A total of 358 patients with chronic knee pain were
screened free-of –cost in “arthritis camps”
in an Indian metropolis. Ninety patients with primary
OA of the knees (ACR classification; Arthritis Rheum
1986; 29; 1039-1049) were found eligible (postanal-gesic
washout pain visual analog score {VAS } ?40 mm in either
or both knees on body weight-bearing activities) to
enroll into a randomized , double-blind, placebo-controlled,
parallel efficacy, single-center, 32-week drug trial
(80% power to detect 25% difference, P = 0.05, 2-sided).
Concurrent analgesics/nonsteroidal anti-inflammatory
drugs and steroids in any form were not allowed. Lifestyle
and /or dietary restrictions, as per routine ‘Ayurveda
practices, were not imposed. Pain VAS (maximum pain
in each knee recorded by the patient during the preceding
48 hours) and modified WOMAC (Western Ontario McMa-ster
University OA Index, Likert scale, version 3.0) were
the primary efficacy variables. The WOMAC section on
“physical function difficulty” was modified
for Indian use and validated before the trial. Routine
laboratory testing was primarily done to monitor drug
safety. At baseline, the groups (active =45, placebo
=45) were well matched for several measures (mean pain
VAS: active =6.17; placebo = 6.5).
|
