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PubMed2001

Management of heartburn in a large, randomized, community-based study: comparison of four therapeutic strategies.

OBJECTIVE: Our objective was to compare four management strategies for heartburn: therapy with an H2-receptor antagonist (ranitidine), therapy with a proton pump inhibitor (lansoprazole), crossover from ranitidine to lansoprazole ("step-up" therapy), and crossover from lansoprazole to ranitidine ("step-down" therapy). METHODS: This was a controlled, double-blind, multicenter trial comprising 593 adults with heartburn, randomized to one of four groups for 20 wk. Subjects received either ranitidine 150 mg b.i.d. for 20 wk, or lansoprazole 30 mg once daily for 20 wk, or ranitidine 150 mg b.i.d. for 8 wk [corrected] followed by lansoprazole 30 mg once daily for 12 wk ("step-up"), or lansoprazole 30 mg once daily for 8 wk followed by ranitidine 150 mg b.i.d. for 12 wk ("step-down"). Outcome measures were based on self-reports in daily diaries of 24-h heartburn severity, measured by maximum daytime and nighttime severity, and percentage of 24-h heartburn-free days measured by absence of both daytime and nighttime heartburn. RESULTS: Median heartburn severity was significantly lower (p < 0.05) for lansoprazole (0.25) than the other groups (0.46 ranitidine, 0.44 "step-up," 0.35 "step-down"). The lansoprazole group had a significantly higher percentage of 24-h heartburn-free days (median 81.4%, p < 0.01) than other groups (66.6, 66.9, and 73.6%, respectively). In the "step-up" and "step-down" groups, heartburn was less severe, and percentages of 24-h heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence. CONCLUSION: Proton pump inhibitor treatment provides more consistent heartburn relief than an H2-receptor antagonist, or "step-up" or "step-down" therapy.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2003

Nighttime heartburn is an under-appreciated clinical problem that impacts sleep and daytime function: the results of a Gallup survey conducted on behalf of the American Gastroenterological Association.

OBJECTIVE: Although a large body of information exists about the prevalence of gastroesophageal reflux disease (GERD) in general, available data specifically addressing nocturnal reflux are limited. Because nocturnal acid reflux is reported to be associated with more severe injuries such as esophagitis and stricture, as well as adenocarcinoma of the esophagus, a better understanding of the prevalence and impact of nighttime heartburn as a sign of nocturnal acid reflux events can have significant potential management implications. The aims of this study were to determine the prevalence of nighttime heartburn and reflux-attributed supraesophageal symptoms among patients with GERD; and the impact of nighttime heartburn on sleep and several activities of daily living that could affect quality of life. METHODS: A nationwide telephone survey of 1000 adults experiencing heartburn at least once a week was conducted by the Gallup Organization on behalf of the American Gastroenterological Association. RESULTS: Altogether, 79% of respondents reported experiencing heartburn at night. Among those, 75% reported that symptoms affected their sleep, 63% believed that heartburn negatively affected their ability to sleep well, and 40% believed that nocturnal heartburn impaired their ability to function the following day. Of the 791 respondents with nighttime heartburn, 71% reported taking over-the-counter medicine for it, but only 29% of these rated this approach extremely effective. Forty-one percent reported trying prescription medicines, and 49% of these rated this approach extremely effective. CONCLUSIONS: Nighttime heartburn occurs in a large majority of adults with GERD, resulting in sleeping difficulties and impaired next-day function. The expected result from implemented therapy for heartburn is not achieved by a sizable percentage of patients.

Activities of Daily Living↗
PubMed2001

Sustained esophageal contraction: a motor correlate of heartburn symptom.

Heartburn occurs in the presence as well as the absence of acid reflux. We searched for a motor correlate of heartburn. Twelve subjects with heartburn were studied with 24-h synchronized pressure, pH, and high-frequency intraluminal ultrasound (HFIUS) imaging of the esophagus. The HFIUS images were analyzed every 2 s for a period of 2 min before and 30 s after the onset of heartburn during 20 acid reflux-positive and 20 acid reflux-negative heartburn episodes. The esophageal muscle thickness was measured as a marker of contraction. Esophageal pressure and HFIUS images were recorded during the Bernstein test in 15 subjects. Sustained esophageal contractions (SECs) were identified during 13 of 20 heartburn episodes associated with acid reflux and 15 of 20 heartburn episodes without acid reflux. SECs were detected during 2 of 40 matched control periods only (P < 0.05). The duration of SECs was 44.9 +/- 26.9 s. The Bernstein test reproduced heartburn symptoms in 8 of 15 subjects. SECs were identified during 6 of 8 (75%) Bernstein-positive and in 1 of 7 (14.3%) Bernstein-negative tests (P = 0.04). We conclude that a SEC precedes both spontaneous and induced heartburn symptoms and may be the cause of heartburn sensation.

Adult↗
PubMed2003

Heartburn in patients with gastro-oesophageal reflux disease in Germany and Sweden: a study on patients' burden of disease.

BACKGROUND: Gastro-oesophageal reflux disease (GORD) is widespread in the general population and presents in most cases with heartburn as the main symptom. The severity of symptoms is not necessarily related to erosive damage to the oesophagus due to acid reflux, but the frequency and severity of symptoms have an impact on the health-related QOL (HR-QOL) of the patient. OBJECTIVE: To characterise patients with GORD who consult a physician because of heartburn with respect to medical background and burden of disease in Germany and Sweden. METHODS: A total of 1011 patients who had been experiencing symptoms of GORD, including heartburn, for at least 1 year were recruited by physicians, who collected data on the patients' previous diagnosis and treatment. The patients themselves were interviewed by telephone about their heartburn. The EuroQOL 5-dimensional HR-QOL questionnaire (EQ-5D) and the Gastrointestinal Symptom Rating Scale (GSRS) were used to measure patient-reported outcomes. RESULTS: About half of the patients had been experiencing symptoms of GORD for >5 years. The majority (54%) perceived the severity of their heartburn as moderate. Thirty-eight percent of the patients had been examined by endoscopy during the last 12 months and 79% of these had macroscopic oesophagitis. Medical treatment for heartburn had been prescribed to 88% of the patients. The mean annual number of days with heartburn was assessed as 170 days per patient, with the majority of patients (64%) experiencing heartburn every week. HR-QOL was reduced in these patients as expressed by EQ-5D scores compared to scores for a general population. Patients with GORD had problems related to gastrointestinal symptoms as rated by GSRS scores. More severe heartburn was associated with a greater number of symptom days and reduced HR-QOL scores, whereas a relationship between the findings at endoscopy and the severity of symptoms or HR-QOL could not be found. CONCLUSION: This study demonstrates that heartburn confers a significant burden on patients with GORD, related to the frequency and severity of symptoms and reflected in the reduction in HR-QOL as perceived by the patients.

Adolescent↗
PubMed1999

A double-blind, placebo-controlled study of the efficacy and safety of non-prescription ranitidine 75 mg in the prevention of meal-induced heartburn.

BACKGROUND: Ranitidine 75 mg (Zantac 75) has been shown to be effective for the treatment of pre-existing heartburn symptoms. AIM: To compare the efficacy of dosing ranitidine 75 mg or placebo 30 min prior to a proven heartburn-provoking meal in completely preventing or reducing subsequent heartburn symptoms. METHODS: A randomized, double-blind, parallel methodology was used at nine investigative centres. Following a screening visit, patients ate a standard test meal consisting of chili, chips and a soft drink on two occasions. On the first occasion, patients received single-blind placebo 30 min before the meal. This meal was used to qualify patients and to ensure the onset of a minimum level of heartburn. Patients who qualified were randomized (n = 284) to receive double-blind ranitidine 75 mg or placebo 30 min before a second test meal administered 4-14 days later at the treatment visit. Patients recorded whether heartburn was present and rated heartburn severity by completing visual analogue scales at 15-min intervals over the 4. 5 h meal evaluation periods. RESULTS: Statistically significant differences favouring ranitidine 75 mg were determined for complete prevention of heartburn (P < 0.006), heartburn severity area under the curve (P < 0.001), a clinical success end-point (P < 0.001), and all other end-points (P < 0.001). CONCLUSIONS: These data clearly demonstrate that ranitidine 75 mg is effective in completely preventing or decreasing heartburn when administered 30 min prior to a provocative meal.

Adult↗
PubMed2003

Esomeprazole resolves chronic heartburn in patients without erosive oesophagitis.

BACKGROUND: Patients with chronic heartburn but with no endoscopic evidence of erosive oesophagitis require gastric acid suppression to relieve symptoms. AIM: To assess the efficacy and safety of esomeprazole in patients with frequent heartburn for >or = 6 months and no evidence of erosive oesophagitis on endoscopy. METHODS: Two randomized, double-blind, 4-week, multi-centre trials with identical methodology compared once-daily esomeprazole, 40 mg (n = 241) or 20 mg (n = 234), with placebo (n = 242) for the rigorous end-point of complete resolution of heartburn. Secondary end-points included the percentage of heartburn-free days and the time to first and sustained resolution of heartburn. RESULTS: Patients treated with either dose of esomeprazole were two to three times more likely to achieve complete resolution of heartburn than patients treated with placebo (P < 0.001). The percentage of heartburn-free days was significantly higher with esomeprazole 40 mg (63%, 66%) or 20 mg (63%, 68%) than with placebo (46%, 36%; P < or = 0.001) in each of the two studies. Esomeprazole was associated with a significantly shorter mean time to first (6-7 days) and sustained (12-17 days) resolution of heartburn compared with placebo (first, 10-12 days; sustained, 21-22 days; P < or = 0.008). The spectrum and frequency of adverse events with esomeprazole were similar to those with placebo. CONCLUSIONS: Esomeprazole, at daily doses of 40 mg or 20 mg, is effective and safe for the treatment of chronic heartburn in patients without erosive oesophagitis.

Adult↗
PubMed2002

Studies on the relationship between esophageal acid exposure, mucosal lesions and heartburn using an acid exposure sensor.

BACKGROUND: In vitro studies of a recently developed acid exposure sensor show that the sensor response (SR) to acid <pH 4 is linearly determined by the duration and degree of acidity. The aim was to determine whether SR correlates with the severity of acid-induced esophageal mucosal lesions and acid-induced heartburn. METHODS: HCl pH 1.5 or saline was infused into the feline esophagus for 5-20 min. Simultaneously, sensor measurements were performed below the infusion port. The histological damage was scored by an independent pathologist. In 15 normal subjects, HCl pH 1 was infused into the esophagus and the severity of the heartburn (0-5) was scored at 5-min intervals. In 10 subjects who experienced heartburn during acid perfusion, initial perfusion with HCl was repeated during heartburn induction time minus 5 min, followed by perfusion with the subject's own gastric juice, titrated to pH 2; heartburn severity was again scored at 5-min intervals. Acid exposure sensors positioned below the infusion port were removed at heartburn scores 1, 2 and 3. RESULTS: A good correlation was found between SR and the histological score for mucosal damage in the cat esophagus (r = 0.64, P < 0.005). There was a good relation between heartburn severity score and acid exposure time (r = 0.84, P < 0.001), and a significant but weaker relation between heartburn severity and SR. CONCLUSION: In cats, there is a good relation between the severity of acid-induced esophageal mucosal lesions and SR. In men, there is a significant correlation between the severity of acid-induced heartburn and the simultaneously measured SR. Therefore, SR measurement has the potential of yielding clinically relevant information in the investigation of GERD.

Adult↗
PubMed2003

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

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

Adult↗
PubMed2004

Pathophysiological characteristics of patients with non-erosive reflux disease differ from those of patients with functional heartburn.

BACKGROUND: Patients with endoscopy-negative heartburn can be subdivided into non-erosive reflux disease and functional heartburn on the basis of abnormal and normal, respectively, oesophageal acid exposure. Different pathophysiological characteristics could explain the reportedly low efficacy of proton pump inhibitors in functional heartburn. AIM: To assess if non-erosive reflux disease and functional heartburn are pathophysiologically distinguishable. METHODS: Oesophageal manometry and pH-monitoring were performed in 145 patients with endoscopy-negative heartburn, in 72 patients with erosive reflux disease, in 58 patients with complicated reflux disease, and in 60 controls. RESULTS: Patients with non-erosive reflux disease (84 cases) and functional heartburn (61 cases) differed with regard to the prevalence of hiatal hernia (49% vs. 31%, P = 0.008), the mean lower oesophageal sphincter tone (18.5 vs. 28.4 mmHg, P < 0.05), and the number of upright diurnal acid refluxes lasting more than 5 min (3.6 vs. 0.37, P < 0.05). The results were very close in thenon-erosive reflux disease, erosive reflux disease and complicated reflux disease groups, whilst patients with functional heartburn were indistinguishable from controls. CONCLUSIONS: Pathophysiological characteristics typical of gastro-oesophageal reflux disease are found in patients with non-erosive reflux disease but not in patients with functional heartburn. This could explain the reportedly low efficacy of proton pump inhibitors in functional heartburn and suggests considering different management strategies.

Adult↗
PubMed2005

Social and medical impact, sleep quality and the pharmaceutical costs of heartburn in Taiwan.

BACKGROUND: Little is known about the social and medical burdens of heartburn in Asia. AIM: To assess the impact of heartburn in Taiwan. METHODS: We applied a questionnaire to 2018 apparently healthy adult Chinese receiving a routine health maintenance programme. Costs of heartburn-related prescriptions were obtained from the Bureau of National Health Insurance of Taiwan. RESULTS: Heartburn prevalence (>1 episode/week) was 7%. Smoking and increased body mass index were associated with heartburn occurrence. Heartburn sufferers reported more atypical gastro-oesophageal reflux disease symptoms, e.g. chest pain, dysphagia and globus. They were more likely to consult physicians, and have an increased frequency and number of days of absenteeism, irrespective of upper gastrointestinal or nongastrointestinal-related illnesses. They experienced sleep disturbances more frequently. The 62 heartburn consulters (48%) were more likely to have co-existing globus, visited physicians more, had more absenteeism, suffered from more sleep disturbances and had higher costs for antacids, proton pump inhibitors, hypnotic/sedatives, tranquilizers and antidepressants than nonconsulters. CONCLUSIONS: Heartburn prevalence in Taiwan is lower than in Western countries. Nevertheless, heartburn in Taiwanese creates a significant burden in terms of social impact, health resource utilization, sleep quality and pharmaceutical costs. The increased costs of psychoactive drugs in consulters suggest that anxiety/depression affects their health-seeking behaviour.

Absenteeism↗
PubMed2005

Predictors of heartburn during sleep in a large prospective cohort study.

BACKGROUND AND AIMS: Nocturnal gastroesophageal reflux, which may result in nocturnal heartburn, has been demonstrated to be associated with a more severe form of gastroesophageal reflux disease (GERD). The aim of this study was to determine the clinical predictors of heartburn during sleep in a large prospective cohort study. METHODS: Study subjects were members of the parent cohorts from which the Sleep Heart Health Study (SHHS) recruited participants. SHHS is a multicenter, longitudinal, cohort study of the cardiovascular consequences of sleep-disordered breathing. As part of the recruitment process, parent cohort members completed a questionnaire that permitted an assessment of the relationships between heartburn during sleep, and patient demographics, sleep abnormalities, medical history, and social habits in nine community-based parent cohorts across the United States. All variables, significant at the p < 0.05 level, were included as independent variables in multivariate logistic regression models with heartburn during sleep status included as the dependent variable RESULTS: A total of 15,314 subjects completed the questions about heartburn during sleep, and of these, 3,806 subjects (24.9%) reported having this symptom. In four increasingly comprehensive multivariate models, increased body mass index (BMI), carbonated soft drink consumption, snoring and daytime sleepiness (Epworth sleepiness scale score), insomnia, hypertension, asthma, and usage of benzodiazepines were strong predictors of heartburn during sleep. In contrast, college education decreased the risk of reporting heartburn during sleep. CONCLUSIONS: Heartburn during sleep is very common in the general population. Reports of this type of symptom of GERD are strongly associated with increased BMI, carbonated soft drink consumption, snoring and daytime sleepiness, insomnia, hypertension, asthma, and usage of benzodiazepines. Overall, heartburn during sleep may be associated with sleep complaints and excessive daytime sleepiness.

Aged↗
PubMed1995

Self-Directed Treatment of Intermittent Heartburn: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Evaluation of Antacid and Low Doses of an H(2)-Receptor Antagonist (Famotidine).

BACKGROUND: Heartburn, a common symptom, is self-treated with oral antacids. Efficacy of antacids has not been demonstrated for individual, spontaneous heartburn episodes. METHODS: We conducted a double-blind, randomized, placebo-controlled, parallel-group study of self-directed treatment for episodic heartburn comparing famotidine (FAM) 5, 10, or 20 mg and antacid (11 mEq ANC) to placebo (PBO) during a 4-week period. Twenty-nine US investigators enrolled a total of 565 outpatients, ages 18--81 years (mean 44.1 years) with heartburn but not seeking care for heartburn. Treatment of spontaneous heartburn episodes was permitted as needed, up to twice daily, with self-administered test drug. An open-label, backup antacid was provided to use if test drug did not provide adequate relief. Patients assessed heartburn relief hourly and recorded use of backup antacid. Relief was defined as complete relief of symptoms without the use of backup antacid. RESULTS: The media proportion of episodes relieved was: PBO, 41%; FAM 5 mg, 59%, 0.05 less-than-or-equal p < 0.10; FAM 10 mg, 70%, p < 0.001; FAM 20 mg, 69%, p < 0.001; antacid, 62%, p < 0.05 (p-values versus PBO). Supplemental analyses incorporating time to relief confirmed that famotidine and antacid provided more rapid and more frequent relief than placebo (odds ratio for relief relative to PBO: FAM 5 mg, 1.55, p = 0.003; FAM 10 mg, 1.94, p < 0.001; FAM 20 mg, 2.13, p < 0.001; antacid 1.57, p = 0.003). The tolerability profile was similar with famotidine, antacid, and placebo. CONCLUSIONS: The positive results with antacid demonstrated for the first time the efficacy of antacid in self-treatment of individual heartburn episodes and provided internal validation of this study paradigm. Patients in this study self-medicated effectively using low doses of famotidine on an as needed basis for spontaneous episodes of heartburn.

Journal Article↗
PubMed1998

Heartburn requiring frequent antacid use may indicate significant illness.

BACKGROUND: Many otherwise healthy individuals with episodic heartburn self-medicate with over-the-counter antacids. We evaluated clinical characteristics of subjects who had never been medically diagnosed as having any upper gastrointestinal tract disorder and who used antacids for symptomatic relief of heartburn. SUBJECTS AND METHODS: Subjects with at least 3 months of frequent heartburn relieved by antacids, and with heartburn on at least 4 of 7 days during the week prior to study entry, had their medical history and gastrointestinal pathological characteristics recorded. Tests included esophagogastroduodenoscopy, esophageal motility and sensitivity studies, and 24-hour pH monitoring. RESULTS: Of 178 subjects screened, 13 were excluded on the basis of other gastrointestinal diseases at baseline, including diffuse esophageal spasm, peptic ulcer disease, dysplastic columnar metaplasia of the esophagus (Barrett's esophagus), and adenocarcinoma. Ten subjects were ineligible because of insufficient baseline heartburn. The remaining 155 eligible subjects had heartburn for an average of 11 years. Forty-seven percent had daily symptoms and 70% described heartburn severity as moderate, even though on endoscopy most (53%) had normal-appearing esophageal mucosa (grade 0 or 1). Esophageal acid sensitivity was present in 86% of subjects. Mean lower esophageal sphincter pressures and esophageal contractile amplitudes were at the lower limits of normal and total esophageal acid contact time was slightly increased. CONCLUSIONS: Chronic heartburn can reflect a wide range of diagnostic findings, including important underlying pathological features, and may warrant a full medical examination to detect such abnormal conditions and to permit selection of appropriate therapy.

Adenocarcinoma↗
PubMed2004

Self-selection and use patterns of over-the-counter omeprazole for frequent heartburn.

BACKGROUND AND AIMS: The Food and Drug Administration approval and subsequent launch of over-the-counter (OTC) omeprazole raises the question whether consumers would use OTC omeprazole appropriately in a "real world" setting. METHODS: A 3-month observational study was conducted in an OTC setting to determine whether consumers could (1) correctly self-select to use omeprazole for frequent heartburn, (2) comply with a product label that calls for 14 consecutive days of once-daily dosing, and (3) use more than 14 doses of medication only under the advice of a physician. Consumers were interviewed at 5 shopping malls in geographically distinct areas of the United States and asked whether they had heartburn. Of the 1999 self-reported heartburn sufferers, 866 determined the product was appropriate for their condition and purchased the product; of these, 758 (88%) returned diaries documenting product usage and physician contact. RESULTS: OTC consumers accurately self-selected; more than 90% of participants had heartburn 2 or more days/week. Analysis of diary data showed a high degree of compliance to label use directions; only 3% of subjects took more than 14 doses without consulting a physician. After 3 months, 43% of subjects did not have recurrence of heartburn. Overall, 75% of subjects had contact with a physician about heartburn before, during, or soon after the study (26% contacted a physician during the 3-month study). Of the 758 subjects, only 1 subject took more than 14 tablets without consulting a physician and had recurrence of heartburn. CONCLUSIONS: Actual use data support that consumers accurately self-select if an OTC proton pump inhibitor is appropriate for use, comply with a 14-day regimen in the OTC setting, and appropriately seek physician involvement for longer-term management of frequent heartburn.

Adolescent↗
PubMed1999

Patterns of consultation and treatment for heartburn: findings from a Singaporean community survey.

BACKGROUND: The prevalence of reflux-type symptoms among community individuals in Singapore is low. AIM: To describe the healthcare-seeking behaviour of those subjects with heartburn. METHODS: A cross-sectional survey, using a reliable and valid questionnaire, was carried out on a race-stratified random sample of residents, aged 21-95 years, in a Singaporean town; 93% responded (n = 696). RESULTS: The ethnic-adjusted prevalence of heartburn for the past 1-year was 4.6%. Sixteen (30%) of the 53 heartburn sufferers had sought consultation for their symptoms. They were more likely to have severe heartburn (P<0.001), and to have complained of nocturnal awakening due to heartburn (P<0.05) than those who did not present to medical attention. Ethnic origin did not influence the consultation pattern. Only 18 (34%) of the 53 heartburn sufferers received pharmacological therapy for their symptoms. The most commonly used medication was antacid. Medication use was associated with symptom severity (P<0.05), but not ethnicity. CONCLUSIONS: Heartburn is uncommon in the general population of Singapore. Few heartburn sufferers seek medical attention, and most do not receive medications for symptomatic control. The decision to seek medical advice and/or to medicate was generally linked to symptom severity, but not to ethnicity.

Adult↗
PubMed2001

Synergy between low-dose ranitidine and antacid in decreasing gastric and oesophageal acidity and relieving meal-induced heartburn.

BACKGROUND: The pathophysiology of recurrent postprandial heartburn and the basis for the effectiveness of antacids or low doses of histamine H2-receptor antagonists have not been well studied. METHODS: The selected subjects (n=26) had heartburn more than four times a week for at least 2 months, which was responsive to antacids. Gastric pH and oesophageal pH were measured for 1 h before, during, and 4.5 h after ingestion of a meal over 0.5 h. Heartburn severity was assessed at 15-min intervals beginning at the end of the meal. Each subject randomly received placebo, 75 mg ranitidine, 420 mg calcium carbonate, and ranitidine plus calcium carbonate. Values for pH were converted to acid concentration (mM) and integrated acidity was calculated from the cumulative, time-weighted means of the acid concentrations for every second of the postprandial recording period. RESULTS: There was a close temporal relationship between heartburn and oesophageal acidity. Most oesophageal acid exposure occurred over a 90-min period that began approximately 45 min after the end of the meal. During this period the gastric acid concentration was less than 5% of maximal. Ranitidine significantly decreased gastric but not oesophageal acidity, whilst antacid significantly decreased oesophageal but not gastric acidity. Ranitidine plus antacid significantly decreased both gastric and oesophageal acidity. Antacid alone and ranitidine plus antacid significantly decreased heartburn severity. CONCLUSIONS: Determining integrated gastric and oesophageal acidity provides novel information regarding the pathophysiology of meal-induced heartburn as well as the actions of low-dose ranitidine and antacid. For subjects with meal-induced heartburn, treatment with low-dose ranitidine plus antacid is particularly effective in decreasing gastric and oesophageal acidity as well as heartburn severity.

Antacids↗
PubMed2001

Effectiveness and safety of nizatidine, 75 mg, for the relief of episodic heartburn.

BACKGROUND: The most frequent cause of episodic heartburn is food and beverage ingestion. Nizatidine, an H2-receptor antagonist, is currently approved for non-prescription use in the prevention and relief of heartburn at a dose of 75 mg up to twice a day. METHODS: Two identical studies were carried out to evaluate the efficacy of nizatidine, 75 mg, compared with placebo in treating heartburn in an "at-home" setting. The studies were multicentre, multiple-dose, placebo-controlled, randomized, parallel group design. A total of 994 subjects were randomized to treatment. Adequate relief of heartburn was assessed at 15, 30 and 45 min and 1, 2 and 3 h following a treatment dose. A subject's responses with respect to time to relief and attainment of adequate relief were combined into a derived response profile, the sustained adequate relief score. Adverse experiences were noted throughout the study period. RESULTS: The individual and combined study results showed that nizatidine, 75 mg, relieved heartburn faster and/or more consistently than placebo. The mean sustained adequate relief score, calculated over a subject's first four episodes, was 2.43 in the nizatidine-treated group compared with 2.14 in the placebo group (P < 0.001). Nizatidine-treated subjects attained sustained adequate relief in a significantly (P < 0.001) larger percentage (75%) of their heartburn episodes than did subjects treated with placebo (66%). No serious adverse experiences were associated with nizatidine treatment. CONCLUSION: Nizatidine, 75 mg, is a safe and effective treatment for episodic heartburn. The results showed that subjects taking nizatidine had heartburn relief that was achieved faster and/or more reliably than did subjects taking placebo.

Adolescent↗
PubMed2003

Screening for Barrett's esophagus in colonoscopy patients with and without heartburn.

BACKGROUND & AIMS: The population prevalence of Barrett's esophagus (BE) is uncertain. Our aim was to describe the prevalence of BE in a volunteer population. METHODS: Upper endoscopy (EGD) was performed in 961 persons with no prior history of EGD who were scheduled for colonoscopy. Symptom questionnaires were completed prior to endoscopy. Biopsy specimens were taken from the gastric cardia and any columnar mucosa extending > or =5 mm into the tubular esophagus and from the stomach for H. pylori infection in the last 812 patients. RESULTS: The study sample was biased toward persons undergoing colonoscopy, males, and persons with upper GI symptoms. The prevalence of BE was 65 of 961 (6.8%) patients, including 12 (1.2%) with long-segment BE (LSBE). Among 556 subjects who had never had heartburn, the prevalences of BE and LSBE were 5.6% and 0.36%, respectively. Among 384 subjects with a history of any heartburn, the prevalences of BE and LSBE were 8.3% and 2.6%, respectively. In a univariate analysis, LSBE was more common in those with any heartburn vs. those with no heartburn (P = 0.01), but the sample size was insufficient to allow multivariate analysis of predictors of LSBE. In a multivariate analysis, BE was associated with increasing age (P = 0.02), white race (P = 0.03), and negative H. pylori status (P = 0.04). Overall, BE was not associated with heartburn, although heartburn was more common in persons with LSBE or circumferential short segments. CONCLUSIONS: LSBE is very uncommon in patients who have no history of heartburn. SSBE is relatively common in persons age > or =40 years with no prior endoscopy, irrespective of heartburn history.

Adult↗