Electroacupuncture plus standard of care for managing refractory functional dyspepsia: protocol of a pragmatic trial with economic evaluation.

INTRODUCTION: This trial proposes to compare the effectiveness and cost-effectiveness of electroacupuncture (EA) plus on-demand gastrocaine with waiting list for EA plus on-demand gastrocaine in providing symptom relief and quality-of-life improvement among patients with functional dyspepsia (FD). METHODS AND ANALYSIS: This is a single-centre, pragmatic, randomised parallel-group, superiority trial comparing the outcomes of (1) EA plus on-demand gastrocaine group and (2) waiting list to EA plus on-demand gastrocaine group. 132 (66/arm) endoscopically confirmed, Helicobacter pylori-negative patients with FD will be recruited. Enrolled patients will respectively be receiving (1) 20 sessions of EA over 10 weeks plus on-demand gastrocaine; or (2) on-demand gastrocaine and being nominated on to a waiting list for EA, which entitles them 20 sessions of EA over 10 weeks after 12 weeks of waiting. The primary outcome will be the between-group difference in proportion of patients achieving adequate relief of symptoms over 12 weeks. The secondary outcomes will include patient-reported change in global symptoms and individual symptoms, Nepean Dyspepsia Index, Nutrient Drink Test, 9-item Patient Health Questionnaire (PHQ9), and 7-item Generalised Anxiety Disorder Scale (GAD7). Adverse events will be assessed formally. Results on direct medical costs and on the EuroQol (EQ-5D) questionnaire will also be used to assess cost-effectiveness. Analysis will follow the intention-to-treat principle using appropriate univariate and multivariate methods. A mixed model analysis taking into account missing data of these outcomes will be performed. Cost-effectiveness analysis will be performed using established approach. ETHICS AND DISSEMINATION: The study is supported by the Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region of China. It has been approved by the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee. Results will be published in peer-reviewed journals and be disseminated in international conference. TRIAL REGISTRATION NUMBER: ChiCTR-IPC-15007109; Pre-result.

Functional dyspepsia: the economic impact to patients.

BACKGROUND: Although highly prevalent, little is known about the economic impact of functional dyspepsia (FD). AIMS: To quantify FD patients' health care utilisation patterns and to estimate direct and indirect costs of FD to patients. METHODS: ICD-9 codes identified adult patients with dyspepsia. A validated questionnaire was mailed to patients who met Rome III criteria for FD. RESULTS: Three hundred and fifty-five patients met all inclusion criteria. The response rate was 63%. The respondents' mean age was 50 (14) years; 75% were women; 52% of respondents rated their FD as moderate. Patients reported 3 visits (mean) to their PCP over 12 months; 75% reported having blood work, 92% an EGD, 59% an ultrasound and 40% a CT scan. The direct cost of testing using Medicare reimbursement rates per patient was $582. To treat FD symptoms, 89% tried dietary changes, 89% over-the-counter medications, 87% prescription medications and 25% alternative therapies. Mean patient expenditure over the last year was $246 for OTC medications (range $0-12,000), $290 for co-payments (range $0-9,000) and $110 for alternative treatments (range $0-3,741). Total mean direct cost yearly to patients was $699. In the 7 days prior to completing the questionnaire, respondents reported a mean of 1.4 h absence from work. Extrapolating the results to the US population, we conservatively calculate the costs of FD were $18.4 billion in 2009. CONCLUSIONS: Functional dyspepsia patients incur significant direct and indirect costs and work productivity is impaired by dyspeptic symptoms.

Use of health care services and pharmaceutical agents in coeliac disease: a prospective nationwide study.

BACKGROUND: Approximately 1% of the population suffer from coeliac disease. However, the disease is heavily underdiagnosed. Unexplained symptoms may lead to incremented medical consultations and productivity losses. The aim here was to estimate the possible concealed burden of untreated coeliac disease and the effects of a gluten-free diet. METHODS: A nationwide cohort of 700 newly detected adult coeliac patients were prospectively evaluated. Health care service use and sickness absence from work during the year before diagnosis were compared with those in the general population; the data obtained from an earlier study. Additionally, the effect of one year on dietary treatment on the aforementioned parameters and on consumption of pharmaceutical agents was assessed. RESULTS: Untreated coeliac patients used primary health care services more frequently than the general population. On a gluten-free diet, visits to primary care decreased significantly from a mean 3.6 to 2.3. The consumption of medicines for dyspepsia (from 3.7 to 2.4 pills/month) and painkillers (6.8-5.5 pills/month) and the number of antibiotic courses (0.6-0.5 prescriptions/year) was reduced. There were no changes in hospitalizations, outpatient visits to secondary and tertiary care, use of other medical services, or sickness absence, but the consumption of nutritional supplements increased on treatment. CONCLUSIONS: Coeliac disease was associated with excessive health care service use and consumption of drugs before diagnosis. Dietary treatment resulted in a diminished burden to the health care system and lower use of on-demand medicines and antibiotic treatment. The results support an augmented diagnostic approach to reduce underdiagnosis of coeliac disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT01145287.

A one-year economic evaluation of six alternative strategies in the management of uninvestigated upper gastrointestinal symptoms in Canadian primary care.

BACKGROUND: The cost-effectiveness of initial strategies in managing Canadian patients with uninvestigated upper gastrointestinalsymptoms remains controversial. OBJECTIVE: To assess the cost-effectiveness of six management approaches to uninvestigated upper gastrointestinal symptoms in the Canadian setting. METHODS: The present study analyzed data from four randomized trials assessing homogeneous and complementary populations of Canadian patients with uninvestigated upper gastrointestinal symptoms with comparable outcomes. Symptom-free months, qualityadjusted life-years (QALYs) and direct costs in Canadian dollars of two management approaches based on the Canadian Dyspepsia Working Group (CanDys) Clinical Management Tool, and four additional strategies (two empirical antisecretory agents, and two prompt endoscopy) were examined and compared. Prevalence data, probabilities, utilities and costs were included in a Markov model, while sensitivity analysis used Monte Carlo simulations. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were determined. RESULTS: Empirical omeprazole cost $226 per QALY ($49 per symptom-free month) per patient. CanDys omeprazole and endoscopy approaches were more effective than empirical omeprazole, but more costly. Alternatives using H2-receptor antagonists were less effective than those using a proton pump inhibitor. No significant differences were found for most incremental cost-effectiveness ratios. As willingness to pay (WTP) thresholds rose from $226 to $24,000 per QALY, empirical antisecretory approaches were less likely to be the most costeffective choice, with CanDys omeprazole progressively becoming a more likely option. For WTP values ranging from $24,000 to $70,000 per QALY, the most clinically relevant range, CanDys omeprazole was the most cost-effective strategy (32% to 46% of the time), with prompt endoscopy-proton pump inhibitor favoured at higher WTP values. CONCLUSIONS: Although no strategy was the indisputable cost effective option, CanDys omeprazole may be the strategy of choiceover a clinically relevant range of WTP assumptions in the initial management of Canadian patients with uninvestigated dyspepsia.

Effectiveness and pharmaceutical cost of sequential treatment for Helicobacter pylori in patients with non-ulcer dyspepsia.

BACKGROUND: A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate than standard 7-day therapy in both peptic ulcer disease and non-ulcer dyspepsia. Its higher performance has recently been confirmed using a halved clarithromycin dose in peptic ulcer disease. AIMS: To evaluate whether an acceptable eradication rate could also be obtained by halving the clarithromycin dose in dyspeptic patients and to assess the role of possible factors affecting the outcome of therapy. METHODS: In a prospective, open-label study, 162 patients with non-ulcer dyspepsia and Helicobacter pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either 10-day sequential therapy, comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (low-dose therapy), or a similar schedule with clarithromycin 500 mg b.d. (high-dose therapy). Four to six weeks after therapy, H. pylori eradication was assessed by endoscopy/histology. RESULTS: A similar H. pylori eradication rate was observed following low- and high-dose regimens for both per protocol (94% vs. 95%; P = N.S.) and intention-to-treat (93% vs. 94%; P = N.S.) analyses. No major side-effects were reported. Halving the clarithromycin dose leads to a per patient saving in pharmaceutical costs of 24.6 euros. None of the variables examined affected the effectiveness of eradication of the sequential regimen. CONCLUSION: A reduction of the clarithromycin dose does not affect H. pylori eradication with the sequential regimen in non-ulcer dyspepsia and affords lower costs.

Treating dyspepsia with acupuncture and homeopathy: reflections on a pilot study by researchers, practitioners and participants.

OBJECTIVES: For people with dyspepsia who are receiving orthodox general practice care, what is the effect on outcome and on NHS costs of adding treatment by a choice of acupuncture or homeopathy? This paper describes and reflects upon a pilot study with user involvement. DESIGN: A randomised pilot study. Patients chose between acupuncture and homeopathy and were then randomised to this preference or to the control group of normal GP care. SETTING AND PARTICIPANTS: Sixty people with dyspepsia (>/=2 weeks) presenting in one UK general practice were recruited in consultations and by letter to those on repeat prescriptions. There were few exclusion criteria. The homeopath and the acupuncturist treated the patient individually according to their normal practice for up to 6 months. After the trial there was a focus group for participants. OUTCOME MEASURES: SF-36 health survey, Measure Yourself Medical Outcome Profile (MYMOP), and General Well-being Index (GWBI). Counts of prescriptions, consultations and referrals from practice computer records. RESULTS: No trend or significant difference between the groups for clinical outcome or NHS costs. Major costs for the 6 months, mean (S.D.) cost per patient, were general practitioner consultations pound 8 (18), prescriptions pound 64 (73), acupuncture pound 175 (52), homeopathy pound 105 (33). Participants gave insights and suggestions which will inform the full trial design. CONCLUSIONS: Reflection on the pilot study data and experience by participants, treating practitioners and researchers led to modifications in the design and a sample size calculation. How to demonstrate individual responses to treatment remains a problem.

Management of dyspepsia across the primary-secondary healthcare interface.

Primary care remains at the frontline of care for most patients and the need to contain healthcare costs has led to a re-evaluation of the divide between primary and secondary care. Dyspepsia has a community prevalence of 25-50%, and forms 5% of the primary care physician's workload, 10% of whom are referred to a specialist. Problems presenting in primary care tend to be undifferentiated; those who do not have alarm symptoms and are under the age of 55 years are unlikely to have serious pathology. Management is largely symptom driven, on an empirical basis rather than on a diagnostic model as in secondary care where investigation rates are higher. The predictive value of symptoms for a specific diagnosis is small; primary care physicians include gastro-oesophageal reflux disease as part of the dyspepsia complex and the overall expenditure on acid suppression therapy is relatively large. The availability of open-access investigations such as endoscopy has influenced specialist referral rates and the ability to diagnose and treat patients with Helicobacter pylori-related problems has opened further opportunities. However, variations in the availability of the recommended diagnostic tests and the implications to primary care clinical practice of some of the new management recommendations (Maastricht II) in some national settings illustrate the divide with secondary care. The gap between primary and secondary care is narrowing in gastroenterology and the two groups need to continue collaboration to attain effective and cost-effective management for their patients.

Empiric antacids and reassurance for acute dyspepsia.

The evaluation of ambulatory patients with dyspepsia frequently includes upper gastrointestinal radiographs (UGIs), a practice of unproven value in low-risk patients. To assess an alternative management strategy without UGIs, 28 patients with upper abdominal pain seen in an adult medical walk-in practice were treated with high-dose antacid therapy for three weeks. The clinical course on antacid therapy was good; 68% of patients reported substantial improvement. Initial requests for UGIs were high among both patients and physicians. Following empiric antacid therapy, requests for UGIs fell from 68% to 32% for patients (p = 0.05) and from 71% to 21% for physicians (p = 0.001). No serious complications were detected after 18 months of follow up. Direct medical charges were reduced by 37%. Empiric antacid therapy for patients at low risk for serious disease relieves dyspepsia and reduces both patient and physician requests for UGIs.