ObjectiveLow-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS.DesignWe conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time.ResultsA total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI −12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI −2.7% to 26.0%) and 5.9% (p=0.404; 95% CI −7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule.ConclusionsMesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy.Trial registration numberClincialTrials.gov number, NCT00626288.
These results confirm the high prevalence of adverse reactions to foods in diarrheic irritable bowel syndrome and the usefulness of cromolyn sodium treatment in these patients.
Irritable Bowel Syndrome (IBS) may be diagnosed on the presence of symptoms, according to Rome II criteria, [corrected] and some studies have shown that abnormal colonic fermentation may be an important factor in the development of symptoms in some patients with IBS. Since the fermentation [corrected] of substrates by the intestinal flora may play a key role in the use of probiotics in the treatment of IBS, seventy [corrected] patients (31 [corrected] males, 39 [corrected] females), mean age 40 years (range = 26-64 years) with IBS, according to Rome II criteria, were enrolled into the study after informed consensus. Patients were randomly assigned to receive for 4 weeks [corrected] either the active preparation containing Lactobacillus plantarum LP 01 [corrected] and Bifidobacterium breve BR 03 [corrected] or Lactobacillus plantarum LP 01 and Lactobacillus acidophilus LA 02, all strains at concentrations of 5 x 10(9) CFU/g) [corrected] or placebo powder containing starch identical to the study product [corrected] To evaluate treatment efficacy two different scores were considered [corrected] Pain score in different abdominal locations after treatment decreased in probiotics groups A and B 42% and 49% versus 25% [corrected] (P < 0.05) in [corrected] placebo group after 14 days and 45% and 49% versus 29.5% [corrected] (P < 0.001) after 28 days. The severity score of characteristic IBD symptoms significantly decreased in probiotic groups A and B [corrected] versus placebo group after 14 days, 49.3% and 55.6% [corrected] versus 8% [corrected] (P < 0.001), and these data were confirmed after 28 days (56% and 55.6% versus 14.4% [corrected] P < 0.001). In conclusion, short-term therapy with Lactobacillus plantarum LP 01 and Bifidobacterium breve BR 03 or Lactobacillus plantarum LP 01 and Lactobacillus acidophilus LA 02 [corrected] may be considered a promising approach for IBS therapy [corrected]
BACKGROUND: The purpose of this study was to show the effect of chronic antral gastric electrical stimulation on the feeding behavior of swine. METHODS: Three groups of swine were investigated; first group control-group, second group- 8 months of electrical antral stimulation (10 Volts; 450 micros; Hertz 100; Mode: Cycling; on time 3.25 s; off time 5.15 s), the third group- 3 months of stimulation with modification of the following parameters- amplitude 8 Volts, Hertz 5. All animals were nourished with a commercial balanced dry feed ad libitum. RESULTS: Group one demonstrated continued increased weight gain. After 90 days of stimulation, group two noted a net decrease of food intake from 12% to 16%, followed by a net cyclical weight loss 30 days later (2 weeks of weight gain followed by 1 week of weight loss). The percentage difference between group one and two in increasing weight was- 12 to 29% respectively. The feed output of the stimulated group (group two) was 12.8 less compared with the control. Finally, group three was used to test a lower stimulation rate, resulting in a shorter rest during feeding and a 7% increase in consumption compared with control. CONCLUSIONS: Long-term antral gastric pacing influences the alimentary behavior of swine. We attempt to extrapolate this influence in humans for possible attendant applications in patients with consumption dysfunction (e.g. bulimia and/or anorexia).
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.