Alosetron versus traditional pharmacotherapy in clinical practice: effects on resource use,health-related quality of life,safety and symptom improvement in women with severe diarrhea-predominant irritable bowel syndrome

Objective: Severe diarrhea-predominant irritable bowel syndrome (IBS-D) is associated with decreased health-related quality of life (HRQOL) and increased health care costs. Treatment recommendations for IBS-D often start with traditional pharmacotherapy (TP), with escalation to alosetron, rifaximin or eluxadoline if there is no success. There has been no previous head-to-head clinical trial comparing IBS-D treatment outcome for alosetron versus TP. This study, GSK protocol S3B30020, evaluated resource use, work productivity, health-related quality of life and global symptom response in women with IBS-D who were treated with alosetron or TP.

Methods: A total of 1956 patients who met criteria for severe IBS-D were randomized to treatment with alosetron 1?mg twice daily (BID) or only TP for up to 24 weeks. Work productivity and resource use were evaluated by standard questionnaires, HRQOL by the IBSQOL instrument and IBS symptoms by the Global Improvement Scale (GIS).

Results: Compared to only TP, alosetron-treated patients reported: (1) fewer clinic/office visits for any health problem (p?=?.0181) or for IBS-D (p?=?.0004); (2) reduced use of over-the-counter medications for IBS-D (p < .0001); (3) fewer days of lost work productivity (p < .0001); (4) decreased restriction of social and outdoor activities (p < .0001); and (5) greater global improvement in IBS-D symptoms (p < .0001). Alosetron treatment improved HRQOL scores for all domains (p < .0001). Incidence of adverse events during alosetron use was not remarkable and was similar to that previously reported.

Conclusions: Alosetron 1?mg BID significantly reduced health care utilization and lost productivity, and significantly improved global IBS symptoms, HRQOL, and participation in outdoor and social activities compared with treatment response to TP.     

A Quality and Cost-Benefit Analysis of Dialyzer Reuse in Hemodialysis Patients

Background. To evaluate the benefits of dialyzer reuse for hemodialysis (HD) patients, including the cost of HD treatment and patient's survival, a comparison was made regarding the standard practice of single-use dialysis. Methods. From January 1, 2005, to December 31, 2005, a total of 128,232 successive HD treatments in 822 patients in Chang Gung Memorial Hospital-Kaohsiung Medical Center were included in this study. Results. Approximately 54.25% (446/822) of patients reused dialyzers. The average times of dialyzer reuse was 2.54. The annual hollow fiber cost is reduced by $241,054.08 U.S. dollars (NT $7,834,257.60). The annual cost of hollow fiber was reduced by $540.48 U.S. dollars (NT $17,565.60) in one patient with dialyzer reuse. The mortality rates in dialyzer reuse and single use groups were 3.1% and 10.9% within one year (p < 0.0001). Multiple logistic regressions showed that single use compared with reuse was associated with higher mortality after adjusting co-morbid conditions including age, diabetes mellitus, etc. Conclusions. We concluded that the benefits of dialyzer reuse included safety in our center and reduction in cost during a 12-month period. Dialyzer reuse may be a safe alternative.     

Loading effects of anterior cervical spine fusion on adjacent segments

Adjacent segment degeneration typically follows anterior cervical spine fusion. However, the primary cause of adjacent segment degeneration remains unknown. Therefore, in order to identify the loading effects that cause adjacent segment degeneration, this study examined the loading effects to superior segments adjacent to fused bone following anterior cervical spine fusion. The C3–C6 cervical spine segments of 12 sheep were examined. Specimens were divided into the following groups: intact spine (group 1); and C5–C6 segments that were fused via cage-instrumented plate fixation (group 2). Specimens were cycled between 20° flexion and 15° extension with a displacement control of 1°/second. The tested parameters included the range of motion (ROM) of each segment, torque and strain on both the body and inferior articular process at the superior segments (C3–C4) adjacent to the fused bone, and the position of the neutral axis of stress at under 20° flexion and 15° extension. Under flexion and Group 2, torque, ROM, and strain on both the bodies and facets of superior segments adjacent to the fused bone were higher than those of Group 1. Under extension and Group 2, ROM for the fused segment was less than that of Group 1; torque, ROM, and stress on both the bodies and facets of superior segments adjacent to the fused bone were higher than those of Group 1. These analytical results indicate that the muscles and ligaments require greater force to achieve cervical motion than the intact spine following anterior cervical spine fusion. In addition, ROM and stress on the bodies and facets of the joint segments adjacent to the fused bone were significantly increased. Under flexion, the neutral axis of the stress on the adjacent segment moved backward, and the stress on the bodies of the segments adjacent to the fused bone increased. These comparative results indicate that increased stress on the adjacent segments is caused by stress-shielding effects. Furthermore, increased stress and ROM of the adjacent segments after long-term bone fusion may accelerate degeneration in adjacent segment.