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

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

Effectiveness of oolong tea and simethicone solution for lens cleansing during colonoscopy: A double-blinded randomized study.

BACKGROUND AND AIMS: water is an imperfect agent for lens cleansing during endoscopy due to its incompetence to clean hydrophobic dirt, whereas amphiphilic surfactants have the potential to overcome the limitation of water. The trial was aimed to evaluate the cleansing effectiveness of 2 typical surfactants (simethicone solution and oolong tea) for colonoscopic lens. METHODS: Oolong tea (O-), low concentration simethicone solution (S1-), high concentration simethicone solution (S2-) and distilled water (D-) were used as washing solutions for colonoscopic lens. Study I: The tip of the colonoscope was immersed in lard oil in order to simulate the blur, and photographs were taken toward a standard colonoscopy image in-vitro pre- and post- each cleansing procedure. The blurred areas of each image were quantified and compared. Study II: 395 consecutive patients who were due to colonoscopy examination were enrolled and randomized into O-, S2-, D-group. The volume of washing solution used and cleansing level during the examination procedure, adenoma and polyp detected per colonoscopy, insertion time and withdraw time were analyzed. RESULTS: Study I: There were no differences in 4 groups for the blurred areas on images before lens cleansing. The blurred areas after lens cleansing were significantly smaller in 3 groups (O- 8.47 ±â€Š20.91 vs S1- 13.06 ±â€Š10.71 vs S2- 6.76 ±â€Š8.49 vs D- 38.24 ±â€Š29.69, P < .05) than water. The decline range of blurred areas after lens cleansing in oolong tea, low concentration simethicone solution, high concentration simethicone solution groups were significantly higher than that in distilled water group (O- 87.35 ±â€Š20.81 vs S1- 78.12 ±â€Š19.24 vs S2- 89.57 ±â€Š8.50 vs D- 53.39 ±â€Š28.45, P < .05). Study II: The volume of washing solution used in S2-group was significantly smaller than that in O-group and D-group. The cleansing level of the colonoscopic lens of O-group was significantly superior than that of S2-group and D-group. CONCLUSIONS: The in-vitro test showed oolong tea and simethicone solution can effectively cleans the colonoscopic lens. The clinical trial demonstrated that oolong tea instead of water is effective to provide better visualization during colonoscopy.Registration: Chictr.org.cn No: ChiCTR1900025606.

Simethicone decreases bloating and improves bowel preparation effectiveness: a systematic review and meta-analysis.

BACKGROUND: Simethicone is an adjunct frequently used during bowel preparation before colonoscopy and currently there is no consensus on whether it should be recommended in standard bowel preparation. We performed a systematic review and meta-analysis to determine the effect simethicone has on bowel cleanliness, adenoma detection rate (ADR), and tolerability. METHODS: We searched the literature for studies that compared colon cleansing of patients that received standard bowel preparation alone and in combination with simethicone prior to colonoscopy. The primary outcomes were colon cleanliness, ADR, and tolerability. RESULTS: Sixteen randomized controlled trials with 5630 patients were included in meta-analysis. Overall, polyethylene glycol (PEG) with simethicone improves colon cleansing compared with PEG alone (odds ratio [OR] 1.48, CI 1.11 to 1.97, P = 0.008). This improvement was seen for single dosing (OR 1.83, CI 1.20 to 2.79, P = 0.005) but not for split dosing (OR 1.32, CI 0.72 to 2.43, P = 0.38). Overall, simethicone had no effect on ADR (OR 1.22, CI 0.81 to 1.83, P = 0.33), but in patients receiving single dosing, simethicone significantly increased ADR (OR 1.96, CI 1.22 to 3.16, P = 0.005). The rates of nausea (OR 0.96, CI 0.75 to 1.24, P = 0.75), vomiting (OR 1.00, CI 0.69 to 1.44, P = 0.99), and abdominal pain (OR 0.69, CI 0.40 to 1.18, P = 0.17) were not significantly different between PEG and PEG + simethicone cohorts. For abdominal bloating, the PEG cohort had greater odds of experiencing bloating than the PEG + simethicone cohort (OR 2.33, CI 1.70 to 3.20, P < 0.00001). CONCLUSIONS: Simethicone improves colon cleanliness and ADR; however, this improvement is not seen in patients receiving split-dose PEG. Furthermore, simethicone decreases abdominal bloating but has no effect on nausea, vomiting, and abdominal pain. Simethicone may be a useful bowel preparation adjunct in patients unable to receive split-dose PEG.

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.

Low-volume plus ascorbic acid vs high-volume plus simethicone bowel preparation before colonoscopy.

AIM: To investigate the effectiveness of low-volume plus ascorbic acid [polyethylene glycol plus ascorbic acid (PEG + Asc)] and high-volume plus simethicone [polyethylene glycol plus simethicone (PEG + Sim)] bowel preparations. METHODS: A total of one hundred and forty-four outpatients (76 males), aged from 20 to 84 years (median age 59.5 years), who attended our Department, were divided into two groups, age and sex matched, and underwent colonoscopy. Two questionnaires, one for patients reporting acceptability and the other for endoscopists evaluating bowel cleansing effectiveness according to validated scales, were completed. Indications, timing of examination and endoscopical findings were recorded. Biopsy forceps were used as a measuring tool in order to determine polyp endoscopic size estimation. Difficulty in completing the preparation was rated in a 5-point Likert scale (1 = easy to 5 = unable). Adverse experiences (fullness, cramps, nausea, vomiting, abdominal pain, headache and insomnia), number of evacuations and types of activities performed during preparation (walking or resting in bed) were also investigated. RESULTS: Seventy-two patients were selected for each group. The two groups were age and sex matched as well as being comparable in terms of medical history and drug therapies taken. Fourteen patients dropped out from the trial because they did not complete the preparation procedure. Ratings of global bowel cleansing examinations were considered to be adequate in 91% of PEG + Asc and 88% of PEG + Sim patients. Residual Stool Score indicated similar levels of amount and consistency of residual stool; there was a significant difference in the percentage of bowel wall visualization in favour of PEG + Sim patients. In the PEG + Sim group, 12 adenomas ≤ 10 mm diameter (5/left colon + 7/right colon) vs 9 (8/left colon + 1/right colon) in the PEG + Asc group were diagnosed. Visualization of small lesions seems to be one of the primary advantages of the PEG + Sim preparation. CONCLUSION: PEG + Asc is a good alternative solution as a bowel preparation but more improvements are necessary in order to achieve the target of a perfect preparation.

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.

Nonsurgical management of partial adhesive small-bowel obstruction with oral therapy: a randomized controlled trial.

BACKGROUND: Patients with partial adhesive small-bowel obstruction are usually managed conservatively, receiving intravenous hydration and nothing by mouth. Previous studies have suggested that this approach is associated with longer hospital stays and an increased risk of delayed surgery. We conducted a randomized controlled trial to see if combining standard conservative treatment with oral administration of a laxative, a digestant and a defoaming agent would reduce the frequency of subsequent surgical intervention and reduce the length of hospital stay. METHODS: We identified 144 consecutive patients admitted between February 2000 and July 2001 with adhesive partial small-bowel obstruction and randomly assigned 128 who met the inclusion criteria to either the control group (intravenous hydration, nasogastric-tube decompression and nothing by mouth) or the intervention group (intravenous hydration, nasogastric-tube decompression and oral therapy with magnesium oxide, Lactobacillus acidophilus and simethicone). The primary outcome measures were the number of patients whose obstruction was successfully treated without surgery and the length of hospital stay. We also monitored rates of complications and recurring obstructions. RESULTS: Of the 128 patients, 63 were in the control group and 65 in the intervention group; the mean ages were 54.4 (standard deviation [SD] 15.9) years and 53.9 (SD 16.3) years respectively. Most of the patients were male. More patients in the intervention group than in the control group had successful treatment without surgery (59 [91%] v. 48 [76%], p = 0.03; relative risk 1.19, 95% confidence interval 1.03-1.40). The mean hospital stay was significantly longer among patients in the control group than among those in the intervention group (4.2 [SD 2.7] v. 1.0 [SD 0.7] days, p < 0.001). The complication and recurrence rates did not differ significantly between the 2 groups. INTERPRETATION: Oral therapy with magnesium oxide, L. acidophilus and simethicone was effective in hastening the resolution of conservatively treated partial adhesive small-bowel obstruction and shortening the hospital stay.

Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study.

BACKGROUND: Capsule endoscopy is a new imaging method for visualization of the entire small bowel. However, no standardized protocol for bowel preparation for capsule endoscopy has been evaluated. METHODS: Capsule endoscopy was performed in 36 consecutive patients, all of whom fasted for 12 hours before ingestion of the capsule. Before capsule endoscopy, 18 patients received 80 mg simethicone and 18 had no supplemental medication for bowel preparation. Two observers, both experienced endoscopists, independently reviewed the examinations in a single-blinded and randomly assigned fashion. Mucosal visibility and intraluminal gas bubbles were assessed and graded by both observers. RESULTS: Bowel preparation with simethicone resulted in significantly better visibility because of fewer intraluminal bubbles (p<0.01). Interobserver agreement was excellent (r>/=0.8; k 0.78: 95% CI[0.57, 0.98] ). No adverse effect of simethicone was observed. CONCLUSIONS: Simethicone may be added to the routine preparation for capsule endoscopy to improve the visibility of small bowel mucosa.

The radiological management of oesophageal food bolus obstruction using a gas-forming agent and barium.

Removal of an impacted food bolus in the lower oesophagus at rigid oesophagoscopy is challenging and carries a significant risk of perforation. We present two cases which were successfully disimpacted radiologically, in order to raise awareness among otolaryngologists of this therapeutic option.

Injectable percutaneous polydimethicone in the treatment of pedal keratomas: a single blind randomized trial.

Thirty-one subjects who presented with plantar (metatarsal lesions only 21 out of 31 patients completed the study) completed a single blind injection of 350-centistroke polydimethicone or saline over a 6 to 9-month period. The injectable silicone conformed to European Economic Community standards and was accepted by the Medical Devices Agency (UK). The subjects were equally divided between male and female. Two randomly divided groups received silicone (n = 16) and sterile saline (n = 15). Total volumes used were not identical between the groups of subjects (p = .05), although the maximum volume was no greater than 1.5 ml in any subject. The effectiveness of the injection was reviewed using a Harris-Beath ink mat, visual analogue scale, alteration in frequency of treatment, and subjective analysis of reduction in lesions before and after by color photography. Essential histopathology was undertaken on 11 subjects. Granulomatous reactions were only positively identified in one case. Nine matched pairs showed no statistically significant difference between the two treatments (p = .082) using parametric and nonparametric tests. This study found no evidence to show that small quantities of medically prepared liquid silicone caused adverse reactions, although two cases were more sensitive after injection of silicone.

Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial.

CONTEXT: Acute diarrhea with gas-related abdominal discomfort is a common, usually self-limited disorder with substantial social and economic impact. OBJECTIVE: To compare the efficacy and safety of a loperamide hydrochloride-simethicone combination product with those of loperamide alone, simethicone alone, and placebo in treating acute diarrhea with gas-related abdominal discomfort. DESIGN: Randomized, placebo-controlled, double-blind trial of 48 hours' duration. SETTING: A primary care, ambulatory practice in Acapulco, Mexico. PATIENTS: A total of 493 outpatient adults aged 18 to 63 years, with acute nonspecific diarrhea with at least moderately severe abdominal discomfort. INTERVENTIONS: Each patient was randomly assigned to receive 2 chewable tablets containing loperamide hydrochloride, 2 mg, and simethicone, 125 mg (n = 124); loperamide hydrochloride, 2 mg (n = 123); simethicone, 125 mg (n = 123); or placebo (n = 123). This was followed by 1 tablet after each unformed stool, up to 4 tablets in any 24-hour period. MAIN OUTCOME MEASURES: Time to last unformed stool and time to complete relief of gas-related abdominal discomfort were the protocol-specified primary outcomes. Secondary outcomes included time to complete relief of diarrhea, number of unformed stools, and patient-assessed variables at the end of the study (overall illness relief, diarrhea relief, and abdominal discomfort relief). RESULTS: Patients who received loperamide-simethicone had significantly (P < .001) shorter time to last unformed stool and faster relief of gas-related abdominal discomfort than patients who received loperamide, simethicone, or placebo alone. Loperamide-simethicone was significantly (P < or = .01) more effective than the other 3 treatments for all end-of-study patient-assessed outcomes and all clinically important secondary outcomes. No significant differences in adverse events were found among treatment groups. CONCLUSIONS: The loperamide-simethicone combination chewable product provides faster and more complete relief of acute nonspecific diarrhea and associated gas-related abdominal discomfort (gas pain, cramps, gas pressure, and bloating) than either of its components or placebo. The combination is well tolerated.

[Prevention from secondary nerve root adhesion: an experimental study].

In the study, 27 dogs were divided into three groups: A, B and C. Then all of the dogs had their lumbar intervertebral disks removed. Into the wounded cavity of group A, 1 ml of dimethicone was dropped and gelatin sponge was applied on the surface of the nerve root of group B. Group C was served as the control. The dogs were killed and the operation area was removed respectively 2 weeks, 4 weeks, and 12 weeks after the operation for macroscopical observation, nerve root motility measurement and histological examination. The result of the experiment proved that dimethicone was fairly effective in the prevention from secondary nerve root adhesion. While gelatin sponge in the process of its absorption induced the formation of quite a few scar tissues, thus aggrevating nerve root adhesion.