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N-acetylcysteine as an adjuvant therapy for Helicobacter pylori eradication.
Fontes, LES, Martimbianco, ALC, Zanin, C, Riera, R
The Cochrane database of systematic reviews. 2019;(2):CD012357
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Abstract
BACKGROUND Helicobacter pylori (H pylori) is one of the most common pathogens to establish and cause infection in human beings, affecting about 50% of the world's population. Prevalence may be as high as 83% in Latin American countries and as low as 17% in North America. Approximately 20% of infected people will manifest disease; people at high risk include those who live in low- and middle-income countries with poor sanitary conditions, since the mechanism of transmission seems to be oral-oral or faecal-oral (mostly during infancy). There are several antibiotic regimens to treat the infection, but antibiotic resistance is growing around the world. New adjuvant drugs - such as probiotics, statins, curcumin, and N-acetylcysteine (NAC) - are being tested to enhance eradication rates.N-acetylcysteine can destabilise the biofilm structure; it also has synergic action with antibiotics, and bactericidal effects. In addition, NAC has antioxidant properties, and has a primary mucolytic effect by reducing the thickness of the gastric mucus layer, both of which may exert beneficial adjuvant effects on H pylori eradication. OBJECTIVES To assess the efficacy and safety of N-acetylcysteine as an adjuvant therapy to antibiotics for Helicobacter pylori eradication. SEARCH METHODS We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to April 2018), Embase (1988 to April 2018), CINAHL (1982 to April 2018), LILACS (1982 to April 2018), grey literature databases and trials registries. We handsearched the reference lists of relevant studies. We screened 726 articles and assessed 18 for eligibility. SELECTION CRITERIA We included randomised controlled trials (RCTs) of any antibiotic regimen plus NAC, in adults infected with H pylori. To be included, trials had to use a control consisting of the same antibiotic regimen with or without placebo. Outcomes of interest were eradication rates, and gastrointestinal, toxic, and allergic adverse events. Reporting of the primary outcomes listed here was not an inclusion criterion for the review. DATA COLLECTION AND ANALYSIS Two review authors independently reviewed and extracted data and completed the 'Risk of bias' assessments. A third review author independently confirmed the 'Risk of bias' assessments. We used Review Manager 5 software for data analysis. We contacted study authors if there was missing information. MAIN RESULTS We included eight RCTs (with a total of 559 participants) in this review. The studies recruited outpatients aged between 17 and 76 years who were referred to endoscopy centres in several different countries. The certainty of evidence was reduced for most outcomes due to the poor methodological quality of included studies; issues mainly related to the generation of allocation sequence, allocation concealment, and blinding (this last domain related specifically to adverse outcomes).We are uncertain whether the addition of NAC to antibiotics improves H pylori eradication rates, compared with the addition of placebo or no NAC (38.8% versus 49.1%, risk ratio (RR) 0.74, 95% confidence interval (CI) 0.51 to 1.08; participants = 559; studies = eight; very low-certainty evidence). A post-hoc sensitivity analysis, in which we removed studies that tested antibiotic regimens no longer recommended in clinical practice, showed that the addition of NAC may improve eradication rates compared to control (27.2% versus 37.6%, RR 0.71, 95% CI 0.53 to 0.94; participants = 397; published studies = five).We are uncertain whether NAC is associated with a higher risk of gastrointestinal adverse events compared to control (23.9% versus 18.9%, RR 1.25, 95% CI 0.85 to 1.85; participants = 336; studies = five; very low-certaintyevidence), or allergic adverse events (2% versus 0%, RR 2.98, 95% CI 0.32 to 27.74; participants = 336; studies = five; very low-certainty evidence). There were no reports of toxic adverse events amongst included studies. AUTHORS' CONCLUSIONS We are uncertain whether the addition of NAC to antibiotics improves H pylori eradication rates compared with the addition of placebo or no NAC. Due to the clinical, statistical and methodological heterogeneity found in included studies, and the uncertainty observed when analysing therapy subgroups, any possible beneficial effect of NAC should be regarded cautiously.We are uncertain whether NAC is associated with a higher risk of gastrointestinal or allergic adverse events compared with placebo or no NAC. There were no reports of toxic adverse events amongst the included studies.Further large, well-designed, randomised clinical studies should be conducted, with good reporting standards and appropriate collection of efficacy and safety outcomes, especially for current recommended antibiotic regimens.
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Saccharomyces boulardii as an adjuvant therapy for Helicobacter pylori eradication: A systematic review and meta-analysis with trial sequential analysis.
Zhou, BG, Chen, LX, Li, B, Wan, LY, Ai, YW
Helicobacter. 2019;(5):e12651
Abstract
BACKGROUND AND AIMS Whether Saccharomyces boulardii (S boulardii) as an adjuvant therapy are beneficial to H pylori eradication remains controversial. The aim of the study was to update and determine the effects of S boulardii as an adjuvant therapy on H pylori eradication rates and adverse effects. METHODS We searched PubMed, Embase, CENTRAL, and Web of Science to collect all randomized controlled trials assessing the effects of S boulardii as an adjuvant therapy for H pylori eradication from inception to February 2019. Quality of evidence was appraised using Grading of Recommendations, Assessment, Development and Evaluation system. Trial sequential analysis was performed to control the risk of type I and type II errors. RESULTS Eighteen trials with 3592 patients were eligible for meta-analysis. Compared with standard eradication regimen, the S boulardii supplementation could significantly improve eradication rates [risk ratio (RR) = 1.09, 95% confidence interval (CI):1.05-1.13; moderate quality evidence] and reduce the incidence of total side effects (RR = 0.47, 95%CI:0.36-0.61; low quality evidence), as well as some gastrointestinal adverse effects, especially diarrhea (RR = 0.33, 95%CI:0.23-0.47; low quality evidence) and constipation (RR = 0.37, 95%CI:0.23-0.57; moderate quality evidence). In addition, the need for discontinuation rate in S boulardii supplementation group was significantly lower than in the control group (RR = 0.33, 95%CI:0.16-0.69, P = .003; moderate quality evidence). The TSA results for overall eradication rates and total side effects indicated that the effects were conclusive. CONCLUSIONS Our meta-analysis shows that S boulardii supplementation on standard eradication therapy significantly increased H pylori eradication rates and reduced the incidence of total side effects and some gastrointestinal adverse effects during eradication therapy.
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The effect of synbiotics in improving Helicobacter pylori eradication: A systematic review and meta-analysis.
Pourmasoumi, M, Najafgholizadeh, A, Hadi, A, Mansour-Ghanaei, F, Joukar, F
Complementary therapies in medicine. 2019;:36-43
Abstract
BACKGROUND Helicobacter pylori is a common human infection, presenting in half of the world's population. The failure of the Helicobacter pylori eradication rate necessitates the assessment of new options. The aim of the present meta-analysis was therefore to assess the role of synbiotics in Helicobacter pylori eradication therapy. METHODS A comprehensive literature search was conducted using PubMed, Google Scholar, Scopus, and Web of Knowledge up to June 2018 to identify all randomized controlled trials assessing the effect of synbiotics on the treatment of Helicobacter pylori. A random-effects model was applied for pooling analysis to compensate for the heterogeneity of included studies. The Cochrane Risk of Bias Tool was applied to assess potential bias risks. RESULTS A total of 6 randomized controlled trials were found which assessed the effect of synbiotics on Helicobacter pylori eradication rate. The pooled effect size of the intention-to-treat showed that synbiotics can improve eradication rate (RR: 1.28; 95% CI: 1.15-1.43; I2 = 0%). Also, common adverse events resulting from antibiotics therapy were significantly reduced by adding synbiotics to conventional antibiotics treatments (RR: 0.47; 95% CI: 0.25-0.90; I2 = 36%). However, no difference in eradication rate was observed from per-protocol treatment between intervention and control groups (RR: 0.90; 95% CI: 0.69-1.16; I2 = 88%). CONCLUSION The present systematic review and meta-analysis suggested synbiotics might improve Helicobacter pylori eradication rates, and reduce adverse effects. However, these findings assessed a low number of studies, and further high-quality studies are needed to confirm these results.
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Assessment of the use of vitamin C and E supplements concomitantly to antibiotic treatment against Helicobacter pylori: A systematic review and meta-analysis.
Caicedo Ochoa, EY, Quintero Moreno, CO, Méndez Fandiño, YR, Sánchez Fonseca, SC, Cortes Motta, HF, Guio Guerra, SA
Medicina clinica. 2018;(2):45-52
Abstract
INTRODUCTION Helicobacter pylori infections affect almost 50% of the world population, constituting a risk factor for benign and malignant gastrointestinal diseases. The increased resistance to antibiotic treatment against this infection represents a dilemma in the search of other therapeutic alternatives. OBJECTIVE To determine the efficacy of the use of vitaminC and E supplements concomitantly to antibiotic treatment against H. pylori infections. METHODS We performed a systematic review on the MedLine (PubMed), Embase and Cochrane Central Register of Clinical Trials (CENTRAL) databases, searching for studies evaluating the efficacy of vitaminC and/or E supplements in the antibiotic treatment of H. pylori infections. The primary outcome was eradication of the infection. The secondary outcome was the adverse effects. The meta-analysis was conducted using the random effects method. RESULTS Ten studies were included and analyzed in two groups. The first group, which was comprised by 973patients, compared the use of supplementation with vitaminC and E, showing that, without discriminating the number of antibiotics used, there was no relationship with the eradication of the infection (OR: 1.98 [95%CI: 0.92-4.29] P=.08). The triple or quadruple antibiotic therapy had no effect on eradication rates either (OR 1.80 [95%CI: 0.64-5.08] P=.26 and OR: 2.84 [95%CI: 0.51-15.56] P=.22, respectively). No effect on the eradication rates was observed either in the group that only assessed the use of vitaminC, comprised by 702patients (OR: 1.17 [95%CI: 0.58-2.31] P=.65). Only four studies reported adverse effects, the most common one being nausea. CONCLUSIONS Supplementation with vitaminC and E in the antibiotic treatment against H. pylori has no effect. However, the reviewed studies had several biases and differences in the dosage of the supplements and antibiotics administered.
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Association of Helicobacter pylori infection with diabetic complications: a meta-analysis.
Wang, F, Fu, Y, Lv, Z
Endocrine research. 2014;(1):7-12
Abstract
UNLABELLED BACKGROUND. Helicobacter pylori (HP) infects more than half of the world's population. The aim of the study was to quantify the association between HP and the risk of diabetic complications. METHODS A literature search was performed to identify studies published between 1998 and 2012 for relevant risk estimates. Fixed and random effect meta-analytical techniques were conducted for ischemic heart disease, retinopathy, neuropathy and nephropathy. RESULTS Eight studies were included. HP was associated with an increase risk of nephropathy and neuropathy (relative risk [RR]: 1.35, 95% CI: 1.06-1.73, p = 0.45 and RR: 1.20, 95% CI: 1.03-1.40, p = 0.29). We also discovered significant associations between bacterial infection and nephropathy risk in Oriental people (RR: 1.73, 95% CI: 1.19-2.50, p = 0.82) and in type 2 diabetic patients (RR: 1.50, 95% CI: 1.11-2.02, p = 0.29). CONCLUSIONS Our meta-analyses suggest a possible relationship between HP and the risk of nephropathy and neuropathy. Our results also suggest that the effect of HP on the risk of nephropathy is stronger in Oriental people and in type 2 DM patients.
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[Does Helicobacter pylori eradication therapy reduce the risk of developing gastric cancer in healthy asymtomatic individuals?].
Kim, YJ, Chung, WC
The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi. 2014;(1):62-5
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Meta-analysis: the effects of Saccharomyces boulardii supplementation on Helicobacter pylori eradication rates and side effects during treatment.
Szajewska, H, Horvath, A, Piwowarczyk, A
Alimentary pharmacology & therapeutics. 2010;(9):1069-79
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BACKGROUND Problems with currently recommended Helicobacter pylori eradication therapies include unsatisfactory eradication rates and/or therapy-associated side effects. AIM: To investigate the effects of Saccharomyces boulardii as supplementation to standard triple therapy on H. pylori eradication rates and therapy-associated side effects. METHODS The Cochrane Library, MEDLINE and EMBASE databases were searched in July 2010, with no language restrictions, for randomized controlled trials (RCTs); additional references were obtained from reviewed articles. RESULTS Five RCTs involving a total of 1307 participants (among them only 90 children) met the inclusion criteria. Compared with placebo or no intervention, S. boulardii given along with triple therapy significantly increased the eradication rate [four RCTs, n = 915, relative risk (RR) 1.13, 95% confidence interval (CI) 1.05-1.21] and reduced the risk of overall H. pylori therapy-related adverse effects (five RCTs, n = 1305, RR 0.46, 95% CI 0.3-0.7), particularly of diarrhoea (four RCTs, n = 1215, RR 0.47, 95% CI 0.32-0.69). There were no significant differences between groups in the risk of other adverse effects. CONCLUSION In patients with H. pylori infection, there is evidence to recommend the use of S. boulardii along with standard triple therapy as an option for increasing the eradication rates and decreasing overall therapy-related side effects, particularly diarrhoea.
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Helicobacter pylori infection and iron stores: a systematic review and meta-analysis.
Muhsen, K, Cohen, D
Helicobacter. 2008;(5):323-40
Abstract
BACKGROUND AND AIMS We carried out a systematic literature review and meta-analysis to evaluate the existing evidence on the association between Helicobacter pylori infection and iron stores. METHODS Twelve case reports and case series, 19 observational epidemiologic studies and six intervention trials were included in the review. RESULTS Although only few studies controlled for multiple potential confounders, most studies reported a positive association, linking between H. pylori and decreased body iron stores in symptomatic and asymptomatic H. pylori-infected subjects. H. pylori infection may be regarded as a risk factor for reduction in body iron stores and also for iron deficiency or iron deficiency anemia, especially in high-risk groups. The results of the meta-analysis of thoroughly designed and analyzed studies revealed an increased risk for iron deficiency anemia; pooled odds ratio (OR) 2.8 (95% confidence interval (CI) 1.9, 4.2) and also for iron deficiency; pooled OR 1.38 (95%CI 1.16-1.65) among H. pylori-infected subjects. The biologic mechanism by which H. pylori induces the alteration in the iron stores is not fully understood, but it seems to involve several pathways, including gastrointestinal blood loss, decrease in the absorption of dietary iron, and enhanced uptake of the iron by the bacterium. CONCLUSIONS H. pylori is associated with reduced iron stores. Future research is needed to determine whether this relationship is a causal association and to better understand its biologic mechanism. The impact of anti-H. pylori therapy on improvement of iron stores needs to be further evaluated in large and well-controlled trials.