Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial ISRCTN25438351Reportar como inadecuado

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BMC Complementary and Alternative Medicine

, 7:34

First Online: 31 October 2007Received: 08 June 2007Accepted: 31 October 2007


BackgroundThe 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.

MethodsSubjects 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.

ResultsSubject 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.

ConclusionBoth 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.

Trial registrationCurrent Controlled Trials ISRCTN25438351.

AbbreviationsMMPmatrix metalloproteinase

IGF-1insulin-like growth factor-1

NF-κBnuclear factor kappa B

AP-1activating factor-1

NSAIDsnon-steroidal anti-inflammatory drugs

GUIDEglucosamine Unum In Die Efficacy

GAITglucosamine-chondroitin arthritis intervention trial

WOMACwestern ontario and mcmaster universities osteoarthritis index

VASvisual analog score

OARSIosteoarthritis research society international

OMERACToutcome measures in rheumatology clinical trials

ARAamerican rheumatology association

Electronic supplementary materialThe online version of this article doi:10.1186-1472-6882-7-34 contains supplementary material, which is available to authorized users.

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Autor: Komal Mehta - Jayesh Gala - Surendra Bhasale - Sattayasheel Naik - Millind Modak - Harshad Thakur - Nivedita Deo - Mark JS


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