Epilepsy as a risk factor for cancer.

AIM: Epilepsy and long term use of antiepileptic drugs have been suggested to be associated with an increased risk of cancer. The authors therefore set out to analyse previous diagnosis of epilepsy as a risk factor for certain cancer forms in a case control study. METHODS: Incident cases of leukaemia, lymphoma, myeloma, and pancreatic cancer were identified from the Swedish Cancer Registry 1987-99, a total of 52 861 cases. Controls (n = 137 485) were randomly selected from the Swedish Population Registry stratified on age, sex, and year of cancer diagnosis. Cases and controls were linked to the Swedish Hospital Discharge Registry for 1969-99 to identify individuals with first time hospital discharge for epilepsy. RESULTS: While an epilepsy diagnosis the same year as a cancer diagnosis carried an increased risk of non-Hodgkin's lymphoma (OR = 2.89, 95% CI 1.89 to 4.41), Hodgkin's disease (OR = 4.77, 95% CI 1.77 to 13.30), leukaemia (OR = 2.55, 95% CI 1.50 to 4.32), acute myeloid leukaemia (OR = 3.65, 95% CI 1.68 to 7.93), and pancreatic cancer (OR = 2.05, 95% CI 1.22 to 3.45), the authors found no support for an association between discharge with a diagnosis of epilepsy two years or more before the diagnosis of cancer and an increased risk of any of the types of cancer included in this analysis. The lack of association was also evident for individuals with an epilepsy diagnosis preceding malignancy/reference year by >10 years. CONCLUSIONS: Clinical examinations prompted by seizure onset probably mainly explain the observed association between epilepsy diagnoses the year before a cancer diagnosis. However, these results lend no support to the suggestion that epilepsy, and presumably long term exposure to antiepileptic drugs, is associated with an increased risk of the types of cancer included in the present study.

American exceptionalism? Similarities and differences in national attitudes toward energy policy and global warming.

Despite sharp differences in government policy, the views of the U.S. public on energy and global warming are remarkably similar to those in Sweden, Britain, and Japan. Americans do exhibit some differences, placing lower priority on the environment and global warming, and with fewer believing that "global warming has been established as a serious problem and immediate action is necessary". There also remains a small hard core of skeptics (< 10%) who do not believe in the science of climate change and the need for action, a group that is much smaller in the other countries surveyed. The similarities are, however, pervasive. Similar preferences are manifest across a wide range of technology and fuel choices, in support of renewables, in research priorities, in a basic understanding of which technologies produce or reduce carbon dioxide (or misunderstandings in the case of nuclear power), and in willingness to pay for solving global warming.

Randomized clinical trial of laparoscopic versus open fundoplication for gastro-oesophageal reflux.

BACKGROUND: The aim of this study was to compare the long-term results of laparoscopic and open antireflux surgery in a randomized clinical trial by investigating subjective and objective outcomes. METHODS: Sixty patients with gastro-oesophageal reflux disease (GORD) were randomized to laparoscopic or open 360 degrees fundoplication. Subjective evaluation using disease-specific and generic questionnaires and structured interviews, and objective evaluation by endoscopy, oesophageal manometry and 24-h pH monitoring, were performed before operation and 1 month, 6 months and 5 years after surgery. RESULTS: Two patients in the laparoscopic group had reoperations for hiatal stricture; one patient in the open group had repair of an incisional hernia, and one patient in each group had surgery for intestinal obstruction. There were no differences in the subjective outcomes of diet, sleep, medication, patient satisfaction and symptoms of GORD after 5 years. Nor were there any differences in objective outcomes determined by endoscopy, manometry or 24-h pH monitoring. Well-being was decreased in all patients before operation but was restored to normal or above-normal values after fundoplication, regardless of the type of surgery. Seven of 28 patients in the open group had complaints regarding the scar. CONCLUSION: Elimination of GORD symptoms improved well-being and eliminated the need for daily acid suppression in most patients, no matter which procedure was employed. These results were apparent 1 month after the operation and were still valid 5 years later.

Heller's esophagomyotomy with or without a 360 degrees floppy Nissen fundoplication for achalasia. Long-term results from a prospective randomized study.

Heller's esophagomyotomy relieves dysphagia but does not restore esophageal peristalsis. The myotomy may induce reflux and the addition of a 360 degrees fundoplication may be hazardous with regard to the remaining aperistaltic esophagus. The aim of this prospectively randomized clinical trial was to compare the outcome for patients with uncomplicated achalasia who underwent an anterior Heller's esophagomyotomy (H group) with or without an additional floppy Nissen fundoplication (H + N group). Between 1984 and 1995, 20 patients were prospectively randomized to one or other of the performed operations, 10 patients per group. Esophagitis including Barrett's esophagus (n = 2) was seen under medical treatment, in 6 of 9 in the H group but none in the H + N group. No patient in the H + N group required postoperative continuous acid-reducing drugs. Twenty-four-hour esophageal pH-studies in median 3.4 years after surgery showed pathological reflux expressed as a percentage of time below pH 4 of 13.1% in the H group compared to 0.15% (P < 0.001) in H + N group. One patient with recurrent dysphagia in the H + N group later had an esophagectomy. The remaining patients reported significant improvement of dysphagia without symptoms of reflux at 8.0 years follow-up. Heller's esophagomyotomy eliminates dysphagia, but can induce advanced reflux that requires medical treatment. The addition of a 360 degrees fundoplication eliminates reflux without adding dysphagia in the majority of patients and can be recommended for most patients with uncomplicated achalasia.

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.

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.

On-demand treatment in patients with oesophagitis and reflux symptoms: comparison of lansoprazole and omeprazole.

BACKGROUND: There are few data on how patients on maintenance treatment of reflux oesophagitis take their medication. This study was designed to investigate the dosing patterns of patients on on-demand treatment and to compare lansoprazole with omeprazole in this regard. METHODS: Patients with reflux oesophagitis, initially treated until absence of symptoms, took capsules of either lansoprazole (30 mg) or omeprazole (20 mg) for 6 months; they were instructed to take the medication only when reflux symptoms occurred. In order to document dosing patterns, the medication was dispensed in bottles supplied with a Medication Event Monitoring System recording date and time the bottles were opened. There were regular follow-up visits with assessment of symptoms. RESULTS: Three-hundred patients were eligible for analysis according to 'all patients treated'. A dosing pattern was found of an increased intake mornings and evenings and constant intervals between intakes. Although there was no correlation between oesophagitis grade or initial symptoms and the amount of medication consumed, the patients had significantly fewer reflux symptoms the more medication they consumed. There was no difference in the number of capsules consumed between the lansoprazole (0.73 capsules/day) and omeprazole groups (0.71 capsules/day). Nor was there any difference between the groups in reflux symptoms during the course of the study. CONCLUSION: Despite rigorous instructions to take medication on demand, the results suggest that it is patient habits more so than symptoms that determine the frequency and interval of medication intake. Symptoms are not therefore decisive for the amount of medication consumed.

Randomized clinical trial of laparoscopic versus open fundoplication: evaluation of psychological well-being and changes in everyday life from a patient perspective.

BACKGROUND: The laparoscopic approach in antireflux surgery might have an impact on the patient's daily activities and well-being. METHODS: Sixty patients were randomized to laparoscopic or open 360 degrees fundoplication. Data were collected by questionnaires and interviews preoperatively, 1 month and 6 months after operation. RESULTS: Five patients in the laparoscopic group were converted to open surgery. Psychological general well-being increased after surgery and reached norm values in both study groups. No significant differences were found between the two types of surgery in the per protocol analysis, while the domain self-control was significantly better after open surgery in the intention-to-treat analysis. There was improvement of diet and sleep in both study groups; after 6 months, disturbed sleep was significantly more uncommon after open surgery. Dysphagia and flatulence were new symptoms that were reported after surgery. Overall perception of the results of the operation did not differ between the groups. CONCLUSIONS: Psychological general well-being, diet and sleep improved after both laparoscopic and open surgery. There were only small differences between the groups, but in some respects the results were better after open surgery.

Short-term outcome after laparoscopic and open 360 degrees fundoplication. A prospective randomized trial.

BACKGROUND: Despite the lack of randomized trials supporting the laparoscopic approach, laparoscopic antireflux surgery has gained widespread acceptance during the last decade. The aim of this study was to compare the short-term symptomatic and objective outcome after laparoscopic and open 360 degrees fundoplication in a prospective randomized clinical trial. METHODS: Sixty patients with GERD were randomized to undergo either laparoscopic (LF) or open 360 degrees fundoplication (OF). Endoscopy, esophageal manometry, 24-h pH monitoring, clinical symptom evaluation, and symptom scoring according to a validated questionnaire (the Gastrointestinal Symptom Rating Scale [GSRS]) was performed preoperatively and 6 months after surgery. RESULTS: Five patients randomized to the laparoscopic group were converted to open surgery. Esophageal acid exposure was restored to normal in all patients. Lower esophageal sphincter length and resting pressure were significantly increased after both laparoscopic and open fundoplication (p < 0.001); there were no differences between the groups. No significant differences were seen in symptomatic outcome, although there was a trend toward a higher rate of mild dysphagia (p = 0.051) after laparoscopic surgery. GSRS revealed a decrease in reflux score (p < 0.001) and abdominal pain score (p < 0.001) postoperatively. There were no significant differences in GSRS scores between the two groups. CONCLUSION: Laparoscopic 360 degrees fundoplication is as effective in treating reflux disease as open fundoplication. Six months postoperatively, no significant differences were seen in symptomatic or objective outcome. Long-term evaluation is needed.

Endoscopic surveillance of columnar-lined esophagus: frequency of intestinal metaplasia detection and impact of antireflux surgery.

OBJECTIVE: To quantify the occurrence of intestinal metaplasia in columnar-lined esophagus (CLE) during endoscopic surveillance and to evaluate the impact of antireflux surgery on the development of intestinal metaplasia. SUMMARY BACKGROUND DATA: The malignant potential in segments of CLE is mainly restricted to those containing intestinal metaplasia. Patients with segments of CLE in which no intestinal metaplasia can be detected are rarely enrolled in a surveillance program but may still be at increased risk of developing esophageal adenocarcinoma because intestinal metaplasia may be missed or may develop with time. METHODS: The occurrence of intestinal metaplasia on biopsy samples was determined on repeated endoscopies in 177 patients enrolled in a surveillance program for CLE. The incidence of intestinal metaplasia in patients with no evidence of intestinal metaplasia on the two first endoscopies was evaluated on the subsequent endoscopies and compared in patients with medically and surgically treated gastroesophageal reflux disease. RESULTS: Intestinal metaplasia was found in 53% of the patients (94/177) on their first surveillance endoscopy and was more prevalent in long segments of CLE. The prevalence of intestinal metaplasia increased markedly with increasing number of surveillance endoscopies. Intestinal metaplasia tended to be detected early in patients with long segments of CLE; in patients with shorter segments, intestinal metaplasia was also detected late in the course of endoscopic surveillance. Patients with surgically treated reflux disease were 10.3 times less likely to develop intestinal metaplasia compared with a group receiving standard medical therapy. CONCLUSION: Biopsy samples from a single endoscopy, despite an adequate biopsy protocol, are insufficient to rule out the presence of intestinal metaplasia. Patients in whom biopsy specimens from a segment of CLE show no intestinal metaplasia have a significant risk of having undetected intestinal metaplasia or of developing intestinal metaplasia with time. Sampling error is probably the reason for the absence of intestinal metaplasia in segments of CLE longer than 4 cm, whereas development of intestinal metaplasia is common in patients with shorter segments of CLE. Antireflux surgery protects against the development of intestinal metaplasia, possibly by better control of reflux of gastric contents.

[Laparoscopic surgery--evidence-based ?]. / Laparoskopisk kirurgi--hur evidensbaserad är den?

The literature has been searched for current results in laparoscopic cholecystectomy, hernia repair, appendectomy and fundoplication. This was performed as a systematic review. Laparoscopic cholecystectomy was judged to be safe and cost/effective, with good patient acceptability. However a need for further studies is indicated. Laparoscopic technique in hernia repair has a longer learning curve and is more expensive than open repair, with no major difference in recurrence rates. It is preferable in bilateral repairs. Laparoscopic appendectomy in the hands of experienced surgeons is cost/effective. Time to recovery is shorter and the rate of infectious complications is lower than in conventional procedures. There are still too few results reported from laparoscopic fundoplication to permit reliable conclusions.

Randomized clinical trial of laparoscopic versus open fundoplication: blind evaluation of recovery and discharge period.

BACKGROUND: There is a widespread belief that introduction of the laparoscopic technique in antireflux surgery has led to easier postoperative recovery. To test this hypothesis a prospective randomized clinical trial with blind evaluation was conducted between laparoscopic and open fundoplication. METHODS: Sixty patients with gastro-oesophageal reflux disease were randomized to open or laparoscopic 360 degrees fundoplication. The type of operation was unknown to the patient and the evaluating nurses after operation. RESULTS: The operating time was longer in the laparoscopy group, median 148 versus 109 min (P < 0.0001). The need for analgesics was less in the laparoscopically operated patients, 33.9 versus 67.5 mg morphine per total hospital stay (P < 0.001). There was no significant difference in postoperative nausea and vomiting. On the first day after operation patients in the laparoscopy group had better respiratory function: forced vital capacity 3.2 versus 2. 2 litres (P = 0.004) and forced expiratory volume 2.6 versus 2.0 litres (P = 0.008). Postoperative hospital stay was shorter in the laparoscopic group, median (range) 3 (2-6) versus 3 (2-10) days (P = 0.021). No difference was found in the duration of sick leave. CONCLUSION: Laparoscopic fundoplication was associated with a longer operating time, better respiratory function, less need for analgesics and a shorter hospital stay, while no reduction in the duration of postoperative sick leave was found compared with open surgery.

Neither low-calorie diet nor vertical banded gastroplasty influence gastro-oesophageal reflux in morbidly obese patients.

OBJECTIVE: Investigate the effect of a liquid diet, and of vertical banded gastroplasty, on gastro-oesophageal reflux in morbidly obese patients. DESIGN: Prospective study, patients being their own controls. SETTING: University hospital, Sweden. SUBJECTS: 25 morbidly obese patients, listed for vertical banded gastroplasty. INTERVENTIONS: 24 hour ambulatory intra-oesophageal pH-monitoring three weeks before operation and repeated after 10-14 days on a liquid very low calorie diet, and finally three weeks after operation, while still on a liquid very low calorie diet. MAIN OUTCOME MEASURES: Percentage of time that pH in the oesophagus was < or =4. RESULTS: There were no changes in the amount of reflux, either after a liquid diet or after vertical banded gastroplasty. CONCLUSIONS: Neither the liquid diet nor vertical banded gastroplasty alone had any appreciable effect on gastro-oesophageal reflux.

Screening for oesophageal adenocarcinoma: an evaluation of a surveillance program for columnar metaplasia of the oesophagus.

BACKGROUND: Screening patients with columnar metaplasia of the oesophagus for adenocarcinoma is controversial owing to the low cancer incidence and diverging opinions as to whether screening improves the prognosis of these patients. Our aim was to evaluate a screening program for adenocarcinoma in patients with columnar metaplasia in the oesophagus, with focus on cancer incidence and costs. METHODS: One hundred and ninety-nine patients with columnar metaplasia of the oesophagus were identified through an endoscopy database, and the original patient records were reviewed. RESULTS: The patients were followed up for 797 years in total and during this time were subjected to 1071 upper gastrointestinal endoscopies. During the screening period 5 patients presented with adenocarcinoma; thus the cancer-incidence was 1 in 159 patient-years. The cost of detecting one cancer was 294,950 SEK (US$ 37,815). However, only four of the five patients were suitable for oesophagectomy, and of these, one patient turned out to have an advanced cancer. All patients developing cancer had columnar metaplasia of the oesophagus longer than 3 cm and specialized columnar epithelium (intestinal metaplasia/Barrett oesophagus). CONCLUSIONS: Low cancer incidence, high costs, and the doubtful prognosis for the patients with identified cancer question the benefits and cost-effectiveness of cancer screening among patients with columnar metaplasia in the oesophagus.

Anastomotic diameters and strictures following esophagectomy and total gastrectomy in 256 patients.

The prevalence of anastomotic strictures in esophageal anastomoses provides us with limited information about the anastomotic healing process. This prospective study evaluates the exact esophageal anastomotic diameters in 256 patients who underwent esophagectomy and esophagogastrostomy without pyloroplasty (n = 107) or total gastrectomy and Roux reconstruction (n = 149). No perioperative chemoradiotherapy was given. Anastomotic strictures and diameters were assessed during endoscopy by a separately inserted (inflated to the anastomotic width) balloon catheter. The anastomotic diameters increased significantly during the first postoperative year in the esophagectomy (p = 0.001) and gastrectomy (p < 0.001) groups. The anastomoses in the gastrectomy group were significantly wider than those in the esophagectomy group 3 (25.7 versus 19.9 mm), 6 (28.5 versus 22.0 mm), and 12 (30.5 versus 23.3 mm) months after surgery (p < 0.001). Neither the anastomotic site (neck or chest) in the esophagectomy group (p = 0.176) nor that in the gastrectomy group (abdomen or chest) (p = 0.577) influenced the anastomotic diameter. Benign anastomotic strictures were most frequently found after 3 months and after esophagectomy. Esophagojejunostomies performed with 2 linear stapling devices or cartridge size 28 mm showed the widest anastomoses with only 1 stricture. Esophagogastric anastomoses following esophagectomy are narrower and develop more strictures than esophagojejunal anastomoses after total gastrectomy, but both dilate during the first year.

Pharyngeal reflux after gastric pull-up esophagectomy with neck and chest anastomoses.

OBJECTIVE: Pharyngeal reflux after a gastric pull-up esophagectomy may cause aspiration. This study evaluates acid exposure to the esophageal remnant and to the pharynx after gastric pull-up esophagectomy and evaluates the impact of additional dissection of the esophagus that is necessary for neck anastomoses versus no neck exploration and proximal chest anastomoses. METHODS: Forty-seven patients had circular stapled anastomoses in the apex of the right chest (n = 27 patients) or manually sutured neck anastomoses (n = 20 patients). A 24-hour double-pH study with the probes placed 3 cm cranial and 3 cm distal to the cricopharyngeal muscle was performed. The percent time pH less than 4 was registered 3, 6, and 12 months after the operation. RESULTS: Mean acid exposure to the proximal pH probe ranged between 0.2% and 0.96% and between 1.45% and 6.5% to the distal pH probe during the 3 measurements. Acid exposure was always lower to the proximal than to the distal probe (P =.001). Patients with neck anastomoses had increasing acid exposure to the distal (P =.023) and proximal (P =.002) pH probes during the study year, whereas patients with chest anastomoses had similar acid exposure. CONCLUSIONS: Acid exposure to the esophageal remnant and to the pharynx increased during the first postoperative year in patients with neck anastomoses but not in patients with proximal chest anastomoses. The results suggest a less favorable acid clearance in patients with the neck approach.

The usefulness of a structured questionnaire in the assessment of symptomatic gastroesophageal reflux disease.

BACKGROUND: The diagnosis of gastroesophageal reflux disease (GERD) rests primarily on recognition of symptom patterns that are classical for reflux disease, but little attention has been paid to the use of a formal questionnaire for identifying such symptom patterns. METHODS: A self-administered questionnaire was developed which has seven items that focus on the nature of the symptoms and the precipitating, exacerbating, and relieving factors. The diagnostic validity of the questionnaire was tested against endoscopy and 24-h pH monitoring. A further evaluation was undertaken in patients with symptoms suggestive of GERD and in patients with non-ulcer dyspepsia, to identify factors that might predict symptom relief during treatment with omeprazole. RESULTS: When endoscopic esophageal mucosal breaks and 24-h pH data were used as criteria for the diagnosis of GERD, the questionnaire had a sensitivity of 92% but a very low specificity of 19%. Symptom relief during treatment with omeprazole was predicted by the presence of heartburn, described as 'a burning feeling rising from the stomach or lower chest up towards the neck' (P = 0.004), and 'relief from antacids' (P = 0.02). In non-ulcer dyspepsia a positive response to omeprazole was confined to the subgroup of patients who identified their main discomfort as heartburn as described above. CONCLUSION: The present questionnaire using descriptive language usefully identified heartburn in patients presenting with upper abdominal symptoms, and this symptom predicted symptom resolution during treatment with omeprazole.

Active or passive chest drainage after oesophagectomy in 101 patients: a prospective randomized study.

BACKGROUND: This study evaluates the efficiency and safety of two methods of chest drainage after uncomplicated oesophagectomy. METHODS: A prospective randomized study between active suction drainage and passive chest drainage was carried out in 101 patients who underwent gastric pull-up oesophagectomy. RESULTS: No difference in the prevalence of pneumothorax during treatment was noted between the active (nine of 55) and the passive (four of 46) drainage groups (P=0.20). Nor was there any difference in the size (P=0.46) and duration (P=0.53) of the pneumothorax. There was no significant difference in right (P=0.84) and left (P=0.61) basal atelectases and the amounts of right (P=0.10) and left (P=0.24) pleural effusions. There were significantly more basal atelectases (P < 0.001) and pleural effusions (P<0.001) in the non-operated left side compared with the operated right side. Postoperative hospital stay was the same in both groups (median 13 days; P=0.86). The hospital mortality rate was two of 101, and was not affected by the type of drainage. CONCLUSION: Passive drainage did not reduce hospital stay, but was as safe and effective as the active system in draining the pleural cavity after uncomplicated oesophagectomy.

One-week omeprazole treatment in the diagnosis of gastro-oesophageal reflux disease.

BACKGROUND: Symptoms of gastro-oesophageal reflux are common, and currently available methods for diagnosing reflux disease are expensive and uncomfortable for the patient. The diagnostic value of a treatment test with omeprazole is unclear. METHODS: Patients with dyspepsia including heartburn admitted for upper gastrointestinal endoscopy were studied in a prospective, randomized, double-blind Scandinavian multicentre study. Before entry 188 patients were enrolled, and 160 were randomized to 1-week treatment with 20 mg omeprazole twice daily or placebo. Gastro-oesophageal reflux disease (GERD) was defined as reflux oesophagitis Savary-Miller grades II-III at endoscopy or pH < 4 exceeding 4% of the total time at 24-h oesophageal pH-monitoring and was found in 135 patients. The treatment test was considered positive when the patient's symptoms improved during the treatment week compared with the pretreatment day. RESULTS: The sensitivity in diagnosing reflux disease was 71-81% with omeprazole as a diagnostic test, compared with 36-47% for placebo during treatment days 3-7. The specificity was similar for the two treatment arms during the first days of the study. During the end of the week a larger proportion of the patients with normal endoscopy and pH test responded to omeprazole treatment, giving omeprazole lower specificity than placebo. The investigators' overall evaluation of whether the patient was a responder to the test had a sensitivity of 75% and a specificity of 55% in the omeprazole-treated patients. The corresponding figures in the placebo group were 17% and 92%, respectively. CONCLUSION: One week of omeprazole treatment is a simple diagnostic test with a fairly high sensitivity. The specificity is poor owing to the placebo effect and to the lack of a gold standard in diagnosing reflux disease.