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PubMedDate not supplied

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.

Abdominal Pain↗
PubMed1998

Effect of simethicone on the accuracy of the rapid urease test.

OBJECTIVE: Simethicone, which is a principal ingredient in the defoaming agent used during gastroscopy, can inhibit the growth of Helicobacter pylori (MIC, 64-128 mg/l). This prospective study was designed to evaluate the in vivo and in vitro effects of simethicone on the accuracy of the rapid urease test (RUT). METHODS: In the in vivo study, three sets of gastric biopsies (two from the antrum, and one from the corpus) were taken from 75 patients. The first set was examined histologically, and the second set was used for the RUT (pre-simethicone RUT). Then, 25 ml simethicone (1200 mg/l) was introduced into the stomach for a contact time of 1 min. A third set of gastric biopsies was taken for the RUT (post-simethicone RUT). In the in vitro clinical study, 41 patients were recruited. The first set of gastric biopsies was used for the RUT (pre-incubation RUT). The second set was incubated in 1 ml of simethicone for 5 min before being used for the RUT (post-incubation RUT). In the spectrophotometric study, urease activity before and after incubation in simethicone for 5 min was quantified in 12 patients by measuring the absorbance at 560 nm. RESULTS: Reading at 15 min, the concordance rate between the pre-simethicone and post-simethicone RUT was 98%. In the in vitro clinical study, the concordance rate between the pre-incubation and post-incubation RUT was 97%. The spectophotometric study showed a significant reduction of 43% in urease activity after incubation in simethicone. CONCLUSION: The application of a defoaming agent containing simethicone does not affect the accuracy of the RUT. However, simethicone modestly suppresses urea hydrolysis.

Diagnostic Techniques, Digestive System↗
PubMed2002

A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia.

AIM: To compare the efficacy of simethicone with placebo and the prokinetic cisapride in patients with functional dyspepsia. METHODS: One hundred and eighty-five patients with functional dyspepsia were randomized and treated in a double-dummy technique with simethicone (105 mg t.d.s.), cisapride (10 mg t.d.s.) or placebo (t.d.s.). The primary outcome measure was the O'Brien global measure of the patients' rating of 10 upper gastrointestinal symptoms (graded as absent = 0, moderate = 1, severe = 2 or very severe = 3). Outcome measures were assessed at baseline and after 2, 4 and 8 weeks of treatment (intention-to-treat). RESULTS: At 2, 4 and 8 weeks, treatment with simethicone and cisapride yielded significantly (all P values < 0.0001) better improvement of symptoms compared to placebo. Simethicone was significantly better than cisapride after 2 weeks (P = 0.0007), but the differences were not statistically significant after 4 and 8 weeks. Patients treated with simethicone judged the efficacy of their treatment as very good in 46% of cases, compared to 15% and 16% receiving cisapride and placebo, respectively. CONCLUSIONS: Simethicone and cisapride were significantly better than placebo for symptom control in patients with functional dyspepsia after 2, 4 and 8 weeks of treatment. Simethicone was also superior to the prokinetic cisapride in the first 2 weeks of treatment.

Adult↗
PubMed1989

The effect of simethicone on colonic visibility after night-prior colonic lavage. A double-blind randomized study.

We prospectively studied 26 patients receiving simethicone (n = 14) or placebo (n = 12) in Colyte (Edlaw Preparations. Inc., Farmingdale, NY, U.S.A.) to determine if the addition of simethicone could improve visibility when administered the night before colonoscopy. Two parameters of visibility were assessed: amount of bubbles and degree of haziness. The effectiveness of a night-prior administration of Colyte to clean the colon of feculent debris was also examined. Patients receiving simethicone had significantly less bubbles (p less than 0.02), but haziness was not improved (p = 0.9). The presence of feculent debris that interfered with the colonoscopic examination was similar in both groups: simethicone 5 of 14 or 35% and placebo 7 of 12 or 58%. Eighty percent (four of five) of patients with feculent debris in the rectosigmoid colon had diverticulosis, and 50% (four of eight) patients with diverticulosis had feculent debris in the rectosigmoid. These data indicate that (a) the combination of simethicone plus Colyte administered the night before colonoscopy improves visibility by diminishing bubbles; (b) this dosage of simethicone is not effective in diminishing haziness when administered the night before colonoscopy; and (c) patients with diverticulosis are likely to have feculent debris in the rectosigmoid colon, and a precolonoscopy enema may be helpful when the diagnosis is known.

Colon↗
PubMed1991

Effect of simethicone on lactulose-induced H2 production and gastrointestinal symptoms.

The results of studies of the effect of simethicone on abdominal gas-related symptoms have been contradictory. In a randomized, double-blind cross-over study, 10 healthy volunteers were given 30 g lactulose and 600 mg simethicone or placebo. End-expiratory breath samples were collected and analyzed for H2 and gastrointestinal symptoms registered. There were no differences in biochemical parameters or symptom score between simethicone and placebo. In contrast to previous studies, we used a sufficiently large dose of lactulose to produce gastrointestinal symptoms, a higher dose of simethicone and placebo tablets containing the same additives as the simethicone tablets. There was no demonstrable effect of simethicone on symptoms or intestinal gas production caused by carbohydrate malabsorption.

Adult↗
PubMed1985

Effect of a simethicone-containing tablet on colonic gas elimination in breath.

The effect of a tablet containing the antiflatulent, simethicone, on intestinal hydrogen (H2) elimination in breath was studied. In three trials, normal subjects (age 12-52 years) received, on subsequent days, lactulose or lactulose with two tablets of either simethicone or placebo in randomized order. Breath samples were collected over 210 min and analyzed by gas chromatography for H2. The time course of H2 expiration above baseline levels was calculated and compared for the three tests. No significant differences in transit time were found. Cumulative H2 expiration was significantly lower after simethicone compared to placebo. H2 production from stool incubated with simethicone or placebo indicated that the drug had no effect in reducing the fermentative production of H2 in vitro. Interestingly, the vehicle present in the tablets could be fermented by intestinal bacteria. Simethicone reduced the amount of H2 eliminated in breath, but this effect was offset partially by H2 production from the fermentation of unabsorbable substances used in the formulation of the tablets.

Adolescent↗
PubMed1998

Evaluation of simethicone for the treatment of postoperative abdominal discomfort in infants.

STUDY OBJECTIVE: To determine whether abdominal discomfort is a cause for distress symptoms in infants following administration of inhalational anesthesia, and to evaluate the effectiveness of simethicone in treating this discomfort. DESIGN: Randomized, double-blinded study. SETTING: Large tertiary care, university-based medical center. PATIENTS: 175 ASA physical status I and II infants under 28 months of age who underwent an inhalational anesthetic for a variety of procedures that were expected to cause relatively little pain. INTERVENTIONS: Children were assessed for the presence of postoperative abdominal discomfort, and, if evident, were randomly given either simethicone or placebo in a double-blinded fashion. MEASUREMENTS AND MAIN RESULTS: Abdominal discomfort was measured using the Faces Legs Activity Cry and Consolability (FLACC) Behavioral Pain Scale. Scores were recorded pre-drug; at 10, 20, and 30 minutes following drug administration; and at discharge. If discomfort had not resolved within 15 minutes after the drug was given, routine analgesics or other medications were administered. Abdominal girth was measured preoperatively, on admission into the postanesthesia care unit (PACU), and at discharge. 21% of infants exhibited symptoms of abdominal discomfort postoperatively. Younger infants were at greater risk for this condition. 36 infants were given either placebo or simethicone, and of these, infants who received simethicone were comfortable earlier and required fewer rescue medications compared with placebo. There were no differences in ability to tolerate oral fluids prior to discharge or in the length of stay in the PACU. CONCLUSIONS: Simethicone is a safe and inexpensive medication that may provide anesthesiologists with an effective treatment choice for suspected postoperative abdominal discomfort in infants.

Abdominal Pain↗
PubMed1999

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.

Cisapride↗
PubMed2007

Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study.

OBJECTIVE: The goal was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized study would improve symptoms of infantile colic. METHODS: Ninety breastfed colicky infants were assigned randomly to receive either the probiotic L. reuteri (10(8) live bacteria per day) or simethicone (60 mg/day) each day for 28 days. The mothers avoided cow's milk in their diet. Parents monitored daily crying times and adverse effects by using a questionnaire. RESULTS: Eighty-three infants completed the trial: 41 in the probiotic group and 42 in the simethicone group. The infants were similar regarding gestational age, birth weight, gender, and crying time at baseline. Daily median crying times in the probiotic and simethicone groups were 159 minutes/day and 177 minutes/day, respectively, on the seventh day and 51 minutes/day and 145 minutes/day on the 28th day. On day 28, 39 patients (95%) were responders in the probiotic group and 3 patients (7%) were responders in the simethicone group. No adverse effects were reported. CONCLUSIONS: In our cohort, L. reuteri improved colicky symptoms in breastfed infants within 1 week of treatment, compared with simethicone, which suggests that probiotics may have a role in the treatment of infantile colic.

Antifoaming Agents↗
PubMed1994

Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial.

OBJECTIVE: To determine the efficacy of simethicone in the treatment of infant colic. DESIGN: Randomized, double blind, placebo-controlled. SETTING: Three general pediatric practices in distinct geographic regions. PATIENTS: Eighty-three infants between 2 and 8 weeks of age with infant colic. INTERVENTIONS: Treatment with simethicone and placebo in double blind crossover fashion. RESULTS: A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group. CONCLUSION: Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.

Colic↗
PubMed1988

Improvement of oral colonic lavage with supplemental simethicone.

We have noted that colons of patients prepared for colonoscopy with Golytely, a nonabsorbable electrolyte lavage solution, frequently contain foam which may obscure small mucosal lesions. Therefore, a randomized, blinded controlled trial was performed to determine the prevalence of Golytely-induced foam and the effect of supplemental simethicone in decreasing the prevalence of foam. Foam was present in 32% of colons prepared with Golytely alone but in none of the colons prepared with Golytely supplemented with simethicone. In addition, only 5% of colons prepared with supplemental simethicone had residual stool noted at the time of colonoscopy, a significant improvement over the 39% prevalence of residual stool in colons prepared with Golytely alone. Addition of simethicone to Golytely lavage decreases the prevalence of colonic foam and residual stool.

Administration, Oral↗
PubMed2004

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.

Adolescent↗
PubMedDate not supplied

The effectiveness of simethicone in improving visibility during colonoscopy: a double-blind randomized study.

The effect of simethicone in improving visibility during colonoscopy was randomly studied in 97 patients receiving either simethicone (N = 49) or placebo (N = 48) in a colon lavage solution. Visibility was assessed by the amount of bubbles and the degree of haziness noted during colonoscopy. The degree of bubbles was scored on a scale of 0 to 3, and haziness was scored on a scale of 0 to 2. Patients receiving simethicone had significantly less bubbles (p less than 0.001) and less haziness (p less than 0.01) in the colon when compared to placebo-treated patients. These data indicate that the addition of simethicone to the colonic lavage solution results in improved colonic visibility and may result in technically easier and more accurate colonoscopy.

Clinical Trials as Topic↗
PubMed1995

The effectiveness of simethicone in improving visibility during colonoscopy when given with a sodium phosphate solution: a double-bind randomized study.

BACKGROUND: Oral sodium phosphate solution is better tolerated than polyethylene glycol when used for colonoscopy preparation, but visibility of the lumen can be impaired because of the presence of bubbles. METHODS: We studied 86 patients receiving either simethicone (n = 42) or placebo (n = 44) in addition to oral sodium phosphate to determine if simethicone improved visibility during colonoscopy. Colonoscopy was performed by a single blinded investigator. Five areas of the colon (rectosigmoid, descending, transverse, ascending, and cecum) were assessed for the presence of bubbles on withdrawal of the endoscope. Bubbles were scored as follows: 0, minimal or none; 1, covering half the lumen; 2, covering the entire circumference; 3 filling the entire lumen. RESULTS: Thirteen patients in the placebo group and only one in the simethicone had significant bubbles ( > or = 1). Additionally, the mean bubble scores were greater in the placebo group in each region of the colon (p < or = 0.05 in rectosigmoid and ascending colon). CONCLUSIONS: This study indicates that taking simethicone with an oral sodium phosphate preparation can improve colonic visibility by diminishing the presence of bubbles. Better visualization could improve detection of mucosal pathologic lesions.

Administration, Oral↗
PubMed1992

Randomized placebo-controlled trial of oral liquid simethicone prior to upper gastrointestinal endoscopy.

It has been suggested that pre-procedural oral simethicone improves visibility in upper GI tract endoscopy. We examined three-hundred-thirty patients referred for upper endoscopy who were randomized and were required to swallow a placebo solution or one of three liquid simethicone solutions 15 min prior to the examination. These solutions contained 65 mg, 65 mg and 195 mg of drug dissolved in 90 ml, 30 ml and 90 ml of water, respectively. Patients treated with both dosages of simethicone revealed significantly less foam and bubbles in both the stomach and the duodenum compared to placebo. Only the 90 ml volume adequately cleared both locations. The reduction of examination time could be found both in patients with an intact stomach and in patients with or without gastric bile reflux, but was most striking in patients with previous gastric resection (examination time being reduced by almost 50% and the need of adjunctive lavage being reduced about 20 fold compared to placebo). In conclusion, pre-procedural oral simethicone should be routinely considered in patients with previous gastric resection. The utility of the drug is less evident in patients with normal gastric anatomy.

Double-Blind Method↗
PubMed1993

Efficacy and tolerability of polyethylene glycol-electrolyte lavage solution with and without simethicone in the preparation of patients with inflammatory bowel disease for colonoscopy.

This placebo-controlled study assessed the efficacy and tolerability of polyethylene glycol-electrolyte lavage solution (PEG-ELS), with and without simethicone, in the preparation of patients with inflammatory bowel disease for colonoscopy. PEG-ELS 4 L plus placebo, or PEG-ELS 4 L plus simethicone 120 mg. was administered according to a randomized double-blind protocol to 115 patients with ulcerative colitis or Crohn's disease. The parameters assessed were: presence of bubbles, degree of haziness, degree of bowel cleansing and patient acceptance. In the 105 patients completing the study, the efficacy of colonic lavage was found to be essentially comparable for the two preparations, although the addition of simethicone showed a significant reduction in the formation of bubbles. Significantly better results were reported by patients treated with the drug combination regarding reduction of general malaise (P = 0.01) and sleep disturbance (P = 0.01). The PEG-ELS solution represents an effective bowel cleansing method which can also be used for patients suffering from inflammatory bowel disease. The addition of simethicone to the traditional formulation is an acceptable development in terms of clinical efficacy and tolerability.

Adult↗
PubMed1979

The value of simethicone in abdominal preparation.

The effectiveness of simethicone in reducing the amount of gastrointestinal gas was investigated with abdominal radiographs in a double-blind study of 169 patients receiving either simethicone or a placebo randomly. There was no statistically significant difference between the two groups. Although simethicone may relieve clinical symptoms and accelerate the transit time of gas, it does not reduce the amount of gas in the gastrointestinal tract. This study indicates that simethicone is not helpful in preparing the patient for radiological examination of the abdomen.

Adolescent↗
PubMed2000

Improved US visualization of the pancreatic tail with simethicone, water, and patient rotation.

PURPOSE: To evaluate the effect of degassed water, simethicone, and patient rotation on ultrasonographic (US) visualization of the pancreatic tail. MATERIALS AND METHODS: Seventy patients in whom visualization of the pancreatic tail was poor at US were reevaluated in the upright position after ingesting 2 cups (500 mL) of water with 80 mg of simethicone followed by rotating three times on the examination table. In a few patients, the right posterior oblique position was used. Pancreatic tail visualization and disbursement of gastric gas were evaluated. Seventy patients who received 500 mL of distilled water only served as control subjects. RESULTS: Pancreatic tail visualization in patients versus control subjects was complete in 55 (79%) versus five (7%) of 70 patients and control subjects, partial in 10 (14%) versus 38 (54%), and not improved in five (7%) versus 27 (39%). The effect on diminishing gastric air was closely correlated with the degree of improved visualization in most patients. All patients tolerated the procedure well, with no side effects. The technique added a mean of 8 versus 5 minutes to the examination in patients versus control subjects. The full acoustic window effect of the simethicone-water mixture lasted approximately 10 minutes. CONCLUSION: The simethicone-water-rotation technique is simple, safe, inexpensive, and effective for improving pancreatic tail visualization in ambulatory patients and is superior to the use of water alone.

Adolescent↗