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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.

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BackgroundThis 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.MethodsPatients (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.ResultsNinety-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.ConclusionThe 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.

ABSTRACT:Osteoarthritis is a chronic painful condition affecting larger joints; most commonly knee joint. Pharmacological control of pain is the mainstay of management of osteoarthritis. Many patientsfail to achieve satisfactory reduction in pain with one of the most commonly prescribed drugs, diclofenac sodium, even after maximum daily allowed doses. Lornoxicam is a newer molecule in the Indian market promising better pain relief in context of low back pain and post knee replacement surgery pain as compared to standard therapies. As per profile of lornoxicam, if it is better than diclofenac sodium then it will be helpful in managing the patients of osteoarthritis more effectively. Till date no comparative clinical trial has been done to compare these two drugs for the management of osteoarthritis knee. So, to evaluate the same we carried out this study to compare safety, efficacy and cost effectiveness of lornoxicam and diclofenac sodium in relieving pain in patients of osteoarthritis knee. This study is a randomized, open labeled, controlled clinical trial having 40 newly diagnosed patients with osteoarthritis knee. After random allocation into two groups i.e. group D and group L (each having 20 patients); group D received diclofenac sodium 50 mg 12 hourly and group L received lornoxicam 4 mg 8 hourly for a period of 3 months. All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy. Adverse drug reactions and cost of therapy was monitored during the study period. Mean decrease in visual analogue scale and time of 100 meter walking test was statistically significant in lornoxicam group as compared to diclofenac sodium. Gastric irritation was reported in one patient from group L and two patients from group D. Lornoxicam significantly relieves pain of osteoarthritis knee than diclofenac sodium without adversely affecting the tolerability to the patients.