Efficacy of Hydros HA, with and without corticosteroid, vs. Synvisc for knee OA .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2017;5(2):22 BMC Musculoskelet Disord. 2015 Mar 18;16:5798 patients with knee osteoarthritis were randomized to an intra-articular injection of Hydros hyaluronic acid, Hydros plus 10mg triamcinolone acetonide (Hydros-TA), or Synvisc-One hyaluronic acid. The purpose of this study was to compare the effects of Hydros hyaluronic acid, with or without the addition of corticosteroid, to Synvisc-One for patient-reported pain and functional improvement after 2, 6, 13, and 26 weeks using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Results demonstrated no significant differences between the Hydros and Synvisc-One groups, or Hydros-TA and Synvisc-One groups, for the reduction in WOMAC Pain, Stiffness, of Function subscores at any time point.
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)?
Sì = 1
Incerto = 0,5
Non rilevante = 0
No = 0
La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.
4/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
0/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.
Perché questo studio era necessario ora?
Both hyaluronic acid and corticosteroid injections are treatment options for mild to moderate knee osteoarthritis that are commonly used in the management of this condition. While high-quality clinical trials have been conducted to determine if there are benefits of a combining hyaluronic acid and corticosteroid injections a definitive conclusion has not been derived from the literature and the development of novel products that combine these treatments necessitates further research.
Qual era la domanda di ricerca principale?
Is there any significant difference between Hydros (hyaluronic acid product), Hydros-TA (hyaluronic acid plus triamcinolone product) and Synvisc-One (hyaluronic acid product) in 26-week efficacy and safety in the treatment of knee osteoarthritis?
- The difference in mean reduction in WOMAC Pain subscore was not significant between the Hydros group and the Synvisc-One group at 2 weeks (-23.3+/-5.6 vs. -28.5+/-5.9; p=0.40), 6 weeks (-32.4+/-5.6 vs. -25.6+/-5.9; p=0.28), 13 weeks (-33.9+/-5.6 vs. -29.0+/-6.0; p=0.43), and 26 weeks (-32.4+/-5.6 vs. -28.9+/-6.0; p=0.64).
- The difference in mean reduction in WOMAC Pain subscore was not significant between the Hydros-TA group and the Synvisc-One group at 2 weeks (-35.6+/-5.2 vs. -28.5+/-5.9; p=0.25), 6 weeks (-33.4+/-5.2 vs. -25.6+/-5.9; p=0.21), 13 weeks (-33.3+/-5.2 vs. -29.0+/-6.0; p=0.49), and 26 weeks (-35.2+/-5.3 vs. -28.9+/-6.0; p=0.33).
- Mean reduction in WOMAC Pain subscore was significantly greater in the Hydros-TA group compared to the Hydros group at 2 weeks (p=0.04), with no significant difference between groups at subsequent time points (p>0.05).
- There was also no significant difference between either the Hydros group or the Hydros-TA group compared to the Synvisc-One group in mean reduction in WOMAC Stiffness or Function subscore at 2, 6, 13, or 26 weeks (all p>0.05).
- OMERACT responder rate after 13 weeks was 21/32 (66%) in the Hydros group, 24/34 (71%) in the Hydros-TA group, and 17/32 (53%) in the Synvisc-One group. Responder rate after 26 weeks was 22/32 (69%) in the Hydros group, 22/34 (65%) in the Hydros-TA group, and 19/32 (59%) in the Synvisc-One group.
Che cosa devo ricordare di più?
In knee osteoarthritis treatment, intra-articular injection with Hydros hyaluronic acid and (Hydro-TA) hyaluronic acid plus triamcinolone acetonide offered no significant differences over a 26-week period for improvement in patient-reported pain and function in comparison to Synvisc-One hyaluronic acid.
Come influenzerà l'assistenza ai miei pazienti?
The results of this study suggest that intra-articular injection of either Hydros or Hydros-TA offers a similar reduction in symptomatic knee osteoarthritis pain to that achieved by intra-articular injection of Synvisc-One. There was a short-term benefit observed with the addition of triamcinolone acetonide to Hydros, with greater reduction in pain observed at 2 weeks, though by 6 weeks, differences between Hydros and Hydros-TA groups were non-significant. It is uncertain whether the effect of additional corticosteroid is clinically relevant. Given the phase 2 nature of this study, small group sizes, and lack of placebo group, larger phase 3 trials are needed to ultimately determine the efficacy of Hydros, with or without additional triamcinolone acetonide, in the treatment of knee osteoarthritis.
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