trial.

BACKGROUND: Esophagogastroduodenoscopy is very useful in diagnosing and treating upper gastrointestinal mucosal disorders, but too much foam and water in stomach decrease its diagnostic efficiency. Simethicone administration can help remove excessive foam. AIMS: To determine the optimal simethicone administration strategies in a comparative randomized controlled clinical trial. METHODS: Adult outpatients with indications for esophagogastroduodenoscopy were enrolled and randomly divided into group 1 (simethicone solution intake 20-30 min before procedure, n = 110), group 2 (simethicone solution intake 31-60 min before procedure, n = 92), and group 3 (simethicone solution intake > 60 min before procedure). Primary and secondary outcomes were procedure time and the patients' satisfaction after the examination. All symptoms like abdominal pain and distension were recorded. RESULTS: No statistically significant differences were found on the patients' demographic and clinical features and mean examination time (all P values > 0.05). The distribution of patients with different endoscopic and pathological diagnosis was comparable among three groups, respectively (P = 0.607; P = 0.289). However, the proportion of patients with Gastric Cleanness Grade A was most in group 2 (n = 73, 79.3%), and patient proportion with Gastric Cleanness Grade C was most found in group 1 (n = 72, 65.5%), which was greatly different (P < 0.001). There was no statistically significant difference on the satisfaction scores [immediately 6 (3-8) vs. 6 (1-10) vs. 6 (1-9), P = 0.533; 2 h after 10 (8-10) vs. 10 (10-10) vs. 10 (8-10), P = 0.463]. CONCLUSION: Simethicone solution intake 31-60 min before esophagogastroduodenoscopy can help obtain the best gastric cleanness, which is recommended in clinical practice (registered at ClinicalTrials.gov, NCT03776916 on December 13, 2018).

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.

Are bowel purgatives and prokinetics useful for small-bowel capsule endoscopy? A prospective randomized controlled study.

BACKGROUND: Capsule endoscopy (CE) is limited by incomplete small-bowel transit and poor view quality in the distal bowel. Currently, there is no consensus regarding the use of bowel purgatives or prokinetics in CE. OBJECTIVE: To evaluate the usefulness of bowel purgatives and prokinetics in small-bowel CE. DESIGN: Prospective single-blind randomized controlled study. SETTING: Academic endoscopy unit. PATIENTS: A total of 150 patients prospectively recruited. INTERVENTION: Patients were randomized to 1 of 4 preparations: "standard" (fluid restriction then nothing by mouth 12 hours before the procedure, water and simethicone at capsule ingestion [S]); "standard" + 10 mg oral metoclopramide before the procedure (M); Citramag + senna bowel-purgative regimen the evening before CE (CS); Citramag + senna + 10 mg metoclopramide before the procedure (CSM). MAIN OUTCOME MEASUREMENTS: Gastric transit time (GTT) and small-bowel transit time (SBTT), completion rates (CR), view quality, and patient acceptability. SECONDARY OUTCOME MEASURES: positive findings, diagnostic yield. RESULTS: No significant difference was noted among groups for GTT (median [minutes] M, CS, and CSM vs S: 17.3, 24.7, and 15.1 minutes vs 16.8 minutes, respectively; P = .62, .18, and .30, respectively), SBTT (median [minutes] M, CS, and CSM vs S: 260, 241, and 201 vs 278, respectively; P = .91, .81, and .32, respectively), or CRs (85%, 85%, and 88% vs 89% for M, CS, and CSM vs S, respectively; P = .74, .74, and 1.00, respectively). There was no significant difference in view quality among groups (of 44: 38, 37, and 40 vs 37 for M, CS, and CSM, vs S, respectively; P = .18, .62, and .12, respectively). Diagnostic yield was similar among the groups. CS and CSM regimens were significantly less convenient (P < .001), and CS was significantly less comfortable (P = .001) than standard preparation. CONCLUSIONS: Bowel purgatives and prokinetics do not improve CRs or view quality at CE, and bowel purgatives reduce patient acceptability.

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.

Comparison of Two Forms of Loperamide-Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial.

BACKGROUND: Acute diarrhoea is a frequent health problem in both travellers and residents that has a social and economic impact. This study compared the efficacy and tolerability of two loperamide-simeticone formulations and a Saccharomyces boulardii capsule as symptomatic treatment. METHODS: This was a prospective, randomised, single (investigator)-blind, three-arm, parallel group, non-inferiority clinical trial in adult subjects with acute diarrhoea at clinics in Mexico and India, with allocation to a loperamide-simeticone 2/125 mg caplet or chewable tablet (maximum eight in 48 h) or S. boulardii (250 mg twice daily for 5 days). OUTCOME MEASURES: The primary outcome measure was the number of unformed stools between 0 and 24 h following the initial dose of study medication (NUS 0-24). The secondary outcome measures were time to last unformed stool (TLUS), time to complete relief of diarrhoea (TCRD), time to complete relief of abdominal discomfort (TCRAD) and the subject's evaluation of treatment effectiveness. Follow-up endpoints at 7 days were feeling of complete wellness; stool passed since final study visit; and continued or recurrent diarrhoea. SUBJECTS: In this study, 415 subjects were randomised to either a loperamide-simeticone caplet (n = 139), loperamide-simeticone chewable tablet (n = 139) or S. boulardii capsule (n = 137) and were included in the intention-to-treat analysis. RESULTS: With regards to mean NUS 0-24, the loperamide-simeticone caplet was non-inferior to loperamide-simeticone tablets (3.4 vs. 3.3; one-sided 97.5 % confidence interval ≤0.5), with both significantly lower than S. boulardii (4.3; p < 0.001). The loperamide-simeticone groups had a shorter median TLUS [14.9 and 14.0 vs. 28.5 h (loperamide-simeticone caplet and chewable tablet groups, respectively, vs. S. boulardii); p < 0.001], TCRD (26.0 and 26.0 vs. 45.8 h; p < 0.001) and TCRAD (12.2 and 12.0 vs. 23.9 h; p < 0.005) than S. boulardii. Treatment effectiveness for overall illness, diarrhoea and abdominal discomfort relief was greater (p < 0.001) in the loperamide-simeticone groups than with S. boulardii. At 7-day follow-up most subjects reported passing stool at least once since the final study visit (loperamide-simeticone caplet 94.1 %, loperamide-simeticone chewable tablet 94.8 %, S. boulardii 97.0 %), did not experience continued or recurrent diarrhoea [loperamide-simeticone caplet 3.7 % (p < 0.03 vs. S. boulardii), loperamide-simeticone chewable tablet 3.7 %, S. boulardii 5.7 %] and felt completely well [loperamide-simeticone caplet 96.3 % (p < 0.02 vs. S. boulardii), loperamide-simeticone chewable tablet 96.3 % (p < 0.02 vs. S. boulardii), S. boulardii 88.6 %]. All treatments were well-tolerated with few adverse events. CONCLUSIONS: The loperamide-simeticone caplet was non-inferior to the original loperamide-simeticone chewable tablet formulation; both formulations can be expected to demonstrate similar clinical efficacy in the relief of symptoms of acute diarrhoea. Both loperamide-simeticone formulations were superior to the S. boulardii capsule in the primary and secondary endpoints. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00807326.

Hypophosphatemic rickets with hypocalciuria following long-term treatment with aluminum-containing antacid.

We present what we believe is the first case of rickets following prolonged treatment with aluminum containing antacids that bind phosphate, in an 18-year-old mentally retarded boy with cerebral palsy and spastic quadriplegia. As expected, serum calcitriol was increased and urinary phosphate excretion was very low. However, in contrast to all published cases of antacid induced hypophosphatemic osteomalacia in adults, despite a substantial increase in bone resorption reflected by urinary total hydroxyproline excretion, urinary calcium excretion was low rather than high, and significant hypocalcemia occurred after antacids were ceased and a phosphate salt administered. We suggest that the skeleton was so under-mineralized because of growth during prolonged phosphate deficiency, possibly augmented by anticonvulsant administration and immobilization, that increased bone resorption did not release enough calcium to cause hypercalciuria, or to prevent hypocalcemia during resumption of normal mineralization.

Randomised double-blind comparison of simethicone with cisapride in functional dyspepsia.

AIM: To compare the efficacy of simethicone with cisapride in patients with functional (non-ulcer) dyspepsia. METHODS: After standardized diagnostic work-up and at least 6-days wash-out of medication, 177 patients with functional dyspepsia were enrolled; 173 of them (age 19-71 years) were randomized and treated using a double-dummy technique with simethicone (84 mg t.d.s.) or cisapride (10 mg t.d.s.). At baseline and after 2 and 4 weeks, the intensity of the symptoms was scored from 0 (absent) to 3 (severe) using a standardized symptom questionnaire. Efficacy of the treatment was judged by the patients as 'very good', 'good', 'moderate' or 'no effect'. RESULTS: A total of 166 patients completed the trial. After 2 and 4 weeks, 34% and 46% (respectively), of the patients treated with simethicone judged the improvement in symptoms to be excellent compared to 13% and 22% (respectively) of patients treated with cisapride (P < 0.01). After 2 weeks the difference in the improvement in the global symptom score was significantly better (Delta30.7%, P < 0.001) for simethicone than for cisapride, while this difference failed statistical significance after 4 weeks (Delta10.2%, P=0.11). CONCLUSIONS: In patients with functional dyspepsia, simethicone relieves symptoms during the first 2 weeks of treatment significantly better than cisapride.

Ocular findings six years after intravitreal silicone injection.

A case of giant retinal tear treated by injection with dimethicone 350 (medical fluid silicone) was observed for six years before enucleation. About four months after the injection, signs of anterior segment ischemia were evident. A year after the injection, an injury resulted in displacement of dimethicone 350 into the anterior chamber. Enucleation was done because of pain.

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)

Silicone granuloma of the facial tissues: a report of seven cases.

The liquid form of silicone, called dimethicone (dimethylpolysiloxane), has been used extensively in some countries during the past 4 decades for soft tissue augmentation. Although considered biologically inert, this material has been reported as potentially inducing, after tissue injection, a granulomatous inflammatory response of variable severity. Interestingly, a remarkable paucity of reports exists about the development of complications after injections of liquid silicone into the facial tissues, especially considering its high frequency of use. The purpose of this article is to describe the clinical and microscopic features of 7 cases of silicone-induced granulomas that developed after injection of the facial tissues for cosmetic purposes and to discuss the differential diagnosis and management of this condition.

Open safety-in-use trial of a new high-potency antacid product.

In an open safety-in-use study, the subjective effectiveness and taste acceptability of a new high-potency antacid product were compared to previous treatment in 109 patients presenting with upper gastro-intestinal disorders of functional origin. Severity of the dominant symptoms prior to treatment was compared with that of symptoms present during treatment. Sixty-seven per cent to 73% of upper gastro-intestinal tract symptoms were completely relieved. Eighty-three per cent versus 48% of patients seen in a private practice setting, as compared with the speciality practice, reported good to excellent results, with 92% versus 56% describing good to excellent taste acceptability. When compared with previous antacid therapy, 70% of the patients preferred the new high-potency formulation to the regular-strength products, for both effectiveness and taste. The incidence of product-related side-effects was low, with only 6.7% experiencing the diarrhoea or loose stools commonly associated with conventional products containing magnesium hydroxide.

Rickets secondary to phosphate depletion. A sequela of antacid use in infancy.

Two infants presented with growth failure and were found to have generalized osteomalacia (rickets) due to phosphate depletion from prolonged administration of an aluminum-containing antacid given for the symptoms of colic. One of the infants developed bilateral proptosis due to craniosynostosis related to the underlying metabolic bone disease. The chronic use of aluminum-containing antacids in infants has potential risk for the growing skeleton and is not innocuous. Therefore, antacid therapy should be used in low doses and very cautiously, with routine monitoring of serum calcium and phosphorus in children taking medications which reduce gastrointestinal phosphate absorption.

[Neurological manifestations in the intoxication of infants by dimethicone combined with homatropine: report of 6 cases]. / Manifestações neurológicas na intoxicação de lactentes pela associação dimeticona e homatropina: relato de 6 casos.

OBJECTIVE: to alert that use of dimethicone plus homatropine in infants up to two months, may cause episodes of transitory extrapyramidal disturbances. METHOD: report 6 infants up to two months old, in daily use of dimethicone plus homatropine, that presented typical symptoms of the basal ganglia dysfunction, characterized by repeated crisis of short duration with tonic back shift of the head (opisthotonos), deviation of the eyes upward with looking fixed and terror expression, maintained in extending hypertonia posture of the 4 members and cry and/or guttural sounds emission. RESULTS: the extrapyramidal symptoms disappeared (and did not return) after interruption of dimethicone plus homatropine. Abnormalities were not verified in neurological examination, EEG and blood tests. CONCLUSIONS: the associated dimethicone/homatropine can produce in infants with less than 2 months, basal ganglia disturbances. The differentiation of these symptoms with the widespread epileptic crisis is essential, in order to avoid the erroneous use of antiepileptic drugs.

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.

Premedication with N-acetylcysteine and simethicone improves mucosal visualization during gastroscopy: a randomized, controlled, endoscopist-blinded study.

OBJECTIVES: Diagnostic gastroscopy provides a unique opportunity to diagnose early oesophagogastric neoplasia; however, intraluminal mucus and bile can obscure mucosal visualization. The aim of this study was to determine whether the use of a premedication solution containing the mucolytic agent N-acetylcysteine and the surfactant simethicone improves mucosal visualization within a UK diagnostic gastroscopy service. MATERIALS AND METHODS: A total of 75 consecutive patients were recruited from a single (S.J.) endoscopist's diagnostic gastroscopy list. They were randomized into three treatment groups: (a) standard control=clear fluids only for 6 h, nil by mouth for 2 h; (b) water control=standard control+100 ml sterile water (given 20 min before gastroscopy); and (c) solution=standard control+100 ml investigated solution (20 min before gastroscopy). The endoscopist was blinded to patient preparation. Inadequate mucosal visualization was defined as fluid/mucus during gastroscopy that could not be suctioned and required flushing with water. The volume of flush, the site at which it was used and the total procedure times were recorded. RESULTS: All three groups showed no statistical difference for age, sex ratio, procedure priority or indication. The mean volume of flush required to obtain clear mucosa was significantly less in the solution group compared with the other groups. The mean overall procedure time was also less in the solution group compared with the other groups. DISCUSSION: Premedication with N-acetylcysteine and simethicone markedly improves mucosal visibility during gastroscopy. It also reduces the time taken for the procedure. This low-cost and well-tolerated intervention may improve detection of early neoplasia.

Simethicone retinopathy in an immature infant.

The authors describe retinal findings in an immature infant consuming simethicone, a common over-the-counter drug used in the treatment of colic. The lesions are most consistent with an embolic phenomenon possibly from systemic absorption of a medication such as simethicone.