Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Alternative treatments are commonly used for various disorders and often taken on-demand. On-demand treatment of gastroesophageal reflux disease (GERD) with pharmaceutical products is an established, cost-effective strategy. Comparisons between alternative medicine and pharmaceutical products are rare. The aim of this trial was to compare on-demand treatment with a pectin-based, raft-forming, natural, anti-reflux agent (PRA) with that of esomeprazole 20 mg (Eso20) in patients with mild/moderate GERD.</p> <p>Methods</p> <p>Patients with mild/moderate GERD were randomised to a six weeks' on-demand treatment with PRA or Eso20 in a pragmatic, open, multicentre trial. Overall satisfaction with treatment, satisfactory relief on a weekly basis, reflux symptoms, and treatment preferences were noted.</p> <p>Results</p> <p>Seventy-seven patients were included in the analyses. Eso20 was significantly superior to PRA for proportion of overall satisfied patients (92% and 58% respectively; p = 0.001), reduction of symptoms (mean symptom scores at the end 5.9 and 8.0 respectively; p = 0.019), proportion of weeks of satisfactory relief (89% and 62% respectively; p = 0.008) and proportion preferring continuation with the same treatment (85% and 42% respectively; p < 0.001). Older patients were more satisfied than younger, and patients preferring on-demand treatment had lower symptom scores at inclusion than those preferring regular treatment.</p> <p>Conclusion</p> <p>On-demand treatment with esomeprazole 20 mg was clearly superior to the pectin-based raft-forming agent. Most patients preferred on-demand treatment to regular treatment. Those preferring regular therapy had significantly more symptoms at inclusion.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: NCT00184522.</p

Constipation and diarrhoea - common adverse drug reactions? A cross sectional study in the general population

BACKGROUND: Constipation and diarrhoea are common complaints and often reported as adverse drug reactions. This study aimed at finding associations between drugs and constipation and diarrhoea in a general population. METHODS: A selection of inhabitants in Oppland County, Norway participated in a cross-sectional survey. Information about demographics, diseases including gastrointestinal complaints classified according to the Rome II criteria and use of drugs were collected on questionnaires. Constipation was defined as functional constipation and constipation predominant Irritable Bowel Syndrome (IBS), and diarrhoea as functional diarrhoea and diarrhoea predominant IBS. Associations between drugs and constipation and diarrhoea were examined with multivariable logistic regression models. Based on the multivariable model, the changes in prevalence (risk difference) of the abdominal complaints for non-users and users of drugs were calculated. RESULTS: In total 11078 subjects were invited, 4622 completed the questionnaires, 640 (13.8%) had constipation and 407 (8.8%) had diarrhoea. To start using drugs increased the prevalence of constipation and diarrhoea with 2.5% and 2.3% respectively. Polypharmacy was an additional risk factor for diarrhoea. Use of furosemide, levothyroxine sodium and ibuprofen was associated with constipation, and lithium and carbamazepine with diarrhoea. The excess drug related prevalence varied from 5.3% for the association between ibuprofen and constipation to 27.5% for the association between lithium and diarrhoea. CONCLUSIONS: Use of drugs was associated with constipation and diarrhoea in the general population. The associations are most likely adverse drug reactions and show that drug-induced symptoms need to be considered in subjects with these complaints

Drugs and Constipation in Elderly in Nursing Homes: What Is the Relation?

Introduction. Constipation is a common adverse drug reaction. Objective. Study associations between drugs and constipation in nursing home residents. Design. Cross-sectional study. Material and Methods. Nursing home residents above 60 years of age were included. Demographics, diet, physical activity, activity of daily living, nutritional status, use of drugs, and diseases were recorded. Constipation was defined as functional constipation or constipation-predominant IBS according to the Rome III criteria and/or regular use of laxatives. Drugs were classified according to the Anatomical-Therapeutic-Chemical Classification System (ATC), and anticholinergic effect was noted. Results. In all, 79 men and 188 women with a mean age of 85.4 (SD 7.1) years were included. The prevalence of constipation was 71.5%. Use of drugs in general, including polypharmacy, was not associated with constipation. Reduced activity of daily living (OR = 0.71, 95% CI : 0.60–0.84, P < 0.001), other antidepressants (N06AX) (OR 3.08, 95% CI : 1.09–8.68, P = 0.03), and benzodiazepine derivatives (N05BA) (OR = 2.80, 95% CI : 1.12–7.04, P = 0.03) were significantly associated with constipation; drugs with markedly anticholinergic effect (OR = 3.7, 95% CI : 0.78–17.53, P = 0.10), natural opium alkaloid (N02AA) (OR = 5.01, 95% CI : 0.95–25.94, P = 0.06), and propionic acid derivatives (M01AE) (OR = 7.00, 95% CI : 0.75–65.08, P = 0.09) showed a trend. Conclusion. In elderly with constipation, focus should be on specific groups of drugs and nonpharmacological factors, not on drugs in general

Drugs and Constipation in Elderly in Nursing Homes: What Is the Relation?

Introduction. Constipation is a common adverse drug reaction. Objective. Study associations between drugs and constipation in nursing home residents. Design. Cross-sectional study. Material and Methods. Nursing home residents above 60 years of age were included. Demographics, diet, physical activity, activity of daily living, nutritional status, use of drugs, and diseases were recorded. Constipation was defined as functional constipation or constipation-predominant IBS according to the Rome III criteria and/or regular use of laxatives. Drugs were classified according to the Anatomical-Therapeutic-Chemical Classification System (ATC), and anticholinergic effect was noted. Results. In all, 79 men and 188 women with a mean age of 85.4 (SD 7.1) years were included. The prevalence of constipation was 71.5%. Use of drugs in general, including polypharmacy, was not associated with constipation. Reduced activity of daily living (OR = 0.71, 95% CI : 0.60-0.84, P &lt; 0.001), other antidepressants (N06AX) (OR 3.08, 95% CI : 1.09-8.68, P = 0.03), and benzodiazepine derivatives (N05BA) (OR = 2.80, 95% CI : 1.12-7.04, P = 0.03) were significantly associated with constipation; drugs with markedly anticholinergic effect (OR = 3.7, 95% CI : 0.78-17.53, P = 0.10), natural opium alkaloid (N02AA) (OR = 5.01, 95% CI : 0.95-25.94, P = 0.06), and propionic acid derivatives (M01AE) (OR = 7.00, 95% CI : 0.75-65.08, P = 0.09) showed a trend. Conclusion. In elderly with constipation, focus should be on specific groups of drugs and nonpharmacological factors, not on drugs in general

A comparison of diagnostic tests for lactose malabsorption - which one is the best?

<p>Abstract</p> <p>Background</p> <p>Perceived milk intolerance is a common complaint, and tests for lactose malabsorption (LM) are unreliable. This study assesses the agreement between diagnostic tests for LM and describes the diagnostic properties of the tests.</p> <p>Methods</p> <p>Patients above 18 years of age with suspected LM were included. After oral intake of 25 g lactose, a combined test with measurement of serum glucose (s-glucose) and hydrogen (H2) and methane (CH4) in expired air was performed and symptoms were recorded. In patients with discrepancies between the results, the combined test was repeated and a gene test for lactose non-persistence was added. The diagnosis of LM was based on an evaluation of all tests. The following tests were compared: Increase in H2, CH4, H2+CH4 and H2+CH4x2 in expired air, increase in s-glucose, and symptoms. The agreement was calculated and the diagnostic properties described.</p> <p>Results</p> <p>Sixty patients were included, seven (12%) had LM. The agreement (kappa-values) between the methods varied from 0.25 to 0.91. The best test was the lactose breath test with measurement of the increase in H2 + CH4x2 in expired air. With a cut-off level < 18 ppm, the area under the ROC-curve was 0.967 and sensitivity was 100%. This shows that measurement of CH4 in addition to H2 improves the diagnostic properties of the breath test.</p> <p>Conclusion</p> <p>The agreement between commonly used methods for the diagnosis of LM was unsatisfactory. A lactose breath test with measurement of H2 + CH4x2 in expired air had the best diagnostic properties.</p

How does comorbidity affect cost of health care in patients with irritable bowel syndrome? A cohort study in general practice

<p>Abstract</p> <p>Background</p> <p>Irritable bowel syndrome (IBS) is associated with other disorders (comorbidity), reduced quality of life and increased use of health resources. We aimed to explore the impact of comorbidity on cost of health care in patients with IBS in general practice.</p> <p>Methods</p> <p>In this cohort study 208 consecutive patients with IBS (Rome II) were recruited. Sociodemographic data, IBS symptoms, and comorbidity (somatic symptoms, organic diseases and psychiatric disorders) were assessed at baseline. Based on a follow up interview after 6-9 months and use of medical records, IBS and non-IBS related health resource use were measured as consultations, hospitalisations, use of medications and alternative health care products and sick leave days. Costs were calculated by national tariffs and reported in Norwegian Kroner (NOK, 1 EURO equals 8 NOK). Multivariate analyses were performed to identify predictors of costs.</p> <p>Results</p> <p>A total of 164 patients (mean age 52 years, 69% female, median duration of IBS 17 years) were available at follow up, 143 patients (88%) had consulted their GP of whom 31 (19%) had consulted for IBS. Mean number of sick- leave days for IBS and comorbidity were 1.7 and 16.3 respectively (p < 0.01), costs related to IBS and comorbidity were 954 NOK and 14854 NOK respectively (p < 0.001). Age, organic diseases and somatic symptoms, but not IBS severity, were significant predictors for total costs.</p> <p>Conclusion</p> <p>Costs for health resource use among patients with IBS in general practice were largely explained by comorbidity, which generated ten times the costs for IBS.</p

What causes treatment failure - the patient, primary care, secondary care or inadequate interaction in the health services?

<p>Abstract</p> <p>Background</p> <p>Optimal treatment gives complete relief of symptoms of many disorders. But even if such treatment is available, some patients have persisting complaints. One disorder, from which the patients should achieve complete relief of symptoms with medical or surgical treatment, is gastroesophageal reflux disease (GERD). Despite the fact that such treatment is cheap, safe and easily available; some patients have persistent complaints after contact with the health services. This study evaluates the causes of treatment failure.</p> <p>Methods</p> <p>Twelve patients with GERD and persistent complaints had a semi-structured interview which focused on the patients' evaluation of treatment failure. The interviews were taped, transcribed and evaluated by 18 physicians, (six general practitioners, six gastroenterologists and six gastrointestinal surgeons) who completed a questionnaire for each patient. The questionnaires were scored, and the relative responsibility for the failure was attributed to the patient, primary care, secondary care and interaction in the health services.</p> <p>Results</p> <p>Failing interaction in the health services was the most important cause of treatment failure, followed by failure in primary care, secondary care and the patient himself; the relative responsibilities were 35%, 28%, 27% and 10% respectively. There was satisfactory agreement about the causes between doctors with different specialities, but significant inter-individual differences between the doctors. The causes of the failures differed between the patients.</p> <p>Conclusions</p> <p>Treatment failure is a complex problem. Inadequate interaction in the health services seems to be important. Improved communication between parts of the health services and with the patients are areas of improvement.</p

Effectiveness of laxatives in elderly - a cross sectional study in nursing homes

<p>Abstract</p> <p>Background</p> <p>Laxatives are efficient drugs, but the effectiveness has been questioned. In nursing homes, the prevalence of constipation is high and laxatives are commonly used drugs. The aims of the study were to assess the effectiveness of laxative therapy in an everyday setting in Norwegian nursing homes, study differences between treatment regimens and factors associated with normal bowel function.</p> <p>Methods</p> <p>A cross-sectional study. After giving informed consent, residents above 60 years of age using laxatives for functional constipation were included, and their characteristics, medical history, use of drugs and bowel functions were recorded. Normal bowel function was defined as bowel movements from 3 times/week to 3 times/day and stool consistency 3-5 on Bristol Stool Form Scale.</p> <p>Results</p> <p>Out of 647 residents in the nursing homes, 197 were included and 116 (59%) had normal bowel function. The treatment effect did not differ significantly between the laxatives, treatment regimens or expected efficacy of the regimens. The treatment was unsatisfactorily adapted to individual needs. In subjects with normal bowel function, 113 (97%) had persistent complaints; 68 (59.5%), 10 (8.0%), 34 (28.6%) and 26 (22.5%) reported straining, manual manoeuvre to facilitate bowel movements, feeling of incomplete bowel movements, and feeling of anorectal obstruction respectively. Good nutritional status, previous or present cancer disease and anxiety/depression were predictors of normal bowel function.</p> <p>Conclusions</p> <p>Treatment of constipation in nursing homes was unsatisfactory. Nearly all patients with normal stool frequency and consistence had some persistent complaints. Improved nutrition and individualization of the treatment could improve the outcome.</p

Disease knowledge after an educational program in patients with GERD – a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Patient education has proved beneficial in several but not all chronic disease. Inconsistent findings may rely on varying educational effects of various programs and differential effects on subgroups of patients. Patients' increase in disease knowledge may serve as a feedback to the educator on how well the education program works – but may not be associated to relevant clinical outcomes like quality of life (QoL). This study aimed to investigate the effects of a group based education program for patients with gastroesophageal reflux disease (GERD) on disease knowledge and the association between knowledge and QoL.</p> <p>Methods</p> <p>Patients with GERD were randomly allocated to education (102 patients) or control (109 patients). The education program was designed as a structured dialogue conveying information about pathophysiology, pharmacological and non-pharmacological treatment of GERD, patients' rights and use of healthcare. Outcomes were a 24 item knowledge test on GERD (score 0 – 24) 2 and 12 months after the educational program and disease specific and general QoL (Digestive symptoms and disease impact, DSIQ, and General Health Questionnaire, GHQ).</p> <p>Results</p> <p>Patients allocated to education achieved higher knowledge test scores than controls at 2 months (17.0 vs. 13.1, p < 0.001) and at 12 months (17.1 vs. 14.0, p < 0.001) follow-up. Knowledge test score was positively associated with having completed advanced school and inversely related to psychiatric illness and poor QoL as perceived by the patients at the time of inclusion. Overall, changes in knowledge test score were not associated with change in QoL.</p> <p>Conclusion</p> <p>A group based education program for patients with GERD designed as a structured dialogue increased patients' disease knowledge, which was retained after 1 year. Changes in GERD-knowledge were not associated with change in QoL.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: NCT0061850</p