| Participants |
Country:
Japan
Mean age: 67
% Female: 75
Mean disease
duration: NR
Duration: 5 wk
Number randomised: 172
(SLM 87, Artz 85)
Inclusion:
diagnosis of knee OA on basis of clinical and xray
informed consent
pain during movement
xray findings: one of osteophyte, JSN, osteoscl‐
erosis
Exclusion:
considered to require an operation
received ia injection of steroid within 2 wks of start
newly administered analgesic, NSAID within 2 wk of start
new PT within 2 wk
pregnant, lactating, or may become pregnant
serious complications such as definite hepatic and renal ftn. disorders
have or have history of hyper‐
sensitivity to drug
those judged by the physi‐
cian in charge to be inappro‐
priate as trial subjects
Baseline values:
movement pain
mild SLM 39%
Artz 35%,
moderate SLM
55%, Artz 61%
severe SLM 6%,
Artz 4% |
| Outcomes |
assessment by attending physician:
daily activity dis‐
order:standing up from chair,up/
down stairs,
squatting, sitting
up straight (easy,
mild,moderate,
severe), walking ftn disorder, pain
(in movement,
when resting,
pressure), knee jt findings (swel‐
ling,feverish
feeling,floating
patella), range of motion: all on 4‐point scales (none,mild,mod‐
erate,severe), +/‐ stagnant synovial fluid,
if present, volume
pt's impression: 7 grades:much
better,better,
slightly better,
unchanged,
slightly worse,
worse, much
worse
pt global improvement : 7 grades:markedly
improved, im‐
proved,slightly
improved, un‐
changed,slightly
deteriorated, de‐
teriorated, mark‐
edly deteriorated
overall safety: 3 grades: safe,
continued use
despite some
problem, discon‐
tinued due to
problem
usefulness: 7 grades:very use‐
ful,useful,slightly
useful,cannot say useful or not,
slightly undesir‐
able, undesir‐
able, very unde‐
sirable
Committee assessment: pain, daily activity disorder, knee jt findings, walking ftn: score/100,
overall severity: 3 grades (mild >=60/100, moderate 30‐50/
100, severe <= 29/100) and global improvement: 7 grades, overall safety & usefulness |
