Relief of osteoarthritis with a herbal-amino acid supplement: A randomized double-blind placebo controlled trial
- 1 University of South Australia, School of Pharmacy & Medical Sciences
- 2 University of South Australia, School of Pharmacy & Medical Sciences
Abstract
A redox active medicinal plant and L-leucine mixture (HLM) was investigated in subjects with established osteoarthritis of the knee in a multi-center, rando- m-ized, placebo-controlled, double-blind clinical trial. A total of 96 subjects with osteoarthritis were enrolled and randomized to either placebo (n = 38) or HLM treatment group (n = 38). The HLM group re- ceived a combination of Uncaria tomentosa (300 mg), Boswellia serrata (200 mg), Lepidium meyenii (1000 mg) and L-Leucine (700 mg) given as 3 capsules once a day. The placebo group received matching capsules with carboxymethylcellulose. The treatment period was 8 weeks, with assessments made at days 7, 14, 28 and 56. The primary outcome was reduction in total WOMAC score. VAS pain, tolerability, investigator assessments, use of rescue medication (acetominophen), and safety assessments of vital signs and laboratory assessments were included. Subject randomization was effective for age, gender and disease severity. In the placebo group 32/38 subjects completed the trial and for HLM 35/38. WOMAC scores (pain, stiffness, physical performance and total) steadily declined over the course of the 8 week study in both groups, but the magnitude was significantly greater for HLM (P < 0.05). Total WOMAC was reduced 46.5% for HLM and 25.4 % for placebo. VAS pain was reduced 21.8% in the placebo group (p < 0.002) but the changes were significantly greater (37.8% p < 0.03) with HLM treatment. Investigator’s global assessment rating of good-excellent was 24/35 (69%) for HLM and 14/32 (44%) for placebo (P = 0.05). Rescue medication consumption and tolerability were comparable for HLM and placebo. No safety issues were evident with either group. As expected a placebo effect was observed, nevertheless HLM was clearly more effective in relieving the symptoms of osteoarthritis. This HLM represents a safe and effective new approach to the management of osteoarthritis symptoms.
- Bay-Jensen A.C., Hoegh-Madsen S., Dam E., Henriksen K., Sondergaard B.C., Pastoureau P., Qvist P., Karsdal M.A. (2010) Which elements are involved in reversible and irreversible cartilage damage in osteoarthritis. Rheumatol. Int., 30: 435-42.
- Miller M.J.S., Akhtar N., Haqqi T.M. Effect of a herbal-leucine mix on the IL-1β-induced cartilage degradation and inflammatory gene expression in human chondrocytes. (2011) BMC Complementary and Alternative Medicine, 11:66
- Chopra A. (2004) Rheumatology: made in India (Camps, COPCORD, HLA, Ayurveda, HAQ, WOMAC and Drug Trials). J Indian Rheumatol Assoc., 12: 43-53.
- Clegg D.O. et al., (2006) Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N. Engl. J. Med., 354: 795-808.
- Bjarnason I., Thjodleifsson B. (1999) Gastrointestinal toxicity of non-steroidal anti-inflammatory drugs: the effect of nimesulide compared with naproxen on the human gastrointestinal tract. Rheumatology, 38: 24-32.
- Biggee B.A., Blinn C.H., Nuity M., Silbert J.E., McAlindon T.E. (2007) Effects of oral glucosamine sulfate on serum glucose and insulin during an oral glucose tolerance test of subjects with osteoarthritis. Ann Rheum. Dis., 66, 260-262.
- Pham T., Cornea A., Blick K.E., Jenkins A., Scofield R.H. (2007) Oral glucosamine in doses used to treat osteoarthritis worsens insulin resistance. Ann J. Med. Sci., 333: 333-339.
- Roman-Blas J.A., Jimenez S.A. (2006) NF-kappaB as a potential therapeutic target in osteoarthritis and rheumatoid arthritis. Osteoarthritis Cartilage.,14: 839-48.
- Kimmatkar N., Thawani V., Hingorani L., Khiyani R. (2003) Efficacy and tolerability of Boswellia serrata extract in treatment of osteoarthritis of knee-a randomized double blind placebo controlled trial. Phytomedicine, 10:3-7
- Sontakke S., Thawani V., Pimpalkhute S., Kabra P., Babhulkar S., Hingorani L. (2007). Open, randomized, controlled clinical trial of Boswellia serrata extract as compared to valdecoxib in osteoarthritis of knee. Indian J. Pharmacol., 39: 27 – 29.
- Sandoval-Chacon M., Thompson J.H., Liu X., Mannick E.E., Sadowska-Krowicka H., Charbonnet R., Clark D.A., Miller M.J.S. (1998) Anti-inflammatory actions of cat's claw: the role of NF-B. Alimentary Pharmacol. Therap., 12: 1279-1289.
- Sandoval M., Charbonnet R.M., Okuhama N.N., Roberts J., Krenova Z., Trentacosti A.M., Miller M.J.S. (2000) Cat’s claw inhibits TNF production and scavenges free radicals: role in cytoprotection. Free Radical Biol. Med., 29: 71-78.