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Biomedical subjects

Nicholas J Talley

Publications and source records attributed to Nicholas J Talley.

At least 73 records · Page 4Linked to original sources
PubMed2005

Tegaserod for the treatment of chronic constipation: a randomized, double-blind, placebo-controlled multinational study.

OBJECTIVES: Chronic constipation is a common, persistent disorder with limited effective treatment options. This study investigated the efficacy, safety, and tolerability of tegaserod in the treatment of chronic constipation. METHODS: After a 2-wk baseline period, patients were randomized to double-blind treatment of 12 wk with tegaserod (2 or 6 mg b.i.d.) or placebo. Response during weeks 1-4 (primary variable) was defined as an increase in complete spontaneous bowel movement (CSBM)/wk. Secondary variables included response during weeks 1-12, patient evaluation of individual symptoms, and global assessment of bowel habits and constipation. RESULTS: One thousand two hundred and sixty-four patients were randomized to tegaserod or placebo. Responder rates for the primary efficacy variable were 35.6% for tegaserod 2 mg b.i.d. (p= 0.0059 vs placebo), 40.2% for 6 mg b.i.d. (p < 0.0001 vs placebo) and 26.7% for placebo. The number needed to treat was 7.3 for the 6 mg b.i.d. dose compared with 11.1 for tegaserod 2 mg b.i.d. Tegaserod 6 mg b.i.d. reduced straining, abdominal bloating/distension, and abdominal pain/discomfort during the 12-wk treatment period compared with placebo (p < 0.05 for all symptoms). Significant improvements were also seen in stool form and in global assessment of bowel habits and constipation. The most common adverse events, headache and abdominal pain, were more frequent with placebo than with tegaserod. CONCLUSIONS: Tegaserod was efficacious in relieving symptoms of chronic constipation and was well tolerated.

Chronic Disease↗
PubMed2005

Rates of endoscopy and endoscopic findings among people with frequent symptoms of gastroesophageal reflux in the community.

BACKGROUND: Epidemiological studies have confirmed that gastroesophageal symptoms are highly prevalent. However, studies linking epidemiology with clinical or chart data are scarce. We aimed to determine the frequency of endoscopy and endoscopic findings, as well as predictors of health-care utilization, among people with reflux symptoms in the community. METHODS: A previous survey of 2,118 Olmsted County, MN, residents in 1993 identified 242 subjects with frequent reflux symptoms (at least weekly) who received care at a medical center in the county. Data were abstracted from Mayo Clinic records between 1988 and 1998. RESULTS: Overall, 130 of the 242 (54%, 95% CI 47-60%) had sought care for reflux. Twenty-five patients (10%) had visited a gastroenterologist; 47 (19%) had an upper endoscopy (EGD), 64 (26%) had an upper GI X-ray, and one had an ambulatory 24-h esophageal pH study. Long segment Barrett's esophagus was detected in 4 (9%) of those having an EGD and adenocarcinoma was found in one patient with Barrett's. Three patients had surgery for gastroesophageal reflux disease. Thirteen patients (5%) died, but no deaths were due to esophageal reflux or adenocarcinoma. Age, higher education, frequent heartburn, and dysphagia were all significant, independent predictors of consulting. CONCLUSIONS: Although many people in the community have frequent reflux symptoms, few have investigations, and deaths were unrelated to reflux disease or its complications. Data from referral clinic or endoscopy series should not be extrapolated to the large numbers of people in the community with symptoms of reflux.

Adenocarcinoma↗
PubMed2005

Improvements with esomeprazole in patients with upper gastrointestinal symptoms taking non-steroidal antiinflammatory drugs, including selective COX-2 inhibitors.

OBJECTIVES: Upper gastrointestinal (GI) symptoms are common in patients using non-steroidal antiinflammatory drugs (NSAIDs) including selective cyclooxygenase (COX)-2 inhibitors and may be acid related. We therefore assessed esomeprazole treatment for upper GI symptoms in these patients. METHODS: A total of 794 and 848 continuous NSAID users, free of gastroduodenal ulcers, erosive esophagitis, and Helicobacter pylori, were enrolled into two identical, multinational, multicenter double-blind studies (NASA1, SPACE1). Moreover, 608 and 556 patients were randomized to receive 4 wk esomeprazole 20 mg, or 40 mg, or placebo once daily. The primary variable was the patient-reported change in the upper GI symptom (pain, discomfort, or burning in the upper abdomen) score on a 7-graded severity scale (0-6) from the 7 days prior to treatment to the last 7 days in the study. RESULTS: Esomeprazole was associated with highly significant symptom improvement compared to placebo. Symptom improvements were 2.30 mean [SD 1.63] on esomeprazole 20 mg and 2.03 [1.56] on esomeprazole 40 mg versus 1.64 [1.57] on placebo in NASA1 and 2.17 [1.34] and 2.12 [1.48]versus 1.56 [1.26], respectively, in SPACE1 (all placebo comparisons at least p < 0.001). Esomeprazole-improved symptoms in patients taking selective COX-2 inhibitors, with changes of 2.21 [1.46] and 1.92 [1.38]versus 1.64 [1.46] in NASA1 and 2.20 [1.26] and 2.24 [1.62]versus 1.58 [1.37] in SPACE1 (all placebo comparisons at least p < 0.05), as well as those on non-selective NSAIDs. Esomeprazole was well tolerated and associated with significant improvements in HRQL. CONCLUSION: Esomeprazole 20 mg and 40 mg improve upper GI symptoms associated with continuous, daily NSAID therapy, including selective COX-2 inhibitors.

Aged↗
PubMed2005

Diagnostic and therapeutic use of proton pump inhibitors in non-cardiac chest pain: a metaanalysis.

OBJECTIVES: To assess (i) the efficacy of short-term proton pump inhibitors (PPIs) in non-cardiac chest pain (NCCP) and (ii) the performance of an empirical short-term treatment with PPI (PPI test) to establish a diagnosis of abnormal acid reflux in NCCP. METHODS: Metaanalysis of English language studies identified by searching MEDLINE (1966-May 2004), EMBASE (1980-May 2004), Cochrane Controlled Trials Register, and abstract books from major gastroenterology meetings (1993-2004). For the metaanalysis of PPI efficacy in NCCP, we selected randomized controlled trials (parallel group and crossover designs) comparing PPI therapy with placebo. For the metaanalysis of PPI test performance, we selected uncontrolled studies comparing the test with a standard reference. RESULTS: Eight studies were included in the PPI efficacy analysis. The pooled risk ratio for continued chest pain after PPI therapy was 0.54 (95% CI 0.41-0.71). The overall number needed to treat was 3 (95% CI 2-4). The pooled sensitivity, specificity, and diagnostic odds ratio for the PPI test versus 24-h pH monitoring and endoscopy were 80%, 74%, and 13.83 (95% CI 5.48-34.91), respectively. All studies were small and there was evidence of publication bias or other small study effects. CONCLUSION: PPI therapy reduces symptoms in NCCP and may be useful as a diagnostic test in identifying abnormal esophageal acid reflux.

Anti-Ulcer Agents↗
PubMed2005

The natural history of childhood abdominal pain and its association with adult irritable bowel syndrome: birth-cohort study.

INTRODUCTION: The natural history of childhood abdominal pain (CAP) and its association with adult irritable bowel syndrome (IBS) remain poorly described. We aim to investigate the characteristics of CAP over the first 11 yr of life and evaluate the association of CAP to IBS at age 26 yr. METHOD: The data were collected from a 1972 birth cohort (Dunedin, NZ) who were re-assessed at ages 3, 5, 7, 9, 11, 13, 15, 18, 21, and 26 yr. IBS was classified according to Manning Criteria, as assessed using symptom data collected at age 26 yr. A history of CAP was established by scrutinizing data for all assessments completed from birth to age 11 yr. Three measures were described: medical service encounters for CAP, parental (mainly maternal) report of stomach pain (frequency over the past year), and a composite measure which included both medical encounters and parent report: three childhood time frames were evaluated-ages 0-7, 7-9, and 9-11 yr. RESULTS: A history of CAP was reported by 18.1% of children. This was typically characterized by CAP on one assessment; complaints over two or more assessment were rare. CAP was slightly more common in females and appeared to peak at age 7-9 yr. IBS at age 26 yr was significantly more common among individuals with a history of CAP between ages 7 and 9 yr compared to those with no such history, as assessed by any history (OR = 1.85; p= 0.02), parental report (OR = 1.82; p= 0.03), and medical service encounters (OR = 3.75; p= 0.03). The association between CAP at age 7-9 yr and adult IBS was not altered by adjustment for sex, socio-economic status, psychiatric disorder at age 26 yr, childhood emotional distress, or mother's score on the Malaise Inventory. CONCLUSIONS: CAP is a common complaint, which can progress to adult IBS in some children.

Abdominal Pain↗
PubMed2005

Gambling with gastroesophageal reflux disease: should we worry about the QALY?

Gastroenterologists mainly deal with chronic organic and functional illnesses that are not life threatening but can be expensive to treat. How this compares with the management of other diseases that cause significant mortality is an important question to answer if health-care resources are to be allocated appropriately. Comparing health care in terms of cost per quality adjusted life year (QALY) gained is one approach to this problem although there are concerns about whose values should be elicited and how QALYs are measured.

Gastroesophageal Reflux↗
PubMed2005

The epidemiology of childhood recurrent abdominal pain in Western countries: a systematic review.

OBJECTIVE: Recurrent abdominal pain (RAP) of childhood is a common problem encountered by clinicians. The aim of this study was to systematically review published literature about the prevalence, incidence, natural history, and co-morbid conditions of childhood RAP in western countries. METHODS: A computer-assisted search of MEDLINE, EMBASE, and Current Contents/Science Edition databases was performed. Study selection criteria included: (1) United States and European population and school-based samples of children; (2) diagnostic criteria of RAP; and (3) published in full manuscript form in English. Data were extracted, tabulated, and presented in descriptive form. RESULT: The prevalence of RAP ranged from 0.3 to 19% (median 8.4; IQR 2.3-14.7). Published studies in children demonstrate a higher prevalence of RAP in females, with the highest prevalence of symptoms between 4 and 6 yr and early adolescence. Identified studies demonstrated associations between RAP and the child's familial and socioeconomic environment. In addition, childhood RAP was reported to be associated with psychological co-morbidity in childhood and adulthood. Population/school-based studies have not, however, established the incidence of this disorder, what features predict long-standing symptoms, or whether RAP is a risk factor for adult functional bowel disorders. CONCLUSION: RAP is a common complaint of childhood with associated familial, psychological, and co-morbid conditions. Epidemiologic studies of RAP in children may offer information on the evolution of functional bowel disorders through the lifespan.

Abdominal Pain↗
PubMed2005

Relationship of gastric emptying and volume changes after a solid meal in humans.

Noninvasive imaging has been developed to measure gastric volumes. The relationship between gastric emptying and volume postprandially is unclear. The aims were to 1) develop a 3-dimensional (3D) single photon emission-computed tomography (SPECT) method to simultaneously measure gastric volume and emptying postprandially, 2) describe the course of gastric volume change during emptying of the meal, and 3) assess a 3D method measuring gastric emptying. In 30 healthy volunteers, we used (111)In-planar and (99m)Tc-SPECT imaging to estimate gastric emptying and volume after a radiolabeled meal. A customized analysis program of SPECT imaging assessed gastric emptying. A Bland-Altman plot assessed the performance of the new SPECT analysis compared with planar analysis. Gastric volume postprandially exceeds the fasting volume plus meal volume. The course of volume change and gastric emptying differ over time. Higher differences in volumes exist relative to fasting plus residual meal volumes at 15 min (median 763 vs. 568 ml, respectively, P < 0.001), 1 h (median 632 vs. 524 ml, P < 0.001), and 2 h (median 518 vs. 428 ml, P < 0.02), in contrast to similar volumes at 3 h (median 320 vs. 314 ml, P = 0.85). Analysis of SPECT imaging accurately measures gastric emptying compared with planar imaging with median differences of 1% (IQR -2.25 to 2.0) at 1 h, 1% (-3.25 to 2.25) at 2 h, and -2.5% (-4 to 0) at 3 h. Gastric volume exceeds meal volume during the first 2 postprandial hours, and simultaneous measurements of gastric volume and emptying can be achieved with a novel 3D SPECT method.

Adult↗
PubMed2005

Differentiating functional constipation from constipation-predominant irritable bowel syndrome: management implications.

Symptoms of constipation are commonly seen in medical practice. Once other medical causes have been excluded, distinguishing patients who have constipation-predominant irritable bowel syndrome (IBS) from those with functional constipation has been considered useful in terms of planning management. However, the criteria used to distinguish IBS from functional constipation are arguably arbitrary, and the availability of new therapeutic approaches may render such distinctions of little practical relevance. In this article, the author presents a review of the management implications of differentiating constipation-predominant IBS from functional constipation.

Biofeedback, Psychology↗
PubMed2005

Environmental versus genetic risk factors for irritable bowel syndrome: clinical and therapeutic implications.

The pathogenesis of irritable bowel syndrome (IBS) has traditionally been based on the biopsychosocial model that emphasizes that the symptom manifestations of IBS and consulting behavior are influenced at least in part by psychological processes. However, there has been increasing interest in trying to identify and unravel potential molecular mechanisms in IBS, and this endeavor has been driven by some evidence that there is a true genetic contribution to IBS. IBS does aggregate in families, and the concordance of IBS is twice as great in monozygotic compared with dizygotic twins in most, but not all, studies. A number of genetic polymorphisms have been associated with IBS but most remain to be independently confirmed, and unknown gene-environment interactions probably remain essential for the disorder to manifest. As we become better able to specify the phenotypes within IBS, it seems likely that increasingly relevant gene associations that have implications for testing and treatment will rapidly be identified. IBS probably represents a collection of several organic diseases, some of which may have a genetic component; the biopsychosocial model, although important, may represent a gross oversimplification of the underlying molecular pathogenesis.

Environment↗
PubMed2004

Lansoprazole in the treatment of functional dyspepsia: two double-blind, randomized, placebo-controlled trials.

PURPOSE: The efficacy of proton pump inhibitor therapy for symptom resolution in patients with functional dyspepsia remains controversial. This study was designed to compare the efficacy of lansoprazole with placebo in relieving upper abdominal discomfort in patients with functional dyspepsia. METHODS: We enrolled 921 patients with functional dyspepsia (defined as persistent or recurrent upper abdominal discomfort during the prior 3 months) and moderate upper abdominal discomfort on at least 30% of screening days; none of the patients had predominant symptoms suggestive of gastroesophageal reflux or endoscopic evidence of erosive or ulcerative esophagitis, or gastric or duodenal ulcer or erosion. Patients were assigned randomly to receive lansoprazole 15 mg (n = 305), lansoprazole 30 mg (n = 308), or placebo (n = 308) daily for 8 weeks. Patients recorded the frequency and severity of symptoms in daily diaries. RESULTS: At week 8, significantly (P <0.001) greater mean reductions in the percentage of days with upper abdominal discomfort were reported in patients treated with lansoprazole 15 mg (35%) or 30 mg (34%) compared with those treated with placebo (19%). Similarly, more patients treated with lansoprazole 15 mg (44%) or 30 mg (44%) reported complete symptom resolution (defined as no episodes of upper abdominal discomfort in the 3 days before the study visit) at 8 weeks than did placebo-treated patients (29%, P <0.001). Improvement of upper abdominal discomfort, however, was seen only in patients who had at least some symptoms of heartburn at enrollment. CONCLUSION: Lansoprazole, at a daily dose of 15 mg or 30 mg, is significantly better than placebo in reducing symptoms of persistent or recurrent upper abdominal discomfort accompanied by at least some symptoms of heartburn.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2004

Cross-cultural development and validation of a patient self-administered questionnaire to assess quality of life in upper gastrointestinal disorders: the PAGI-QOL.

OBJECTIVE: Summarize the Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QOL) development and provide results on its reliability and validity from the international psychometric validation in dyspepsia, GastroEsophageal Reflux Disease (GERD), and gastroparesis. METHODS: Subjects completed the pilot PAGI-QOL at baseline and 8 weeks; and a subsample also at 2 weeks. Other assessments were: Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index, SF-36, number of disability days. RESULTS: 1736 patients completed the PAGI-QOL at baseline. The questionnaire was reduced, producing a 30-item final version covering five domains: Daily Activities, Clothing, Diet and Food Habits, Relationship (REL), and Psychological Well-Being and Distress. Internal consistency was excellent (Cronbach's alpha range: 0.83-0.96). Test-retest reproducibility was good: intraclass correlations coefficients were over 0.70 except for the REL scale (0.61). Concurrent validity between the PAGI-QOL total score and all SF-36 subscale scores was good with moderate (0.52) to strong (0.72) correlations. PAGI-QOL scores showed excellent discriminant properties: patients who had spent some days in bed, had missed some days at work, and were kept from usual activities had much lower PAGI-QOL scores than those who did not (p < 0.0001). CONCLUSION: The PAGI-QOL is a valid and reliable instrument assessing quality of life in patients with dyspepsia, GERD, or gastroparesis.

Cross-Cultural Comparison↗
PubMed2004

Functional dyspepsia: drugs for new (and old) therapeutic targets.

The therapeutic management of functional dyspepsia remains a major challenge for the gastroenterologist. Current therapies available are based on putative underlying pathophysiologic mechanisms, including gastric acid sensitivity, slow gastric emptying and Helicobacter pylori infection, but only a small proportion of patients achieve symptomatic benefit from these therapeutic approaches. Relatively novel mechanistic concepts under testing include impaired gastric accomodation, visceral hypersensitivity, and central nervous system dysfunction. Serotonergic modulators (e.g. the 5-HT4 agonist tegaserod, the 5-HT3 antagonist alosetron and the 5-HT1P agonist sumatriptan), CCK-1 antagonists (e.g. dexloxiglumide), opioid agonists (e.g. asimadoline), N-methyl-D-aspartate (NMDA) receptor antagonists (e.g dextromethorphan), neurokinin antagonists (e.g. talnetant), capsaicin-like agents and antidepressants are among the agents currently under investigation. It seems unlikely, however, that targeting a single mechanism with an individual drug will result in complete symptom remission in most cases.

Dyspepsia↗
PubMed2004

Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders.

BACKGROUND AND AIMS: Determining clinically meaningful change of patient-reported outcome measures is important for evaluating effectiveness of treatments for gastrointestinal (GI) diseases. This study evaluates responsiveness of the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) in gastroesophageal reflux disease (GERD) and dyspepsia. METHODS: The PAGI-SYM was based on a review of the published literature and interviews with patients and clinicians. Items were developed to be linguistically and culturally appropriate for multicountry studies. The PAGI-SYM includes 6 subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Subjects with GERD (n = 810) or dyspepsia (n = 767) participated in this multicountry, observational study. All subjects completed the PAGI-SYM, a global symptom relief questionnaire, and a measure of patient-rated change in GI-related symptoms, the Overall Treatment Effect (OTE) scale. Responsiveness was evaluated at 8 weeks by comparing groups by disease, symptom relief, and OTE (improved, stable, and worsened). RESULTS: Subjects reporting symptom relief reported significantly lower (better) PAGI-SYM scores than those reporting no symptom relief ( P < 0.0001 to P < 0.0005). Subjects with improvements in overall GI symptoms exhibited significant decreases in PAGI-SYM subscale scores compared with those who remained the same or worsened (all P values < 0.0001). Effect sizes ranged from 0.21-1.28, and standard errors of measurement ranged from 0.29-0.63, depending on subscale and disease sample. CONCLUSIONS: The PAGI-SYM is a brief symptom severity instrument that measures common GI symptoms. Results suggest that the PAGI-SYM is responsive and sensitive to change in clinical status in subjects with GERD or dyspepsia.

Adult↗
PubMed2004

Responsiveness and interpretation of a quality of life questionnaire specific to upper gastrointestinal disorders.

BACKGROUND AND AIMS: The Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) has been developed and validated to assess quality of life in gastroesophageal reflux disease, dyspepsia, and gastroparesis. The aim of this work was to assess responsiveness of the PAGI-QOL to clinical changes and provide guidance for the interpretation of score changes. METHODS: The analysis was based on 2 observational multicenter, longitudinal, 8-week observation studies, one in the United States and one in 5 European countries. The Overall Treatment Effect scale completed by patients and clinicians at 8 weeks was used to define groups of improved, worsened, and stable patients. Responsiveness was assessed by describing the change in PAGI-QOL scores for each of these groups, comparing these changes over time, and calculating effect sizes and standardized response means. These data were used to define the minimal clinically important difference. RESULTS: A total of 1736 patients with upper gastrointestinal disorders were analyzed. High sensitivity to change over time was demonstrated, with effect sizes and standardized response means in improved patients for the PAGI-QOL total score ranging from 0.79-1.41. A change of 0.4 for the PAGI-QOL total score might be considered as the minimal clinically important difference when comparing pretreatment and post-treatment PAGI-QOL total scores. CONCLUSIONS: The PAGI-QOL questionnaire is a responsive and clinically relevant instrument for assessing quality of life in patients with upper gastrointestinal disorders.

Adolescent↗
PubMed2004

Clinical presentation and personality factors are predictors of the response to treatment in patients with functional dyspepsia; a randomized, double-blind placebo-controlled crossover study.

The role of psychological factors or symptom pattern for the response to treatment in patients with unexplained (functional) dyspepsia is unknown. We hypothesized that patients with reflux- and ulcer-like symptoms would be more likely to respond to acid-lowering therapy, while psychological disturbances would be associated with a less favorable response to treatment. Seventy-eight patients with a diagnosis of functional dyspepsia were recruited and 75 completed the trial. Patients were treated for 4 weeks in a double-blind, placebo-controlled crossover trial starting in random order with either active drug (ranitidine, 150 mg b.d.) or placebo. Every 7 days, medication was switched from active drug to placebo, or vice versa. At entry, patient characteristics were assessed utilizing a semistructured standardized interview and standardized questionnaires, and weekly intensity of symptoms was assessed utilizing a visual analogue scale. Patients with a greater reduction of the symptom score during active treatment and an overall reduction of the global symptom score by more than 50% at the end of the study period were categorized as responders. Logistic regression analysis was utilized to assess the influence of symptom type and presence of psychological disturbances on the treatment response. During treatment the symptom score decreased significantly, from 32.1 +/- 1.44 (SD) to 21.3 +/- 1.9 at the end of the trial (P < 0.001). Twenty of 75 were responders. High scores for somatization (OR, 3.6; 95% Cl, 1.2-11.4), anxiety (OR, 3.3; 95% Cl, 0.9-11.8), and reflux-like symptoms (OR, 5.3; 95% Cl, 1.7-16.7) were associated with response to treatment, while dysmotility-like symptoms were associated with an unfavorable response (OR, 0.3; 95% Cl, 0.1-0.9). Symptom pattern and psychological disturbances are independent predictors of treatment response. Patients with reflux-like symptoms and greater psychological disturbances are more likely to respond to an acid-lowering compound.

Adult↗