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Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial.

ABSTRACT: Alternative treatments are commonly used for various disorders and often taken on-demand. On-demand treatment of gastroesophageal reflux disease (GERD) with pharmaceutical products is an established, cost-effective strategy. Comparisons between alternative medicine and pharmaceutical products are rare. The aim of this trial was to compare on-demand treatment with a pectin-based, raft-forming, natural, anti-reflux agent (PRA) with that of esomeprazole 20 mg (Eso20) in patients with mild/moderate GERD.Patients with mild/moderate GERD were randomised to a six weeks' on-demand treatment with PRA or Eso20 in a pragmatic, open, multicentre trial. Overall satisfaction with treatment, satisfactory relief on a weekly basis, reflux symptoms, and treatment preferences were noted.Seventy-seven patients were included in the analyses. Eso20 was significantly superior to PRA for proportion of overall satisfied patients (92% and 58% respectively; p = 0.001), reduction of symptoms (mean symptom scores at the end 5.9 and 8.0 respectively; p = 0.019), proportion of weeks of satisfactory relief (89% and 62% respectively; p = 0.008) and proportion preferring continuation with the same treatment (85% and 42% respectively; p < 0.001). Older patients were more satisfied than younger, and patients preferring on-demand treatment had lower symptom scores at inclusion than those preferring regular treatment.On-demand treatment with esomeprazole 20 mg was clearly superior to the pectin-based raft-forming agent. Most patients preferred on-demand treatment to regular treatment. Those preferring regular therapy had significantly more symptoms at inclusion.

SUBMITTER: Farup PG

PROVIDER: S-EPMC2657103 | biostudies-literature | 2009 Feb

REPOSITORIES: biostudies-literature

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Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial.

Farup Per G PG Heibert Mathis M Høeg Victor V

BMC complementary and alternative medicine 20090224

<h4>Background</h4>Alternative treatments are commonly used for various disorders and often taken on-demand. On-demand treatment of gastroesophageal reflux disease (GERD) with pharmaceutical products is an established, cost-effective strategy. Comparisons between alternative medicine and pharmaceutical products are rare. The aim of this trial was to compare on-demand treatment with a pectin-based, raft-forming, natural, anti-reflux agent (PRA) with that of esomeprazole 20 mg (Eso20) in patients ...[more]

PMID: 19236727

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Project description:It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted.ClinicalTrials.gov NCT01915173.

Project description:To compare magnetic imaging-assisted colonoscopy (MIC) with conventional colonoscopy (CC).Magnetic imaging technology provides a computer-generated image of the shape and position of the colonoscope onto a monitor to give visual guidance to the endoscopist. It is designed to improve colonoscopy performance and tolerability for patients by enabling visualization of loop formation and endoscope position. Recently, a new version of MIC technology was developed for which there are limited data.To evaluate this latest generation of MIC among experienced rather than inexperienced or trainee endoscopists, a prospective randomized trial was performed using only gastroenterologists with therapeutic endoscopy training. Consecutive patients undergoing elective outpatient colonoscopy were randomized to MIC or CC, with patients blinded to their group assignment. Endoscopic procedural metrics and quantities of conscious sedation medications were recorded during the procedures. The procedure was classified as "usual" or "difficult" by the endoscopist at the conclusion of each case based on the need for adjunctive maneuvers to facilitate endoscope advancement. After more than one hour post-procedure, patients completed a 10 cm visual analogue pain scale to reflect the degree of discomfort experienced during their colonoscopy. The primary outcome was patient comfort expressed by the visual analogue pain score. Secondary outcomes consisted of endoscopic procedural metrics as well as a sedation score derived from standardized dose increments of the conscious sedation medications.Two hundred fifty-three patients were randomized and underwent MIC or CC between September 2011 and October 2012. The groups were similar in terms of the indications for colonoscopy and patient characteristics. There were no differences in cecal intubation rates (100% vs 99%), insertion distance-to-cecum (82 cm vs 83 cm), time-to-cecum (6.5 min vs 7.2 min), or polyp detection rate (47% vs 52%) between the MIC and CC groups. The primary outcome of mean pain score (1.0 vs 0.9 out of 10, P = 0.41) did not differ between MIC and CC groups, nor did the mean sedation score (8.2 vs 8.5, P = 0.34). Within the subgroup of cases considered more challenging or difficult, time-to-cecum was significantly faster with MIC compared to CC, 10.1 min vs 13.4 min respectively (P = 0.01). Sensitivity analyses confirmed a similar pattern of overall findings when each endoscopist was considered separately, demonstrating that the mean results for the entire group were not unduly influenced by outlier results from any one endoscopist.Although the latest version of MIC resulted in faster times-to-cecum within a subgroup of more challenging cases, overall it was no better than CC in terms of patient comfort, sedation requirements and endoscopic procedural metrics, when performed in experienced hands.

Project description:Importance:Restoration of the esophagogastric junction competence is critical for effective long-term treatment of gastroesophageal reflux disease. Surgical repair results in such restoration, but mechanical adverse effects seem unavoidable. Minimizing these adverse effects without jeopardizing reflux control is warranted. Objective:To determine whether partial fundoplication (PF) or total fundoplication (TF) is superior in laparoscopic antireflux surgery. Design, Setting, and Participants:In this double-blind, randomized clinical trial of 1171 patients scheduled for laparoscopic antireflux surgery at a single university-affiliated center between November 19, 2001, and January 24, 2006, 456 patients were randomized and followed up for 5 years. Data were collected from November 2001 to April 2012, and data were analyzed from April 2012 to September 2018. Interventions:A 270° posterior PF or a 360° Nissen TF. Main Outcomes and Measures:Esophageal acid exposure at 3 years after surgery. Result:Of the 456 randomized patients, 268 (58.8%) were male, and the mean (SD) age was 49.0 (11.7) years. A total of 229 patients were randomized to PF, and 227 patients were randomized to TF. At 3 years postoperatively, the median (interquartile range) esophageal acid exposure was reduced from 14.6% (9.8-21.9) to 1.8% (0.7-4.4) after PF and from 16.0% (10.4-22.7) to 2.5% (0.8-6.8) after TF (P = .31). Likewise, reflux symptoms were equally and effectively controlled. Early postoperative dysphagia (6 weeks) was common in both groups but then decreased toward normality. A small but statistically significant difference in favor of PF was noted in the mean (SD) scoring of dysphagia for liquids at 6 weeks (PF, 1.6 [0.9]; TF, 1.9 [1.3]; P = .01) and for solid food at 12 months (PF, 1.3 [1.0]; TF, 1.9 [1.4]; P < .001) and 24 months (PF, 1.3 [0.9]; TF, 1.7 [1.2]; P = .001). Quality of life was reduced before surgery but increased to normal values after surgery and remained so over 5-year follow-up, with no difference between the groups. Conclusions and Relevance:The results from this randomized clinical trial suggest that although PF and TF could be recommended for treatment of gastroesophageal reflux disease, PF might be superior by inducing less dysphagia. Trial Registration:ClinicalTrials.gov identifier: NCT03659487.

Project description:Background and objectiveOmeprazole is a proton pump inhibitor that is used in acid suppression therapy in infants. Infants cannot swallow the oral tablets or capsules. Since, infants require a non-standard dose of omeprazole, the granules or tablets are often crushed or suspended in water or sodium bicarbonate, which may destroy the enteric coating. In this study we explore the efficacy and pharmacokinetics of rectally administered omeprazole in infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH) and compare these with orally administered omeprazole.MethodsInfants (6-12 weeks postnatal and bodyweight > 3 kg) with EA or CDH and GERD were randomized to receive a single dose of 1 mg/kg omeprazole rectally or orally. The primary outcome was the percentage of infants for whom omeprazole was effective according to predefined criteria for 24-h intraesophageal pH. Secondary outcomes were the percentages of time that gastric pH was < 3 or < 4, as well as the pharmacokinetic parameters.ResultsSeventeen infants, 4 with EA and 13 with CDH, were included. The proportion of infants for whom omeprazole was effective was 56% (5 of 9 infants) after rectal administration and 50% (4 of 8 infants) after oral administration. The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration. Rectal and oral administration of omeprazole resulted in similar serum exposure.ConclusionsA single rectal omeprazole dose (1 mg/kg) results in consistent increases in intraesophageal and gastric pH in infants with EA- or CDH-related GERD, similar to an oral dose. Considering the challenges with existing oral formulations, rectal omeprazole presents as an innovative, promising alternative for infants with pathological GERD.Clinical trial registerClinicalTrials.gov Identifier: NCT00226044.

Dataset Information

Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial.

Publications

Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial.

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