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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.

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Related in: MedlinePlus

Sequential response rates as determined by a 20% reduction in the WOMAC pain scores in reparagen (red, n = 48) and glucosamine sulfate (blue, n = 47).
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Figure 2: Sequential response rates as determined by a 20% reduction in the WOMAC pain scores in reparagen (red, n = 48) and glucosamine sulfate (blue, n = 47).

Mentions: Response rate was calculated in accordance with the method described in the GAIT study [11]. This method uses a 20% reduction in WOMAC pain as the primary assessment of a response to treatment. Using this criteria both treatments were associated with a large proportion of responders within one week of treatment (reparagen 47.9%; glucosamine 46.8%). Response to both treatments continued to increase for the duration of the study protocol (Fig. 2). At week 4 the response rates were similar with both treatments: reparagen 81.2%, glucosamine 74.5% and at the conclusion of the study at week 8: reparagen 93.7%, glucosamine 89.4% (Table 4).


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)

Sequential response rates as determined by a 20% reduction in the WOMAC pain scores in reparagen (red, n = 48) and glucosamine sulfate (blue, n = 47).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 2: Sequential response rates as determined by a 20% reduction in the WOMAC pain scores in reparagen (red, n = 48) and glucosamine sulfate (blue, n = 47).
Mentions: Response rate was calculated in accordance with the method described in the GAIT study [11]. This method uses a 20% reduction in WOMAC pain as the primary assessment of a response to treatment. Using this criteria both treatments were associated with a large proportion of responders within one week of treatment (reparagen 47.9%; glucosamine 46.8%). Response to both treatments continued to increase for the duration of the study protocol (Fig. 2). At week 4 the response rates were similar with both treatments: reparagen 81.2%, glucosamine 74.5% and at the conclusion of the study at week 8: reparagen 93.7%, glucosamine 89.4% (Table 4).

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