VISCOSUPPLEMENTATION ET OSTEOARTHRITE

VISCOSUPPLEMENTATION ET OSTEOARTHRITE
QUESTION : Chez les patients avec arthrose du genou qui désirent une
amélioration de leur qualité de vie, est-ce que la viscosupplémentation est plus
efficace que l’infiltration avec des corticosteroides pour améliorer la qualité de
vie?
AUTEUR : Marie-Isabelle Desrosiers (OCTOBRE 2007)
P
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patient avec OA genou
viscosupplémentation
infiltration aux corticostéroïdes
amélioration qualité de vie
(réduction douleur, durée d'efficacité et amélioration mobilité)
CONTEXTE: Une de mes patientes âgées avec une arthose au genou et
calcifications méniscales n'obtient pas de soulagement adéquat avec Pennsaid
et acétaminophène. Elle ne désire pas de chirurgie et me demande d'augmenter
sa qualité de vie. Toutefois, je ne connaissais pas les résultats potentiels de la
viscosupplémentation versus l'infiltration pour l’aider à faire un choix éclairé. Je
n'avais que des données anectodales de médecins.
RECHERCHE:
Bandolier : Oestoarthritis and injection* :
4 revues intéressantes : Intra-articular hyaluronic acid for knee osteoarthritis;
Hyaluronic acid injections for OA knee; Hylan G-F20 for arthritis and Steroid
injections for OA knee
Clinical evidence: 1 revue: OA of the knee
Up to Date: information simiuilaire donc non discutée ici
RÉSULTATS:
1) BANDOLIER. Intra-articular hyaluronic acid for knee osteoarthritis
J Arrich et al. Intra-articular hyaluronic acid for the treatment of
osteoarthritis of the knee: systematic review and meta-analysis. Canadian
Medical Association Journal, 2005 Apr 12;172(8):1039-43
Revue systématique des revues publiées jusqu’en avril 2004. Ils ont examiné
des issues cliniques prédéfinies comme la douleur au repos, la douleur au
mouvement, etc. Selon le site Bandolier, c’est la meilleure revue sur le sujet et la
seule à émettre des commentaires sur la méthodologie des études évoquées.
Leur conclusion : No trial that was randomised, double blind, and with an
intention to treat analysis could demonstrate any benefit. Benefit was shown in
trials that were open, or which were of per-protocol analysis. It may not be
beyond the bounds of belief that a small number of patients could benefit with
long term use of injections of hyaluronic acid into their knee joints. As things
stand, this does not look like a reasonable therapy.
Other systematic reviews of the same topic:
M Pagnano, G Westrich. Successful nonoperative management of chronic
osteoarthritis of the knee: safety and efficacy of retreatment with intraarticular hyaluronate. Osteoarthritis and cartilage 2005 13: 751-761. The review
of Pagnano & Westrich examines the evidence from studies of continued long
term use, and concludes that there is benefit. However, of the six studies, only
one is randomised. Studies are small, some with just a few patients.
CT Wang et al. Therapeutic effects of hyaluronic acid on osteoarthritis of
the knee. A meta-analysis of randomized controlled trials. Journal of Bone
and Joint Surgery 2004; 86-A (3): 538-545. The review examines the evidence
from 20 trials (for a total of 1647 randomly assigned knees (818 knees treated
with hyaluronic acid injection and 829 treated with placebo injection). Only singleblind or double-blind randomized controlled trials that compared the therapeutic
effect of intra-articular injection of hyaluronic acid with that of intra-articular
injection of a placebo to treat osteoarthritis of the knee were included in this
meta-analysis. Subgroup analysis and meta-regression analysis showed that
lower methodological quality such as a single-blind or single-center design
resulted in higher estimates of hyaluronic acid efficacy, that introduction of
acetaminophen as an escape analgesic in the trial resulted in lower estimates of
hyaluronic acid efficacy, and that patients older than sixty-five years of age and
those with the most advanced radiographic stage of osteoarthritis (complete loss
of the joint space) were less likely to benefit from intra-articular injection of
hyaluronic acid.
2) BANDOLIER. Hyaluronic acid injections for OA knee
Deux revues systématiques :
a) GH Lo et al. Intra-articular hyaluronic acid in treatment of knee
osteoarthritis: a meta-analysis. JAMA 2003 290: 3115-3121.
This review included 22 trials, 19 published in full, with 2949 patients. Trial size
was 24 to 408 participants. Effect size was calculated for each study, and pooled.
Of the 22 trials, only three individually had a statistically significant effect size.
Overall the effect size was 0.3 (95% CI 0.2 to 0.5), indicating a small effect.
Omitting three trials with the largest molecular weight (6,000 kD), the effect size
was even smaller at 0.2 (0.1 to 0.3).
Three trials (268 patients) used 6,000 kD hyaluronic acid, one of which was very
small, with just 30 patients. The two larger studies differed in their conclusion,
one with a very large effect size, and one no different from placebo.
b) A Aggarwal, IP Sempowski. Hyaluronic acid injections for knee
osteoarthritis. Systematic review of the literature. Canadian Family Physician
2004 50: 249-256.
The second review included 13 randomised trials and five case series. The
randomised trials were included in the first review. Three of the five case series
were prospective, were small, and lasted six months to two years. Three used
6,000 kD hyaluronic acid, but only one was prospective. All reported some
degree of pain relief in some patients.
N.B. Adverse events reported included injection site pain and swelling in 2% to
23% of injections. Gastrointestinal adverse events and back pain were also
reported.
Leur conclusion : Bandolier looks for outcomes that are more meaningful, like
patients improved, or changes in a scale, or, better still, some clinically useful but
simply described outcome that we can understand. Then we have the chance of
comparing interventions, and can check whether the patients in different trials are
the same. Here we failed.
3) BANDOLIER. Hylan G-F20 for arthritis
M Espallargues, JM Pons. Efficacy and safety of viscosupplementation with
Hylan G-F 20 for the treatment of knee osteoarthritis. International Journal of
Technology Assessment in Health Care 2003 19: 41-56.
Hylan G-F 20 in limited studies appears to be more effective than placebo, and
perhaps as effective as NSAIDs for reducing pain in knee osteoarthritis.
There were fourteen identified studies, seven of which were randomised trials,
and of which four were full publications and three abstracts. Four of the other
seven reports were abstracts.
Four of the randomised studies compared Hylan G-F 20 with placebo. All were
described as double blind. Three were of at least 12 weeks duration, and mean
VAS pain scores at the end of treatment. Two studies apparently also reported
the number of patients with pain scores of 20 mm or below at the end of
treatment, with NNTs in individual studies of 1.3 (90% of patients with Hylan G-F
20 with low pain scores) and 3.8 (39% with low pain scores). Two randomised
trials comparing Hylan G-F 20 with oral NSAIDs showed little difference, but with
a tendency for lower scores at the end of treatment with Hylan G-F 20 than with
NSAID.
Leur conclusion: This is a comprehensive review, though with information on only
190 patients in longer term comparisons with placebo in randomised trials. Of
course, placebo in this context is not necessarily doing nothing, as arthrocentesis
itself may involve removing the joint effusion, and both sham injections and
saline injections were used as placebo. The reality, though, is that there is
insufficient high-quality research upon which to build definite conclusions.
4) BANDOLIER. Steroid injections for OA knee
2 revues systématiques :
M Godwin, M Dawes. Intra-articular steroid injections for painful knees:
systematic review with meta-analysis. Canadian Family Physician 2004 50:
241-248. Révision de la littérature jusqu’à décembre 2002. RCT avec injection
intra-articulaire de corticostéroides de longue action comparativement au
placebo : 5 études.
B Arroll, F Goodyear-Smith. Corticosteroid injections for osteoarthritis of the
knee: meta-analysis. British Medical Journal 2004 328: 869-870. Révision de
la littérature jusqu’à 2003. RCT avec n’importe quel stéroïde comparé à un
placebo :10 études (placebo= injection de salin dans toutes les études sauf une;
pour cette dernière « sham injection »).
La majorité des RCT était réalisés avec une dose de stéroides qui équivalait de
25 à 50 mg de prednisone (bien que l’écart fut de 6 à 80 mg).
There were six studies with outcomes of improvement up to two weeks. This was
not a clearly defined term in many of the studies. In these six studies with 317
patients, five used long acting corticosteroids. Improvement up to two weeks
occurred in 74% of patients with a steroid injection and 45% given placebo. The
relative benefit was 1.7 (95% CI 1.4 to 2.0), and the number needed to treat for
one patient to have improvement was 3.4 (2.5 to 5.1). The weighted mean
reduction in visual analogue pain scores was 17 mm on a 100 mm scale.
There were three studies with 192 patients had results at 16-24 weeks after the
injection. Two used long acting corticosteroid, and the other used hydrocortisone
(and was an older study with a low quality score). Overall, 33% of steroid treated
patients had improvement at 16-24 weeks compared, and 16% of those given
placebo. The relative benefit was 2.1 (1.2 to 3.5), and the NNT 5.8 (3.4 to 19).
Adverse consequences of the intra-articular injections were not reported.
Leur conclusion: What we have here is some very limited data with implications
for clinical practice. It is likely that intra-articular corticosteroids produce some
pain relief, perhaps for some weeks. There are many problems, though:
-The outcome of improvement or decreased pain is not robust. It may well be that
a more rigorous examination of this literature could eliminate some or all of the
studies because of the lack of definition of outcomes or their measurement. The
studies might not be valid.
-The trials may not mirror clinical practice, especially with regard to use of local
anaesthetic, with the practice of joint lavage, and with regard to choice of
corticosteroid or dose used. The studies may not be relevant.
-The studies were small individually, and in total. The results could be overturned
by a large, well-conducted, negative study being published, or by uncovering
negative unpublished studies.
Clinical practice and experience suggests that intra-articular steroid injections are
helpful for painful knees in osteoarthritis. The trouble is that half of the patients
improved with saline alone, and the additional benefits of adding steroid were
moderate. Some will say that this is the power of psychiatry with needles, but it is
equally possible that the improvement would have come about anyway, because
of the ups and downs of symptoms. In many ways the situation resembles that of
many alternative therapies, though those usually have less evidence to support
them.
5) CLINICAL EVIDENCE : Osteoarthritis of the knee
Ils ont fait une revue systématique en 2006 des traitements chirurgicaux et nonchirurgicaux pour l’osteoarthrie du genou (Révision en de bases de données
diverses de 1966 à octobre 2006). Ils classifient les corticostéroides intraarticulaires et l’hyaluronan intra-articulaire de «likely to be beneficial » pour
diminuer la douleur mais spécifient que les études sont de pauvre qualité.
a) Corticostéroides intra-articulaire :
Comparé avec placebo : diminue la douleur à 1-3 sem, mais pas long terme
(évidence de basse qualité).
Comparé avec hyaluronan : pourrait être moins efficace à diminuer la douleur,
cependant pourrait être autant efficace dans le court terme (évidence de très
basse qualité).
Bénéfices :
Corticostéroides intra-articulaire vs placebo
1 revue systématique qui démontre une diminution de la douleur à une semaine
si on compare avec un placebo (8 RCT; WMD -21.9, 95% CI -29.9 to -13.9). Il y
avait aussi un bénéfice à 2 semaines (RR 1.81, 95% CI 1.09 -3.00) et à 3
semaines (RR 3.11, 95% CI 1.61 – 6.01). Toutefois, il manque d’évidences après
4 semaines.
Corticostéroides intra-articulaire vs hyaluronan
1 revue systématique sans différence significative de la douleur à 1-4 semaines
(3RCT, 85 personnes, WMD -4.90; 95% CI -9.9 à 0.01 P=0.05). L’hyaluronan et
ses dérivés sont significativement plus efficaces que les corticostéroides pour
réduire la douleur à 5-13 semaines (2 RCT, WMD -7.73, 95%, CI -12.81 to -2,64
P = 0.0003).
Effets néfastes :
Les complications répertoriées sont rares : augmentation des symptômes,
atrophie des tissus, nécrose graisseuse, calcification, athropathie secondaire aux
corticostéroides et nécrose vasculaire. Il y a un risque théorique d’infection, mais
aucune évidence à cet effet.
b) Hyaluronan intra-articulaire :
Comparé avec placebo : possible amélioration de la douleur et de la fonction
jusqu’à 13 semaines, mais pas de bénéfices à long-terme (évidence de basse
qualité) .
Comparé avec corticostéroides intra-articulaire : pourrait être plus efficace à
diminuer la douleur à 5-13 sem, cependant les 2 pourraient être aussi efficaces
un que l’autre dans le court terme (évidence de très basse qualité).
Bénéfices :
Hyaluronan vs placebo
2 revues systématiques et 2 RCT.
Amélioration de la mise en charge entre 1-26 semaines (1-4 sem (22 RCT :
WMD -7.7, 95% CI -11.3 to -4.1, P < 0.0001) 5-13 sem (17 RCT : wMD -13.0, CI
-17.8-8.2 p < 0.00001) 14-26 sem (9 RCT : CI -14.8 to -3.2 p=0.002). Pas
d’amélioration entre 45-52 sem.
Diminution de la douleur (2e revue , 11 RCT, 1443 personnes) : efficace
modérément entre 5-7 sem, 8-10 sem, mais pas entre 15-22 sem (visual
analogue scale 4.4 à 1 sem, 95% CI 1.1 to 7.2 VS 17.7 at 5 to 7 wks, 95% CI
7.5 to 28.0 VS 18.1 at 12-15 wks, 95% CI 6.3 to 29.9; p value not reported) .
Donc évidence qui suggère une diminution des symptômes jusqu’à 6 mois.
Effets néfastes :
Les complications sont rares et sont principalement des effets locaux et des
plaintes gastro-intestinales.
CONCLUSION :
Il n'existe donc pas beaucoup de preuves que l’un ou l’autre des traitements
proposés (stéroides intra-articulaires ou acide hyaluronique intra-articulaire) soit
très efficace. Lorsque l’on compare les corticostéroides et l’injection de
hyaluronan avec le placebo, on dénote dans beaucoup d’études une diminution
de la douleur à court terme, mais pas à long terme sauf dans une revue où le
bénéfice de l’hyaluronan s’était prolongé jusqu’à 6 mois. Dans la seule revue
systématique comparant les steroides intra-articulaires à l’hyaluronan, ce dernier
semble mieux contrôler la douleur à moyen terme (5-13 semaines). Ces deux
modalités de traitement demeurent donc des choix qui pourraient s’avérer
bénéfiques pour la clientèle dont les douleurs ne répondent pas bien aux
exercices et/ou aux anti-inflammatoires. Toutefois, il est important de bien
informer le patient sur la variabilité des réponses cliniques à la douleur. Il y a
aussi le coût de l’hyaluronan, qui est un facteur pouvant influencer la décision.