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

• Published in: Phytotherapy research Vol. 33; no. 5; pp. 1457 - 1468
• Main Authors: Majeed, Muhammed, Majeed, Shaheen, Narayanan, Narayanan K., Nagabhushanam, Kalyanam
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01-05-2019; John Wiley and Sons Inc
• Subjects: Acids; Aged; anti‐inflammatory; Arthritis; Biocompatibility; Biological activity; Boswellia - chemistry; Boswellia serrata; Boswellia serrata extract; cathepsin G; Clinical trials; Dietary supplements; Double-Blind Method; Double-blind studies; Effectiveness; Female; high‐sensitive C‐reactive protein; Humans; Inflammation; Knee; knee osteoarthritis; Male; microsomal prostaglandin E synthase‐1; Middle Aged; Osteoarthritis; Osteoarthritis, Knee - drug therapy; Osteophytes; Pain; Pain - drug therapy; Pain Measurement; Patients; Pilot Projects; Plant Extracts - adverse effects; Plant Extracts - therapeutic use; Randomization; Safety; Serum levels; Stiffness; Triterpenes - administration & dosage; anti-inflammatory; cathepsin G; high-sensitive C-reactive protein; Boswellia serrata extract; knee osteoarthritis; microsomal prostaglandin E synthase-1
• ISSN: 0951-418X; 1099-1573
• DOI: 10.1002/ptr.6338

A double‐blind, placebo‐controlled human trial was conducted to evaluate the safety and efficacy of a standardized oral supplementation of Boswellin®, a novel extract of Boswellia serrata extract (BSE) containing 3‐acetyl‐11‐keto‐β‐boswellic acid (AKBBA) with β‐boswellic acid (BBA). A total of 48 patients with osteoarthritis (OA) of the knee were randomized and allocated to the BSE and placebo groups for intervention. Patients were administered BSE or placebo for a period of 120 days. The trial results revealed that BSE treatment significantly improved the physical function of the patients by reducing pain and stiffness compared with placebo. Radiographic assessments showed improved knee joint gap and reduced osteophytes (spur) confirming the efficacy of BSE treatment. BSE also significantly reduced the serum levels of high‐sensitive C‐reactive protein, a potential inflammatory marker associated with OA of the knee. No serious adverse events were reported. This is the first study with BSE conducted for a period of 120 days, longer than any other previous clinical trial on patients with OA of the knee. The findings provide evidence that biologically active constituents of BSE, namely, AKBBA and BBA, act synergistically to exert anti‐inflammatory/anti‐arthritic activity showing improvement in physical and functional ability and reducing the pain and stiffness.