- Email: [email protected]
Rabeprazole efficacy in erosive GERD: subgroup analyses from the future of acid suppression therapy (F.A.S.T.) trial
AJG – September, Suppl., 2001
January 1998 and September 2000. The manometric patterns, the intrarectal and anal residual pressures during straining and their ratio (defecation index) were assessed. Results: A normal pattern consisting of adequate propulsive force and adequate relaxation was seen in 65 (40%) patients. Additionally, three types of abnormal patterns were recognized (fig); Type 1: Adequate propulsive force with inappropriate anal contraction, n ⫽ 30 (19%); Type II: Inadequate propulsive force with inappropriate anal contraction, n ⫽ 46 (29%); Type III: Adequate propulsive force with failure to relax, n ⫽ 20 (12%). The intrarectal pressure (mmHg, mean ⫾ SEM) was: 50 ⫾ 3 (normal pattern), 55 ⫾ 4 (Type I), 21 ⫾ 2 (Type II), and 44 ⫾ 3 (Type III). The anal residual pressure was: 28 ⫾ 2 (normal pattern), 79 ⫾ 5 (Type I), 61 ⫾ 6 (Type II), and 44 ⫾ 4 (Type III). The defecation index was: 3 ⫾ 0.6 (normal pattern), 0.7 ⫾ 0.005 (Type I), 0.7 ⫾ 0.3 (Type II), and 1.2 ⫾ 0.1 (Type III). Conclusions: Sixty percent of patients with difficult defecation exhibited abnormal manometry, all of whom had a low (p ⬍ 0.05) defecation index suggestion of rectoanal incoordination or dyssynergia. Inadequate propulsive force (Type II) is a common phenomenon in patients with difficult defecation. All three patterns should be considered as diagnostic of dyssynergia.
100 Age, specialty, and practice setting predict GERD prescribing behavior Randal P. Riesett, M.D.1, Brian E. Lacy, M.D.1* and Amy Mitchell, B.S.1, 1Marvin M. Schuster Motility Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States. Purpose: Gastroesophageal reflux disease (GERD) affects 40% of adult Americans each month. Despite the high prevalence of GERD, and the expense of diagnosing and treating it, little is known about physician behavior in the evaluation and treatment of GERD. Aims: To examine physician patterns of evaluating GERD, and determine the prescribing behavior of different physicians (FP ⫽ family practice; INT ⫽ internal medicine; GI ⫽ gastroenterology) using 8 case scenarios. Methods: 687 physicians in Maryland were randomly identified from medical society lists and professional organizations. An identical 2 page survey was sent to each physician. 1 week later, a reminder postcard was sent. If the questionnaire was not returned within 2 weeks, a second, identical questionnaire was mailed, with a reminder postcard 1 week later. The survey contained 7 demographic questions (age, sex, degree, specialty, practice setting, practice location, years in practice); 8 questions which involved daily practice, and knowledge of published GERD guidelines; and 8 case scenarios which ranged from mild, intermittent GERD Sx, to constant Sx, to the presence of warning signs. Results: 214 questionnaires (31.1%) were returned; 36.3% ⫽ FP, 29.6% ⫽ INT; 29.6% ⫽ GI, 4.7% ⫽ other. 82% were Male, 18% were Female. Years of practice: 60.5% ⬎15 yrs; 17.6% ⫽ 11–15 yrs; 15.7% ⫽ 5–10 yrs; 6.2% ⫽ 1– 4 yrs. For uncomplicated reflux disease, 77.8% recommended no testing, while 5.9% requested a barium swallow. 8% of FP requested a barium swallow, compared to 6% INT, and 1.6% GI (p ⫽ .02). In a case with persistent GERD Sx and dysphagia, 52% of FP recommended EGD, as opposed to 69% of INT, and 85% of GI (p ⬍ .0002). For chronic GERD Sx ⬎5 yrs without warning signs, 82% of GI recommended EGD, while only 45% of FP did (p ⬍ .0122). The number of years of practice was found to influence prescribing behavior for mild intermittent GERD Sx (p ⫽ .03), and persistent chronic GERD Sx (p ⫽ .0017). Physicians ⬎50 yrs of age were significantly (p ⫽ .038) more likely to prescribe PPIs for mild to persistent GERD Sx, as opposed to physicians ⬍ age 50. Physicians in an academic setting were more likely to employ step-down therapy in patients with well-controlled GERD Sx on a PPI, as opposed to physicians in an HMO setting.
Abstracts
S33
Conclusions: The age, scope of practice (specialty type), number of years in practice, and practice setting were found to significantly affect how patients with GERD were evaluated and treated, using a case scenario questionnaire. Note: This study was funded by the Marvin M. Schuster Motility Center and an unrestricted educational grant from Wyeth-Ayerst.
101 Outcomes of laparoscopic Nissen fundoplications at The Western Pennsylvania Hospital Gilbertas Rimkus, M.D.1, Devora E Hathaway, BSN1, Daniel J Gagne, M.D.1 and Philip F Caushaj, M.D., FACG1*. 1Department of Surgery, Temple University School of Medicine Clinical Campus, The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States. Purpose: In the U.S., more than 10% of adults have symptoms of gastroesophageal reflux disease (GERD). Most patients can be effectively treated with traditional medical management utilizing dietary modification, weight loss, raising the head of the bed, antacids, H2 blockers and proton pump inhibitors (PPI). Although there is minimal literature data comparing PPI and surgical treatment, it seems that long-term relief of GERD may be achieved more efficiently with antireflux surgery or Laparoscopic Nissen fundoplication. Methods: Using retrospective chart review we evaluated outcomes of 29 laparoscopic Nissen fundoplications done at The Western Pennsylvania Hospital between April, 1996 and March, 2001. Outcome evaluation included reflux symptoms, preoperative and postoperative studies, complications of surgery and need for medical antireflux therapy postoperatively. Results: All patients were diagnosed with GERD preoperatively, 11 patients had hiatel and 4 had paraesophageal hernias. Eighty-four percent of patients were treated with PPI preoperatively. Duration of treatment varied between 1 month and 3 years. No deaths, esophageal injuries, or splenic injuries occured. Average hospital stay was 3 days. Eighty-six percent of patients were symptomatically improved after the surgery. Thirty-four percent of patients had transient postoperative dysphagia. Preoperative symptoms did not correlate with postoperative dysphagia; also there was no correlation between additional procedures preformed with laparoscopic Nissen fundoplication and postoperative symptoms (P ⬎ 0.05). Three patients had recurrent heartburn postoperatively and required medications, two of them were found to have failed fundoplication and underwernt re-do surgery. Conclusions: Current trends indicate that laparoscopic fundoplication is being used increasingly as an alternative to long-term medical therapy of GERD. Relief of typical reflux symptoms can be anticipated in over 90% of patients undergoing Nissen fundoplication, although mild dysphagia occurs after the procedure, this is transient in most patients. Laparoscopic Nissen fundoplication can be performed safely and effectively in the community hospital setting with all of the advantages of a minimally invasive approach. This can be achieved with a hospital stay of 48 hours and a low incidence of postsurgical complications.
102 Rabeprazole efficacy in erosive GERD: subgroup analyses from the future of acid suppression therapy (F.A.S.T.) trial Malcolm Robinson, MD; Eddie Cheung, MD; Anita Murthy, PharmD; Leonard Jokubaitis, MD Oklahoma Foundation for Digestive Research, University of Oklahoma Health Sciences Center, Oklahoma City, OK. Purpose: To evaluate symptom relief with rabeprazole (RAB) 20 mg in patients with endoscopically diagnosed erosive gastroesophageal reflux disease (GERD). Efficacy was analyzed according to age, gender, esophagitis severity, and presence of Barrett’s esophagus (BE). Methods: Open-label RAB 20 mg once daily was given, and patients rated symptom severity at baseline, Days 1 through 7, and Week 4, using a 4-point scale (0 ⫽ none to 3 ⫽ severe). Results: From Day 1 through Day 7, all subgroups achieved significant relief of daytime or nighttime heart-
S34
Abstracts
AJG – Vol. 96, No. 9, Suppl., 2001
burn (HB) (P ⬍ 0.001), paralleling all patients enrolled (table). Week 4 efficacy was also comparable for these subpopulations. Conclusion: Rabeprazole 20 mg once daily provided effective symptom relief with only minimal differences noted in relation to age, gender, esophagitis grade, or presence of BE. Complete ReliefDaytime HB (%) Subgroup Male Female ⬍65 years old ⱖ65 years old Grade 2 Grade 3/4 BE All patients
Complete ReliefNight HB (%)
Day 1
Day 7
Day 1
Day 7
67.4 59.4 61.4 73.7 61.1 70.0 69.8 64.0
85.2 75.5 78.8 89.4 78.0 86.3 84.9 81.1
72.9 64.0 68.3 72.4 68.5 70.9 74.3 69.2
88.4 82.3 84.1 90.3 84.5 88.1 87.4 85.7
Supported by: Eisai Inc., Teaneck, New Jersey, and Janssen Research Foundation, Titusville, New Jersey.
Purpose: To observe if resolution of gastroesophageal reflux by means of the stretta procedure, in patients with reflux associated bronchial asthma, as determined by their pneumologist and confirmed by the gastroenterologist, results in significant improvement of the asthma. Methods: Patients who met the criteria for reflux induced bronchial asthma as evidenced by pulmonary function tests, 24 hr pH monitoring and upper endoscopy were offered the stretta procedure. After the procedure they were followed for up to 8 months, to assess symptom improvement Results: Six patients met the criteria. All of them were using twice daily PPI’s, plus agonists/steroids, as prescribed by their pulmonologist/gastroenterologist. The six patients underwent the stretta procedure without any complications. One month after the procedure the patients were able to discontinue use of PPI’s and had decreased their need for bronchial asthma medications to a minimum. After up to 8 months of follow up, none of the patients has required hospital admission due to exacerbated asthma. Conclusions: The stretta procedure for gastroesophageal reflux disease can be of great benefit for those patients with reflux induced bronchial asthma, decreasing the need for medications and hospital admissions, thus the cost of treating this disease.
103 Esophageal sensitivity to Barostat balloon distention and Bernstein acid infusion: which test is best? Sheila Rodriguez-Stanley, PhD1, Sattar Zubaidi, MD1 and Philip B Miner, MD, FACG1*. 1The Oklahoma Foundation for Digestive Research, Oklahoma City, OK, United States. Purpose: There are presumed differences in esophageal receptor activation (ie. mechanical and chemical) in patients that present with esophageal pain. The acceptable standardized clinical tests such as esophagogastroduodenoscopy, 24-h pH monitoring and esophageal manometry (EM) often do not provide an answer for the patient’s pain. Methods: We performed Barostat balloon distention and Bernstein acid infusion in addition to EM and 24 h pH on 35 patients (9 M, 26F) that presented to the GI Lab with various esophageal/gastric complaints. The modified Bernstein test consisted of intraesophageal infusion of saline followed by .1 N HCI (maximum 10 min each). Time to first sensation and pain were recorded. Barostat balloon distention was performed with a high-compliance polyethylene balloon (4-cm length, 5-cm diameter, 80-ml maximum volume) placed 5 cm above the LES. Volume- and pressurecontrolled distentions were performed and corresponding sensory and pain thresholds were recorded. Results: 51% of patients reported their typical pain with volume-controlled balloon distention and 54% reported their typical pain with less than 10-min acid infusion. 34% of patients reported their typical pain with both balloon distention and acid infusion. Overall, pain with acid infusion was not related to pain induced by balloon distention volume (R2 ⫽ .0306) or pressure (R2 ⫽ .0002). Four patient groups were identified: 1) hypersensitive to balloon and acid (pain with ⱕ 5 min acid infusion and ⱕ 22 ml balloon distention), 2) hypersensitive to balloon (ⱕ 22 ml balloon distention), 3) hypersensitive to acid (pain with ⱕ 5 min acid infusion), and 4) hypersensitive to neither. Conclusions: Pain induced by the Bernstein and Barostat can identify patients with different sensory pathways for their esophageal pain such as 1) mechano- and chemo-sensitive, 2) mechano-sensitive, 3) chemo-sensitive, and 4) neither (pain of unknown origin). Our data suggest that both Bernstein acid infusion and Barostat balloon distention are necessary tests to assess esophageal hyperalgesia.
104 Extraesophageal reflux symptoms reversed by anti reflux procedure: stretta Alvaro Reymunde,M.D., FACG 1* and Nilda Santiago,M.D.1. 1Ponce Gastroenterology Research, Ponce, Puerto Rico, Puerto Rico.
105 Stretta procedure: A good and cost effective alternative to long term proton pump inhibitors; A clinical experience after 82 consecutive procedures Alvaro Reymunde, M.D., FACG1* and Nilda Santiago, M.D.1. 1Ponce Gastroenterology Research, Ponce, Puerto Rico, Puerto Rico. Purpose: To evaluate the success of the stretta procedure in patients with classic symptoms of gastroesophageal reflux disease as measured by symptomatic improvement and need for medication. Methods: Patients were evaluated for possible stretta procedure and selected according to the following citeria: daily reflux symptoms with classic heartburn, needing daily use of PPI’s for ⬎ 1 year, in addition to observing a strict antireflux diet. Patients with evidence of hypersecretory states or baseline endoscopic evidence of esophagitis ⬎ 1 or presence of Barrett’s were excluded. The stretta procedure was performed by a single endoscopist, on an ambulatory basis. The patients were followed for a mean period of 4 months. They were evaluated on the basis of the need to continue observing antireflux diet and lifestyle modifications, and symptomatic improvement. Quality of life pre and post procedure were also evaluated. Results: 150 patients were evaluated. 82 patients underwent the procedure. Seventy five percent of those had non erosive esophagitis and 25% esophagitis grade 1. Four weeks after the procedure, 97% of the patients were able to discontinue the use of PPI’s and were instructed to use only Tums at bedtime. They were also able to return to a normal unrestricted diet. The patient’s quality of life improved by 70% in those patients, now that they had no dietary restrictions and no need for daily medication. There were no serious adverse events and patients only complained of mild chest discomfort during the first 24 hours after the procedure, which did not require the use of any pain relief medication. Conclusions: The stretta procedure is a safe and well tolerated procedure which has proven to be effective in the treatment and improvement of quality of life in patients with classic GERD. Since it is well known that there is usually no progression in the degree of esophagitis from baseline EGD (according to a 15 year follow up study) and the aim of our study was to measure symptom improvement we followed the same apporach used in clinical practice, to treat GERD symptoms in patients without alarm signs and if the patients become asymptomatic not to test for possible changes in pH.
January 1998 and September 2000. The manometric patterns, the intrarectal and anal residual pressures during straining and their ratio (defecation index) were assessed. Results: A normal pattern consisting of adequate propulsive force and adequate relaxation was seen in 65 (40%) patients. Additionally, three types of abnormal patterns were recognized (fig); Type 1: Adequate propulsive force with inappropriate anal contraction, n ⫽ 30 (19%); Type II: Inadequate propulsive force with inappropriate anal contraction, n ⫽ 46 (29%); Type III: Adequate propulsive force with failure to relax, n ⫽ 20 (12%). The intrarectal pressure (mmHg, mean ⫾ SEM) was: 50 ⫾ 3 (normal pattern), 55 ⫾ 4 (Type I), 21 ⫾ 2 (Type II), and 44 ⫾ 3 (Type III). The anal residual pressure was: 28 ⫾ 2 (normal pattern), 79 ⫾ 5 (Type I), 61 ⫾ 6 (Type II), and 44 ⫾ 4 (Type III). The defecation index was: 3 ⫾ 0.6 (normal pattern), 0.7 ⫾ 0.005 (Type I), 0.7 ⫾ 0.3 (Type II), and 1.2 ⫾ 0.1 (Type III). Conclusions: Sixty percent of patients with difficult defecation exhibited abnormal manometry, all of whom had a low (p ⬍ 0.05) defecation index suggestion of rectoanal incoordination or dyssynergia. Inadequate propulsive force (Type II) is a common phenomenon in patients with difficult defecation. All three patterns should be considered as diagnostic of dyssynergia.
100 Age, specialty, and practice setting predict GERD prescribing behavior Randal P. Riesett, M.D.1, Brian E. Lacy, M.D.1* and Amy Mitchell, B.S.1, 1Marvin M. Schuster Motility Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States. Purpose: Gastroesophageal reflux disease (GERD) affects 40% of adult Americans each month. Despite the high prevalence of GERD, and the expense of diagnosing and treating it, little is known about physician behavior in the evaluation and treatment of GERD. Aims: To examine physician patterns of evaluating GERD, and determine the prescribing behavior of different physicians (FP ⫽ family practice; INT ⫽ internal medicine; GI ⫽ gastroenterology) using 8 case scenarios. Methods: 687 physicians in Maryland were randomly identified from medical society lists and professional organizations. An identical 2 page survey was sent to each physician. 1 week later, a reminder postcard was sent. If the questionnaire was not returned within 2 weeks, a second, identical questionnaire was mailed, with a reminder postcard 1 week later. The survey contained 7 demographic questions (age, sex, degree, specialty, practice setting, practice location, years in practice); 8 questions which involved daily practice, and knowledge of published GERD guidelines; and 8 case scenarios which ranged from mild, intermittent GERD Sx, to constant Sx, to the presence of warning signs. Results: 214 questionnaires (31.1%) were returned; 36.3% ⫽ FP, 29.6% ⫽ INT; 29.6% ⫽ GI, 4.7% ⫽ other. 82% were Male, 18% were Female. Years of practice: 60.5% ⬎15 yrs; 17.6% ⫽ 11–15 yrs; 15.7% ⫽ 5–10 yrs; 6.2% ⫽ 1– 4 yrs. For uncomplicated reflux disease, 77.8% recommended no testing, while 5.9% requested a barium swallow. 8% of FP requested a barium swallow, compared to 6% INT, and 1.6% GI (p ⫽ .02). In a case with persistent GERD Sx and dysphagia, 52% of FP recommended EGD, as opposed to 69% of INT, and 85% of GI (p ⬍ .0002). For chronic GERD Sx ⬎5 yrs without warning signs, 82% of GI recommended EGD, while only 45% of FP did (p ⬍ .0122). The number of years of practice was found to influence prescribing behavior for mild intermittent GERD Sx (p ⫽ .03), and persistent chronic GERD Sx (p ⫽ .0017). Physicians ⬎50 yrs of age were significantly (p ⫽ .038) more likely to prescribe PPIs for mild to persistent GERD Sx, as opposed to physicians ⬍ age 50. Physicians in an academic setting were more likely to employ step-down therapy in patients with well-controlled GERD Sx on a PPI, as opposed to physicians in an HMO setting.
Abstracts
S33
Conclusions: The age, scope of practice (specialty type), number of years in practice, and practice setting were found to significantly affect how patients with GERD were evaluated and treated, using a case scenario questionnaire. Note: This study was funded by the Marvin M. Schuster Motility Center and an unrestricted educational grant from Wyeth-Ayerst.
101 Outcomes of laparoscopic Nissen fundoplications at The Western Pennsylvania Hospital Gilbertas Rimkus, M.D.1, Devora E Hathaway, BSN1, Daniel J Gagne, M.D.1 and Philip F Caushaj, M.D., FACG1*. 1Department of Surgery, Temple University School of Medicine Clinical Campus, The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States. Purpose: In the U.S., more than 10% of adults have symptoms of gastroesophageal reflux disease (GERD). Most patients can be effectively treated with traditional medical management utilizing dietary modification, weight loss, raising the head of the bed, antacids, H2 blockers and proton pump inhibitors (PPI). Although there is minimal literature data comparing PPI and surgical treatment, it seems that long-term relief of GERD may be achieved more efficiently with antireflux surgery or Laparoscopic Nissen fundoplication. Methods: Using retrospective chart review we evaluated outcomes of 29 laparoscopic Nissen fundoplications done at The Western Pennsylvania Hospital between April, 1996 and March, 2001. Outcome evaluation included reflux symptoms, preoperative and postoperative studies, complications of surgery and need for medical antireflux therapy postoperatively. Results: All patients were diagnosed with GERD preoperatively, 11 patients had hiatel and 4 had paraesophageal hernias. Eighty-four percent of patients were treated with PPI preoperatively. Duration of treatment varied between 1 month and 3 years. No deaths, esophageal injuries, or splenic injuries occured. Average hospital stay was 3 days. Eighty-six percent of patients were symptomatically improved after the surgery. Thirty-four percent of patients had transient postoperative dysphagia. Preoperative symptoms did not correlate with postoperative dysphagia; also there was no correlation between additional procedures preformed with laparoscopic Nissen fundoplication and postoperative symptoms (P ⬎ 0.05). Three patients had recurrent heartburn postoperatively and required medications, two of them were found to have failed fundoplication and underwernt re-do surgery. Conclusions: Current trends indicate that laparoscopic fundoplication is being used increasingly as an alternative to long-term medical therapy of GERD. Relief of typical reflux symptoms can be anticipated in over 90% of patients undergoing Nissen fundoplication, although mild dysphagia occurs after the procedure, this is transient in most patients. Laparoscopic Nissen fundoplication can be performed safely and effectively in the community hospital setting with all of the advantages of a minimally invasive approach. This can be achieved with a hospital stay of 48 hours and a low incidence of postsurgical complications.
102 Rabeprazole efficacy in erosive GERD: subgroup analyses from the future of acid suppression therapy (F.A.S.T.) trial Malcolm Robinson, MD; Eddie Cheung, MD; Anita Murthy, PharmD; Leonard Jokubaitis, MD Oklahoma Foundation for Digestive Research, University of Oklahoma Health Sciences Center, Oklahoma City, OK. Purpose: To evaluate symptom relief with rabeprazole (RAB) 20 mg in patients with endoscopically diagnosed erosive gastroesophageal reflux disease (GERD). Efficacy was analyzed according to age, gender, esophagitis severity, and presence of Barrett’s esophagus (BE). Methods: Open-label RAB 20 mg once daily was given, and patients rated symptom severity at baseline, Days 1 through 7, and Week 4, using a 4-point scale (0 ⫽ none to 3 ⫽ severe). Results: From Day 1 through Day 7, all subgroups achieved significant relief of daytime or nighttime heart-
S34
Abstracts
AJG – Vol. 96, No. 9, Suppl., 2001
burn (HB) (P ⬍ 0.001), paralleling all patients enrolled (table). Week 4 efficacy was also comparable for these subpopulations. Conclusion: Rabeprazole 20 mg once daily provided effective symptom relief with only minimal differences noted in relation to age, gender, esophagitis grade, or presence of BE. Complete ReliefDaytime HB (%) Subgroup Male Female ⬍65 years old ⱖ65 years old Grade 2 Grade 3/4 BE All patients
Complete ReliefNight HB (%)
Day 1
Day 7
Day 1
Day 7
67.4 59.4 61.4 73.7 61.1 70.0 69.8 64.0
85.2 75.5 78.8 89.4 78.0 86.3 84.9 81.1
72.9 64.0 68.3 72.4 68.5 70.9 74.3 69.2
88.4 82.3 84.1 90.3 84.5 88.1 87.4 85.7
Supported by: Eisai Inc., Teaneck, New Jersey, and Janssen Research Foundation, Titusville, New Jersey.
Purpose: To observe if resolution of gastroesophageal reflux by means of the stretta procedure, in patients with reflux associated bronchial asthma, as determined by their pneumologist and confirmed by the gastroenterologist, results in significant improvement of the asthma. Methods: Patients who met the criteria for reflux induced bronchial asthma as evidenced by pulmonary function tests, 24 hr pH monitoring and upper endoscopy were offered the stretta procedure. After the procedure they were followed for up to 8 months, to assess symptom improvement Results: Six patients met the criteria. All of them were using twice daily PPI’s, plus agonists/steroids, as prescribed by their pulmonologist/gastroenterologist. The six patients underwent the stretta procedure without any complications. One month after the procedure the patients were able to discontinue use of PPI’s and had decreased their need for bronchial asthma medications to a minimum. After up to 8 months of follow up, none of the patients has required hospital admission due to exacerbated asthma. Conclusions: The stretta procedure for gastroesophageal reflux disease can be of great benefit for those patients with reflux induced bronchial asthma, decreasing the need for medications and hospital admissions, thus the cost of treating this disease.
103 Esophageal sensitivity to Barostat balloon distention and Bernstein acid infusion: which test is best? Sheila Rodriguez-Stanley, PhD1, Sattar Zubaidi, MD1 and Philip B Miner, MD, FACG1*. 1The Oklahoma Foundation for Digestive Research, Oklahoma City, OK, United States. Purpose: There are presumed differences in esophageal receptor activation (ie. mechanical and chemical) in patients that present with esophageal pain. The acceptable standardized clinical tests such as esophagogastroduodenoscopy, 24-h pH monitoring and esophageal manometry (EM) often do not provide an answer for the patient’s pain. Methods: We performed Barostat balloon distention and Bernstein acid infusion in addition to EM and 24 h pH on 35 patients (9 M, 26F) that presented to the GI Lab with various esophageal/gastric complaints. The modified Bernstein test consisted of intraesophageal infusion of saline followed by .1 N HCI (maximum 10 min each). Time to first sensation and pain were recorded. Barostat balloon distention was performed with a high-compliance polyethylene balloon (4-cm length, 5-cm diameter, 80-ml maximum volume) placed 5 cm above the LES. Volume- and pressurecontrolled distentions were performed and corresponding sensory and pain thresholds were recorded. Results: 51% of patients reported their typical pain with volume-controlled balloon distention and 54% reported their typical pain with less than 10-min acid infusion. 34% of patients reported their typical pain with both balloon distention and acid infusion. Overall, pain with acid infusion was not related to pain induced by balloon distention volume (R2 ⫽ .0306) or pressure (R2 ⫽ .0002). Four patient groups were identified: 1) hypersensitive to balloon and acid (pain with ⱕ 5 min acid infusion and ⱕ 22 ml balloon distention), 2) hypersensitive to balloon (ⱕ 22 ml balloon distention), 3) hypersensitive to acid (pain with ⱕ 5 min acid infusion), and 4) hypersensitive to neither. Conclusions: Pain induced by the Bernstein and Barostat can identify patients with different sensory pathways for their esophageal pain such as 1) mechano- and chemo-sensitive, 2) mechano-sensitive, 3) chemo-sensitive, and 4) neither (pain of unknown origin). Our data suggest that both Bernstein acid infusion and Barostat balloon distention are necessary tests to assess esophageal hyperalgesia.
104 Extraesophageal reflux symptoms reversed by anti reflux procedure: stretta Alvaro Reymunde,M.D., FACG 1* and Nilda Santiago,M.D.1. 1Ponce Gastroenterology Research, Ponce, Puerto Rico, Puerto Rico.
105 Stretta procedure: A good and cost effective alternative to long term proton pump inhibitors; A clinical experience after 82 consecutive procedures Alvaro Reymunde, M.D., FACG1* and Nilda Santiago, M.D.1. 1Ponce Gastroenterology Research, Ponce, Puerto Rico, Puerto Rico. Purpose: To evaluate the success of the stretta procedure in patients with classic symptoms of gastroesophageal reflux disease as measured by symptomatic improvement and need for medication. Methods: Patients were evaluated for possible stretta procedure and selected according to the following citeria: daily reflux symptoms with classic heartburn, needing daily use of PPI’s for ⬎ 1 year, in addition to observing a strict antireflux diet. Patients with evidence of hypersecretory states or baseline endoscopic evidence of esophagitis ⬎ 1 or presence of Barrett’s were excluded. The stretta procedure was performed by a single endoscopist, on an ambulatory basis. The patients were followed for a mean period of 4 months. They were evaluated on the basis of the need to continue observing antireflux diet and lifestyle modifications, and symptomatic improvement. Quality of life pre and post procedure were also evaluated. Results: 150 patients were evaluated. 82 patients underwent the procedure. Seventy five percent of those had non erosive esophagitis and 25% esophagitis grade 1. Four weeks after the procedure, 97% of the patients were able to discontinue the use of PPI’s and were instructed to use only Tums at bedtime. They were also able to return to a normal unrestricted diet. The patient’s quality of life improved by 70% in those patients, now that they had no dietary restrictions and no need for daily medication. There were no serious adverse events and patients only complained of mild chest discomfort during the first 24 hours after the procedure, which did not require the use of any pain relief medication. Conclusions: The stretta procedure is a safe and well tolerated procedure which has proven to be effective in the treatment and improvement of quality of life in patients with classic GERD. Since it is well known that there is usually no progression in the degree of esophagitis from baseline EGD (according to a 15 year follow up study) and the aim of our study was to measure symptom improvement we followed the same apporach used in clinical practice, to treat GERD symptoms in patients without alarm signs and if the patients become asymptomatic not to test for possible changes in pH.