-
1.
Improved Hemoglobin Response with Ferric Carboxymaltose in Patients with Gastrointestinal-Related Iron-Deficiency Anemia Versus Oral Iron.
Lichtenstein, GR, Onken, JE
Digestive diseases and sciences. 2018;(11):3009-3019
-
-
Free full text
-
Abstract
AIMS: To compare the efficacy and safety of intravenous (IV) ferric carboxymaltose (FCM) versus oral iron and other IV iron therapies in patients with iron-deficiency anemia (IDA) resulting from gastrointestinal (GI) disorders. METHODS A pooled analysis of four prospective, randomized, active-controlled trials in patients with IDA was performed. Efficacy measures included change from baseline in hemoglobin (Hb), ferritin, and transferrin saturation (TSAT) and correlations of baseline Hb, ferritin, and TSAT to change in Hb. The incidence and type of adverse events were evaluated. RESULTS A total of 191 patients were evaluated. The mean change in Hb from baseline to the maximum value was 0.8 g/dL with oral iron (P = 0.001 vs. FCM), 2.2 g/dL with FCM, 2.0 g/dL with any IV iron (P = 0.391 vs. FCM), and 1.9 g/dL with iron sucrose (P = 0.329 vs. FCM). Patients treated with FCM and iron sucrose had larger increases in Hb. This effect may have been attributed to a lower baseline Hb level. Drug-related adverse events occurred in 11.9, 12, 26.2, and 25% and serious adverse events (SAEs) occurred in 6.9, 4, 9.8, and 12.5% of patients in the FCM, oral iron, other IV iron therapies, and iron sucrose groups, respectively. No SAEs were considered treatment related in the FCM group, compared with two treatment-related SAEs in two patients (6.3%) in the iron sucrose group. CONCLUSIONS FCM is an effective therapy in patients with IDA who have GI disorders and has a safety profile comparable to that of other IV iron agents.
-
2.
Modulation of gastrointestinal motility beyond metoclopramide and domperidone : Pharmacological and clinical evidence for phytotherapy in functional gastrointestinal disorders.
Madisch, A, Vinson, BR, Abdel-Aziz, H, Kelber, O, Nieber, K, Kraft, K, Storr, M
Wiener medizinische Wochenschrift (1946). 2017;(7-8):160-168
-
-
Free full text
-
Abstract
The prokinetic cisapride, an important therapeutic option in functional gastrointestinal (GI) disorders, was withdrawn from the market 15 years ago due to rare severe side effects. Likewise in 2014, the use of metoclopramide (MCP) and domperidone in functional GI disorders (FGID) was restricted, consequently leaving a therapeutic gap in clinical practice. A systematic review revealed that the herbal medicinal product (HMP) STW 5 presents a therapeutic option equivalent to MCP and cisapride. STW 5 is the only HMP for which efficacy has been shown in randomized controlled clinical trials (RCTs) in functional dyspepsia and irritable bowel syndrome, based on its multitarget effect on numerous etiological factors. Due to an outstanding favorable safety profile, STW 5 allows an effective and safe use in FGID without a limitation of the duration of the treatment.
-
3.
Interventions That Affect Gastrointestinal Motility in Hospitalized Adult Patients: A Systematic Review and Meta-Analysis of Double-Blind Placebo-Controlled Randomized Trials.
Asrani, VM, Yoon, HD, Megill, RD, Windsor, JA, Petrov, MS
Medicine. 2016;(5):e2463
-
-
Free full text
-
Abstract
Gastrointestinal (GI) dysmotility is a common complication in acute, critically ill, postoperative, and chronic patients that may lead to impaired nutrient delivery, poor clinical, and patient-reported outcomes. Several pharmacological and nonpharmacological interventions to treat GI dysmotility were investigated in dozens of clinical studies. However, they often yielded conflicting results, at least in part, because various (nonstandardized) definitions of GI dysmotility were used and methodological quality of studies was poor. While a universally accepted definition of GI dysmotility is yet to be developed, a systematic analysis of data derived from double-blind placebo-controlled randomized trials may provide robust data on absolute and relative effectiveness of various interventions as the study outcome (GI motility) was assessed in the least biased manner.To systematically review data from double-blind placebo-controlled randomized trials to determine and compare the effectiveness of interventions that affect GI motility.Three electronic databases (MEDLINE, SCOPUS, and EMBASE) were searched. A random effects model was used for meta-analysis. The summary estimates were reported as mean difference (MD) with the corresponding 95% confidence interval (CI).A total of 38 double-blind placebo-controlled randomized trials involving 2371 patients were eligible for inclusion in the systematic review. These studies investigated a total of 20 different interventions, of which 6 interventions were meta-analyzed. Of them, the use of dopamine receptor antagonists (MD, -8.99; 95% CI, -17.72 to -0.27; P = 0.04) and macrolides (MD, -26.04; 95% CI, -51.25 to -0.82; P = 0.04) significantly improved GI motility compared with the placebo group. The use of botulism toxin significantly impaired GI motility compared with the placebo group (MD, 5.31; 95% CI, -0.04 to 10.67; P = 0.05). Other interventions (dietary factors, probiotics, hormones) did not affect GI motility.Based on the best available data and taking into account the safety profile of each class of intervention, dopamine receptor antagonists and macrolides significantly improve GI motility and are medications of choice in treating GI dysmotility.
-
4.
Gastrointestinal side effects in liver transplant recipients taking enteric-coated mycophenolate sodium vs. mycophenolate mofetil.
Lopez-Solis, R, DeVera, M, Steel, J, Fedorek, S, Sturdevant, M, Hughes, C, Humar, A
Clinical transplantation. 2014;(7):783-8
Abstract
In the setting of liver transplantation, mycophenolate mofetil (MMF) may be used as an adjuvant therapy for immunosuppression to prevent graft rejection; however, its use may be limited due to severe gastrointestinal (GI) side effects. In contrast, enteric-coated mycophenolate sodium (EC-MPS) may be associated with less severe side effects and hence better tolerability. We compared the side effects of EC-MPS to MMF in liver transplant patients in a de novo study (Study I-randomized, prospective, double-blinded) and a conversion study (Study II). In both studies, the severity of GI symptoms was assessed at various time points using the Gastrointestinal Symptoms Rating Scale (GSRS) survey, a validated survey of GI symptoms (abdominal pain, reflux, indigestion, diarrhea, and constipation). In Study I, the symptoms of 30 recipients receiving EC-MPS (n = 15) were compared to 15 recipients receiving MMF. A multivariate analysis of variance (MANOVA) of the total GSRS scores and symptom syndrome subscores revealed no significant difference (p > 0.05) between the two medications over time. A conversion study (Study II) with 29 participants, however, showed that over time, all GI symptoms improved significantly (p < 0.001) when the patients were treated with EC-MPS instead of MMF.
-
5.
[Gastrointestinal motility disorders. Effective phytotherapy alternatives to MCP (metoclopramide)].
MMW Fortschritte der Medizin. 2014;(19):80-1
-
6.
Safety of a dual potential prebiotic system from Mexican agave "Metlin® and Metlos®", incorporated to an infant formula for term newborn babies: a randomized controlled trial.
López-Velázquez, G, Díaz-García, L, Anzo, A, Parra-Ortiz, M, Llamosas-Gallardo, B, Ortiz-Hernández, AA, Mancilla-Ramírez, J, Cruz-Rubio, JM, Gutiérrez-Castrellón, P
Revista de investigacion clinica; organo del Hospital de Enfermedades de la Nutricion. 2013;(6):483-90
Abstract
RATIONALE Infant formulae are being supplemented with probiotics, prebiotics, or symbiotic despite uncertainties regarding their efficacy. Mexican agave is an interesting source of fructans with particular features and with potential prebiotic effects. MATERIAL AND METHODS RCT in 600 healthy term babies (20 ± 7 days), allocated to receive standard infant formula (control) or infant formula added with a dual prebiotic system "Metlin® and Metlos®", from Mexican agave. Primary outcomes include stools frequency, stools consistency, gastrointestinal intolerance (frequency of abdominal distension, flatulency, regurgitations, vomiting). Secondary outcomes include changes on weight and height along the study and frequency of dermatologic problems (eczema). RESULTS In 66,120 days of total follow-up, there were no differences on the frequency of stools passage (Human Milk: 3.8 ± 2.4 evacuations per day; Pro + Metlin + Metlos 3.6 ± 2.0; Pro + Metlin 3.6 ± 2; only Pro 3.4 ± 2.3¸ only formula 3.4 ± 2.0; p NS). Consistency of stools was similar between human milk and prebiotics supplemented groups. Also the frequency of gastrointestinal symptoms was significantly low between these groups. CONCLUSIONS Fructans derivate from agave and added to infant formula are safe and well tolerated by Mexican healthy term babies.
-
7.
A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections.
Towfigh, S, Pasternak, J, Poirier, A, Leister, H, Babinchak, T
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases. 2010;(8):1274-81
-
-
Free full text
-
Abstract
Tigecycline (TGC) has demonstrated clinical efficacy and safety, in comparison with imipenem/cilastatin in phase 3 clinical trials, for complicated intra-abdominal infection (cIAI). The present study comprised a multicentre, open-label, randomized study of TGC vs. ceftriaxone plus metronidazole (CTX/MET) for the treatment of patients with cIAI. Eligible subjects were randomized (1:1) to receive either an initial dose of TGC (100 mg) followed by 50 mg every 12 h or CTX (2 g once daily) plus MET (1-2 g daily), for 4-14 days. The primary endpoint was the clinical response in the clinically evaluable (CE) population at the test of cure (TOC) assessment. Of 473 randomized subjects, 376 were CE. Among these, clinical cure rates were 70.4% (133/189) with TGC vs. 74.3% (139/187) with CTX/MET (95% CI -13.1 to 5.1; p 0.009 for non-inferiority). Clinical cure rates for subjects with Acute Physiological and Chronic Health Evaluation II scores > or =10 were 56.8% (21/37) with TGC vs. 58.3% (21/36) with CTX/MET. The microbiologic response was similar between the two treatment arms, with microbiological eradication at TOC achieved in 68.1% (94/138) of TGC-treated subjects and 71.5% (98/137) of CTX/MET-treated subjects. (The most frequently reported adverse events (AEs) for both treatment arms were nausea (TGC, 38.6% vs CTX/MET, 27.7%) and vomiting (TGC, 23.3% vs CTX/MET, 17.7%). Overall discontinuation rates as a result of an AE were 8.9% and 4.8% in TGC- and comparator-treated subjects, respectively. The results obtained in the present study demonstrate that TGC monotherapy is non-inferior to a combination regimen of CTX/MET with respect to treating subjects with cIAI.
-
8.
Safety and adequacy of a semi-elemental formula for children with gastro-intestinal disease.
Vandenplas, Y, Plaskie, K, Hauser, B
Amino acids. 2010;(3):909-14
-
-
Free full text
-
Abstract
A prospective, open trial was conducted to evaluate the nutritional adequacy of a semi-elemental diet in 47 children with functional gastro-intestinal disorders. Nutritional adequacy was assessed based on growth relative to Euro-growth standards for body mass index (BMI)-for-age z-scores and evaluations of blood parameters. Twenty-five patients completed the study. In total, 533 l of "New-Alfare" was consumed during 775 trial-days. The mean intake per infant was 85.8 +/- 26.8 kcal/kg/day or 122.5 +/- 38.3 ml/kg/day. Weight and length evolution during the 4 weeks trial were within normal range. The mean BMI-for-age z-score (P < 0.05) and albumin concentration (P < 0.01) increased significantly after 4 weeks. Plasma threonine concentration decreased significantly (P = 0.01) and the tryptophan concentration increased (P = 0.06). No adverse events related to the study formula were reported. These results show that "New Alfaré" is safe and nutritionally adequate for pediatric patients with gastro-intestinal disease.
-
9.
Gastrointestinal tolerability of etoricoxib in rheumatoid arthritis patients: results of the etoricoxib vs diclofenac sodium gastrointestinal tolerability and effectiveness trial (EDGE-II).
Krueger, K, Lino, L, Dore, R, Radominski, S, Zhang, Y, Kaur, A, Simpson, R, Curtis, S
Annals of the rheumatic diseases. 2008;(3):315-22
Abstract
OBJECTIVE A randomised, double-blind study to compare the gastrointestinal (GI) tolerability, safety and efficacy of etoricoxib and diclofenac in patients with rheumatoid arthritis (RA). PATIENTS AND METHODS A total of 4086 patients (mean age 60.8 years) diagnosed with RA were enrolled and received etoricoxib 90 mg daily (n = 2032) or diclofenac 75 mg twice daily (n = 2054). Use of gastroprotective agents and low-dose aspirin was allowed. The prespecified primary end point consisted of the cumulative rate of patient discontinuations due to clinical and laboratory GI adverse experiences (AEs). General safety was also assessed, including adjudicated thrombotic cardiovascular event data. Efficacy was evaluated using the Patient Global Assessment of Disease Status (PGADS; 0-4 point scale). RESULTS Mean (SD; maximum) duration of treatment was 19.3 (10.3; 32.9) and 19.1 (10.4; 33.1) months in the etoricoxib and diclofenac groups, respectively. The cumulative discontinuation rate due to GI AEs was significantly lower with etoricoxib than diclofenac (5.2 vs 8.5 events per 100 patient-years, respectively; hazard ratio 0.62 (95% CI: 0.47, 0.81; p CONCLUSIONS Etoricoxib 90 mg demonstrated a significantly lower risk for discontinuing treatment due to GI AEs compared with diclofenac 150 mg. Discontinuations from renovascular AEs, although less common than discontinuations from GI AEs, were significantly higher with etoricoxib.
-
10.
[Current status of ultrasound in gastroenterology--bowel and upper gastrointestinal tract--part 2].
Nuernberg, D, Ignee, A, Dietrich, CF
Zeitschrift fur Gastroenterologie. 2008;(4):355-66
Abstract
Ultrasound has gained acceptance in the diagnosis of diseases of the gastrointestinal tract beside the classical methods such as endoscopy and X-ray. In a previous publication we discussed the use of ultrasound in emergency diagnostics (e. g., acute appendicitis, diverticulitis/peridiverticulitis, ileus, invagination and perforation) (part 1). Because of the vast extent of this topic, in this overview we will focus on the current role of ultrasound in the detection and assessment of chronic inflammatory bowel diseases, rare forms of colitis (e. g., bacterial, pseudomembranous and neutropenic colitis as well as intestinal tuberculosis), ischaemic bowel diseases as well as diseases of the upper gastrointestinal tract. In chronic inflammatory bowel diseases, ultrasound can give important additional information such as extension, activity, complication (fistula, abscess, stenosis) and in differential diagnosis. It plays an important role in follow-up investigations and can possibly reduce the number of endoscopic examinations. There is still some debate going on about the significance of colour Doppler ultrasound in assessing the activity and differentiation of stenosis. Furthermore, ultrasound is used as a method to guide interventional therapies for abscesses (puncture and drainage). Colour Doppler ultrasound can diagnose ischaemic bowel diseases and also differentiate these from other aetiologies. Ultrasound plays a greater role in the follow-up and assessment of chronic intestinal ischaemia. In the diagnosis of stomach diseases under favourable conditions ultrasound can show changes of the stomach wall, tumours, ulcers and their complication (perforation, penetration) and disturbances of the motility. But an exclusion is not possible.