Boswellia Extract May Be Beneficial for Reducing Inflammation and Pain in Patients Newly Diagnosed with Knee Osteoarthritis
Osteoarthritis (OA) is a common age-related disorder associated with chronic inflammation, joint pain, decreased mobility, and negative impact on quality of life. OA of the knee is the most common form of arthritis. Acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) are the primary medications used for symptoms related to OA of the knee. These pharmacological interventions often lead to gastrointestinal, renal, and cardiovascular risk. Gum resin extracted from boswellia (Boswellia serrata, Burseraceae) has been used in Ayurvedic medicine to treat chronic inflammatory diseases, including OA. Studies have shown boswellia extract to be beneficial for treating age-related inflammatory disorders. In this randomized, double-blind, placebo-controlled pilot study, Boswellin (Sabinsa Corporation; East Windsor, New Jersey) was evaluated for its efficacy and safety in treating OA of the knee and to determine the interactions of b-boswellic acid with progression of OA of the knee.
Male and female patients between the ages of 35 and 75 years with newly diagnosed knee OA were recruited for the study at the Kempegowda Institute of Medical Sciences, Bangalore, India. Patients were included with a minimum pain visual analog scale (VAS) score >4 when walking during the 24 hours preceding recruitment, ambulant and requiring regular anti-inflammatory drug therapy, not receiving drug therapy, or seeking a change in drug therapy, willingness to complete the trial, and ability to walk and give both verbal and written information. Patients were excluded with known hypersensitivity to herbal extracts or dietary supplements, pregnant or lactating, or women of child-bearing potential and not using contraceptives, or women who tested positive in a urine pregnancy test. Other exclusion criteria included corticosteroid therapy within the previous three months, high doses of NSAID therapy, or other herbal or drug therapies, incapacitated or wheelchair-bound, nondegenerative and degenerative joint disease, and other medical conditions.
Between March 18, 2014 and June 6, 2014, 48 patients newly diagnosed or untreated with mild to moderate severity of knee OA were recruited. Patients were randomly assigned to receive either boswellia extract (BSE) (n=24) or the placebo (n=24). No description of the placebo ingredients was given. Patients were instructed to consume two tablets of 169.33 mg of BSE or the placebo each day for 120 days. No concomitant medications were permitted. The BSE tablets contained a mean value of 87.3 mg of b-boswellic acids, including ³ 30% of 3-acetyl-11-keto-b-boswellic acid (AKBBA), 1.5% of 11-keto-b-boswellic acid (KBBA), ³ 3.5% 3-acetyl-b-boswellic acid (ABBA), and ³ 7.5% of b-boswellic acid (BBA) with no less than 50% per weight of total boswellic acids. Both the BSE and placebo tablets were coated and packaged identically to facilitate blinding. Investigators and investigational site personnel were blinded to the medication codes. Tablets were dispensed during each study visit for twice-daily dosing for a one-month period.
Regular home visits were conducted to ensure study compliance. Patients completed a diary to record daily study and non-study medications and adverse events. Unused tablets were returned and counted. Forty-two patients completed the study (BSE, n=22; placebo, n=20). Six patients discontinued the study due to personal reasons (BSE, n=2; placebo, n=4), resulting in 42 patients completing the study. The Western Ontario McMaster Index (WOMAC) was used to assess pain, stiffness, and physical function at Days 0, 30, 60, 90, and 120. Patients completed a six-minute walking test, VAS pain score, and European Quality of Life (QOL) Five Dimension score at each visit. Serum hs-C-reactive protein (hs-CRP) samples were collected during patient visits. Additionally, physical exams were performed measuring active and passive range of motion, muscle strength, ligament stability, and joint tenderness. Radiological x-ray images were taken at baseline and at the conclusion of the study.
Height, weight, and body mass index were recorded at baseline and at 120 days. No significant differences were observed between the two groups. A significant difference in efficacy assessments, including WOMAC, Physicians Global Assessment, 6-min walk, VAS scores, and QOL-5 Dimension scores, was observed between baseline and Day 120 in the BSE group (P=0.0001 for each assessment), and between the BSE and placebo groups (P=0.0001 for each assessment); however, no statistical difference was observed within the placebo group.
The BSE group showed a significant decrease in WOMAC scores between baseline and Day 120 (69.4 ±8.06 and 42.3 ±4.84, respectively; P=0.0001). A significant increase in the Physicians Global Assessment for pain was observed in the BSE group from baseline to Day 120 (5.6 ±0.91 and 8.5 ±0.64, respectively; P=0.0001). Patients in the BSE group increased scores significantly during the 6-min walking test from baseline to Day 120 (218.0 ±26.51 and 297.3 ±27.89, respectively; P=0.0001). The VAS pain score significantly decreased from baseline to the end of the study period in the BSE group (6.4 ±1.24 and 3.7 ±1.35, respectively; P=0.0001). Lastly, the QOL Five Dimension scores showed a significant decrease from baseline to Day 120 in the BSE group (10.9 ±1.71 and 6.3 ±0.88, respectively; P=0.0001).
Radiological x-ray imaging showed an increase in the gap between the knee joints and a decrease in osteophytes (spurs) in patients in the BSE group at the conclusion of the study. This difference was not observed in the placebo group. A significant decrease in the hs-CRP was observed in the BSE group compared to the placebo (P<0.01). No statistical differences were observed for the biochemical and hematological parameters. No adverse events were recorded. No safety concerns were reported.
Oral intake of BSE containing AKBBA and BBA significantly improved physical function, and reduced pain and stiffness in patients newly diagnosed with knee OA. Results of this study suggest that BSE may inhibit hs-CRP induced by local inflammation and increase joint space within the knee. The authors conclude that BSE (Boswellin) may be a “viable candidate for the treatment of OA of the knee.”
Majeed M, Majeed S, Narayanan NK, Nagabhushanam K. A pilot, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of a novel Boswellia serrata extract in the management of osteoarthritis of the knee. Phytother Res. May 2019;33(5):1457-1468. doi: 10.1002/ptr.6338.
All of the authors are affiliated with Sami Labs Limited or Sabinsa Corporation. Sabinsa Corporation and Sami Labs hold patents/trademarks covering Boswellin.