Randomized Study Indicates That Patients With Herniated Disk Improved With or Without Surgery

CHICAGO, IL -- November 21, 2006 -- Patients with lumbar disk herniation who had surgery or nonoperative treatments showed similar levels of improvement in the reduction of pain over a 2- year period, according to a randomized trial in the November 22/29 issue of Journal of the America Medical Association (JAMA). In all cases patients who had surgery did slightly better.

Lumbar diskectomy (surgical removal, in part or whole, of an intervertebral disk)is the most common surgical procedure performed in the United States for patients haviing back and leg pain. The vast majority of the procedures are elective. However, lumbar disk herniation (protrusion from its normal position is often seen on imaging studies in the absence of symptoms and can regress over time without surgery, according to background information in the article. High variation in regional diskectomy rates in the U.S and lower rates internationally raise questions regarding the appropriateness and effectiveness of some of these sur geries, compared to nonoperative care, with evidence inconclusive on the optimal treatment.

James N. Weinstein, DO, MSc, of Dartmouth Medical School, Hanover, N. H., and colleagues compared the outcomes of surgical and nonoperative treatment for lumbar intervertebral disk herniation in the Spine Patient Outcomes Research Trial (SPORT), which included both a randomized trial study group and observational study group who declined to be randomized in favor of desingnating their own treatment.

The randomized clinical trial enrolled patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 U.S. states. The participants included 472 patients (average age, 42 years; 42% women) who were candidates for sugery, with imaging-confirmed lumbar intervertebral disk hernation and persitent signs and symptoms of radiculopathy (involvement of the spinal nerve roots characterized by pain that radiates from the spine, such as down the leg) for at least 6 weeks. Patients were randomized to undergo diskectomy (n=232)vs. nonoperative treatment (n=240), wihitch included physical therapy, education/counseling with home exercise instruction, and nonsteroidal anti-inflammatory drugs, if tolerated. There was follow-up at 6 weeks, 3months, and 1 and 2 years.

The researchers found that adherence to assigned treatment was limited: 50% of patients assigned to sugery within 3 months of enrollment, while 30% of those assigned to nonoperative treatment received surgery in the same period.

Intent-to-treat analyses (in which group outcomes were assessed based on the therapy to which the patient was ini tially assigned) demonstrated substantial improvements for all primary (pain and physical function measures) and secondary outcomes (sciatica severity, satisfaction with symptoms, self-reported improvement, and employment status) in bothtreatment groups. The intent-to-treat analysis likely underrepresents the true treatment effect, while the as-treated analysis likely overestimates the true treatment effect.

" Patients in the both the surgery and nonoperative treatment groups improved substantially over the first 2 years,"the authors write. " Between-group differences in improvements were consistently in favor of surgery for all outcomes and at all time periods but were small and not statistically significant except for the secondary measures of sciatica severity and self-rated improvement. Because of the high numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted basead on the intent-to-treat analysis alone."

JAMA. 2006;296:2441-2450.

Observational Study Demonstrates that Patients Who Chose Surgery Had Great Improvement

In the Companion article, which was the observational study of SPORT, patients with persistent sciatica who had diskectomy or usual care reported improvement over 2 years, although patients who chose surgery experienced greater improvement.

The observational study group, treated at 13 spine clinics in 11 U.S. states between March 2000 and March 2003, included patients who met SPORT eligibility criteria but declined randomization. Of the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperativ care.

At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain, physical function, and on a disability index. Thease differences narrowed somewhat at 2 years.

"In this nonrandomized evaluation of patients with persistent sciatica from lumbar disk hernation who had operative or usual care, both treatment groups improved considerably over 2 years. Nonrandomized comparisons of self-reportd outcomes are subject to potential confounding and must be interpreted cautiously. Nevertheless, patients who underwent diskectomy had significantly better self-reported outcomes than those who had usual care," the authors conclude.

JAMA.2006;296:2451-2459

Editorial: Interpreting Surgical Trials With Subjective Outcomes
In an accompanying editorial, David R. Flum, MD, MPH, of the University of Washington, Seatle, and a Contributing Editor, JAMA, comments on the SPORT articles.

"Althoung at first this finding [from the observational study] suggests that surgery is more beneficial than usual care, this interpretation may be flawed. Patients who elected to have surgery were different in many ways than those who did not. A higher level of disease severity among operative-care patients might be considered a conservative bias in that treatment effects among patients with similar disability might be even greater. But if anything has been learned from the legacy of sham [placebo procedure similar to intervention] - controlled trials, these differences may also include a greater expectation of success among patients having the more invasive intervention."

" Helping balance the competing risks and benefits of operative and nonoperative approaches to discogenic [ disorder originating in or from an intervertebral disk] pain and neurologic symptoms was the goal of the SPORT trial. Because of limitations in design and study operation, the proper role and benefits of these competing interventions are still unclear. Given the number of patients potentially exposed to the risks of these strategies, a sham surgical trial may be the only effective and ethical next step."

JAMA. 2006;296:2483-2485.

Editorial: Surgical Treatment of Lumbar Disk Disorders

In another editorial, Eugene Caragee, MD, of Stanford University Medical Center, Stanford, Calif, discusses the findings of SPORT.

These findings suggest that in most cases there is no clear reason to advocate strongly for sugery apart from patient prefernce. For the patient with emotional, family, and economic resouces to handle mild or moderate sciatica, surgery may have little to offer. In fact, this was the profile of many patients who opted against surgery in the SPORT trial: older participants with higher income and higher education but with milder pain and disability. Furthermore, the SPORT data clearly show that the risk of serious problems (i.e. neurologic deterioration, cauda equina syndrome [characterized by intense leg pain, numbness and weakness or paralysis of legs, buttocks or genitalia],or progression of spinal instabilitty) when receiving nonoperative care is extremeli small. The fear of many patients and surgeons that not removing a large disk herniation will likely have catastrophic neurologic consequences is simply not borne out. Thus, these data help both clinicians and patients make better informed decisions based on each patient's needs and expectations."

Dr. Carragee has received support from the U.S. Department of the Army for research in this field.

JAMA. 2006;296:2485-2487

SOURCE: American Medical Association