Zusammenfassung
Ziel dieser Übersichtsarbeit war es, die Wirksamkeit und Sicherheit von Chemonukleolyse
und intradiskaler Elektrotherapie (IDET) zur Behandlung von Patienten mit diskogenen
Schmerzen auf Basis von rezent publizierten Daten zu Schmerzreduktion, Funktionalität
und Komplikationsraten zu evaluieren. In mehreren Datenbanken wurde systematisch nach
englisch- und deutschsprachigen Arbeiten, die zwischen 2003 und 2008 publiziert wurden,
gesucht. Durch Handsuche wurden weitere Arbeiten identifiziert. Für die Darstellung
der Evidenz wurden nur Ergebnisse aus systematischen Reviews und kontrollierten Studien
berücksichtigt. Die Beurteilung der internen Validität der Arbeiten erfolgte durch
2 Autoren, unabhängig voneinander. Die Datenextraktion wurde von einem Autor durchgeführt,
ein zweiter überprüfte die Vollständigkeit und Korrektheit der extrahierten Daten.
Die Evidenz zur Wirksamkeit der Chemonukleolyse mit Chymopapain oder Kollagenase ist
in 2 qualitativ hochwertigen rezenten systematischen Reviews zusammengefasst. Zur
Nukleolyse mittels eines O 2 O3 -Gemischs konnten 5 kontrollierte Studien mit zum Teil eingeschränkter methodischer
Qualität gefunden werden, die die Wirksamkeit des Verfahrens im Vergleich zur Mikrodiskektomie
oder der Anwendung alternativer Substanzen zeigen. Es gibt kaum Daten zu Komplikationen
der O 2 O3 -Nukleolyse. Die Autoren der 6 identifizierten systematischen Reviews zur IDET kommen
zu unterschiedlichen Bewertungen der Wirksamkeit des Verfahrens. Auch die Ergebnisse
aus den 3 eingeschlossenen kontrollierten Studien zur IDET, von denen 2 als qualitativ
hochwertig zu betrachten sind, sind widersprüchlich. Die Komplikationsrate des Verfahrens
liegt bei 0 – 15 %. Für die Chemonukleolyse liegen derzeit also überzeugendere Wirksamkeitsdaten
vor als für die IDET. Dies könnte auch durch die klarere Indikationsstellung bedingt
sein. Allerdings sollten Sicherheitsaspekte noch besser untersucht und in der Literatur
präsentiert werden.
Abstract
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
(O2 O3 -nucleolysis). Some of those studies were of limited methodological quality, but all
showed the efficacy of O 2 O3 -nucleolysis in comparison to microdiscectomy or the use of alternative substances.
There is hardly any data regarding O 2 O3 -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.
Key words
spine - percutaneous - chemonucleolysis - intradiscal electrothermal therapy - evidence
Literatur
1
Röllinghoff M, Sobottke R, Koy T. et al .
Minimalinvasive Operationen an der Lendenwirbelsäule.
Z Orthop Unfall.
2008;
146
267-280
2
Puig S, Felder-Puig R.
Evidenzbasierte Radiologie: Ein neuer Ansatz zur Bewertung von klinisch angewandter
radiologischer Diagnostik und Therapie.
Fortschr Röntgenstr.
2006;
178
671-679
3
Smith L.
Enzyme dissolution of the nucleus pulposus in humans.
JAMA.
1964;
187
137-140
4
Lehnert T, Mundackatharappel S, Schwarz W. et al .
Nukleolyse beim Bandscheibenvorfall.
Radiologe.
2006;
46
513-519
5
Raj P P.
Intervertebral disc: Anatomy-physiology-pathophysiology-treatment.
Pain Pract.
2008;
8
18-44
6
Kelekis A D, Somon T, Yilmaz H. et al .
Interventional spine procedures.
Eur J Radiol.
2005;
55
362-383
7
Teh J, Ostlere S.
Percutaneous spinal procedures.
Imaging.
2005;
17
258-267
8
Saal J A, Saal J S.
Management of chronic discogenic low back pain with a thermal intradiscal catheter:
a preliminary report.
Spine.
2000;
25
382-388
9
Chou L H, Lew H L, Coelho P C. et al .
Intradiscal electrothermal annuloplasty.
Am J Phys Med Rehabil.
2005;
84
538-549
10
Kim Y S, Chin D K, Cho Y E. et al .
Predictors of successful outcome for lumbar chemonucleolysis: analysis of 3000 cases
during the past 14 years.
Neurosurgery.
2002;
52
123-129
11
Muto M, Ambrosanio G, Guarniere G. et al .
Low back pain and sciatica: treatment with intradiscal-intraforaminal O 2-O3 injection.
Our experience.
Radiol med.
2008;
113
695-706
12
Singh K, Ledet E, Carl A. et al .
Intradiscal therapy: a review of current treatment modalities.
Spine.
2005;
30
S20-S26
13
Gibson J N, Waddell G, Gibson J NA. et al .
Surgical interventions for lumbar disc prolapse: updated Cochrane Review.
Spine.
2007;
32
1735-1747
14
Couto J M, Castilho E A, Menezes P R. et al .
Chemonucleolysis in lumbar disc herniation: a meta-analysis.
Clinics.
2007;
62
175-180
15 Lühmann D, Burkhardt-Hammer T, Borowski C. et al .Minimal-invasive Verfahren zur
Behandlung des Bandscheibenvorfalls. Köln; DAHTA@DIMDI 2005
16
Gibson J N, Grant I C, Waddell G. et al .
The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis.
Spine.
1999;
24
1820-1832
17
Andreula C F, Simonetti L, Santis de F. et al .
Minimally invasive oxygen-ozone therapy for lumbar disc herniation.
AJNR.
2003;
24
996-1000
18
Paradiso R, Alexandre A.
The different outcomes of patients with disc herniation treated either by microdiscectomy,
or by intradiscal ozone injection.
Acta Neurochir.
2005;
92
139-142
19
Buric J.
Ozone chemyonucleolysis vs microdiscectomy. Prospective controlled study with 18 months
follow-up.
Rivista Italiana di Ossigeno-Ozonterapia.
2005;
4
49-54
20
Bonetti M, Fontana A, Cotticelli B. et al .
Intraforaminal O(2)-O(3) versus periradicular steroidal infiltrations in lower back
pain: randomized controlled study.
AJNR.
2005;
26
996-1000
21
Gallucci M, Limbucci N, Zugaro L. et al .
Sciatica: treatment with intradiscal and intraforaminal injections of steroid and
oxygen-ozone versus steroid only.
Radiology.
2007;
242
907-913
22
Gibson J NA, Waddell G.
Surgery for degenerative lumbar spondylosis. Updated Cochrane Review.
Spine.
2005;
30
2312-2320
23
Appleby D, Andersson G, Totta M.
Meta-analysis of the efficacy and safety of intradiscal electrothermal therapy (IDET).
Pain Med.
2006;
7
308-316
24
Andersson G B, Mekhail N A, Block J E. et al .
Treatment of intractable discogenic low back pain. A systematic review of spinal fusion
and intradiscal electrothermal therapy (IDET).
Pain Physician.
2006;
9
237-248
25
Freeman B J, Freeman B JC.
IDET: a critical appraisal of the evidence.
Eur Spine J.
2006;
15
S448-S457
26
Urrutia G, Kovacs F, Nishishinya M B. et al .
Percutaneous thermocoagulation intradiscal techniques for discogenic low back pain.
Spine.
2007;
32
1146-1154
27
Derby R, Baker R M, Lee C H. et al .
Evidence-informed management of chronic low back pain with intradiscal electrothermal
therapy.
Spine J.
2008;
8
80-95
28 Banken R. Intradiscal electrothermal therapy for discogenic low back pain. Montreal;
Agence d"Evaluation des Technologies et des Modes d"Intervention en Sante (AETMIS)
2005
29
Bogduk N, Karasek M.
Two-year follow-up of a controlled trial of intradiscal electrothermal anuloplasty
for chronic low back pain resulting from internal disc disruption.
Spine J.
2002;
2
343-350
30
Pauza K J, Howell S, Dreyfuss P. et al .
A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the
treatment of discogenic low back pain.
Spine J.
2004;
4
27-35
31
Freeman B J, Fraser R D, Cain C M. et al .
A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus
placebo for the treatment of chronic discogenic low back pain.
Spine.
2005;
30
2369-2377
32
Barendse G A, Den Berg S G, Kessels A H. et al .
Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation
for chronic discogenic back pain: lack of effect from a 90-second 70° lesion.
Spine.
2001;
26
287-292
33
Dworkin R H, Turk D C, Wyrwich K W. et al .
Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical
Trials: IMMPACT Recommendations.
J Pain.
2008;
9
105-121
34
Copay A G, Glassman S D, Subach B R. et al .
Minimum clinically important difference in lumbar spine surgery patients: a choice
of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire
Short Form 36, and pain scales.
Spine J.
2008;
8
968-974
35
Karasek van M, Bogduk N.
Twelve-month follow-up of a controlled trial of intradiscal thermal anuloplasty for
back pain due to internal disc disruption.
Spine.
2000;
25
2601-2607
36
Kapural L, Hayek S, Malak O. et al .
Intradiscal thermal annuloplasty versus intradiscal radiofrequency ablation for the
treatment of discogenic pain: a prospective matched control trial.
Pain Med.
2005;
6
425-431
37
Ginanneschi F, Cervelli C, Milani P. et al .
Ventral and dorsal root injury after oxygen-ozone therapy for lumbar disk herniation.
Surg Neurol.
2006;
66
619-620
38
Gazzeri R, Galarza M, Neroni M. et al .
Fulminating septicemia secondary to oxygen-ozone therapy for lumbar disc herniation:
case report.
Spine.
2007;
32
e121-e123
39
GRADE Working Group .
Grading quality of evidence and strength of recommendations.
BMJ.
2004;
328
1490
40
Johnson B A.
Therapeutic periradicular injections: it"s a gas!.
AJNR.
2005;
26
988-989
41
Kapural L.
Indications for minimally invasive disk and vertebral procedures.
Pain Med.
2008;
9
S65-S72
42
Sibell D M, Fleisch J M.
Intervention for low back pain: What does the evidence tell us?.
Curr Pain Headache Rep.
2007;
11
14-19
43
Kapural L, Mekhail N.
A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus
placebo for the treatment of chronic discogenic low back pain.
Spine.
2006;
31
1636; author reply 1637
44
Andersson G B, Mekhail N A, Block J E.
A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus
placebo for the treatment of chronic discogenic low back pain.
Spine.
2006;
31
1637-1638; author reply 1638
45
Andersson G B, Block J E.
Re: Urrutia G, Kovacs F, Nishishinya MB, et al. Percutaneous thermocoagulation intradiscal
techniques for discogenic low back pain.
Spine.
2007;
32
2927-2928; author reply 2928 – 2929
Dr. Rosemarie Felder-Puig
Ludwig Boltzmann Institut für Health Technology Assessment
Garnisong. 7 / 20
1090 Wien
Österreich
Phone: ++ 43/1/2 36 81 19-0
Fax: ++ 43/1/2 36 81 19-99
Email: rosemarie.felder-puig@lbihpr.lbg.ac.at