simethicone and Abdominal-Pain

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).. 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.. 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.. 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.. 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.

Topics: Abdominal Pain; Adult; Double-Blind Method; Female; Humans; Irritable Bowel Syndrome; Male; Morpholines; Quality of Life; Simethicone; Treatment Outcome

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.. 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.. 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.. 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.. 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.

Topics: Abdominal Pain; Antifoaming Agents; Double-Blind Method; Drug Combinations; Female; Humans; Irritable Bowel Syndrome; Male; Middle Aged; Propylamines; Quality of Life; Serotonin Receptor Agonists; Simethicone; Treatment Outcome

Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects 15-20% of the Western population.. 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.. 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).. 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.. 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).. 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.

Topics: Abdominal Pain; Adult; Aged; Antifoaming Agents; Bacillus; Combined Modality Therapy; Double-Blind Method; Female; Humans; Intestines; Irritable Bowel Syndrome; Male; Middle Aged; Probiotics; Rome; Simethicone; Time Factors; Treatment Outcome; Young Adult

Alverine citrate and simeticone combination has been used for almost 20 years in irritable bowel syndrome (IBS), but supportive scientific evidence of efficacy was limited.. To evaluate the efficacy of alverine citrate and simeticone combination in patients with IBS-related abdominal pain/discomfort.. A total of 412 IBS patients meeting ROME III criteria were included in this double-blind randomized placebo-controlled study if their abdominal pain/discomfort intensity was at least 60 mm on a 0-100 mm visual analogue scale (VAS) during a 2-week run-in treatment-free period. Patients were randomly assigned through the use of Interactive Voice Response System to receive either alverine citrate 60 mg with simeticone 300 mg three times daily or matching placebo for 4 weeks.. The full analysis set included 409 patients (71.4% female: mean age: 46.2 +/- 13.9 years). At week 4, alverine citrate and simeticone group had lower VAS scores of abdominal pain/discomfort (median: 40 mm vs. 50 mm, P = 0.047) and higher responder rate (46.8% vs. 34.3%, OR = 1.3; P = 0.01) as compared with placebo group. Patient receiving alverine citrate and simeticone reported greater global symptom improvement compared with those receiving placebo (P = 0.0001). Reported adverse events were similar in both groups.. Alverine citrate/simeticone combination was significantly more effective than placebo in relieving abdominal pain/discomfort in patients with IBS.

Topics: Abdominal Pain; Adolescent; Adult; Aged; Antifoaming Agents; Double-Blind Method; Drug Combinations; Female; Humans; Irritable Bowel Syndrome; Male; Middle Aged; Parasympatholytics; Propylamines; Simethicone; Treatment Outcome

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

Topics: Abdominal Pain; Acute Disease; Adolescent; Adult; Aged; Antidiarrheals; Antifoaming Agents; Diarrhea; Double-Blind Method; Drug Combinations; Female; Flatulence; Gases; Humans; Intestines; Loperamide; Male; Middle Aged; Placebos; Simethicone; Treatment Outcome

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.. Randomized, double-blinded study.. Large tertiary care, university-based medical center.. 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.. 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.. 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.. Simethicone is a safe and inexpensive medication that may provide anesthesiologists with an effective treatment choice for suspected postoperative abdominal discomfort in infants.

Topics: Abdominal Pain; Anesthesia, Inhalation; Crying; Double-Blind Method; Female; Gastrointestinal Agents; Humans; Infant; Infant, Newborn; Male; Pain Measurement; Simethicone

Topics: Abdominal Pain; Antifoaming Agents; Drug Therapy, Combination; Humans; Irritable Bowel Syndrome; Meta-Analysis as Topic; Parasympatholytics; Propylamines; Randomized Controlled Trials as Topic; Simethicone

The authors performed this study to compare the cost and diagnostic abilities of ultrasound (US) performed with and without the use of an oral contrast material recently approved by the U.S. Food and Drug Administration.. An interactive decision-analytic model was constructed to compare US performed with and without contrast material (SonoRx; Bracco Diagnostics) for the evaluation of patients with abdominal pain who were suspected of having pancreatic disease. The model considered all resources that might be used to evaluate a patient suspected of having pancreatic disease (eg, US, computed tomography [CT], endoscopic retrograde cholangiopancreatography, fine-needle aspiration biopsy, and open biopsy). The literature and an expert panel were the clinical data sources. Cost estimates were based on Medicare and non-Medicare reimbursements. The primary cost-effectiveness measure was the cost to achieve a diagnosis.. SonoRx-enhanced US was less expensive than unenhanced US ($714 vs $808, respectively, with Medicare costs; $1,612 vs $1,878, respectively, with non-Medicare costs) and as effective (0.785 vs 0.782, respectively). SonoRx-enhanced US was more cost-effective than unenhanced US ($909 vs $1,034, respectively, with Medicare costs; $2,052 vs $2,401, respectively, with non-Medicare costs). This relationship was maintained throughout extensive sensitivity analyses.. SonoRx-enhanced US is more cost-effective than unenhanced US, primarily because it avoids the need for CT. CT may be avoided owing to the higher probability of obtaining optimal US scans with oral contrast material.

Topics: Abdominal Pain; Administration, Oral; Cellulose; Contrast Media; Cost-Benefit Analysis; Decision Making; Diagnosis, Differential; Humans; Insurance, Health, Reimbursement; Models, Economic; Pancreatic Diseases; Sensitivity and Specificity; Simethicone; Ultrasonography