Benefits of an Herbal-amino Acid Supplement in Osteoarthritis: Results of a Randomized Double-Blind Placebo Controlled Trial

Abstract

Osteoarthritis is the most common form of joint disease and reflects a chronic inflammation that over time can result in joint destruction including the loss of articular cartilage and exposure of underlying bone. In a multi-center, randomised, placebo-controlled, double-blind clinical trial, a medicinal plant and L-leucine mixture (HLM) was studied in subjects with established osteoarthritis of the knee. \nA total of 96 osteoarthritic subjects were enrolled and randomly assigned to either a placebo (n = 38) or an HLM treatment group (n = 38). The HLM group received a combination of Uncaria tomentosa (300 mg), Boswellia serrata (200 mg), Lepidium meyenii (1000 mg) and L-Leucine (700 mg) once a day. The placebo group received matching capsules with carboxymethylcellulose. The treatment lasted eight weeks, with assessments on days seven, fourteen, twenty-eight, and fifty six.The primary goal was to lower the total WOMAC score.VAS pain, tolerability, investigator assessments, use of rescue medication (acetominophen), and vital sign and laboratory assessments were all included.Subject randomization worked well in terms of age, gender, and disease severity. The trial was completed by 32/38 subjects in the placebo group and 35/38 in the HLM group. WOMAC scores (pain, stiffness, physical performance, and total) decreased steadily in both groups over the course of the 8-week study, but the magnitude was significantly greater in 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. \nThe investigator s overall rating of good-excellent for HLM was 24/35 (69%) and 14/32 (44%) for placebo (P = 0.05).The consumption and tolerability of rescue medications were comparable for HLM and placebo. These properties of HLM warranted a clinical investigation to further investigate its potential as a treatment for osteoarthritis, which is the focus of this report. There were no safety concerns with either group.Although a placebo effect was observed, HLM was clearly more effective in relieving osteoarthritis symptoms. This HLM represents a new, safe, and effective approach to managing osteoarthritis symptoms.