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A 10-Year Follow-Up of a Randomized Prospective Study of 2 Treatments for Chronic Rhinosinusitis Without Nasal Polyps and Investigation of the Impact of Gastroeosophageal Reflux Disease in the Resistance to Treatment.
Lechien, JR, Debie, G, Mahillon, V, Thill, MP, Rodriguez, A, Horoi, M, Kampouridis, S, Muls, V, Saussez, S
Ear, nose, & throat journal. 2021;(5_suppl):569S-577S
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Abstract
OBJECTIVES To compare the 2 long-term medical strategies in chronic rhinosinusitis without nasal polyps (CRSnNP) and to identify the role of gastroesophageal reflux disease (GERD) and Helicobacter pylori as factors of treatment failure. MATERIAL AND METHODS Fifty-seven patients with CRSnNP were randomized into 2 therapeutic groups. The first group was treated with 4 weeks of amoxicillin/clavulanate and a short course of oral steroids. The second group received 8 weeks of clarithromycin. Sinonasal Outcome Test-20 (SNOT-20) and Lund and Mackay scores were assessed at baseline and after treatment, and GERD Health-Related Quality of Life (GERD-HRQL) questionnaire was evaluated in all patients. Patients with a GERD-HRQL score >8 received esogastroscopy and H pylori detection. Patients were followed during a 10-year period for clinical course and GERD evolution. The 10-year evolution of patients was described in terms of recurrence, medical, and surgical treatments. RESULTS Thirty-seven patients completed the study; SNOT-20 and Lund and Mackay scores similarly improved in both groups. Amoxicillin/clavulanate group had significantly more adverse reactions than the clarithromycin group (P = .03). After the therapeutic course, 35% (amoxicillin/clavulanate) and 41% (clarithromycin) of patients needed functional endoscopic sinus surgery (FESS). During the long-term follow-up, 54% (amoxicillin/clavulanate) and 40% (clarithromycin) of patients had late CRSnNP recurrence; FESS was performed in less than 15% of cases of recurrence. Gastroesophageal reflux disease complaint's severity was associated with late recurrence of CRSnNP. CONCLUSION Amoxicillin/clavulanate and clarithromycin would be competitive treatments for CRSnNP. Gastroesophageal reflux disease seems to be a negative factor for treatment response and recurrence.
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Low FODMAPs diet or usual dietary advice for the treatment of refractory gastroesophageal reflux disease: An open-labeled randomized trial.
Rivière, P, Vauquelin, B, Rolland, E, Melchior, C, Roman, S, Bruley des Varannes, S, Mion, F, Gourcerol, G, Sacher-Huvelin, S, Zerbib, F
Neurogastroenterology and motility. 2021;(9):e14181
Abstract
BACKGROUND The low FODMAPs (fermentable oligo-, di-, monosaccharides, and polyols) diet improves lower gastrointestinal symptoms. Patients suffering from proton pump inhibitor (PPI) refractory gastroesophageal reflux disease (GERD) have limited treatment options. We investigated the efficacy of a low FODMAPs diet in patients with PPI refractory GERD. METHODS This multicenter, randomized, open-label study compared the efficacy of a 4-week low FODMAPs diet and usual dietary advice (ie, low-fat diet and head of bed elevation) in patients with symptomatic PPI refractory GERD, defined by a Reflux Disease Questionnaire (RDQ) score >3 and abnormal pH-impedance monitoring on PPIs. The primary endpoint was the percentage of responders (RDQ ≤3) at the end of the diet. RESULTS Thirty-one patients (55% women, median age 45 years) were included, 16 randomized in the low FODMAPs diet group and 15 in the usual dietary advice group. Adherence to the assigned diet was good, with a significant difference in the FODMAPs intake per day between the low FODMAPs diet (2.5 g) and the usual dietary advice group (13 g) (p < 0.001). There was no difference in response rates (RDQ score ≤3) between the low FODMAPs diet (6/16, 37.5%) and usual dietary advice (3/15, 20%) groups (p = 0.43). Total RDQ score and dyspepsia subscore decreased significantly over time in both groups (p = 0.002), with no difference according to the assigned diet group (p = 0.85). CONCLUSION Low FODMAPs diet and usual dietary advice have similar but limited beneficial effects on symptoms in patients with PPI refractory GERD.
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Role of feeding strategy bundle with acid-suppressive therapy in infants with esophageal acid reflux exposure: a randomized controlled trial.
Jadcherla, SR, Hasenstab, KA, Wei, L, Osborn, EK, Viswanathan, S, Gulati, IK, Slaughter, JL, Di Lorenzo, C
Pediatric research. 2021;(3):645-652
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Abstract
OBJECTIVE To test the hypothesis that a feeding bundle concurrent with acid suppression is superior to acid suppression alone in improving gastroesophageal reflux disease (GERD) attributed-symptom scores and feeding outcomes in neonatal ICU infants. METHODS Infants (N = 76) between 34 and 60 weeks' postmenstrual age with acid reflux index > 3% were randomly allocated to study (acid-suppressive therapy + feeding bundle) or conventional (acid-suppressive therapy only) arms for 4 weeks. Feeding bundle included: total fluid volume < 140 mL/kg/day, fed over 30 min in right lateral position, and supine postprandial position. Primary outcome was independent oral feeding and/or ≥6-point decrease in symptom score (I-GERQ-R). Secondary outcomes included growth (weight, length, head circumference), length of hospital stay (LOHS, days), airway (oxygen at discharge), and developmental (Bayley scores) milestones. RESULTS Of 688 screened: 76 infants were randomized and used for the primary outcome as intent-to-treat, and secondary outcomes analyzed for 72 infants (N = 35 conventional, N = 37 study). For study vs. conventional groups, respectively: (a) 33% (95% CI, 19-49%) vs. 44% (95% CI, 28-62%), P = 0.28 achieved primary outcome success, and (b) secondary outcomes did not significantly differ (P > 0.05). CONCLUSIONS Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes. IMPACT Conservative feeding therapies are thought to modify GERD symptoms and its consequences. However, in this randomized controlled trial in convalescing neonatal ICU infants with GERD symptoms, when controlling for preterm or full-term birth and severity of esophageal acid reflux index, the effectiveness of acid suppression plus a feeding modification bundle (volume restriction, intra- and postprandial body positions, and prolonged feeding periods) vs. acid suppression alone, administered over a 4-week period was not superior in improving symptom scores or feeding outcomes. Restrictive feeding strategies are of no impact in modifying GERD symptoms or clinically meaningful outcomes. Further studies are needed to define true GERD and to identify effective therapies in modifying pathophysiology and outcomes. The improvement in symptoms and feeding outcomes over time irrespective of feeding modifications may suggest a maturational effect. This study justifies the use of placebo-controlled randomized clinical trial among NICU infants with objectively defined GERD.
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Safety considerations when managing gastro-esophageal reflux disease in infants.
Simon, M, Levy, EI, Vandenplas, Y
Expert opinion on drug safety. 2021;(1):37-49
Abstract
Introduction: Gastro-esophageal reflux disease (GERD) in infants is worldwide diagnosed with increasing frequency, resulting in an increasing number of infants exposed to treatment. In this review, we focus on the safety of therapeutic options. Areas covered: English articles were searched from 1990 until May 2020 in PubMed and Google Scholar. Evidence suggests that non-pharmacological treatment is often effective and safe. Guidelines restrict pharmacological treatment to acid-suppressive medication, which is associated with adverse effects, often related to gastro-intestinal dysbiosis and consequences of the latter. Aluminum-free alginates have some efficacy and are not associated with relevant adverse effects. Especially in infants, GERD is often nonacid related. Prokinetics are not recommended because of lack of efficacy and numerous adverse effects. Expert opinion: Pediatric trials are underpowered regarding adverse effects. The number of infants exposed to anti-secretory agents is increasing worldwide, often without indication. Informing healthcare providers about adverse effects of acid-secretory medication may contribute to a more rational use. Acid inhibiting agents such as alginates are a drug class associated with limited efficacy and devoid of serious adverse effects. Regarding prokinetics, the risk of adverse effects outweighs the benefit. Reassurance of parents and nutritional management of GERD in infants is effective and safe.
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The pharmacotherapeutic management of gastroesophageal reflux disease (GERD).
Chapelle, N, Ben Ghezala, I, Barkun, A, Bardou, M
Expert opinion on pharmacotherapy. 2021;(2):219-227
Abstract
INTRODUCTION Gastroesophageal reflux disease (GERD) is a very common worldwide condition, affecting about 15-20% of the whole population, and representing a major burden for health-care systems. Because of its frequency, health physicians - family doctors as well as specialists - should be aware of the different pharmacotherapeutic approaches in managing GERD, according to disease severity. AREAS COVERED Authors summarize the pharmacological management of GERD in adults, present the different pharmaceutical classes, and review the evidence on efficacy for each treatment according to the most common clinical scenarios: non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE), and proton-pump inhibitor (PPI) refractory GERD. They also provide an overview of treatments under development. EXPERT OPINION To date, PPIs remain the most effective treatment option for both NERD and EE. However, Potassium-Competitive Acid blockers (PCAB) may be considered, with at least similar efficacy in Asian populations. Preliminary data suggest that PCABs could be superior to classic PPIs in patients with severe EE, and may also be of particular interest in the management of PPI-refractory GERD patients. Their definitive role in GERD management, however, still remains to be determined based on properly designed and conducted randomized clinical trials.
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A standardized extract of Opuntia ficus-indica (L.) Mill and Olea europaea L. improves gastrointestinal discomfort: A double-blinded randomized-controlled study.
Malfa, GA, Di Giacomo, C, Cardia, L, Sorbara, EE, Mannucci, C, Calapai, G
Phytotherapy research : PTR. 2021;(7):3756-3768
Abstract
Gastrointestinal discomfort (GD), which often includes gastroesophageal reflux disease (GERD), is a common disorder in healthy adults affecting 40% of the worldwide population. The symptoms related to GD can have a negative impact on the quality of life (QoL). Current treatments for GERD are associated with side effects. We conducted a randomized double-blind placebo-controlled trial to assess the effect of a standardized extract of Opuntia ficus-indica L. cladodes and Olea europaea L. leaves on the symptoms and QoL of healthy adults with GD. One hundred healthy participants with GD were enrolled in the study and divided into two groups: 60 participants taking verum (400 mg/day) and 40 taking the placebo for 8 weeks. The Gastrointestinal Quality of Life index (GIQLI) and GERD Symptom Assessment Scale (GSAS) questionnaires were administered at the beginning of the study and after 4 and 8 weeks. The group treated with verum experienced a statistically significant improvement of GIQLI and GSAS scores (p < .001). Moreover, the effect size measured revealed a clinical significance. A day-dependent improvement of symptoms was also observed. The standardized extract represents a fast, effective, and well-tolerated treatment for improving symptoms related to GD and GERD.
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Efficacy of a new nutraceutical formulation (CHETOGERD®) in patients with nonerosive reflux disease (NERD): a prospective observational study.
Fiorini, G, Saracino, IM, Pavoni, M, Saccomanno, L, Vaira, D
Internal and emergency medicine. 2020;(7):1265-1269
Abstract
Nonerosive reflux disease (NERD) is a gastrointestinal disorder that leads to symptoms such as heartburn and regurgitation without visible esophageal mucosal injury, and it is treated with proton-pump inhibitors (PPIs). CHETOGERD® gel or orosoluble (oro) formulations-an association of natural active ingredient: hyaluronic acid, altea, malva, apple active TM, Aloe vera, L-triptophan, calcium gluconate, sodium bicarbonate, Musa paradisiaca)-may be an alternative or a coadjutant treatment in patients with NERD. The aim of the study was to evaluate, prospectively, the efficacy of CHETOGERD® gel and oro in inducing symptom's reduction or remission, in consecutive patients with NERD. Patients were divided in two groups and treated with CHETOGERD® gel or CHETOGERD® oro, 3 sachets/day for 3 months, decreased to 1 sachet/day for other 3 months. Symptoms were evaluated at baseline, 3 and 6 months using the reflux disease questionnaire (RDQ). Symptoms' remission was defined as reduction of retrosternal pain or burning, epigastric pain or burning, regurgitation and acid sensation in mouth. Frequency, distribution analyses and non-parametric tests were used for the statistical analysis. Results were considered statistically significant for p values < 0.05. Four hundred and twenty-three patients (M/F 240/183; mean age 50 years) were diagnosed with NERD and were consecutively enrolled. 146 patients underwent therapy with CHETOGERD® gel, while 277 were treated with CHETOGERD® oro. 108 patients from the first group and 172 patients from the second group completed follow up at 3 months, while 100 patients from each group completed follow-up at 6 months. Both formulations were able to significantly reduce the frequency and intensity of symptoms analysed with RDQ. No adverse events were reported. CHETOGERD® gel and oro are two valid alternatives to control symptoms in patients with nonerosive reflux disease.
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Extraesophageal syndrome of gastroesophageal reflux: relationships with lung disease and transplantation outcome.
Chan, WW, Ahuja, N, Fisichella, PM, Gavini, S, Rangan, V, Vela, MF
Annals of the New York Academy of Sciences. 2020;(1):95-105
Abstract
Gastroesophageal reflux disease (GERD) is prevalent and may be associated with both esophageal and extraesophageal syndromes, which include various pulmonary conditions. GERD may lead to pulmonary complications through the "reflux" (aspiration) or "reflex" (refluxate-triggered, vagally mediated airway spasm) mechanisms. While GERD may cause or worsen pulmonary disorders, changes in respiratory mechanics due to lung disease may also increase reflux. Typical esophageal symptoms are frequently absent and objective assessment with reflux monitoring is often needed for diagnosis. Impedance monitoring should be considered in addition to traditional pH study due to the involvement of both acidic and weakly acidic/nonacidic reflux. Antireflux therapy may improve outcomes of some pulmonary complications of GERD, although careful selection of a candidate is paramount to successful outcomes. Further research is needed to identify the optimal testing strategy and patient phenotypes that would benefit from antireflux therapy to improve pulmonary outcomes.
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Gastroesophageal Reflux Disease and Probiotics: A Systematic Review.
Cheng, J, Ouwehand, AC
Nutrients. 2020;(1)
Abstract
Probiotic is little known for its benefits on upper gastrointestinal health. The objective of this systematic review was to examine the efficacy of probiotics in alleviating the frequency and severity of symptoms in gastroesophageal reflux disease (GERD) in the general adult population. The PubMed and Web of Science databases were searched for prospective studies on GERD, heartburn, regurgitation, and dyspepsia, without any limitation on sample size. The Jadad scale was used to evaluate the quality of randomized controlled trials. In total, 13 prospective studies that were published in 12 articles were included in the analysis and scored per the Jadad scale as high- (five studies), medium- (two), and low- (six) quality. One article reported on two probiotic groups; thus, 14 comparisons were included in the selected studies, of which 11 (79%) reported positive benefits of probiotics on symptoms of GERD. Five out of 11 positive outcomes (45%) noted benefits on reflux symptoms: three noted reduced regurgitation; improvements in reflux or heartburn were seen in one study; five (45%) saw improvements in dyspepsia symptoms; and nine (81%) saw improvements in other upper gastrointestinal symptoms, such as nausea (three studies), abdominal pain (five), and gas-related symptoms (four), such as belching, gurgling, and burping. In conclusion, probiotic use can be beneficial for GERD symptoms, such as regurgitation and heartburn. However, proper placebo-controlled, randomized, and double-blinded clinical trials with a sufficient number of participants are warranted to confirm its efficacy in alleviating these symptoms. Further, interventions with longer durations and an intermediate analysis of endpoints should be considered to determine the proper therapeutic window.
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Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper.
Deraman, MA, Abdul Hafidz, MI, Lawenko, RM, Ma, ZF, Wong, MS, Coyle, C, Lee, YY
Alimentary pharmacology & therapeutics. 2020;(11):1014-1021
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BACKGROUND Late-night supper increases the risk of postprandial reflux from the acid pocket especially in obesity. An alginate-based, raft-forming medication may be useful for obese patients with GERD. AIMS To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants. METHODS Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH < 4 at lower oesophagus and improvement in frequency and visual analogue score (VAS) of regurgitation. RESULTS Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5 years, males 77.8% and BMI 32.8 kg/m2 ) were randomised to Gaviscon Advance (n = 13) or antacid (n = 13). Median pH of the acid pocket but not the lower oesophagus was suppressed with Gaviscon Advance vs antacid (all P < 0.04) Gaviscon Advance but not antacid significantly reduced in % time pH < 4, symptom frequency and VAS on day 2 vs day 1 (all P < 0.05). CONCLUSIONS Among obese individuals, Gaviscon Advance was superior to a non-alginate antacid in post-supper suppression of the acid pocket. (Clinical trial registration unique identifier: NCT03516188).