Study Title:

Boswellia Extract 5-Loxin Effective for Knee Osteoarthritis

Study Abstract

Introduction
5-Loxin® is a novel Boswellia serrata extract enriched with 30% 3-O-acetyl-11-keto-beta-boswellic acid (AKBA), which exhibits potential anti-inflammatory properties by inhibiting the 5-lipoxygenase enzyme. A 90-day, double-blind, randomized, placebo-controlled study was conducted to evaluate the efficacy and safety of 5-Loxin® in the treatment of osteoarthritis (OA) of the knee.

Methods
Seventy-five OA patients were included in the study. The patients received either 100 mg (n = 25) or 250 mg (n = 25) of 5-Loxin® daily or a placebo (n = 25) for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 7, 30, 60 and 90. Additionally, the cartilage degrading enzyme matrix metalloproteinase-3 was also evaluated in synovial fluid from OA patients. Measurement of a battery of biochemical parameters in serum and haematological parameters, and urine analysis were performed to evaluate the safety of 5-Loxin® in OA patients.

Results
Seventy patients completed the study. At the end of the study, both doses of 5-Loxin® conferred clinically and statistically significant improvements in pain scores and physical function scores in OA patients. Interestingly, significant improvements in pain score and functional ability were recorded in the treatment group supplemented with 250 mg 5-Loxin® as early as 7 days after the start of treatment. Corroborating the improvements in pain scores in treatment groups, we also noted significant reduction in synovial fluid matrix metalloproteinase-3. In comparison with placebo, the safety parameters were almost unchanged in the treatment groups.

Conclusion
5-Loxin® reduces pain and improves physical functioning significantly in OA patients; and it is safe for human consumption. 5-Loxin® may exert its beneficial effects by controlling inflammatory responses through reducing proinflammatory modulators, and it may improve joint health by reducing the enzymatic degradation of cartilage in OA patients.

From press release:

PL Thomas (PLT), in alliance with Laila Nutraceuticals, India, jointly announced the publication of a new study using their exclusive dietary supplement ingredient, 5-LOXIN®. In the study, 5-LOXIN supplementation conferred clinically and statistically significant improvements in pain scores and physical function scores in OA patients at doses of 100mg and 250mg daily. Interestingly, significant improvements in pain score and functional ability were recorded in as early as 7 days after the start of treatment. Corroborating the improvements in pain scores in treatment groups, a significant reduction in synovial fluid MMP activity, enzymes which damage connective tissue, was noted. 5-LOXIN was found to be well-tolerated, with no safety concerns. Arthritis Research & Therapy 2008, 10:R85doi:10.1186/ar2461.

The study was led by Siba Raychaudhuri, a faculty member of the University of California, Davis, in the United States. According to an interview with the journal, Dr. Raychaudhuri said, "The high incidence of adverse affects associated with currently available medications has created great interest in the search for an effective and safe alternative treatment."

The ingredient used by the authors was 5-LOXIN, (a unique, patent pending extract of Boswellia seratta) providing 30% AKBA (3-O-acetyl-11-keto-beta-boswellic acid).

Raychaudhuri continued, "AKBA has anti-inflammatory properties, and we have shown that a Boswellia serrata extract with concentrated AKBA can be an effective treatment for osteoarthritis of the knee."

Seventy-five OA patients were included in the study. Divided into three groups of 25, the patients were given daily either 100 mg 5-LOXIN, 250 mg 5-LOXIN or a placebo for 90 days. Each patient was evaluated for pain and physical functions by using the standard tools (VAS - visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 7, 30, 60 and 90. Additionally, the cartilage degrading enzyme matrix metalloproteinase-3 was also evaluated in synovial fluid of the knee from OA patients.

According to the authors, "In this study, the compound was shown to have no major adverse effects in our osteoarthritis patients. It is safe for human consumption and even for long-term use."

5-LOXIN is available in North America in Osteo Bi-Flex products with the Joint Shield blend sold in food, drug and mass market and club stores.

About Laila Nutraceuticals (LN)

LN is a division of Laila Group, the largest producer of herbal extracts in India. LN works with Laila Impex Research Center to develop, manufacture and commercialize standardized herbal extracts & phytochemicals worldwide, and supports this work with patents and publications.

Study Information

Krishanu Sengupta , Krishnaraju V Alluri, Andey Rama Satish, Simanchala Mishra, Trimurtulu Golakoti, Kadainti VS Sarma, Dipak Dey and Siba P Raychaudhuri.
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
Cellular and Molecular Biology Division, Laila Impex R&D Center, Jawahar Autonagar, Vijayawada, 520 007 India.

Full Study

http://arthritis-research.com/content/10/4/R85