Persistence and adherence to proton pump inhibitors in daily clinical practice

BACKGROUND: Proton pump inhibitors are widely used, but little is known about the usage pattern in different indications. AIM: To analyse proton pump inhibitor usage patterns in the general population. METHODS: A cohort of 16 311 incident proton pump inhibitor users was identified in the Integrated Primary Care Information database, a Dutch general practice research database. Persistence and adherence were calculated by indication. Risk factors were identified by logistic regression analysis. RESULTS: One-year persistence was 31% in patients using proton pump inhibitors for gastro-oesophageal reflux. Persistence was higher in oesophagitis grade A/B (54%), grade C/D (73%) and Barrett's oesophagus (72%), compared to patients with only reflux symptoms (27%). Approximately 25% of patients with non-reflux dyspepsia or Helicobacter pylori-associated indications used proton pump inhibitors for more than 6 months. Half of all patients used proton pump inhibitors <80% of time indicating intermittent use, which was independent of indication. Exception were patients with Barrett's oesophagus, who were most adherent. CONCLUSIONS: A substantial proportion of patients with indications not requiring long-term treatment use proton pump inhibitors for an extended period. Half of the patients used proton pump inhibitors on-demand or intermittently. Such usage pattern is probably sufficient for most patients, but may be inadequate if proton pump inhibitors are used for serious diseases, such as severe oesophagitis or Barrett's oesophagus.     

Symptoms in patients on long-term proton pump inhibitors: prevalence and predictors

Background  Symptom control in primary care patients on long-term proton pump inhibitor (PPI) treatment is poorly understood.
Aim  To explore associations between symptom control and demographics, lifestyle, PPI use, diagnosis and Helicobacter pylori status.
Methods  A cross-sectional survey ( n  = 726) using note reviews, questionnaires and carbon-13 urea breath testing. Determinants of symptom control [Leeds Dyspepsia Questionnaire (LDQ), Carlsson and Dent Reflux Questionnaire (CDRQ), health-related quality-of-life measures (EuroQoL: EQ-5D and EQ-VAS)] were explored using stepwise linear regression.
Results  Moderate or severe dyspepsia symptoms occurred in 61% of subjects (LDQ) and reflux symptoms in 59% (CDRQ). Age, gender, smoking and body mass index had little or no influence upon symptom control or PPI use. Average symptom scores and PPI use were lower in patients with non-ulcer dyspepsia and gastro-protection than gastro-oesophageal reflux disease (GERD) and uninvestigated dyspepsia. H. pylori infection was associated with lower reflux symptom scores only in patients with GERD and uninvestigated dyspepsia. EQ-5D was not able to discriminate between diagnostic groups, although the EQ-VAS performed well.
Conclusions  A majority of patients suffered ongoing moderate or severe symptoms. GERD and uninvestigated dyspepsia were associated with poorer long-term symptom control; H. pylori appeared to have a protective effect on reflux symptoms in these patients.     

A validated symptoms questionnaire (Chinese GERDQ) for the diagnosis of gastro-oesophageal reflux disease in the Chinese population

BACKGROUND AND AIMS: To develop a validated gastro-oesophageal disease (GERD) symptom questionnaire for the Chinese population. METHODS: One hundred Chinese patients with GERD and 101 healthy Chinese controls were presented with a 20-item GERD questionnaire in the Chinese language (Chinese GERDQ). Quality of life in GERD patients was assessed by SF-36. A standard dose of proton pump inhibitors for 4 weeks was prescribed to 35 patients with newly diagnosed GERD. The Chinese GERDQ was performed before, 4 weeks and 8 weeks after treatment. Concept, content, construct, discriminant validity and reliability of the questionnaire were assessed. RESULTS: Seven items were selected by logistic regression to account for most of the differences between controls and GERD patients with a good reproducibility and internal consistency. A cut-off score of equal or greater than 12 was determined to discriminate between controls and GERD patients with a sensitivity of 82% and a specificity of 84%. The Chinese GERDQ correlated negatively with five domains of the SF-36 and discriminated between GERD patients who reported symptomatic improvement during proton pump inhibitor treatment and symptoms deterioration upon withdrawal of proton pump inhibitor treatment. CONCLUSIONS: The Chinese GERDQ could be used in epidemiological studies to assess the frequency and severity of GERD in patient populations and in interventional studies of GERD.     

Eradication of Helicobacter pylori does not decrease the long-term use of acid-suppressive medication

BACKGROUND: Many patients are not symptom-free after eradication therapy for Helicobacter pylori and continue to use proton pump inhibitors or H2-receptor antagonists (H2-RAs). AIM: To ascertain whether a cohort of patients treated for H. pylori were still taking either proton pump inhibitors or H2-RAs more than 4 years after H. pylori eradication therapy. METHODS: In 1993-94, a cohort of 167 patients were given eradication therapy for their H. pylori infection. By means of questionnaires to the patient, general practitioner and pharmacist we were able to retrieve data from 151 patients. The use (at the time of questionnaire) of proton pump inhibitors or H2-RAs was noted. RESULTS: Indications for eradication therapy were peptic ulcer disease: 28 patients (19%) or functional dyspepsia: 123 patients (82%). Mean time of follow-up was 1466 +/- 21 days. In this group, 77 patients (51%) still used acid-suppressive medication (proton pump inhibitors 44% and H2-RAs 7%) at the time of the survey (mean follow-up more than 4 years after eradication). In the group treated for peptic ulcer disease (n=28), only nine patients still used proton pump inhibitors or H2-RAs. In contrast, 68 patients who were treated for functional dyspepsia (total number 123) still used proton pump inhibitors or H2-RAs (55%) (P < 0.05). CONCLUSION: Even after successful H. pylori eradication, < 50% of patients stop acid-suppressive therapy. This contributes significantly to economic cost and raises doubts about the practice of routinely eradicating H. pylori in patients with functional dyspepsia. In contrast, the majority of peptic ulcer patients are able to stop acid-suppressive medication.     

Long-term use of proton pump inhibitors and vitamin B12 status in elderly individuals

Background  Some studies have shown that short-term use of proton pump inhibitors decreases the absorption of vitamin B12, but the results of studies into long-term proton pump inhibitor use and vitamin B12 deficiency are inconsistent.
Aim  To investigate whether long-term proton pump inhibitor use is associated with an abnormal vitamin B12 status in elderly individuals.
Methods  One hundred and twenty-five long-term (>3, years) proton pump inhibitor users aged 65, years and above were recruited from general practices. Their 125 partners (who did not use proton pump inhibitors) served as the reference group. Vitamin B12 status was determined by serum levels of vitamin B12 and homocysteine, and mean corpuscular volume.
Results  No differences in mean vitamin B12 levels were observed between the long-term proton pump inhibitor users and their partners [345 (s.d. 126), p m vs. 339 (s.d. 133), p m , P, = , 0.73], even after adjustment for age, gender, Helicobacter pylori status and C-reactive protein levels ( P, = , 0.87). Four proton pump inhibitor users and three partners had vitamin B12 levels <150, p m (3% vs. 2%, P, = , 1.00). No differences between the groups were observed in homocysteine levels and mean corpuscular volume.
Conclusions  No association between long-term proton pump inhibitor use and vitamin B12 status was observed. Regular testing for low vitamin B12 levels in elderly patients on long-term treatment with proton pump inhibitors is therefore not recommended.     

Is it possible to predict treatment response to a proton pump inhibitor in functional dyspepsia?

BACKGROUND: The efficacy of proton pump inhibitors in functional dyspepsia is modest and the prognostic factors are almost unknown. METHODS: Data were pooled on patients (n = 826) with a diagnosis of functional dyspepsia from two placebo-controlled trials who were treated with omeprazole, 10 or 20 mg once daily, for 4 weeks. Self-administered questionnaires for the assessment of symptoms and health-related quality of life were completed before entry, and epigastric pain/discomfort was recorded on diary cards. Treatment success was defined as the complete absence of epigastric pain/discomfort on each of the last 3 days of week 4. Prognostic factors were identified by multiple logistic regression analysis. RESULTS: The most discriminating predictor of treatment success (P < 0.0001) was the number of days with epigastric pain/discomfort during the first week of treatment. Fewer days with symptoms during the first week led to higher response rates at 4 weeks. In addition, age > 40 years, bothersome heartburn, low scores for bloating, epigastric pain and diarrhoea, history of symptoms for < 3 months and low impairment of vitality at baseline were identified as positive predictors of outcome. CONCLUSIONS: Early response to treatment with a proton pump inhibitor, during the first week, seems to predict the outcome after 4 weeks in patients with functional dyspepsia.     

Controlled trial of interventions to increase testing and treatment for Helicobacter pylori and reduce medication use in patients with chronic acid-related symptoms

BACKGROUND: Many symptomatic patients take proton pump inhibitors or histamine-2 blockers for years and those without gastro-oesophageal reflux disease might benefit from Helicobacter pylori eradication. AIM: To increase testing and treatment of H. pylori and reduce chronic use of proton pump inhibitors and histamine-2 blockers. METHODS: We conducted a three-armed controlled trial in 14 managed care practices. We included adults who used proton pump inhibitors or histamine-2 blockers for >1 year and excluded those with gastro-oesophageal reflux disease or previous endoscopy. We compared usual care (n = 312 patients from 6 practices) to low-intensity (n = 147 from 3 practices) and high-intensity (n = 122 from 5 practices) interventions. Low-intensity intervention consisted of guidelines, patient-lists, and a "toolkit"; high-intensity intervention added academic group detailing by a gastroenterologist with reinforcement by pharmacists. RESULTS: Compared with usual care, the high-intensity intervention increased H. pylori test-ordering (29% versus 9% at 12 months, P = 0.02). About half (23 of 58) of patients tested positive and 22 received eradication treatments. The high-intensity intervention decreased proton pump inhibitor use by 9% per year (P = 0.028), but did not alter histamine-2 blocker use. The low intensity intervention was ineffective. CONCLUSIONS: Providing guidelines, patient-lists, and toolkits was no better than usual care. Adding group detailing and pharmacist reinforcements led to improvements in H. pylori management and decreases in proton pump inhibitor use.     

Onset of symptom relief with rabeprazole: a community-based, open-label assessment of patients with erosive oesophagitis

BACKGROUND: In numerous clinical trials, proton pump inhibitors have demonstrated potent acid suppression and healing of erosive oesophagitis, as well as successful symptom relief for the entire spectrum of gastro-oesophageal reflux disease. AIM: The 'Future of Acid Suppression Therapy' (FAST) trial evaluated, in actual clinical practice, the timing of symptom relief, changes in symptom severity, health-related quality of life and safety in endoscopically confirmed erosive gastro-oesophageal reflux disease treated with rabeprazole. METHODS: This open-label, multicentre study enrolled 2579 patients to receive rabeprazole treatment using 20 mg once daily for 8 weeks. Between two clinical visits (at enrollment and week 8), patients used an interactive voice response system to rate gastro-oesophageal reflux disease symptoms. Subgroup analyses of efficacy were conducted for gender, age, Hetzel-Dent grade, presence of Barrett's oesophagus and for patients reporting previously ineffective symptom relief with omeprazole or lansoprazole. RESULTS: On day 1, rabeprazole significantly decreased daytime and night-time heartburn severity, regurgitation and belching. Complete relief of daytime and night-time heartburn was achieved in 64.0% and 69.2% of symptomatic patients, respectively, on day 1, and in 81.1% and 85.7% of patients, respectively, on day 7. Patients with moderate or severe heartburn symptoms at baseline achieved an even greater degree of satisfactory symptom relief (none or mild) from day 1 onwards. The median time to satisfactory heartburn relief was 2 days. Subgroup analyses showed no consistent differences in efficacy compared to the overall population treated. Health-related quality of life in patients was significantly lower than that of the US general population and improved significantly after 8 weeks of rabeprazole therapy. Rabeprazole was well tolerated, with headache as the most common adverse event, reported by less than 2% of the study population. CONCLUSIONS: In this large, open-label trial, rabeprazole rapidly and effectively relieved gastro-oesophageal reflux disease symptoms in most patients with erosive oesophagitis. Substantial symptom relief was noted on day 1; improvement continued over the first week and at week 4. By week 8, the health-related quality of life had also improved vs. baseline.     

Clinical trial: acupuncture vs. doubling the proton pump inhibitor dose in refractory heartburn

BACKGROUND: The current standard of care in proton pump inhibitor failure is to double the proton pump inhibitor dose, despite limited therapeutic gain. Aims To determine the efficacy of adding acupuncture vs. doubling the proton pump inhibitor dose in gastro-oesophageal reflux disease patients who failed symptomatically on proton pump inhibitors once daily. METHODS: Thirty patients with classic heartburn symptoms who continued to be symptomatic on standard-dose proton pump inhibitors were enrolled into the study. All participants underwent upper endoscopy while on proton pump inhibitors once daily. Subsequently, patients were randomized to either adding acupuncture to their proton pump inhibitor or doubling the proton pump inhibitor dose over a period of 4 weeks. Acupuncture was delivered twice a week by an expert. RESULTS: The two groups did not differ in demographic parameters. The acupuncture + proton pump inhibitor group demonstrated a significant decrease in the mean daytime heartburn, night-time heartburn and acid regurgitation scores at the end of treatment when compared with baseline, while the double-dose proton pump inhibitor group did not demonstrate a significant change in their clinical endpoints. Mean general health score was only significantly improved in the acupuncture + proton pump inhibitor group. CONCLUSION: Adding acupuncture is more effective than doubling the proton pump inhibitor dose in controlling gastro-oesophageal reflux disease-related symptoms in patients who failed standard-dose proton pump inhibitors.     

Reappraisal of non-invasive management strategies for uninvestigated dyspepsia: a cost-minimization analysis

BACKGROUND: The benefits of the Helicobacter pylori test-and-treat strategy are attributable largely to the cure of peptic ulcer disease while limiting the use of endoscopy. AIM: To reappraise the test-and-treat strategy and empirical proton pump inhibitor therapy for the management of uninvestigated dyspepsia in the light of the decreasing prevalence of H. pylori infection, peptic ulcer disease and peptic ulcer disease attributable to H. pylori. METHODS: Using a decision analytical model, we estimated the cost per patient with uninvestigated dyspepsia managed with the test-and-treat strategy ($25/test; H.pylori treatment, $200) or proton pump inhibitor ($90/month). Endoscopy ($550) guided therapy for persistent or recurrent symptoms. RESULTS: In the base case (25%H. pylori prevalence, 20% likelihood of peptic ulcer disease, 75% of ulcers due to H.pylori), the cost per patient is $545 with the test-and-treat strategy and $529 with proton pump inhibitor, and both strategies yield similar clinical outcomes at 1 year. H. pylori prevalence, the likelihood of peptic ulcer disease and the proportion of ulcers due to H.pylori are important determinants of the least costly strategy. At an H. pylori prevalence below 20%, proton pump inhibitor is consistently less costly than the test-and-treat strategy. CONCLUSIONS: As the H. pylori prevalence, the likelihood of peptic ulcer disease and the proportion of ulcers due to H. pylori decrease, empirical proton pump inhibitor becomes less costly than the test-and-treat strategy for the management of uninvestigated dyspepsia. Given the modest cost differential between the strategies, the test-and-treat strategy may be favoured if patients without peptic ulcer disease derive long-term benefit from H.pylori eradication.     

Consequences of long-term proton pump blockade: insights from studies of patients with gastrinomas

Proton pump inhibitors are being increasingly used and for longer periods of time, especially in patients with gastroesophageal reflux disease. Each of these trends has led to numerous studies and reviews of the potential risk-benefit ratio of the long-term use of proton pump inhibitors. Both long-term effects of hypergastrinaemia due to the profound acid suppression caused by proton pump inhibitors as well as the effects of hypo-/achlorhydria per se have been raised and studied. Potential areas of concern that have been raised in the long-term use of proton pump inhibitors, which could alter this risk-benefit ratio include: gastric carcinoid formation; the development of rebound acid hypersecretion when proton pump inhibitor treatment is stopped; the development of tolerance; increased oxyntic gastritis in H. pylori patients and the possibility of increasing the risk of gastric cancer; the possible stimulation of growth of non-gastric tumours due to hypergastrinaemia; and the possible effect of the hypo/achlorhydria on nutrient absorption, particularly iron and vitamin B12. Because few patients with idiopathic gastro-oesophageal reflux disease/peptic ulcer disease have been treated long-term (i.e., >10 years), there is little known to address the above areas of potential concern. Most patients with gastrinomas with Zollinger-Ellison syndrome have life-long hypergastrinaemia, require continuous proton pump inhibitors treatment and a number of studies report results of >5-10 years of tratment and follow-up. Therefore, an analysis of Zollinger-Ellison syndrome patients can provide important insights into some of the safety concerns raised above. In this paper, results from studies of Zollinger-Ellison syndrome patients and other recent studies dealing with the safety concerns above, are briefly reviewed.     

The clinical and economic impact of competing management strategies for gastro-oesophageal reflux disease

BACKGROUND: Gastro-oesophageal reflux disease (GERD) is a common disorder in the primary care setting. Traditional management strategies consist of sequentially intensive therapeutic trials followed by invasive diagnostic testing for nonresponders. A high dose proton pump inhibitor trial (the "proton pump inhibitor test") has been shown to be an accurate diagnostic alternative, and may be an efficient initial approach to patients with GERD symptoms. AIM: To examine the clinical, economic and policy implications of alternative management strategies for GERD. METHODS: Decision analysis was used to calculate the clinical and economic outcomes of competing management strategies. The traditional strategy incorporates sequential therapeutic trials with more intensive therapy ("step-up" approach) followed by sequential invasive diagnostic testing of nonresponders. The "proton pump inhibitor test" strategy includes an initial "proton pump inhibitor test" (7 days of omeprazole; 40 mg AM + 20 mg PM daily) followed by less intensive therapeutic trials in those testing positive ("step-down" approach) with sequential invasive diagnostic testing as needed. Cost estimates were based on Medicare reimbursement and average wholesale drug prices. Probability estimates were derived from a systematic review of the published medical literature. Model results are reported as the average and incremental cost-per-symptom free patient and cost-per-quality-adjusted life-years (QALYs) gained. RESULTS: The average cost per patient was 1045 US dollars for the traditional step-up management strategy, compared to 1172 US dollars for the "proton pump inhibitor test" and step-down strategy. The percentage of patients who were symptom-free at 1 year was 50% for the traditional management strategy compared to 75% for the "proton pump inhibitor test" strategy. The "proton pump inhibitor test" strategy results in QALY gains of 0.01-0.05 depending on the utility estimate employed. The incremental cost-effectiveness ratio for the "proton pump inhibitor test" strategy is 510 US dollars per additional symptomatic cure over 1 year, and between 2822-10,160 US dollars per QALY gained. The traditional management strategy resulted in a greater than 5-fold increase in the utilization of upper endoscopy, which was partially offset by a 47% reduction in the use of ambulatory 24-h oesophageal pH monitoring. The reduced effectiveness of the traditional management strategy may be attributed in part to a 118% increase in the use of "high-dose" H2RAs while reducing the use of standard dose proton pump inhibitors by only 42% and "high-dose" proton pump inhibitors by 57%. CONCLUSIONS: Based on the results of this analysis, strategies utilizing the initial PPI test followed by a "step-down" approach may result in improved symptom relief and quality of life over 1 year, and more appropriate utilization of invasive diagnostic testing at a small marginal increase in total costs. These findings warrant a prospective trial comparing these competing management strategies.     

Review article: potential gastrointestinal effects of long-term acid suppression with proton pump inhibitors

This review examines the evidence for the development of adverse effects due to prolonged gastric acid suppression with proton pump inhibitors. Potential areas of concern regarding long-term proton pump inhibitor use have included: carcinoid formation; development of gastric adenocarcinoma (especially in patients with Helicobacter pylori infection); bacterial overgrowth; enteric infections; and malabsorption of fat, minerals, and vitamins. Prolonged proton pump inhibitor use may lead to enterochromaffin-like cell hyperplasia, but has not been demonstrated to increase the risk of carcinoid formation. Long-term proton pump inhibitor treatment has not been documented to hasten the development or the progression of atrophic gastritis to intestinal metaplasia and gastric cancer, although long-term studies are required to allow definitive conclusions. At present, we do not recommend that patients be tested routinely for H. pylori infection when using proton pump inhibitors for prolonged periods. Gastric bacterial overgrowth does increase with acid suppression, but important clinical sequelae, such a higher rate of gastric adenocarcinoma, have not been seen. The risk of enteric infection may increase with acid suppression, although this does not seem to be a common clinical problem with prolonged proton pump inhibitor use. The absorption of fats and minerals does not appear to be significantly impaired with chronic acid suppression. However, vitamin B12 concentration may be decreased when gastric acid is markedly suppressed for prolonged periods (e.g. Zolllinger-Ellison syndrome), and vitamin B12 levels should probably be assessed in patients taking high-dose proton pump inhibitors for many years. Thus, current evidence suggests that prolonged gastric acid suppression with proton pump inhibitors rarely, if ever, produces adverse events. Nevertheless, continued follow-up of patients taking proton pump inhibitors for extended periods will provide greater experience regarding the potential gastrointestinal adverse effects of long-term acid suppression.     

Increased risk of fundic gland polyps during long-term proton pump inhibitor therapy

BACKGROUND: It is controversial whether proton pump inhibitor use leads to fundic gland polyp development. AIM: To determine whether fundic gland polyp development is due to proton pump inhibitor use and to investigate mechanisms involved. METHODS: Proton pump inhibitor use and the presence of fundic gland polyps were assessed in consecutive patients undergoing oesophagogastroduodenoscopy. Biopsies from fundic gland polyps and gastric mucosa were taken. Dysplasia was graded as negative, low or high grade. Prevalence of parietal cell hyperplasia and parietal cell protrusions and the proportional cystic area were assessed. RESULTS: 599 patients participated, 322 used proton pump inhibitors, 107 had fundic gland polyps. Long-term proton pump inhibitor use was associated with an increased risk of fundic gland polyps (1-4.9 years use: OR 2.2, 95% CI: 1.3-3.8; > or =5 years: OR 3.8, 95% CI: 2.2-6.7) while short-term therapy (<1 year) was not (OR 1.0, 95% CI: 0.5-1.8). Low-grade dysplasia was found in one fundic gland polyp. Fundic gland polyps associated with long-term proton pump inhibitor use had a larger proportional cystic area and higher frequency of parietal cell hyperplasia and parietal cell protrusion. CONCLUSIONS: Long-term proton pump inhibitor use is associated with an up to fourfold increase in the risk of fundic gland polyps. Risk of dysplasia is negligible. Aetiologically, these polyps seem to arise because of parietal cell hyperplasia and parietal cell protrusions resulting from acid suppression.     

帕罗西汀对功能性消化不良患者生活质量的影响

目的：探讨帕罗西汀对功能性消化不良（FD）患者的疗效及生活质量的影响。方法采用自身对照研究,选择符合罗马Ⅲ标准的36例FD患者,给予帕罗西汀治疗,疗程8周。FD患者的临床疗效和生活质量采用症状严重程度指数、症状频率指数、汉化版简明健康调查量表（SF-36）进行评分。结果36例均完成治疗,在治疗终点,患者的临床症状均有明显改善（P ＜0.01）;症状的严重程度指数（9.80±1.5 vs 5.48±0.84）和频率指数（9.60±1.6 vs 5.0±0.76）均有显著降低;在治疗的第4周和第8周,FD患者在生理功能、生理职能、躯体疼痛、活力、情感职能、精神健康、社会功能和总体健康8个维度,均较治疗前改善,差异有显著性,且在治疗的第8周,改善最为明显（P＜0.01）。结论帕罗西汀可以缓解FD患者临床症状,提高其生活质量。     

Clinical trial: short- and long-term benefit of relaxation training for irritable bowel syndrome

BACKGROUND: Psychotherapy is effective in treating irritable bowel syndrome, but the effect of relaxation training, a brief psychological group intervention, is not known. AIM: To determine the efficacy of relaxation training in a large cohort of irritable bowel syndrome patients. METHODS: Ninety-eight irritable bowel syndrome patients were included in this randomized controlled trial. Forty-six patients received standard medical care (CON) and 52 received four 90-min sessions of relaxation training in small groups in addition to standard medical care. Irritable bowel syndrome symptom severity, medical consumption and quality of life were assessed at baseline in patients and in 38 healthy controls and evaluated in patients at 3, 6 and 12 months after intervention. RESULTS: Irritable bowel syndrome symptom severity was significantly reduced in the relaxation training group compared to CON at 3, 6 and 12 months after treatment (time-by-treatment interaction, P = 0.002). The number needed to treat for long-term improvement was 5. Quality of life had improved (general health, P = 0.017; health change, P = 0.05). Frequency of doctor visits was reduced (P = 0.039). CONCLUSIONS: Relaxation training is a brief group intervention that significantly improves symptom severity, general health perception and medical consumption in irritable bowel syndrome patients immediately after, as well as 6 and 12 months after intervention.     

Clinical trial: evaluation of a clinical decision-support model for upper abdominal complaints in primary-care practice

Background: Gastro-oesophageal reflux disease (GERD) and dyspepsia affect 25-40% of the general population. In the absence of alarm symptoms, the current recommended policy in young dyspeptic patients is a 'test and treat' strategy for Helicobacter pylori; in GERD patients, a therapeutic trial with proton pump inhibitors is the treatment of choice. AIM: To create a short and simple clinical algorithm, for the diagnosis and treatment of patients with upper gastrointestinal complaints. METHODS: The clinical usefulness and cost-effectiveness of the new algorithm were evaluated in a controlled clinical trial, held in primary-care clinics in Israel. Clinical and economical treatment outcomes were evaluated after 1, 3 and 6 months comparing doctors who used the algorithm (cases) vs. those who did not (controls). RESULTS: 78 cases and 54 controls completed the 6 months of follow up. The improvement in symptom severity and quality of life was greater in the cases than in the controls (P < 0.05). General practitioner clinics visits (P = 0.04), gastroenterology clinics visits (P = 0.02) and medication costs (P = 0.004) were all significantly reduced among cases. Controls underwent also more imaging tests (computerized tomography, ultrasound and X-ray) and endoscopies. The average cost for 6 months' treatment and follow-up was $US 199 for cases compared with an average of $US 336 in the control group. CONCLUSION: The use of a clinical decision-support tool can facilitate and promote the implementation of management guidelines by general practitioners. The short algorithm presented in the study was found to be useful and easy to apply in clinical practice. Its effectiveness can be further increased by implementing it in computerized medical systems.     

The effect of over-the-counter ranitidine 75 mg on night-time heartburn in patients with erosive oesophagitis on daily proton pump inhibitor maintenance therapy

BACKGROUND: H2-receptor antagonists are widely used with proton pump inhibitors. AIM: To determine if H2-receptor antagonists used in conjunction with proton pump inhibitors were effective for nocturnal heartburn in patients taking proton pump inhibitors. METHODS: We evaluated 386 patients with erosive oesophagitis documented at endoscopy who were receiving single daily maintenance proton pump inhibitor therapy to determine if they had symptoms of nocturnal heartburn. Patients with two or more episodes of night-time a week were invited to participate in the study. Patients were randomly assigned to a single dose of an over-the-counter preparation of ranitidine 75 mg at bedtime or matching placebo for 14 days. RESULTS: The prevalence of nocturnal symptoms was 10.6%. Mean symptom scores on the first day of the trial (baseline) were similar between the treatment group (1.1 +/- 0.9) and the placebo group (1.1 +/- 1.1). On day 3, symptom scores were significantly lower in the ranitidine group (0.71 +/- 0.69) compared with the control group (1.4 +/- 1.2; P = 0.045). On day 14, mean symptom scores were similar in the ranitidine group (0.82 +/- 0.95) and the control group (1 +/- 0.84). CONCLUSIONS: Nocturnal heartburn is uncommon on proton pump inhibitor therapy; the addition of ranitidine at bedtime resulted in a decrease in symptom scores on day 3 but there were no differences on day 14.     

Symptom overlap in patients with upper gastrointestinal complaints in the Canadian confirmatory acid suppression test (CAST) study: further psychometric validation of the reflux disease questionnaire

BACKGROUND: The reflux disease questionnaire (RDQ) is a short, patient-completed instrument. AIMS: To investigate the psychometric characteristics of the RDQ in patients with heartburn-predominant (HB) and non-heartburn predominant (NHB) dyspepsia. METHODS: HB (n = 388) and NHB (n = 733) patients were randomized to esomeprazole 40 mg daily or twice daily for 1 week, followed by 3 weeks of esomeprazole 40 mg daily. RESULTS: High factor loadings (0.78-0.86) supported the 'regurgitation' dimension of the RDQ. Overlapping factor loadings in the 'heartburn' and 'dyspepsia' dimensions suggested symptom overlap. All dimensions demonstrated high internal consistency (Cronbach's alpha: 0.79-0.90). Intra-class correlation coefficients over 4 weeks were good (0.66-0.85). The RDQ showed good responsiveness over 4 weeks of treatment, with high effect sizes (> or =0.80). Moderate or large symptom improvements were reported by 90% and 77% of HB and NHB patients, respectively, following treatment. Patients who responded to acid suppression also experienced symptom benefits in all RDQ dimensions. CONCLUSIONS: The RDQ is reliable, valid and responsive to change in HB and NHB patients. The symptom overlap is important but need not play a major role in determining treatment strategy as both patient groups benefited from proton pump inhibitor treatment.