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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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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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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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Abstract
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).
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Application of mineral waters in the complex treatment of patients with gastroesophageal reflux disease.
Dragomiretska, NV, Babov, KD, Gushcha, SG, Zabolotna, IB, Plakida, AL, Izha, AN, Babova, IK, Nasibullin, BA, Trubka, IA
Minerva gastroenterologica e dietologica. 2020;(3):225-237
Abstract
BACKGROUND Gastroesophageal reflux disease (GERD) is one of the most common gastric pathologies. Recently, there has been a growing interest in the healing effects of mineral waters (MW). METHODS Ninety patients with GERD were under observation. The study used the following methods: anamnestic, clinical, studies of biochemical blood parameters, ultrasonographic studies of the digestive system, fibroesophagogastroduodenoscopy with intragastric pH-metric. After preliminary research, all patients were randomly divided into three groups of 30 people. The control group (group 1) who were prescribed a basic treatment complex-dietary and proton pump inhibitor group drugs. Patients of group 2 in addition to the standard course of treatment received boric highly mineralized bicarbonate sodium water. Patients of group 3 in addition to the basic therapy were prescribed an internal course treatment of highly mineralized sulfate-bicarbonate sodium-magnesium water. RESULTS The use of the basic complex of treatment for a month in control group did not lead to a significant leveling of signs of dyspeptic and asthenic syndromes. The use of boron highly mineralized sodium bicarbonate water led to a significant leveling of signs of abdominal pain and dyspeptic syndromes, improvement of acid-forming function of the stomach, but no reliable dynamics were observed in eliminating signs of cytolytic, mesenchymal inflammatory and cholestatic syndromes. Application of highly mineralized sulfate-hydrocarbonate sodium magnesium water improves the elimination of dyspepsia and pain syndromes, normalization of the functional state of the liver. CONCLUSIONS The obtained data confirm the prospects of using highly mineralized mineral waters in the complex treatment of GERD patients.
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Effect of Gastric Acid Suppressants on Response to a Physical Activity Intervention and Major Mobility Disability in Older Adults: Results from the Lifestyle Interventions for Elders (LIFE) Study.
Squires, PJ, Pahor, M, Manini, TM, Brown, JD
Pharmacotherapy. 2019;(8):816-826
Abstract
OBJECTIVES Proton pump inhibitors (PPIs) and histamine2 receptor antagonists (H2 RAs) are associated with pharmacologic effects that may be detrimental to mobility and response to physical activity. Mobility disability and injurious fall outcomes in PPI and H2 RA users were compared with nonusers in this secondary analysis of data from the Lifestyle Interventions for Elders (LIFE) study. METHODS Participants ages 70-89 years were randomized to a physical activity (PA) or successful aging intervention and evaluated by medication use. Confounders included baseline demographic characteristics, physical function, cognitive function, sleep quality, and acid reflux symptoms that were adjusted via propensity score weighting. Outcomes were incident and persistent major mobility disability (MMD and pMMD) and injurious falls. Weighted proportional hazard models evaluated independent and interaction effects of PPIs and H2 RAs. RESULTS No interaction was found between PPIs and H2 RAs and the PA intervention. Drug use associations were significant for H2 RAs (hazard ratio [HR] 1.74 [95% confidence interval [CI] 1.12-2.68]) and PPIs (HR 1.32 [95% CI 1.02-1.70]) compared with nonusers for pMMD. PPIs were associated with increased injurious falls compared with nonusers (HR 1.44 [95% CI 1.06-1.96]). Pooling of data from the H2 RA and PPI exposure groups showed a 26% increase in MMD (HR 1.26 [95% CI 1.07-1.48]), a 44% increase in pMMD (HR 1.44 [95% CI 1.16-1.77]), and a 48% increase in injurious falls (HR 1.48 [95% CI 1.15-1.91]) compared with nonusers. All direct comparisons between PPIs and H2 RAs were nonsignificant. CONCLUSIONS Compared with nonusers, participants using either PPIs or H2 RAs had an increased risk of MMD, pMMD, and injurious falls. It is not known if these effects are related to the individual pharmacology of each medication, reduced acid secretion, or the underlying disease state. Further study is required to determine causality.
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Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk: A Randomized Controlled Trial.
Uygur, O, Yalaz, M, Can, N, Koroglu, OA, Kultursay, N
Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine. 2019;(3):154-158
Abstract
PURPOSE Feeding intolerance is one of the most frequent problems among preterm infants. These infants are fed with expressed breast milk or preterm formulas of which the temperature is not routinely measured. In this study, we aimed to examine the effects of feeds with warm milk versus room temperature milk in preterm infants. MATERIALS AND METHODS Infants with a birth weight ≤1,500 g or gestational age ≤34 weeks were included in the study and assigned to two different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were exclusively breast milk-fed, and some received breast milk and artificial milk (mixed feeding). Feeding tolerance of infants in both groups and the consequences were evaluated. RESULTS In total, 80 preterm infants (group 1 fed with milk at 22-24°C, n = 40; group 2 fed with milk at 32-34°C, n = 40) were prospectively included in the study. There was a slight decrease in gastric residual frequency in infants fed with breast milk in group 2. Apnea was significantly more frequent in group 1 (p = 0.006), and these infants needed more anti-reflux treatment (p = 0.013). CONCLUSION According to our results, warming enteral feeds close to body temperature are encouraging especially due to the decrease in gastric residual frequency, apnea of prematurity, and need for anti-reflux treatment. More studies may confirm the positive effect of warm enteral feeds on feeding tolerance in preterm infants.
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Effect of wu chu yu tang on gastroesophageal reflux disease: Randomized, double-blind, placebo-controlled trial.
Shih, YS, Tsai, CH, Li, TC, Yu, CJ, Chou, JW, Feng, CL, Wang, KT, Lai, HC, Hsieh, CL
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2019;:118-125
Abstract
BACKGROUND The main symptoms of gastroesophageal reflux disease GERD are heartburn and acid regurgitation. Proton-pump inhibitors (PPI) are considered to be safe and effective for the treatment of GERD. In traditional Chinese medicine, wu chu yu tang (WCYT) is used to treat nausea after eating, vomiting, and diarrhea. PURPOSE We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the therapeutic effect of WCYT on GERD using omeprazole as a PPI for the positive control. METHODS Ninety patients with GERD were randomly assigned to the 1) control group (CG), who received an oral administration of omeprazole (20 mg) once per day and given WCYT placebo (3.0 g) three times per day for 4 weeks continuously; or the 2) treatment group (TG), who received oral administration of omeprazole (20 mg) placebo once per day and WCYT (3.0 g) three times per day for 4 weeks continuously. RESULTS Seventy-seven patients (37 in CG, 40 in TG) completed the trial. Both Reflux Disease Questionnaire (RDQ) and Gastroesophageal Reflux Disease Questionnaire (GERDQ) scores was less in the second assessment (V2) and in the third assessment (V3) than those in V1 (first assessment; baseline) in the CG and TG groups (all p < 0.001); the score difference of both RDQ and GERDQ between V2 and V1 was similar between CG and TG (p = 1.00, p = 0.54, respectively). The score difference of both RDQ and GERD between V3 and V1 was less in the CG group than those of the TG group (both p = 0.004). CONCLUSION WCYT has an effect similar to omeprazole for GERD treatment. Furthermore, this effect resulting from WCYT appeared to be maintained for a longer period of time than did that of omeprazole. A study with a larger sample size and longer study period is needed to corroborate our findings.
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Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects.
Kim, E, Kim, A, Yi, S, Kim, YK, Jang, SB, Byun, HM, Yoon, SH, Cho, JY, Jang, IJ, Yu, KS, et al
European journal of clinical pharmacology. 2018;(10):1261-1272
Abstract
PURPOSE YH4808 is a potassium-competitive acid blocker, developed for the treatment of acid-related disorders. Two clinical studies in healthy male subjects were conducted to evaluate the effect of food on the pharmacokinetics of YH4808. METHODS The first study, a randomized, three-treatment, three-period, crossover study, compared pharmacokinetics of YH4808 (300 mg) after a single dose at fed state with a standard or a high-fat meal to those at fasted state. The second study, a randomized, two-treatment, two-period, crossover study, investigated pharmacokinetics at fasted or fed state with a standard meal after twice daily dose of YH4808 (100 mg) for 7 days. Bloods for pharmacokinetic evaluation were sampled up to 48 h post-dose and 24 h post-dose at steady state, respectively. The pharmacokinetic parameters were estimated by non-compartmental method. RESULTS After single dosing, the geometric means of maximum plasma concentration increased by 1.2 and 2.1 times in the fed states with a standard meal and a high-fat meal, respectively, of that in fasted state. Corresponding values of area under the plasma concentration-time curve (AUC) from time 0 to the last measurable time point increased by 1.8 and 2.8 times, respectively. After multiple dosing, the geometric mean for 24-h AUC at steady state slightly increased in fed state by 1.1 times of that in fasted state. CONCLUSIONS As fat content of the food increased, the systemic exposure of YH4808 after single dosing increased. However, systemic exposures at steady state after multiple dosing between fasted and fed states were similar. TRIAL REGISTRATION ClinicalTrials.gov registry no.: NCT01520012.