Limits...
Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351].

Mehta K, Gala J, Bhasale S, Naik S, Modak M, Thakur H, Deo N, Miller MJ - BMC Complement Altern Med (2007)

Bottom Line: 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.Response rates were high and the safety profile was excellent, with significantly less rescue medication use with reparagen.

View Article: PubMed Central - HTML - PubMed

Affiliation: 1Vedic Lifesciences, Pvt. Ltd., Mumbai, India. clinical@ayuherbal.com

ABSTRACT

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.

Conclusion: 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.

Trial registration: Current Controlled Trials ISRCTN25438351.

Show MeSH

Related in: MedlinePlus

Study profile including enrollments and outcomes.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC2131759&req=5

Figure 1: Study profile including enrollments and outcomes.

Mentions: Drop-outs from the study were similar in both groups, disposition of subjects are described in Figure 1. There were some drop-outs due to lack of efficacy and pain associated with the condition between baseline measurements and the first two weeks of treatment. Subsequent losses were largely due to a failure to come for follow-up or for unrelated conditions and adverse events necessitating withdrawal. These adverse events were deemed to be unrelated to the treatments and included single cases of accident, loose bowel motions, hepatitis, gastric ulcer and viral fever. In the glucosamine group a serious adverse event at week 6, specifically gallstones requiring surgery and this was deemed to be unrelated to the treatment. In the glucosamine group 87% of the recruited subjects successfully completed the study, and for reparagen 79% completed the study.


Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351].

Mehta K, Gala J, Bhasale S, Naik S, Modak M, Thakur H, Deo N, Miller MJ - BMC Complement Altern Med (2007)

Study profile including enrollments and outcomes.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2131759&req=5

Figure 1: Study profile including enrollments and outcomes.
Mentions: Drop-outs from the study were similar in both groups, disposition of subjects are described in Figure 1. There were some drop-outs due to lack of efficacy and pain associated with the condition between baseline measurements and the first two weeks of treatment. Subsequent losses were largely due to a failure to come for follow-up or for unrelated conditions and adverse events necessitating withdrawal. These adverse events were deemed to be unrelated to the treatments and included single cases of accident, loose bowel motions, hepatitis, gastric ulcer and viral fever. In the glucosamine group a serious adverse event at week 6, specifically gallstones requiring surgery and this was deemed to be unrelated to the treatment. In the glucosamine group 87% of the recruited subjects successfully completed the study, and for reparagen 79% completed the study.

Bottom Line: 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.Response rates were high and the safety profile was excellent, with significantly less rescue medication use with reparagen.

View Article: PubMed Central - HTML - PubMed

Affiliation: 1Vedic Lifesciences, Pvt. Ltd., Mumbai, India. clinical@ayuherbal.com

ABSTRACT

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.

Conclusion: 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.

Trial registration: Current Controlled Trials ISRCTN25438351.

Show MeSH
Related in: MedlinePlus