Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351].
BACKGROUND
The efficacy and safety of a dietary supplement derived from South American botanicals was compared to glucosamine sulfate in osteoarthritis subjects in a Mumbai-based multi-center, randomized, double-blind study.


METHODS
Subjects (n = 95) were screened and randomized to receive glucosamine sulfate (n = 47, 1500 mg/day) or reparagen (n = 48, 1800 mg/day), a polyherbal consisting of 300 mg of vincaria (Uncaria guianensis) and 1500 mg of RNI 249 (Lepidium meyenii) administered orally, twice daily. Primary efficacy variable was response rate based on a 20% improvement in WOMAC pain scores. Additional outcomes were WOMAC scores for pain, stiffness and function, visual analog score (VAS) for pain, with assessments at 1, 2, 4, 6 and 8 weeks. Tolerability, investigator and subject global assessments and rescue medication consumption (paracetamol) were measured together with safety assessments including vital signs and laboratory based assays.


RESULTS
Subject randomization was effective: age, gender and disease status distribution was similar in both groups. The response rates (20% reduction in WOMAC pain) were substantial for both glucosamine (89%) and reparagen (94%) and supported by investigator and subject assessments. Using related criteria response rates to reparagen were favorable when compared to glucosamine. Compared to baseline both treatments showed significant benefits in WOMAC and VAS outcomes within one week (P < 0.05), with a similar, progressive improvement over the course of the 8 week treatment protocol (45-62% reduction in WOMAC or VAS scores). Tolerability was excellent, no serious adverse events were noted and safety parameters were unchanged. Rescue medication use was significantly lower in the reparagen group (p < 0.01) at each assessment period. Serum IGF-1 levels were unaltered by treatments.


CONCLUSIONS
Both reparagen and glucosamine sulfate produced substantial improvements in pain, stiffness and function in subjects with osteoarthritis. Response rates were high and the safety profile was excellent, with significantly less rescue medication use with reparagen. Reparagen represents a new natural productive alternative in the management of joint health.


BACKGROUND
Current Controlled Trials ISRCTN25438351.
Mehta
Komal
K
1Vedic Lifesciences, Pvt. Ltd., Mumbai, India. clinical@ayuherbal.com
Gala
Jayesh
J
Bhasale
Surendra
S
Naik
Sattayasheel
S
Modak
Millind
M
Thakur
Harshad
H
Deo
Nivedita
N
Miller
Mark J S
MJ
D000082:Acetaminophen / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D005944:Glucosamine / Q000627:therapeutic use*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D010147:Pain Measurement; D010936:Plant Extracts / Q000627:therapeutic use*; D016896:Treatment Outcome
D010936:Plant Extracts; C510404:reparagen; D000082:Acetaminophen; D007334:Insulin-Like Growth Factor I; D005944:Glucosamine