ABSTRACT
INTRODUCTION: Treatment of lumbar disc herniation (LDH) using condoliase chemonucleolysis (CC) requires more time than surgery to demonstrate therapeutic effects. This study aimed to identify patients who show significant improvement in leg pain very early after CC and to determine pretreatment factors that can predict a very early therapeutic response. METHODS: The study included 52 patients who underwent CC for treatment-resistant LDH. Scores for low back and leg pain measured by a numerical rating scale were assessed at four time points (1 day, 1 week, 1 month, and 3 months after CC). Patients who reported subjective pain relief the day after treatment and further exhibited an improved straight leg raising (SLR) angle compared to pretreatment were classified as "very early responders (VER)". RESULTS: Of the 52 patients, 39 (75%) were VER, and 13 (25%) were non-VER. The VER showed earlier improvement in leg pain. The VER had a significantly higher proportion of positive SLR test patients (p = 0.01) and a significantly smaller pretreatment SLR angle compared to the non-VER (VER vs. non-VER: 40.6 ± 19.0 vs. 63.1 ± 16.9, p < 0.001). There were no significant differences in the level, type, and size of LDH and the disc regression rate between the two groups. CONCLUSIONS: Patients with a smaller pretreatment SLR angle are more likely to experience very early or early symptomatic relief, with a significant and sustained reduction in leg pain up to 3 months after CC treatment.
Subject(s)
Intervertebral Disc Chemolysis , Intervertebral Disc Displacement , Lumbar Vertebrae , Humans , Male , Female , Middle Aged , Lumbar Vertebrae/surgery , Adult , Treatment Outcome , Intervertebral Disc Chemolysis/methods , Aged , Low Back Pain/drug therapy , Low Back Pain/etiology , Pain Measurement , Chymopapain/therapeutic useABSTRACT
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 radiological findings preoperatively with the clinical outcome between the groups at 1 year, 10 to 13, and 24 to 27 years of follow-up. 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. However, it ceased to be manufactured in 2001. METHODS: One hundred consecutive patients were enrolled for the study and randomized according to age, sex, and disc level. Preoperatively, their anteroposterior, lateral lumbar spine, and lateral lumbosacral angle radiographs were obtained, and a myelogram was performed. At 10 to 13 years, 32 of the original patients (18 chemonucleolysis and 14 surgery) and at 24 to 27 years, 45 patients (24 chemonucleolysis and 21 surgery) were assessed by lateral lumbosacral angle radiographs. RESULTS: Using the myelographical findings, small, medium, and large herniations were digested by chymopapain with more of the failures being the larger ones. There was an equal degree of degenerative change as measured by disc height loss in the young and older age groups and the degree of degenerative change did not relate to outcome. The size of the defect did not relate to the degree of disc height loss. There was a slight loss of disc height over time in both groups. There was no difference in the loss of disc height between the treatments at any of the follow-up time points. CONCLUSION: Chemonucleolysis is as effective as surgery when assessed according to intention-to-treat analysis. The loss of disc height over time is the same in both groups. The authors think that restoration of its availability would be beneficial to patients. LEVEL OF EVIDENCE: 1.
Subject(s)
Chymopapain/therapeutic use , Diskectomy/methods , Intervertebral Disc Chemolysis/methods , Intervertebral Disc Displacement/surgery , Adolescent , Adult , Aged , Chymopapain/administration & dosage , Diskectomy/adverse effects , Female , Follow-Up Studies , Humans , Intervertebral Disc/diagnostic imaging , Intervertebral Disc/surgery , Intervertebral Disc Chemolysis/adverse effects , Lumbar Vertebrae/radiation effects , Lumbar Vertebrae/surgery , Male , Middle Aged , Prospective Studies , Radiography , Sacrum/radiation effects , Sacrum/surgery , Time Factors , Treatment Outcome , Young AdultABSTRACT
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.
Subject(s)
Chymopapain/therapeutic use , Diskectomy/methods , Intervertebral Disc Chemolysis/methods , Intervertebral Disc Displacement/surgery , Adolescent , Adult , Aged , Back Pain/diagnosis , Back Pain/etiology , Chymopapain/administration & dosage , Diskectomy/adverse effects , Female , Follow-Up Studies , Humans , Intervertebral Disc Chemolysis/adverse effects , 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 AdultABSTRACT
We evaluated the efficacy and safety of chemonucleolysis and intradiscal electrothermal therapy (IDET) on the basis of the data presented in recently published papers with respect to pain relief, function, and complication rates. Detailed searches for English and German articles published between 2003 and 2008 were performed in a number of electronic databases. Further publications were identified by manual search. For summarizing the evidence, we considered only systematic reviews and controlled studies. The internal validity of reviews and studies was judged by two authors independently. Data extraction was performed by one author, and the extracted data was checked for completeness and correctness by a second author. The evidence of the efficacy of chemonucleolysis using chymopapain or collagenase is summarized in two recent, high-quality systematic reviews. We found 5 controlled studies evaluating nucleolysis using an oxygen-ozone mixture (O (2)O (3)-nucleolysis). Some of those studies were of limited methodological quality, but all showed the efficacy of O (2)O (3)-nucleolysis in comparison to microdiscectomy or the use of alternative substances. There is hardly any data regarding O (2)O (3)-nucleolysis complications. Regarding IDET, the authors of the 6 identified systematic reviews come to different conclusions about the efficacy of the procedure. The results of the 3 included controlled IDET studies, of which 2 are of high methodological quality, are also conflicting. The complication rates range from 0 to 15 %. In summary, the evidence of efficacy is presently more compelling for chemonucleolysis than for IDET. This may also be because indications for chemonucleolysis are more firmly established. However, safety aspects should be better evaluated and presented in the literature.
Subject(s)
Evidence-Based Medicine , Hyperthermia, Induced/methods , Intervertebral Disc Chemolysis/methods , Intervertebral Disc Displacement/surgery , Chymopapain/adverse effects , Chymopapain/therapeutic use , Collagenases/adverse effects , Collagenases/therapeutic use , Combined Modality Therapy , Diskectomy/adverse effects , Humans , Hyperthermia, Induced/adverse effects , Intervertebral Disc Chemolysis/adverse effects , Microsurgery/adverse effects , Oxygen/adverse effects , Oxygen/therapeutic use , Ozone/adverse effects , Ozone/therapeutic use , Pain Measurement , Patient Satisfaction , Postoperative Complications/etiology , Quality of Life , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
STUDY DESIGN: An updated Cochrane Review. OBJECTIVES: To assess the effects of surgical interventions for the treatment of lumbar disc prolapse. SUMMARY OF BACKGROUND DATA: Disc prolapse accounts for 5% of low back disorders yet is one of the most common reasons for surgery. There is still little scientific evidence supporting some interventions. METHODS: Use of standard Cochrane review methods to analyze all randomized controlled trials published up to January 1, 2007. RESULTS: Forty randomized controlled trials (RCTs) and 2 quasi-RCTs were identified. Many of the early trials were of some form of chemonucleolysis, whereas the majority of the later studies either compared different techniques of discectomy or the use of some form of membrane to reduce epidural scarring. Four trials directly compared discectomy with conservative management, and these give suggestive rather than conclusive results. However, other trials show that discectomy produces better clinical outcomes than chemonucleolysis, and that in turn is better than placebo. Microdiscectomy gives broadly comparable results to standard discectomy. Recent trials of an interposition gel covering the dura (5 trials) and of fat (4 trials) show that they can reduce scar formation, although there is limited evidence about the effect on clinical outcomes. There is insufficient evidence on other percutaneous discectomy techniques to draw firm conclusions. Three small RCTs of laser discectomy do not provide conclusive evidence on its efficacy. There are no published RCTs of coblation therapy or transforaminal endoscopic discectomy. CONCLUSION: Surgical discectomy for carefully selected patients with sciatica due to lumbar disc prolapse provides faster relief from the acute attack than conservative management, although any positive or negative effects on the lifetime natural history of the underlying disc disease are still unclear. The evidence for other minimally invasive techniques remains unclear except for chemonucleolysis using chymopapain, which is no longer widely available.
Subject(s)
Intervertebral Disc Displacement/surgery , Intervertebral Disc/surgery , Lumbar Vertebrae/surgery , Neurosurgical Procedures/statistics & numerical data , Chymopapain/therapeutic use , Cicatrix/prevention & control , Cicatrix/therapy , Diskectomy/adverse effects , Diskectomy/statistics & numerical data , Diskectomy/trends , Dura Mater/surgery , Endoscopy/statistics & numerical data , Endoscopy/trends , Gels/therapeutic use , Humans , Intervertebral Disc/pathology , Intervertebral Disc/physiopathology , Intervertebral Disc Chemolysis/statistics & numerical data , Intervertebral Disc Chemolysis/trends , Laser Therapy , Lumbar Vertebrae/pathology , Lumbar Vertebrae/physiopathology , Neurosurgical Procedures/methods , Neurosurgical Procedures/trends , Postoperative Complications/etiology , Postoperative Complications/physiopathology , Postoperative Complications/prevention & control , Randomized Controlled Trials as Topic/statistics & numerical data , Sciatica/surgery , Treatment OutcomeABSTRACT
PURPOSE: To carry out a systematic review and meta-analysis of the efficacy of chemonucleolysis in the treatment of lumbar disc herniation. METHODS: Clinical trials were selected from 3 electronic databases (The Cochrane Controlled Trials Register, MEDLINE, and EMBASE). Data were analyzed with the software STATA, using the meta command. RESULTS: Twenty-two clinical trials were eligible. For chemonucleolysis versus placebo, the summary risk ratio estimate for pain relief as outcome was 1.51 (95% CI: 1.27-1.80). The summary estimate was 1.07 (95% CI: 0.95-1.20) for the comparison between chymopapain and collagenase. Regarding chemonucleolysis with chymopapain versus surgery, the fixed-effect summary estimate of effect for pain relief was 0.93 (95% CI: 0.88-0.98) with surgery as the reference group. In this case, heterogeneity was statistically significant. CONCLUSIONS: Chemonucleolysis with chymopapain was superior to placebo and was as effective as collagenase in the treatment of lumbar disc prolapse. Results for studies comparing chemonucleolysis with surgery were heterogeneous, making it difficult to interpret the summary measure of effect.
Subject(s)
Chymopapain/therapeutic use , Collagenases/therapeutic use , Intervertebral Disc Chemolysis/standards , Intervertebral Disc Displacement/drug therapy , Controlled Clinical Trials as Topic/standards , Databases, Bibliographic/statistics & numerical data , Humans , Placebos/therapeutic use , Randomized Controlled Trials as TopicABSTRACT
PURPOSE: To carry out a systematic review and meta-analysis of the efficacy of chemonucleolysis in the treatment of lumbar disc herniation. METHODS: Clinical trials were selected from 3 electronic databases (The Cochrane Controlled Trials Register, MEDLINE, and EMBASE). Data were analyzed with the software STATA, using the meta command. RESULTS: Twenty-two clinical trials were eligible. For chemonucleolysis versus placebo, the summary risk ratio estimate for pain relief as outcome was 1.51 (95 percent CI: 1.27-1.80). The summary estimate was 1.07 (95 percent CI: 0.95-1.20) for the comparison between chymopapain and collagenase. Regarding chemonucleolysis with chymopapain versus surgery, the fixed-effect summary estimate of effect for pain relief was 0.93 (95 percent CI: 0.88-0.98) with surgery as the reference group. In this case, heterogeneity was statistically significant. CONCLUSIONS: Chemonucleolysis with chymopapain was superior to placebo and was as effective as collagenase in the treatment of lumbar disc prolapse. Results for studies comparing chemonucleolysis with surgery were heterogeneous, making it difficult to interpret the summary measure of effect.
OBJETIVO: Avaliar a eficácia da quimonucleólise no tratamento da hérnia de disco lombar por meio de uma metanálise de ensaios clínicos. MÉTODOS: Os ensaios clínicos foram selecionados de três bases de dados eletrônicas( Cochrane, MEDLINE, e EMBASE). Os dados foram analisados por intermédio do aplicativo STATA, com o comando meta. RESULTADOS: trabalhamos com 22 ensaios clínicos. Para a comparação entre quimonucleólise e placebo, a estimativa da razão de riscos, tendo melhora da dor como desfecho, foi de 1,51 (I 95 por cento C: 1,27-1,80). Aquela medida foi de 1,07 (I 95 por cento C: 0,95-1,20) para a comparação entre quimopapaína e colagenase. Em um modelo de efeitos fixos, a razão de risco, para melhora da dor, foi 0,93 (I 95 por cento C: 0,88-0,98), tendo a discectomia como grupo de referência. Nesse caso, um teste de heterogeneidade foi considerado estatisticamente significante. CONCLUSÕES: a eficácia da quimonucleólise foi superior à do placebo e semelhante à da colagenase. Os resultados dos estudos referentes à comparação entre quimonucleólise e cirurgia foram heterogêneos, o que implica interpretação não-trivial da medida de efeito.
Subject(s)
Humans , Chymopapain/therapeutic use , Collagenases/therapeutic use , Intervertebral Disc Chemolysis/standards , Intervertebral Disc Displacement/drug therapy , Controlled Clinical Trials as Topic/standards , Databases, Bibliographic/statistics & numerical data , Placebos/therapeutic use , Randomized Controlled Trials as TopicABSTRACT
STUDY DESIGN: A prospective randomized study involving 280 consecutive cases of lumbar disc herniation managed either by an endoscopic discectomy alone or an endoscopic discectomy combined with an intradiscal injection of a low dose (1000 U) of chymopapain. OBJECTIVE: To compare outcome, complications, and reherniations of both techniques. SUMMARY OF BACKGROUND DATA: Despite a low complication rate, posterolateral endoscopic nucleotomy has made a lengthy evolution because of an assumed limited indication. Chemonucleolysis, however, proven to be safe and effective, has not continued to be accepted by the majority in the spinal community as microdiscectomy is considered to be more reliable. METHOD: A total of 280 consecutive patients with a primary herniated, including sequestrated, lumbar disc with predominant leg pain, was randomized. A clinical follow-up was performed at 3 months, and at 1 and 2 years after the index operation with an extensive questionnaire, including the visual analog scale for pain and the MacNab criteria. The cohort integrity at 3 months was 100%, at 1 year 96%, and at 2 years 92%. RESULTS: At the 3-month evaluation, only minor complications were registered. At 1-year postoperatively, group 1 (endoscopy alone) had a recurrence rate of 6.9% compared to group 2 (the combination therapy), with a recurrence rate of 1.6%, which was a statistically significant difference in favor of the combination therapy (P = 0045). At the 2-year follow-up, group 1 reported that 85.4% had an excellent or good result, 6.9% a fair result, and 7.7% were not satisfied. At the 2-year follow-up, group 2 reported that 93.3% had an excellent or good result, 2.5% a fair result, and 4.2% were not satisfied. This outcome was statistically significant in favor of the group including chymopapain. There were no infections or patients with any form of permanent iatrogenic nerve damage, and no patients had a major complication. CONCLUSIONS: A high percentage of patient satisfaction could be obtained with a posterior lateral endoscopic discectomy for lumbar disc herniation, and a statistically significant improvement of the results was obtained when an intradiscal injection of 1000 U of chymopapain was added. There was a low recurrence rate with no major complications. The method can be applied in any type of lumbar disc herniation, including the L5-S1 level.
Subject(s)
Chymopapain/therapeutic use , Diskectomy/methods , Endoscopy/methods , Intervertebral Disc Chemolysis , Intervertebral Disc Displacement/drug therapy , Lumbar Vertebrae/surgery , Adult , Chymopapain/administration & dosage , Combined Modality Therapy , Decompression, Surgical , Female , Follow-Up Studies , Humans , Injections, Intralesional , Intervertebral Disc Displacement/complications , Intervertebral Disc Displacement/surgery , Male , Middle Aged , Minimally Invasive Surgical Procedures , Patient Satisfaction , Postoperative Complications/epidemiology , Prospective Studies , Recovery of Function , Recurrence , Sciatica/etiology , Severity of Illness Index , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Since the first injection of chymopapain in 1963, percutaneous intradiscal therapies have been used to treat discogenic back and leg pain. The percutaneous discectomy techniques treat contained disc herniations not by resecting the prolapsed disc material but rather through central decompression of the disc. By removing a small volume of tissue from the disc nucleus, a large reduction in overall disc pressure is achieved with consequent relief of neural compression. DISC Nucleoplasty and Dekompressor are the two leading percutaneous discectomy technologies currently. Although rigorous clinical testing of their efficacy is ongoing, there has now been a 40-year history confirming the concept of percutaneous disc decompression, and initial results are very promising. Discogenic low back pain can also arise from annular tears and other forms of internal disc derangement (IDD). Annuloplasty techniques, such as IntraDiscal Electrothermal Therapy (IDET) and discTRODE, have been developed over the past decade that thermally treat the lesions of IDD. Although the therapeutic mechanisms of thermal annuloplasty have yet to be fully elucidated, research studies demonstrate that the procedure can be effective for appropriately selected patients with degenerative disc disease characterized by discographically proven painful annular fissures. Other novel intradiscal therapies are emerging for percutaneous treatment of discogenic pain and await more widespread clinical evaluation.
Subject(s)
Diskectomy, Percutaneous , Low Back Pain/therapy , Lumbar Vertebrae , Chymopapain/administration & dosage , Chymopapain/therapeutic use , Humans , Intervertebral Disc Displacement , Low Back Pain/drug therapy , Patient SelectionABSTRACT
PURPOSE: Recently, MMP-7 and MMP-3 have been found to play a crucial role in the natural resorption process of herniated discs. We therefore examined the role of these recombinant human matrix metalloproteinases (rh MMPs) in the treatment of herniated discs. METHODS: (a) Surgical samples of herniated disc were cultured in the presence or absence of rh MMPs, and wet weight was measured 24h later. (b) The rh MMPs were administered into normal rabbit intervertebral discs, and after 1 week spine samples were stained with Safranin O. (c) The rh MMPs were administered into canine herniated discs in vivo. Myelography and MRI were performed prior to and 1 week after administration. Spine samples were examined histologically. Whole disc tissue was collected, total protein was extracted, and Western blot analysis was performed. RESULTS: (a) Proteoglycan degradation was found in MMP-7, MMP-3, and chymopapain-treated samples. MMP-7 and chymopapain-treated samples displayed a significant loss in wet weight (p<0.01). (b) Normal disc tissues after administration of rh MMP-7, MMP-3, and chymopapain showed an extensive loss of Safranin O staining. (c) The rh MMP-7-treated discs had a marked decrease in protruded herniation by MRI. Herniated discs after administration of MMP-7 and chymopapain showed a significant decrease in protruded mass 7 days after administration compared with saline-treated discs when evaluated by myelography (p<0.01). The rh MMP-7-treated discs displayed a clear loss of Safranin O staining in the nucleus pulposus. Proteoglycan expression was barely detectable in disc tissues after MMP-7 administration, whereas obvious expression was obtained in saline-treated or untreated disc tissues. CONCLUSIONS: Exposure to rh MMP-7 resulted in promising proteoglycan loss in human surgical samples, normal rabbit intervertebral discs, and natural canine herniated discs. Administration of rh MMP-7 may facilitate the resorption process of herniated discs.
Subject(s)
Intervertebral Disc Displacement/drug therapy , Matrix Metalloproteinase 7/therapeutic use , Adult , Animals , Chymopapain/therapeutic use , Dogs , Humans , Intervertebral Disc/metabolism , Male , Matrix Metalloproteinase 3/therapeutic use , Matrix Metalloproteinase 7/pharmacology , Middle Aged , Organ Culture Techniques , Proteoglycans/metabolism , Rabbits , Recombinant Proteins/therapeutic useABSTRACT
PURPOSE OF THE STUDY: We studied the efficacy of papaine for treatment of herniated discs at a mean 10-year follow-up and compared results with other series and other treatments. MATERIAL AND METHODS: From an initial group of 160 patients, 96 patients, 53 men and 43 women, mean age 39 years, were selected for evaluation. These patients had 46 L4L5 herniations and 50 L5S1 herniations. All 96 patients were operated in the same department and received the same dose of papaine under the same anesthesia conditions. All patients were followed regularly to 3 months postoperatively then were reviewed 3 to 17 years after surgery. Inquiries were made about return to work, pain, and activity. Physical examination and x-rays were obtained for all patients. RESULTS: There were no neurological complications in our series. Seventeen patients required a second procedure for sciatic pain. Most of the patients continued their normal occupational and social activities after papaine treatment, but many of them had chronic lumbar pain. DISCUSSION: Our results were comparable with series reporting a similar long follow-up. Surgery is more efficient than papaine but long-term results are equivalent. CONCLUSION: Chemopapaine treatment provided good long-term results in our patients, similar to surgery. Chemonucleolysis may be employed as first line treatment for young patients with non-excluded disc herniation with sciatic pain.
Subject(s)
Chymopapain/therapeutic use , Intervertebral Disc Chemolysis , Intervertebral Disc Displacement/drug therapy , Lumbar Vertebrae , Adolescent , Adult , Aged , Female , Humans , Intervertebral Disc Chemolysis/adverse effects , Male , Middle Aged , Retrospective Studies , Time FactorsABSTRACT
STUDY DESIGN: A 5-year clinical follow-up assessment of a prospective randomized study of chemonucleolysis using chymopapain (4000 IU) or collagenase (400 ABC units) was performed. SUMMARY OF BACKGROUND DATA: Intradiscal therapy can be performed for patients with contained discs by chemonucleolysis, percutaneous discectomy, or laser ablation. The oldest intradiscal therapy is chemonucleolysis with chymopapain. OBJECTIVE: The purpose of this study was to compare prospectively the efficacy of chymopapain and collagenase for intradiscal injection. METHODS: In this study, 100 patients with indication for intradiscal therapy were prospectively randomized to treatment with either chymopapain or collagenase. 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 chymopapain group and from 8.6 to 0.9 in the collagenase group. Microdiscectomy at the injected level was required for 23 patients (14 in the collagenase 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 one minor anaphylactic reaction, and effective even over the long term. Collagenase may need further study and cannot be recommended at this time.
Subject(s)
Chymopapain/therapeutic use , Collagenases/therapeutic use , Intervertebral Disc Chemolysis/methods , Intervertebral Disc Displacement/therapy , Low Back Pain/therapy , Adult , Anaphylaxis/chemically induced , Chymopapain/adverse effects , Diskectomy , Female , Humans , Intervertebral Disc Displacement/complications , Intervertebral Disc Displacement/surgery , Low Back Pain/etiology , Lumbar Vertebrae/drug effects , Lumbar Vertebrae/surgery , Male , Middle Aged , Pain Measurement , Prospective Studies , Random Allocation , Treatment OutcomeABSTRACT
This review presents the history of chemonucleolysis, the techniques, indications, contraindications, and complications. Presenting an historical overview and comparison of success rates with surgical discectomy may provide a fresh understanding of the controversy surrounding chemonucleolysis and establish its efficacy in relation to more invasive treatments. A review of the literature from 1973 through 1998 for chemonucleolysis, open discectomy, and microdiscectomy provided published success rates for these procedures, and a mean rate with standard deviation was determined. In the experience and opinion of the authors, chemonucleolysis remains a viable alternative for patients who have exhausted all conservative means of treatment. Proper patient selection leads to success rates comparable to open discectomy and microdiscectomy.
Subject(s)
Intervertebral Disc Chemolysis/trends , Chymopapain/therapeutic use , Contraindications , Diskectomy/methods , Humans , Intervertebral Disc Chemolysis/adverse effects , Intervertebral Disc Chemolysis/methods , Laser Therapy , Microsurgery , Orthopedics/methods , Patient SelectionABSTRACT
Chemonucleolysis using chymopapain is the least invasive technique used to treat a herniated lumbar pulposus. After 37 years of clinical experience, multiple clinical trials, a national multicenter, double-blind study mandated by the Food and Drug Administration, and heated controversy in the scientific community, the injection of chymopapain to treat herniated discs has (in appropriately selected patients) proven as successful as laminectomy, with fewer complications and the advantage of considerable cost savings.
Subject(s)
Chymopapain/therapeutic use , Intervertebral Disc Chemolysis , Intervertebral Disc Displacement/drug therapy , Lumbar Vertebrae , Humans , Intervertebral Disc Chemolysis/methods , Patient SelectionABSTRACT
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.
Subject(s)
Chymopapain/therapeutic use , Intervertebral Disc Chemolysis/methods , Intervertebral Disc Displacement/therapy , Lumbar Vertebrae , Manipulation, Spinal/methods , Sciatica/therapy , Adolescent , Adult , Costs and Cost Analysis , Disability Evaluation , Humans , Intervertebral Disc Chemolysis/economics , Intervertebral Disc Displacement/complications , Low Back Pain/physiopathology , Low Back Pain/therapy , Manipulation, Spinal/economics , Middle Aged , Prospective Studies , Sciatica/etiology , Single-Blind Method , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Although chemonucleolysis with chymopapain is a long-established treatment for lumbar intervertebral disc herniation, serious complications have been reported. Accordingly, alternative substances for chemonucleolysis have been sought. The main beneficial effect of chemonucleolysis derives from the decrease in intradiscal pressure. Several previous studies have investigated the relationship between physiological saline injection and disc mechanics in cadaveric specimens [2, 5, 16]. However, no previous study has assessed the intradiscal pressure after intradiscal injection of "hypertonic saline" in living animals. The present study compared the changes in intradiscal pressure after intradiscal injection of hypertonic saline with those after chymopapain injection. The lumbar intervertebral discs of 26 living rabbits were examined: 10% hypertonic saline was injected in ten rabbits, and chymopapain (10 pikokatal units) was injected intradiscally in another ten, with the remaining six being used as controls. The intradiscal pressure was measured at 1, 4, and 12 weeks after injection. The intradiscal pressure of the hypertonic saline-injected group at 4 weeks was significantly lower than that of the control group, but by 12 weeks it had recovered. On the other hand, that of the chymopapain-injected group remained significantly lower than that of the control group at 12 weeks. The results of this study found that hypertonic saline injected into the intervertebral discs temporarily decreased the intradiscal pressure.
Subject(s)
Intervertebral Disc/physiology , Lumbar Vertebrae/physiology , Saline Solution, Hypertonic/administration & dosage , Animals , Biomechanical Phenomena , Chymopapain/therapeutic use , Decompression, Surgical , Disease Models, Animal , Hydrostatic Pressure , Intervertebral Disc/drug effects , Intervertebral Disc/pathology , Intervertebral Disc Chemolysis , Lumbar Vertebrae/drug effects , Lumbar Vertebrae/pathology , Male , RabbitsABSTRACT
Concerning the so-called minimal invasive procedures currently available for the treatment of lumbar disc prolapse (percutaneous endoscopic discectomy, APLD, laser decompression, chemonucleolysis), the intradiscal application of Chymopapain represents the method with the longest period of clinical use and experience. Long-term studies have shown good clinical results. When considering of the indication and the few contraindications--particularly allergic diathesis--chemonucleolysis provides a low-risk, efficient, minimally invasive therapy that closes the therapeutic window between conservative and open surgical treatment.
Subject(s)
Chymopapain/therapeutic use , Intervertebral Disc Chemolysis , Intervertebral Disc Displacement/drug therapy , Lumbar Vertebrae , Biomechanical Phenomena , Chymopapain/adverse effects , Follow-Up Studies , Humans , Intervertebral Disc Displacement/diagnostic imaging , Lumbar Vertebrae/diagnostic imaging , Lumbar Vertebrae/drug effects , Prospective Studies , Radiography , Randomized Controlled Trials as TopicABSTRACT
A review was made of 85 patients who received a second injection of chymopapain because of a recurrent disc herniation between 1980 and 1996. All patients were pretreated for 3 days with H1 and H2 receptor blockers. Immediate sensitivity reactions were not seen. Four Type 1 and one Type 2 reactions were seen after the the second injection. No other complications were seen. In this group of 85 patients, 66 patients received a second injection at the same level as primary treatment after a period of 57.1 months (range, 2-143 months). Two patients were lost to followup. Four patients had surgery, three with good results. Good results and no complications were seen in three patients who had a third chemonucleolysis because of another recurrence after 15, 40, and 56 months, respectively. The remaining 57 patients were interviewed after 64 months (range, 3-143 months). Using the Prolo scale, 51 patients were rated as having excellent or good results, and six patients were rated as having fair or poor results.
Subject(s)
Chymopapain/therapeutic use , Intervertebral Disc Chemolysis , Intervertebral Disc Displacement/drug therapy , Lumbar Vertebrae , Adolescent , Adult , Aged , Chymopapain/adverse effects , Female , Humans , Male , Middle Aged , Recurrence , Retreatment , Retrospective Studies , Treatment OutcomeABSTRACT
STUDY DESIGN: Serial changes in the rate of proteoglycan synthesis in rabbit discs after chemonucleolytic treatment with chymopapain and chondroitinase ABC were measured using an in vitro method. OBJECTIVES: To determine the retained ability of the intervertebral disc to synthesize proteoglycans after chemonucleolytic treatment. SUMMARY OF BACKGROUND DATA: Most previous studies describe radiologic and histologic changes that occur after chemonucleolytic treatment. However, in humans it is not clear whether reconstitution of the disc space with normal nucleus proteoglycans can occur with time. METHODS: Twenty-five rabbits were treated with chymopapain (10 units/0.1 mL/disc) and chondroitinase ABC (5 units/0.1 mL/disc) by intradisc injection. Five rabbits were killed at each interval, 1, 2, 4, 8 and 12 weeks after injection. Radiologic changes in the disc height were noted, and the rate of proteoglycan synthesis was determined biochemically. RESULTS: After injection, no significant recovery of disc height was seen in either enzyme group after the initial disc narrowing. The average rate of proteoglycan synthesis in control rabbit intervertebral discs, those which had not been surgically treated, was 27.1 (x 10(-6) mmols sulphate/hour/dry weight). Twelve weeks after injection, the values were 21.6 in the saline group, 8.9 in the chondroitinase ABC group, and 8.2 in the chymopapain group. CONCLUSIONS: Doses within the therapeutic range can damage disc cells, at least in the rabbit, so that proteoglycan synthesis declined to 30% of control rates, and no significant recovery of disc height was observed.