Article type
Year
Abstract
Background: Intervertebral disk herniation, which frequently occurred in patients aged 25-50, has high incidence rate and recurrence rate. It usually gives unfavorably physical and economic impacts on patients and their families. It is necessary to identify an effective and cost-effective treatment especially in developing countries with limited health resources. The treatments for IDH are classified as non-surgical, surgical and conservative intervention. Chymopapain and collagenase chemonucleolysis are the most frequently used ones of the non-surgical therapy.
Objectives: To assess effectiveness and safety of collagenase treatment for intervertebral disk herniation.
Methods: The Cochrane Library, Medline, Embase, Chinese Biomedical database, Chinese VIP database and database maintained by Center for Research and Dissemination were searched. Grey literature was also attempted to obtain by Internet search and contact of pharmaceutical factory and clinical experts. All data were searched to August 31, 2003.
Controlled clinical trials regardless of randomization, comparing collagenase with other treatment in patients with intervertebral-disk-herniation were included. Two reviewers assessed trial quality and extracted data from published papers. Additional information was sought from the authors if necessary.
Results: One hundred and eleven studies (33 in English and 79 in Chinese) with 8749 patients were included, of which 16 were randomized controlled trials (3 in English and 13 in Chinese) and 3 described generation of randomization, 2 descried blinding. The loss of follow-up and allocation concealment were generally not described.
14 studies with 2027 patients compared collagenase chemonucleolysis with surgical treatment. And there is not sufficient evidence to judge the relative merits of collagenase chemonucleolysis compared with surgical treatment. But the available evidence showed collagenase chemonucleolysis is more cost-effective, convenient and less invasive. 4 studies with 479 patients compared collagenase chemonucleolysis with placebo or conservative treatment. And 4 studies compared collagenase chemonucleolysis with hormone treatment. All evidence suggested collagenase for intervertebral-disk- herniation is more effective than placebo, conservative treatment and hormone thyeapy. 6 studies with 614 patients compared chymopapain with collagenase for IDH. And there is insufficient evidence to show statistically significant differences between collagenase and chymopapain for IDH. 15 studies with 2363 patients compared the combination of collagenase and other drugs with any drug alone. The effectiveness of the combination of collagenase and other drugs was better than any drug alone. 16 studies involved the adverse effects of collagenase for intervertebral-disk- herniation. The major adverse effects of collagenase chemonucleolysis include pain, back spasms, secondary sequestrations, local side effects Ccauda equina syndromes Canaphylaxis, the injury of nerve system, disc-space infection.
Conclusions: Our data indicated that collagenase for IDH is more effective than placebo, conservative treatment and hormone treatment. And there is insufficient evidence to show statistically significant differences among collagenase, chymopapain and surgical treatment. Due to low quality of studies, the result is only for consideration. More quality studies of collagenase for IDH should be conducted.
Objectives: To assess effectiveness and safety of collagenase treatment for intervertebral disk herniation.
Methods: The Cochrane Library, Medline, Embase, Chinese Biomedical database, Chinese VIP database and database maintained by Center for Research and Dissemination were searched. Grey literature was also attempted to obtain by Internet search and contact of pharmaceutical factory and clinical experts. All data were searched to August 31, 2003.
Controlled clinical trials regardless of randomization, comparing collagenase with other treatment in patients with intervertebral-disk-herniation were included. Two reviewers assessed trial quality and extracted data from published papers. Additional information was sought from the authors if necessary.
Results: One hundred and eleven studies (33 in English and 79 in Chinese) with 8749 patients were included, of which 16 were randomized controlled trials (3 in English and 13 in Chinese) and 3 described generation of randomization, 2 descried blinding. The loss of follow-up and allocation concealment were generally not described.
14 studies with 2027 patients compared collagenase chemonucleolysis with surgical treatment. And there is not sufficient evidence to judge the relative merits of collagenase chemonucleolysis compared with surgical treatment. But the available evidence showed collagenase chemonucleolysis is more cost-effective, convenient and less invasive. 4 studies with 479 patients compared collagenase chemonucleolysis with placebo or conservative treatment. And 4 studies compared collagenase chemonucleolysis with hormone treatment. All evidence suggested collagenase for intervertebral-disk- herniation is more effective than placebo, conservative treatment and hormone thyeapy. 6 studies with 614 patients compared chymopapain with collagenase for IDH. And there is insufficient evidence to show statistically significant differences between collagenase and chymopapain for IDH. 15 studies with 2363 patients compared the combination of collagenase and other drugs with any drug alone. The effectiveness of the combination of collagenase and other drugs was better than any drug alone. 16 studies involved the adverse effects of collagenase for intervertebral-disk- herniation. The major adverse effects of collagenase chemonucleolysis include pain, back spasms, secondary sequestrations, local side effects Ccauda equina syndromes Canaphylaxis, the injury of nerve system, disc-space infection.
Conclusions: Our data indicated that collagenase for IDH is more effective than placebo, conservative treatment and hormone treatment. And there is insufficient evidence to show statistically significant differences among collagenase, chymopapain and surgical treatment. Due to low quality of studies, the result is only for consideration. More quality studies of collagenase for IDH should be conducted.