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Effect of esomeprazole on nighttime heartburn and sleep quality in patients with GERD: a randomized, placebo-controlled trial.

OBJECTIVES: Sleep disturbances are common in patients with gastroesophageal reflux disease (GERD). This study examined the effects of esomeprazole on nighttime heartburn, GERD-related sleep disturbances, sleep quality, work productivity, and regular activities. METHODS: This multicenter, randomized, double-blind, placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn (recorded by patient diary during screening). Patients received oral esomeprazole 40 mg (n = 220) or 20 mg (n = 226) or placebo (n = 229) once daily for 4 wk. The primary outcome was relief of nighttime heartburn. Secondary outcomes included resolution of sleep disturbances, sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire, and work productivity measured by the Work Productivity and Activity Impairment Questionnaire. RESULTS: Nighttime heartburn was relieved in 53.1% (111/209), 50.5% (111/220), and 12.7% (28/221) of patients who received esomeprazole 40 mg, esomeprazole 20 mg, and placebo, respectively. Differences (95% CI) versus placebo were 40.5% (32.4%, 48.5%) and 37.8% (29.9%, 45.7%) and were highly significant (p < 0.0001). GERD-related sleep disturbances resolved in significantly more (p < 0.0001) patients who received esomeprazole 40 (73.7%) or 20 mg (73.2%) than in those who received placebo (41.2%). Both esomeprazole groups had greater PSQI global score changes from baseline (p < 0.0001 vs placebo) and more (p < 0.0001 vs placebo) work hours saved per week per patient compared with baseline (esomeprazole 40 mg, 11.6 h; esomeprazole 20 mg, 12.3 h; placebo, 6.2 h). CONCLUSIONS: Esomeprazole reduced nighttime heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity.

Administration, Oral↗

Comparison of gastro-oesophageal reflux disease and heartburn diagnoses in UK primary care.

OBJECTIVE: It is unclear how gastro-oesophageal reflux disease (GORD) is diagnosed in primary care. The aim of this study is to compare patients given a diagnosis of GORD with those diagnosed with heartburn. RESEARCH DESIGN AND METHODS: Data from the UK General Practice Research Database were extracted for patients newly diagnosed with heartburn (n = 1841) or GORD (n = 5318) in 1996. MAIN OUTCOME MEASURES: Patient characteristics, morbidity, healthcare use and prescribed treatments were compared using unconditional logistic regression analysis. RESULTS: GORD was diagnosed more frequently than heartburn (3.2 vs. 1.1 per 1000 patient-years). A diagnosis of GORD was less likely among females (odds ratio (OR): 0.8; confidence interval (CI): 0.7-0.9), smokers (OR: 0.8; CI: 0.7-0.9) and patients who consulted their physician frequently (OR: 0.8; CI: 0.7-0.9). There was a wide distribution in the ratio of GORD-to-heartburn diagnoses between primary care practices (mean 2.9; range 0-infinity). GORD patients were more likely to receive proton pump inhibitors (OR: 2.9; CI: 2.6-3.4), but 24% of GORD patients and 40% of heartburn patients received no acid-suppressive treatment in the month after diagnosis. CONCLUSIONS: Several factors influenced the diagnosis of gastro-oesophageal reflux symptoms by primary care physicians. Further research is needed to aid the diagnosis of GORD in primary care.

Adolescent↗

Heartburn without oesophagitis: efficacy of omeprazole therapy and features determining therapeutic response.

BACKGROUND: Data are limited on the value of effective antisecretory therapy in the relief of heartburn in patients without oesophagitis. METHODS: Patients with heartburn, without endoscopic signs of oesophagitis, were randomized to double-blind treatment with omeprazole, 20 or 10 mg once daily, or placebo, for 4 weeks (n = 509). Pre-treatment oesophageal acid exposure was assessed using 24-h intra-oesophageal pH monitoring. Heartburn was assessed at 2 and 4 weeks. RESULTS: At 4 weeks the proportion of patients with complete absence of heartburn was 46% (95% confidence interval, 39-53%) with 20 mg omeprazole, 31% (25-38%) with 10 mg omeprazole, and 13% (7-20%) with placebo. Satisfaction with therapy was reported by 66%, 57%, and 31% of the patients, respectively. CONCLUSION: Omeprazole, 20 and 10 mg once daily, provides rapid relief of heartburn in patients without endoscopic oesophagitis.

Anti-Ulcer Agents↗

Heartburn is more likely to recur after Toupet fundoplication than Nissen fundoplication.

Toupet (270 degrees) fundoplication is commonly recommended for patients with gastroesophageal reflux (GER) and esophageal dysmotility. However, Toupet fundoplication may be less effective at protecting against reflux than Nissen (360 degrees) fundoplication. We therefore compared the effectiveness and durability of both types of fundoplication as a function of preoperative esophageal motility. From January 1992 through January 1998, 669 patients with GER underwent laparoscopic fundoplication (78 Toupet, 591 Nissen). Patients scored heartburn, regurgitation, and dysphagia preoperatively, and at 6 weeks and 1 year postoperatively, using a 0 ("none") to 3 ("severe") scale. We compared symptom scores (Wilcoxon rank sum test) and redo fundoplication rates (Fisher exact test) in Toupet and Nissen patients. We also performed subgroup analyses on 81 patients with impaired esophageal motility (mean peristaltic amplitude, <30 mm Hg or peristalsis <70% of wet swallows) and 588 patients with normal esophageal motility. Toupet and Nissen patients reported similar preoperative heartburn, regurgitation, and dysphagia. At 6 weeks after operation, heartburn and regurgitation were similarly improved in both groups, but dysphagia was more prevalent among Nissen patients. After 1 year, heartburn and regurgitation were re-emerging in Toupet patients, and dysphagia was again similar between groups. Patients with impaired motility who have Nissen fundoplication are no more likely to suffer persistent dysphagia than their counterparts who have Toupet fundoplication. In addition, patients with normal motility are more likely to develop symptom recurrence after Toupet fundoplication than Nissen fundoplication, with no distinction in dysphagia rates. We conclude that since Toupet patients suffer more heartburn recurrence than Nissen patients, with similar dysphagia, selective use of Toupet fundoplication requires further study.

Deglutition Disorders↗

Endoscopic and histologic findings in Iranian patients with heartburn.

BACKGROUND: Heartburn is a common manifestation of gastroesophageal reflux disease. Barrett's esophagus and esophageal adenocarcinoma, known complications of this disease, appear to be less prevalent in Asia than in Western countries. We looked for endoscopic and histologic evidence of Barrett's esophagus in Iranian patients with heartburn. METHODS: During September 2001 to September 2003, endoscopy was done in all patients with heartburn, either lasting longer than 3 months (n=1182) or for 1-3 months but resistant to 4 weeks of omeprazole therapy (n=66). Biopsy was taken from columnar-lined mucosa above the GE junction, at 5 cm above the Z line in normal- appearing mucosa, and from any abnormal areas. RESULTS: Of the 1248 patients (mean age 45 [SD 15.5] years, 750 men; duration of heartburn 68 [SD 87.5] months), 960 (66.5%) had erosive esophagitis and 30 (2.4%) had Barrett's esophagus, including 10 and 20 with long- and short-segment involvement, respectively. Of 134 patients with normal-appearing mucosa, 122 had histologic evidence of esophagitis. CONCLUSION: Barrett's esophagus may be less common in Iran than in Western countries, despite presence of severe heartburn and erosive esophagitis.

Adult↗

Symptomatic and endoscopic outcome of heartburn 3-4.5 years after starting lansoprazole therapy: a prospective study of 142 patients.

BACKGROUND: Heartburn is a common symptom with great impact on quality of life and on the economy. An approach that helps to alleviate patients' symptoms, decrease the burden on the economy, and improve longterm outcome is needed. Step-down therapy, starting with the proton pump inhibitor lansoprazole, seems to achieve these goals. METHODS: All patients who were referred to the gastroenterology clinic at the University Health Center to evaluate their heartburn and who met the inclusion criteria were included in the present study. Symptomatic and endoscopic evaluations were carried out and then they were started on the proton pump inhibitor lansoprazole to achieve symptomatic control. Step-down therapy was carried out for these patients, provided their symptoms remained controlled. At the end of the study symptomatic and endoscopic outcomes were evaluated. RESULTS: Heartburn was controlled on lansoprazole 30 mg/per day in 76.1% of patients, and 18.3% required double this dose. Initial endoscopy showed normal findings in 38.7%, while 61.3% showed various grades of esophagitis including 1.4% with Barrett's epithelium. Of 119 patients who completed the study, 17 were non-compliant to therapy, 52 were controlled on minimal therapy, 42 required lansoprazole to be kept symptom-free, and 8 patients had surgery. Endoscopic esophagitis was healed or attenuated in all compliant patients. No new cases of Barrett's appeared during follow up. CONCLUSIONS: Most of the patients with heartburn can be controlled on proton pump inhibitors, with improvement in the grade of endoscopic esophagitis. Half of these patients can be kept on minimal therapy after a period of 3-4.5 years with maintenance of improvement, while the remainder still need proton pump inhibitors for control.

2-Pyridinylmethylsulfinylbenzimidazoles↗

Esophageal visceral sensitivity to bile salts in patients with functional heartburn and in healthy control subjects.

Patients with nonerosive gastroesophageal reflux disease often have relatively low esophageal acid exposure and respond suboptimally to gastric acid suppression. In these patients, other constituents of gastric contents may induce esophageal symptoms. We have demonstrated that gastric contents can cause heartburn when the gastric pH >4. (Aliment Pharm Ther 14:129-134, 2000). The aim of this study was to determine relative sensitivities to chenodeoxycholic and ursodeoxycholic acids, and 0.1 N HCl, administered as provocative perfusion tests. Patients with functional heartburn and healthy control subjects were evaluated. Patients underwent a modified Bernstein acid infusion test and esophageal Barostat balloon distention. Time and volume to pain were recorded. Barostat balloon distention was performed using our standard protocol. Stepwise distentions were performed and pain was recorded. Sensitivity to chenodeoxycholic acid (Cheno) and Ursodeoxycholic acid (Urso) were assessed similarly to the Bernstein test using 2 mM concentrations of each, followed immediately by 5 mM if no pain was reported with 2 mM. Volume of bile acid infusion and length of time until pain was induced were assessed and compared to the same endpoints for acid sensitivity. "Total" time and "total" volume to induce pain were calculated for Cheno and Urso. Least-squares means were generated and two-tailed t-tests and regression analyses were performed (P < 0.05 level of significance). Ten functional heartburn patients and six healthy controls were evaluated (3 M, 13 F; age range, 19 to 56 years). Since five of six controls had pain with acid infusion (hypersensitive), all subjects were analyzed as one group. Only three subjects (all controls) had no pain with infusion of 2 mM Cheno and received the follow-up infusion of 5 mM. These same three subjects tolerated the maximum infusion (150 ml and 15 min) of 5 mM Cheno. Nine subjects did not have pain with 2 mM Urso and received the follow-up infusion of 5 mM Urso (five functional heartburn, four controls). Significantly more subjects tolerated the maximum bile acid infusion of 2 mM Urso vs 2 mM Cheno (nine vs three; P < 0.05, Chi-square test). The pain threshold (volume and time) for Urso was significantly higher than that for Cheno and acid (P < 0.05), and the pain threshold for Cheno was significantly higher than that for acid (P < 0.05). Conclusions are as follows: (1) Bile acids differ in their ability to induce pain. (2) Changing bile acid composition by treatment with Urso may change symptom presentation and symptom severity in patients with bile acid-induced esophageal pain.

Adult↗

Effect of tegaserod on esophageal pain threshold, regurgitation, and symptom relief in patients with functional heartburn and mechanical sensitivity.

BACKGROUND & AIMS: Tegaserod, a 5-HT4-receptor partial agonist, effectively treats irritable bowel syndrome with constipation. The role of tegaserod in functional disorders of the upper gastrointestinal (GI) tract is unclear. The aims of this study were to determine if tegaserod improves esophageal pain with mechanical and chemical stimuli, GI symptom profile, and global preference in patients with functional heartburn. METHODS: Patients with functional heartburn, as defined by Rome II criteria, underwent esophageal barostat and acid-infusion sensory tests. Mechanical hypersensitivity was required for entry. The baseline GI symptom profile was rated before treatment. Patients were blinded to treatment and randomly assigned to tegaserod 6 mg twice daily or placebo for 14 days, and crossed-over to the alternate treatment after 7 to 10 days of washout. Patients underwent sensory tests and rated GI symptoms after each treatment. Global treatment preference was completed at the end of the study. RESULTS: Forty-two patients (15 men, 27 women; age, 20-68 y) completed the study. The predominant baseline symptoms in addition to heartburn included upper-abdominal pain, upper-abdominal discomfort, regurgitation, chest pain, early satiety, and postmeal bloating. Tegaserod significantly increased balloon pressure to pain (P = .04) and the mean (P = .002) and maximum wall tension at pain (P = .0004). Tegaserod did not alter pain with acid infusion. Tegaserod significantly decreased the frequency of occurrence of heartburn/acid reflux (P = .004), regurgitation (P = .048), and distress from regurgitation (P = .039). The global preference for tegaserod was 63.4% vs 12.2% for placebo. CONCLUSIONS: Tegaserod improved the esophageal pain threshold to mechanical distention, and distressing upper-GI symptoms in patients with functional heartburn.

Adult↗

Assessment of relationship between acid reflux and heartburn using receiver operating characteristic curves.

Arguments proposed in this article may explain why a subgroup of patients, having so-called "functional heartburn," does not respond to acid inhibition therapy [19,20]. It is highly likely that acid is not the cause of heartburn in this group of subjects. These conclusions are supported further by observations of Wiener et al [2] and Howard et al [21], who found that a subgroup of patients with high SI have a negative Bernstein test, which suggests that the presence of acid in the esophagus at the time of spontaneous heartburn may be coincidental and does not reflect a cause-and-effect relationship between the two. The motor events responsible for the occurrence of acid reflux (longitudinal muscle contraction of the esophagus [SEC] associated with transient LES relaxation) may be the cause of heartburn sensation.

Gastric Acidity Determination↗

A randomized, double-blind comparison of two different coffee-roasting processes on development of heartburn and dyspepsia in coffee-sensitive individuals.

The mechanism underlying coffee-induced heartburn and dyspepsia remains poorly understood. This has led to speculation that variations in coffee processing may be important. The primary objective of this study was to determine whether a coffee brewed with coffee beans processed using conduction roasting will result in fewer symptoms of gastroesophageal reflux and dyspepsia in coffee-sensitive individuals compared to a differently processed yet otherwise similar coffee. Thirty coffee-sensitive individuals completed this single-center, randomized, double-blind, crossover study in which the symptoms of heartburn, regurgitation and dyspepsia were assessed following coffee consumption both in the fasting state and after ingestion of a standard test meal. Consumption of both coffees resulted in heartburn, regurgitation, and dyspepsia in most individuals. No significant differences in the frequency or severity of heartburn, regurgitation, or dyspepsia were demonstrated between the two coffees either in the fasting state or after the test meal. We conclude that differences in the coffee bean roasting process do not result in marked differences in coffee-induced upper gastrointestinal symptoms.

Adult↗

Cost-effectiveness and cost-utility of long-term management strategies for heartburn.

OBJECTIVES: To compare the expected costs and outcomes of seven alternative long-term primary care strategies for the management of patients with moderate-to-severe heartburn over a 1-year period. METHODS: A decision-analytic model was developed to estimate costs and effects (weeks with heartburn symptoms and quality adjusted life years [QALYs]) for each strategy. Meta-analyses were used to synthesize acute treatment and maintenance studies and physician surveys to collect information on patient management. The impact of uncertainty on the base case results was assessed using probabilistic sensitivity analysis. Probability distributions were defined for key model parameters and techniques of Monte Carlo simulation were used to draw values from these distributions. Cost-effectiveness acceptability curves (CEACs) conditional on the monetary value decision makers are willing to pay for a symptom-free day or QALY were created for each strategy. RESULTS: In the base case, no strategy was strictly dominated by any other strategy. However, two strategies (maintenance H2-receptor antagonists H2RA] and step-down proton pump inhibitor PPI]) were dominated through principles of extended dominance. The least costly and least effective strategy was intermittent H2RA, while maintenance PPI was the most costly and most effective. CONCLUSIONS: This analysis showed that the best way of managing patients with heartburn depends on how much society is willing to pay to achieve health improvements. Based on the commonly quoted threshold of US 50,000 dollars per QALY, the optimal primary care strategy for managing patients with moderate-to-severe heartburn symptoms is to treat the symptoms with a PPI followed by maintenance therapy with an H2RA to prevent symptomatic recurrence.

Canada↗

What is heartburn worth? A cost-utility analysis of management strategies.

OBJECTIVE: To determine the best treatment strategy for the management of patients presenting with symptoms consistent with uncomplicated heartburn. METHODS: We performed a cost-utility analysis of 4 alternatives: empirical proton pump inhibitor, empirical histamine2-receptor antagonist, and diagnostic strategies consisting of either esophagogastroduodenoscopy (EGD) or an upper gastrointestinal series before treatment. The time horizon of the model was 1 year. The base case analysis assumed a cohort of otherwise healthy 45-year-old individuals in a primary care practice. MAIN RESULTS: Empirical treatment with a proton pump inhibitor was projected to provide the greatest quality-adjusted survival for the cohort. Empirical treatment with a histamine2 receptor antagonist was projected to be the least costly of the alternatives. The marginal cost-effectiveness of using a proton pump inhibitor over a histamine2-receptor antagonist was approximately $10,400 per quality-adjusted life year (QALY) gained in the base case analysis and was less than $50,000 per QALY as long as the utility for heartburn was less than 0.95. Both diagnostic strategies were dominated by proton pump inhibitor alternative. CONCLUSIONS: Empirical treatment seems to be the optimal initial management strategy for patients with heartburn, but the choice between a proton pump inhibitor or histamine2-receptor antagonist depends on the impact of heartburn on quality of life.

Anti-Ulcer Agents↗

Characterization of the cerebral cortical representation of heartburn in GERD patients.

Although symptoms arising from the esophagus such as heartburn and pain can at times become challenging clinical problems, esophageal viscerosensation, especially with regard to chemical stimulation in humans, is incompletely understood. Our aims were 1) to characterize and ascertain the reproducibility of cerebral cortical registration of heartburn and 2) to elucidate the differences between these findings and those of esophageal subliminal acid stimulation in asymptomatic controls. We studied 11 gastroesophageal reflux disease (GERD) patients (9 males, 30-55 yr) and 15 healthy controls (8 males, 21-49 yr). Cerebral cortical functional magnetic resonance imaging (fMRI) activity was recorded twice in each subject, during two 5-min intervals of 0.1 N HCl, separated by 5 min of NaCl perfusion. Time from onset of acid perfusion to instant of fMRI signal increase and first report of heartburn averaged 1.60 +/- 0.80 and 1.85 +/- 0.60 min, respectively. Average maximum percent signal increase in the GERD patients (16.3 +/- 3.5%) was significantly greater than that of healthy controls (3.8 +/- 0.9%; P < 0.01). Temporal fMRI signal characteristics during heartburn were significantly different from those of subliminal acid stimulation in controls (P < 0.01). Activated cortical regions included sensory/motor, parieto-occipital, cingulate and prefrontal regions, and the insula. There was 92% concordance between the activated Brodmann areas in repeated studies of GERD patients. Cortical activity associated with perceived and unperceived esophageal acid exposure in GERD patients and healthy controls, respectively, involves multiple brain regions but occurs more rapidly and with greater intensity in GERD patients than the activity in response to subliminal acid exposure in healthy controls. The cortical pain-processing pathway seems to be involved in perception of esophageal acid exposure and could explain the variations encountered in clinical practice defining this sensation.

Adult↗

Use of H2-receptor antagonists in patients with dyspepsia and heartburn: a cost comparison.

OBJECTIVE: Under the Pharmaceutical Benefits Scheme, the use of H2-receptor antagonists (H2A) in the treatment of dyspepsia and heartburn is only subsidised when there is a proven diagnosis of ulcer. This study compared the costs of this Australian practice with a simulation of British practice, which allows unrestricted prescribing of subsidised H2A. DESIGN: Patients with heartburn and/or dyspepsia were prospectively randomised to either a "British" group treated freely at the discretion of their general practitioner without necessarily being investigated or an "Australian" group where use of H2A was allowed only after gastroscopy or a barium meal had demonstrated a peptic ulcer or ulcerative oesophagitis. The patients were followed up for six months and all direct and indirect costs were recorded. SETTING: Forty-nine Sydney general practitioners recruited primary care patients for the study. PATIENTS: Any patient with heartburn or dyspepsia was considered for recruitment; 139 patients entered the study and 137 completed it. MAIN OUTCOME MEASURES: The outcome measures were the costs of general practitioner consultations, specialist consultations, radiology and gastroscopy, other tests, H2A, other medications, personal costs, and total cost per patient. RESULTS: The cumulative total cost per patient at the end of the study was equivalent in the "Australian" ($392) and "British" ($406) groups. A higher initial cost per patient of H2A in the "British" group was offset by a rapid decrease in the proportion that continued to use H2A and by the cost of specialist consultations and investigations in the "Australian" group. CONCLUSION: Over a six-month period the cost of early investigation of heartburn and dyspepsia was equivalent to the cost of a therapeutic trial of H2A.

Adult↗

[Nationwide epidemiological survey regarding heartburn and reflux esophagitis in Japanese].

The details on prevalence of heartburn and reflux esophagitis have not been clarified, since no large-scale survey has been conducted to date. Accordingly, we conducted the nationwide survey regarding prevalence of heartburn and reflux esophagitis by asking new outpatients and patients with the first endoscopy to be performed who visited the medical institutions participating in this survey to fill out the questionnaire and undergo endoscopy. The result showed that heartburn was reported from 1,994 patients (42.2%) out of 4,723, and reflux esophagitis classified as grade A-D was reported from 602 patients (16.7%) out of 3,608. Meanwhile, fat intake, sweet food and anti-inflammatory analgesics were proven to be causes of heart-burn. Furthermore, frequency of heartburn and severity of reflux esophagitis were slightly correlated, although those were not necessarily obviously related.

Adult↗

Heartburn severity does not predict disease severity in patients with erosive esophagitis.

BACKGROUND: For patients with gastroesophageal reflux disease (GERD), it is often assumed by treating physicians that the severity of heartburn correlates with the severity of erosive esophagitis (EE). OBJECTIVE: This is a post hoc analysis of data from 5 clinical trials that investigate the relationship between the baseline severity of heartburn and the baseline severity of EE. METHODS: Patients with endoscopically confirmed EE were assessed for heartburn symptoms with a 4-point scale at baseline and during treatment for 8 weeks with various proton pump inhibitors in 5 double-blind trials in which esomeprazole was the common comparator. EE was graded with the Los Angeles (LA) classification system. In these trials, healing and symptom response were evaluated by endoscopy and questionnaire after 4 weeks of treatment. Patients who were not healed were treated for an additional 4 weeks and reevaluated. RESULTS: A total of 11,945 patients with endoscopically confirmed EE participated in the 5 trials, with patients receiving esomeprazole 40 mg (n = 5068), esomeprazole 20 mg (n = 1243), omeprazole 20 mg (n = 3018), or lansoprazole 30 mg (n = 2616). Approximately one quarter of the 11,945 GERD patients in these 5 trials had severe EE (defined as LA grades C or D), regardless of their baseline heartburn severity. CONCLUSION: The severity of GERD symptoms does not correlate well with disease severity. These findings indicate that endoscopy may have value in GERD patients in identifying those with EE, and if empirical therapy is chosen, then longer courses (4-8 weeks) of antisecretory therapy may be necessary to ensure healing of unrecognized esophagitis.

Clinical Trials as Topic↗

Esophageal acid contact time and heartburn in acute treatment with ranitidine and metoclopramide.

Ranitidine and metoclopramide were compared for their ability to reduce esophageal acid contact time and heartburn. Twelve patients with histories of heartburn received ranitidine 150 mg bid, metoclopramide 10 mg qid, and placebo (ranitidine-matched) bid in a randomized, open-label, crossover fashion. Esophageal pH was monitored with an antimony electrode and portable recording unit for 24 h under strictly controlled laboratory conditions. Ranitidine significantly (p less than or equal to 0.05) reduced 24-h acid contact time from 11.6% to 6.4%. Reflux episode frequency was also significantly (p less than or equal to 0.05) reduced from 82 to 45 episodes per day and from 12 to 2 episodes at night. In contrast, metoclopramide did not reduce 24-h acid contact time or daytime reflux episode frequency, although nighttime episode frequency was significantly (p less than or equal to 0.05) decreased. Only ranitidine significantly reduced heartburn frequency and severity. We conclude that acute treatment with ranitidine, but not metoclopramide, significantly reduces esophageal acid contact time, reflux episode frequency, and heartburn frequency and severity in patients with gastroesophageal reflux.

Adult↗

Prevention of meal-induced heartburn and regurgitation with metoclopramide in patients with gastroesophageal reflux.

Ten patients with gastroesophageal reflux disease participated in a randomized, double-blind, crossover study in which they received a single 20-mg oral dose of metoclopramide or a placebo 15 minutes before a provocative test meal. All patients had previously been challenged with the test meal and had exhibited symptoms of heartburn and regurgitation. Metoclopramide reduced the severity of heartburn from the onset, its effect reaching statistical significance within two hours and persisting for at least five hours. Eighty percent of the patients who received metoclopramide, compared with only 30% of placebo-treated patients, were completely free of heartburn at the end of the trial. A significant reduction in regurgitation during the 1 1/2 to four hours after the test meal was also noted with metoclopramide. No adverse effects occurred. The ability of metoclopramide to prevent the symptoms of heartburn and regurgitation induced by a provocative meal in patients with gastroesophageal reflux was clearly demonstrated.

Adult↗