Biomedical subjects

J G Hatlebakk

Publications and source records attributed to J G Hatlebakk.

At least 19 recordsLinked to original sources

PubMed2006

Changes of gastric mucosal architecture during long-term omeprazole therapy: results of a randomized clinical trial.

BACKGROUND: The impact of long-term acid suppression on the gastric mucosa remains controversial. AIM: To report further observations on an established cohort of patients with gastro-oesophageal reflux disease, after 7 years of follow-up. METHODS: Of the original cohort randomized to either antireflux surgery or omeprazole, 117 and 98 patients remained in the medical and surgical arms, respectively. Gastric biopsies were taken at baseline and throughout the study. RESULTS: Fifty-three antireflux surgery and 39 omeprazole-treated patients had Helicobacter pylori infection at randomization. Eighty-three omeprazole-treated and 60 antireflux surgery patients remained H. pylori negative over the 7 years, and no change was observed in mucosal morphology except for a change in endocrine cell population (linear and diffuse hyperplasia, P = 0.03). During the 7-year study many patients, who were initially H. pylori infected, had the infection eradicated leaving only 13 omeprazole and 12 antireflux surgery patients still infected. In these patients, omeprazole induced a deterioration of the mucosal inflammation scores (P = 0.01) with a numerical increase of glandular atrophy. CONCLUSIONS: Long-term omeprazole therapy does not alter the exocrine oxyntic mucosal morphology in H. pylori-negative patients, but mucosal endocrine cells appear to be under proliferative stimulation; in H. pylori-positive patients there are changes in mucosal inflammation and atrophy.

Aged↗

PubMed2006

A multimodal laser Doppler and endosonographic distension device for studying mechanosensation and mucosal blood flow in the oesophagus.

We describe the development of a multimodal device combining bag distension, manometry, high frequency intraluminal ultrasound, laser Doppler flowmetry and symptom registration. Bench tests showed that the different modalities did not influence each other. During bag distension we obtained high quality images of the oesophageal wall for computing biomechanical parameters, and laser Doppler signals showing variation in mucosal perfusion. We conclude that the principle of measurement is sound and that the device can provide a basis for further studies.

Animals↗

PubMed2004

Diagnostic approach to suspected irritable bowel syndrome.

Diagnostic activity in patients with suspected irritable bowel syndrome (IBS) should be brief and focussed, limited to investigations that are likely to exclude serious alternative diagnoses and when negative support a positive diagnosis of IBS. The diagnosis of IBS is clinical, and is robust over time, although other symptoms may add to the clinical picture and other symptoms of functional disorders are common. The most important differential diagnoses are celiac disease, colorectal carcinoma and colitis. 'Red Flag' symptoms and signs should be considered indications for full colonoscopy, which should be performed with a low threshold in patients above 50 years of age. Serologic markers are useful to exclude celiac disease, but positive tests must be confirmed with duodenal biopsies.

Diagnosis, Differential↗

PubMed2003

Review article: gastric acidity--comparison of esomeprazole with other proton pump inhibitors.

Gastric acid suppression is the most effective medical therapy to control acidic gastro-oesophageal reflux: individuals in whom therapy fails usually have inadequate acid suppression. Twenty-four-hour intragastric pH-metry measures the percentage of time that gastric pH is above 4 or 3, the critical thresholds for tissue damage and symptom generation in the distal oesophagus. Effective medical therapy must control gastric acidity throughout the daytime, including the postprandial period. It is therefore useful to report the percentage of patients in whom gastric acidity is controlled above pH 4 for at least 16 out of 24 h. Esomeprazole was compared with standard-dose proton pump inhibitors in healthy volunteers and patients with gastro-oesophageal reflux disease. Esomeprazole, 40 mg daily, was significantly more effective at controlling gastric acidity above pH 4 for more than 16 h than lansoprazole, 30 mg daily (38% of individuals vs. 5%, respectively). Esomeprazole, 40 mg daily, also suppressed gastric acidity more effectively and in more individuals than pantoprazole, 40 mg daily, and rabeprazole, 20 mg daily. Esomeprazole, 20 mg daily, was significantly more effective at controlling gastric acidity than lansoprazole, 15 mg daily. The improved acid control with esomeprazole compared with other proton pump inhibitors is likely to result in superior healing rates and improved symptom relief, with fewer therapy-resistant patients.

Anti-Ulcer Agents↗

PubMed2003

Symptom-relieving effect of esomeprazole 40 mg daily in patients with heartburn.

BACKGROUND: To assess symptom relief in patients with heartburn following treatment with esomeprazole 40 mg daily. METHODS: Patients with heartburn (for > or = 6 months) were assessed in this double-blind, multicenter study. After a 3-day single-blind placebo run-in, 440 patients were randomized to esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d. or placebo for 14 days. Heartburn symptoms were recorded daily; as insufficient patients had data available from days 13 and 14, analyses included data up to day 12. Gastroesophageal reflux disease (GERD) was diagnosed by upper GI endoscopy and 24-h pH-monitoring. The primary end-point was total heartburn relief defined as no heartburn symptoms during the preceding 24-h period. RESULTS: 240 patients had erosive esophagitis (EO) and 114 patients had GERD defined by pH-monitoring. Proportions of patients with total heartburn relief increased during the first days of treatment and stabilized after Day 4. Total heartburn relief occurred in 67%-73%, 62%-70%, and 21%-32% of patients in the esomeprazole 40 mg o.d., esomeprazole 20 mg b.i.d., and placebo groups, respectively, between days 6 and 12. Proportions of patients with total heartburn relief were higher in patients with EO (71%-80% of patients from Day 4 onwards) compared to those without EO (52%-67% of patients from Day 4 onwards). Figures for patients diagnosed by pH-monitoring were 65%-73% of those with a positive diagnosis and 51%-58% with a negative diagnosis. CONCLUSION: Esomeprazole 40 mg o.d. treatment produces total heartburn relief in a high proportion of patients with GERD. Once-daily esomeprazole 40 mg dosing is recommended as no advantage was gained by splitting the dose.

Adult↗

PubMed2003

One-week esomeprazole treatment: an effective confirmatory test in patients with suspected gastroesophageal reflux disease.

BACKGROUND: Symptomatic response to acid inhibition can be used as a guide in diagnosing patients with reflux symptoms. The proton-pump inhibitor (PPI) omeprazole has been used as such a diagnostic tool. Intragastric acid control with esomeprazole is more effective than other PPIs and has the potential to offer an advance in the diagnostic use of PPIs. METHODS: Patients experiencing heartburn (for > or = 6 months) were studied in this randomized, double-blind, multicenter study. Following a 3-day placebo run-in, 440 patients were randomized to 14 days' treatment with esomeprazole 40 mg once daily (o.d.), esomeprazole 20 mg twice daily (b.i.d.) or placebo. Heartburn symptoms were recorded daily. Endoscopy and 24-h esophageal pH-monitoring were performed to determine the presence of gastroesophageal reflux disease (GERD). The esomeprazole treatment test was considered positive if patients' symptoms improved during the treatment period compared with symptoms recorded on Day 0. RESULTS: 63 patients were excluded from the analysis due to lack of symptoms on Day 0 or failure to complete pH-monitoring. The sensitivity of an esomeprazole treatment test in confirming GERD increased during the first days of treatment and stabilized between 79% and 86% after 5 days (both esomeprazole arms). The corresponding figure for the placebo arm was 36%. Specificity was variable (24%-65%) for both active treatment and placebo. CONCLUSION: A treatment test with esomeprazole 40 mg has a high sensitivity in confirming GERD. Furthermore, the data indicate that 1-week treatment with a once-daily dosage is sufficient to ensure adequate diagnosis.

Adult↗

PubMed2002

Eradication of Helicobacter pylori does not increase acid reflux in patients with mild to moderate reflux oesophagitis.

BACKGROUND: A substantial minority of patients with gastro-oesophageal reflux disease (GERD) are infected with Helicobacter pylori, but there is controversy as to whether these patients should be treated for their infection. We hypothesized that H. pylori eradication increases gastro-oesophageal acid reflux in such patients with time. METHODS: Thirty-five consecutive H. pylori-infected patients (16 M and 19 F) with mild or moderate reflux oesophagitis were enrolled. Twenty-four-hour intra-oesophageal (n = 35) and intragastric (n = 12) pH-metry was recorded before and 15 months after H. pylori eradication. Gastric biopsy specimens from the antrum and corpus were obtained from 10 consecutive patients before and 15 months after H. pylori eradication. RESULTS: Fifteen months after eradication of H. pylori there was a significant decrease in percentage time oesophageal pH < 4 in the recumbent position only (P = 0.04). Despite a marked reduction in the severity of gastritis, there was no significant change in gastric acidity, total intra-oesophageal acid exposure or symptom score. Heartburn improved in 12, worsened in 7. and remained unchanged in 16 patients (P = 0.36) without any significant relationship to individual changes in acid exposure (P = 0.60). CONCLUSIONS: H. pylori eradication does not increase gastric acidity or gastro-oesophageal acid reflux in patients with mild to moderate reflux oesophagitis over the first 15 months.

Adult↗

PubMed2002

Patients with endoscopic gastritis and/or duodenitis improve markedly following eradication of Helicobacter pylori, although less so than patients with ulcers.

BACKGROUND: It is well documented that dyspepsia in patients with peptic ulcer disease (PUD) improves markedly after eradication of Helicobacter pylori, while rarely does it improve in patients with functional dyspepsia. There is a large group of H. pylori-infected patients who do not qualify for either diagnosis, but in whom eradication may be considered. The aim of this study was to compare symptom severity, change in gastrointestinal symptoms 1 year after eradication and satisfaction with therapy between PUD patients and patients with endoscopic diagnoses of gastritis and/or duodenitis (G/D patients). METHODS: The patients were randomized to one of four triple regimens containing ranitidine bismuth and metronidazole, and either oxytetracycline or spiramycine. Eradication was assessed with the 14C-urea breath test. GI symptoms were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS) and the Ulcer Esophagitis Subjective Symptoms Scale (UESS) questionnaires. RESULTS: One-hundred-and-eighty-three patients were recruited from GI outpatient clinics. Patients with PUD and G/D had similar severity of symptoms before eradication therapy. One year after H. pylori eradication, 99% of the PUD patients and 75% of the G/D patients felt better regarding their main upper GI complaint. Abdominal pain score decreased by 48% as measured by GSRS and by 78% as measured by UESS in the PUD group and by 25% and 47%, respectively, in the G/D group. Reflux symptoms decreased by 41% and 63% in PUD patients and by 28% and 45% in G/D patients; indigestion by 30% and 47% in PUD and by 20% and 34% in G/D; eating discomfort by 60% in PUD and by 35% in G/D. Sleep quality score improved by 68% in PUD and by 41% in NU patients. Constipation decreased by 22% in the PUD group. All these differences in symptoms were highly significant compared to baseline. Diarrhoea was unchanged. CONCLUSIONS: Abdominal pain, reflux symptoms, indigestion and the ability to eat and sleep improved in both PUD and G/D patients 1 year after H. pylori eradication. Chronic diarrhoea was not induced. Abdominal pain improved significantly more in PUD than in G/D patients. Further study of the effect of H.pylori eradication in G/D patients is warranted.

Anti-Bacterial Agents↗

PubMed2002

Intragastric maldistribution of a liquid meal in patients with reflux oesophagitis assessed by three dimensional ultrasonography.

BACKGROUND AND AIMS: Our aim was to study intragastric volume and distribution of a liquid meal in patients with reflux oesophagitis using three dimensional ultrasonography. METHODS: Twenty patients and 20 healthy controls underwent ultrasonographic measurements of the stomach using a position sensor based on magnetic scanhead tracking for acquisition of three dimensional images. In vivo accuracy of the method was evaluated by scanning a soup filled barostat bag positioned in the proximal stomach of six healthy subjects. RESULTS: In the volume range 100-700 ml, our three dimensional system showed excellent correlation (r=0.99) between estimated and true volumes (limits of agreement -3.4 to 11.0 ml) and a low interobserver variation (limits of agreement -10.9 to 6.7 ml). After ingestion of a 500 ml meat soup meal, patients with reflux oesophagitis revealed a larger volume of the total and proximal stomach at two and 10 minutes (p=0.05; p=0.01, respectively), and an increased proximal/distal intragastric volume ratio at 10 minutes (p=0.04). Patients also experienced more epigastric fullness than controls (p=0.0006). CONCLUSIONS: The present three dimensional ultrasound system showed excellent agreement with true volumes and low interobserver variation. Soon after a liquid meal, patients with reflux oesophagitis have abnormal pooling of the ingested liquid in the proximal stomach.

Adult↗

PubMed2001

Continued (5-year) followup of a randomized clinical study comparing antireflux surgery and omeprazole in gastroesophageal reflux disease.

BACKGROUND: The efficacy of antireflux surgery (ARS) and proton pump inhibitor therapy in the control of gastroesophageal reflux disease is well established. A direct comparison between these therapies is warranted to assess the benefits of respective therapies. STUDY DESIGN: There were 310 patients with erosive esophagitis enrolled in the trial. There were 155 patients randomized to continuous omeprazole therapy and 155 to open antireflux surgery, of whom 144 later had an operation. Because of various withdrawals during the study course, 122 patients originally having an antireflux operation completed the 5-year followup; the corresponding figure in the omeprazole group was 133. Symptoms, endoscopy, and quality-of-life questionnaires were used to document clinical outcomes. Treatment failure was defined to occur if at least one of the following criteria were fulfilled: Moderate or severe heartburn or acid regurgitation during the last 7 days before the respective visit; Esophagitis of at least grade 2; Moderate or severe dysphagia or odynophagia symptoms reported in combination with mild heartburn or regurgitation; If randomized to surgery and subsequently required omeprazole for more than 8 weeks to control symptoms, or having a reoperation; If randomized to omeprazole and considered by the responsible physician to require antireflux surgery to control symptoms; If randomized to omeprazole and the patient, for any reason, preferred antireflux surgery during the course of the study. Treatment failure was the primary outcomes variable. RESULTS: When the time to treatment failure was analyzed by use of the intention to treat approach, applying the life table analysis technique, a highly significant difference between the two strategies was revealed (p < 0.001), with more treatment failures in patients who originally were randomized to omeprazole treatment. The protocol also allowed dose adjustment in patients allocated to omeprazole therapy to either 40 or 60 mg daily in case of symptom recurrence. The curves subsequently describing the failure rates still remained separated in favor of surgery, although the difference did not reach statistical significance (p = 0.088). Quality of life assessment revealed values within normal ranges in both therapy arms during the 5 years. CONCLUSIONS: In this randomized multicenter trial with a 5-year followup, we found antireflux surgery to be more effective than omeprazole in controlling gastroesophageal reflux disease as measured by the treatment failure rates. But if the dose of omeprazole was adjusted in case of relapse, the two therapeutic strategies reached levels of efficacy that were not statistically different.

Aged↗

PubMed2001

Gastric accommodation studied by ultrasonography in patients with reflux esophagitis.

The aim of this study was to investigate gastric accommodation to a meal in patients with reflux esophagitis using ultrasonography. Twenty consecutive patients with reflux esophagitis of grade I (14) or II (6) and 20 healthy subjects underwent ultrasonographic measurements of the stomach before and after ingestion of a 500 ml soup meal. Reflux esophagitis patients revealed a significantly larger sagittal area of the proximal stomach at 5 min (P = 0.002) and 15 min (P = 0.007) postprandially and experienced more epigastric fullness after the meal (P = 0.0006). Postprandial fullness and sagittal area of the proximal stomach correlated significantly (r = 0.69; P = 0.0007). We conclude that patients with mild or moderate reflux esophagitis have a larger sagittal area of the proximal stomach and more postprandial fullness in response to a soup meal than healthy subjects. Postprandial distension of the proximal stomach may be a pathogenetic factor in reflux esophagitis.

Adult↗

PubMed2001

Stability of gastric secretory inhibition during 6-month treatment with omeprazole in patients with gastroesophageal reflux disease.

OBJECTIVE: A trend toward relapse of reflux symptoms and esophagitis during long-term treatment with proton pump inhibitors has been reported. The purpose of this study was to evaluate the existence of tachyphylaxia to the effect of proton pump inhibitors on gastric acidity and gastroesophageal reflux over time. METHODS: A total of 23 patients with reflux esophagitis underwent 24-h intragastric and intraesophageal pH-metry after 7, 90, and 180 days of continued dosing with 20 mg of omeprazole once daily before breakfast. RESULTS: The total median percentages of time gastric pH <4 (interquartile range) were 49% (35-70%), 60% (36-76%), and 42% (26-66%) after 7, 90, and 180 days (p = 0.14). Percentages of time gastric pH <3 were 41%, 54%, and 34%, respectively (p = 0.19). The median percentages of total time esophageal pH <4 were 1.1%, 2.5%, and 1.1%, respectively (p = 0.70). Healing of esophagitis was achieved in 84% of the patients after 6 months. Heartburn improved in six, worsened in three, and was unchanged in 10 patients (p = 0.16). There was no statistical significant relationship between change in esophageal acid exposure and change in severity of heartburn. CONCLUSIONS: A dose of 20 mg of omeprazole once daily consistently controlled patients' symptoms and kept gastric acidity at a stable level over a period of 6 months. There is no evidence of diminution in the effects of 20 mg of omeprazole over time that could indicate the development of tolerance.

Adolescent↗

PubMed2001

Controversies in dyspepsia.

Even in the absence of visible lesions like an ulcer, cancer or oesophagitis, patients with functional dyspepsia may complain of severe dyspeptic symptoms and have a poor quality of life. Characteristically, these patients also often have a low estimate of their own health and have complaints from several organ systems. The cause of the disease is not known. Both central nervous system and gastric disturbances appear to be involved, and their relative importance is controversial. There is no clear beneficial effect of acid suppression or H. pylori eradication although effects of such therapy may be seen in minor subgroups. New findings emphasise the importance of distinguishing between functional dyspepsia and gastro-oesophageal reflux disease, which exhibit completely different gastric accommodation patterns to a meal and have very different therapeutic potential. The effect of drugs like glyceryl trinitrate, glucagon, sumatriptan and buspirone which all concomitantly improve symptoms and gastric accommodation support the important role of abnormal gastric accommodation to meals in patients with functional dyspepsia. A hypothetical model for the pathogenesis of functional dyspepsia is presented. It incorporates four established abnormalities: various psychological abnormalities, low vagal tone, impaired gastric relaxation, and visceral hypersensitivity, in a logical interplay along the brain-gut axis.

Dyspepsia↗

PubMed2000

Gastric acidity and acid breakthrough with twice-daily omeprazole or lansoprazole.

BACKGROUND: In patients with severe gastro-oesophageal reflux disease (GERD), proton pump inhibitors are being used increasingly in twice-daily regimens to improve control of gastric acidity. Few data exist to compare the ability of the most-often used proton pump inhibitors, omeprazole and lansoprazole, to control gastric acid at twice-daily dosage regimens. Nocturnal acid breakthrough, defined as gastric pH < 4.0 continuously for > 60 min, may compromise treatment goals in patients with GERD. AIM: To compare the effects of omeprazole 20 mg b.d. or lansoprazole 30 mg b.d. on gastric acidity and the relative ability of each dosage regimen to prevent acid breakthrough. METHODS: In a crossover pharmacodynamic study, 20 healthy volunteers (10 male, 10 female, mean age 38 years) were given omeprazole 20 mg b.d. or lansoprazole 30 mg b.d. for 7 days each, in a randomized manner. Each dosage regimen was separated by a minimum 7-day period where no medication was administered. On day 7 of each regimen, 24-h intragastric pH-metry was performed. The percentage of time for which gastric pH was below 4.0 and 3.0, the occurrence of daytime and nocturnal acid breakthrough, and the duration of action of each regimen were compared. Non-parametric statistics for paired data were used. RESULTS: The percentage time for which gastric pH was below 4.0 was significantly lower with omeprazole 20 mg b.d. (median 14.8%) than with lansoprazole 30 mg b. d. (median 24.2; P=0.0372). Fourteen subjects showed more effective acid control when taking omeprazole; these were significantly more often H. pylori-negative patients compared with those for whom acid control was better on lansoprazole (P < 0.001). Nocturnal acid breakthrough occurred in seven patients (35%) on omeprazole and in 10 (50%) on lansoprazole (N.S.). CONCLUSION: In healthy volunteers, twice-daily dosing of omeprazole 20 mg b.d. appears to be significantly more effective than lansoprazole 30 mg b.d. in controlling gastric acidity. The clinical importance of such a difference remains to be defined in GERD patients.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed2000

Proton pump inhibitors: better acid suppression when taken before a meal than without a meal.

BACKGROUND: Proton pump inhibitors including omeprazole and lansoprazole inhibit gastric acid secretion by selectively and non-competitively inactivating the H+, K+ ATPase molecules of the parietal cell, but possibly only those that are actively secreting acid. This might imply that stimulation of acid secretion by a meal is necessary for optimal inhibition of gastric secretion. AIM: To quantify and compare the effect on daytime gastric acidity of omeprazole 20 mg or lansoprazole 30 mg daily taken 15 min before breakfast, with that of the same drug taken without a meal. METHODS: Twenty-one healthy volunteers were randomized to receive either omeprazole or lansoprazole. They were given the drug for two separate periods of 7 days in randomized order and at least 7 days apart. During one period the study medication was taken before breakfast; during the other it was taken at the same hour, but with no meal until 12:00 hours. Lunch was standardized. On day 7, intragastric pH-metry was performed, starting at 08:00 hours. Tracings were analysed for the 8-h period from 08:00 hours until 16:00 hours with regard to percentage time for which gastric pH was below 4.0 and 3.0, and median gastric pH. Tracings were also analysed after removing the 1 h breakfast period, to exclude the buffering effect of the meal. RESULTS: When taking the drug with breakfast, the median percentage time for which gastric pH < 4.0 was 17.2 (interquartile range 4.6-45.5), compared with 42.0 (interquartile range 31.4-48.8) when taken without food (P=0.01). Fifteen subjects had better control of gastric acidity when the medication was taken with breakfast. A pH threshold of 3 and median pH showed similar differences. When the breakfast period was removed, the differences were no longer statistically significant. CONCLUSIONS: When therapy with omeprazole or lansoprazole is indicated, medication should be taken before a meal for optimal control of daytime gastric acidity.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed2000

Long-term management of gastro-oesophageal reflux disease with omeprazole or open antireflux surgery: results of a prospective, randomized clinical trial. The Nordic GORD Study Group.

BACKGROUND AND AIM: The efficacy of antireflux surgery (ARS) and omeprazole treatment in the control of gastrooesophageal reflux disease (GORD) are well established. We have compared these two therapeutic options in a randomized, clinical trial. PATIENTS AND METHODS: Three hundred and ten patients with erosive oesophagitis were enrolled into the trial. After a run-in period when all patients had < or = 40 mg of omeprazole daily to heal the oesophagitis and relieve symptoms, 155 patients were randomized to continuous omeprazole therapy and 155 to open antireflux surgery, of whom 144 later had an operation. One hundred and thirty-nine and 129 in the omeprazole and antireflux surgery groups, respectively, completed the 3-year follow-up. Symptoms, 24-h pH monitoring and endoscopy were used to document the outcome. Quality of life was evaluated by the psychological general well-being (PGWB) index and the gastrointestinal symptom rating scale (GSRS). RESULTS: Analysis of time to treatment failure (defined as moderate to severe GORD symptoms for > or = 3 days during the last 7 days, oesophagitis or changed therapy) revealed a significant difference in favour of antireflux surgery (P = 0.0016). Seventeen patients originally submitted to antireflux surgery experienced symptom relapse alone, 14 had oesophagitis at endoscopy and another six had omeprazole for different reasons, leaving 97 patients in clinical remission after 3 years. The corresponding figures in the omeprazole arm were 50 relapses, 18 with oesophagitis, two had surgery, leaving 77 patients in remission. Allowing a dose adjustment in the case of relapse in those on omeprazole therapy to either 40 or 60 mg, the curves describing the failure rates were not significantly different from each other. Quality of life assessment showed a comparable outcome in the two study groups. CONCLUSION: In this randomized multicentre trial we found antireflux surgery to be very efficacious in controlling GORD, a level of control which could also be achieved by omeprazole provided that advantage was taken of the opportunity of adjusting the dose.

Adult↗

PubMed1999

Heartburn treatment in primary care: randomised, double blind study for 8 weeks.

OBJECTIVE: To compare the effects and tolerability of omeprazole and cisapride with that of placebo for control of heartburn in primary care patients. DESIGN: Randomised, double blind, placebo controlled study. SETTING: 65 primary care practices in Norway. PARTICIPANTS: 483 untreated patients with complaints of heartburn >/=3 days a week, with at most grade 1 reflux oesophagitis. INTERVENTIONS: Omeprazole 20 mg once daily, cisapride 20 mg twice daily, or placebo for 8 weeks. MAIN OUTCOME MEASURES: Adequate control of heartburn, defined as </=1 day of the past 7 days with no more than mild heartburn, after 4 weeks of treatment. RESULTS: In the all patients treated analysis, adequate control of heartburn was achieved in 71% of patients taking omeprazole, 22% taking cisapride, and 18% taking placebo after 4 weeks of treatment (omeprazole v cisapride and placebo, P<0.0001; cisapride v placebo, non-significant). Results were comparable in patients with or without reflux oesophagitis. In patients treated with omeprazole only, symptom control was achieved significantly more often in patients positive for Helicobacter pylori. Antacid use was 2-3 times greater in patients taking cisapride or placebo than in those taking omeprazole. Relief of non-reflux symptoms did not significantly differ between the three groups. Significantly more patients taking cisapride reported adverse events than those taking omeprazole or placebo. CONCLUSIONS: Omeprazole 20 mg once daily was highly effective in relieving heartburn whereas cisapride 20 mg twice daily was not significantly more effective than placebo.

Anti-Ulcer Agents↗

PubMed1999

Medical therapy. Management of the refractory patient.

Although relatively rare, GERD patients refractory to medical therapy remain a challenge for the clinician. Refractoriness can be diagnosed only if the patient is properly studied on medication and if what should be adequate medical therapy has been given a sufficient therapeutic trial. Use of 24-hour intragastric and intraesophageal pH-metry has improved the ability to manage patients who appear to be nonresponders. Simple advice and minor adjustments to medical therapy are usually all that is needed for most patients, but in some, management requires knowledge of the principles outlined in this article. If followed, only a small group of patients should be medically refractory.

2-Pyridinylmethylsulfinylbenzimidazoles↗