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At least 127 records · Page 7Linked to original sources
PubMed2005

Esomeprazole in the treatment of patients with heartburn and other upper gastrointestinal symptoms, referred to primary care -- results of the in-practice evaluation program in Romania.

BACKGROUND AND AIM: The real-life clinical setting has been known to provide, sometimes, results different from controlled study outcomes. IPEP (InPractice Evaluation Program) was designed to evaluate the efficacy of esomeprazole in providing symptom relief in patients with reflux disease who present to primary care physicians for heartburn and symptoms that are poorly controlled by other drugs, thus testing the efficacy of the drug in day-to-day practice. METHODS: 119 primary care physicians and 22 internal medicine specialists, widely distributed geographically, participated in the program. The frequency and severity of three symptoms (heartburn, acid regurgitation and upper abdominal pain) were assessed before and at the end of one month treatment with esomeprazole 40 mg once daily. RESULTS: Follow-up data from 747 patients enrolled in IPEP was available to evaluate the efficacy of the intervention. Over 80% of the enrolled patients reported a decrease in the frequency of symptoms to less than one episode per week for all the three major symptoms (heartburn, acid regurgitation and upper abdominal pain). Regarding the severity of symptoms, 50-60% of the patients reported total relief, while 30-40% reported persistence of symptoms, but admitted them to be milder and with lower frequency. At the end of treatment, no patient reported severe or extremely severe symptoms. CONCLUSIONS: The results of this routine clinical practice program are consistent with data reported in controlled trials indicating the efficacy of esomeprazole even in patients with upper gastrointestinal symptoms "refractory" to treatments prescribed by primary care practitioners.

Administration, Oral↗
PubMedDate not supplied

Cimetidine QID and BID in rapid heartburn relief and healing of lesions in gastroesophageal reflux disease.

This multicenter, double-blind, randomized, placebo-controlled trial investigated QID and BID regimens of cimetidine (total daily dosage of 1600 mg) in adult patients with moderate or severe gastroesophageal reflux disease. Healing of endoscopically documented lesions and heartburn pain relief were compared among three treatment groups: placebo (n = 82), cimetidine 800 mg BID (n = 85), and cimetidine 400 mg QID (n = 83). To maintain the double-blind conditions, all groups received two tablets QID (a combination of placebo and drug). Healing and improvement were evaluated with repeat endoscopy at 6 and 12 weeks, and pain severity for daytime and nighttime heartburn was recorded separately on diary cards and was rated on a four-point scale (severe = 3, moderate = 2, mild = 1, or none = 0). Efficacy results for the three treatment groups are presented in the following order: placebo, cimetidine 800 mg BID, and cimetidine 400 mg QID. Cumulative healing at week 12, using life-table methods, was 42%, 60% (P < 0.05 vs placebo), and 66% (P < 0.01 vs placebo), respectively. Cumulative improvement was 49%, 66% (P < 0.05 vs placebo), and 75% (P < 0.01 vs placebo), respectively. Median time in days to achieve 24 hours of complete freedom from heartburn was 18, 9, and 4 (P < 0.01 vs placebo), respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1999

On demand therapy with omeprazole for the long-term management of patients with heartburn without oesophagitis--a placebo-controlled randomized trial.

AIM: To observe the natural course of gastro-oesophageal reflux disease (GERD) in patients without oesophagitis following effective symptom relief, and to determine the place of acid pump inhibitor therapy in the long-term management of these patients. METHODS: We investigated the efficacy of on-demand therapy with omeprazole 20 mg or 10 mg, or placebo in a double-blind, randomized multicentre trial. It involved 424 patients with troublesome heartburn without endoscopic evidence of oesophagitis in whom heartburn had been resolved with short-term treatment. Patients were told to take study medication on demand once daily on recurrence of symptoms until symptoms resolved over a 6-month period. They also had access to antacids. The primary efficacy variable was time to discontinuation of treatment, due to unwillingness to continue. RESULTS: According to life-table analysis, after 6 months the remission rates were 83% (95% CI: 77-89%) with omeprazole 20 mg, 69% (61-77%) with omeprazole 10 mg, and 56% (46-64%) with placebo (P < 0.01 for all intergroup differences). The mean (s.d.) number of study medications used per day in these groups was 0.43 (0.27), 0.41 (0.27) and 0.47 (0.27), respectively. The use of antacids was highest in the placebo group and lowest in the omeprazole 20 mg group. Treatment failure was associated with more than a doubling of antacid use, and a deterioration in patient quality of life. CONCLUSIONS: Approximately 50% of patients with heartburn who do not have oesophagitis need acid inhibitory therapy in addition to antacid medication to maintain a normal quality of life. On-demand therapy with omeprazole 20 mg, is an effective treatment strategy in these patients.

Adult↗
PubMed1995

Efficacy and Tolerability of Famotidine in Preventing Heartburn and Related Symptoms of Upper Gastrointestinal Discomfort.

This randomized, double-blind, placebo-controlled, four-way crossover trial was designed to compare the efficacy of famotidine and placebo in preventing meal-provoked upper gastrointestinal symptoms. One hundred twenty-one subjects (58 men and 63 women), aged 20--61 years, were randomly assigned to one of four treatment sequences which included single oral doses of placebo, famotidine 5 mg, famotidine 10 mg, and famotidine 20 mg, spaced approximately 7 days apart. To be eligible for randomization, subjects had to have at least a 2-month history of heartburn and acid/sour stomach occurring at least three times per week. Treatment was administered 1 h prior to ingestion of test meals (chili and wine). Rescue antacid medication (Maalox((R))) was available for subjects who required additional relief. Heartburn severity. acid/sour stomach, and overall discomfort were evaluated on a six-point scale immediately prior to each test meal and every 15 min thereafter for 5 h. A global evaluation of the test medication, using a five-point scale, was performed prior to rescue medication use or at the end of each treatment session. Heartburn and peak acid/sour stomach were rated as significantly milder following prophylactic treatment with famotidine 5, 10, and 20 mg compared to placebo. Treatment with all three doses of famotidine was rated as "good" or "excellent" by significantly more subjects (58--63%) than following treatment with placebo (38%). In addition, rescue medication was used by significantly fewer subjects following famotidine (17--18%) compared to placebo (37%). Famotidine was generally well tolerated in this trial, with type and frequency of reported adverse experiences similar to that observed following placebo. These results indicated that famotidine doses of 5, 10, and 20 mg were significantly more effective than placebo in preventing symptoms of upper gastrointestinal distress when administered 1 h in advance of meal provocation.

Journal Article↗
PubMed1983

Heartburn treated with tapwater.

A very simple and effective method against heartburn (Hb) is described; it consists in drinking 1-2 glasses of tapwater. A larger scale trial of the method is also recommended against heartburn during the first trimester of pregnancy and possibly against peptic ulcer.

Drinking↗
PubMed2005

Air swallowing can be responsible for non-response of heartburn to high-dose proton pump inhibitor.

Intraluminal electrical impedance is a novel technique, which is able for the first time to provide a qualitative assessment of refluxed material moving from the stomach to the oesophagus. In other words, the presence of air can be differentiated from that of liquid, because the former is characterised by high and the latter by low impedance compared with baseline. Moreover, the combined measurement of electrical impedance and pH-metry permits to distinguish acid from non-acid liquid reflux. One of the most important clinical applications of this method is to assess the reasons for poor response of GORD patients to high-dose proton pump inhibitors. This case report describes the results of impedance in the evaluation of a young woman, who did not respond to twice-daily doses of rabeprazole. She continued to complain of heartburn as major symptom and impedance allowed us to clarify that it was not related to acid or non-acid reflux, but to air swallowing. Therefore, this technique identified aerophagia to be responsible for persistent heartburn despite high-dose proton pump inhibitor and prevented the adoption of more aggressive, but probably unuseful therapies, such as the surgical one.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2003

Living with chronic heartburn: insights into its debilitating effects.

Heartburn is a common, often disabling condition. Twenty percent of adults exhibit symptoms at least once weekly. Few obtain complete satisfactory relief of their symptoms without the simultaneous implementation of significant lifestyle modifications and appropriate pharmacologic intervention. Poor sleep and chronic symptoms impair the QoL in 25% to 30% of such cases. Nocturnal symptoms are more troublesome, more difficult to treat, and are often manifested by extraesophageal symptoms. Several patients, however, unknown to their physicians continue to experience heartburn, despite lifestyle changes and taking prescription drugs. Adequate acid suppression is currently essential to effective management of the condition.

Gastroesophageal Reflux↗
PubMed1999

Dyspepsia and heartburn.

Dyspepsia and heartburn are the two cardinal symptoms of foregut dysfunction. When confronting such a problem, that physician must first learn to discern between the two, because treatment can be quite different for the conditions presenting with these symptoms. This article details the approach to work-up and treatment of patients presenting with dyspepsia or heartburn.

Diagnosis, Differential↗
PubMed2003

Factor structure of the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire evaluated in patients with heartburn predominant reflux disease.

AIM: To test whether the original factor structure of the Quality of Life in Reflux and Dyspepsia (QOLRAD) can be replicated in Nordic patients and English speaking patients. PATIENTS AND METHODS: Clinical trial patients with heartburn without esophagitis completed the Swedish, Norwegian, Finnish and Danish versions (n = 634) and the English version (n = 1185). The factor structure was examined using models generated by exploratory and confirmatory factor analysis. RESULTS: The exploratory factor analysis suggested that the original five-factor structure solution was the most optimal. The Nordic versions explained 67% and the English version 72% of the variance. The factor loading of 22 out of 25 items was >0.55. In the confirmatory factor analysis, because of the sample size, only the Swedish and Norwegian data were used. Confirmatory factor analysis indicated an acceptable goodness of fit of the five-factor solution to the data with a goodness of fit index of 0.85 in the Swedish, 0.77 in the Norwegian and 0.91 in the English speaking population. The internal consistency reliability ranged from 0.70 to 0.94 (in the Nordic translations) and from 0.85 to 0.92 (in the English version), supporting the homogeneity of the items within the factors and thus their construct validity. The QOLRAD distinguished severity and frequency of heartburn, thereby documenting its known-group validity to distinguish between groups of patients. CONCLUSIONS: The factor structure and dimensionality of the English version and the Swedish and Norwegian translations of the QOLRAD could be replicated by the exploratory and confirmed by the confirmatory factor analysis. The QOLRAD is a valid and reliable instrument for use in clinical trials.

Adolescent↗
PubMed2006

Value of heartburn for diagnosing gastroesophageal reflux disease in severely obese patients.

OBJECTIVE: To evaluate the prevalence of gastroesophageal reflux disease (GERD) in severely obese patients and the association between symptoms and objective data of GERD in this population. RESEARCH METHODS AND PROCEDURES: A total of 158 consecutive severely obese patients (BMI > or = 40 kg/m(2)) were prospectively evaluated. Symptoms were evaluated by a structured clinical questionnaire. Objective assessment was made by ambulatory 24-hour esophageal pH monitoring and endoscopy. GERD was defined by the presence of symptoms or complications (esophagitis). The clinical criterion defining GERD was the presence of at least two episodes of heartburn per week. RESULTS: The mean age of the 138 patients subjected to complete study was 42.6 +/- 10.2 years, with a BMI of 50.1 +/- 6.9 kg/m(2) (range, 40.6 to 69.4 kg/m(2)); 78% were women. The prevalence of GERD evaluated by symptoms and/or esophagitis was 33.3% (46/138). Clinical criteria of GERD were present in 31/138 cases (22.5%), and 26 (18.8%) had esophagitis. In 69/138 patients (50%), pHmetry was abnormal. Fifty-three patients with esophagitis and/or abnormal pHmetry were asymptomatic. The sensitivity of heartburn as a diagnostic criterion of GERD in patients with severe obesity was 29.3%, with a specificity of 85.7%. No significant association was observed between severe obesity grade and the prevalence of symptoms and/or objective data. DISCUSSION: Asymptomatic gastroesophageal reflux (abnormal esophageal acid exposure and/or reflux esophagitis) is more common than symptomatic gastroesophageal reflux in severely obese patients. Increased BMI is not associated with a greater prevalence of GERD in these patients.

Adult↗
PubMed2002

Effects of antacid formulation on postprandial oesophageal acidity in patients with a history of episodic heartburn.

BACKGROUND: Heartburn self-treatment with antacids is extremely common. If the oesophagus is the primary site of antacid action, chewable antacids might raise the oesophageal pH more effectively than swallowable tablets. AIM: To establish a model to assess postprandial acid reflux and to compare the onset and duration of action on oesophageal pH of different antacid formulations. METHODS: Twenty subjects with a history of episodic heartburn underwent eight pH monitoring sessions each for 5.5 h postprandially. One hour after consuming a meal consisting of chili, cheese, raw onions and cola, subjects received 750 mg, 1500 mg and 3000 mg of either chewable or swallowable CaCO3 tablets, an effervescent bicarbonate solution or placebo. Oesophageal and gastric pH data were collected. RESULTS: Mean intra-oesophageal pH remained lower than baseline for more than 1 h (pH range 5-5.5) postprandially, indicating reflux of somewhat acidic intragastric contents into the oesophagus. The onset of action on oesophageal pH was similar for all antacids (30-35 min). The duration of action on pH varied: chewable tablets and effervescent bicarbonate had relatively long durations of action (oesophagus, 40-45 min; stomach, 100-180 min); swallowable tablets had little effect. CONCLUSIONS: The meal model used in this study dependably produced acidic gastro-oesophageal reflux. Antacids increased oesophageal pH independent of gastric pH, demonstrating that chewing antacids controls oesophageal acidity more effectively than swallowing antacid tablets.

Adult↗
PubMed2003

[Socioepidemic analysis of sources of information and medical care for a subpopulation of female and male participants in a nationwide informative campaign in Germany on "Danger Signal: Heartburn"].

Whilst the prevalence of gastroesophageal reflux is increasing, most people are unaware of its possible consequences. Therefore, in Autumn 2000 a nationwide information campaign was launched on the symptoms of gastroesophageal reflux and its possible treatments. One part of the information campaign was a telephone hotline which was followed by an interview by phone or a mailed questionnaire. The objective of this was to find out more about the people concerned and their complaints. The subjects of both data sets were on average 53 respectively 57 years old, half of them were female and over 60 % had had heartburn for more than two years. The interview showed that 53 % took notice of the hotline by a press release. The interviewed persons gathered information in general about health-related issues primarily from newspapers and TV reports and from their physician. 81.7 % of the questionnaire sample had already at least one gastroscopy. Another 9.5 % made use of medical services because of their complaints in the last year. 8.8 % used exclusively over-the-counter medication for relief from their complaints. These three groups of different degrees of utilisation differed in respect of age, intensity and duration of the symptom heartburn and lifestyle-factors such as smoking. Those who had a gastroscopy were older, symptoms were more prolonged, more severe, more often and comprised a wider range of symptoms and less cigarette consumption. The analysis of both samples showed that the telephone hotline was used mainly by people who had had their symptoms for a long time and had already been in medical care. The chosen means of information stated by the sample indicate that media are prominently involved in disseminating information and educating the public.

Age Factors↗
PubMed2006

The prevalence of fullness, heartburn and nausea among persons with and without diabetes mellitus in Germany.

BACKGROUND: Gastrointestinal symptoms are commonly reported among persons with diabetes mellitus and are attributed to gastropathy as an expression of autonomic neuropathy. These symptoms are also frequent in the general population. The goal of this study was to compare the prevalence of fullness, heartburn and nausea in the German population among persons with and without diabetes mellitus. METHODS: A cross-sectional study was performed using the German Federal Health Surveys 1987, 1991 and 1998, and involving a representative random sample of German citizens (n = 18 411) aged 25 to 69 years. A comparison was made of the prevalence of self-reported symptoms among persons with and without self-reported diabetes mellitus. RESULTS: Diabetes mellitus is significantly associated only with nausea in males (OR, 1.75) and in females (OR, 1.88). In both groups, persons with or without diabetes, the prevalence of fullness (28 vs. 21 %) and heartburn (23 vs. 18 %) are about the same, whereas nausea is much less common (12 vs. 6 %). Women suffered more often from nausea than men in people with diabetes and from fullness and nausea in non-diabetic patients. No correlation between age group and the percentage of persons (both sexes) suffering from a certain complaint can be found in persons with diabetes. CONCLUSIONS: The prevalence of some gastrointestinal symptoms is higher in persons with diabetes. It is related to gender, but not to age. The association with diabetic gastropathy remains unclear.

Adolescent↗
PubMed2006

Psychological factors as a predictor of treatment response in patients with heartburn: a pooled analysis of clinical trials.

OBJECTIVE: A pooled analysis, using data from three prospective, randomized, double-blind, placebo-controlled, clinical studies, was undertaken to determine the relationship between well-being and subsequent clinical response to acid suppressant therapy in 1887 adult patients with reflux symptoms (with/without endoscopically verified erosive esophagitis). MATERIAL AND METHODS: Well-being was assessed at study entry using the Psychological General Well-Being (PGWB) Index. Patients were assessed for complete relief of heartburn (absence of symptoms in the preceding 7 days) after 4 weeks' treatment (omeprazole 10 or 20 mg once daily; ranitidine 150 mg twice daily). RESULTS: Multiple logistic regression analysis identified baseline PGWB Index total score and anxiety score as independent prognostic indicators of treatment response in endoscopy-positive patients (n=1333). Thus, the likelihood of achieving complete heartburn relief was impaired by high baseline levels of anxiety or a low total well-being score. In the endoscopy-negative group, high levels of depression and low vitality scores affected treatment response adversely. Furthermore, age (for endoscopy-positive patients only) and body mass index (for endoscopy-negative patients only) showed an association with treatment outcome. Gender seemed to have no prognostic value on treatment outcome. CONCLUSIONS: Patient well-being may be a useful prognostic indicator in patients presenting with reflux symptoms, with a high level of anxiety predicating against a response to acid suppressant therapy, particularly in those with normal endoscopic findings.

Adolescent↗
PubMed2005

Beyond heartburn: a systematic review of the extra-oesophageal spectrum of reflux-induced disease.

BACKGROUND: Gastro-oesophageal reflux disease (GORD) is a chronic condition affecting up to one-quarter of the Western population. GORD is characterized by heartburn and acid regurgitation, but is reported to be associated with a spectrum of extra-oesophageal symptoms. OBJECTIVE: The aim of this systematic review was to critically evaluate postulated extra-oesophageal symptoms of GORD. METHODS: Extra-oesophageal symptoms were identified from population-based studies evaluating their association with GORD (either defined as heartburn and/or acid regurgitation, or diagnosed in general practice). The response of these symptoms to acid-suppressive therapy was investigated using randomized, double-blind, placebo-controlled studies. Pathogenic mechanisms were evaluated using clinical and preclinical studies. RESULTS: An association between GORD and symptoms or a diagnosis of chest pain/angina, cough, sinusitis and gall-bladder disease was evident from three eligible population-based studies of GORD. Randomized placebo-controlled studies (n=20) showed that acid-suppressive therapy provides symptomatic relief of chest pain, asthma and, potentially, chronic cough and laryngitis. Mechanistic models, based on direct physical damage by refluxate or vagally mediated reflexes, support a causal role for GORD in chest pain and respiratory symptoms, but not in gall-bladder disease. CONCLUSION: GORD is likely to play a causal role in chest pain and possibly asthma, chronic cough and laryngitis. Further investigation is desirable, particularly for other potential extra-oesophageal manifestations of GORD such as chronic obstructive pulmonary disease, sinusitis, bronchitis and otitis. Acid-suppressive therapy is likely to benefit patients with non-cardiac chest pain, but further placebo-controlled studies are needed for other symptoms comprising the extra-oesophageal spectrum of GORD.

Asthma↗
PubMed2005

Treatment of patients with heartburn without endoscopic evaluation: on-demand treatment after effective continuous administration of lansoprazole 15 mg.

BACKGROUND: Relapse is frequent after initial treatment for gastro-oesophageal reflux. An alternative strategy to intermittent or continuous therapy may be on-demand treatment. AIM: To compare the efficacy and safety of on-demand lansoprazole 15 mg and placebo treatment in patients with gastro-oesophageal reflux. METHODS: This was a multicentre, randomized, double-blind study in two parallel groups of patients. In the acute study phase, all included patients (n = 203) were treated with lansoprazole 15 mg (once per day) for 4 weeks. At week 4, asymptomatic patients entered the 6-month, on-demand, follow-up phase and were randomized to receive either lansoprazole 15 mg (once per day) or placebo. RESULTS: A higher percentage of patients in the lansoprazole group completed the 6-month follow-up than in the placebo group [81% vs. 61% (P = 0.003)]. Only 16% of patients in the lansoprazole group discontinued the study for insufficient control of heartburn vs. 28% in the placebo group (P = 0.046). The mean daily intake in patients who completed the study was 1-5 capsules/day in the lansoprazole 15 mg group. CONCLUSIONS: On-demand treatment with lansoprazole 15 mg in symptomatic patients after short-term, continuous treatment is a promising therapeutic alternative to intermittent and continuous treatment to maintain heartburn control in patients with gastro-oesophageal reflux.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2006

Non-erosive reflux disease, functional heartburn and gastroesophageal reflux disease; insights into pathophysiology and clinical presentation.

Non-erosive reflux disease (NERD) has emerged as a real entity in the spectrum of gastroesophageal reflux disease (GERD) and may, indeed, represent the most common manifestation of reflux disease. Recent information indicates NERD can be further subclassified based on the results of pH studies and suggests that functional heartburn needs to be differentiated as that subgroup of patients in which there appears to be no relationship between symptoms, however 'typical' of GERD, and acid exposure. Other aspects of NERD need to be appreciated, including overlap with functional dyspepsia and the potential variations in response to such therapeutic interventions as acid-suppressive therapy and fundoplication. It seems quite possible that our failure to separate functional heartburn from NERD, in general, has contributed, in large measure, to diagnostic difficulties and therapeutic disappointment in GERD. An appreciation of the range of entities, of different etiology and pathology, within NERD will foster the development of effective approaches to the assessment and therapy of this challenging disorder.

Gastroesophageal Reflux↗
PubMed1990

Is mucaine an appropriate medication for the relief of heartburn during pregnancy?

A double blind comparative study comparing Mucaine, Mucaine without oxethazaine, and placebo was carried out with 50 patients with symptoms of heartburn during late pregnancy. We found that the 2 active treatments were more effective than placebo for the relief of heartburn, but there was no statistically significant difference between groups for the relief of nausea and regurgitation. There was a significant difference in the percentage of days of use of each medication, with the placebo being used least frequently. Although not statistically significant, for the 3 measures for which placebo differed from the active treatments, patients showed a better response to mucaine. This suggests that the addition of oxethazaine may be of benefit. The lack of statistical significance may be due to the relatively small number of cases, and the findings are promising. No side effects were recorded for any treatment.

Adult↗