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.

Effect of psychosocial stressors on patients with Crohn's disease: threatening life experiences and family relations.

BACKGROUND AND AIMS: Threatening life experiences and adverse family relations are major psychosocial stressors affecting mental and physical health in chronic illnesses, but their influence in Crohn's disease (CD) is unclear. We assessed whether these stressors would predict the psychological and medical condition of CD patients. METHODS: Consecutive adult CD patients completed a series of instruments including demography, Patient Harvey-Bradshaw Index (P-HBI), Short Inflammatory Bowel Disease Questionnaire (SIBDQ), short-form survey instrument (SF-36), brief symptom inventory (BSI), family assessment device (FAD), and list of threatening life experiences (LTE). Associations of FAD and LTE with P-HBI, SIBDQ, SF-36, and BSI were examined by multiple linear and quantile regression analyses. RESULTS: The cohort included 391 patients, mean age 38.38±13.95 years, 59.6% women, with intermediate economic status. The median scores were as follows: P-HBI 4 (2-8), FAD 1.67 (1.3-2.1), LTE 1 (0-3), SF-36 physical health 43.75 (33.7-51.0), SF-36 mental health 42.99 (34.1-51.9), and BSI-Global Severity Index 0.81 (0.4-1.4). The SIBDQ was 47.27±13.9. LTE was associated with increased P-HBI in all quantiles and FAD in the 50% quantile. FAD and LTE were associated with reduced SIBDQ (P<0.001). Higher LTE was associated with lower SF-36 physical and mental health (P<0.001); FAD was associated with reduced mental health (P<0.001). FAD and LTE were associated positively with GSI in all quantiles; age was associated negatively. CONCLUSION: CD patients with more threatening life experiences and adverse family relations were less healthy both physically and mentally. Physicians offering patients sociopsychological therapy should relate to threatening life experiences and family relations.

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.

[Iron-deficiency anemia related to ancylostoma duodenale infection among Ethiopian immigrants to Israel].

BACKGROUND: Among the diseases imported by the Ethiopian immigrants to Israel are many parasite infections. Hookworm infections, caused by the nematodes Necator americanus and Ancylostoma duodenale, involve the gastrointestinal tract, causing iron-deficiency anemia. OBJECTIVES: To evaluate the rate of iron-deficiency anemia related to hookworm infections among immigrants from an endemic area. METHODS: We retrospectively studied the medical records of all Ethiopians over the age of 18, who immigrated to Israel in the early 90's, in two primary care clinics of Clalit Health Services in Ofakim. RESULTS: Sixty patients (64%) had evidence of A. duodenale infection. The mean hemoglobin level was 11.92.3 g/dl in the Ancylostoma group and 13.81.6 g/dl in the control group (p = 0.0001). Analyzing the data according to the patient's sex revealed significant differences in the hemoglobin levels between the Ancylostoma group and the control group. Patients infected with A. duodenale had significantly lower mean corpuscular volume (MCV) and serum iron, and were likely to have eosinophilia and hypoalbuminemia. CONCLUSION: Among the Ethiopian immigrant population, Ancylostoma duodenale infection is a common cause of iron deficiency anemia. In young patients it should be ruled out before invasive and expensive investigations are performed.

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.