Background
An international group of experts evaluated and revised recommendations for ambulatory reflux monitoring for the diagnosis of gastro‐esophageal reflux disease (GERD).
Methods
Literature ...search was focused on indications and technical recommendations for GERD testing and phenotypes definitions. Statements were proposed and discussed during several structured meetings.
Key Results
Reflux testing should be performed after cessation of acid suppressive medication in patients with a low likelihood of GERD. In this setting, testing can be either catheter‐based or wireless pH‐monitoring or pH‐impedance monitoring. In patients with a high probability of GERD (esophagitis grade C and D, histology proven Barrett's mucosa >1 cm, peptic stricture, previous positive pH monitoring) and persistent symptoms, pH‐impedance monitoring should be performed on treatment. Recommendations are provided for data acquisition and analysis. Esophageal acid exposure is considered as pathological if acid exposure time (AET) is greater than 6% on pH testing. Number of reflux episodes and baseline impedance are exploratory metrics that may complement AET. Positive symptom reflux association is defined as symptom index (SI) >50% or symptom association probability (SAP) >95%. A positive symptom‐reflux association in the absence of pathological AET defines hypersensitivity to reflux.
Conclusions and Inferences
The consensus group determined that grade C or D esophagitis, peptic stricture, histology proven Barrett's mucosa >1 cm, and esophageal acid exposure greater >6% are sufficient to define pathological GERD. Further testing should be considered when none of these criteria are fulfilled.
The consensus group proposes to define pathological GERD as at least one of the following criteria: Grade C or D esophagitis, peptic stricture, Barrett's mucosa >1 cm and esophageal acid exposure >6%. Number of reflux episodes and baseline impedance should be considered as exploratory tools for further research.
Background
Treatment of gastro‐esophageal reflux refractory symptoms is challenging. This monocenter retrospective study assessed the value of preoperative pH‐impedance monitoring ‘on’ therapy to ...predict functional outcome after laparoscopic fundoplication in patients with refractory reflux symptoms.
Methods
Patients with a preoperative pH‐impedance monitoring ‘on’ proton pump inhibitors (PPIs) twice daily were assessed at least 6 months after a laparoscopic fundoplication for refractory reflux symptoms. Failure of fundoplication was defined by a Visick score > 2. Postoperative symptoms were assessed by the reflux disease questionnaire (RDQ). The pH‐impedance parameters analyzed were the number of reflux events (total, acid, non‐acid), esophageal acid exposure time, esophageal bolus exposure time, and symptom‐reflux association defined by symptom index (SI) >50% and symptom association probability (SAP) >95%.
Key Results
Thirty‐three patients (18 female patients, median age 46 years) were assessed after a mean follow‐up of 41.3 (range 7–102.2) months. Seven (21.2%) patients were considered as failures. Compared to patients with favorable outcome, these patients were more often ‘on’ PPI therapy (86% vs 23%, p < 0.05) and had higher RDQ scores in each domain: heartburn (p < 0.05), regurgitation (p < 0.05) and dyspepsia (p < 0.05). A positive SAP was the only pH‐impedance parameter statistically associated with successful postoperative outcome (p = 0.004).
Conclusions & Inferences
On therapy, a preoperative positive symptom association probability is the only pH‐impedance parameter associated with favorable outcome after laparoscopic fundoplication for refractory reflux symptoms. These results should be confirmed by prospective studies.
In patients with refractory reflux symptoms, the role of antireflux surgery is debated. There is no consensus regarding patients' selection for surgery. We conducted a retrospective study in two groups of patients with favorable (n = 26) and unsatisfactory outcomes (n = 7) who had preoperative esophageal pH‐impedance monitoring on double dose PPIs. On therapy, neither pH‐impedance reflux parameters nor positive SI could help to discriminate patients with favorable and unsatisfactory outcomes. Only a positive SAP was significantly associated with successful clinical outcome.
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Approximately 20% of patients have persistent symptoms of gastro-oesophageal reflux despite proton pump inhibitor (PPI) therapy. The aim of this study was to assess the determinants of reflux ...perception in patients on PPI therapy.
20 patients with typical gastro-oesophageal reflux symptoms (heartburn and/or regurgitation) despite double-dose PPIs (twice daily) were included in this study. Ambulatory 24 h pH-impedance studies were performed in all patients. The characteristics of symptomatic and asymptomatic reflux episodes were compared. Symptoms were considered globally and separately for heartburn and regurgitation.
A total of 1273 reflux episodes were detected including 243 (19.1%) acidic, 1018 (80.0%) weakly acidic and 12 (0.9%) weakly alkaline reflux episodes. Overall, 312 (24.5%) reflux episodes were symptomatic. The only factor associated with reflux perception was high proximal extent (p = 0.037). Compared with regurgitation, reflux episodes associated with heartburn were more frequently pure liquid (p = 0.009) and acidic (p = 0.027), had a lower nadir pH (p<0.001), were more frequently preceded by acid reflux episodes (p<0.001) and had a longer reflux bolus clearance time (p<0.001).
High proximal extent of the refluxate is the only factor associated with reflux perception in patients on double-dose PPI. However, compared with regurgitation, composition of the refluxate, sensitisation of the oesophagus by preceding acid exposure and delayed bolus clearance appear to play a role in heartburn perception.
Background
Open studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double‐blind crossover RCT.
...Methods
Patients with at least two of the following criteria were included: fewer than three bowel movements per week; straining to evacuate on more than 25 per cent of attempts; or sensation of incomplete evacuation on more than 25 per cent of occasions. Response to therapy was defined as at least three bowel movements per week and/or more than 50 per cent improvement in symptoms. Responders to an initial 3‐week peripheral nerve evaluation were offered permanent implantation of a pulse generator and were assigned randomly in a crossover design to two 8‐week intervals of active or sham stimulation. At the end of the two trial periods, the patients received active stimulation until the final evaluation at 1 year.
Results
Thirty‐six patients (34 women; mean(s.d.) age 45(14) years) underwent peripheral nerve evaluation. Twenty responded and received a permanent stimulator. A positive response was observed in 12 of 20 and 11 of 20 patients after active and sham stimulation periods respectively (P = 0·746). Pain related to the device occurred in five patients and wound infection or haematoma in three, leading to definitive removal of the pulse generator in two patients. At 1 year, 11 of the 20 patients with an implanted device continued to respond. Stimulation had no significant effect on colonic transit time.
Conclusion
These results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number: NCT01629303 (http://www.clinicaltrials.gov).
Limited value in constipation
Summary
Background
Recently, a new enteropathy has been described: olmesartan‐associated enteropathy. However, the association has been questioned: a phase 3 trial and a cohort study found no ...association between gastrointestinal events and olmesartan.
Aim
To collect French cases of sartan‐associated enteropathy to describe further this entity, confirm or refute causality, and determine if the association exists with other sartans.
Methods
French gastroenterologists were invited to report cases of sartan‐associated enteropathy and collect clinical, biological and histological data. Patients with diarrhoea and histological duodenal abnormalities were included.
Results
Thirty‐six patients with olmesartan‐associated enteropathy were reported, including 32 with villous atrophy and four without. There was only one patient with irbesartan‐associated enteropathy. None of the patients died. Patients with villous atrophy had diarrhoea, vomiting, renal failure, hypokalaemia, body weight loss and hypoalbuminaemia. Thirty‐one patients were hospitalised; four required intensive care. Anti‐transglutaminase and anti‐enterocyte antibodies were negative; anti‐nuclear antibodies were positive (9/11). Endoscopic duodenal biopsies showed villous atrophy (32/32) and polyclonal intra‐epithelial CD3+CD8+ lymphocytosis (11/11). Exactly, 14/15 patients responded to steroids and/or immunosuppressants, prescribed because of suspected autoimmune enteropathy. Ten olmesartan interruptions were followed by reintroductions before steroids or immunosuppressants. Interruptions were followed by remissions (9/10), but reintroductions were followed by relapses (9/9). Twenty‐nine patients were in remission since olmesartan interruption, including 26 without immunosuppressants. Patients with normal villi had similar clinical characteristics, but mild histological abnormalities (intra‐epithelial lymphocytosis and lamina propria lymphocytic infiltration).
Conclusions
Olmesartan causes a severe and immune‐mediated enteropathy, with or without villous atrophy. Enteropathy associated with other sartans seems to be very rare.
The objective of this study was to show that although transcutaneous electrical tibial nerve stimulation (TENS) is being increasingly used to treat fecal incontinence (FI), its efficacy has never ...been proved using controlled trials.
In this randomized, double-blind, sham-controlled trial, 144 patients aged 30-82 years from nine centers were randomly assigned to receive either active or sham stimulations for 3 months. The primary end point was the response to treatment based on the number of incontinence and urgency episodes. Secondary end points were severity scores, quality of life scores, delay to postpone defecation, patient self-assessment of treatment efficacy, physician assessment of TENS efficacy, anorectal manometry, and adverse events.
No statistically significant difference was seen between active and sham TENS in terms of an improvement in the median number of FI/urgency episodes per week. Thirty-four patients (47%) who received the active TENS treatment exhibited a >30% decrease in the FI severity score compared with 19 patients (27%) who received the sham treatment (odds ratio 2.4, 95% confidence interval 1.1-5.1, P=0.02). No differences in delay to postpone defecation, patient self-assessment of treatment efficacy, or anorectal manometry were seen between the two groups. The evaluating physicians rated the active stimulations as more effective than the sham stimulations (P=0.01). One minor therapy-related adverse event was observed (1.5%) (see Supplementary Consort 1b).
We failed to demonstrate any benefit of TENS on our primary end-point.
Background
The role of gastroesophageal reflux in chronic laryngeal symptoms is difficult to establish. The aim of this study was to characterize pharyngeal and esophageal pH–impedance reflux ...patterns in a group of patients with suspected laryngopharyngeal reflux and to determine predictive factors of response to proton pump inhibitors.
Methods
Patients with chronic pharyngolaryngeal symptoms were evaluated with a symptom score questionnaire, laryngoscopy, and 24‐hour pharyngeal and esophageal pH–impedance monitoring at baseline and after 8‐week treatment with esomeprazole 40 mg b.i.d. Response to treatment was defined by a diminution of more than 50% of the score for the primary symptom. Reflux patterns and baseline impedance values were compared to those obtained in 46 healthy subjects.
Key Results
Twenty‐four patients were included (17 women, median age 54 years), all previously refractory to antisecretory therapy. Symptom scores were 46 (32–62) and 40 (27–76) off and on therapy, respectively (P=.1). There was no significant difference between patients and controls for pH–impedance reflux parameters and baseline values off and on therapy in distal and proximal esophagus and in the pharynx. Median numbers of pharyngeal reflux were 0 and 0 off and on therapy, respectively. Only two patients were responders to treatment, both with excessive distal reflux but no pharyngeal reflux. Only one patient had abnormal pharyngeal reflux but did not respond to proton pump inhibitors.
Conclusions
Patients with suspected laryngopharyngeal reflux refractory to therapy do not exhibit abnormal pharyngeal or esophageal pH–impedance reflux. In these patients, laryngopharyngeal reflux is unlikely.
The role of gastroesophageal reflux in chronic laryngeal symptoms is difficult to establish. This prospective study shows that patients with suspected laryngopharyngeal reflux refractory to therapy do not exhibit abnormal pharyngeal or esophageal pH–impedance reflux. In these patients, laryngopharyngeal reflux is unlikely and has been largely overestimated.
Summary
Background : Impedance‐pH monitoring is the most sensitive method for detection and characterization of gastro‐oesophageal reflux episodes. Normal values from European subjects are lacking.
...Aim : To build a database of gastro‐oesophageal reflux patterns from French and Belgian healthy subjects.
Methods : Seventy‐two healthy subjects (35 men, mean age 35 years, 18–72) underwent 24‐h ambulatory impedance‐pH studies. Gastro‐oesophageal reflux episodes were detected using impedance and characterized by pH as acid, weakly acidic, or weakly alkaline. Analysis was performed visually and effects of age, gender and intra‐individual reproducibility were evaluated.
Results : The total number of gastro‐oesophageal reflux episodes was 44 (25,58,75) of which 59% were acid, 28% were weakly acidic and 10% weakly alkaline. Half of gastro‐oesophageal reflux episodes were mixed (liquid/gas) and 22% reached 15 cm above the lower oesophageal sphincter. The bolus clearance time was 11 s while acid was chemically cleared in 34 s. Male gender was associated with increased number and proximal extent of total and acid gastro‐oesophageal reflux. Repeated studies in 27 subjects showed good reproducibility for number, acidity and air–liquid composition of reflux (Kendall's W‐values = 0.72–0.85).
Conclusions : This study demonstrates good reproducibility of 24‐h ambulatory impedance‐pH studies and provides values of reflux patterns in healthy subjects for comparisons with European gastro‐oesophageal reflux disease patients.
Background
Criteria for transient lower esophageal sphincter relaxations (TLESRs) are well‐defined for Dentsleeve manometry. As high‐resolution manometry (HRM) is now the gold standard to assess ...esophageal motility, our aim was to propose a consensus definition of TLESRs using HRM.
Methods
Postprandial esophageal HRM combined with impedance was performed in 10 patients with gastroesophageal reflux disease. Transient lower esophageal sphincter relaxations identification was performed by 17 experts using a Delphi process. Four investigators then characterized TLESR candidates that achieved 100% agreement (TLESR events) and those that achieved less than 25% agreement (non‐events) after the third round. Logistic regression and decision tree analysis were used to define optimal diagnostic criteria.
Key Results
All diagnostic criteria were more frequently encountered in the 57 TLESR events than in the 52 non‐events. Crural diaphragm (CD) inhibition and LES relaxation duration >10 seconds had the highest predictive value to identify TLESR. Based on decision tree analysis, reflux on impedance, esophageal shortening, common cavity, upper esophageal sphincter relaxation without swallow and secondary peristalsis were alternate diagnostic criteria.
Conclusion & Inferences
Using HRM, TLESR might be defined as LES relaxation occurring in absence of swallowing, lasting more than 10 seconds and associated with CD inhibition.
A consensus definition of transient lower espohageal sphincter relaxation (TLESR) using high resolution manometry is proposed. TLESR is defined as LES relaxation occurring in absence of swallowing, lasting more than 10 seconds and associated with crural definition inhibition. Reflux on impedance, esophageal shortening, common cavity, upper esophageal sphincter relaxation without swallow and secondary peristalsis are alternate diagnostic criteria.
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