| Methods |
Randomised
Controlled
Trial
Double‐blind
X‐ray scorers blinded
Placebo‐ controlled
Parallel group
Multicentre (46 rheumatology departments)
Parallel‐group
Multicentre
ITT (LOCF)
Repeat treatme |
| Participants |
Country:
France
Mean age: 64.8
% Female: 68
Mean disease duration: NR
Duration: 1 y
Number randomised: 301
(NRD+PLDIA 131, PLINJ+DIA
85, PLINJ+PLDIA 85)
Inclusion:
outpt fulfilling the ACR clinical or radiological criteria for the diagnosis of knee OA,
presenc eof a symptomatic primary painful medial femorotibial knee OA defined by a daily pain VAS score >30 mm in the previous mth,
medial joint space width >2mm,
radiographic evidence of knee OA, eligibility criteria and quality of radiographic films were verified by a central reader
Exclusion:
evidence of secondary knee OA (possibly due to injury, inflam‐
mation or meta‐
bolic rheumatic disease, osteonecrosis, Paget's disease, villonodular synovitis, haemophilia),
prior ia HA treatment, other ia injection including lavage and corticosteroids within the previous 3 mth,
treatment with diacerein in the 3 mth before inclusion and use of any other anti‐osteoarthritic drugs in the 2 mth before inclusion,
contraindication to IA injection (anticoagulants, haematological anomalies),
severe knee OA (JSW <2 mm, surgery required on the evaluated knee in the year)
Baseline values:
Pain (0‐100)
NRD: 61.7
DIA: 59.6
PL: 59.1
Lequesne
NRD: 11.1
DIA: 10.5
PL: 10.5
Pt global (0‐100)
NRD: 59.7
DIA: 59.0
PL: 57.3
% of painful days during previous mth (0‐100)
NRD: 85.5
DIA: 83.0
PL: 82.6
JSW (mm)
NRD: 4.5
DIA: 4.5
PL: 4.7 |
| Interventions |
1) NRD 101 ‐ 3 courses of 3 IA injections+ oral placebo,
2) IA injections of saline + Diacerein 50 mg twice daily,
3) IA injections of saline + oral placebo
Concurrent therapy: Allowed to take analgesics as rescue drugs but 2‐day washout before evaluation visit; aspirin <500 mg/day allowed; NSAID allowed but 7‐day washout requied before each evaluation visit; no systemic corticosteroid, IA treatment or any potential symptom modifying drug was allowed during the study |
| Outcomes |
Pain (0‐100 mm VAS),
Lequesne,
Pt. global assessment of disease activity (0‐100 mm VAS),
% of painful days during previous months (0‐100 mm VAS),
use of concomitant treatments (analgesics and NSAIDs) evaluated by numbers of days of intake between each clinic visit,
pt and investigator global assessment of treatment efficacy (5 point Likert: very good, good, moderate, bad, very bad),
investigator global assessment of treatment safety on 5 level Likert scale,
Structural:
JSW, Kellgren Lawrence grade,
osteophyte score on antero‐posterior X‐ray,
% of progressors (joint space narrowing 0.5 mm) |
| Notes |
Jadad's: 5/5
R‐2, B‐2, W‐1 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
