Prospective randomized trial of chemonucleolysis compared with surgery for soft disc herniation with 1-year, intermediate, and long-term outcome: part I: the clinical outcome

Spine (Phila Pa 1976). 2013 Aug 1;38(17):E1051-7. doi: 10.1097/BRS.0b013e31829729b3.


Study design: A prospective consecutive series of 100 patients computer randomized into 2 groups to have treatment by either chemonucleolysis or surgery.

Objective: To compare the complications and clinical outcome between the groups at 1 year, and at 10 to 13 and 24 to 27 years.

Summary of background data: Chemonucleolysis was introduced in 1964 and became widely used. Its efficacy was proven by several randomized studies when compared with a placebo and surgery. The manufacturing of Chemonucleolysis was ceased in 2001.

Methods: One hundred consecutive patients were enrolled for the study and randomized according to age, sex, and disc level. They were followed up at 1 year with self-assessment questionnaires to establish if they were completely better, improved, the same or worse. At 10 to 13 years, 61 patients (32 chemonuceolysis and 29 surgery) and at 24 to 27 years, 45 patients (24 chemonucleolysis and 21 surgery) were self-assessed by questionnaire according to the Macnab criteria.

Results: Forty-eight patients were treated by chemonucleolysis and 52 by surgery. Ten patients treated by chemonucleolysis underwent surgery within 8 weeks. At 1 year, 10 to 13 years, and 24 to 27 years, 94%, 72%, and 63% of patients treated by chemonucleolysis had good or excellent results compared with 96%, 72%, and 67% of patients who underwent surgery, respectively. There was no difference in the clinical outcome between the treatments at any of the follow-up time points. There were 2 serious complications, 1in each treatment group.

Conclusion: Chemonucleolysis is as effective as surgery when assessed according to intention-to-treat analysis, with reduced complications, and age has no bearing on the outcome. The authors think that restoration of its availability would be beneficial to patients.

Level of evidence: 1.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Back Pain / diagnosis
  • Back Pain / etiology
  • Chymopapain / administration & dosage
  • Chymopapain / therapeutic use*
  • Diskectomy / adverse effects
  • Diskectomy / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Intervertebral Disc Chemolysis / adverse effects
  • Intervertebral Disc Chemolysis / methods*
  • Intervertebral Disc Displacement / surgery*
  • Leg / physiopathology
  • Lumbar Vertebrae / surgery
  • Male
  • Middle Aged
  • Pain / diagnosis
  • Pain / etiology
  • Postoperative Complications / diagnosis
  • Postoperative Complications / etiology
  • Prospective Studies
  • Sacrum / surgery
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Chymopapain