Natural minerals used as food supplement provides early relief from osteoarthritis of knee symptoms: a randomized, placebo controlled clinical trial

摘要

Objective: This study was conducted to evaluate the therapeutic effects of a natural food supplement on walking distance, pain and joint mobility, in subjects with moderate to severe osteoarthritis of the knee. Methods: The study was a double-blinded, parallel-group, where 100 patients with mild-to-moderate osteoarthritis of knee were randomly assigned to receive either Mineral supplement or an identical placebo. The data regarding the demography, OA of Knee using X-ray and ultrasound were recorded at the baseline and at 8, 12, and 24 weeks. The primary efficacy was measured by WOMAC and Visual Analog Scale (VAS) for pain, consumption of rescue medication (NSAIDs or analgesics), and tolerability; secondary efficacy was measured by improvement in the radiological changes, ultrasound and synovial fluid assessments. Safety measures included vital signs and laboratory based assays. Results: 93 out of 100 subjects successfully completed the study. Seven subjects did not complete the study. Reasons for withdrawal were adverse events, personal or lack of efficacy, and few were drop-outs as they did not meet the selection criteria at base line. One of these subjects had nausea as an adverse event in the mineral supplement group. The active group that received supplement showed improvements in WOMAC and VAS after 8 weeks (p < 0.001) as compared to placebo, but the improvement was not statistically significant. In reference to base line values CTMD (R) treated group had considerably faster onset of benefit while placebo-treated individuals failed to show significant benefits. Ultrasonography and synovial fluid examination revealed improvement in cartilage structure. Rescue medication intake was 18 - 23% lower in supplemented as compared to placebo group. Tolerability was good in both the groups. No serious adverse events were noted and safety parameters remained unchanged. Conclusion: This preliminary study suggested that the natural food supplement may increase range of motion and walking distances in subjects with OA of the knee and reduced use of NSAIDs over 12 weeks of treatment. This clinical study brings forth need of mineral supplement as an important component of treatment, which is both safe and effective, for patients of Osteoarthritis. Further evaluation in larger study samples will confirm its utility in the management of osteoarthritis.