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PubMed1977

Pregnancy heartburn in Nigerians and Caucasians with theories about aetiology based on manometric recordings from the oesophagus and stomach.

A study by questionnaire of the incidence of pregnancy heartburn in two groups of Nigerians and one group of Caucasians showed an incidence of 9-8 per cent in all Nigerians as against 78-8 per cent in Caucasians. The difference was highly significant (chi 2 = 102-75; P less than 0-0001). An oesophageal manometric study of the lower esophageal sphincter in 12 non-pregnant women and in 12 pregnant Nigerians (10 without heartburn and 2 with heartburn) showed that the mean lower oesophageal sphincter pressure (+/- SD) in the pregnant patients without heartburn was 20-1 +/- 7-0 mm Hg as against 17-9 +/- 7-0 in the non-pregnant women. While one pregnant subject without heartburn had a lower oesophageal sphincter which was partially displaced into the thorax, none of the non-pregnant women had such sphincter displacement. The two pregnant women with heartburn had low resting sphincter pressures and in both of them the sphincters were partially in the thorax. It is argued that pregnancy heartburn is due to the displacement of the lower oesophageal sphincter into the negative pressure environment of the thorax where the sphincter is less capable of resisting reflux. It is also argued that pregnancy heartburn is commoner in Caucasians that in Nigerians because the spincter in non-pregnant Caucasians is often partly intrathoracic and is thus more easily displaced completely into the thorax by the pregnant uterus.

Black or African American↗
PubMed1992

Determinants of pregnancy heartburn.

OBJECTIVE: To study the prevalence and severity of reflux symptoms in pregnancy. DESIGN: Self-administered questionnaire detailing age, race, gestational age, parity, weight, height, symptoms and severity of gastro-oesophageal reflux. SETTING: An antenatal clinic in a teaching hospital. SUBJECTS: 607 consecutive women at various stages of pregnancy were recruited during attendance at antenatal clinic. RESULTS: The prevalence of heartburn increased with gestational age (22% in the first, 39% in the second, and 72% in the third trimester; P < 0.0001), as did severity of heartburn (P < 0.0001). Pharyngeal regurgitation as a symptom showed little increase during advancing pregnancy. Symptoms of heartburn rapidly increased towards the end of the second trimester. The decrease in heartburn traditionally expected during the last three weeks of pregnancy (fetal head descent) was not observed. Logistic regression analysis showed increased risk of suffering heartburn with increasing gestational age (P < 0.0001), pre-pregnancy heartburn (P < 0.0001), parity (P < 0.0001) and inversely with maternal age (P < 0.05) but not with body mass index before pregnancy, race, or weight gain in pregnancy. CONCLUSION: Heartburn, but less so pharyngeal regurgitation, increases in prevalence and severity with gestational age and parity. We speculate that hormone-related impairment of distal oesophageal clearance mechanisms may have a crucial bearing on whether heartburn develops in those individuals at greatest risk.

Adult↗
PubMed1991

Relationship of heartburn with histopathological changes in esophagus and stomach in patients with duodenal ulcer.

Histopathological changes in the esophagus and gastric antrum were studied in 47 patients with duodenal ulcer. Twenty three (49%) patients complained of heartburn. Esophagitis was present in 87% of the patients with heartburn and in 71% of the patients with no heartburn. In the majority, esophagitis was of mild to moderate severity. Gastritis was present in 83% (atrophic type in 22%) of patients with heartburn compared to 96% (25% atrophic type) of patients without heartburn. There was no statistical difference in the incidence of esophagitis and gastritis between the heartburn and no heartburn groups. This study suggests that histologic esophagitis and gastritis occur frequently in patients with duodenal ulcer and the presence of heartburn is not related to these histologic changes.

Adult↗
PubMed1993

The symptom index. Differential usefulness in suspected acid-related complaints of heartburn and chest pain.

The symptom index is a quantitative measure developed for assessing the relationship between gastroesophageal reflux and symptoms. Controversy exists, however, over its accuracy and the appropriate threshold for defining acid-related symptoms of heartburn and chest pain. Therefore, a retrospective review was done of 153 consecutive patients referred to our esophageal laboratory. Three groups were identified: patients with normal 24-hr pH tests and no esophagitis, patients with abnormal 24-hr pH tests and no esophagitis, and patients with abnormal 24 hr pH values and endoscopic esophagitis. If symptoms occurred during the pH study, a symptom index (number of acid related symptoms/total number of symptoms x 100%) was calculated separately for heartburn and chest pain. Heartburn and chest pain episodes were similar among the three groups. However, the mean symptom index for heartburn was significantly (P < 0.001) higher in the patient groups with abnormal pH values [abnormal pH/no esophagitis: 70 +/- 7.1% (+/- SE); abnormal pH/esophagitis: 85 +/- 4.6%] as compared to those with normal studies, ie, functional heartburn (26 +/- 10.7%). The mean symptom index for chest pain was similar for all three groups. Using receiver operating characteristic curves, a heartburn symptom index > or = 50% had excellent sensitivity (93%) and good specificity (71%) for acid reflux disease, especially if patients complain of multiple episodes of heartburn. In contrast, an optimal symptom index threshold for defining acid-related chest pain episodes could not be defined.

Adult↗
PubMed2003

Comparison of objective outcomes following laparoscopic Nissen fundoplication versus laparoscopic gastric bypass in the morbidly obese with heartburn.

BACKGROUND: Heartburn and gastroesophageal reflux disease (GERD) affects approximately 25-50% of morbidly obese patients. Although objective physiologic testing has been reported extensively in patients following Nissen fundoplication, there are no previous reports of such testing in morbidly obese patients. A life-saving surgical alternative for the morbidly obese patient is gastric bypass surgery, which usually improves heartburn symptoms in addition to many serious health conditions such as diabetes, hypertension, and sleep apnea. We hypothesized that, in morbidly obese patients, gastric bypass surgery would be as effective as Nissen fundoplication in reducing both heartburn symptoms and esophageal acid exposure, as reflected by the DeMeester score. METHODS: Between 1995 and 2000, all patients undergoing laparoscopic Nissen fundoplication (LN) and laparoscopic gastric bypass (LGB) in our practice underwent preoperative and postoperative esophageal physiologic testing. Patients were included in this study that were morbidly obese and had significant heartburn symptoms or objective evidence of acid reflux, and had repeat esophageal physiologic testing after either LN or LGB. Data were obtained through retrospective review of prospectively collected data. RESULTS: Twelve patients met the inclusion criteria: six patients who had LN and six who had LGB. The mean body mass index (BMI) was 55 kg/m2 in the LGB group and 39.8 in the LN group. After surgery, the mean DeMeester score decreased from 64.3 to 2.8 in the LN group ( p = 0.01) and from 34.7 to 5.7 in the LGB group ( p = 0.1). Both groups' mean postoperative DeMeester scores were normal after surgery, and there was no significant difference between the two groups ( p = 0.3). Both groups experienced a significant improvement in heartburn symptoms postoperatively. The mean preoperative symptom score improved from 3.5 to 0.5 in the LN group ( p = 0.01) and from 2.2 to 0.2 in the LGB group ( p = 0.003). There was no difference in the mean postoperative symptom scores between the groups ( p = 0.35). After surgery, mean LES resting pressures increased from 12.9 to 35.5 ( p = 0.003) in the LN group and from 23.6 to 29.7 ( p = 0.45) in the LGB group. There were no complications in either group. CONCLUSION: Results of this study show that laparoscopic gastric bypass and laparoscopic Nissen fundoplication are both effective in treating heartburn symptoms and objective acid reflux in morbidly obese patients. The health benefits of weight loss after laparoscopic gastric bypass should make this operation the procedure of choice in the morbidly obese patient with heartburn.

Adult↗
PubMed2006

Impact of nocturnal heartburn on quality of life, sleep, and productivity: the SINERGE study.

The aim of the SINERGE study was to assess the impact of nocturnal heartburn on quality of life, sleep, and productivity. Ambulatory patients >/=18 years old and classified as defined cases of nocturnal heartburn (n=337), nonnocturnal heartburn (n=139), uncontrolled hypertension (n=198), and symptomatic depression (n=104) were included in this cross-sectional study. Information on age, gender, body mass index, and comorbidity was collected and the following validated questionnaires were applied: SF-12, Pittsburgh Sleep Quality Index, and Work Productivity and Activity Impairment questionnaire. The prevalence of primary care consultation for heartburn and nocturnal heartburn was 4.7% and 1.9%, respectively. Health-related quality of life, sleep, and productivity were significantly impaired in patients with frequent nocturnal heartburn symptoms as compared with those of the patients without nocturnal symptoms or patients with hypertension. Nocturnal heartburn poses a considerable burden for the sufferer because of the impact on quality of life, sleep, and daily activities.

Circadian Rhythm↗
PubMed2005

Early heartburn relief with proton pump inhibitors: a systematic review and meta-analysis of clinical trials.

BACKGROUND & AIMS: Proton pump inhibitors (PPIs) are often taken for short-term treatment of heartburn. We performed a systematic review of the efficacy of PPIs for heartburn relief within the first 1-2 days of therapy. METHODS: Bibliographic databases were searched for clinical trials of PPIs in patients with heartburn that provided information about the proportion with heartburn relief at day 1-2. The sample size-weighted pooled proportions of patients with complete or sustained (7 consecutive days) relief were calculated. Meta-analyses of randomized comparisons of PPIs were also performed. RESULTS: Eighteen trials met inclusion criteria. At day 1 of PPI therapy, complete 24-hour, daytime, nighttime, and sustained heartburn relief occurred in 0.31 (95% confidence interval [CI], 0.30-0.32), 0.49 (95% CI, 0.48-0.50), 0.55 (95% CI, 0.53-0.56), and 0.21 (95% CI, 0.20-0.22) of patients. Up to 37% of the heartburn relief achievable with 28 days of PPIs occurred on day 1. Placebo was significantly less effective than PPIs for 24-hour relief on day 1 (relative risk [RR], 0.41; 95% CI, 0.29-0.58), and single-dose PPI therapy was less effective than double-dose therapy (RR, 0.82; 95% CI, 0.74-0.92). CONCLUSIONS: Complete heartburn relief for the entire day occurs in approximately 30% of patients after their first PPI dose and 9% of patients after their first placebo (RR for relief on day 1 for placebo versus PPI was 0.41 [95% CI, 0.28-0.58]). Although PPIs might provide benefit from the first day of therapy, most patients will not have symptom relief with 1 or 2 days of PPI therapy.

Clinical Trials as Topic↗
PubMed2006

Treatment of patients with persistent heartburn symptoms: a double-blind, randomized trial.

BACKGROUND & AIMS: Common treatment practices in patients who continue to be symptomatic on proton pump inhibitor once-daily treatment include either increasing the dosage or the use of supplemental medication. This trial's purpose was to compare 2 therapeutic strategies, increasing the proton pump inhibitor dosage to twice daily versus switching to another proton pump inhibitor, in patients with persistent heartburn while receiving standard-dose proton pump inhibitor therapy. METHODS: This multicenter, randomized, double-blind, double-dummy trial included patients with persistent heartburn symptoms while receiving therapy with lansoprazole 30 mg once daily. Patients were randomly assigned to treatment for 8 weeks with either single-dose esomeprazole (40 mg once daily) (n = 138) or lansoprazole 30 mg twice daily (n = 144). The primary efficacy variable was the percentage of heartburn-free days from day 8 to the end of treatment. RESULTS: Single-dose esomeprazole was at least as effective as twice-daily lansoprazole for the primary end point of percentage of heartburn-free days during the study period (54.4% and 57.5%, respectively). Symptom scores improved from baseline in similar numbers of patients for heartburn (83.3% of patients in each group), acid regurgitation (76.8% vs 72.9%, P = .58), and epigastric pain (67.4% vs 61.1%, P = .32), and rescue antacid use was also similar (0.4 tablets/day vs 0.5 tablets/day, P = .50). CONCLUSIONS: Switching patients with persistent heartburn on a standard-dose proton pump inhibitor to a different proton pump inhibitor was as effective as increasing the proton pump inhibitor dosage to twice daily for controlling heartburn symptoms.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1997

Prevention of heartburn relapse by low-dose famotidine: a test meal model for duration of symptom control.

AIM: To establish whether patients taking famotidine 10 mg to treat an episode of heartburn were protected from a recurrence of symptoms after a subsequent test meal. METHODS: Frequent heartburn sufferers (n = 366) were randomized to receive double blind treatment with famotidine 10 mg or 2 x 250 mg chewable alginate tablets within 30 min of a spontaneous episode of heartburn. After 4 h, patients with no or slight residual symptoms consumed a meal likely to induce heartburn. Over the next 4 h patients recorded the severity of heartburn and any consumption of 'rescue' antacids. At the end of this time they rated the global efficacy of their treatment in controlling meal-induced symptoms. RESULTS: Study groups were well matched for all baseline characteristics. Of the 366 randomized patients, 276 took study medication and data from 269 patients (132 famotidine, 137 alginate) were analysed for efficacy. Compared to the alginate control group famotidine treated patients reported better global efficacy following the test meal (P < 0.001; relative odds for a more favourable response: 2.26 [95% CI: 1.45-3.53]). Fewer patients receiving famotidine resorted to antacid rescue (P = 0.038; relative odds for a more favourable response: 2.24 [95% CI: 1.04-4.79]) and peak heartburn was significantly less severe with famotidine treatment (P < 0.001: relative odds for a more favourable response: 2.90 [95% CI: 1.85-4.53]). Eleven famotidine-treated patients (8%) and 13 alginate patients (9%) reported adverse events. CONCLUSION: Compared to patients receiving an alginate preparation, patients self medicating with famotidine 10 mg for heartburn are better protected against a recurrence of their symptoms when they next eat. This suggests that the duration of acid control (9 h) previously demonstrated with this dose translates into a similar duration of measurable symptom control during the day.

Adolescent↗
PubMed2004

Heartburn severity underestimates erosive esophagitis severity in elderly patients with gastroesophageal reflux disease.

BACKGROUND & AIMS: Gastroesophageal reflux disease is common in adults of all ages, but its complications are more frequent in elderly patients. Although heartburn is the most common symptom of reflux disease, it is unclear whether the severity of heartburn reliably indicates the severity of erosive esophagitis. We therefore assessed the relationship between age, severe heartburn symptoms, and severe erosive esophagitis. METHODS: This post hoc analysis of baseline data on the severity of both heartburn and erosive esophagitis pooled data from 5 prospective, randomized, controlled clinical trials that assessed the effect of proton pump inhibitors on healing of erosive esophagitis and symptom resolution. The clinical trials were conducted in 683 private and academic offices and hospital-based gastroenterology practices and involved 11,945 patients aged 18 years and older with gastroesophageal reflux disease and erosive esophagitis. RESULTS: A progressive increase in the prevalence of severe erosive esophagitis was observed with each decade of age, ranging from 12% in patients aged <21 years to 37% in patients aged >70 years. Among patients with severe esophagitis, severe heartburn was less frequent in the older age groups: ranging from 82% of patients aged <21 years to 34% of those aged >70 years. Each of these associations was statistically significant (P < 0.001). CONCLUSIONS: Although the prevalence of severe erosive esophagitis increases with age, the severity of heartburn is an unreliable indicator of the severity of erosive disease. More aggressive investigation and treatment may be necessary for elderly patients, regardless of the reported severity of heartburn.

Adult↗
PubMedDate not supplied

The effect of life stress on symptoms of heartburn.

OBJECTIVE: Psychosocial stressors have been associated with exacerbations of symptoms in functional and inflammatory disorders of the gastrointestinal tract. The present longitudinal study tests the general hypothesis that life stressors can exacerbate symptoms in patients with chronic heartburn. METHODS: Sixty subjects with current heartburn symptoms were recruited by community advertisement and assessed for presence of stressful life events retrospectively over the preceding 6 months and prospectively for 4 months. Symptom severity by daily diary, quality of life, and psychological symptoms of anxiety, depression, and vital exhaustion were also measured. RESULTS: The presence of a severe, sustained life stress during the previous 6 months significantly predicted increased heartburn symptoms during the following 4 months. In addition, symptoms showed a strong, independent correlation with vital exhaustion. Affective and subjective stress ratings were not strongly related to heartburn severity; however, anxiety showed the strongest relationship to impaired quality of life and depression to heartburn medication use. CONCLUSIONS: As with other chronic conditions such as irritable bowel syndrome (IBS), heartburn severity appears to be most responsive to major life events and not an accumulation of more minor stressors or fluctuations in mood. In addition, vital exhaustion, which may in part result from sustained stress, may represent the psychophysiological symptom complex most closely associated with heartburn exacerbation. Potential mechanisms for these results include increased level and frequency of esophageal acid exposure, inhibition of gastric emptying of acid, or stress-induced hypersensitivity.

Adult↗
PubMed1995

Low dose famotidine in the prevention of sleep disturbance caused by heartburn after an evening meal.

AIM: To determine whether, in a susceptible population, dosing with 10 mg famotidine 1 h before an evening meal could decrease the interference with sleep caused by heartburn. METHODS: Patients with a history of frequent heartburn (n = 309) were randomized to receive 10 mg famotidine or placebo 1 h before an evening meal likely to induce symptoms. Patients assessed the efficacy of the treatment in preventing heartburn after the meal, at bedtime and during the night. The number of awakenings due to heartburn and the consumption of antacid tablets taken to alleviate symptoms were also recorded. RESULTS: Treatment groups were well matched and data from 302 patients were available for analysis. Compared to placebo, famotidine treated patients had: less heartburn after the meal (P < 0.0001 mean global scores), less interference with getting to sleep (P = 0.0156 mean global scores), fewer awakenings (P = 0.0001 difference in mean number) and better control of heartburn during the night (P < 0.0001 mean global scores). They were also almost three times less likely to need antacid treatment than the placebo group during the night (relative odds for no antacid 2.78 (95% CI: 1.29-5.96). Only four patients in each group suffered adverse events. CONCLUSION: Taking a 10 mg dose of famotidine 1 h before an evening meal appears to be a successful and well tolerated strategy for preventing post-prandial heartburn and avoiding the associated interference with sleep.

Adult↗
PubMed2005

Heartburn-dominant, uninvestigated dyspepsia: a comparison of 'PPI-start' and 'H2-RA-start' management strategies in primary care--the CADET-HR Study.

BACKGROUND: There are few data on empiric, stepped therapy for heartburn relief or subsequent relapse in primary care. AIMS: To compare heartburn relief produced by a proton pump inhibitor-start or an H(2)-receptor antagonist-start with step-up therapy, as needed, followed by a treatment-free period to assess relapse. METHODS: Heartburn-dominant uninvestigated dyspepsia patients from 46 primary care centres were randomized to one of two active treatment strategies: omeprazole 20 mg daily (proton pump inhibitor-start) or ranitidine 150 mg bid (H2-receptor antagonist-start) for the first 4-8 weeks, stepping up to omeprazole 40 or 20 mg daily, respectively, for 4-8 weeks for persistent symptoms. Daily diaries documented heartburn relief (score < or = 3/7 on < or = of 7 prior days) and relapse (score > or = 4 on > or = 2 of 7 prior days). RESULTS: For 'proton pump inhibitor-start' (n = 196) vs. 'H2-receptor antagonist-start' (n = 194), respectively, heartburn relief occurred in 55.1% vs. 27.3% (P < 0.001) at 4 weeks and in 88.3% vs. 87.1% at 16 weeks. After therapy, 308 patients were heartburn-free (159 vs. 149); median times to relapse were 8 vs. 9 days and cumulative relapse rates were 78.6% vs. 75.8%, respectively. CONCLUSIONS: An empiric 'proton pump inhibitor-start' strategy relieves heartburn more effectively than an 'H2-receptor antagonist-start' strategy up to 12 weeks but has no effect on subsequent relapse, which is rapid in most patients.

Adolescent↗
PubMed2006

Pregnancy folklore revisited: the case of heartburn and hair.

BACKGROUND: Folklore can originate by detection of actual associations between seemingly unrelated events and perpetuated through oral tradition. The objective of this study was to determine whether a common pregnancy belief that women who experience a lot of heartburn give birth to newborns with a lot of hair is accurate. METHODS: Sixty-four pregnant women ranked the severity of their degree of heartburn during pregnancy. Independent coders rated newborn hair volume using 2 photographs of the infant's head, taken shortly after birth. RESULTS: Most (78%) women reported some degree of heartburn. Symptom severity was unrelated to fetal sex and maternal characteristics including parity, age, or weight. The simple linear relationship between heartburn severity and hair volume was significant r(s)(62) = 0.40, p < 0.001. Categorical analysis by severity score and hair ranking revealed a similar association (chi(2)= 23.93, p < 0.05). Most (23/28) women who reported moderate or severe heartburn gave birth to babies with average or above average amounts of hair, and conversely, most (10/12) women reporting no heartburn had babies with less than average or no hair. CONCLUSIONS: Contrary to expectations, it appears that an association between heartburn severity during pregnancy and newborn hair does exist. We propose a shared biologic mechanism involving a dual role of pregnancy hormones in both the relaxation of the lower esophageal sphincter and the modulation of fetal hair growth.

Adult↗
PubMed1999

High- versus standard-dose ranitidine for control of heartburn in poorly responsive acid reflux disease: a prospective, controlled trial.

OBJECTIVE: H2-receptor antagonists are commonly used as initial therapy in patients with gastroesophageal reflux disease (GERD) and are frequently continued at the same or higher doses when symptoms persist after 4-6 wk of therapy. Our objective was to compare the efficacy of twice-daily treatment with either ranitidine 150 mg b.i.d. or 300 mg b.i.d. in resolving heartburn in GERD patients who remained symptomatic after 6 wk of therapy with ranitidine 150 mg b.i.d. METHODS: This was a two-phase, prospective study. In the first phase, GERD patients with heartburn on > or = 4 of the 7 days before entry were treated with open-label ranitidine 150 mg b.i.d. for 6 wk. In the second phase, patients who were still symptomatic were randomized to 8 wk of double-blind ranitidine therapy at either the same (150 mg b.i.d.) or a higher dose (300 mg b.i.d.). The primary efficacy variable was the resolution of heartburn at wk 4 and 8, as monitored through diary cards. RESULTS: Of the 481 patients treated for 6 wk in phase I, 285 (59%) were still symptomatic; 271 patients (95% of those still symptomatic) were randomized to double-blind treatment with ranitidine. In phase II, 45% of the patients in each treatment group experienced no more than mild heartburn; complete heartburn resolution was observed in <20% of patients in either group at wk 4 and 8. There were no significant differences in efficacy between the two treatment groups. CONCLUSIONS: These results indicate that the majority of GERD patients still have symptoms of heartburn after 6 wk of ranitidine therapy. Only a minority of these patients experience complete relief of heartburn after an additional 8 wk of treatment, which demonstrates that doubling the dose of ranitidine is not efficacious.

Adult↗
PubMed1999

Esophageal hypersensitivity may be a major cause of heartburn.

OBJECTIVE: Little is known about esophageal nociceptive thresholds in chronic heartburn sufferers with normal clinical findings. The aim of this study was to evaluate and to characterize the pathogenesis of heartburn in subjects who chronically use antacids and had not sought medical attention. METHODS: Subjects (N = 152) with chronic heartburn of > or = 3 months duration underwent endoscopic grading of the esophagus, esophageal manometry, Bernstein testing, intraesophageal balloon distention (IEBD), and 24-h esophageal pH monitoring. RESULTS: Normal acid contact time (ACT < or = 6%) was observed in 43% of these subjects with recurrent heartburn. Of subjects with normal ACT, 64% had normal LES pressure (> or = 10 mm Hg), 79% had normal esophageal endoscopy, 89% developed heartburn during Bernstein acid infusion, and 52% perceived IEBD as painful. CONCLUSIONS: Approximately 30% of individuals chronically using antacids for heartburn had esophageal sensitivity to mechanical or chemical stimuli despite negative endoscopy and pH monitoring. Our findings suggest that a significant subset of typical heartburn sufferers have a lower threshold for esophageal sensation and pain, which may influence options for pharmacological intervention in such subjects.

Adult↗
PubMed2004

Randomised controlled trial of effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux: Bristol helicobacter project.

OBJECTIVES: To investigate the effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux. DESIGN: Cross sectional study, followed by a randomised placebo controlled trial. SETTING: Seven general practices in Bristol, England. PARTICIPANTS: 10,537 people, aged 20-59 years, with and without H pylori infection (determined by the (13)C-urea breath test). MAIN OUTCOME MEASURES: Prevalence of heartburn and gastro-oesophageal acid reflux at baseline and two years after treatment to eradicate H pylori infection. RESULTS: At baseline, H pylori infection was associated with increased prevalence of heartburn (odds ratio 1.14, 95% confidence interval 1.05 to 1.23) but not reflux (1.05, 0.97 to 1.14). In participants with H pylori infection, active treatment had no effect on the overall prevalence of heartburn (0.99, 0.88 to 1.12) or reflux (1.04, 0.91 to 1.19) and did not improve pre-existing symptoms of heartburn or reflux. CONCLUSIONS: H pylori infection is associated with a slightly increased prevalence of heartburn but not reflux. Treatment to eradicate H pylori has no net benefit in patients with heartburn or gastro-oesophageal reflux.

Adult↗
PubMed1999

An evaluation of increasing doses of ranitidine for treatment of heartburn.

BACKGROUND: This was a randomized, double-blind, placebo-controlled, multicentre, parallel group, dose-ranging trial of ranitidine tablets for relief of episodic heartburn. Adult out-patients who reported heartburn relieved by antacids at least seven times per week were eligible. METHODS: Patients who successfully completed a 1-week single-blind placebo run-in phase and who did not achieve adequate relief in more than 50% of heartburn episodes were randomized to a 1-week, double-blind treatment phase during which they received ranitidine doses of 25, 75 or 125 mg, or placebo. RESULTS: Of 577 patients randomized, 566 had at least one evaluable heartburn episode and were included in the intention-to-treat analysis. All three ranitidine doses were statistically significantly superior to placebo in providing overall episodic heartburn relief for the first episode (P < 0.002), last episode (P</=0.004), and all episodes combined (P < 0.001). The ranitidine 75 mg and 125 mg doses provided sustained relief (relief within 60 min of dosing that lasted throughout the 4-h evaluation period) to a greater proportion of patients for each individual episode (43-56% for 75 mg and 42-57% for 125 mg) than the ranitidine 25 mg dose (35-50%) or placebo (21-29%). The incidence of adverse events was similar in all treatment groups. CONCLUSIONS: All three ranitidine doses (125, 75 and 25 mg) are safe and superior to placebo in providing adequate relief for heartburn. Ranitidine's onset of relief was progressive and clearly present by 30 min as shown by statistically significant differences for the 75 mg dose when compared to placebo. Similarly, patients treated with ranitidine 75 mg and 125 mg consumed statistically fewer rescue antacids than placebo-treated patients for the first episode. All three doses were well tolerated, with adverse event profiles similar to those of placebo.

Adult↗