OSTEOARTHRITIS
Change in knee osteoarthritis cartilage detected by delayed gadolinium enhanced magnetic resonance imaging following treatment with collagen hydrolysate: a pilot randomized controlled trial
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by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(5):24 Osteoarthritis Cartilage. 2011 Apr;19(4):399-405. doi: 10.1016/j.joca.2011.01.001. Epub 2011 Jan 18Exclusive Author Interview
Dr. Flechsenhar discusses the use of collagen hydrolysate in the treatment of OA.
31 patients with knee osteoarthritis (OA) were randomized to receive collagen hydrolysate (CH) or a placebo to determine whether dGEMRIC or T2 mapping would be able to distinguish the changes in knee hyaline cartilage in these patients. Following assessments over a 48 week period, the results displayed that dGEMRIC was able to identify changes in cartilage status in the medial tibia and lateral tibia regions in patients who received CH. However, cartilage changes were not noticeable between the CH and placebo groups when using T2 mapping.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Ja = 1
Ungewiss = 0.5
Nicht relevant = 0
Nein = 0
Die Bewertung der Berichtskriterien bewertet die Transparenz, mit der die Autoren die methodischen und studienspezifischen Merkmale der Studie in der Veröffentlichung angeben. Die Bewertung ist in fünf Kategorien unterteilt, die im Folgenden vorgestellt werden.
3/4
Randomização
3/4
Medições dos resultados
4/4
Inclusão / Exclusão
2/4
Descrição da terapia
4/4
Estatística
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Der Fragilitätsindex ist ein Instrument, das bei der Interpretation signifikanter Ergebnisse hilft und ein Maß für die Stärke eines Ergebnisses liefert. Der Fragilitätsindex gibt die Anzahl der aufeinanderfolgenden Ereignisse an, die zu einem dichotomen Ergebnis hinzugefügt werden müssen, damit das Ergebnis nicht mehr signifikant ist. Eine kleine Zahl steht für ein schwächeres Ergebnis und eine große Zahl für ein stärkeres Ergebnis.
Warum wurde diese Studie jetzt benötigt?
Developing pharmaceuticals to treat OA has been a challenge as a suitable biomarker of articular health has yet to be identified. However, magnetic resonance imaging (MRI)-based approaches, such as gadolinium enhanced MRI of cartilage (dGEMRIC) and T2 mapping, that assess the change in osteoarthritic joint structure have given the opportunity to evaluate the pathological development in articular cartilage. Collagen hydrolysate (CH) is a product that is considered to improve cartilage health. CH induces the production of type 2 collagen and proteoglycans in the extracellular matrix, which then is absorbed and accumulated in the hyaline cartilage. This study aimed to determine whether changes in knee hyaline cartilage could be distinguished between patients receiving CH versus a placebo by using dGEMRIC or T2 mapping.
Was war die wichtigste Forschungsfrage?
Were dGEMRIC or T2 mapping able to distinguish changes in knee hyaline cartilage between patients receiving collagen hydrolysate versus a placebo, when measured over a period of 48 weeks?
Was waren die wichtigsten Ergebnisse?
- There was a significant difference in medial tibia and lateral tibia dGEMRIC change scores (ie. change from baseline) to 24 weeks between the CH group (Medial tibia: 29.6 +/- 70.5; Lateral tibia: 25.5 +/- 60.2) and the placebo group (Medial tibia: -30.0 +/- 62.6; Lateral tibia: -28.5 +/- 47.8) (Medial tibia: p=0.03; Lateral tibia: p=0.02). At 48 weeks, the change scores did not differ significantly between the two groups (Medial tibia: p=0.08; Lateral tibia: p=0.07).
- No significant differences in central medial femur, posterior medial femur, central lateral femur, and posterior lateral femur dGEMRIC change scores at either 24 or 48 weeks (all p>0.10).
- The T2 values at all the time points indicated that little change occurred in the cartilage regions of interest. Changes in T1 values were only significant for the posterior lateral femur region at 48 weeks for both the CH group (Mean change: -1.1) and the placebo group (Mean change: +1.8) (p=0.05).
- The total amount of analgesic used over a 48 week period did not differ significantly between the two groups. Clinical assessments (WOMAC, 20-m walk, Chair stand) also did not differ significantly between groups.
- In the CH group, 43 adverse events (13 participants) were reported compared to 45 cases (13 participants) in the placebo group; 39 of these events were considered unrelated to the consumption of CH in the CH group, while all events in the placebo group were considered unrelated to the consumption of the placebo.
- For all patients, the average dosing adherence was 96%, ranging from 49-100%, with no significant difference between the CH group (96.6%) and placebo group (95.8%) for compliance (p>0.05).
Was sollte ich mir besonders merken?
The results suggested that dGEMRIC was able to identify changes in cartilage status in the medial tibia and lateral tibia regions within 6 months in patients who received collagen hydrolysate. No differences in cartilage changes were noticed between the collagen hydrolysate and placebo groups when using T2 mapping.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
As this was a pilot study, further research needs to be conducted in order to affirm the results collected from this study. Future studies should consider incorporating morphometric MRI sequences into the study design and increase sample size.
HAFTUNGSAUSSCHLUSS
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