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.

Comorbidities and co-medications among 28 089 people living with HIV: A nationwide cohort study from 2009 to 2019 in Japan.

OBJECTIVES: Comorbidities are associated with a high burden of disease in people living with HIV (PLWH). The objective was to investigate the prevalence of chronic comorbidities and use of co-medications in PLWH in Japan. METHODS: This study retrospectively analysed clinical information from PLWH receiving antiretroviral therapy (ART) between April 2009 and March 2019. Demographic characteristics, numbers and types of chronic comorbidities, and numbers and types of non-ART co-medications, were described by age groups. The source of data was the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). RESULTS: Overall, 28 089 PLWH (male 91.9%) who used ART were identified. Out of 28 089 PLWH, 81.5% had at least one chronic comorbidity. The numbers of AIDS-defining cancers and non-AIDS-defining cancers in this Japanese cohort were 2432 (8.7%) and 2485 (8.8%), respectively. The cumulative burden of comorbidities including non-AIDS-defining cancer increased with age. Changes in trend between 2009 and 2019 were observed, including a higher proportion of PLWH diagnosed at ≥ 70 years old [2019 (4.7%) vs. 2009 (2.4%)] and a decreasing percentage of patients with AIDS-defining cancers (down from 6.3% to 4.8% between 2009 and 2019). The most common co-medications during the most recent 3-month period were lipid-regulating/anti-atheroma preparations (11.3%), antacids, antiflatulents and anti-ulcerants (9.6%), and agents acting on the renin-angiotensin system (8.1%). The three most common therapeutic categories of co-medications during the study period were antacids, antiflatulents and anti-ulcerants (35.0%), systemic antihistamines (33.7%) and psycholeptics (27.1%). More than 30% of PLWH aged > 40 years used at least one co-medication in a 3-month period, while more than half of PLWH aged > 30 years had at least one co-medication prescribed concomitantly for a total of ≥ 90 days during the study period, and the numbers of co-medications used were greater in the older age groups. CONCLUSIONS: The burden of chronic comorbidities and co-medication were found to be greater in older, as compared to younger patients, among 28 089 PLWH in a nationwide study in Japan. This finding suggests the need to identify elderly PLWH and to appropriately manage their HIV and comorbidities.

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.

Comparison of common interventions for the treatment of infantile colic: a systematic review of reviews and guidelines.

OBJECTIVE: To conduct a systematic review of systematic reviews and national guidelines to assess the effectiveness of four treatment approaches (manual therapy, probiotics, proton pump inhibitors and simethicone) on colic symptoms including infant crying time, sleep distress and adverse events. METHODS: We searched PubMed, Embase, Cochrane and Mantis for studies published between 2009 and 2019. Inclusion criteria were systematic reviews and guidelines that used evidence and expert panel opinion. Three reviewers independently selected articles by title, abstract and full paper review. Data were extracted by one reviewer and checked by a second. Selected studies were assessed for quality using modified standardised checklists by two authors. Meta-analysed data for our outcomes of interest were extracted and narrative conclusions were assessed. RESULTS: Thirty-two studies were selected. High-level evidence showed that probiotics were most effective for reducing crying time in breastfed infants (range -25 min to -65 min over 24 hours). Manual therapies had moderate to low-quality evidence showing reduced crying time (range -33 min to -76 min per 24 hours). Simethicone had moderate to low evidence showing no benefit or negative effect. One meta-analysis did not support the use of proton pump inhibitors for reducing crying time and fussing. Three national guidelines unanimously recommended the use of education, parental reassurance, advice and guidance and clinical evaluation of mother and baby. Consensus on other advice and treatments did not exist. CONCLUSIONS: The strongest evidence for the treatment of colic was probiotics for breastfed infants, followed by weaker but favourable evidence for manual therapy indicated by crying time. Both forms of treatment carried a low risk of serious adverse events. The guidance reviewed did not reflect these findings. PROSPERO REGISTRATION NUMBER: CRD42019139074.

The role of oral simethicone on the adenoma detection rate and other quality indicators of screening colonoscopy: a randomized, controlled, observer-blinded clinical trial.

BACKGROUND AND AIMS: Combining simethicone (SIM) with a colon preparation agent has been shown to improve mucosal visibility during screening colonoscopy, but its effect on the adenoma detection rate (ADR) remains unclear. SIM is commonly used through the endoscope to eliminate bubbles during endoscopy. However, this practice recently has been associated with endoscope-transmitted infections. Our aims were to determine the role of SIM added to a polyethylene glycol preparation on the ADR, procedure times, colon preparation, and intraprocedural use of SIM. METHODS: This was a randomized, controlled, observer-blinded, clinical trial of patients undergoing screening colonoscopy. Patients with a high risk of colorectal cancer were excluded. Patients were randomly assigned to 2 different preparations: polyethylene glycol plus SIM or polyethylene glycol. Two endoscopists blinded to patient preparation regimens scored its quality by using the Boston Bowel Preparation scale (BBPS) and the bubble scale. Interobserver agreement was calculated. The polyp detection rate, ADR, intraprocedural use of SIM, cecal intubation time, and withdrawal time were recorded. For study purposes, cecal intubation time and withdrawal time were combined to determine the effective procedure time. RESULTS: No significant difference between the polyethylene glycol plus SIM and polyethylene glycol arms was seen regarding the ADR (33.3% vs 38.8%; P = .881) and effective procedure time (759.3 ± 253.1 seconds vs 800.2 ± 459.6 seconds; P = .373), respectively. Intraprocedural use of SIM as well as the bubble scale score were significantly lower in the polyethylene glycol plus SIM arm (1.6% vs 48.9%; P ≤ .05) and (0.1 vs 2.1; P ≤ .05), respectively. Conversely, no difference was found in the BBPS scores. The interobserver agreement for both scores was strong (bubble scale score kappa = .537; P < .05; BBPS score kappa = .184; P <.05). CONCLUSION: Adding SIM to a polyethylene glycol preparation did not improve the ADR or effective procedure time. Nevertheless, it resulted in lower bubble scale scores, and more importantly, in less intraprocedural use of SIM. This simple and inexpensive intervention may have the potential to reduce the risk of endoscope-transmitted infections. (Clinical trial registration number: NCT03119168.).

Preprocedural Administration of Simethicone and Otilonium Bromide Improves the Quality of Endoscopic Retrograde Cholangiopancreatography: A Prospective Randomized Trial.

PURPOSE: Endoscopic retrograde cholangiopancreaticography (ERCP) is performed for diagnostic and therapeutic purposes in patients with pancreaticobiliary diseases. We investigated the role of simethicone and concomitant otilonium bromide during ERCP. PATIENTS AND METHODS: This prospective randomized study included 120 patients who underwent ERCP (study and control group=60 patients each). The study group received otilonium bromide and simethicone. The control group received no medication. RESULTS: The quantity of duodenal foam and bubbles in the study group was significantly lesser than that in the control group. The duodenal motility score was 2.1±0.7 and 4.3±0.9 in the study and the control groups, respectively. Endoscopist satisfaction was good in 82%, moderate in 15%, and poor in 3% of ERCPs in the study group and good in 15%, moderate in 65%, and poor in 25% of ERCPs in the control group. The study group showed a shorter ERCP duration than the control group. CONCLUSIONS: Simethicone and otilonium bromide administered concomitantly reduce duodenal motility and foam/bubble formation, which facilitates papilla of Vater catheterization to reduce procedure time.

The effect of simethicone on postoperative ileus in patients undergoing colorectal surgery (SPOT), a randomized controlled trial.

BACKGROUND: Postoperative ileus is a poorly understood multifactorial outcome following colorectal surgery that presents significant clinical challenges and contributes to increased morbidity, length of stay, and healthcare cost. To date, there are few pharmacological interventions that shorten the duration of postoperative ileus. OBJECTIVE: This study is the first to evaluate the efficacy of simethicone in treating postoperative ileus symptoms in patients undergoing colorectal surgery. DESIGN: A multicenter, double-blinded, placebo controlled randomized controlled trial. SETTINGS: This trial was conducted at two academic tertiary care centres in Ontario, Canada. PARTICIPANTS: 118 patients undergoing colorectal surgery. INTERVENTIONS: Patients were randomized to receive either a five-day course of oral simethicone (n = 58) or a placebo (n = 60). MAIN OUTCOME MEASURES: The primary outcome was time to first passage of flatus. Secondary outcomes included time to first bowel movement, postoperative length of stay, and postoperative pain. Statistical analyses were performed on an intention-to-treat basis. Statistical significance set at p = 0.05. RESULTS: The median time to first passage of flatus in simethicone arm was 25.2 h and 26.7 h in controls (P = 0.98). There were no significant differences in the median time to first bowel movement (simethicone = 41.1 h vs. control = 42.9 h, P = 0.91) or median length of hospital stay (simethicone = 4.5 days vs. control = 4.0 days, P = 0.63). CONCLUSIONS: This study failed to show a difference in return of gastrointestinal motility in patients receiving simethicone following colorectal surgery. Postoperative ileus remains a significant clinical and economic burden to the healthcare system and further research is needed to identify a reliable and effective method of treatment.

Effect of premedication on lesion detection rate and visualization of the mucosa during upper gastrointestinal endoscopy: a multicenter large sample randomized controlled double-blind study.

BACKGROUND: Premedication in upper gastrointestinal endoscopy for higher lesions detection rate has not been well studied so far. This study aimed to confirm whether premedication could improve the detection rate of early cancer or precancerous lesions and mucosal visibility. METHOD: From July 2015 to December 2015, 7200 participants from 6 centers were screened by endoscopy with one of the 4 following premedications randomly: (1) water (group D); (2) pronase (group A); (3) simethicone (group B); (4) pronase and simethicone (group C). Early cancer and precancerous lesions detection rates were taken as the primary endpoints, and mucosal visibility was taken as the secondary endpoint. They were compared among four groups to determine different premedication effects in terms of different anatomical sites. Trial was registered at Chinese Clinical Trial Registry; the registration number is ChiCTR-IOR-17010985. RESULTS: The upper gastrointestinal overall precancerous lesion detection rates among four groups were 8.7, 8.4, 10.0, and 10.3%, the overall early cancer detection rates were 1.3, 1.4%, 1.5, and 1.6%, both without significant difference (p = 0.138 and 0.878). However, the visibility score distributions between control group (D) and premedication groups (A, B, and C) were all statistically significant, with all anatomical sites p values < 0.001. Subgroup analyses, from 2 centers without screening before, also showed significant difference in esophageal (3.9, 3.3, 4.5, and 8.4% with p = 0.004) and overall (7.0, 5.5, 7.3, and 12.0% with p = 0.004) precancerous lesion detection rate. CONCLUSIONS: Premedication with pronase and simethicone may not increase lesion detection rates but could significantly increase the upper gastrointestinal mucosal visibility.

To prep or not to prep - that is the question: A randomized trial on the use of antiflatulent medication as part of bowel preparation for patients having image guided external beam radiation therapy to the prostate.

INTRODUCTION: Radiation therapy is a standard treatment option for prostate cancer. With growing use of escalated doses and tighter margins, procedures to limit rectal size variation are needed to reduce prostate motion, increase treatment accuracy, and minimize rectal toxicity. This prospective study was done to determine whether the introduction of an antiflatulent medication would decrease rectal distention at computed tomography (CT) simulation and throughout a course of radiation therapy. METHODS AND MATERIALS: Patients undergoing a radical course of radiation therapy to the prostate/prostate bed were eligible to participate. Participants were randomly assigned to the intervention arm (antiflatulent medication) or the control arm (no medication). For each participant, the number of CT simulation rescans was recorded. Rectal diameters were measured on CT simulation and treatment cone beam CT scans. Acute rectal toxicities were assessed at baseline and weekly using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. A χ2 analysis was used to compare the number of participants requiring a rescan in each study arm. Change in rectal diameter over time was assessed using repeated measures analysis of variance. RESULTS: A total of 78 patients participated, with equal numbers assigned to each study arm. There was no significant difference between arms in the number of participants requiring a CT simulation rescan (P = .5551). There was no significant variation in rectal diameter between arms (P = .8999); however, there was a significant effect of time (P = .0017) and a significant interaction effect between study arm and time on rectal diameter (P = .0141). No acute rectal toxicities above grade 2 were reported. CONCLUSIONS: The addition of antiflatulent medication did not affect the frequency of CT simulation rescans. Both time and the interaction between study arm and time had a statistically significant effect on rectal diameter, although neither finding was clinically significant. Instead, standardized bowel preparation education developed for this study may have been sufficient to limit rectal size variation.

A real world evaluation of a treatment for infant colic based on the experience and perceptions of 4004 parents.

Infant colic (IC) is a common condition in young babies seen by primary care health professionals, especially health visitors. Nevertheless, the diagnostic criteria for IC are vague, which has resulted in a lack of clarity in published guidance on its causes and treatment. Credence has been given to alternative therapies, while health professionals are sceptical about the efficacy of over-the-counter treatments. Some 4004 parents of babies considered to have IC participated in this retrospective real world evidence study on the efficacy of a simeticone suspension in the treatment of IC. They were recruited via social media sources and were eligible for inclusion if their baby had received at least one dose of the simeticone suspension. Data were collected via an online questionnaire. The results showed that crying and discomfort-associated behaviour reduced and the babies' sleeping patterns improved following use of the suspension. More than two-thirds (69.7%) of respondents, who either used the suspension on its own or alongside another treatment, reported improvements in the signs of IC within one day. Almost all (93.2%) considered that its use was associated with either complete resolution of IC or had some effect on symptoms.

Effect of magnesium alginate plus simethicone on gastroesophageal reflux in infants.

OBJECTIVES: Gastroesophageal reflux (GER) is a frequently occurring condition in infants capable of causing distressing symptoms. The aim of our study is to evaluate the efficacy of Mg alginate plus simethicone (Gastrotuss Baby, DMG Italia SRL, Pomezia, Italy), compared with rice-starch-thickened formula or with reassurance alone, in the treatment of GER in infants. METHODS: The present randomized controlled trial was conducted in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised). The patients were randomized into 3 groups according to treatment (group A: Mg alginate plus simethicone; group B: thickened formula; group C: reassurance with lifestyle changes). Evaluation of symptom scores was performed after 1 month (T1) and 2 months (T2). RESULTS: A total of 64 (85.3%) of 75 enrolled infants (median age 5 months; range 1-10) concluded the study. After 1 month of treatment (T1), infants treated with Mg alginate plus simethicone showed a statistically significant improvement in symptoms compared with the thickened formula and reassurance (P < 0.03, <0.0001, respectively). At the end of the study, all 3 groups of patients showed a significant reduction in symptom scores (P < 0.002, <0.038, <0.03, respectively). Median symptom score values were more significantly reduced in group A than in group B and in group C (group A vs group B P < 0.002; group A vs group C P < 0.0001; group B vs group C P < 0.001). CONCLUSIONS: Mg alginate plus simethicone seems to be more efficacious on GER symptom scores than thickened formula and reassurance with lifestyle changes alone.

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.

Small bowel cleansing for capsule endoscopy in paediatric patients: a prospective randomized single-blind study.

BACKGROUND: Small bowel cleansing by capsule endoscopy has never been addressed in children. METHODS: Randomized controlled trial to evaluate the effect of five bowel preparation regimens on the mucosal visibility surface (as percentage of visualized surface area). Group A: a clear liquid diet for 12 h on the day before; Group B: high volume polyethylene glycol (50 mL/kg, up to 2Lt/die); Group C: low volume polyethylene glycol (25 mL/kg up to 1Lt/die); Group D: 20 mL (376 mg) of oral simethicone; Group E: 25 mL/kg (up to 1Lt/die) of polyethylene glycol solution plus 20 mL (376 mg) of oral simethicone. RESULTS: Overall, 198 patients (53% male, median age 13 years) were enrolled. Preparation regimen visualization scores were 14.1 ± 4.2, 18.9 ± 5.1, 17.8 ± 5.5, 14.9 ± 4.8 and 20.9 ± 4.6 in groups A, B, C, D and E, respectively (P < 0.01). Positive findings were found in 172 cases (87%), but no significant differences were observed in the diagnostic yield and tolerability. Interobserver agreement, k = 0.89 (95% CI 0.83 ± 0.71). CONCLUSION: This is the first report in children that supports the use of 25 mL/kg (up to 1Lt/die) of polyethylene glycol solution plus 20 mL (376 mg) of oral simethicone as the preparation of choice for capsule endoscopy.

On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study.

BACKGROUND: In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients' quality of life (QoL). A randomised, double-blind, placebo-controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief. AIM: As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on-demand ACS treatment vs. that of usual treatments. METHODS: Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on-demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6. RESULTS: A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p < 0.0008). The IBS-severity symptom score (IBS-SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS-SSS < 75 was more frequent in the ACS group (37.7% vs. 16.0%; p < 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on-demand ACS treatment, which was associated with both lower direct and indirect costs. CONCLUSIONS: After 6 months, on-demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments.

Influence of simethicone and alverine on stress-induced alterations of colonic permeability and sensitivity in rats: beneficial effect of their association.

OBJECTIVES: Alverine, an antispasmodic agent for the treatment of irritable bowel syndrome (IBS), may be combined with simethicone, a protective agent of the mucosa. Stress is a major factor triggering abdominal pain in IBS and causing hypersensitivity to colonic distension in animals through an increased colonic permeability. The antinociceptive effects of alverine and simethicone, separately or in association, were evaluated on stress-induced colonic hypersensitivity to distension in rats. The influence of simethicone on altered permeability was also tested. METHODS: Groups of 8-10 female adult Wistar rats (200-250 g) housed individually were used. Gut paracellular permeability was evaluated after 2 h of partial restraint stress using oral gavage with 5¹Cr-EDTA and 24 h of urine collection. The number of abdominal cramps during colonic distension was evaluated in animals equipped with electrodes on their abdominal striated muscles. KEY FINDINGS: At 200 mg/kg p.o. twice a day, but not at lower doses, simethicone reduced stress-induced increase of colonic permeability and hypersensitivity to distension. Administered alone at 10 mg/kg p.o., alverine also reduced stress-induced hypersensitivity to distension; lower doses were inactive. However, alverine administered at an inactive dose with simethicone suppressed stress-induced hypersensitivity to distension. CONCLUSIONS: We conclude that both simethicone and alverine have visceral antinociceptive effects by two different mechanisms and that simethicone exerts a potentiating effect on the antinociceptive action of alverine.

The effects of loperamide, or loperamide plus simethicone, on the distribution of gut water as assessed by MRI in a mannitol model of secretory diarrhoea.

BACKGROUND: Loperamide (LOP) is an anti-diarrhoeal agent which is thought to act largely by slowing transit with an uncertain effect on the fluid content of the small and large bowel in humans. Adding simethicone (SIM) to LOP improves its efficacy, but the mechanism of interaction is unclear. Novel MRI techniques to assess small bowel water content (SBWC) have shown that mannitol solutions markedly increase SBWC and can be used as a model of diarrhoea. AIM: We aimed to use quantitative MRI techniques to compare the actions in the gut of LOP and LOP + SIM in a model of secretory diarrhoea using mannitol. METHODS: A total of 18 healthy volunteers ingested capsules containing placebo (PLA) or 12 mg LOP or 12 mg LOP + 125 mg SIM. After 100 min they were given a drink containing 5% mannitol in 350 mL of water. They underwent baseline fasting and postprandial serial MRI scans at 45 min intervals for 4.5 h after ingesting the drink. A range of MRI sequences was acquired to image the gut. RESULTS: LOP and LOP + SIM significantly accelerated gastric emptying (P < 0.03) and reduced SBWC during the late phase (135-270 min after mannitol ingestion), P < 0.009, while delaying arrival of fluid in the ascending colon (AC). The relaxation time T2 of the contents of the AC was reduced by both drugs (P < 0.0001). CONCLUSIONS: LOP and LOP + SIM accelerate gastric emptying, but reduce small bowel water content which may contribute to the delay in oral-caecal transit and overall anti-diarrhoeal effect.

Infantile colic: a systematic review of medical and conventional therapies.

AIM: Infantile colic is a prevalent and distressing condition for which there is no proven standard therapy. The aim of this paper is to review medical and conventional treatments for infantile colic. METHODS: A systematic literature review was undertaken of studies on medical and conventional interventions for infantile colic from 1980 to March 2009. The results and methodological rigour of included studies were analysed using the CONSORT (Consolidated Standards Of Reporting Trials) 2001 statement checklist and Centre for Evidence Based Medicine critical appraisal tools. RESULTS: Nineteen studies and two literature reviews were included for review. Pharmacological studies on Simethicone gave conflicting results and with Dicyclomine hydrochloride and Cimetropium bromide results were favourable but side effects were noted along with issues in study methodology. Some nutritional studies reported favourable results for the use of hydrolysed formulas in bottle-fed infants or low-allergen maternal diets in breastfed infants but not for the use of additional fibre or lactase. There were several issues in regards to methodological rigour. Behavioural studies on the use of increased stimulation gave unfavourable results, whereas results from the use of decreased stimulation and contingent music were favourable. These studies demonstrated poor methodological rigour. CONCLUSION: There is some scientific evidence to support the use of a casein hydrolysate formula in formula-fed infants or a low-allergen maternal diet in breastfed infants with infantile colic. However, there is little scientific evidence to support the use of Simethicone, Dicyclomine hydrochloride, Cimetropium bromide, lactase, additional fibre or behavioural interventions. Further research of good methodological quality on low-allergenic formulas and maternal diets is indicated.

Probiotics for the treatment of systemic sclerosis-associated gastrointestinal bloating/ distention.

OBJECTIVES: Treatment for gastrointestinal tract (GIT) disease in systemic sclerosis (SSc) is challenging as no immunosuppressive or anti-fibrotic therapy is available with clearly proven efficacy. Probiotics are viable, non-pathogenic microorganisms that are hypothesized to improve the composition of the intestinal microbiota from a potentially harmful composition to a composition that is beneficial to the host. Our hypothesis is that GIT symptoms in SSc patients with moderate bloating would improve with probiotic implementation. METHODS: Ten patients with a moderate-to-severe distention/bloating score (1.25-3.00) on the University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0), but otherwise stable organ disease not requiring any medication adjustment were recruited from the University of Utah Scleroderma Center. We compared the GIT 2.0 scores at baseline and after 2 months of use of Align (bifidobacterium infantis; 109 CFU per capsule) or Culturelle (lactobacillus GG; 109 CFU per capsule) using paired t-test and calculated effect size (ES). RESULTS: Significant improvement in total GIT 2.0 score (ES = 0.82), reflux (ES = 0.33), bloating/distention (ES = 1.76), and emotional scales (ES = 0.18) were reported after two months of daily probiotic use. CONCLUSIONS: This pilot study suggests probiotics significantly improve the reflux, distention/ bloating, and total GIT scales in SSc patients. As hypothesized, the largest effect was seen in distention/bloating scale. Probiotics may be useful for treatment of SSc-associated distention/ bloating.

Efficacy of a simethicone, activated charcoal and magnesium oxide combination (Carbosymag®) in functional dyspepsia: results of a general practice-based randomized trial.

BACKGROUND: A simethicone, activated charcoal and magnesium oxide combination (Carbosymag(®)) has been used for almost 20 years in functional dyspepsia, but there is limited scientific evidence of efficacy. AIM: We evaluated the efficacy of Carbosymag(®) in 18- to 49-year-old patients with functional dyspepsia. METHODS: A total of 276 dyspeptic patients consulting a general practitioner and meeting the Rome III criteria were included in this prospective placebo-controlled study. Variations in overall and individual dyspeptic symptoms were evaluated after 1 month of treatment. RESULTS: At the end of the treatment period, overall dyspeptic symptom intensity was significantly lower in the Carbosymag(®) group (P=0.01). The intensity of post-prandial fullness, epigastric pain, epigastric burning and abdominal bloating was significantly reduced in the Carbosymag(®) group relative to the placebo group (P<0.05). The number need to treat to induce a 70-% decrease in overall dyspeptic symptoms by Carbosymag(®) was 7 (IC 95%: 4-32). CONCLUSION: A simethicone, activated charcoal and magnesium oxide combination (Carbosymag(®)) was significantly more effective than a placebo on overall symptom intensity in dyspeptic patients consulting a general practitioner.

Small bowel preparations for capsule endoscopy with mannitol and simethicone: a prospective, randomized, clinical trial.

BACKGROUND AND OBJECTIVE: There is no consensus concerning small bowel preparation before capsule endoscopy (CE). This study evaluated the effects of 4 regimens on small bowel cleansing and diagnostic yield. METHODS: Patients were randomly divided into 4 groups. Group A consumed a clear liquid diet after lunch on the day before CE, followed by overnight fasting. Group B took 250 mL 20% mannitol and 1 L 0.9% saline orally at 05:00 hours on the day of the procedure. In group C, the same regimen was taken at 20:00 hours on the day before and at 05:00 hours on the day of CE. In group D, in addition to the group C regimen, 20 mL oral simethicone was taken 30 minutes before CE. RESULTS: Two hundred patients were prospectively enrolled, and 7 were excluded from the final analysis because of incomplete small bowel transit. No significant difference was noted among the 4 groups for small bowel transit time. Bowel preparation in group D was significantly better than for the other regimens for overall cleansing of the proximal small bowel, and showed improved overall cleansing of the distal small bowel when compared with 10-hours overnight fasting. Pathological lesions of the proximal and distal small bowel were, respectively, achieved in 82 and 74 patients, mostly distributed in group D. CONCLUSIONS: Small bowel preparation that involves split-dose oral mannitol plus single-dose simethicone for CE can improve mucosal visualization and subsequent diagnostic yield when compared with 10-hours overnight fasting.