Single-blind randomised controlled trial of chemonucleolysis and manipulation in the treatment of symptomatic lumbar disc herniation.

This single-blind randomised clinical trial compared osteopathic manipulative treatment with chemonucleolysis (used as a control of known efficacy) for symptomatic lumbar disc herniation. Forty patients with sciatica due to this diagnosis (confirmed by imaging) were treated either by chemonucleolysis or manipulation. Outcomes (leg pain, back pain and self-reported disability) were measured at 2 weeks, 6 weeks and 12 months. The mean values for all outcomes improved in both groups. By 12 months, there was no statistically significant difference in outcome between the treatments, but manipulation produced a statistically significant greater improvement for back pain and disability in the first few weeks. A similar number from both groups required additional orthopaedic intervention; there were no serious complications. Crude cost analysis suggested an overall financial advantage from manipulation. Because osteopathic manipulation produced a 12-month outcome that was equivalent to chemonucleolysis, it can be considered as an option for the treatment of symptomatic lumbar disc herniation, at least in the absence of clear indications for surgery. Further study into the value of manipulation at a more acute stage is warranted.

Efficacy of lumbar discectomy and percutaneous treatments for lumbar disc herniation.

The changing health care environment necessitates careful re-evaluation of all costly elective procedures. Low back surgery is a typical example. This article reviews the current literature addressing the efficacy of surgery and invasive percutaneous treatments for discogenic sciatica. It also discusses the prospects for the continuation of reimbursement for these procedures under a system of managed health care. Relevant articles were identified using the MEDLINE and Current Contents databases, from bibliographies of articles identified from these databases, from recommendations of experts in the field, and from the Canadian Cochrane++ Collaboration. The review includes randomized clinical trials, meta-analyses, published practice guidelines and large case series. The literature is classified and discussed in these quality strata. The review includes 9 randomized trials, 6 meta-analyses or review articles, one evidence-based practice guideline, 38 surgical case series and 35 additional references. Though incomplete, the existing evidence indicates that open discectomy shortens the duration of discogenic sciatica in selected patients. Neurologic outcomes are similar in operated and unoperated patients. Predominant leg pain, evidence of nerve root tension and concordant symptoms and imaging findings, are associated with favorable surgical results. Chemonucleolysis is also associated with more rapid pain relief than conservative treatment, but provides less certain benefit than standard discectomy. Available data on other percutaneous disc treatments do not currently support a statement on efficacy. Various percutaneous techniques are available but there is no solid scientific evidence of efficacy. The benefits of open discectomy, principally reduced duration of pain, appear to justify its use in carefully selected patients when discogenic sciatica fails to improve with conservative measures. Though elective, the procedure will probably continue to be available under managed care, but with increasing scrutiny of operative indications.

Chemonucleolysis.

Even with a history of controversy and troubling complications, chymopapain has endured the test of time to show 30 years of clinical success in the treatment of herniated nucleus pulposus. Strict attention to indications, contraindications, and technique ensures safety and efficacy of treatment. A trend to decreased dosage may result in less postinjection spasm. Between 1982-1991, 121 adverse events in 135,000 patients were reported to the Food and Drug Administration and investigated. Seven cases of fatal anaphylaxis, 24 infections, 32 bleeding problems, 32 neurologic events, and 15 miscellaneous occurrences were found. Overall mortality rate was 0.019%. All categories were of lesser incidence than complications with laminectomy. Long-term results show that improvement after chemonucleolysis is maintained, whereas the outcome after laminectomy is reported to deteriorate with time. Cost savings with chemonucleolysis over laminectomy are largely a matter of shorter hospitalization. A protocol for cervical chemonucleolysis is being developed in the United States after good results have been shown in Spain and France. Other enzymes continue under investigation, but chymopapain remains the standard to which they are compared.

Chemonucleolysis versus laminectomy. A cohort comparison of effectiveness and charges.

STUDY DESIGN: A prospective cohort study was done comparing 100 consecutive chemonucleolysis patients with 100 consecutive laminectomy patients. OBJECTIVES: The effectiveness and cost of chymopapain chemonucleolysis was compared with that of laminectomy to manage herniated lumbar discs. SUMMARY OF BACKGROUND DATA: Although the efficacy of chemonucleolysis has been established, controversy regarding the relative benefits of chemonucleolysis and laminectomy continues to arise. The relative cost-effectiveness of the two procedures has not been evaluated previously in a cohort study. METHODS: Patients in both treatment groups were of comparable age, height and weight, and worker's compensation status. Patients with migrated disc were not considered for chemonucleolysis. Improvement in pain, paresthesia, straight-leg raising, reflexes, motor loss, and sensory function, self-reported overall improvement, ability to maintain employment, and charge of treatment were used to measure treatment success. RESULTS: Clinical assessment after 6 weeks showed 92% of laminectomy patients compared with 82% of chemonucleolysis patients compared with 82% of chemonucleolysis patients had successful results (P = 0.058). Chemonucleolysis patients had greater improvement in numbness (P = 0.014) and sensory and motor functions (P = 0.002). After 6 months, 88% of chemonucleolysis patients and 85% of laminectomy patients had successful results, with a greater improvement in sensory status of chemonucleolysis patients and 82% of laminectomy patients had successful results, and more chemonucleolysis patients than laminectomy results, the average charge savings for chemonucleolysis patients was +5365 when chemonucleolysis was performed instead of laminectomy. CONCLUSION: This study shows that chemonucleolysis is an effective as laminectomy in appropriately selected patients but at lower charge and can contribute substantially to reducing short-and long-term health costs.

Chemonucleolysis versus surgical discectomy for sciatica secondary to lumbar disc herniation. A cost and quality-of-life evaluation.

The objective of this study was to evaluate and compare the cost and effects on quality of life [using quality-adjusted life years (QALYs)] of 2 treatments for sciatica secondary to lumbar disc herniation: chemonucleolysis and surgical discectomy. The design involved a combination of decision analysis and Rosser index, with assessment of probabilities from long term clinical series. Utility was based on patients' subjective assessment using a simplified self-administered Health Measurement Questionnaire (HMQ). 146 patients from 7 hospitals were enrolled, 2 to 3 months after chemonucleolysis or surgery. The end-points used were cost and QALYs for each intervention, every year for years 1 to 7. At the time of analysis (1990), the total cost of surgical discectomy was FF15,400, compared with FF8000 for chemonucleolysis. After 1 year, and including the costs of reoperation for failure and relapse and long term medical costs for the non-reoperated unsatisfactory results, discectomy costs were almost 40% higher than those of chemonucleolysis. Ratios remain unchanged after 7 years. QALY results reveal an additional benefit of 52 days of good health associated with chemonucleolysis.

Chemonucleolysis as an alternative to laminectomy for the herniated lumbar disc. Experience with patients in a private orthopedic practice.

Three hundred thirty-five patients with herniated lumbar intervertebral discs were injected with chymopapain. The overall success rate was 76%. The success rate was higher for private insurance patients (89%) than for Worker's Compensation patients (66%). There were no serious complications and patients spent fewer days in the hospital and returned to work faster than patients with laminectomies. Chemonucleolysis is an excellent alternative to open surgery for treatment of a herniated lumbar disc, especially if patients are selected carefully and good technique is strictly followed.