Heartburn Symptom Scores Research Articles

Analysis of the Effectiveness of Biling Weitong Granules Combined with Trimethoprim and Vonoprazan in The Treatment of Reflux Esophagitis

Objective: To analyze the effectiveness of Biling Weitong Granules (BLWTG) combined with trimethoprim and vonoprazan in treating reflux esophagitis. Methods: Sixty patients with reflux esophagitis admitted to our hospital from March 2020 to March 2023 were selected as study subjects and randomly divided into a control group and an experimental group, with 30 cases in each group. The control group received only the combination treatment of trimethoprim and vonoprazan, while the experimental group was treated with BLWTG based on the control group. The acid reflux and heartburn symptom scores, quality-of-life scores, clinical efficacy, Chinese medicine symptom incidences, and the occurrence of adverse reactions before and after treatment in the two groups were compared. Results: After treatment, the acid reflux and heartburn symptom scores of patients in the experimental group were lower than those of the treatment control group, and the quality-of-life scores were higher than those of the treatment control group (P < 0.05). The total clinical efficacy of the experimental group was 96.66%, which was significantly higher than that of the control group (73.33%, P < 0.05). After treatment, the incidence of Chinese medicine symptoms, such as nausea and vomiting, abdominal distension and abdominal pain, and loss of appetite of the patients in the experimental group were significantly lower than those of the control group (P < 0.05). During the treatment period, there was no significant difference in the incidence of adverse reactions between the two groups, which indicated that the safety of the two treatments was comparable (P > 0.05). Conclusion: BLWTG combined with trimethoprim and vonoprazan was safe and reliable in treating reflux esophagitis, effectively relieving the symptoms and improving its clinical efficacy. This treatment is worthy of popularization.

A novel prostanoid EP1 receptor antagonist, ONO-8539, reduces acid-induced heartburn symptoms in healthy male volunteers: a randomized clinical trial.

Patients with proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) have unmet clinical needs. Recently, we reported that esophageal prostaglandin E2 (PGE2) plays a crucial role in the generation of heartburn. In the present study, we focused on the PGE2 receptor, EP1, and investigated the effects of ONO-8539, a novel EP1 receptor antagonist, on heartburn symptoms in healthy male volunteers. This prospective, double-blind, placebo-controlled, two-period crossover study was performed in 20 healthy male subjects. The novel prostanoid EP1 receptor antagonist, ONO-8539 (450mg), was administered once 4h prior to acid perfusion test. During the test, hydrochloric acid (0.15moll-1) was perfused into the lower esophagus for 30min. Acid perception threshold was quantified by the time to first sensation of heartburn and intensity of GI symptoms determined using a validated categorical rating scale, and the area under the curve (AUC) as the total symptom score. ONO-8539 significantly reduced a total heartburn symptom score, not other upper GI symptom scores, during acid perfusion compared with placebo (AUC for heartburn, 85.0±10.6 for placebo and 56.5±7.2 for ONO-8539; P< 0.01), and significantly extended the time to first sensation of heartburn compared with placebo (5.7±4.3min for placebo and 9.7±7.2min for ONO-8539; P<0.05). ONO-8539 attenuated acid-induced heartburn in healthy male subjects, suggesting that EP1 receptors play a role in generation of heartburn symptoms. ONO-8539 is a potential novel therapeutic option for controlling heartburn symptoms in GERD patients. Clinical Trials Registry No: UMIN000015753.

Upper Gastrointestinal Symptoms Predictive of Candida Esophagitis and Erosive Esophagitis in HIV and Non-HIV Patients: An Endoscopy-Based Cross-Sectional Study of 6011 Patients.

Upper gastrointestinal (GI) symptoms are common in both HIV and non-HIV-infected patients, but the difference of GI symptom severity between 2 groups remains unknown. Candida esophagitis and erosive esophagitis, 2 major types of esophagitis, are seen in both HIV and non-HIV-infected patients, but differences in GI symptoms that are predictive of esophagitis between 2 groups remain unknown. We aimed to determine whether GI symptoms differ between HIV-infected and non-HIV-infected patients, and identify specific symptoms of candida esophagitis and erosive esophagitis between 2 groups.We prospectively enrolled 6011 patients (HIV, 430; non-HIV, 5581) who underwent endoscopy and completed questionnaires. Nine upper GI symptoms (epigastric pain, heartburn, acid regurgitation, hunger cramps, nausea, early satiety, belching, dysphagia, and odynophagia) were evaluated using a 7-point Likert scale. Associations between esophagitis and symptoms were analyzed by the multivariate logistic regression model adjusted for age, sex, and proton pump inhibitors.Endoscopy revealed GI-organic diseases in 33.4% (2010/6.011) of patients. The prevalence of candida esophagitis and erosive esophagitis was 11.2% and 12.1% in HIV-infected patients, respectively, whereas it was 2.9% and 10.7 % in non-HIV-infected patients, respectively. After excluding GI-organic diseases, HIV-infected patients had significantly (P < 0.05) higher symptom scores for heartburn, hunger cramps, nausea, early satiety, belching, dysphagia, and odynophagia than non-HIV-infected patients. In HIV-infected patients, any symptom was not significantly associated with CD4 cell count. In multivariate analysis, none of the 9 GI symptoms were associated with candida esophagitis in HIV-infected patients, whereas dysphagia and odynophagia were independently (P < 0.05) associated with candida esophagitis in non-HIV-infected patients. However, heartburn and acid regurgitation were independently (P < 0.05) associated with erosive esophagitis in both patient groups. The internal consistency test using Cronbach's α revealed that the 9 symptom scores were reliable in both HIV (α, 0.86) and non-HIV-infected patients (α, 0.85).This large-scale endoscopy-based study showed that HIV-infected patients have greater GI symptom scores compared with non-HIV-infected patients even after excluding GI-organic diseases. None of the upper GI symptoms predict candida esophagitis in HIV-infected patients, but dysphagia and odynophagia predict candida esophagitis in non-HIV-infected patients. Heartburn and acid regurgitation predict erosive esophagitis in both patient groups.

The Impact of Laparoscopic Nissen Fundoplication on the Long-Term Quality of Life in Patients With Gastroesophageal Reflux Disease

Laparoscopic Nissen fundoplication is now the most common surgical procedure for treatment of gastroesophageal reflux disease (GERD), offering promising long-term outcomes. Outcomes for 46 patients with GERD who underwent Nissen fundoplication during the last 5 years (November 2007-June 2012) were prospectively studied using a structured questionnaire that evaluated clinical symptom scores for heartburn, dysphagia, and satisfaction with clinical outcomes. Postoperative care of the patients including analgesia, median hospital stay, overall cost, and complications was also studied. Clinical follow-up data for 2 years after surgery were available for all 46 patients. Forty-two patients (91.3%) were satisfied with their quality of life and only eight patients (17.4%) continued to receive antacids after surgery. Dysphagia to solid and liquid occasionally appeared in 26.1% (N = 12) and 17.4% (N = 8) of patients, respectively. Laparoscopic Nissen fundoplication was an effective long-term treatment for GERD. The operation resulted in a significant reduction of symptoms and minimized the use of antacid drugs with a high degree of patient satisfaction. Although some patients may have returned to antacid treatment at late follow-up or continued to complain of mild discomfort, they were overall pleased with the outcome.

A prospective cross-sectional study of laparoscopic subtotal Lind fundoplication for gastro-oesophageal reflux disease – A durable and effective anti-reflux procedure

Introduction: Laparoscopic partial fundoplication for gastro-oesophageal reflux disease (GORD) is reported to have fewer side effects when compared to Nissen fundoplication, but doubts remain over its long term durability in controlling reflux. The aim of this study was to assess outcome of symptoms for all patients presenting with GORD undergoing routine laparoscopic subtotal Lind fundoplication. Materials & Methods: All patients undergoing laparoscopic fundoplication between August, 1999 and November, 2007 performed by a single surgeon were included in the study. The anti-reflux procedure studied was laparoscopic Lind (300°) fundoplication with crural repair in all cases. Patients completed pre and post-operative questionnaires containing validated scoring systems for heartburn, gas bloat, dysphagia and overall patient satisfaction. Results: Over the 100-month period, 320 consecutive patients underwent laparoscopic subtotal Lind fundoplication. Of these, 256 (80%) replied to the questionnaire at a mean of 31 months (range 3–96 months) following surgery. 91.4% of respondents had an improvement in heartburn symptom score with a significant reduction in score from 7.74 preoperatively to 1.25 postoperatively (p < 0.001). There was also a significant reduction of mean modified Visick score for reflux control (heartburn and regurgitation) from 3.49 preoperatively to 1.48 after surgery (p < 0.001). In total, 22 patients developed recurrent reflux symptoms with half of these reporting their recurrence within two years following surgery. Because of this all were tested with post-operative pH testing, yet only one had a 24-h pH time outside the normal range. Overall patient satisfaction was high with a visual analogue score of 9 and 88% of the patients claimed they would have the operation again. Conclusion: Laparoscopic Lind fundoplication demonstrates excellent reflux control when performed routinely for all patients presenting with GORD. This technique is both durable and efficacious in controlling reflux symptoms.

A preliminary investigation of anti-reflux intervention for gastroesophageal reflux related childhood-to-adult persistent asthma.

BackgroundChildhood-to-adult persistent asthma is usually considered to be an atopic disease. However gastroesophageal reflux may also play an important role in this phenotype of asthma, especially when it is refractory to pulmonary medicine.MethodsFifty-seven consecutive GERD patients who had decades of childhood-to-adult persistent asthmatic symptoms refractory to pulmonary medication were enrolled. GERD was assessed by a symptom questionnaire, endoscopy, reflux monitoring, and manometry, and treated by Stretta radiofrequency (SRF) or laparoscopic Nissen fundoplication (LNF). The outcomes were followed up with a questionnaire for an average of 3.3 ± 1.1 years.ResultsUpper esophageal sphincter hypotonia, lower esophageal sphincter (LES) hypotonia, shortened LES, and esophageal body dyskinesia were demonstrated by esophagus manometry in 50.9%, 43.9%, 35.1%, and 45.6% of the patients, respectively. The symptom scores for heartburn, regurgitation, coughing, wheezing, and chest tightness significantly decreased from 5.8 ± 2.0, 5.6 ± 2.0, 7.3 ± 1.6, 8.4 ± 1.2, and 8.1 ± 1.5, to 1.2 ± 1.8, 1.1 ± 1.6, 2.8 ± 2.5, 3.8 ± 2.7, and 3.9 ± 2.7, respectively, after anti-reflux treatment (P < 0.001).ConclusionsEsophagus dysfunction is high in childhood-to-adult persistent asthmatic patients with GERD. SRF and LNF are both effective for esophagus symptoms as well as persistent asthmatic symptoms for these patients. GER may relate with asthmatic symptoms in some patients. Evaluating asthmatic patients for possible treatment of the underlying cause, such as GERD, may improve symptoms and prevent disease persistence.

A standardized method for measuring intercellular spaces in esophageal biopsies in patients with suspected gastroesophageal reflux disease (the intercellular space ratio)

Objective. Dilated intercellular space (DIS) in esophageal biopsies is regarded as a possible early sign of mucosal injury in gastroesophageal reflux disease (GERD). This study presents a standardized approach of intercellular space measurement. Material and methods. Distal and proximal esophageal biopsies were taken from 19 patients with suspected GERD, and examined with TEM. A grid containing 150 line-crossing points was applied upon each photomicrograph. The number of points falling on the intercellular space was divided by the total number of points of the grid, thereby creating a ratio called the intercellular space ratio (ISR). The ISR method was validated with regard to intra- and interobserver agreement, and was compared to a widely used method for measuring intercellular space diameter developed by Tobey et al. (Tobey NA, Carson JL, Alkiek RA, Orlando RC. Dilated intercellular spaces: a morphological feature of acid reflux–damaged human esophageal epithelium. Gastroenterology 1996;111(5):1200–1205). The ISR was also compared to other markers for GERD. Results. Pearson's correlation coefficients for intra- and interobserver agreement were 0.91 (p < 0.001) and 0.82 (p < 0.001), respectively. The Pearson's correlation coefficient between the ISR and the intercellular space diameter according to Tobey et al., measured in the same micrographs, was 0.32 (p < 0.001). The proximal ISR correlated significantly with the distal ISR (Spearman's rho = 0.57, p = 0.010), and with heartburn symptom score (Spearman's rho = 0.50, p = 0.028). Conclusions. The ISR showed a high intraobserver and interobserver agreement. It also displayed good external validity when compared to other markers for gastroesophageal reflux. A rather poor correlation was however found between the ISR and the intercellular space diameter measured as described by Tobey et al.

The role of short-limb Roux-en-Y reconstruction for failed antireflux surgery: a single-center 5-year experience

Revisionary fundoplication is the mainstay of treatment for failed previous fundoplication, but is not always feasible. We report our experience with use of short-limb Roux-en-Y (RNY) reconstruction for failed antireflux procedures. Prospectively collected data were retrospectively analyzed for morbidity, mortality, pre- and postprocedure symptom scores (scale 0-3), body mass index (BMI), and patient satisfaction (scale 1-10). Seventy-two patients with 1-4 (median 1) previous antireflux procedures underwent RNY reconstruction, either to gastric pouch (n = 64) or to the esophagus (n = 8). There were 37 laparoscopic, 24 open abdominal, and two combined thoracic-abdominal procedures. Nine additional patients underwent conversion from laparoscopy to open surgery. Mean follow-up of 20.7 months (± 12.9 months) was available in 63 (88%) patients. The overall median scores for heartburn, regurgitation, dysphagia, chest pain, and nausea were 0 or 1. There were 72 major and minor complications noted that affected 33 (46%) patients, with no in-hospital or 30-day mortality observed. The most common complications were anastomotic strictures, bowel obstructions, respiratory complications, and dumping. Mean postoperative BMI was 24.6 (± 4.4) kg/m(2) compared with preoperative BMI of 31.4 (± 6.1) kg/m(2). Mean reported satisfaction score was 8.2 (± 2.1), and 89% of the patients would recommend the procedure to a friend. Pre- and postoperative symptoms could be compared in 57 patients, and significant decrease in median symptom scores for heartburn (2-0, P < 0.05), regurgitation (1-0, P < 0.05), and dysphagia (2-0, P < 0.05) was confirmed. There was an increase in reported nausea (0-1, P < 0.05). Short-limb RNY reconstruction is an effective remedial procedure for a subset of patients with failed antireflux surgery, but morbidity is significant.

Laparoscopic Antireflux Surgery in Patients with Throat Symptoms: A Word of Caution

A subset of patients undergoing laparoscopic fundoplication presents with atypical throat symptoms, and the benefit of surgery in these patients is debated. These patients can present with throat symptoms alone or in combination with typical reflux symptoms. We evaluated the clinical outcome in these patients and compared their outcomes with a larger group of patients who did not have throat symptoms before fundoplication. Outcome data for 893 consecutive patients who underwent a laparoscopic fundoplication from January 2002 to June 2008 were collected prospectively and managed on a database. Ninety-three patients with atypical throat symptoms were identified, and divided into subgroups with (n=66) and without (n=27) typical reflux symptoms (heartburn and/or regurgitation), and outcomes were compared with patients (n=800) who didn't have throat symptoms. Symptoms were assessed with analog symptom scores for heartburn and dysphagia, as well as satisfaction with the surgical outcome. Case records for patients with throat symptoms were also reviewed to obtain more detail about specific throat symptoms and their resolution. Cough was the commonest atypical symptom, followed by sore throat. Heartburn scores improved following surgery in all patient groups. Dysphagia was more common 3 months after surgery in patients without throat symptoms, although there were no differences for dysphagia at later follow-up. Following surgery satisfaction scores were highest in patients with atypical throat symptoms who also had typical reflux symptoms, and the scores were lowest in patients who only had atypical throat symptoms. Nearly twice as many patients who had throat and reflux symptoms reported improvement or resolution of symptoms, compared to patients who only had throat symptoms. Fundoplication achieves a good outcome in patients with atypical throat symptoms who also report typical symptoms of reflux. However, surgeons should be cautious about operating on the subgroup of patients with objective evidence of gastroesophageal reflux who describe throat symptoms but do not report heartburn or regurgitation. In this subgroup, expectations of a good outcome should be minimized.

Laparoscopic tailored Nissen fundoplication

It is difficult sometimes to determine the suture points for proper Nissen fundoplication under laparoscopy. We introduce a new procedure to define the suture points in Laparoscopic Nissen fundoplication (LNF). After dissection of the hiatus and mobilization of the fundus, the circumference of the esophagus c is measured at a point 2-cm cranial from the esophagogastric junction over the 52-Fr bougie. The inner diameter of the fundoplication is calculated based on the esophageal diameter. To create a 2-cm fundoplication in which the greater curvature of the gastric fundus is moved straight toward the cranial side without any twist, we located points a and b, which correspond to the top of the left and right suture positions on fundoplication, respectively. Approximately 2 cm of floppy Nissen is constructed by suturing caudally with intervals of ~1 cm. A total of 20 patients (3 men, 17 women, mean age, 64.5 years) with gastroesophageal reflux disease and/or hiatal hernia underwent LNF using this procedure. LNF was successful in all 20 patients. There were no complications except for mild dysphagia in two patients, which disappeared within 3 weeks. Improvement of the symptom scores for heartburn, regurgitation, and dysphagia was observed in all patients. The evaluation of the fundoplication by the morphologic scores was quite satisfactory. During a median follow-up period of 30 months, 19 patients exhibited no recurrence, and 1 patient had a mild recurrence but was controlled by PPI on demand. Our new procedure is very safe and effective to create a proper Nissen fundoplication. In addition, our preliminary findings highlight the feasibility of precise localization of suture points without the need to measure the circumference of the esophagus and that LNF could be performed without a bougie.

Long-term outcomes of revisional surgery following laparoscopic fundoplication

A small proportion of patients who have laparoscopic antireflux procedures require revisional surgery. This study investigated long-term clinical outcomes. Patients requiring late revisional surgery following laparoscopic fundoplication for gastro-oesophageal reflux were identified from a prospective database. Long-term outcomes were determined using a questionnaire evaluating symptom scores for heartburn, dysphagia and satisfaction. The database search found 109 patients, including 98 (5.6 per cent) of 1751 patients who had primary surgery in the authors' unit. Indications for surgical revision were dysphagia (52 patients), recurrent reflux (36), mechanical symptoms related to paraoesophageal herniation (16) and atypical symptoms (five). The median time to revision was 26 months. Outcome data were available for 104 patients (median follow-up 66 months) and satisfaction data for 102, 88 of whom were highly satisfied (62.7 per cent) or satisfied (23.5 per cent) with the outcome. Patients who had revision for dysphagia had a higher incidence of poorly controlled heartburn (20 versus 2 per cent; P = 0.004), troublesome dysphagia (16 versus 6 per cent; P = 0.118) and a lower satisfaction score (P = 0.023) than those with recurrent reflux or paraoesophageal herniation. Revisional surgery following laparoscopic fundoplication can produce good long-term results, but revision for dysphagia has less satisfactory outcomes.

Laparoscopic antireflux surgery in the elderly

Both gastroesophageal reflux and paraesophageal hernias are more common in the elderly, but often these patients are not referred for surgery because of their age. In this study we determined the outcome for laparoscopic antireflux surgery in patients aged 70 years or older, in whom either symptoms of gastroesophageal reflux or a large paraesophageal hernia was the indication for surgery. From a prospectively maintained clinical database of patients undergoing laparoscopic antireflux surgery, all patients aged 70 years or older were identified and their outcome was determined. Two hundred ten patients were identified. In 129 a large paraesophageal hiatus hernia was the primary indication for surgery, and in 81 patients the indication was reflux. Mean operation time was significantly longer in patients undergoing surgery for a large hiatus hernia (109 vs. 72 min), and conversion to open surgery was required more often (11.6% vs. 4.4%), compared to patients with reflux alone. Follow-up information was available for 95% of patients. Postoperative symptom scores for heartburn and dysphagia improved significantly and patients' satisfaction with surgery was high. Laparoscopic antireflux surgery in patients aged 70 years or older has a satisfactory clinical outcome. Elderly patients should not be refused laparoscopic antireflux surgery only because of their age.

Laparoscopic Nissen Fundoplication: Clinical Outcomes at 10 Years

Laparoscopic Nissen fundoplication is now the most common operative procedure for treatment of gastroesophageal reflux disease, although longterm clinical outcomes after this procedure remain uncertain. Outcomes for 250 patients who underwent Nissen (total) fundoplication at least 10 years ago (September 1991 to August 1995) were determined prospectively using a structured questionnaire that evaluated clinical symptom scores for heartburn, dysphagia, and satisfaction with clinical outcomes. Clinical followup data for at least 10 years (120 to 167 months) after operation were available for 226 patients, an additional 21 patients had died, making outcomes for 247 patients (99%). Of the three (1%) remaining patients, one was lost to followup and dementia developed in two. One hundred eighty-seven (83%) patients were highly satisfied with the clinical outcomes. One hundred eighty-nine (84%) had good or excellent control of heartburn. Symptom scores for heartburn, dysphagia, and overall satisfaction were unchanged from 5-year followup data. Forty-two (17%) patients underwent revision operations, 28 (22%) were in the first 125 patients and 14 (11%) in the subsequent 125 patients. Antireflux medication use increased gradually, resulting in 47 (21%) patients using medication at 10 years. Of 21 deaths, 1 was postoperative and the remaining 20 were similar to that predicted for a matched population. A high preoperative heartburn score correlated with high patient satisfaction and lower dysphagia score at 10 or more years (p = 0.038 and p = 0.041, respectively). Laparoscopic Nissen fundoplication is an effective longterm treatment for gastroesophageal reflux disease.

HP33P LAPAROSCOPIC ANTI‐REFLUX SURGERY IN THE ELDERLY

Purpose Elderly patients can experience refractory symptoms of gastroesophageal reflux disease (GORD) with or without a large para‐oesophageal hernia (POH). The aim of this study was to analyse the outcome of laparoscopic anti‐reflux surgery in patients older than 70 years.Methodology Patients were identified from a prospective database, which documents patients who underwent anti‐reflux surgery between 1992 and 2006. Pre‐operative symptoms and investigations, operative details and post‐operative outcome were analyzed.Results 226 patients (mean age 76 yrs; 77 males,149 females) were included. In 92 patients GORD and in 134 patients a large POH was the primary indication for surgery. Nissen fundoplication was performed in 90 (40%), 90 anterior in 70 (31%), Dor in 59 (26%), Toupet in 1 (0.4%) and no fundoplication was performed in 6 patients (3%). Conversion rate was 10%. There were more intra‐operative complications in the large POH group than in the GORD group (8% vs. 1%; p = 0.03), operation time was longer (109 vs. 78 minutes; p &lt; 0.001), and mortality post‐operatively was higher (1.5% vs. 0%; p = 0.24). Overall short‐term re‐operation rate was 6% and did not differ between both groups. Mean follow‐up was 3.7 years. The symptom scores for heartburn and dysphagia improved significantly in both groups with subjective outcome in the POH group being slightly better. Overall mean satisfaction score (0–10) was 8.2. The GORD patients used significantly more reflux‐medications post‐operatively (40% vs. 21%; p = 0.007).Conclusion Anti‐reflux surgery in patients of 70 yrs and older is safe. Patients with a large POH encounter more complications but this does not compromise symptomatic outcome.

Endoluminal gastroplication for the treatment of gastroesophageal reflux disease: A 2‐year prospective pilot study from Taiwan

Endoluminal gastroplication (ELGP) offers a minimally invasive option for the treatment of gastroesophageal reflux disease (GERD) in Western countries. However, long-term outcomes of ELGP in Asian populations have not been investigated. The aim of this prospective study was to evaluate the long-term benefits of ELGP in Asian patients with GERD. Taiwanese patients diagnosed with GERD were enrolled and had the procedure performed with EndoCinch. The assessment included symptom scoring, validated GERD questionnaires, esophagogastroduodenoscopy, esophageal manometry and 24-h pH monitoring before and after the procedure over a 2-year period. Twenty-one consecutive patients were recruited and underwent ELGP. Patients reported improved heartburn symptom score (mean 64.0 vs 21.1, P < 0.001), regurgitation frequency score (mean 2.4 vs 1.3, P < 0.001), and GERD health-related quality of life (mean 23.1 vs 10.1, P < 0.001) at 24 months. The mean total time of pH < 4 reduced from 121.7 min to 67.1 min (P = 0.008) and mean DeMeester score reduced from 32.9 to 17.6 (P = 0.011) at 3 months. Antisecretory drug discontinuation rate was 81%, 57%, 52% and 48% at 1, 6, 12 and 24 months, respectively. Of the patients who had a favorable initial response to ELGP at 1 month, 41% resumed antisecretory medications at 24 months follow-up. All adverse events were mild and transient. Endoluminal gastroplication is a safe and modestly effective endotherapy for patients with GERD. It significantly improved symptoms in an Asian population. Approximately one in two patients continues to be off medication at 24 months follow-up. However, the long-term efficacy and durability are still to be determined.

Endoluminal Gastroplasty (EndoCinchtm) versus Endoscopic Polymer Implantation (Enteryxtm) for Treatment of Gastroesophageal Reflux Disease: 6-Month Results of a Prospective, Randomized Trial

The aim of this study was to compare and determine the efficiency and safety of two newly introduced endoscopic antireflux procedures in the treatment of gastroesophageal reflux disease (GERD). In a prospective, randomized trial, endoluminal gastroplasty (EndoCinch) was compared with polymer injection (Enteryx) employing 51 consecutive patients dependent on proton pump inhibitor therapy. Follow-up evaluation included drug consumption, symptoms, quality-of-life scoring, endoscopy, pH monitoring, manometry, and documentation of adverse events. Twenty-six patients were assigned to EndoCinch treatment, 23 patients received Enteryx implantation, and two patients dropped out before applying endoscopic therapy. At 6 months, proton pump inhibitor therapy could be stopped or dosage was reduced by > or =50% in 20 of 26 (77%) EndoCinch-treated patients and in 20 of 23 patients treated by Enteryx (87%, p= 0.365), which differed significantly in both groups compared to the pre-interventional status (p < 0.0001). Esophageal acid reflux (pH < 4) decreased from 14.5% to 9.6% in EndoCinch-treated patients (p= 0.071) and from 15.5% to 13.9% in patients treated by Enteryx (p= 0.930). Heartburn symptom score, modified DeMeester score, gastrointestinal life quality index, and SF-36 physical health survey score improved significantly in both groups postinterventionally (p < 0.0001). Approximately 25% of the patients in both groups required retreatment in an attempt to achieve symptom control. This is the first prospective, randomized study directly comparing two endoscopic anti-GERD techniques. EndoCinch and Enteryx seem to be equally successful in the treatment of GERD significantly reducing the proton pump inhibitor dosages, and also by improving symptoms of patients. Both endoluminal antireflux procedures may be promising therapeutic options; long-term evaluation will have to show if the positive initial results can be maintained.

Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial

Endoluminal gastroplication has shown promise for the treatment of GERD in short-term studies. Until now, long-term outcome data have been lacking. A prospective, multicenter trial enrolled 85 patients with GERD to be treated with endoluminal gastroplication. Inclusion criteria were 3 or more heartburn or regurgitation episodes per week, >4.2% time in 24 hours with esophageal pH < 4, and dependency on antisecretory medications. Exclusion criteria were the presence of varices, achalasia, aperistalsis, or previous gastric resection. Patients underwent manometry, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patient diaries were used to assess medication use and to estimate annual medication cost. At 1- and 2-year follow-up, patients had significant reductions in median heartburn symptom scores (72 at baseline [interquartile range (IQR) 90-48] vs. 4 at 12 months [IQR 43-0] and 16 at 24 months [IQR 53-3.5]; p < 0.0001 vs. baseline) and median regurgitation symptoms (2 at baseline [IQR 3-1] vs. 0 at 12 months (IQR 1-0) and 1 at 24 months [IQR 1-0]; p < 0.0001 vs. baseline). Of all patients, 59% and 52% showed heartburn symptom resolution at 12 and 24 months, respectively ( p < 0.0001 vs. baseline). Also, 83% and 77% had regurgitation symptom resolution at 12 and 24 months, respectively (p < 0.0001 vs. baseline). Proton pump inhibitor use also was significantly reduced at 12 and 24 months after the procedure. At 2-year follow-up, median annualized medication costs were reduced by 88% (1381 US dollars) (p < 0.0001). Endoluminal gastroplication significantly reduced the duration and the number of episodes of esophageal acid exposure (p < 0.0001 vs. baseline). Only 7 patients experienced adverse events. Endoscopic gastroplication is safe and effective, and is associated with symptom reductions in patients with GERD for at least 24 months.

Gender Differences in Gastroesophageal Reflux Disease: Myth or Reality?

Purpose: Foregut symptoms in women are often thought to be functional or psychological in nature, hence many female patients do not undergo investigation of their upper gastrointestinal symptoms. The aim of this study is to determine if there is a gender difference in the presentation, diagnostic evaluations or response to endoscopic therapy of patients with gastroesophageal reflux disease (GERD). Methods: Patients with typical GERD symptoms referred for endoscopic therapy were evaluated with upper endoscopy, manometry and pH studies. Reflux symptoms were assessed using the following scoring system: Heartburn(HB) Symptom Score (HSS) = HB frequency × HB severity; where HB frequency is: 0=none, 1=<3 episodes per wk, 2=3-5 episodes per wk, 3=daily; HB severity is recorded by patient using a 32 point visual analog scale. Regurgitation Frequency Score (RFS): 0=none, 1=<3 episodes per wk, 2=3-5 episodes per wk, 3=daily. Extra-esophageal manifestations were recorded.Endoscopic treatment consisted of intraluminal gastroplications at the gastroesophageal junction. Results: Ninety-five patients (37 M, 58 F) with the following baseline profile were studied (males vs. females): mean age of 47 ± 17 years vs. 50 ± 13 years, BMI 29 ± 6 vs. 28 ± 5, HSS of 45 ± 31 vs. 46 ± 24, and RFS of 1.7 ± 1.1 vs. 1.8 ± 1.1. The prevalence of extra-esophageal symptoms was similar in men and women: chest pain in 25% vs. 22%, wheezing in 5% vs. 15%, cough in 19% vs. 22%, and reflux laryngitis in 13% vs. 27%. Males had significantly more erosive esophagitis: 38% vs. 13% (p=0.05). The incidence of hiatal hernias and Barrett's esophagus were comparable (males vs. females): 30% vs. 48% (p=0.3) and 13% vs. 5% (p=0.2) respectively. Manometric and pH studies failed to reveal any gender differences (males vs. females): lower esophageal sphincter pressures were 16 ± 8 mmHg vs.13 ± 5 mmHg and total percentage time pH less than 4.0 was 15 ± 13% vs. 18 ± 17%. The response to endoscopic therapy was also similar between genders (males vs. females): complete response 27% vs. 39%, partial response 38% vs. 44%, and no response 22% vs. 17%. Conclusions: The prevalence of typical and extra-esophageal GERD symptoms, and the clinical response to endoscopic therapy are the same for men and women. Male and female patients with GERD have very similar manometric and ambulatory pH study findings. The only gender difference we found was a higher incidence of erosive esophagitis in men. Patients with gastroesophageal reflux symptoms should be evaluated and treated the same regardless of their gender.

The Clinical Efficacy of the Endoscopic Suturing Device for Treatment of Gastroesophageal Reflux Disease

Purpose: The Endoscopic Suturing DeviceTM (ESD) (Wilson-Cook Medical Inc, Winston-Salem, NC) is a flexible transoral suturing system available for soft tissue apposition in the gastrointestinal tract. The efficacy of anti-reflux procedures using ESD has not been reported. The aim of this study is to determine the efficacy and safety of endoscopic anti-reflux procedures using the ESD. Methods: Patients with typical gastroesophageal reflux symptoms despite proton pump inhibitor (PPI) therapy were evaluated with upper endoscopy, manometry and 24 hour pH studies. Those patients with abnormal pH studies underwent endoscopic anti-reflux procedures using ESD. The anti-reflux procedure consisted of placement of circumferential mucosal sutures at 1 to 2 cm below the squamo-columnar junction. Outcomes assessed were symptoms of heartburn (HB) and regurgitation, medication use, and procedure-related complications. Reflux symptoms were assessed using the following scoring system: heartburn symptom score (HSS) = HB frequency times HB severity; where HB frequency is: 0=none, 1=<3 episodes per wk, 2=3-5 episodes per wk, 3=daily; HB severity is recorded by patient using a 32 point visual analog scale. Regurgitation frequency scores (RFS): 0=none, 1=<3 episodes per wk, 2=3-5 episodes per wk, 3=daily. All patients were evaluated at baseline and at 1 to 9 months following the procedure. Results: Ten patients (4 M, 6 F) with an average age of 47 years underwent anti-reflux procedures using ESD with a mean follow-up of 3 months. Pre-procedure endoscopic findings were: hiatal hernias (3), circumferential erosive esophagitis (1) and Barrett's esophagus (1). Baseline manometry and ambulatory pH study findings were: lower esophageal sphincter pressure of 14.7 ± 1.2 mmHg, total percentage time esophageal pH less than 4.0 was 13.4 ± 2.7 %, and DeMeester score of 45 ± 8. Both heartburn and regurgitation symptoms were improved after the procedure: HSS decreased from 43 ± 9 to 18 ± 10 (p=0.07) and RFS was reduced from 2.4 ± 0.2 to 0.7 ± 0.3 (p<0.01). PPI use also significantly decreased after the procedure, from an average of 12 to 4.2 doses/week (p<0.01). The patient with circumferential esophagitis demonstrated complete healing on follow-up upper endoscopy. One patient developed self-limited bleeding after the procedure. Conclusions: An anti-reflux procedure with Endoscopic Suturing Device (ESD) shows good short-term clinical efficacy in patients with gastroesophageal reflux disease refractory to medical therapy.

Does the Number of Sutures Make a Difference? A Study with a New Device for Endoluminal Treatment of Gastroesophageal Reflux

INTRODUCTION: In patients with gastroesophageal reflux (GERD) who remain symptomatic or do not wish to stay on long-term medical treatment, and are not enthused by the prospect of surgery, endoluminal methods offer a less invasive alternative. These methods attempt to create an anti-reflux barrier by suture, injection, or by inducing scar. We report our experience a new (Wilson-Cook) endoscopic suturing device (ESD). METHODS: Patients were treated with ESD and followed prospectively. All patients had abnormal 24-hour pH and/or manometric studies. All took proton pump inhibitors (PPI), supplemented in some with antacid or prokinetic. Symptoms were scored on scale 0 to 3 (nil/mild/moderate/severe). Data were analyzed for symptom relief, reduction in PPI use, and procedural variables. RESULTS: Thus far, 19 patients (11 men, 8 women), age 15 to 63 years (mean 36, median 32) have been treated. Sutures applied were mean 2.4 (range 1-5). Available follow-up is median 9, mean 12, and range 7-16 months. Mean Pre-ESD symptom scores for heartburn, pain, and regurgitation were 2.3, 1.8, and 1.9, respectively. In addition, 14 patients had extra-esophageal symptoms (sore throat, respiratory symptoms, otalgia, etc). Mean scores at 1 month after ESD for heartburn, pain, and regurgitation were 0.4, 0.5, and 0.2, respectively (p<0.05). At 6 months the scores were 0.7, 0.8, and 1.0, respectively (p<0.05). Number of patients for 12 month scores is insufficient, however, for follow-up thus far while 11/19 (58%) have fewer symptoms, only 9/19 (47%) patients remain symptom-free. PPI requirements are nil in 8/19 (42%)and occasional in 3 of the remaining 11 patients. Sutures applied were 1, 2, 3, 4, and 5 for 7, 4, 4, 2 and 2 patients, respectively. Of the 8 patients who received 3 or more sutures, 7(88%) remain remain symptom-free and require no PPI, compared to the 11 patients who received 1 or 2 sutures (p<0.05). There have been no complications. CONCLUSION: Although treatment with ESD reduced symptoms and the need for medications in patients with GERD, the benifit was sustained only in patients who received 3 or more sutures. The device merits longer term evaluation in a larger number of patients with better definition of methodologic variables, such as the number of sutures suggested by the present series.