Herbal Extract Safe and Effective for OA

A resin extracted from the herb Boswellia serrata has recently been touted as a treatment for arthritis due to its anti-inflammatory and pain-relieving properties. Studies have found that the most biologically active component in the herb is 3-O-acetyl-11-keto-beta-boswellic acid (AKBA). This compound inhibits the action of 5-lipoxygenase, which is an enzyme involved in the biochemical cascade that leads to inflammation.

What Problem Was Studied?

To enhance the effectiveness of Boswellia resin, an extract was developed that increased the total concentration of AKBA to 30 percent from 0.5 percent in unenriched resin. The company that created the extract funded a study to determine the safety and effectiveness of this enriched compound (called 5-Loxin) on the symptoms of osteoarthritis (OA).

What Was Done in the Study?

Siba P. Raychaudhuri, MD, of University of California Davis Medical Center, holds a current Arthritis Investigator Award from the Arthritis Foundation for a project involving nerve growth factors and their involvement in psoriatic arthritis.

An international research team, including Arthritis Foundation-funded scientist Siba Raychaudhuri, MD, was compiled to conduct a double-blind, randomized, placebo-controlled trial of the compound. A total of 75 people with mild to moderate knee OA were selected and randomly assigned to one of three groups: 25 people received 100 mg/day of the enriched extract; 25 received 250 mg/day of the enriched extract; and 25 people received a placebo.

All participants were assessed for pain and physical ability before the study began and again after seven, 30, 60 and 90 days of treatment. Synovial fluid was collected from the participants’ knees at the beginning of the study and again after 90 days’ treatment.

What Were the Study Results?

Both dosage levels of 5-Loxin improved pain and physical ability scores between baseline and 90 days. These improvements were statistically significant when compared with the changes seen in the placebo group. The group receiving the higher dosage showed a greater improvement than did the lower-dose group.

When analyzing the synovial fluid obtained before and after treatment, it was found that both treatment groups had greatly reduced levels of the cartilage-degrading enzyme matrix metalloprotease-3 (MMP-3), and this effect was greater for the higher-dose group. The MMP-3 level in the placebo group, however, remained virtually unchanged from day 0 to day 90.

Laboratory tests were performed throughout the trial to evaluate safety. None of the parameters tested yielded significant changes in the treatment groups compared with the placebo group. Five of the 75 participants withdrew from the study due to viral infection.

What Does This mean for People With OA?

The authors summarize their results, “5-Loxin significantly improved joint function and exhibited better therapeutic efficacy at 250 mg/day than at 100 mg/day; it reduces pain rapidly, as early as after 1 week of treatment; it reduces levels of the cartilage-degrading enzyme MMP-3 in synovial fluid; and most importantly, 5-Loxin is safe for human consumption, even long term.” Dr. Raychaudhuri goes on to conclude, “Our clinical trial has demonstrated that 5-Loxin is effective and safe. Thus, this will be an additional option to the currently available pain management for osteoarthritis. It is likely 5-Loxin will also help the patients with rheumatoid arthritis. Currently we are extending both laboratory and clinical studies to investigate how effective it will be in RA.”

Sengupta K, Alluri KV, Sathis AR, et al. A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin ® for treatment of osteoarthritis of the knee. Arthritis Research & Therapy 2008; July 30.

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