Early relief of osteoarthritis symptoms with a natural mineral supplement and a herbomineral combination: a randomized controlled trial [ISRCTN38432711]

Abstract

Background: This study was designed to determine if a natural mineral supplement, sierrasil, alone and in combination with a cat's claw extract (Uncaria guianensis), vincaria, has therapeutic potential in mild to moderate osteoarthritis of the knee.

Methods: Patients (n = 107) with mild to moderate osteoarthritis of the knee were randomly assigned to one of 4 groups; high dose sierrasil (3 g/day), low dose sierrasil (2 g/day), low dose sierrasil (2 g/day) + cat's claw extract (100 mg/day) or placebo, administered for 8 weeks. Treatment was double blinded. Primary efficacy variables were WOMAC scores (A, B, C and total). Visual analog score (VAS) for pain, consumption of rescue medication (paracetamol), and tolerability were secondary variables. Safety measures included vital signs and laboratory-based assays.

Results: Ninety-one of the 107 patients successfully completed the protocol. All four groups showed improvement in WOMAC and VAS scores after 8 weeks (p < 0.001), in all 3 groups receiving sierrasil the magnitude of benefits were greater vs. placebo (WOMAC Total 38-43% vs. 27%) but this was not statistically significant. In reference to baseline values sierrasil treated groups had a considerably faster onset of benefits. Placebo-treated individuals failed to show significant benefits at 4 weeks (11% reduction in total WOMAC). In contrast, after 1 or 2 weeks of therapy all the sierrasil groups displayed significant reductions in WOMAC scores (p < 0.05) and at week 4 displayed a 38-43% improvement. VAS was significantly improved at 4 weeks in all groups (p < 0.001) but was significantly greater in all sierrasil groups compared to placebo (p < 0.05). Rescue medication use was 28-23% lower in the herbomineral combination and high dose sierrasil groups although not statistically different from placebo (P = 0.101 and P = 0.193, respectively). Tolerability was good for all groups, no serious adverse events were noted and safety parameters remained unchanged.

Conclusion: The natural mineral supplement, sierrasil alone and in combination with a cat's claw extract, improved joint health and function within 1-2 weeks of treatment but significant benefits over placebo were not sustained, possibly due to rescue medication masking. Sierrasil may offer an alternative therapy in subjects with joint pain and dysfunction.

Figure 1

Sequential changes in WOMAC A (pain) scores expressed as a percentage of baseline values. Placebo (blue, n = 22), high dose sierrasil (green, n = 20), low dose sierrasil (red, n = 21) and low dose sierrasil + cat's claw extract (orange, n = 25) all demonstrated a time dependent improvement in the pain indices of WOMAC A. However, in the placebo group this was delayed until the last month of the study. All sierrasil treated groups displayed a faster onset of action.

Figure 2

Sequential changes in WOMAC B (stiffness) scores expressed as a percentage of baseline values. Placebo (blue, n = 22), high dose sierrasil (green, n = 20), low dose sierrasil (red, n = 21) and low dose sierrasil + cat's claw extract (orange, n = 25) displayed a time dependent improvement in WOMAC B scores, measuring stiffness, over the course of the study. A trend for a faster onset of improvement was evident in all sierrasil treated groups when compared to placebo controls.

Figure 3

Sequential changes in WOMAC C (physical activity) scores expressed as a percentage of baseline values. Placebo (blue, n = 22), high dose sierrasil (green, n = 20), low dose sierrasil (red, n = 21) and low dose sierrasil + cat's claw extract (orange, n = 25) displayed a time dependent improvement in physical activity and function scores (WOMAC C). A trend for a faster onset of benefits was evident in all sierrasil treated groups versus placebo.

Figure 4

Sequential changes in WOMAC total scores expressed as a percentage of baseline values. Placebo (blue, n = 22), high dose sierrasil (green, n = 20), low dose sierrasil (red, n = 21) and low dose sierrasil + cat's claw extract (orange, n = 25) displayed a time dependent improvement in total WOMAC Scores. There was a trend for a faster onset of action in all sierrasil treated groups when compared to placebo responses.

Figure 5

Sequential changes in VAS (pain) expressed as a percentage of baseline values. Placebo (blue, n = 22), high dose sierrasil (green, n = 20), low dose sierrasil (red, n = 21) and low dose sierrasil + cat's claw extract (orange, n = 25) displayed a time dependent improvement in VAS scores for pain. However, there was a trend for a faster onset of benefits in the sierrasil treated groups compared to placebo.

Figure 6

Consumption of rescue medication (paracetamol) for the study duration. Results for placebo (blue column, n = 19), high dose sierrasil (green column, n = 19), low dose sierrasil (red column, n = 20) and low dose sierrasil + cat's claw extract (orange column, n = 23) groups are expressed as mean ± sem. There was no significant difference in rescue medication use between the various groups, although a trend for less paracetamol consumption was evident in both the high dose sierrasil and low dose + cat's claw groups which approached significance (p = 0.119 and p = 0.101 vs placebo respectively).