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Heartburn risk factors, knowledge, and prevention strategies: a population-based survey of individuals with heartburn.

BACKGROUND: Twenty-five million adults experience heartburn daily. To target individuals for prevention programs, characteristics of persons with heartburn and the associated causes of this condition must first be identified. METHODS: We conducted a population-based telephone survey of 2000 individuals with heartburn to describe the cause of the disease, knowledge of risk factors, and prevention strategies. RESULTS: Lifestyle and work habits, and certain food and beverage consumption, were associated with heartburn. Women reported the onset of heartburn about 5 years later than men. Survey respondents were unaware of the risk factors for heartburn, and sex-dependent differences in knowledge were apparent. Logistic regression modeling identified increasing age, female sex, higher level of education, and frequent vs infrequent heartburn as significant (P<.02) predictors of whether patients told a physician about their heartburn symptoms. Increasing age, higher body mass index, and reduced level of education were significant (P<.02) predictors of frequent vs infrequent heartburn in this study population. CONCLUSION: The findings of this study provide a framework for the development of a heartburn prevention program based on lifestyle modification.

Adult↗

Managing heartburn at the 'base' of the GERD 'iceberg': effervescent ranitidine 150 mg b.d. provides faster and better heartburn relief than antacids.

BACKGROUND: Many individuals with heartburn self-medicate with antacids for relief of their symptoms. AIM: To compare efficacy of effervescent ranitidine to as-needed calcium carbonate antacids in subjects who self-treat heartburn. METHODS: A total of 155 subjects with frequent antacid-responsive heartburn were randomized to receive effervescent ranitidine 150 mg tablets b.d., or as-needed calcium carbonate 750 mg for 12 weeks. Endoscopic oesophagitis severity and mucosal histology were assessed at baseline, and at weeks 6 and 12. Heartburn frequency, severity, and antacid consumption were recorded daily, and quality of life was assessed at baseline, and at weeks 6 and 12. RESULTS: Heartburn frequency and severity were significantly decreased after 1 day of ranitidine (P < 0.02). By week 6, ranitidine had significantly decreased rescue antacid consumption (7.3 tablets, P < 0.001) vs. antacids (14.1 tablets). Endoscopic oesophagitis healing (</= grade 1) was significantly better with ranitidine (55%, P=0.022) vs. antacids (29%). Quality of life was improved by both treatments; however, ranitidine was numerically superior for all quality of life parameters, statistically superior for several quality of life indices at week 6 and for the pain-related index by week 12 (P < 0. 05). CONCLUSIONS: For subjects self-administering antacids for chronic heartburn, effervescent ranitidine 150 mg b.d. is more effective than antacids in reducing heartburn, healing erosive oesophagitis, alleviating pain, and improving quality of life.

Adult↗

Nonprescription doses of ranitidine are effective in the relief of episodic heartburn.

BACKGROUND: Many Americans have heartburn or related symptoms monthly and >20% experience heartburn at least once per day. Although many self-treat episodic heartburn with nonprescription antacids, newer treatments that decrease gastric volume and increase the pH of refluxed material are proving effective and popular in relieving heartburn. AIM: To evaluate the safety and efficacy of low-dose regimens of ranitidine for the relief of heartburn. METHODS: Adults with at least a 3-month history of heartburn were eligible for this randomized, double-blind, parallel group, multicenter dose-ranging study. Following a 1-week, open-label run-in phase to document baseline heartburn frequency, subjects were randomly assigned to receive treatment with one tablet of either ranitidine, 75 mg (n = 537); ranitidine, 25 mg (n = 539); or placebo (n = 544), to be taken as needed up to four times daily for 2 weeks for the relief of heartburn. RESULTS: The ranitidine 75-mg regimen was statistically (P < 0.05) and clinically (as defined a priori as > or =10% improvement) more effective than placebo in relieving episodic heartburn and in reducing antacid consumption. Ranitidine, 25 mg, was also statistically superior (P < 0.05) to placebo in providing heartburn relief. In addition, both regimens were superior to placebo in providing heartburn relief within 30 to 45 minutes of dosing. Ranitidine continued to be as effective over placebo in the treatment of the last heartburn episode as in the treatment of the first heartburn episode. Ranitidine was also equally effective over placebo in the treatment of mild, moderate, and severe episodes of heartburn. Ranitidine, 75 mg, was statistically superior to placebo for the relief of nocturnal heartburn episodes, whereas ranitidine, 25 mg, was not. All treatments were well tolerated and adverse events occurred no more frequently with the ranitidine regimens than with placebo. CONCLUSIONS: Low-dose ranitidine provides prompt and lasting relief of heartburn and has a safety profile comparable to that of placebo.

Adult↗

A double-blind, placebo-controlled study of the effectiveness and safety of nizatidine in the prevention of postprandial heartburn.

BACKGROUND: Heartburn is frequently associated with overindulgence in food and drink, meal-stimulated gastric acid secretion, and a gastroesophageal reflux with a pH of 4 or lower. Nizatidine is a selective histamine2 receptor antagonist that effectively suppresses gastric acid secretion at lower than prescription doses and has been approved for nonprescription use in the prevention of postprandial heartburn. OBJECTIVE: To examine the relative effectiveness of 3 dose levels of nizatidine (225 mg, 75 mg, and 25 mg) in preventing postprandial heartburn. METHODS: Four hundred thirteen subjects with documented moderate to severe heartburn following a standard meal that provoked heartburn were randomized to receive a single dose of nizatidine at 225 mg (n = 104), 75 mg (n = 101), or 25 mg (n = 105), or placebo (n = 103) 30 minutes before the meal, at 30 minutes (immediately after completing the meal), and at 60, 90, 120, 150, 180, and 210 minutes (from beginning the meal), subjects assessed the presence or absence of heartburn (yes or no) and the severity of heartburn (100-mm visual analog scale). RESULTS: The use of both 225 mg and 75 mg of nizatidine were significantly better than placebo in preventing heartburn in the proportion of subjects with complete prevention of heartburn (15 [14.4%] and 15 [14.9%], respectively, vs 3 [2.9%]; P < .001); the effects of nizatidine, 25 mg, in 7 subjects (7%) were not distinguishable from placebo. Similar results for nizatidine, 225 mg and 75 mg, were seen for longest duration of no heartburn, total duration of no heartburn, the average severity of heartburn, and the peak heartburn severity. All 3 doses of nizatidine were superior to placebo (P < .001) in reducing average and peak heartburn severity and were well tolerated. CONCLUSIONS: Single doses of 225 mg and 75 mg of nizatidine administered 30 minutes before a standard meal intended to provoke heartburn are significantly more effective than placebo for the prevention and/or reduction of postprandial heartburn.

Adult↗

Comparison of Prilosec OTC (omeprazole magnesium 20.6 mg) to placebo for 14 days in the treatment of frequent heartburn.

PURPOSE: Consumer surveys have identified an over-the-counter (OTC) medication that provides complete and long-lasting relief of frequent heartburn as an unmet consumer need. The purpose of the two identical studies reported in this paper was to evaluate the safety and effectiveness of 10.3 and 20.6 mg omeprazole magnesium, referred to as Ome-Mg 10 and Ome-Mg 20, respectively (equivalent to 10 and 20 mg omeprazole) for the treatment of frequent heartburn administered as a novel 14-day OTC regimen. SUBJECTS AND METHODS: Subjects with frequent heartburn (heartburn two or more days per week) took Ome-Mg 10, Ome-Mg 20, or placebo for 14 consecutive mornings. Statistical analyses compared percentage of subjects with no heartburn 24 h after the first dose, after the last dose (day 14), and percentage of days that subjects were heartburn-free. Nocturnal heartburn and heartburn rated no more than mild were also assessed. RESULTS: Twenty-four hours following the first dose, nearly 50% of subjects receiving Ome-Mg 20 reported no heartburn, and more than 80% receiving Ome-Mg 20 had no more than mild heartburn. Both doses were significantly more effective than placebo on days 1 and 14 for percentage of subjects heartburn-free for 24 h (P < or = 0.003), and across all 14 days for percentage of heartburn-free days (P < 0.001). Ome-Mg 20 was significantly more effective than placebo in preventing nocturnal heartburn across all 14 days (P < 0.001). Ome-Mg was well tolerated. CONCLUSION: These trials demonstrated the safety and effectiveness of a novel 14-day regimen of Ome-Mg 20 in completely preventing heartburn for 24 h establishing it as an excellent self-care treatment for frequent heartburn and supporting the approval of Prilosec OTC.

Adult↗

Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease.

BACKGROUND: Medical treatments for gastro-oesophageal reflux disease (GERD) vary in their ability to completely resolve heartburn and other symptoms. Although GERD reduces health-related quality of life (HRQL) little is known about the relationship between resolution of heartburn symptoms with medical therapy and HRQL. We evaluated the association between complete resolution of heartburn symptoms and functioning and well-being in three samples of patients with GERD. METHODS: We analysed baseline and follow-up assessments of heartburn symptoms and HRQL scores from three clinical trials (total n=1351) comparing omeprazole and ranitidine for acute symptomatic treatment of GERD. Heartburn symptoms were measured using patient diaries and/or patient self-report. HRQL was assessed using the Psychological General Well-Being Index (PGWB) in all three clinical trials and the SF-36 Health Survey in two clinical trials. Resolution of heartburn symptoms was defined as no heartburn reported during the assessment period. RESULTS: We observed statistically significant differences favouring patients with no heartburn symptoms on the PGWB total score (P=0.018 to P < 0.0001) and anxiety (P=0.002 to P < 0.0001), general health (P=0.05 to P < 0. 0001), positive well-being (P=0.028 to P < 0.0001) and vitality (P=0. 05 to P < 0.0001) sub-scale scores at 4-14 weeks. Patients with no heartburn reported better SF-36 pain (P=0.005 to P < 0.0001) and general health perceptions (P=0.032 to P < 0.0001) compared with patients still experiencing heartburn symptoms at 4-24 weeks. SF-36 physical component summary scores were significantly better in patients with no heartburn symptoms compared with patients with heartburn symptoms at 4-24 weeks (P=0.013 to P=0.009), while mental component summary scores were only significantly different at 24 weeks (P=0.0005) in one of the two studies where the SF-36 was utilized. CONCLUSIONS: Complete resolution of heartburn symptoms was consistently associated with improvement in HRQL; the greatest impact was observed on measures of psychological well-being and physical functioning and well-being. Effective treatment of GERD that completely resolves heartburn results in clinically significant improvement in patient HRQL.

Anti-Ulcer Agents↗

Comparing lansoprazole and omeprazole in onset of heartburn relief: results of a randomized, controlled trial in erosive esophagitis patients.

OBJECTIVE: This randomized, double-blind, multicenter study was conducted to confirm a previous finding that lansoprazole relieves heartburn faster than omeprazole in patients with erosive esophagitis. METHODS: A total of 3510 patients with erosive esophagitis and at least one episode of moderate to very severe daytime and/or nighttime heartburn during the 3 days immediately before the screening visit were randomized to lansoprazole 30 mg once daily or omeprazole 20 mg once daily for 8 wk. Patients recorded the presence and severity of daytime and nighttime heartburn in daily diaries. On treatment days 1-4, patients were telephoned to confirm the completion of their daily diary. The primary efficacy parameters were the percentage of heartburn-free days and heartburn-free nights, as well as the average severity of daytime and nighttime heartburn. RESULTS: During treatment day I and all evaluation time points including the entire 8-wk treatment period, significantly (p < 0.05) higher percentages of patients treated with lansoprazole than those treated with omeprazole did not experience a single episode of heartburn. Onset of heartburn relief was more rapid in lansoprazole-treated versus omeprazole-treated patients: on day 1, 33% versus 25% of lansoprazole- versus omeprazole-treated patients were heartburn-free. The percentages of heartburn-free days and heartburn-free nights were also significantly (p < 0.01) greater for patients treated with lansoprazole at all evaluation time points. Heartburn severity was significantly less among those treated with lansoprazole compared with omeprazole. Both treatments were safe and well tolerated. CONCLUSIONS: Over 8 wk, lansoprazole 30 mg once daily relieved heartburn symptoms faster and more effectively than omeprazole 20 mg once daily in patients with erosive esophagitis.

2-Pyridinylmethylsulfinylbenzimidazoles↗

Relationships between the acidity and osmolality of popular beverages and reported postprandial heartburn.

BACKGROUND/AIMS: Although many beverages produce heartburn, the relationship between the acidity and osmolality of beverages and heartburn is unclear. The aim of this study was to relate the acidity and osmolality of beverages with their ability to cause heartburn. METHODS: We measured pH, total titratable acidity, and osmolality of 38 beverages in vitro and then correlated acidity and osmolality with the amount of heartburn reported by questionnaire in 394 people with heartburn. RESULTS: Among 17 citrus drinks and juices, titratable acidity correlated with reported heartburn scores (r = 0.65; P = 0.004). Soft drinks had the lowest pH readings of any beverages studied, and decreasing pH among soft drinks was correlated with reported heartburn scores (r = 0.82; P < 0.001). Alcoholic beverages (wines and beer), coffee, and (to a lesser extent) tea were associated with significant amounts of reported heartburn when compared with water. Milk was also associated with a modest amount of reported heartburn that was related to its fat content. Osmolality of beverages was unrelated to reported heartburn. CONCLUSIONS: High titratable acidity of citrus drinks and juices and low pH of soft drinks are associated with more reported heartburn. Our findings provide a foundation for dietary advice in patients with heartburn and reflux esophagitis.

Acids↗

Low-dose ranitidine for the relief of heartburn.

BACKGROUND: Approximately 30% of adults in the USA suffer from heartburn or related symptoms monthly; more than 20% of these sufferers experience heartburn at least once per day. Although many rely on self-medication with antacids for the relief of their symptoms, treatments that decrease gastric volume as well as increase the pH of refluxed material should be more effective in relieving heartburn. AIM: To compare the safety and efficacy of low-dose regimens of ranitidine for the relief of heartburn. METHODS: Adults with at least a 3-month history of heartburn were eligible for this randomized, double-blind, parallel group, multicentre dose-ranging study. Following a 1-week open-label run-in phase to document baseline heartburn frequency, subjects were randomized to receive treatment with one tablet of either ranitidine 75 mg (n = 491), ranitidine 25 mg (n = 504), or placebo (n = 494), to be taken as needed up to four times daily for 2 weeks for the relief of heartburn. RESULTS: The ranitidine 75 mg regimen was clinically (> 10 percentage points) and statistically (P < 0.05) significantly more effective than placebo for all measured efficacy end-points in relieving heartburn and reducing antacid consumption. In addition, the ranitidine 75 mg regimen was superior to placebo in providing heartburn relief within 30 min of dosing that lasted for up to 12 h. Ranitidine 25 mg was observed to be statistically superior (P < 0.05) but not clinically different from placebo, as defined a priori, in providing heartburn relief. All treatments were well tolerated and adverse events occurred no more frequently with the ranitidine regimens than with placebo. CONCLUSIONS: Ranitidine 75 mg provides prompt relief of heartburn that lasts for up to 12 h and has a safety profile comparable to that of placebo.

Adolescent↗

Heartburn in patients with achalasia.

Heartburn, the main symptom of gastrooesophageal reflux disease (GORD), might be expected to occur infrequently in achalasia, a disorder characterised by a hypertensive lower oesophageal sphincter (LOS) that fails to relax. Nevertheless, it is often described by patients with achalasia. The medical records of 32 patients with untreated achalasia who complained of heartburn, and of 35 similar patients who denied the symptom, were reviewed to explore the implications of heartburn in this condition. Data on endoscopic and manometric findings, and on the onset and duration of oesophageal symptoms were collected. Three patterns of heartburn were observed: (1) in 8 patients (25%) the onset of heartburn followed the onset of dysphagia, (2) in 15 patients (47%) heartburn preceded the onset of dysphagia and persisted as dysphagia progressed, and (3) in 9 patients (28%), heartburn preceded the onset of dysphagia and stopped as dysphagia progressed. The mean (SD) basal LOS pressure in the patients with heartburn (38 (16) mm Hg) was significantly lower than that in patients without the symptom (52 (26) mm Hg); the lowest LOS pressure (29 (11) mm Hg) was observed in the subset of patients whose heartburn preceded the onset of dysphagia and then stopped. It is concluded that patients who have achalasia with heartburn have lower basal LOS pressures than patients who have achalasia without this symptom. In some patients with achalasia, the appearance of dysphagia is heralded by the disappearance of longstanding heartburn. For these patients, it is speculated that achalasia develops in the setting of underlying GORD.

Deglutition Disorders↗

Prevalence of heartburn and gastroesophageal reflux disease in the urban Brazilian population.

BACKGROUND: The epidemiological aspects of heartburn and gastroesophageal reflux disease have been object of growing interest in the last decade because of its increasing prevalence and the complications of the disease. AIMS: To evaluate the prevalence of heartburn and gastroesophageal reflux disease as well as their main characteristics in the Brazilian urban population. METHODS: A national inquire enrolling 13,959 adults was conducted in 22 Brazilian cities. The inclusion criteria were the presence of heartburn at least once a week ("heartburn group") and age greater than 16 years old. Individuals with heartburn with frequency of more than once a week were considered as having gastroesophageal reflux disease (GERD group). Factors related to the complaint were asked such as predisposing factors, habits (tobacco, alcohol and coffee intake) and body mass index. In this populational study a probabilistic model was used. RESULTS: The results are presented in absolute and relative frequency, which were ponderated estimates of the respective population figures. The global prevalence of heartburn was 11.9% (1,651 persons). Heartburn once a week was present in 4.6% (637 persons) and GERD in 7.3% (1,014 persons). The average ages of both groups were similar (men: 36.9 +/- 15.0; women: 39.6 +/- 15.1 yrs). Females were more affected in both groups. The occurrence of GERD increased with age and was more prevalent after 55 years old. The body mass index was in the normal range and similar in both groups (men: 24.7 +/- 4.6; women: 25.3 +/- 5.2 kg/m(2)). In both groups the individuals related their symptoms to food intake, fatty and spicy foods (heartburn group: 64.7%, 28.5%, 17.7%; GERD group: 55.0%, 25.9%, 11.7% respectively). In GERD group, stress (24.2%), health problems (22.3%) were more related to the symptoms than in heartburn group (20.0% and 15.0% respectively). CONCLUSIONS: The global prevalence of heartburn (11.9%) is relatively high in the Brazilian urban population, although lower than the reported figure to other countries. Heartburn and GERD have higher prevalence in women and both are related to food intake, fatty and spicy foods; GERD is more prevalent in individuals older than 35 years old.

Adolescent↗

Omeprazole is more effective than cimetidine for the relief of all grades of gastro-oesophageal reflux disease-associated heartburn, irrespective of the presence or absence of endoscopic oesophagitis.

BACKGROUND: Previous studies have demonstrated greater efficacy for omeprazole compared with cimetidine in patients with endoscopically verified oesophagitis, but excluded the substantial group of gastro-oesophageal reflux disease (GERD) patients with reflux symptoms but without endoscopic abnormality. This prospective, randomized, double-blind study compared omeprazole and cimetidine in the treatment of GERD-associated heartburn both in patients with symptomatic non-ulcerative oesophagitis and in those with heartburn but without oesophagitis. METHODS: A total of 221 patients with heartburn and oesophageal mucosa grade 0 (normal, n = 51), 1 (no macroscopic erosions, n = 52), 2 (isolated erosions, n = 97) or 3 (confluent erosions, n = 21) were randomized to receive double-blind either omeprazole 20 mg daily or cimetidine 400 mg q.d.s. for a period of 4 weeks. Those still symptomatic after 4 weeks of treatment received omeprazole 20 mg daily for a further 4 weeks. RESULTS: There was no correlation between severity of heartburn and endoscopic grade at entry (correlation coefficient = 0.196). After 4 weeks of treatment, the proportion of patients in whom heartburn was controlled (no more than mild symptoms on no more than 1 day in the previous 7) on omeprazole (66%; 74/112) was more than double that on cimetidine (31%; 34/109) (P < 0.0001). There was no significant difference between the relief of heartburn in the 47% of patients without unequivocal oesophagitis (endoscopic grade 0 or 1) and in the 53% of patients with erosive oesophagitis (grade 2 or 3) (P = 0.31). Only treatment with omeprazole (P < 0.0001) and lower severity of heartburn at entry (P < 0.01) were significant in predicting heartburn relief. Amongst those patients requiring an additional 4 weeks of treatment with omeprazole, 67% (54/81) reported that their heartburn was controlled after 8 weeks of treatment. CONCLUSION: We conclude that omeprazole is superior to cimetidine for the relief of all grades of heartburn in GERD, whether or not the patient has unequivocal endoscopic oesophagitis.

Adolescent↗

Onset of action during on-demand treatment with maalox suspension or low-dose ranitidine for heartburn.

AIM: To compare the onset of action of the local antacid Maalox and the systemic H2-antagonist ranitidine, during 'on demand' ambulant treatment of a single heartburn episode, using a randomized, parallel group, double-blind, double-dummy design. METHODS: Subjects with self-perceived heartburn without known gastrointestinal disease or interfering treatments were selected with questionnaires. The study was performed unsupervised, whenever heartburn required medication. An electronic patient diary gave instructions when to take study medication, and provided visual analogue scales and five-item relief ratings for heartburn, at frequent time intervals activated by an alarm-clock. RESULTS: After a study of the natural history of heartburn and the feasibility of the study procedures in 23 patients, 49 subjects took Maalox and 45 ranitidine. Half of these experienced meaningful heartburn relief within 19 min after Maalox, and within 70 min after ranitidine. One hour after intake, the average heartburn relief score was 3.43 in the Maalox group and 3.04 in the ranitidine group (3 means 'slight improvement' and 4 'strong improvement'). Heartburn was similar in both groups after 3 h. CONCLUSIONS: Maalox provides faster relief of heartburn than ranitidine. Heartburn can be assessed frequently and reliably under ambulant conditions using an electronic patient diary.

Adult↗

Heartburn in Belgium: prevalence, impact on daily life, and utilization of medical resources.

BACKGROUND: Gastro-oesophageal reflux disease (GORD) is a frequently occurring disease that may be considered a public health issue, particularly in developed countries. The specificity of heartburn for the diagnosis of GORD is good. Our aim was to define the prevalence of heartburn in Belgium, characterizing both its impact on everyday life and the ensuing use of medical resources. METHODS: Two thousand people living in Belgium, selected randomly after stratification, were interviewed face to face. The main question in the questionnaire used in this interview concerned the presence over the previous 12 months of a burning sensation in the epigastric and/or retrosternal region. This was followed by 21 secondary questions on the characteristics of the population studied, the impact of heartburn on everyday life, and the medical resources used. RESULTS: Twenty-eight per cent of the population interviewed reported heartburn. This symptom was present at least once a week in 42% of sufferers. Heartburn was more frequent in women than men (P < 0.05) and was not distributed uniformly throughout the various regions of the country (P < 0.05). Seventy-seven per cent of the people with heartburn found that it had a significantly negative impact on their daily lives (in 27%, this effect was strong). Heartburn associated with a substantial negative impact on daily life was characterized by a higher frequency of symptoms (P < 0.0001), a longer duration of the problem (P = 0.006), and the presence of pain (P < 0.0001) and anxiety (P < 0.0001). Fifty-six per cent of individuals with heartburn had already sought medical advice, 45% had undergone an upper-gastrointestinal tract endoscopy, and 59% were taking medications. Among patients complaining that heartburn had a substantial negative effect on their everyday lives, 21.6% had not sought medical advice and 22.2% did not take any medication. CONCLUSION: Heartburn is very frequent in Belgium and is associated with a considerable negative impact on everyday life. It also generates a significant use of medical resources. However, among the patients complaining of a substantial negative effect on their daily lives, one-fifth (which would represent 1.5% of the Belgian population) seemed to lack appropriate care.

Adolescent↗