Rh. Wittenberg et al., Five-year results from chemonucleolysis with chymopapain or collagenase - A prospective randomized study, SPINE, 26(17), 2001, pp. 1835-1841
Study Design. A 5-year clinical follow-up assessment of a prospective rando
mized study of chemonucleolysis using chymopapain (4000 IU) or collagenase
(400 ABC units) was performed.
Summary of Background Data. Intradiscal therapy can be performed for patien
ts with contained discs by chemonucleolysis, percutaneous discectomy, or la
ser ablation. The oldest intradiscal therapy is chemonucleolysis with chymo
papain.
Objective. The purpose of this study was to compare prospectively the effic
acy of chymopapain and collagenase for intradiscal injection.
Methods. In this study, 100 patients with indication for intradiscal therap
y were prospectively randomized to treatment with either chymopapain or col
lagenase. All the injections were performed by the double-needle technique
with the patient under general anesthesia. The mean age of the patients was
35.5 years in the chymopapain group and 38 years in the collagenase group.
An equal number of injections was performed at L4-L5 and L5-S1.
Results. After 5 years, good and excellent results were observed in 72% of
the chymopapain group and 52% of the collagenase group when the surgically
treated and lost patients were graded as poor. Using a scale of 0 (no pain)
to 10 (intractable pain), the pain level dropped from 8.5 to 0.7 in the ch
ymopapain group and from 8.6 to 0.9 in the collagenase group. Microdiscecto
my at the injected level was required for 23 patients (14 in the collagenas
e group and 9 in the chymopapain group).
Conclusions. After 5 years, no deterioration had,occurred, as compared with
the 1-year follow-up assessment. Chymopapain has proved to be safe, with o
ne minor anaphylactic reaction, and effective even over the long term. Coll
agenase may need further study and cannot be recommended at this time.