Surgical vs. Nonoperative Treatment for Lumbar Disk Herniation December 5, 2006
Posted by healthweb in Neurology, Surgery.8 comments
The Spine Patient Outcomes Research Trial (SPORT) Observational Cohort.(JAMA, November 22/29, 2006)
Posted by Dr. David Weir
Background:-Lumbar discectomy is the most common surgical intervention for sciatic-like pain in the United States. -The effectiveness of surgery vs. nonoperative treatment of back and leg symptoms remains controversial.
Methods:
-Prospective observational study. Patients were evaluated at 6 weeks, 3 months, 6 months, 1 year, and 2 years of follow-up.
-Inclusion criteria- 18 years or older with intervertebral disk herniation and persistent symptoms despite some nonoperative treatment for at least 6 weeks. Radicular pain, positive straight leg test, corresponding neurologic deficit with disk herniation on CT or MRI that corresponded to clinical symptoms.
-Exclusion criteria- prior lumbar surgery, cauda equine syndrome, scoliosis greater than 15 degrees, segmental instability, vertebral fractures, spine infection or tumor, inflammatory spondyloarthropathy, pregnancy, unwillingness to have surgery within 6 months.
-Primary endpoints- Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) bodily pain and physical function scales and the AmericanAcademy of Orthopedic Surgeons version of the Oswestry Disability Index (ODI).
-Secondary endpoints- Self-reported improvement, work status, and satisfaction with current symptoms and care.-The study was powered to detect a 10-point difference in the SF-36 and a comparable difference in the ODI. -743 patients enrolled, 521 chose surgery, 222 chose nonoperative care. At 2 years 96%of the surgery arm underwent surgery and 22% of the nonoperative care group underwent surgery. Results:
-In the surgery group the adjusted change in the SF-36 score at 2 years was 42.6 for bodily pain and 43.9 for physical function. The change in the ODI score at 2 years was -37.6.- In the nonoperative group the adjusted change in the SF-36 score at 2 years was 32.4 for bodily pain and 31.9 for physical function. The change in the ODI score at 2 years was -24.2.-The difference between the two groups at two years (treatment effect) was 10.2 (95%CI, 5.9-14.5) for SF-36 bodily pain, 12.0 (95%CI 7.9-16.1) for SF-36 physical function, and -13.4 (95%CI -17.0 to -9.7) for ODI score. (Higher SF-36 scores indicate less severe symptoms, a lower ODI score indicates less severe symptoms). (more…)
High-Dose Atorvastatin after Stroke or Transient Ischemic Attack” (NEJM, August 10, 2006) August 24, 2006
Posted by healthweb in Neurology.1 comment so far
Summary by Jon Arnason
Background: Statins have been found to reduce the risk of stroke in patients with increased risk for cardiovascular disease. It has been shown that individuals who have had a prior stroke are at risk for having subsequent strokes as well as other cardiovascular events.
Primary Question: In patients with a prior stroke or TIA, does the administration of a high dose statin reduce the risk of subsequent stroke
Study Design: Double blinded, placebo controlled controlled study. 6670 patients with prior stroke or TIA 1 to 6 months prior to randomization were selected, with an LDL from 100 to 190 and no known CAD. 1939 were excluded, secondary to exclusion criteria (atrial fibrillation, other cardiac sources of embolism, subarachnoid hemorrhage), withdrew consent, or had an adverse event prior to receiving treatment. 4731 underwent randomization with intention to treat. One group received 80mg of atorvastatin the second received placebo. The primary end point was a first nonfatal or fatal stroke
Primary Outcomes:
Stroke: Primary end point (stroke) occurred in 265 (11.2%) patients in the treatment group and 311(13.1%) in the placebo group. Absolute risk reduction 1.9%, relative risk reduction 18.0%.
Secondary Outcomes
LDL: Mean LDL cholesterol levels were similar in the two groups at randomization. After one month LDL in the treatment group was 61.3 and 133.5 in the placebo group.
Stroke or TIA: 375 (15.9%) in treatment group, 476 (20.1%) in placebo group.
Major Coronary Event: 81 (3.4%) in treatment group, 120 (5.1%) in placebo group
Major Cardiovascular Event: 334 (14.1%) in treatment group, 407 (17.2%) in placebo group.
Death: Death occurred in 216 (9.1%)patients in the treatment group, 211 (8.9%) in the placebo group (P =0.98, though not powered t detect difference).
Ischemic Stroke: 218 in treatment group, 274 in placebo group.
Hemorrhagic Stroke: 55 in treatment group, 33 in placebo group.
Adverse effects were similar between the two groups.
Take Home Points: Treatment with 80mg of atorvastatin per day reduces the risk of stroke and fatal strokes in patients without CAD and with cholesterol 100-190 who had a recent stroke or TIA. Also found to reduce the risk of cardiovascular events, suggesting that stroke or TIA should be considered a CAD equivalent. However, saw an increase in hemorrhagic stoke in treatment group, as has been suggested by prior epidemiologic studies linking low LDL with brain hemorrhage.
