A randomized, double-blind study to compare low-dose with standard-dose chymopapain in the treatment of herniated lumbar intervertebral discs.
Postoperative low-back pain and spasm are the main drawbacks of chymopapain chemonucleolysis. To investigate if low-dose chymopapain could reduce this adverse reaction, without modifying the efficacy, 118 patients with persistent low-back and radicular pain due to a lumbar disc herniation underwent chemonucleolysis. 60 patients were randomly selected to receive 2 mL of standard-dose chymopapain (4,000 units) and 58 to receive 2 mL of low dose (2,000 units). The clinical outcome was assessed on study days 1, 30, and 60, and after 1 year by physicians who were unaware of the treatment, and on the basis of the patients' self evaluation. At day 60, Chemonucleolysis was rated as successful in 81% of the cases by the investigator and in 80% by the patient's self assessment. The percentage of good results was remarkably similar in the two treatment groups and this finding was confirmed after 1 year. There was some evidence that the low-dose treatment resulted in less frequent postoperative back pain but the difference was not statistically significant. Moreover, a comparable incidence of acute low-back pain and spasm was observed in the two treatment groups. Low-dose chemonucleolysis appears to be as effective as the standard dose, but the use of 2,000 units does not significantly lower the postoperative back pain.
Benoist
M
M
Department of Orthopaedic Surgery, Hôpital Beaujon, Clichy, France.
Bonneville
J F
JF
Lassale
B
B
Runge
M
M
Gillard
C
C
Vazquez-Suarez
J
J
Deburge
A
A
D000328:Adult; D000368:Aged; D002917:Chymopapain / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007404:Intervertebral Disc Chemolysis; D007405:Intervertebral Disc Displacement / Q000628:therapy*; D017116:Low Back Pain / Q000209:etiology; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D002917:Chymopapain