Simeticone 125mg capsules

Objective: Eluxadoline is a newly approved drug for irritable bowel syndrome (IBS), but it has rarely been compared with positive controls. We aimed to compare eluxadoline with antispasmodics in the treatment of IBS. Methods: We searched the OVID Medline, Embase, and the Cochrane Central Register of Controlled Trials databases for randomized controlled trials (RCTs) comparing eluxadoline or antispasmodics with placebo. The search was conducted from 1 January 1980, to 1 September 2020, without any language restrictions. The primary efficacy outcome was the relief of abdominal pain, defined by a reduction of pain scores of at least 30% from baseline. The secondary efficacy outcome was the relief of global IBS symptoms, defined by a composite response of a decrease in abdominal pain and improvement in stool consistency on the same day for at least 50% of the days assessed. The data were pooled using a random-effects model. Outcome estimates were pooled by using Risk Ratios (RRs) and P-scores. Results: Forty-two trials with 8,457 participants were included from 45 articles. Compared with placebo, each of drotaverine, pinaverium, alverine combined with simethicone (ACS) and eluxadoline 100 mg was highly effective in the relief of abdominal pain, with drotaverine [RR, 2.71 (95% CI, 1.70 to 4.32), P-score = 0.95] ranking first. Drotaverine, otilonium, cimetropium, pinaverium, and eluxadoline 100 mg had significantly high the relief of global IBS symptomss, for which drotaverine [RR, 2.45 (95% CI, 1.42 to 4.22), P-score = 0.95] was ranked first. No significant difference was found between these interventions. Pinaverium had a significantly higher the relief of global IBS symptoms than eluxadoline [RR, 1.72 (95% CI, 1.33 to 2.21)] on sensitivity analysis. However, no significant difference was found in the number of adverse events between each intervention and the placebo. Conclusion: Our network meta-analysis showed that eluxadoline 100 mg was at least as effective as antispasmodics in relieving abdominal pain in IBS. But eluxadoline had more reported adverse events. Antispasmodics are still the first choice for the treatment of IBS.

Abstract licence: CC BY

ObjectiveThe aim of the study was to demonstrate that an administration of mucolytic solution with a maximum dose of simethicone and n -acetylcysteine before upper endoscopy improves mucosal visibility compared to a group without administration of mucolytic solution or water.MethodsThis study was a double-blind, randomized controlled trial. Patients were randomized into four groups, with the administration of 100 ml of water + 600 mg n -acetylcysteine + 400 mg simethicone, 100 ml of water + 400 mg n -acetylcysteine + 20 mg simethicone, 100 ml of water, and without any water or mucolytic solution. During the examination, a total of 10 images were taken in the defined areas. The overall visibility score was given by the sum of the 0-5 scores of the five areas and was assessed by the endoscopist performing the procedure and the blinded endoscopists using static images.ResultsA total of 129 patients were randomized. The group of patients did not differ in age, sex distribution, and indications significantly. The overall visibility score as assessed by the endoscopist performing the procedure was significantly higher in the group with the maximum dose of mucolytic solution compared to the group without solution or water (18.9 ± 2.9 vs. 16.6 ± 3.3, P  = 0.023). This difference was not evident by the blinded evaluation of static photographs.ConclusionAdministration of mucolytic solution with a maximum dose of n -acetylcysteine and simethicone before upper endoscopy improved mucosal visibility in the upper gastrointestinal tract compared with the group without any preparation while evaluated by performing endoscopist.

Abstract licence: CC BY-NC-ND

Background: Proton pump inhibitors are effective for functional dyspepsia but ineffective in relieving postprandial distress syndrome. Curcuma longa might be effective for postprandial distress syndrome. The objective of this study was to compare the efficacy of Curcuma longa and simethicone for postprandial distress syndrome in an open-label randomized-controlled trial. Methods: This trial was conducted between July 2018 and February 2019. In total, 78 patients were randomly assigned to receive 4 weeks of treatment with 750 or 1,500 mg oral Curcuma longa per day or 240 mg simethicone per day. The patients assessed their symptoms using the dyspepsia Global Overall Symptom scale at baseline, week 2, and week 4. After stopping medication for 2 weeks, the patients assessed recurrent symptoms and day of recurrence by themselves at the end of week 6. Results: In total, 78 patients underwent randomization (27 in 750 mg Curcuma longa, 26 in 1500 mg Curcuma longa, and 25 in simethicone groups). After 2 weeks, there were no significant differences in all mean changes of symptoms scores (95%CI) of postprandial distress syndrome [-4.1 (-4.5, -2.6) vs -4.3 (-5.2, -3.3) vs -4.2 (-4.8, -3.5), P=0.954]. Over a period of 4 weeks, the reduction in mean scores was greater among participants receiving simethicone (although not statistically significant) compared with two intervention groups [-4.6 (-5.7, -3.6) vs -5.4 (-6.6, -4.1) vs -6.2 (-7.2, -5.2), P=0.122]. The rate of recurrence was significantly lower in simethicone than the two Curcuma longa groups (42.9 vs 45.5 vs 13.6%, P=0.047). There was no serious adverse event reported in all three groups. Conclusions:Curcuma longa had a similar effect on treatment outcomes to simethicone after 2 and 4 weeks, but the recurrence rate of symptoms was significantly higher without serious adverse events. Registration: Registered with the Thai Clinical Trials Registry on 31 January 2018; TCTR20180131001.

Abstract licence: CC BY

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

Abstract licence: CC BY-NC 4.0