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dGEMRIC able to detect change in knee OA cartilage after collagen hydrolysate treatment
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March 2014
dGEMRIC able to detect change in knee OA cartilage after collagen hydrolysate treatment
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
Change in knee osteoarthritis cartilage detected by delayed gadolinium enhanced magnetic resonance imaging following treatment with collagen hydrolysate: a pilot randomized controlled trial
Osteoarthritis Cartilage. 2011 Apr;19(4):399-405. doi: 10.1016/j.joca.2011.01.001. Epub 2011 Jan 18Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
OE EXCLUSIVE
Dr. Flechsenhar discusses the use of collagen hydrolysate in the treatment of OA.
Synopsis
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.
Publication Funding Details
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Funding:
Industry funded
Sponsor:
Gelita AG
Conflicts:
None disclosed
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)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
2/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
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.
What was the principal research question?
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?
Study Characteristics
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Population:
31 patients with knee OA, ranging from mild to moderate severity, WOMAC pain subscale score >1, and knee radiographs that displayed relative preservation of tibiofemoral joint space (>3mm) (Age: >49) (29 patients completed follow-up)
Intervention:
CH Group: Patients received a collagen hydrolysate mixture (Fortigel) consisting of 10 g collagen hydrolysate, 0.4 g fructose, malt extract, citric acid, xanthan, potassium sorbate, acesulfame-K, sucralose, and natural and artificial flavours in 10 mL of water. Study medication was dispensed in 8-week supply (Mean age: 58.9 +/- 8.0) (n=15)
Comparison:
Placebo Group: Patients received a mixture that was indistinguishable in appearance and taste from the CH mixture. The placebo consisted of 0.4 g fructose, malt extract, citric acid, xanthan, potassium sorbate, acesulfame-K, sucralose, and natural and artificial flavours in 10 mL of water. Study medication was dispensed in 8-week supply (Mean age: 60.3 +/- 8.5) (n=15)
Outcomes:
The primary outcome measure was the change in dGEMRIC T1 relaxation time in central weight-bearing medial and lateral femoral cartilage, posterior medial and lateral femoral cartilage, and medial and lateral tibial plateau cartilage. The secondary outcome measures were the change in T2 relaxation time in the above mentioned cartilage regions of interest (ROIs), pain (measured using the WOMAC-Likert Scale version 3 and a global visual analog scale (VAS)), functional capacity (measured by the timed 20 m walk and chair stand tests), amount of analgesia consumed, study adherence (measured by the number of ampoules returned at follow-up divided by the number of days from the time of the last visit), and the occurrence of adverse effects.
Methods:
RCT: Prospective; Single center; Double-blinded (patients and outcome assessors); Placebo-controlled; Pilot trial
Time:
Outcomes were measured prior to and 8, 16, 24, 32, 40, and 48 weeks following treatment
What were the important findings?
- 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).
What should I remember most?
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.
How will this affect the care of my patients?
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.
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