| Methods |
Randomised
Controlled
Trial
Double‐blind
Placebo‐ controlled
Parallel‐group
2 wk washout all OA medications
ITT analysis |
| Participants |
Country:
Canada
Mean age: 65.5
% Female: 46
Mean disease
duration: NR
Duration: 12 wk
Number randomised: 120
(30/group)
Inclusion:
radiographic evidence of Grade 1 to 3 medial compartment unilateral knee OA [Grade 1‐23%,
Grade 2 ‐ 45%,
Grade 3 ‐ 32%]
>=3 cm current rest pain
absence of non‐OA arthritides
Exclusion:
previous NSAID intolerance
gastrointestinal hemorrhage
peptic ulcer disease
avian allergy
intraarticular injection of HA or corticosteroid in previous 6 mth
regular con‐
consumption of "herbal" OA products (e.g. glucosamine sulfate)
Baseline values:
WOMAC pain
HA+PL: 3.32
NSAID+PL: 4.22
NSAID+HA: 3.65
PL: 3.62
WOMAC function
HA+PL: 4.10
NSAID+PL: 4.32
NSAID+HA: 3.90
PL: 4.72
Rest pain:
HA+PL:3.29
NSAID+PL:3.34
NSAID+HA:3.60
PL:3.30
Baseline xray:
HA+PL: 2.2 (0.3)
NSAID+HA: 2.2 (0.5)
NSAID+PL: 2.3 (0.4)
PL: 2.2 (0.2) based on Altman et al 1987 Arthritis Rheum. |
| Interventions |
Suplasyn 20 mg
3 weekly injections
+ placebo (lactose 100 mg po bid)
Suplasyn 20 mg
3 weekly injections + 75 mg diclofenac/
200 ug misoprostol
po bid (Arthrotec)
Saline 2 ml
3 weekly injections + 75 mg diclofenac/
200 ug misoprostol
po bid (Arthrotec)
Saline 2 ml
3 weekly injections
+ placebo (lactose 100 mg po bid)
All pts received 10 min home‐based resistance exercise program to be done at least 3x/wk but preferably most days/wk
Concurrent therapy:
325 mg acetaminophen |
| Outcomes |
self‐report of cur‐
rent pain at rest on VAS
WOMAC OA Index
functional perfor‐
mance of self‐
paced walking test and a self‐
paced stepping test ‐ VAS scale
of pain after completion and performance time
range of motion
VO2 max |
| Notes |
Jadad's:5/5
R‐2,B‐2,W‐1
Unilateral only
Discrepancy between abstract and paper for rest pain mean and sd at baseline and sd at 4 wk. The sd for SPW and SPS pain at wk4 changed as well but WOMAC pain and function and walk time values did not change.
Results only presented for Week 4 not Week 12.
Study supported by Bioniche Life Sciences Inc.
Dr. Hildebrand is affiliated with Bioniche Life Sciences Inc.
Editorial reports that a factorial design analysis most efficient; a reanalysis found no evidence that Suplasyn had a signficant or important clinical effect on pain. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
