Efficacy and safety of sequential versus quadruple therapy as second-line treatment for helicobacter pylori infection-A randomized controlled trial.

BACKGROUND AND AIMS: Quadruple therapy is recommended as second-line treatment for Helicobacter pylori eradication failure. However, high cost, multiple side effects, and low adherence rates are major drawbacks to its routine use. Our aim was to compare the efficacy and safety of sequential versus quadruple regimens as second line treatment for persistent Helicobacter pylori infection. METHODS: Prospective, randomized, open label trial was conducted at a large academic, tertiary care center in Israel. Patients who previously failed a standard triple treatment eradication course were randomly assigned (1:1) to receive a 10-day sequential therapy course, or a 14-day quadruple regimen. Compliance and adverse events were evaluated by telephone questionnaires. The primary endpoint for analysis was the rate of Helicobacter pylori eradication as defined by either a negative 13C-urea breath-test, or stool antigen test, 4-16 weeks after treatment assessed under the non-inferiority hypothesis. The trial was terminated prematurely due to low recruitment rates. See S1 Checklist for CONSORT checklist. RESULTS: One hundred and one patients were randomized. Per modified intention-to-treat analysis, eradication rate was 49% in the sequential versus 42.5% in the quadruple regimen group (p-value for non-inferiority 0.02). Forty-two (84.0%) versus 33 (64.7%) patients completed treatment in the sequential and quadruple groups respectively (p 0.027). Gastrointestinal side effects were more common in the quadruple regimen group. CONCLUSION: Sequential treatment when used as a second line regimen, was non-inferior to the standard of care quadruple regimen in achieving Helicobacter pylori eradication, and was associated with better compliance and fewer adverse effects. Both treatment protocols failed to show an adequate eradication rate in the population of Southern Israel. TRIAL REGISTRATION: ClinicalTrials.gov NCT01481844.

The epidemiology of primary biliary cirrhosis in southern Israel.

BACKGROUND: The epidemiology of primary biliary cirrhosis has changed significantly over the last decade, with a trend towards increasing prevalence in many places around the world. OBJECTIVES: To determine the overall prevalence of PBC in southern Israel and the specific rates for different immigrant groups between January 1993 and October 2004. METHODS: Multiple case-finding methods were used to identify all cases of PBC in the study region. Age-adjusted prevalence rates were compared among the different immigrant groups. RESULTS: A total of 47 cases of PBC were identified with an overall prevalence of 55 cases per million. All patients were women, and all except for a Bedouin Arab were Jewish. Foreign-born patients comprised 70% of our PBC cohort even though they represent only 45.4% of the regional population. This predominance of immigrants did not change when the rates were adjusted for age (P < 0.001). The prevalence rates were 40, 177, and 58 cases per million for those born in Israel, North Africa or Asia, and Eastern Europe, respectively. The age-specific prevalence rate for women older than 40 years varied from 135 cases per million among those born in Israel to 450 among immigrants from Eastern Europe and the former USSR to 700 cases per million among immigrants from North Africa and Asia. CONCLUSIONS: The prevalence of PBC in southern Israel is similar to that reported from some European countries. The rate is much higher among Jews than Arabs and among immigrants to Israel compared to native Israelis.

Polysomnographic and actigraphic evidence of sleep fragmentation in patients with irritable bowel syndrome.

STUDY OBJECTIVE: To characterize the function and quality of sleep in patients with irritable bowel syndrome (IBS). DESIGN: A prospective study with a historic comparison group. SETTING: A regional hospital that also serves as a tertiary referral center. PATIENTS: Eighteen patients with IBS and a comparison group of 20 matched adults with mild benign snoring. INTERVENTIONS: A polysomnography study and a wrist actigraphy study. MEASUREMENTS: All subjects underwent sleep studies and completed self-report questionnaires (IBS severity, psychosocial variables, sleep function, and Epworth Sleepiness Scale). Fourteen IBS and 11 comparison patients underwent actigraphy. RESULTS: The IBS patients had more than 70% less slow-wave stage sleep (4.5 +/- 7.3% vs 19.3 +/- 12.9%; P = 0.006), compensated by increased stage 2 sleep (72.2 +/- 6.6% vs 60.1 +/- 16.8%; P = 0.01). The IBS group had significant sleep fragmentation with a significantly higher arousal and awakening index (P < 0.001), a longer wake period after sleep onset (P = 0.02), and more downward shifts to lighter sleep stages (P = 0.01). The 4-night actigraphy study supported the polysomnography findings. The sleep fragmentation index was significantly higher (P = 0.008) in the IBS group. The IBS patients reported greater daytime sleepiness (9.0 +/- 4.8 vs 6.4 +/- 4.8, Epworth Sleepiness Scale score, P < 0.01) and greater impairment in quality of life, which correlated significantly with the sleep fragmentation indexes. The difference between the groups was not due to differences in baseline anxiety/depression levels. CONCLUSIONS: Patients with IBS have impaired sleep quality, reduced slow-wave sleep activity, and significant sleep fragmentation. The cause-and-effect relationship of these findings with patients' daytime symptoms should be studied further.

Endoscopic self-expanding metal stents for acute colonic obstruction.

The current study presents our experience with the introduction of self-expanding metal stents (SEMS) and assesses success rate, clinical outcomes, and complications. We conducted a historical cohort study reviewing endoscopic SEMS insertions between 2000 and 2010. Overall, 51 patients underwent stent insertion: 38 with an emergent procedure and 13 with a semielective procedure. SEMS was inserted in 27 men and 24 women with a mean age of 68.9 years. Colonic malignancy was the cause of obstruction in all patients. The tumors were localized in the rectosigmoid in 33 (64.7%), in the left colon in 16 (31.4%), and in the right colon in two cases (3.9%). Endoscopic SEMS insertion was technically successful in 68.4 per cent of patients in an emergency and in 84.6 per cent of patients in a semielective setting. Successful stent insertion allowed a "bridge to surgery" in 23 and palliative care in 14 patients. Stent migration occurred in three, obstruction in two, and bowel perforation in three cases. Nineteen patients in the emergent group underwent a subsequent successful semielective colonic resection within 8.1 days (range, 2 to 30 days) of stent insertion. There were two cases (11.1%) of major and four cases (22.2%) of minor postoperative complications in this series. No anastomotic leaks were observed. Mean postoperative hospitalization was 10.1 days (range, 5 to 45 days). Endoscopic stent insertion is a relatively simple procedure providing an effective first-line treatment for relief of symptoms of acute malignant colorectal obstruction, preventing acute perforation, and serving either as a preoperative procedure (allowing lower morbidity semielective surgery) or as palliative care.

Does insertion of a rectal tube after colonoscopy reduce patient discomfort and improve satisfaction?

BACKGROUND: Distention of the colon is a major contributor to patient discomfort after colonoscopy. Some physicians and nurses believe insertion of a rectal tube relieves this discomfort and improves patient satisfaction with the procedure. This prospective, randomized, controlled trial assessed rectal tube insertion for reduction or prevention of abdominal bloating and discomfort after colonoscopy. METHODS: One hundred fifty-seven patients were prospectively randomized to groups with (n = 68) and without (n = 89) rectal tube insertion after colonoscopy. Patients were evaluated for bloating, discomfort, and pain before the procedure, at its conclusion, at discharge, and 24 hours later (by telephone). Satisfaction was also assessed at discharge and 24 hours later. RESULTS: There were no differences between groups with respect to age, gender, hospitalization status, comorbidity, or socioeconomic status. In both groups the cecum was reached in 90% of patients and procedure time was similar. There were no differences between the groups in abdominal bloating (patient and nurse assessment), abdominal discomfort, or satisfaction at any time point. There were no serious complications. The subgroup of patients who experienced more severe pain and discomfort, regardless of whether a rectal tube was inserted, was characterized by more complaints of bloating, more incomplete procedures, and a higher rate of previous abdominal operations. CONCLUSIONS: Insertion of a rectal tube after colonoscopy does not affect abdominal bloating, pain, or discomfort during recovery from the procedure or over the subsequent 24 hours, nor does it affect overall patient satisfaction.