Session
Speaker
Potassium Humate Reduces Clinica (WOMAC) and Biological (hs-
CRP) Markers of Disease in Patients with Osteoarthritis of the Knee
C. E. J. van Rensburg, B.E. Badenhorst, J.R. Snyman, P. J. Becker
South Africaa
A randomized, double-blind, placebo-controlled, single centre,
cross-over study was conducted to determine if potassium humate, derived
from brown coal, is safe and effective in reducing pain and inflammation
in osteoarthritis of the knee.
Participants were enrolled for a total of 14 weeks, starting with
an initial 1-week washout period, after which they were randomly assigned
to either potassium humate or placebo, administered for 6 weeks three
times daily. Following another 1-week washout period, participants
were crossed over to the other treatment for another 6 weeks. Paracetamol
was allowed as rescue medication for the duration of the trial. The
primary efficacy variable was WOMAC scores (visual analogue version)
for pain, stiffness, physical function and total score. The secondary
efficacy variables included assays for hs-CRP, rescue mediation use,
adverse effects and tolerability.
There was a significantly greater clinical benefit with potassium
humate over placebo with reduction in all the WOMAC subscale scores
for pain. When adjusted for baseline, potassium humate showed greater
reduction in hs-CRP levels than placebo. Tolerability was good for
all groups. Safety parameters remained mostly unchanged.
In conclusion, potassium humate showed benefit over placebo in patients
with OA of the knee, with a statistically significant reduction in
hs-CRP levels. The patient reported outcomes proved a clinically significant
benefit of potassium humate over placebo; this however, did not reach
statistically significance. This may be attributed to sample size
limitation and the carry-over effect. Potassium humate demonstrated
a good safety profile with placebo like tolerance.
|