TheraPearl Eye Mask and Blephasteam for the treatment of meibomian gland dysfunction: a randomized, comparative clinical trial.

Meibomian gland dysfunction (MGD) is the most common cause of dry eye disease (DED). In this study, we aimed to compare the effects of eyelid warming treatment using either TheraPearl Eye Mask (Bausch & Lomb Inc., New York, USA) or Blephasteam (Spectrum Thea Pharmaceuticals LTD, Macclesfield, UK) in a Norwegian population with mild to moderate MGD-related DED. An open label, randomized comparative trial with seventy patients (49 females, 21 males; mean age 53.6 years). Patients were randomly assigned to treatment with Blephasteam (n = 37) or TheraPearl (n = 33). All received a hyaluronic acid based artificial tear substitute (Hylo-Comod, Ursapharm, Saarbrücken, Germany). Patients were examined at baseline, and at three and six months initiation of treatment. Treatment efficacy was primarily evaluated by fluorescein breakup time (FBUT) and Ocular Surface Disease Index (OSDI) scores. Other outcome measures included ocular surface staining (OSS), Schirmer's test, and meibomian quality and expressibility. Baseline parameter values did not differ between the groups. After six months of treatment, Blephasteam improved FBUT by 3.9 s (p < 0.01) and OSDI by 13.7 (p < 0.01), TheraPearl improved FBUT by 2.6 s (p < 0.01) and OSDI by 12.6 (p < 0.01). No difference between treatments was detected at 6 months (p = 0.11 for FBUT and p = 0.71 for OSDI), nor were there differences in the other tested parameters between the treatment groups. Blephasteam and TheraPearl are equally effective in treating mild to moderate MGD in a Norwegian population after 6-months of treatment.Clinicaltrials.gov ID: NCT03318874; Protocol ID: 2014/1983; First registration: 24/10/2017.

Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations.

BACKGROUND AND AIMS: Since 2008, a plethora of research studies has compared the efficacy of water-assisted (aided) colonoscopy (WAC) and underwater resection (UWR) of colorectal lesions with standard colonoscopy. We reviewed and graded the research evidence with potential clinical application. We conducted a modified Delphi consensus among experienced colonoscopists on definitions and practice of water immersion (WI), water exchange (WE), and UWR. METHODS: Major databases were searched to obtain research reports that could potentially shape clinical practice related to WAC and UWR. Pertinent references were graded (Grading of Recommendations, Assessment, Development and Evaluation). Extracted data supporting evidence-based statements were tabulated and provided to respondents. We received responses from 55 (85% surveyed) experienced colonoscopists (37 experts and 18 nonexperts in WAC) from 16 countries in 3 rounds. Voting was conducted anonymously in the second and third round, with ≥80% agreement defined as consensus. We aimed to obtain consensus in all statements. RESULTS: In the first and the second modified Delphi rounds, 20 proposed statements were decreased to 14 and then 11 statements. After the third round, the combined responses from all respondents depicted the consensus in 11 statements (S): definitions of WI (S1) and WE (S2), procedural features (S3-S5), impact on bowel cleanliness (S6), adenoma detection (S7), pain score (S8), and UWR (S9-S11). CONCLUSIONS: The most important consensus statements are that WI and WE are not the same in implementation and outcomes. Because studies that could potentially shape clinical practice of WAC and UWR were chosen for review, this modified Delphi consensus supports recommendations for the use of WAC in clinical practice.

Endoscopic stent treatment of a duodenal ulcer perforation using a semi-covered stent.

Placement of a covered self-expandable metal stent when primary surgery had failed to close the duodenal ulcer perforation or as a primary modality is a promising procedure when compared to other currently available types of surgical rescue or intervention.

Low adherence to Helicobacter pylori testing in hospitalized patients with bleeding peptic ulcer disease.

BACKGROUND: Helicobacter pylori (H. pylori) testing in patients with bleeding ulcers is recommended by society guidelines and considered a quality indicator. The aim of the study is to examine the proportion of patients with bleeding ulcers who had H. pylori testing and identify predictors associated with H. pylori testing. MATERIALS AND METHODS: Consecutive hospitalized patients with bleeding ulcers documented endoscopically at a single center from 10/2004-5/2011 were identified retrospectively from an endoscopy database. The proportion of patients undergoing direct H. pylori testing (histology, rapid urease test, breath test or stool antigen) and any H. pylori testing (direct or serologic) were determined. RESULTS: Among 330 patients with bleeding ulcers, 105 (32%, 95% CI 27-37%) underwent direct testing and another 52 (16%, 95% CI 12-20%) had serologic testing during a median follow-up of 9 months (range, 0-86). H. pylori testing occurred at the index hospitalization in 146 (93%) of the 157 patients tested. Among the 105 patients who had direct H. pylori testing, 90 (86%) had biopsy-based testing during the initial endoscopy. On multivariate analysis, undergoing biopsy of a gastric ulcer was strongly associated with having direct H. pylori testing performed (OR = 5.1, 95% CI 2.3-11.5; p < .0001). CONCLUSIONS: Among patients hospitalized with bleeding ulcers, less than half received H. pylori testing and less than a third received the more accurate direct testing. Most of the direct H. pylori testing was biopsy-based with very few being tested after the index hospitalization. Efforts to increase H. pylori testing in patients with bleeding ulcers are needed to improve outcomes.

Bleeding Meckel's diverticulum diagnosed and treated by double-balloon enteroscopy.

Meckel's diverticulum (MD) is the most common congenital anomaly of the gastrointestinal (GI) tract. The diagnosis of symptomatic MD has been cumbersome. Several case reports been published regarding direct visualization of MD with double balloon enteroscopy (DBE); diagnosing a bleeding MD leading to surgical resection. We report the use of DBE for the treatment of a bleeding MD.

Helicobacter pylori breath testing in an open access system has a high rate of potentially false negative results due to protocol violations.

BACKGROUND: Among available tests to detect Helicobacter pylori (H. pylori), urea breath test (UBT) is the most accurate when performed correctly in research protocols with unknown validity in clinic settings. MATERIAL AND METHODS: A total of 595 subjects at a gastroenterology clinic were tested 620 times with UBT. Detailed information about three known factors (recent proton-pump inhibitors (PPI), antibiotics, or bismuth, H. pylori eradication treatment finished <4 weeks ago, and gastric resection) to make UBT unreliable were prospectively recorded before each test. RESULTS: Twenty-three percent (120 of 526) of all negative tests fell in one or more of the three categories, which had the potential to make UBT unreliable. Of those carried out on persons without being treated before, the potential false negative rate was 15%. Among those with previous eradication treatment, the rate was around 45%. CONCLUSIONS: If a negative UBT could be false negative in up to 23% of cases, then it has a serious lack of negative predictive value. A negative UBT should be considered false negative until potential protocol violations are excluded.

A pilot study to assess feasibility of the water method to aid colonoscope insertion in community settings in the United States.

BACKGROUND: The water method decreases patient discomfort and sedation requirement. Applicability in non-veteran community settings in the United States (U.S.) has not been reported. AIMS: Our aim is to perform a pilot study to establish feasibility of use the water method at 2 community sites. We tested the hypothesis that compared with air insufflation patients examined with the water method would require less sedation without adverse impact on outcomes. METHODS: Two performance improvement projects were carried out. Consecutive patients who consented to respond to a questionnaire after colonoscopy were enrolled. Project 1: The design was single-blinded (patient only); quasi-randomized - odd days (water), even days (air). Colonoscopy was performed by a staff attending. Project 2: A supervised trainee performed the reported procedures. In both, patient demographics (age, gender and body mass index), amount of sedation required during colonoscopy and procedure-related variables were recorded. The patients completed a questionnaire that enquired about discomfort during colonoscopy and willingness to repeat the procedure within 24 hours after the procedure. RESULTS: Project 1: Significantly lower doses of fentanyl and midazolam were used and a higher adenoma detection rate (ADR) was demonstrated in the water group. Project 2: 100% cecal intubation rate was achieved by the supervised trainee. CONCLUSION: This is the first pilot report in the U.S. documenting feasibility of the water method as the principal modality to aid colonoscope insertion in both male and female community patients. In a head-to-head comparison, significant reduction of sedation requirement is confirmed as hypothesized. No adverse impact on outcomes was noted.

DDW 2011 cutting edge colonoscopy techniques - state of the art lecture master class - warm water infusion/CO(2) insufflation for colonoscopy.

Pain limits the success of cecal intubation in unsedated patient. Carbon dioxide infusion instead of air insufflation and water infusion as an adjunction to air insufflation have both been investigated as modalities to minimize pain associated with colonoscopy. Multiple RCT support an effect of carbon dioxide in reducing pain after colonoscopy. A modern method of water infusion as the sole modality for aiding colonoscope insertion has been shown to reduce pain during and after colonoscopy. Favorable effects in reducing discomfort have been documented in both sedated and unsedated patients. Because of the need to perform water exchange in the patients with suboptimal bowel perparation, a serendipitous consequence of salvage cleansing is evident with application of the water method. The associated increase in adenoma detection especially in the proximal colon is most intriguing. The hypothesis that the water method during insertion combined with carbon dioxide insufflation during withdrawal will optimally decrease colonoscopy pain should be evaluated. The implications of increased adenoma detection by the water method also deserve to be studied.

Push enteroscopy has a 96% cecal intubation rate in colonoscopies that failed because of redundant colons.

BACKGROUND: Performing a complete colonoscopy to the cecum is important for ruling out malignancy and other lesions, but failure rates are significant with a standard colonoscope. A previous study using a push enteroscope for failed colonoscopies had a completion rate of 68.7%. OBJECTIVE: To improve the cecal intubation rate by using a newer version of a push enteroscope. DESIGN: Retrospective study at first, then a prospective study. SETTING: Single-center veterans health care system. PATIENTS: A total of 47 patients in whom the cecum was not reached with a regular adult colonoscope between January 2007 and December 2010 were included. Those with poor bowel preparation were excluded. INTERVENTIONS: Repeat colonoscopy using a new version of a push enteroscope. MAIN OUTCOME MEASUREMENTS: The rate of cecal intubation and additional pathological findings. RESULTS: The cecum or terminal ileum was reached in 45 patients (96%). Additional significant pathological findings in the previously unexamined colon were seen in 18 patients (38%). LIMITATIONS: Small sample size, lack of comparison with other endoscopes. CONCLUSIONS: Colonoscopy with a push enteroscope could be advanced to either the terminal ileum or cecum in 96% of patients, which is one of the highest known completion rates in patients in whom colonoscopy failed. Clinical management changed in all patients with additional findings.

Safety of same-day endoscopic ultrasound and endoscopic retrograde cholangiopancreatography under conscious sedation.

AIM: To assess the tolerability and safety of same-day tandem procedures, endoscopic ultrasound (EUS) followed by endoscopic retrograde cholangiopancreatography (ERCP) under conscious sedation. METHODS: A retrospective review was conducted at Loma Linda University Medical Center, a tertiary-care center. All 54 patients who underwent EUS followed by ERCP (group A) from 2004 to 2006 were included in the study. A second group of 56 patients who underwent EUS only (group B), and a third group of 53 patients who underwent ERCP only (group C) during the same time period were selected consecutively as control groups for comparison. RESULTS: Conscious sedation was used in 96% of patients in group A. Mean dosages of meperidine and midazolam used in group A were significantly higher than in group B or C. Mean recovery time in group A was not statistically longer than in group B or C. There was no significant difference in the incidence of sedation-related and procedural-related complications. CONCLUSION: Tandem EUS/ERCP procedure can be safely performed under conscious sedation with minimal adverse events. Combined procedures, however, are associated with higher dosages of sedatives, and slightly longer recovery time.

Prevention of colorectal cancer with vitamin D.

The fact that colorectal cancer (CRC) is the second leading cause of cancer mortality in the United States emphasizes the need for more effective preventive and therapeutic modalities. There is growing evidence that vitamin D may reduce the incidence of CRC. Results of epidemiologic, in vitro, in vivo animal and clinical studies suggest that a low serum vitamin D level may be a serious risk factor for CRC and a high serum vitamin D level may reduce the risk of CRC. On a molecular level, vitamin D suppresses CRC development and growth by affecting cell proliferation, differentiation, apoptosis, and angiogenesis. Vitamin D insufficiency and CRC are common in the elderly population. Vitamin D insufficiency is simple to screen for and treatable with vitamin D supplementation. Serum 25-hydroxyvitamin D (calcidiol) is the best measure of vitamin D status and should be checked routinely for individuals with risk factors for CRC. Maintaining serum concentrations of calcidiol above 32 ng/ml (80 nmol/l) in individuals whose serum calcidiol level is low may help prevent CRC as well as osteoporosis, fractures, infections, and cardiovascular disease. Daily calcidiol intake of 1000 International Units can increase serum vitamin D to sufficient levels in most elderly persons and, based on available data, may substantially lower the incidence of CRC with minimal risks.

Lifestyle of patients with self-reported food hypersensitivity differ little from controls.

The aim of this study was to examine the lifestyle of adult patients with abdominal discomfort (i.e., diarrhea, bloating, pain, and irregular defecation) self-attributed to food hypersensitivity and compare it with controls to see if the patients had a special lifestyle explaining their symptoms. Forty-six participants in this study were adult ethnic Norwegians referred by general practitioners to the Centre for Occupational and Environmental Allergy at Haukeland University Hospital because of gastrointestinal complaints, which the patients or their doctors suspected could be due to food allergy. They were compared with 70 age- and sex-matched volunteer controls from the general population. All participants filled out an extensive questionnaire focusing on different lifestyle aspects. One hundred percent of the patients and 43% of the controls (p < .0001) reported hypersensitivity to at least one food item. Significantly, fewer patients than controls reported daily consumption of milk (p = .004), coffee (p = .02), and alcohol (p = .008) for the past year. Among consumers, the participants used less milk (P = .002) and coffee (P = .04) than controls. Eating habits, meal patterns, quality of sleep, the amount of exercise, and use of painkillers were similar in both groups. There were small differences in lifestyle between the patients and the controls. Patients with gastrointestinal complaints self-attributed to food hypersensitivity used less milk, coffee, and alcohol, but none of those differences explain their symptoms. Such lifestyle would rather be expected to lessen symptoms, and we postulate that it is the consequence of their food intolerance and not its cause.

Clinical review of the management of fulminant clostridium difficile infection.

BACKGROUND: Clostridium difficile infection (CDI) is a frequent cause of morbidity and mortality among elderly hospitalized patients. A small but increasing number of patients have developed fulminant CDI, and a significant number of these patients require emergency colectomy. In this review, we discuss the risk factors, pathophysiology, diagnosis, and management of fulminant CDI. DATA SOURCES: A literature search (Medline, Embase, Cochrane Library, Biosis, Science Citation Index, Ovid Journals) was performed from the period between January 1980 and June 2008 using the key words "Clostridium difficile,""pseudomembranous enterocolitis,""colectomy,""acute abdomen,""antibiotic-associated diarrhea," or "fulminant Clostridium difficile colitis." Articles not in English or not related to human subjects were excluded. For this review, we analyzed the articles identified in our original search and those articles cited in the original review articles. No randomized trials were found on the surgical management of fulminant CDI and only retrospective studies with a minimum of five patients were used in the review. With respect to medical treatment, we based our review on guideline articles, systematic reviews, and available randomized trials. CONCLUSION: Both the incidence and severity of CDI are increasing. Fulminant CDI is underappreciated as a life-threatening disease because of a lack of awareness of its severity and its nonspecific clinical syndrome. Early diagnosis and treatment are essential for a good outcome, and early surgical intervention should be used in patients who are unresponsive to medical therapy. The surgical procedure of choice is a total abdominal colectomy with end ileostomy, although the mortality rate remains high.

Pain attacks in non-complicated and complicated gallstone disease have a characteristic pattern and are accompanied by dyspepsia in most patients: the results of a prospective study.

OBJECTIVE: The cardinal indication for surgical treatment of gallstones is pain attacks. However, following cholecystectomy, 20% of patients remain symptomatic. It is unclear to what extent post-cholecystectomy symptoms can be ascribed to persistence of preoperative symptoms or to new pathology. The pain and digestive pattern in gallstone patients has not been defined in a recent setting with ultrasonography as the diagnostic method. The aim of this study was to characterize a pain pattern that is typical for gallstone disease and to describe the extent of associated dyspepsia. MATERIAL AND METHODS: A total of 220 patients with symptomatic gallstone disease including complicated disease (acute cholecystitis and common bile duct stones) were interviewed using detailed questionnaires to disclose pain patterns and symptoms of indigestion. RESULTS: All patients had pain in the right upper quadrant (RUQ) including the upper midline epigastrium. The pain was localized to the right subcostal area in 20% and to the upper epigastrium in 14%, and in the rest (66%) it was more evenly distributed. An area of maximal pain could be defined in 90%. Maximal pain was located under the costal arch in 51% of patients and in the epigastrium in 41%, but in 3% behind the sternum and in 5% in the back. The pain was referred to the back in 63% of the patients. The mean visual analogue scale (VAS) score was very high: 90 mm on a 0-100 scale. A pattern of incipient or low-grade warning pain with a subsequent relatively steady state until subsiding in the same fashion was present in 90% of the patients. An urge to walk around was experienced by 71%. Pain attacks usually occurred in the late evening or at night (77%), with 85% of the attacks lasting for more than one hour and almost never less than half an hour. Sixty-six percent of the patients were intolerant to at least one kind of food, but only 48% to fatty foods. Symptoms of functional indigestion (gastroesophageal reflux, dyspepsia or irritable bowel symptoms) were seen in the vast majority in association with attacks. CONCLUSIONS: Gallstone-associated pain follows a certain pattern in the majority of patients. The pain is located in a defined area with a point of maximum intensity, is usually referred, and occurs mainly at night with duration of more than one hour. The majority of patients experience functional indigestion, mainly of the reflux type or dyspepsia.

Quality of life in patients with subjective food hypersensitivity: applicability of the 10-item short form of the Nepean Dyspepsia Index.

The aim of this study was to investigate quality of life and applicability of the 10-item short form of the Nepean Dyspepsia Index (SF-NDI) in patients with subjective food hypersensitivity. Fifty-two adult patients and 120 controls were examined using three questionnaires: Quality of life Nepean Dyspepsia Index (NDI), Gastrointestinal Symptom Rating Scale (GSRS), and Ulcer Esophagitis Subjective Symptoms Scale (UESS). To document psychometric properties, 20 of the patients filled in the SF-NDI questionnaire once more 4 weeks later. Patients had poor quality of life compared with controls from health care workers or general population (P < 0.001). Scores on SF-NDI were significantly correlated with scores on the GSRS (r = 0.34, P = 0.02) and UESS (r = 0.41, P = 0.003). The SF-NDI performed very satisfactorily, with a high reliability, construct validity, and responsiveness. Patients with subjective food hypersensitivity have considerably reduced quality of life. The SF-NDI provides reliable, responsive, and clinically valid measures of quality of life in these patients.

Altered dopamine D2 receptor function in fibromyalgia patients: a neuroendocrine study with buspirone in women with fibromyalgia compared to female population based controls.

BACKGROUND: To what extent fibromyalgia belongs to affective spectrum disorders or anxiety spectrum disorders remains disputed. Buspirone induces a hypothermic response, which most likely is due to 5-HT(1A) autoreceptor stimulation, and growth hormone (GH) release, which probably is related to postsynaptic 5-HT(1A) receptor stimulation. The prolactin response to buspirone has been suggested to be mediated through dopamine (DA) antagonistic effects. OBJECTIVES: Based on the assumption that fibromyalgia is more strongly related to stress and anxiety than affective spectrum disorders, we hypothesized that compared to population controls, fibromyalgia patients should demonstrate an increased prolactin response (DA sensitivity) to buspirone challenge test, but no difference in hypothermic response or GH release (5HT sensitivity). METHOD: A 60-mg dose of buspirone was given orally to 22 premenopausal women with fibromyalgia and 14 age and sex matched healthy control subjects. Core body temperature, growth hormone and prolactin levels were analyzed at baseline and after 60, 90, and 150 min. RESULTS: Fibromyalgia patients showed an augmented prolactin response to buspirone compared to controls. Temperature and growth hormone responses did not differ from controls. CONCLUSIONS: Dopaminergic rather than serotonergic neurotransmission is altered in fibromyalgia, suggesting increased sensitivity or density of dopamine D(2) receptors in fibromyalgia patients. Stress and anxiety is an important modulator of dopaminergic neurotransmission. Our results suggest that fibromyalgia is related to anxiety and associated with disturbance in the stress response systems.

Factors explaining variance in perceived pain in women with fibromyalgia.

BACKGROUND: We hypothesized that a substantial proportion of the subjectively experienced variance in pain in fibromyalgia patients would be explained by psychological factors alone, but that a combined model, including neuroendocrine and autonomic factors, would give the most parsimonious explanation of variance in pain. METHODS: Psychometric assessment included McGill Pain Questionnaire, General Health Questionnaire, Hospital Anxiety and Depression Rating Scale, Eysenck personality Inventory, Neuroticism and Lie subscales, Toronto Alexithymia Scale, and Multidimensional Health Locus of Control Scale and was performed in 42 female patients with fibromyalgia and 48 female age matched random sample population controls. A subgroup of the original sample (22 fibromyalgia patients and 13 controls) underwent a pharmacological challenge test with buspirone to assess autonomic and adrenocortical reactivity to serotonergic challenge. RESULTS: Although fibromyalgia patients scored high on neuroticism, anxiety, depression and general distress, only a minor part of variance in pain was explained by psychological factors alone. High pain score was associated with high neuroticism, low baseline cortisol level and small drop in systolic blood pressure after buspirone challenge test. This model explained 41.5% of total pain in fibromyalgia patients. In population controls, psychological factors alone were significant predictors for variance in pain. CONCLUSION: Fibromyalgia patients may have reduced reactivity in the central sympathetic system or perturbations in the sympathetic-parasympathetic balance. This study shows that a biopsychosocial model, including psychological factors as well as factors related to perturbations of the autonomic nervous system and hypothalamic-pituitary-adrenal axis, is needed to explain perceived pain in fibromyalgia patients.