Efficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study

Malkanthi Evans, Dale Wilson, Najla Guthrie KGK Synergize Inc., London, ON, Canada Purpose: This study evaluated the efficacy of a hydrothermal mineral complex (HMC) supplement in participants with knee osteoarthritis. Patients and methods: This was a double-blind, placebo-controlled, 12-week cros...

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Autores principales: Evans M, Wilson D, Guthrie N
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Publicado: Dove Medical Press 2014
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spelling oai:doaj.org-article:973e6f490ddf48898f6b77081e28b8232021-12-02T01:04:39ZEfficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study1179-156Xhttps://doaj.org/article/973e6f490ddf48898f6b77081e28b8232014-10-01T00:00:00Zhttp://www.dovepress.com/efficacy-of-a-natural-mineral-complex-in-north-american-adults-with-os-peer-reviewed-article-OARRRhttps://doaj.org/toc/1179-156X Malkanthi Evans, Dale Wilson, Najla Guthrie KGK Synergize Inc., London, ON, Canada Purpose: This study evaluated the efficacy of a hydrothermal mineral complex (HMC) supplement in participants with knee osteoarthritis. Patients and methods: This was a double-blind, placebo-controlled, 12-week crossover study with 150 participants receiving either placebo or HMC for 4 weeks, with a 4-week washout period. The primary endpoint was WOMAC™ pain, and secondary endpoints were WOMAC™ physical function and stiffness, the 36-Item Short Form Health Survey (SF-36), high-sensitivity C-reactive protein, tumor necrosis factor a, interleukin 6, and safety. Results: There were no significant differences in WOMAC™ pain, stiffness, or physical function scores between groups. Within groups, subjects on both HMC and placebo reported improvements (P<0.001) in all WOMAC™ domains. HMC performed significantly better in total SF-36 scores (P=0.05) and physical function (P=0.02), and had improved total physical activity (P=0.06) and social functioning (P=0.09) scores compared with placebo. Within groups, physical function (P=0.01), limitations due to mental health/emotional well-being (P=0.02), bodily pain (P=0.001), and total physical (P=0.003) and mental health scores (P=0.02) improved in participants on HMC, whereas improvements in bodily pain (P=0.001), general health (P=0.01), and total physical activity (P=0.04) were reported in placebo. Subjects on HMC with body mass index (BMI) <25 kg/m2 showed a trend toward decreased pain scores (P=0.10), while pain increased in those administered placebo. Minimal clinically important improvement (MCII) in WOMAC™ pain scores increased from 28% of HMC-administered participants at week 2 to 41% at week 4, and decreased to 37% after 2 weeks of washout. In comparison, 41% of placebo-administered subjects achieved MCII by week 2 and week 4. A 10.4% greater increase in tumor necrosis factor α levels was seen in participants receiving placebo than those receiving HMC (P=0.07). There were no differences between groups in adverse events. Conclusion: HMC significantly improved physical function and total physical activity, improving the quality of life of participants. HMC was most effective in normal-weight subjects. Increased dosage may be required for North American subjects with BMI >25 kg/m2. Keywords: knee osteoarthritis, WOMAC™, SF-36, hydrothermal mineral complexEvans MWilson DGuthrie NDove Medical PressarticleDiseases of the musculoskeletal systemRC925-935ENOpen Access Rheumatology: Research and Reviews, Vol 2014, Iss default, Pp 91-103 (2014)
institution DOAJ
collection DOAJ
language EN
topic Diseases of the musculoskeletal system
RC925-935
spellingShingle Diseases of the musculoskeletal system
RC925-935
Evans M
Wilson D
Guthrie N
Efficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study
description Malkanthi Evans, Dale Wilson, Najla Guthrie KGK Synergize Inc., London, ON, Canada Purpose: This study evaluated the efficacy of a hydrothermal mineral complex (HMC) supplement in participants with knee osteoarthritis. Patients and methods: This was a double-blind, placebo-controlled, 12-week crossover study with 150 participants receiving either placebo or HMC for 4 weeks, with a 4-week washout period. The primary endpoint was WOMAC™ pain, and secondary endpoints were WOMAC™ physical function and stiffness, the 36-Item Short Form Health Survey (SF-36), high-sensitivity C-reactive protein, tumor necrosis factor a, interleukin 6, and safety. Results: There were no significant differences in WOMAC™ pain, stiffness, or physical function scores between groups. Within groups, subjects on both HMC and placebo reported improvements (P<0.001) in all WOMAC™ domains. HMC performed significantly better in total SF-36 scores (P=0.05) and physical function (P=0.02), and had improved total physical activity (P=0.06) and social functioning (P=0.09) scores compared with placebo. Within groups, physical function (P=0.01), limitations due to mental health/emotional well-being (P=0.02), bodily pain (P=0.001), and total physical (P=0.003) and mental health scores (P=0.02) improved in participants on HMC, whereas improvements in bodily pain (P=0.001), general health (P=0.01), and total physical activity (P=0.04) were reported in placebo. Subjects on HMC with body mass index (BMI) <25 kg/m2 showed a trend toward decreased pain scores (P=0.10), while pain increased in those administered placebo. Minimal clinically important improvement (MCII) in WOMAC™ pain scores increased from 28% of HMC-administered participants at week 2 to 41% at week 4, and decreased to 37% after 2 weeks of washout. In comparison, 41% of placebo-administered subjects achieved MCII by week 2 and week 4. A 10.4% greater increase in tumor necrosis factor α levels was seen in participants receiving placebo than those receiving HMC (P=0.07). There were no differences between groups in adverse events. Conclusion: HMC significantly improved physical function and total physical activity, improving the quality of life of participants. HMC was most effective in normal-weight subjects. Increased dosage may be required for North American subjects with BMI >25 kg/m2. Keywords: knee osteoarthritis, WOMAC™, SF-36, hydrothermal mineral complex
format article
author Evans M
Wilson D
Guthrie N
author_facet Evans M
Wilson D
Guthrie N
author_sort Evans M
title Efficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study
title_short Efficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study
title_full Efficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study
title_fullStr Efficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study
title_full_unstemmed Efficacy of a natural mineral complex in North American adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study
title_sort efficacy of a natural mineral complex in north american adults with osteoarthritis of the knee: a randomized double-blind placebo-controlled study
publisher Dove Medical Press
publishDate 2014
url https://doaj.org/article/973e6f490ddf48898f6b77081e28b823
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AT guthrien efficacyofanaturalmineralcomplexinnorthamericanadultswithosteoarthritisofthekneearandomizeddoubleblindplacebocontrolledstudy
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