Randomized study indicates that patients with herniated disk improved with or without surgery

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 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 having 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 surgeries, compared to nonoperative care, with evidence inconclusive on the optimal treatment.

James N. Weinstein, D.O., M.Sc., 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 an observational study group who declined to be randomized in favor of designating 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 percent women) who were candidates for surgery, with imaging-confirmed lumbar intervertebral disk herniation and persistent 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), which included physical therapy, education/counseling with home exercise instruction, and nonsteroidal anti-inflammatory drugs, if tolerated. There was follow-up at 6 weeks, 3 months, 6 months, and 1 and 2 years.

The researchers found that adherence to assigned treatment was limited: 50 percent of patients assigned to surgery received surgery within 3 months of enrollment, while 30 percent 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 initially 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 both treatment 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 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 based on the intent-to-treat analysis alone."

(JAMA. 2006;296:2441-2450. Available pre-embargo to the media at www.jamamedia.org.)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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 nonoperative 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. These differences narrowed somewhat at 2 years.

"In this nonrandomized evaluation of patients with persistent sciatica from lumbar disk herniation who had operative or usual care, both treatment groups improved considerably over 2 years. Nonrandomized comparisons of self-reported 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. Available pre-embargo to the media at www.jamamedia.org.)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

In an accompanying editorial, David R. Flum, M.D., M.P.H., of the University of Washington, Seattle, and a Contributing Editor, JAMA, comments on the SPORT articles.

"Although 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 large 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. Available pre-embargo to the media at www.jamamedia.org.)

Editor's Note: Financial disclosures - none reported.

In another editorial, Eugene Carragee, M.D., 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 surgery apart from patient preference. For the patient with emotional, family, and economic resources 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 instability) when receiving nonoperative care is extremely 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."

(JAMA. 2006;296:2485-2487. Available pre-embargo to the media at www.jamamedia.org.)

Editor's Note: Dr. Carragee has received support from the U.S. Department of the Army for research in this field.

For more information, contact JAMA/Archives Media Relations at 312/464-JAMA or e-mail mediarelations@jama-archives.org.