Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial).

BACKGROUND: Despite promising evidence that laparoscopic fundoplication provides better short-term relief of gastro-oesophageal reflux disease (GORD) than continued medical management, uncertainty remains about whether benefits are sustained and outweigh risks. OBJECTIVE: To evaluate the long-term clinical effectiveness, cost-effectiveness and safety of laparoscopic surgery among people with GORD requiring long-term medication and suitable for both surgical and medical management. DESIGN: Five-year follow-up of a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. Cost-effectiveness was assessed alongside the trial using a NHS perspective for costs and expressing health outcomes in terms of quality-adjusted life-years (QALYs). SETTING: Follow-up was by annual postal questionnaire and selective hospital case notes review; initial recruitment in 21 UK hospitals. PARTICIPANTS: Questionnaire responders among the 810 original participants. At entry, all had documented evidence of GORD and symptoms for > 12 months. Questionnaire response rates (years 1-5) were from 89.5% to 68.9%. INTERVENTIONS: Three hundred and fifty-seven participants were recruited to the randomised comparison (178 randomised to surgical management and 179 randomised to continued medical management) and 453 to the preference groups (261 surgical management and 192 medical management). The surgeon chose the type of fundoplication. MAIN OUTCOME MEASURES: Primary: disease-specific outcome measure (the REFLUX questionnaire); secondary: Short Form questionnaire-36 items (SF-36), European Quality of Life-5 Dimensions (EQ-5D), NHS resource use, reflux medication, complications. RESULTS: The randomised groups were well balanced. By 5 years, 63% in the randomised surgical group and 13% in the randomised medical management group had received a total or partial wrap fundoplication (85% and 3% in the preference groups), with few perioperative complications and no associated deaths. At 1 year (and 5 years) after surgery, 36% (41%) in the randomised surgical group - 15% (26%) of those who had surgery - were taking proton pump inhibitor medication compared with 87% (82%) in the randomised medical group. At each year, differences in the REFLUX score significantly favoured the randomised surgical group (a third of a SD; p< 0.01 at 5 years). SF-36 and EQ-5D scores also favoured surgery, but differences attenuated over time and were generally not statistically significant at 5 years. The worse the symptoms at trial entry, the larger the benefit observed after surgery. Those randomised to medical management who subsequently had surgery had low baseline scores that markedly improved after surgery. Following fundoplication, 3% had surgical treatment for a complication and 4% had subsequent reflux-related operations - most often revision of the wrap. Dysphagia, flatulence and inability to vomit were similar in the two randomised groups. The economic analysis indicated that surgery was the more cost-effective option for this patient group. The incremental cost-effectiveness ratio for surgery in the base case was £7028 per additional QALY; these findings were robust to changes in approaches and assumptions. The probability of surgery being cost-effective at a threshold of £20,000 per additional QALY was > 0.80 for all analyses. CONCLUSIONS: After 5 years, laparoscopic fundoplication continues to provide better relief of GORD symptoms with associated improved health-related quality of life. Complications of surgery were uncommon. Despite being initially more costly, a surgical policy is highly likely to be cost-effective. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15517081. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 22. See the HTA programme website for further project information.

Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX).

OBJECTIVES: To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD). DESIGN: Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups). SETTING: Initial recruitment in 21 UK hospitals. PARTICIPANTS: Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. INTERVENTION: The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. MAIN OUTCOME MEASURES: Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications. RESULTS: By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), P<0.001, at five years). SF-36 and EQ-5D scores also favoured surgery, but were not statistically significant at five years. After fundoplication, 3% (12/364) had surgical treatment for a complication and 4% (16) had subsequent reflux-related operations-most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups. CONCLUSIONS: After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse symptoms caused by surgery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15517081.

Diagnosis and management of non-erosive reflux disease--the Vevey NERD Consensus Group.

BACKGROUND/AIMS: Although considerable information exists regarding gastroesophageal reflux disease with erosions, much less is known of non-erosive reflux disease (NERD), the dominant form of reflux disease in the developed world. METHODS: An expert international group using the modified Delphi technique examined the quality of evidence and established levels of agreement relating to different aspects of NERD. Discussion focused on clinical presentation, assessment of clinical outcome, pathobiological mechanisms, and clinical strategies for diagnosis and management. RESULTS: Consensus was reached on 85 specific statements. NERD was defined as a condition with reflux symptoms in the absence of mucosal lesions or breaks detected by conventional endoscopy, and without prior effective acid-suppressive therapy. Evidence supporting this diagnosis included: responsiveness to acid suppression therapy, abnormal reflux monitoring or the identification of specific novel endoscopic and histological findings. Functional heartburn was considered a separate entity not related to acid reflux. Proton pump inhibitors are the definitive therapy for NERD, with efficacy best evaluated by validated quality-of-life instruments. Adjunctive antacids or H(2) receptor antagonists are ineffective, surgery seldom indicated. CONCLUSIONS: Little is known of the pathobiology of NERD. Further elucidation of the mechanisms of mucosal and visceral hypersensitivity is required to improve NERD management.

A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia.

Impaired gastric accommodation, hypersensitivity to distension and delayed gastric emptying are major pathophysiological mechanisms in functional dyspepsia (FD). Acotiamide (Z-338) was well-tolerated in healthy volunteers. To determine the effect of three doses of Acotiamide on major pathophysiological mechanisms, symptoms, quality of life (QOL) and safety in functional dyspeptics. A phase IIa, randomized, double-blind, placebo-controlled study (14, 21 and 28 days, respectively, for run-in, study drug administration and follow-up). Gastric accommodation, sensitivity to distension and gastric emptying were assessed by barostat and (13)C breath test, symptoms by daily diary cards and QOL by SF-36. A total of 71 patients were enrolled (62 evaluable). There was no effect on gastric emptying and sensitivity to distension. 300 mg was better than placebo for meal accommodation (P = 0.024). 100 mg was better than placebo at week 2 for upper abdominal bloating (P = 0.001) and overall symptom score (P = 0.022), and at week 3 for bloating (P = 0.008) and heartburn (P = 0.041). 100 mg was also better than placebo for QOL (physical function) (P = 0.003). Acotiamide was safe and well-tolerated in patients with FD. The involved mechanism could at least in part depend on an effect on meal-induced accommodation. 100 mg Acotiamide exhibited the potential to improve FD symptoms and QOL. Further studies are indicated.

The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease - a UK collaborative study. The REFLUX trial.

OBJECTIVES: To evaluate the clinical effectiveness, cost-effectiveness and safety of a policy of relatively early laparoscopic surgery compared with continued medical management amongst people with gastro-oesophageal reflux disease (GORD) judged suitable for both policies. DESIGN: Relative clinical effectiveness was assessed by a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. The economic evaluation compared the cost-effectiveness of the two management policies in order to identify the most efficient provision of future care and describe the resource impact that various policies for fundoplication would have on the NHS. SETTING: A total of 21 hospitals throughout the UK with a local partnership between surgeon(s) and gastroenterologist(s) who shared the secondary care of patients with GORD. PARTICIPANTS: The 810 participants, who were identified retrospectively or prospectively via their participating clinicians, had both documented evidence of GORD (endoscopy and/or manometry/24-hour pH monitoring) and symptoms for longer than 12 months. In addition, the recruiting clinician(s) was clinically uncertain about which management policy was best. INTERVENTION: Of the 810 eligible patients who consented to participate, 357 were recruited to the randomised arm of the trial (178 allocated to surgical management, 179 allocated to continued, but optimised, medical management) and 453 recruited to the parallel non-randomised preference arm (261 chose surgical management, 192 chose to continue with best medical management). The type of fundoplication was left to the discretion of the surgeon. MAIN OUTCOME MEASURES: Participants completed a baseline REFLUX questionnaire, developed specifically for this study, containing a disease-specific outcome measure, the Short Form with 36 Items (SF-36), the EuroQol-5 Dimensions (EQ-5D) and the Beliefs about Medicines and Surgery questionnaires (BMQ/BSQ). Postal questionnaires were completed at participant-specific time intervals after joining the trial (equivalent to approximately 3 and 12 months after surgery). Intraoperative data were recorded by the surgeons and all other in-hospital data were collected by the research nurse. At the end of the study period, participants completed a discrete choice experiment questionnaire. RESULTS: The randomised groups were well balanced at entry. Participants had been taking GORD medication for a median of 32 months; the mean age of participants was 46 years and 66% were men. Of 178 randomised to surgery, 111 (62%) actually had fundoplication. There was a mixture of clinical and personal reasons why some patients did not have surgery, sometimes related to long waiting times. A total or partial wrap procedure was performed depending on surgeon preference. Complications were uncommon and there were no deaths associated with surgery. By the equivalent of 12 months after surgery, 38% in the randomised surgical group (14% amongst those who had surgery) were taking reflux medication compared with 90% in the randomised medical group. There were substantial differences (one-third to one-half standard deviation) favouring the randomised surgical group across the health status measures, the size depending on assumptions about the proportion that actually had fundoplication. These differences were the same or somewhat smaller than differences observed at 3 months. The lower the REFLUX score, the worse the symptoms at trial entry and the larger the benefit observed after surgery. The preference surgical group had the lowest REFLUX scores at baseline. These scores improved substantially after surgery, and by 12 months they were better than those in the preference medical group. The BMQ/BSQ and discrete choice experiment did distinguish the preference groups from each other and from the randomised groups. The latter indicated that the risk of serious complications was the most important single attribute of a treatment option. A within-trial cost-effectiveness analysis suggested that the surgery policy was more costly (mean 2049 pounds) but also more effective [+0.088 quality-adjusted life-years (QALYs)]. The estimated incremental cost per QALY was 19,000-23,000 pounds, with a probability between 46% (when 62% received surgery) and 19% (when all received surgery) of cost-effectiveness at a threshold of 20,000 pounds per QALY. Modelling plausible longer-term scenarios (such as lifetime benefit after surgery) indicated a greater likelihood (74%) of cost-effectiveness at a threshold of 20,000 pounds, but applying a range of alternative scenarios indicated wide uncertainty. The expected value of perfect information was greatest for longer-term quality of life and proportions of surgical patients requiring medication. CONCLUSIONS: Amongst patients requiring long-term medication to control symptoms of GORD, surgical management significantly increases general and reflux-specific health-related quality of life measures, at least up to 12 months after surgery. Complications of surgery were rare. A surgical policy is, however, more costly than continued medical management. At a threshold of 20,000 pounds per QALY it may well be cost-effective, especially when putative longer-term benefits are taken into account, but this is uncertain. The more troublesome the symptoms, the greater the potential benefit from surgery. Uncertainty about cost-effectiveness would be greatly reduced by more reliable information about relative longer-term costs and benefits of surgical and medical policies. This could be through extended follow-up of the REFLUX trial cohorts or of other cohorts of fundoplication patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15517081.

Validation of a brief symptom questionnaire (ReQuest in Practice) for patients with gastro-oesophageal reflux disease.

BACKGROUND: A clinical need exists for a means of assessing symptom control in patients with gastro-oesophageal reflux disease. The ReQuest questionnaire has been extensively validated for symptom assessment in both erosive and non-erosive gastro-oesophageal reflux disease but was designed for research purposes. We derived a shorter version (ReQuest in Practice) that would be more convenient for clinical practice. AIM: To validate ReQuest in Practice in patients suffering from gastro-oesophageal reflux disease. METHODS: Multicentre, non-interventional, crossover comparison. Patients completed ReQuest in Practice followed by ReQuest or vice versa. Before and after a planned endoscopy, patients completed the health-related quality of life questionnaire GERDyzer. Internal consistency and the Intraclass Correlation Coefficient were calculated. Construct validity was evaluated by correlation with ReQuest and GERDyzer. RESULTS: There was high internal consistency of ReQuest in Practice (Cronbach's alpha: 0.9) and a high Intraclass Correlation Coefficient of 0.99. The measurement error of ReQuest in Practice was 4.1. High correlation between ReQuest in Practice and ReQuest (Spearman correlation coefficient: 0.9) and GERDyzer (Spearman correlation coefficient: 0.8) demonstrated construct validity. CONCLUSIONS: ReQuest in Practice was proven to be valid and reliable. Its close correlation with ReQuest makes it a promising tool to guide the clinical management of patients across the full spectrum of both erosive and non-erosive gastro-oesophageal reflux disease.

Systematic review: the safety and tolerability of pharmacological agents for treatment of irritable bowel syndrome--a European perspective.

AIM: To use an evidence-based approach to evaluate the safety and tolerability of the treatments available for irritable bowel syndrome (IBS), or in clinical development, in Europe. A separate review appraises the evidence for the efficacy of these therapies. METHODS: A literature search (for 1980 to 2005) was completed for all relevant clinical trial data and other articles which included safety information on the use of pharmacological IBS therapies. Clinical trials were scored according to the level of safety information, and adverse event incidence reported when possible. RESULTS: The tolerability of many of the agents used to treat IBS in Europe is poorly understood. However, serotonergic agents, such as tegaserod and alosetron, which are currently unavailable in Europe, have undergone rigorous assessment in IBS and their benefits have been established. Following initial marketing of alosetron for use in patients with IBS with diarrhoea, concerns about severe constipation and ischaemic colitis resulted in restriction of its use to women with severe IBS symptoms. This highlights the importance of post-marketing surveillance and post-marketing studies in refining the therapeutic indication of new IBS therapies, which will help to identify appropriate recipients for the drug and establish the impact of adverse reactions in clinical practice. CONCLUSIONS: There is a significant lack of data on the safety and tolerability of the therapies currently used routinely to treat IBS in Europe. The newer agents have undergone rigorous assessment, such that their benefits and risks in treating IBS are established. Defining their place among the spectrum of available therapies remains challenging when the benefits and risks of the older treatments are so poorly characterized.

Review article: diagnosis and clinical investigation of gastro-oesophageal reflux disease: a European view.

In Western populations, many individuals with symptoms of gastro-oesophageal reflux disease (GERD) do not bother to seek medical attention because their symptoms are mild and acceptably controlled by self-medication. Among those who do consult physicians, only a minority present with the classical clinical symptoms of heartburn and regurgitation: more often the pattern is a nonspecific combination of upper gastrointestinal complaints that do not permit confident clinical diagnosis. Oesophagitis is now found in less than 50% of GERD patients and those without oesophagitis are sometimes said to have 'non-erosive reflux disease'. If a patient's clinical history is inadequate for diagnosis and the oesophageal endoscopic appearances are normal, ambulatory pH monitoring may be required if the diagnostic uncertainty is to be resolved. Despite initial enthusiasm, the 'Proton Pump test' for GERD has proved unreliable and has fallen from favour. Intraluminal impedence measurement is currently considered a research tool only. Most European gastroenterologists acknowledge the occurrence of 'atypical' presentations of GERD, including noncardiac chest pain, asthma and hoarseness (laryngitis), though confirmation of GERD as the cause of such symptoms in individual patients is often difficult.

Review article: sleep and its relationship to gastro-oesophageal reflux.

Gastro-oesophageal reflux disease (GERD) is among the most common gastrointestinal conditions in the USA. For most symptomatic patients, reflux events occur during both daytime and night-time hours. Whereas daytime reflux events tend to be frequent but brief, reflux events that occur during sleep are comparatively less frequent but significantly longer. Longer oesophageal acid-clearance and acid-mucosal contact times during sleep are at least partly due to several physiological changes associated with sleep, including dramatic declines in saliva production and frequency of swallowing, decreased conscious perception of heartburn and consequent arousal and clearance behaviours, and slower gastric emptying. Obstructive sleep apnea syndrome and obesity seem to predispose some patients to nocturnal GERD, and the presence of either of these conditions may help to identify patients with symptoms consistent with GERD. Recognition and treatment of night-time GERD are important because it can be associated with decreased quality of life (including sleep disruption) and increased risk of serious oesophageal and respiratory complications.

Impact of alcohol related disease and inpatient workload of gastroenterologists in Scotland.

BACKGROUND: Concern among Scots gastroenterologists about alcohol related illness prompted this inpatient prevalence study during the winter of 2000-01. AIMS: To study gastrenterology inpatient workload due to alcohol-related illness, to determine how much was specialty specific, and if there were regional variations. METHODS: 40 Consultant gastrenterologists throughout Scotland collected data on the prevalence of alcohol related conditions among inpatients under their care on each of three specified days during the winter of 2000/2001. All inpatients under the care of participating consultants on the designated study days were included in the study. Overall return rate was 65%. Patients were categorised as follows; (a) general medical inpatients admitted for reasons other than alcohol related illness (b) general medical inpatients with no gastrointestinal or liver disease, but whose admission to hospital was primarily related to alcohol misuse, (c) gastrointestinal (including liver) inpatients admitted for reasons unrelated to alcohol intake, and with no alcohol related disease, and (d) gastrointestinal inpatients whose admission to hospital resulted from alcohol related disease. Additionally the numbers of patients with (e) decompensated liver disease of all causes, (f) decompensated alcoholic liver disease, and (g) the numbers "blocking" acute beds after initial hospitalisation with an alcohol related illness were collected. RESULTS: Overall, 829 general medical and 538 gastroenterology inpatients were entered in the study; total 1367 (705 male, 662 female). Of these, 25% (337/1367) were admitted because of alcohol related illness: 15% (201/1367) had decompensated alcoholic liver disease. Of 538 gastroenterology inpatients, 238 (44%) had problems related to alcohol and 201 of these (37% of all gastoenterology inpatients) had decompensated alcoholic liver disease. Of 246 inpatients with decompensated liver disease, 82% (201) had alcoholic liver disease. Alcohol related illness was significantly more prevalent among male inpatients in the West of Scotland. 10% of specialist gastroentelogy beds were occupied by patients whose discharge was delayed because of alcohol related problems. CONCLUSION: Most Scottish gastroenterlogists contribute to general medical receiving but their specialist inpatient workload is dominated by treatment of patients with alcohol related disease. (44% in gastroenterology v 12% in general medicine). Inpatients with decompensated alcoholic liver disease form 37% of gastroenterology workload. Alcohol related disease contributes to delayed discharge in acute medical units, especially in gastroenterology wards. There are regional differences in prevalence of alcohol related disease, which is greatest in male inpatients in the West of Scotland. Here, alcoholic liver disease accounts for nearly a decompensated liver disease. The findings point to a need to review the current patterns of acute service provision for alcohol related illnesses, so as to assess and improve both the linical effectiveness and cost effectiveness of care, and to ensure that alternatives to acute hospital admission are available when appropriate. This need should not be neglected while efforts are simultaneously being made to improve the early detection of alcohol abuse and prevent irreversible alcohol related disease.

Contemporary understanding and management of reflux and constipation in the general population and pregnancy: a consensus meeting.

BACKGROUND: Gastro-oesophageal reflux disease (GERD) and constipation have a major impact on public health; however, the wide variety of treatment options presents difficulties for recommending therapy. Lack of definitive guidelines in pharmacy and general practice medicine further exacerbates the decision dilemma. AIMS: To address these issues, a panel of experts discussed the principles and practice of treating GERD and constipation in the general population and in pregnancy, with the aim of developing respective treatment guidelines. RESULTS: The panel recommended antacids 'on-demand' as the first-line over-the-counter treatment in reflux, and as rescue medication for immediate relief when reflux breaks through with proton pump inhibitors. Calcium/magnesium-based antacids were recommended as the treatment of choice for pregnant women because of their good safety profile. In constipation, current data do not distinguish a hierarchy between polyethylene glycol (PEG)-based laxatives and other first-line treatments, although limitations are associated with stimulant- and bulk-forming laxatives. Where data are available, PEG is superior to lactulose in terms of efficacy. In pregnancy, PEG-based laxatives meet the criteria for the ideal treatment. CONCLUSIONS: The experts developed algorithms that present healthcare professionals with clear treatment options and management strategies for GERD and constipation in pharmacy and general practice medicine.

Clinical perspectives, mechanisms, diagnosis and management of irritable bowel syndrome.

This consensus document reviews the current status of the epidemiology, social impact, patient quality of life, pathophysiology, diagnosis and treatment of irritable bowel syndrome. Current evidence suggests that two major mechanisms may interact in irritable bowel syndrome: altered gastrointestinal motility and increased sensitivity of the intestine. However, other factors, such as psychosocial factors, intake of food and prior infection, may contribute to its development. Management of patients is based on a positive diagnosis of the symptom complex, careful history and physical examination to exclude 'red flags' as risk factors for organic disease, and, if indicated, investigations to exclude other disorders. Therapeutic choices include dietary fibre for constipation, opioid agents for diarrhoea and low-dose antidepressants or infrequent use of antispasmodics for pain, although the evidence basis for efficacy is limited or in some cases absent. Psychotherapy and hypnotherapy are the subject of ongoing study. Treatment should be tailored to patient needs and fears. Novel therapies are emerging, and drugs acting on serotonin receptors have proven efficacy and a scientific rationale and, if approved, should be useful in the overall management of patients with irritable bowel syndrome. Patient and physician education, early identification of psychosocial issues and better therapies are important strategies to reduce the suffering and societal cost of irritable bowel syndrome.

Present medical management of Barrett's oesophagus.

The management of Barrett's oesophagus should aim to treat symptoms, and prevent complications of reflux. Treatment of choice is a proton pump inhibitor, with the option of surgical treatment in younger patients. Uncertainties remain about the significance of short segment Barrett's oesophagus. Doubts also remain about the benefit and cost-effectiveness of conventional surveillance of Barrett's oesophagus; for patients with an annual cancer risk of 0.5% 5-yearly endoscopy and biopsies for patients without dysplasia represent the best strategy Novel modalities such as photodynamic therapy have shown encouraging results for high grade dysplasia or early cancer for patients unsuitable for surgery. Finally, agents such as cyclooxygenase-2 inhibitors hold promise for prevention of malignancy in Barrett's oesophagus.

Pattern of ambulatory pharyngo-oesophageal motility and pH-metry in healthy volunteers.

Oesophago-pharyngeal reflux is widely accepted as an aetiological factor in many laryngeal and lower respiratory tract diseases. This study aims to establish normal reference ranges for pharyngo-oesophageal pH and pressure. Twenty-five asymptomatic healthy volunteers underwent ambulatory pharyngo-oesophageal pressure and pH-metry. Acid exposure times were very low. Only one subject showed any evidence of oesophago-pharyngeal reflux during recumbency. Two distinct upper oesophageal sphincter pressure patterns were observed during recumbency-one with episodic dry swallows and moderate tonic pressures, the other with almost complete manometric quiescence. Negative results, i.e. the exclusion of abnormal cervical reflux, appear to be more achievable than quantifiable positive results, but this is not absolutely clear from our results. Categorisation of an individual as having abnormal upper pH-metry requires use of a synchronous pharyngeal probe. pH-metry is likely to be of value in establishing the role of reflux in relation to laryngeal or respiratory disease.

Prevalence of upper gastrointestinal symptoms in the general population: a systematic review.

BACKGROUND: A systematic review was undertaken of all studies published as of December 1997, on the population prevalence of upper gastrointestinal (GI) symptoms. METHODS: Studies excluded from consideration were those conducted on subjects attending hospital or primary care clinics, or who were hospitalized or institutionalized; or where studies were conducted in the workplace or on occupational groups. Studies meeting the following criteria were included in the comparative analysis: period studied, sample size and response rate all reported; vague terms such as 'dyspepsia' or 'indigestion' defined if enquired about; abdominal pain or discomfort enquired about; patients with a history, or evidence, of organic disease not excluded from the results. Follow-up studies on groups of patients previously studied were also not included. RESULTS: In the 10 selected studies, the reported prevalence of upper abdominal symptoms (mostly upper abdominal pain or discomfort) ranged from approximately 8% to 54%, while the prevalence of heartburn and/or regurgitation ranged from 10% to 48% for heartburn, from 9% to 45% for regurgitation and 21% to 59% for both/either. CONCLUSIONS: In the case of upper abdominal symptoms, the most likely explanation for the broad range of prevalence reported is variation in the definition of symptoms. In the case of heartburn and regurgitation, different understandings of these terms by different investigators and subjects may have contributed to the range of results. Symptom definitions and what is understood by them should be among the most important considerations when undertaking population prevalence studies on upper GI symptoms, to allow comparisons to be made between studies.

Simultaneous measurement of gastric emptying of a solid meal by ultrasound and by scintigraphy.

OBJECTIVE: Although ultrasonic imaging may represent a valid alternative to scintigraphy for measurement of gastric emptying, most studies comparing the two methods have been carried out with liquid meals. The aim of this study was to compare scintigraphic and ultrasonographic measurements of gastric emptying of a solid meal in healthy subjects and in patients with possible delay in emptying. METHODS: Nineteen subjects were studied: five controls, six patients with gastroesophageal reflux, and eight patients with dysmotility-like dyspepsia. Gastric emptying was measured by both scintigraphy and ultrasonography after ingestion of an 800-calorie solid, realistic meal containing 99mTc-labeled chicken liver. Scintigraphic measurements were made every 15 min for 6 h, and ultrasonic imaging of antral sections was undertaken every 15 min for the first 1 h and every 30 min thereafter. Total emptying times were calculated independently using the two methods, and the emptying patterns recorded by the two methods were compared. RESULTS: Maximal antral dilation occurred 30 min (range 0-90 min) after the end of the meal and persisted until 96 +/- 42 min, by which time gastric radioactivity had decreased from its maximum by 43% +/- 23%. From this time on, the antral cross-sectional area returned toward the basal value, declining faster than the gastric counts recorded by scintigraphy. Total emptying times measured by ultrasound and by scintigraphy were in good agreement in all subjects, with a mean difference of only 4.5 min (limits of agreement, -17.1 to 21.6 min). CONCLUSIONS: Ultrasonographic measurement of antral cross-sectional area provides a valid alternative to scintigraphy for the measurement of total gastric emptying of a solid meal. It is less reliable if other parameters of gastric emptying such as T(1/2) are required.